medicines policy (acute, mental health, learning disabilities and community … › sitesplus ›...

HYWEL DDA UNIVERSITY HEALTH BOARD

Database No: 268 of 130 Version 2.0 Medicines Policy April 2015

Medicines Policy (Acute, Mental Health, Learning Disabilities and Community

Services)

Policy Number: 268 Supersedes: 3606/2493 Standards For

Healthcare Services No/s

Version No:

Date Of Review:

Reviewer Name:

Completed Action:

Approved by: Date

Approved:

New Review Date:

2.0 Sept 2014-April

2015 Mandy James Sue Beach

Complete review of

version 0.8 April 2018

Brief Summary of Document:

This document is for use by HB staff and provides direction for the prescribing, administration, ordering, transportation, storage, safe handling and disposal of medicinal products (including Controlled Drugs within Acute and Community settings of Hywel Dda University Health Board (HDUHB)

To be read in conjunction with:

341 Prescription and administration of emergency oxygen in adults Guidelines 008 Consent to Examination or Treatment Policy 374 Mental Capacity Act 2005 Policy 176 Non Medical Prescribing Policy 163 Deprivation of Liberty Safeguards: Guidance and procedure for staff 206 Prescribing at the Primary/Secondary Interface across HDUHB 331Enteral Feeding Policy AWMSG Guidance for adults who cannot swallow. AWMSG Polypharmacy Guidance

Classification: Clinical Category: Policy Freedom Of Information Status

Open

Authorised by: Dr Phil Kloer Job Title

Interim Medical Director

Signature:

Responsible Officer/Author:

Sue Beach Chris Hayes

Job Title:

Lead Clinical Development Pharmacist



Assistant Director of Nursing

Contact Details:

Dept

Medicines Management Nursing

Base

Prince Philip Hospital Withybush General Hospital

Tel No 01554 783462 01437 834475

E-mail: [email protected] [email protected]

Scope ORGANISATION

WIDE DIRECTORATE

DEPARTMENT ONLY COUNTY ONLY

Staff Group

Administrative/ Estates

Allied Health Professionals Ancillary Maintenance

Medical & Dental Nursing Scientific & Professional Other

CONSULTATION

Please indicate the name of the individual(s)/group(s) or committee(s) involved in the consultation process and state date agreement obtained.

Individual(s)

Head of Acute Nursing Services and Community Service Nurse Managers Directorate Nurses for Scheduled and Unscheduled Care Head of Nursing Mental Health

Date(s) Sept 2014 to march 2015

Group(s)

Prescribing Workstream and Senior Pharmacists Multidisciplinary working group

Date(s) Jan – March 2015

Committee(s) MMG Date(s) March 2015

RATIFYING AUTHORITY (in accordance with the Schedule of Delegation)

KEY

COMMENTS/ POINTS TO NOTE

NAME OF COMMITTEE

A = Approval Required Date Approval

Obtained FR = Final Ratification

Clinical Policy Review Group FR

Date Equality Impact Assessment Undertaken

December 2011 Reviewed December 2014

Group completing

Equality impact assessment

Amy Jayham Review: Sue Beach, Jackie Hooper

Please enter any keywords to be used in the policy search system to

enable staff to locate this policy Safe Administration, Dispensing, Storage, Medicines

Document Implementation Plan



How Will This Policy Be Implemented?

Through the acute, community and mental health services structure of the Heath Board.

Who Should Use The Document?

Prescribers (Medical and Non Medical), Nursing, Professions allied to medicine, Pharmacy and Medicines Management, portering and inter-hospital transport and estates.

What (if any) Training/Financial Implications are Associated with this document?

Update training on changes to the policy will be required. Individual training needs at ward/department level depending on experience of each member of staff will need assessment and action.

What are the Action Plan/Timescales for implementing this policy?

Action By Whom By When

Circulation through acute, community and mental health service structures

Policy Group

Develop summary of changes and brief presentation for managers

MJ & SEB 31th May 2015

Intranet MJ & SEB 31st May 2015

Newsletter MJ & SEB 31st May 2015



CONTENTS 1. INTRODUCTION ............................................................................................................... 7

2. POLICY STATEMENT ....................................................................................................... 7

3. SCOPE .............................................................................................................................. 7

4. AIM .................................................................................................................................... 7

5. OBJECTIVES .................................................................................................................... 7

6. PRESCRIBING, ADMINISTRATION, ORDERING, TRANSPORT, STORAGE,

CONTROL AND DISPOSAL OF MEDICINES .................................................................. 8

6.1 Prescribing .................................................................................................................. 8

6.1.1 Writing a Prescription .............................................................................................. 8

6.1.2 Prescription Exceptions ......................................................................................... 10

6.1.3 Hospital Inpatients and Day Patients..................................................................... 10

6.1.4 Community Services ............................................................................................. 12

6.1.5 Patients being discharged from hospital or transferred to other establishments ... 13

6.1.6 Prescribing Controlled Drugs ................................................................................ 14

6.2 Administration of Medicinal Products ..................................................................... 18

6.2.1 Professional Accountability ................................................................................... 18

6.2.2 Two registered Healthcare Professionals .............................................................. 20

6.2.3 Administration of Controlled Drugs (CDs) ............................................................. 21

6.2.4 Intravenous (IV) Administration ............................................................................. 23

6.2.5 Drug Omissions ..................................................................................................... 24

6.2.6 Adverse Drug Reactions (ADR) ............................................................................ 24

6.2.7 Defective Product Reporting and Alerts ................................................................ 24

6.2.8 Medicine Related 'Patient Safety Incidents' ........................................................... 24

6.2.9 Reflective Practice / Clinical Supervision .............................................................. 26

6.2.10 Self-Administration of Medicinal Products ............................................................. 26

6.2.11 Medication for Discharge ....................................................................................... 27

6.2.12 Complementary Therapies .................................................................................... 28

6.2.13 Consent and Covert Administration of Medicines .................................................. 28

6.2.14 Administration of Medicines as Part of Clinical Trials ............................................ 31

6.2.15 Administration of unlicensed medicines or licensed medicines outside their product licences ................................................................................................................. 31

6.2.16 Crushing of Tablets or Opening of Capsules ......................................................... 32

6.2.17 Enteral Syringes .................................................................................................... 32

6.3 Ordering and Supply of Medicinal Products........................................................... 33

6.3.1 Responsibility of Pharmacy Department ............................................................... 33



6.3.2 Ordering and Supply Procedures .......................................................................... 33

6.3.3 Emergency Supplies ............................................................................................. 36

6.3.4 Omitted Doses ...................................................................................................... 37

6.3.5 Medicinal Products for use in Community Clinics or Family Planning Clinics ........ 37

6.3.6 Medicinal Products for use by Other Hospital Department .................................... 37

6.4 Transport of Medicinal Products ............................................................................. 37

6.4.1 Internal Transport within a Hospital Site. ............................................................... 37

6.4.2 Transport between NHS Organisations from Pharmacy Departments (Including Community & GP practices) .................................................................................. 39

6.4.3 Delivery of Medicines to Patient’s Home (External Contractors - Taxis) ............... 39

6.4.4 Additional Actions for Oncology Medicines ........................................................... 40

6.4.5 Personnel .............................................................................................................. 40

6.4.6 Community Services ............................................................................................. 40

6.5 Storage of Medicinal Products ................................................................................. 41

6.5.1 General ................................................................................................................. 41

6.5.2 Standards for storage facilities .............................................................................. 41

6.5.3 Medicinal Products for Internal Use....................................................................... 42

6.5.4 Medicinal Products for External Use ..................................................................... 42

6.5.5 Disinfectant Cupboard ........................................................................................... 42

6.5.6 Reagent Cupboard ................................................................................................ 42

6.5.7 Medicines Refrigerator .......................................................................................... 42

6.5.8 Portable Medicine Trolley/ Medicines Cupboards. ................................................ 42

6.5.9 Individual Patient Medication Lockers ................................................................... 43

6.5.10 Storage and recording of self-administration of rescue medications ..................... 43

6.5.11 Intravenous Fluids ................................................................................................. 43

6.5.12 High Risk Medicines .............................................................................................. 43

6.5.13 Emergency Drug Boxes and Trays........................................................................ 44

6.5.14 Flammable Cupboard ............................................................................................ 44

6.5.15 Inhalation Anaesthetic Agents ............................................................................... 44

6.5.16 Medical Gas Cylinders .......................................................................................... 44

6.6 Control of Medicinal Products ................................................................................. 44

6.6.1 Keys ...................................................................................................................... 44

6.6.2 Checking Stock-Balance of Controlled Drugs (Wards and Departments) ............. 45

6.6.3 Apparent Excessive Use of a Specific Medicinal Product in Hospital .................... 45

6.6.4 Apparent Loss of Medicinal Products .................................................................... 46

6.6.5 Inspection of Stock, Storage Facilities and Maintenance of Records in Hospitals 46

6.6.6 Change to Medication Container Labels ............................................................... 46



6.7 Medicinal Products Brought into Hospital by Patients .......................................... 46

6.7.1 Patient Admission Process .................................................................................... 46

6.7.2 Assessment of safety of patients own medication ................................................. 46

6.7.3 Guidelines for Nursing Staff on the Use of Patient’s Own Medication in Hospital . 47

6.7.4 Patient’s Own Controlled Drugs ............................................................................ 48

6.7.5 Unidentified suspected illicit substances ............................................................... 49

6.8 Disposal of Medicinal Products ............................................................................... 49

6.8.1 Disposal of Patients’ Own Medication ................................................................... 49

6.8.2 Disposal of Patients’ Own Controlled Drugs .......................................................... 50

6.9 Disposal and Destruction of Medicinal Products ................................................... 51

6.9.1 Unwanted and out-of-date Stock Items in Hospital................................................ 51

6.9.2 Unwanted and out-of-date non-stock items in hospital .......................................... 51

6.9.3 Patient Controlled Analgesia/Epidurals ................................................................. 52

6.9.4 Patient’s Own Medication no longer required. ....................................................... 52

6.9.5 Unwanted Controlled Drugs in Community ........................................................... 52

6.9.6 Method of Destruction of Controlled Drugs ........................................................... 53

7. RESPONSIBILITIES........................................................................................................ 54

7.1 Chief Executive and Board (as commissioner/provider) ....................................... 54

7.2 Director of Nursing & Midwifery .............................................................................. 54

7.3 Head of Medicines Management .............................................................................. 54

7.4 Medical Director ........................................................................................................ 54

7.5 Senior Management Leads ....................................................................................... 54

7.6 Individual staff (registered Healthcare professionals) ........................................... 54

7.7 HDUHB Medicines Management Group and Clinical Policy Review Group ......... 54

8. TRAINING ....................................................................................................................... 54

9. MONITORING/ASSURANCE .......................................................................................... 55

10. FURTHER INFORMATION ............................................................................................. 55

10.1 References ................................................................................................................. 55

11. REVIEW ........................................................................................................................... 56

12. GLOSSARY OF TERMS ................................................................................................. 56

13. APPENDICES ................................................................................................................. 59



1. INTRODUCTION This policy provides direction for the prescribing, administration, ordering, transportation, storage, and safe handling of medicinal products including Controlled Drugs within the Acute & Community Sector of Hywel Dda University Health Board (HDUHB). 2. POLICY STATEMENT It is the policy of Hywel Dda University Health Board (HDUHB) to ensure that the administration, ordering, transportation, storage, and safe handling of medicinal products including Controlled Drugs conforms with current legislation: Medicines Act 1968 and the Human Medicines Regulation 2012, Misuse of Drugs Act 1971 (including regulations made under these Acts) , Controlled Drugs (Supervisions of Management and Use (Wales) ) regulations and with the Midwives Rules and Standards published by the Nursing & Midwifery Council (May 2008). The law has been supplemented by guidance issued by the (then) Department of Health and Social Security and the (then) Welsh Office, as indicated below:

Security of Drugs Liable to Misuse HM(70)1; WHC(77)38; WHN(78)56. Measures for Controlling Drugs on the Wards HM(70)36.

All staff involved in the prescribing, administration, ordering, transportation, storage, and safe handling and disposal of medicinal products including Controlled Drugs must be familiar with the legislation and guidance and base their practice upon the legal requirements and guidance which is contained within this document. This policy provides a standardised approach which must be used across the HB without variation. 3. SCOPE This policy applies to:

• All Health Board employees who prescribe, administer, order, transport, store and handle medicinal products including Controlled Drugs e.g. registered nurses and midwives, medical staff, pharmacists, student nurses/midwives, operating department assistants and allied health professionals and healthcare support workers.

• All patients under the care of the HDUHB.

This policy applies to all services within the acute and community setting.

Adherence to this policy is the responsibility of all staff employed by HDUHB. 4. AIM The aim of this policy is to set out a framework to promote safe and secure systems for controlling and handling and administration of medicinal products including Controlled Drugs in hospitals and clinics operated by HDUHB as part of an overall medicines’ management process. 5. OBJECTIVES The aim of the policy is achieved by all HB employees:

• prescribing

• administering



• ordering

• transporting

• storing

• controlling and disposing of medicines (including Controlled Drugs) in compliance with legislation and HB requirements and procedures.

6. PRESCRIBING, ADMINISTRATION, ORDERING, TRANSPORT, STORAGE, CONTROL AND DISPOSAL OF MEDICINES

6.1 Prescribing 6.1.1 Writing a Prescription All prescriptions must be signed in ink by qualified and registered medical/dental staff, or by authorised independent or supplementary prescriber. Prescribers must add their appropriate professional registration number. For the purpose of this policy the prescription chart and All Wales In-patient Medication Administration Record are inter changeable and relate to the same document. Medical/dental students, doctors undertaking clinical attachments, nurses and other non-medical staff are not allowed to prescribe or to copy prescriptions for signature by medical/dental staff other than in defined clinical situation/ environment which has been previously approved through the HDUHB Medicines Management Group (MMG) Medical Students are permitted to rewrite prescriptions and write prescriptions as part of their final year Student Assistantships. All Prescriptions charts and prescriptions must be checked and signed by a supervising qualified medical prescriber (F1 and above). Clinical responsibility rests with the prescriber who signed it. [MMG Jan 2014] Pharmacists and Medicines Management accredited Pharmacy Technicians are permitted to transcribe/write out TTHs using hospital discharge prescriptions or WP10HP and WP10HIP for signature by medical or independent prescribers. Prescriptions transcribed by Pharmacy Technicians will be clinically checked by a Pharmacist as per pharmacy SOPs prior to signature. [MMG Mar 2015] HDUHB endorses the All Wales Medicines Strategy Group (AWMSG) Prescription Writing Standards) http://www.awmsg.org/docs/awmsg/medman/All%20Wales%20Prescription%20Writing%20Standards.pdf For outpatient prescriptions for Sexual Health and Genitourinary Medicine it is acceptable for the unique patient number, first name and Date of Birth to be used in place of the full name, address and hospital number.[MMG Jan 2015] All prescriptions should comply with the HDUHB Medicines Formulary. http://hywelddahb.inform.wales.nhs.uk/

The prescribing of Controlled Drugs within Schedules 1, 2, 3, 4 and 5 of the Misuse of Drugs Act 1971 must be in accordance with current legislation as set out in the British National Formulary (BNF) in line with the Misuse of Drugs Regulations 2001 (and subsequent amendments)



http://www.legislation.gov.uk/uksi/2001/3998/contents/made

The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008, states that organisations are required to appoint accountable officers. For further information on the roles and responsibilities of the Accountable office and Authorised Witness. (See Appendix A)

The prescribing/supply of wound cleansing and management products should be guided by the HDUHB Tissue Viability and Wound Management Guidelines. http://howis.wales.nhs.uk/sitesplus/documents/862/037TissueViabilityandWoundManagementGuidelines.pdf The prescribing of stoma products should be guided by the HDUHB Stoma Formulary Guidelines. http://howis.wales.nhs.uk/sitesplus/documents/862/HDHBStomaguidanceFormularyFinal%20v2%20Sept%202014.pdf If a non-formulary item is required the prescriber must contact the pharmacy team for advice. Oxygen may be prescribed in line with the British Thoracic Society guidelines. Please refer to this Guideline for emergency oxygen use in adult patients (2008) for full details: https://www.brit-thoracic.org.uk/document-library/clinical-information/oxygen/emergency-oxygen-use-in-adult-patients-guideline/emergency-oxygen-use-in-adult-patients-guideline/ Patients should not smoke while taking oxygen (HDUHB Smoke Free Policy http://www.wales.nhs.uk/sitesplus/862/opendoc/194807) Community nursing staff may be required to transport oxygen or Entonox ® in their vehicles. It is the responsibility of each healthcare professional to ensure they have appropriate insurance to cover this activity and they must also display a badge to say they are carrying Oxygen (O2) in the community. Verbal prescribing is not acceptable other than in emergency situations when the doctor is not present and the prescription will be written when the clinical situation allows at the earliest possible opportunity but no later than 24 hours. Non-medical independent prescribers must also follow their professional guidance. Pharmacists are able to make some straight forward amendments to prescriptions as detailed in the HDUHB Pharmacist Enabling and Therapeutic Switch Guideline (Acute Sector) which is available at: http://howis.wales.nhs.uk/sitesplus/documents/862/Pharmacist%20Enabling%20and%20Therapeutic%20Switch%20Guideline%20v%201.2%20Jan%202014.pdf (Appendix B) Any alterations made to a prescription must be clearly annotated on the in-patient administration record and medical notes line with the Guideline. For out-patient prescriptions this should be annotated on the out-patient prescription [MMG Jan 2015].

Prescribers must not prescribe / administer any medicine for themselves, close family, friends or other staff (except when they are registered patients).. Further information can be found at: http://howis.wales.nhs.uk/sitesplus/documents/862/Self%20Prescribing%20Letter%20v%203%20Final.pdf



If staff require treatment they should attend their registered GP, GP Out-of-Hours and Accident & Emergency (in exceptional circumstances).

All documents used for prescribing, administering and monitoring medicines (for example, insulin charts, DKA charts, supplementary prescription for epidural levobupivacaine, TOP prescription labels) must be approved by MMG before use. [MMG 2015] 6.1.2 Prescription Exceptions Authorised Healthcare Professionals can supply or administer medicinal products in the absence of an individual prescription, only under the terms of Patient Group Direction (PGD), Patient Specific Direction (PSD) or HDUHB agreed protocol. [MMG October 2014] The medication administration record is not a prescription but a direction to administer medication. It must be signed by a registered prescriber and authorises the delegation to administer medication on the prescriber’s behalf. However, in doing so the registrant is accountable for their actions and for raising any concerns about the direction with the prescriber, for example, in respect to clarity, dose and frequency. Midwives must refer to their own additional guidance which can be found on the NMC website (Midwives exemptions frequently asked questions) which sets out exemptions and specific regulations relating to their own profession. The full list of exemptions is available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/Midwives/ Other Healthcare Professionals (e.g. podiatrists, paramedics) must refer to their own professional bodies for a list of current medicines that fall into this prescription exemption and at: http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/index.htm Regulation 238 of the Human Medicines Regulations 2012 allows for certain prescription only medicines to be administered by anyone for the purpose of saving life in an emergency. These include adrenaline 1 in1000 (1mg/mL) by intramuscular injection for the emergency treatment of anaphylaxis, naloxone and glucagon The full list can be found at: http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/Administrationofinjectablemedicinesforthepurposeofsavinglifeinanemergency/index.htm 6.1.3 Hospital Inpatients and Day Patients All medicinal products administered to patients within all hospitals and community in the Health Board must be in accordance with clear printed instructions written on one of the following:

• All Wales In-patient Medication Administration Record

• approved HDUHB [MMG] prescribing, administration and monitoring charts (including labels)

• within the patient’s medical records (e.g. A&E, MIU, Anaesthetic Record)

• Recording compliance with a PGD or PSD or HDUHB-approved protocol.



The Medication Administration Record (or medical record) must bear the following patient details:

• full name

• address

• NHS number (or unit number)

• ward

• date of birth

• details of any known drug idiosyncrasies/allergies, including the drug names, strength and type of response (e.g. anaphylaxis). These must be given in the RED box on the front left hand side of the inpatient chart. If no allergy is known, indicate NO KNOWN ALLERGY.

• weight where appropriate (in kilograms). The prescription, written LEGIBLY AND IN BLACK INDELIBLE INK in the appropriate section of the chart/record, must state:

• date (day/month/year) of commencement of the therapy. If a new prescription chart is written, the date of commencement must be transferred and remain the date when the therapy was first commenced

• the approved name of the drug (and its trade name, where appropriate) in capital letters and its pharmaceutical form, e.g. tablets, mixture etc

• the dose, expressed in metric units

• in combination products, the administration dose expressed as the number of tablets (e.g. co-amilofruse 5/40, dose 1 tab in the morning). The route of administration must be clearly indicated

• no Latin abbreviations on inpatient charts

• the times of administration (24 hour clock) and/or the dosage intervals

• the signature, bleep number, professional registration number of the prescriber. Midwives must sign the prescription chart for any medicine that they prescribe under the Midwives Exemptions (Section 6.1.2 above). Each prescriber must sign a departmental/ward signatory list to enable ready identification of signature. This list is held in pharmacy. A copy of all doctors’ signatures is also held in the Medical Staffing department. Human Resources (Medical staffing) are responsible for collation and distribution of medical staff signatures and GMC registration number and maintaining records up to date. Copies of approved independent non-medical prescribers signatures and professional registration number is collated and regularly forwarded to the pharmacy department. When a patient is admitted from another Hospital outside HDUHB, the HDUHB prescriber should medically review the patient on admission and write a new All Wales Inpatient Medication Administration Record based on the discharge documentation provided. The prescription must be rewritten when the route, frequency, dose or any other aspect of a drug therapy is changed. This must be indicated by completing the dose change section of the original entry or by rewriting the whole entry. Treatment to be discontinued / altered must be crossed out by a “Z” through the drug name and dated and initialled by the responsible prescriber.



Prescriptions for “As required and variable dose medications” must indicate the maximum frequency and maximum dose within a specified period of time. ‘As required medication’ must be cross-referenced to the regular prescription and the indication completed. The All Wales In-patient Medication Administration Record of in-patients should be medically reviewed daily (in acute wards), including at each ward round. Review of the All Wales In-patient Medication Administration Record by clinical pharmacists should take place each week day in acute in-patient wards and at intervals as agreed with the Senior Sisters in other in-patient areas. Pharmacy teams will undertake medicines reconciliation of a patient on admission in line with NICE/NPSA recommendations. Further information and guidance on this process can be found in Appendix C. Refer to All Wales Prescription Writing Standards: http://www.awmsg.org/docs/awmsg/medman/All%20Wales%20Prescription%20Writing%20Standards.pdf The e-learning training resource “All Wales Administration Record’ is available through the link: https://learning.wales.nhs.uk/

6.1.3.1 Prescribing in theatres and recovery All medicines should be prescribed on the patient’s All Wales Administration Record, anesthetic record or patients Acute Clinical Record (medical notes) prior to administration.(Reference: The College of Operating Department Practitioners Standard of Good Practice Guidance in relation to Controlled Drugs 2007) Before the patient is transferred to a ward from recovery a check must be made that all medicines administered to patients in theatre and recovery have been prescribed and administration recorded on the patient’s All Wales Administration Record, anesthetic record or patients Acute Clinical Record (medical notes) before being transferred to a ward.

6.1.3.2 Day Patients (medical, surgical. mental health and rehabilitation) When a patient is admitted as a day patient a formal record of the medicines that the patient is taking is made and a formal assessment of whether the patient is suitable for self-administration must be undertaken. HDUHB Guidelines for the Self-Administration of Inpatients’ Own Medicines (Appendix J) can be accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/Guidelines%20for%20self-administration%20of%20patients%20own%20medicines%20v1%20Final%20Website.pdf 6.1.4 Community Services Any medication that is administered by HB employees in the community should be prescribed using one of the following processes:

• WP10 prescription by a GP (or non medical independent prescriber) and dispensed by a community pharmacy.

• WP10HP prescription by a hospital doctor (or hospital based non medical independent prescriber WP10HIP) and dispensed by a community pharmacy.



• prescribed using a hospital discharge prescription (dispensed from the hospital pharmacy or approved stock held by the Acute Response Team) and administered on an All Wales In-Patient Medication Administration Chart (both need to be signed by the prescriber).

6.1.5 Patients being discharged from hospital or transferred to other establishments All prescriptions for out-patients and patients discharged from hospital or transferred to other establishments must be written on an appropriate discharge form for the unit, a: WP10HP, or the discharge prescription form. It must state following patient details:

• full name

• address

• NHS number ( or unit number)

• ward

• date of birth

• details of any known drug idiosyncrasies/allergies

• weight where clinically appropriate In addition, the following medication details must be included:

• the frequency of doses and/or time of administration.

• an indication as to whether treatment is to be continued by the General Practitioner, including any information on dose titrations to be carried out.

• signature and date. In the case of community hospitals, it is acceptable to fax this through to the hospital pharmacy, or following discussion and agreement with the general practitioner, by issuing a WP10HP for the patient to obtain the prescription from a community pharmacy. After the discharge (TTH) prescription has been dispensed one copy is retained in pharmacy, one in the patients notes, one copy is sent to the GP (either via the patient or directly according to local practice) and he final copy is sent to Clinical C ]oding. In the event that a patient needs to be discharged outside of pharmacy department opening hours a nurse and the discharging doctor will take responsibility for "assembling" and "dispensing" the TTH. Both the nurse and doctor will be required to sign the dispensed section of the TTH, and the appropriate copy must be kept in a designated area for the pharmacy department to collect. Any discrepancies between the TTH and the medicines available in the cabinet must be discussed with the on-call pharmacist. The Standing Operating Procedure for Provision of Safe Patient Discharge during Out of Hours Dispensing in pharmacy out of hours can be seen in Appendix D. [MMG Jan 2015] 6.1.5.1 Transfer to establishments outside HDUHB When patients are transferred to an establishment outside HDUB, a full medical summary including the medication record and the time the last doses were given should be provided. The original prescription must not be send; a signed and dated photocopy is acceptable. 6.1.5.2 Transfer within HDUHB wards and hospitals When patients are transferred between the Health Board’s own wards/hospitals, continuation of the All Wales Inpatient Medication Administration Record is acceptable, with review by the



medical practitioner to whom responsibility for the patient’s care has been transferred. Ward details must be amended to ensure medications are distributed to the correct area. Individually dispensed medication together with the patient’s own drugs must also be transferred. The green bags should be used to ensure the safe transfer of all medicines for that patient. Green bags are available from the hospital pharmacy departments. 6.1.6 Prescribing Controlled Drugs

• There are additional requirements for the prescribing of Controlled Drugs in accordance with the Misuse of Drugs Regulations 2001 (as set out in the BNF: Controlled Drugs and drug dependence)

• Prescribers can only prescribe or administer any Controlled Drugs to registered patients.

• In-patient drug charts that are correctly completed as specified in 6.1.3 are sufficient to comply with the CD regulations for in-patients.

• Prescribers should also refer to the following Health Board Guidance: The Prescribing, Dispensing and Administration of Opioid Medicines in Adults http://howis.wales.nhs.uk/sitesplus/documents/862/161-ThePrescribingdispensingandAdminofOpioidMedicinesinAdultsGuidelines.pdf

• The prescribing and supply of Schedule 1 Controlled Drugs (drugs not used medically e.g.lysergide) requires specific Home Office authority which the Health Board does not currently hold.

6.1.6.1 Prescribing Controlled Drugs for Out-patients

• All prescriptions for Controlled Drugs must be handwritten [local HB requirement as electronic

prescription is not currently available] and require the following: o full name (first name, initials and family name) and address of patient the form

and where appropriate, the strength o either the total quantity (in both words and figures) of the preparation or the

number (in both words and figures) of dosage units as appropriate, to be supplied; in any other case the total quantity (in both words and figures) of the Controlled Drug to be supplied:

o the dose. Note: One tablet/capsule as directed is acceptable but ‘as directed’ not acceptable.

o the words for ‘dental treatment only’ if issued by a dentist o It is good practice to include the NHS number and date of birth.

• It is an offence for a prescriber to issue an incomplete Outpatient or Discharge prescription and a pharmacist is not permitted by law, to dispense prescriptions for Controlled Drugs unless all the required information is detailed in the prescription. Failure to comply with the legislation concerning the writing of prescriptions will result in inconvenience to patients and delays in supplying the necessary medicines.

• Prescriptions for Schedule 2, 3 and 4 CDs are limited to a quantity necessary for up to 30 days treatment.

• Prescriptions for Schedule 2, 3 and 4 CDs are valid for 28 days from either the date of prescribing or a “valid from” date specified by the prescriber and written on the prescription.

• Prescriptions with minor technical errors, but where the prescribers intentions are clear, may be dispensed provided the pharmacist completes the details in indelible pen and signs the addition e.g. words and figures requirement for total quantity.



• Prescriptions must contain a unique patient identification number (NHS or unit number).

• It is good practice to ask individuals collecting Schedule 2 or 3 CDs, at the point when they are handed to them, to sign the back of the prescription form as confirmation of collection. Where the person collecting the CDs does not agree to sign the back of the form, pharmacists may apply their discretion on whether or not to supply the CDs. If a pharmacist does not supply the CD to the collector, they must make alternative arrangements to ensure that the patient receives their medicine.

• For peripheral units without a pharmacy, faxed/carbon copy prescriptions may be accepted by pharmacy to enable assembly of the prescription in advance. However, the original copy must be received before the final release of the prescription. Schedule 4 and 5 CDs may be supplied from a fax or carbon copy prescription in lieu of the original copy being available within 24 hrs.

6.1.6.2 Prescribing Controlled Drugs for Discharge & Transfer of In-patients When Controlled Drugs are prescribed on discharge or transfer, the following information must be entered on the prescription form (also see BNF Guidance on Controlled Drug and drug dependence prescriptions):

• the prescription must be in ink or other-wise as to be indelible.

• the name, address and NHS Number (or unit number) of the patient must be specified.

• the full name, form, strength and dosage of the preparation must be stated. The total quantity of medicinal product to be supplied must be specified in both words and figures.

• for liquid preparations the total volume should be noted in millilitres in both words and figures.

• the prescription must be signed in full and dated; where appropriate the Doctors bleep number must be added.

Within the Community Nursing Service, Controlled Drugs that are prescribed as part of the Guidelines for Care in the Last Days of Life must be written up by an authorised medical or non-medical prescriber for administration by the District Nurse. http://howis.wales.nhs.uk/sitesplus/862/page/49623

6.1.6.3 Prescribing Controlled Drugs for treating addiction or dependance No doctor may administer or authorise the supply of cocaine, diamorphine or dipipanone to ‘registered addicts’ (dependent patients), except for the purpose of treating organic disease or injury, unless licensed to do so by the Secretary of State. If a newly admitted patient states that he/she is an addict on medication for their addiction, then the medication and dosage must be confirmed with a third party. The prescriber is responsible for obtaining this confirmation.

The third party must be any of the following:

• patient's G.P.

• patient's community pharmacist

• or a member of the Community Drug & Alcohol Team.

The ward nurse/midwife or hospital pharmacist must inform whoever supplies the patient’s medication in the community (community pharmacy or Community Drug & Alcohol Team) of the patient’s admission. The hospital team should liaise with the supplying community



pharmacy or Community Drug & Alcohol Team on discharge to communicate details of dosage and quantity supplied and when the next supply is due.

6.1.6.4 Prescribing of Controlled Drugs by Non-Medical Independent Prescribers Nurse and pharmacist Independent prescribers can prescribe, supply or administer, or direct any person to administer any Controlled Drug in schedule 2 to 5 of the Misuse of Drugs regulations. Physiotherapist and podiatrist independent prescribers can prescribe, administer and supply a limited number of Controlled Drugs. Please refer to the HDUHB Non- Medical Independent Prescribers Policy for full details: http://howis.wales.nhs.uk/sitesplus/documents/862/176PolicyOnNonMedicalPrescribingV2.pdf

6.1.6.5 Prescribing of Controlled Drugs by Supplementary Non-Medical Prescribers Supplementary nurse and pharmacist prescribers can supply, prescribe, and administer or direct any person to administer any Controlled Drug as long as it is within the Clinical Management Plan specific to that patient and agreed between the designated supervisory medical practitioner (DSMP), the supplementary prescriber and the patient. Chiropodists, podiatrists, physiotherapists, radiographers and optometrists who are supplementary prescribers are NOT able to prescribe CDs.

6.1.6.6 Administration and supply of Controlled Drugs under Patient Group Directions Individual Controlled Drugs can be supplied or administered under patient group directions (PGDs) in the following situations:

• nurses and pharmacists, when acting in their capacity under a PGD, are authorised to supply, or offer to supply diamorphine and morphine where administration of such drugs is required for the immediate, necessary treatment of sick or injured persons (excluding the treatment of addiction)

• Registered pharmacists, chiropodists and podiatrists, dental hygienists and therapists, dietitians, midwives, nurses, occupational therapists, optometrists, orthoptists, orthotist and prosthetists, paramedics, physiotherapists, radiographers, speech & language therapists can supply and administer any drug listed in Schedule 4 of the Regulations except anabolic steroids and injectable formulations for the purpose of treating a person who is addicted to a drug. They can also supply and administer any drug listed in Schedule 5 of the regulations.

• midazolam (Schedule 3) can also be used under a PGD.

• Whenever a supply or administration is made under a patient group direction (PGD) or patient specific direction (PSD) supported by a care plan, a record must be made in the patients’ notes, signed and dated by the person operating under the PGD/PSD (where an inpatient medication chart is not being used).

Regulation 238 of the Human Medicines Regulations 2012 allows for certain prescription only medicines to be administered by anyone for the purpose of saving life in an emergency. These include adrenaline 1 in1000 (1mg/mL) by intramuscular injection for the emergency treatment of anaphylaxis, naloxone and glucagon. The full list can be found at: http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/Administrationofinjectablemedicinesforthepurposeofsavinglifeinanemergency/index.htm



6.1.6.7 Administration of Controlled Drugs by Midwives

Midwives can supply and administer a range of medicines as set out in the guidance: ‘Midwives and Medicines’. The list of exemptions is available at: http://www.mhra.gov.uk/Howweregulate/Medicines/Availabilityprescribingsellingandsupplyingofmedicines/ExemptionsfromMedicinesActrestrictions/Midwives/

• midwives can possess in their own right and administer parenterally, without a prescription, diamorphine, morphine and pethidine provided it is in the course of their professional midwifery practice.

• midwives cannot prescribe these medicines or delegate administration to another healthcare professional including another midwife.

• each midwife must make their own assessment prior to each administration. The administration of the medicine should be recorded on the All Wales In-Patient Medication Administration Record and Midwife’s records.

• administration of medicines by a midwife should be regularly audited by their named supervisor of midwives.

6.1.6.8 Private Prescriptions for Controlled Drugs

• Only prescribers who are registered with Shared Services and accepted onto the HDUHB Private Prescriber Register can write a private prescription for a Controlled Drug.

• Private Prescriptions for Controlled Drugs to be dispensed by community pharmacists must be written on WP10 PCD or WP10 PCDSS for Schedule 2 and 3 Controlled Drugs.

• Copies of private prescriptions for Schedule 2 or 3 Controlled Drugs dispensed by a community pharmacy are sent to Health Solutions Wales at the end of each month for analysis.



6.2 Administration of Medicinal Products The definition “administration” of medicinal products in this context may be taken as meaning:

• the direct administration of medication to a patient

• assisting the patient with administration of medication, or

• overseeing the self administration of medication by a patient. Medicinal products shall only be administered when there is:

• a written prescription (including on the All Wales In-patient Medicines Administration Record) signed by o qualified medical/dental staff o authorised independent/supplementary prescribers

• a patient group direction

• an HDUHB agreed protocol

• a midwife (and other professionals) in compliance with their exemptions and specific regulations relating to their own profession.

• exemption for the purpose of saving life in an emergency.

Do not give when:

• there is any doubt about the legibility of the prescription, the drug dosage, route, time, frequency, compatibility of drugs or allergies. The prescriber (or a nominated deputy/pharmacist) must be contacted before administration.

If staff require treatment they should attend their registered GP, GP Out-of-Hours or Accident & Emergency (the latter only in an emergency). Staff must not use ward or departmental stock, patients’ own medicines, medicines dispensed for individual patients or medicines due for disposal for their own self-treatment. 6.2.1 Professional Accountability for the administration of Medicinal Products Prescribed medication must be administered by registered healthcare professionals who are assessed as competent to administer medicinal products and are aware of their personal accountability. Registered nurses (first and second level), midwives, healthcare professionals, operating department practitioners (ODP) can administer medicines within their role without involving a second person. However certain medicines and groups of patients require a second-check (see 6.2.2). Additional competencies are required for the administration of intravenous (IV) fluids and injections and syringe drivers. Healthcare support workers who have demonstrated competencies as set out in the All Wales Minimum Standards for Immunisation training for HCSWs may administer vaccinations only, as part of a PSD, within a GP practice. In the following circumstances, until competence is assessed and demonstrated, a second check is required:

• where a nurse/healthcare professional is newly registered

• where a nurse is undergoing a Return to Practice programme.



• where a nurse/healthcare professional is working in an unfamiliar clinical environment.

• where a nurse/healthcare professional returns after a prolonged period of absence e.g. maternity leave, career break. This will be dependent on individual circumstances and will be the decision of the Ward Sister / Senior Nurse/Head of department for that service and documented in the individual’s personal file.

6.2.1.1 Standards of Practice for the administration of Medicinal Products In the administration of medicinal products via any route, it is expected that every registered Healthcare Professional will demonstrate professional accountability for practice by taking the following actions:

1. be certain of the identity of the patient to whom the medicine is to be administered. 2. check that the patient is not allergic to the medicine before administering it. 3. know the therapeutic uses of the medicine, its normal dosage, side effects, precautions

and contra-indications 4. be aware of the patient’s care plan and medical status. 5. check that the prescription and the label on the medicine dispensed is clear and legible. 6. check the expiry date 7. consider the dosage, weight (where appropriate), method of administration, route and

timing. 8. use the opportunity to emphasise to patients and their carers, the importance and

implications of the prescribed treatment and enhance their understanding of the effects and side-effects and provide additional relevant information when requested or required (e.g. Patient Information Leaflets (PIL))

9. make a clear, accurate and immediate record of all medicines administered- administration must be observed before this record is made.

10. where the medicine or fluid is given as an intermittent or continuous infusion the administration chart should be signed immediately after the infusion has been commenced.

11. monitor, evaluate and record the effects of the medicines administered and report to the appropriate prescribing medical practitioner or pharmacist immediately if any adverse reactions to the prescribed medication are identified.

12. when two or more All Wales Inpatient Medication Administration Records (e.g. two or more standard charts or a standard chart and a warfarin chart), are in use, ensure:

• that they are secured together

• that the patient’s name and identification number is on each chart

• that the number of All Wales Inpatient Medication Administration Records in use is clearly indicated on the front of all Inpatient Medication Administration Records (e.g. 1 of 2 charts).

13. that in the event of an intentionally withheld or refused drug administration by the patient or carer or guardian (in the case of a child), an immediate, clear and accurate record must be made. This must be discussed with the responsible medical practitioner (or on-call doctor).

The administration of medicinal products must be guided by the relevant nursing procedures in the current edition of the Royal Marsden Manual of Clinical Nursing Procedures, (the Royal Marsden can be accessed via the HDUHB website on the Health Board Intranet or on www. blackwellroyalmarsdenmanual.com ) and the HDUHB’s policies/training manuals in relation to use of infusion devices, syringe drivers, dedicated pumps, PCA and epidural devices and the



NPSA Safe Medication Practice Programme on Injectables (2007/8) http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812 . For reference the standard operating procedures (SOPs) that cover the preparation and administration of injectable medicines can be seen in Appendix F 6.2.2 Doubling checking for the preparation and administration of intravenous Medicinal Products. Two registered Healthcare Professionals are required for the process of checking the preparation of any intravenous medication. The signature of the second registered Healthcare Professional is for the purpose of checking the medicine only. Each registered professional is accountable for the part that they undertake in the checking and administration of the medicine and, thus, should be a registered nurse/health professional, medical or dental officer or pharmacist. The second checker must ensure that:

• The prescription is named for an individual patient

• The drug is appropriately prescribed and not contraindicated by other prescribed medication, patient allergy status or the current clinical condition of the patient.

• The drug is mixed and prepared correctly for the route of administration

• Calculated dosages and rates of administration are accurate

• Where the second person is also checking the administration they must carry out additional checks as below.

However please note the following Two Registered Healthcare Professionals will always be required for both the checking and the administration of medicines in the following situations:

• For the IV or S/C administration of all high risk medicines. These are defined as insulin, methotraxate. heparin, low molecular weight heparin, medicines with a complex preparation method (eg IV liposomal amphotericin), immunoglobulins , anti-arrhythmic drugs and thrombolytic drugs.

• When the medicinal product is a Controlled Drug (CD)

• For the administration of a cytotoxic agent;

• Where the recipient of the medicinal product is a child/young person or neonate;

• When calculation of dosage is required (including dose adjustments for infusions already set up.

• When an IV or S/C infusion is commenced or the rate of the infusion is changed two registered Healthcare Professionals are required for both checking and the administration of the infusion. Two signatures are required on both the prescription chart and the Infusion Monitoring Charts.

• Where the second person is also checking the administration the second person carries an equal accountability for the administration of the medication. The second person must, thus, undertake all the checks outlined in Section 6.2.1.1 as if they were administering the medicine themselves.

Student Nurses Student nurses require instruction, education, observation and assessment in the undertaking of clinical procedures and practice, Where a registered nurse delegates work to someone who



is not registered with the NMC they remain fully accountable for the actions of that individual (NMC Code of Conduct 2008 http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf ). Only a final year student nurse, if they are assessed as competent, can act as the second person for the purpose of checking the preparation and administration of intravenous medicinal products. Temporary (including Bank) Nurses The HB is responsible for the competence of their Healthcare professionals. Staff employed on a temporary contract must only work within their competencies.

Newly appointed registered nurses (who work on the bank) are assessed/trained by the HB Clinical Skills Trainer and are assessed on the ward on their first shift in the Health Board. Agency Nurses Agencies are responsible for the competence of their nurses and individuals will only be allowed to work within their competencies. [N.B. March 2015. The Health Board is currently undertaking a ‘task & finish’ review of the role of agency nurses in the administration of medicines within the Health Board]. Please note: if there is any doubt about any aspect of the prescription that is to be administered whether this is the IV route or any other ALWAYS check/clarify concerns with the available information sources, the ward pharmacist, the prescriber or with another registered Healthcare Professional BEFORE administration. Additional checking procedures can be implemented in response to local circumstances and notified to MMG. For reference SOPs that cover the preparation and administration of injectable medicines can be seen in Appendix F 6.2.3 Administration of Controlled Drugs (CDs) Important Note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are SOPs in place for a range of activities relating to CD including administration. Please refer to Appendix G for a full list of areas requiring a SOP.

(i) There must be two members of staff involved in the administration of a Controlled Drug, one of whom must be a registered nurse (RN), doctor or ODP.

(ii) The second person i.e. the checker can be an RN, ODP, doctor, pharmacist or radiographer (Band 6).

(iii) Exceptions to the above include:

• Where a ward, department or clinical area is staffed by one registered Healthcare Professional it is permissible for a HCSW (who has successfully completed the competency based assessment (Appendix E) and Radiographers (Band 6) to check Controlled Drugs with the registered Healthcare Professional.

• HCSW and radiographers (Band 6) are providing a second check to confirm that, with reference to the All Wales Inpatient Medication Administration Record, the following details are correct: o drug name, dose and expiry date o patient’s details (patient’s name, address, date of birth) at the bedside



(in this situation, responsibility for the administration remains with the registered Healthcare Professional).

• where the ward has introduced the Standard Operating Procedure for single nurse administration of morphine sulphate (10mg/5ml) oral solution (“Oramorph®”) (Appendix H) This process is only acceptable when there has been prior authorisation from the Director of Nursing & Midwifery and Director of Therapies (or delegated deputy) and is supported by an approved protocol. A list of those HCSW and Radiographers (Band 6) must be held by the Head of Nursing for Acute Services and Community Services Nurse Manager and be made available to the Accountable Officer and Director of Nursing on request.

• Within Community Services the following will apply to the administration of CD’s: o The administration of a Controlled Drug will be undertaken by one registered

nurse and, wherever possible, a second check may be confirmed by a carer/relative. All drugs should be stored within a plastic lidded box in the patient’s home as advised by the community nursing staff. The Controlled Drugs remain the patient’s property.

o The Community Healthcare Professional should advise patients or relatives on safe storage of medicinal products in the home e.g. out of the reach and sight of children, away from a hot radiator or areas with steam such as kitchens or bathrooms.

• Theatres- see section 6.2.4.1

(iv) It is permissible for final year student nurses to administer oral, rectal or topical CDs (not parenteral) provided they are assessed as competent. However the responsibility for the administration remains with the registered Healthcare Professional. Two registered Healthcare Professionals must check & balance the CD register and the student must witness and sign.

(v) The person administering the drug must complete the entry in the CD record book and sign it immediately after the drug has been administered.

(vi) The second person must sign the CD book to confirm that the administration and appropriate disposal of excess / waste has been correctly carried out and recorded.

(vii) The administration record on the prescription sheet must be signed at the same time. (viii) The stock balances in the CD record book must be checked against the quantity in

the CD cupboard on a daily basis. These must be identical. Discrepancies must be reported to the line/on-site manager immediately, investigated immediately and other parties contacted when necessary/if not resolved. All incidents involving a CD must be reported on DATIX.

(ix) Each different drug and preparation (i.e. form, strength etc) must have a separate page in the CD record book. Therefore if a dose requires the use of two strengths of a preparation both pages of the Controlled Drug register must be completed. All entries must be made in black ink.

(x) In Community CDs are recorded in a stock balance sheet in each patient’s home in the nursing documentation.

Note: In all settings; injectable CDs should be for single use only unless the label specifically indicates it is licensed and intended for use on more than one occasion or to provide more than one dose on any one occasion. Community Services (see 6.2.3 iii. & x.)



In the community it is acceptable for one registered nurse to administer without a second check. 6.2.4 Intravenous (IV) Administration of Controlled Drugs

As per 6.2.2 above: The involvement of a Second Registered Healthcare Professional will always be required in the hospital setting to check both the preparation AND the administration of IV medicines in the following circumstances (This is in addition to those identified in 6.2.1.):

• When the medicinal product is a Controlled Drug (CD) Please note: if there is any doubt about any aspect of the prescription that is to be administered whether this is the IV route or any other ALWAYS check/clarify concerns with the available information sources, pharmacist, prescriber or with another registered Healthcare Professional BEFORE administration. Further checking procedures can be implemented in response to local circumstances. 6.2.4.1 Exclusions for double checks: (i) Controlled Drugs in Theatre where:

• Within Theatres only, the preparation of any Controlled Drug must be checked by the anaesthetist, or other medical practitioner, and another appropriately trained person, e.g. a registered nurse or an ODP

• If a 2nd dose of that previously prepared and checked drug is required, the anaesthetist, or other medical practitioner, may administer it without needing to be observed by a second person. This is in order to maintain the optimum anaesthesia or analgesia for the patient as required.

• The anaesthetist or other medical practitioner is responsible for documenting the name of the drug and dose given on the anaesthetic chart, on the All Wales In-patient Medication Administration Record, or elsewhere in the body of the notes.

• The anaesthetist, or other medical practitioner, is personally responsible for safely disposing of any unused drug in an open ampoule or syringe and for returning any unopened ampoules to the nurse or ODP responsible for the Controlled Drugs at that time.

(ii) Community Services Community nurses may administer IV drugs as prescribed by the appropriate medical (GP or hospital doctor) or non-independent prescriber without a second check.

In all situations involving a second person, the second person carries accountability for the administration of the medication and, thus, must be a registered nurse/health professional, medical or dental officer or pharmacist. The second person must undertake all the checks outlined in Section 6.2.3 and clarify any concerns before administration as if they were administering the medicine themselves. The administration of medicinal products must be guided by the relevant nursing procedures in the current edition of the Royal Marsden Manual of Clinical Nursing Procedures, (the Royal Marsden can be accessed through the desktop icon and/or the HDUHB Intranet) These



include procedures for infusion devices, syringe drivers, dedicated pumps, PCA and epidural devices. 6.2.5 Drug Omissions

1. Any drug omission must have the reason for not administering documented on the prescription chart and in the patient’s notes along with any relevant actions taken.

2. In the event that a prescribed medicine is unavailable on the ward (non-stock item and/or individual patients’ drugs are unsuitable for re-use) every effort must be made to obtain this from an alternative source:

• emergency drug cupboard

• inter ward borrowing (see form in Appendix K)

• asking a relative to bring item from home

• on-call pharmacy service 3. If the above actions result in failure to access the medicine, a Datix incident report must

be completed. A Datix incidence report is not required if the on call pharmacist advises that there is no clinical urgency for the medicine to be administered (e.g. calcium & vitamin D).

4. Regular audits will be undertaken jointly with nursing and pharmacy staff to identify any common themes reducing timely patient access to their medicines.

6.2.6 Adverse Drug Reactions (ADR) Immediate action must be taken to reduce the effect of the ADR e.g. stopping IV fluid and the vial/original pack must be bagged and labelled accordingly where safe to do so. Any ADR must be reported to the prescriber or another appropriate medical/dental officer, pharmacist and the senior nurse/sister and an entry made in the patient’s medical notes.

The prescribing doctor / pharmacist / nurse should/must report ADRs using the Yellow Card Scheme to the MHRA (https://yellowcard.mhra.gov.uk/). Guidance on which ADRs should be reported can be found at: https://yellowcard.mhra.gov.uk/_assets/files/HCP-leaflet-072013.pdf. A competent patient must be informed if they have suffered an adverse drug reaction. Where a patient lacks capacity, the patient and the patient’s family and/or carers and in case of a child the parent/guardian must be informed that an adverse reaction has occurred and has been documented. For anaphylaxis or significant adverse reactions in community the patient would be admitted to the acute sector for 24 hours’ observation. 6.2.7 Defective Product Reporting and Alerts

• Any defective products (e.g. injection not reconstituting as expected/particles in solution) must be reported to the pharmacy department, who will report to the All Wales QA Pharmacist and MHRA in line with departmental standard operating procedures.

• Alerts relating to defective medicines will be dealt with by the pharmacy department in line with departmental standard operating procedures and Health Board Alerts Policy.

6.2.8 Medicine Related 'Patient Safety Incidents'



A patient safety incident is defined by the NPSA as: "an unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS funded healthcare." These include:

• Incidents that have occurred (errors/adverse incidents)

• Incidents that have been prevented (near misses).

• Incidents in the prescribing, dispensing and administration of medicines can, in the main, be categorised as follows:

o Incorrect medicine o Incorrect dose o Incorrect route o Incorrect patient o Incorrect time o Omission of medicine o Use of medicines which have expired o Other (e.g. loss of keys or medicines).

For further information, please refer to the medication incident 'trigger list' poster, displayed in clinical areas (Appendix I) It is important that an open culture exists in order to encourage the immediate reporting of errors or incidents in the administration of medicines. If an error is made this must be reported to the line manager immediately. Any errors that are made in the community setting must be reported to the responsible doctor (including if out of hours) immediately and take any remedial action as advised. Record the drug and dosage given.

In the event of an error in administration of medicinal products, the following actions must be taken:

• take immediate action e.g. stop infusions,

• inform the doctor immediately.

• record the drug and dosage given.

• retain the original pack/vial and ‘bag & tag’ for safe keeping, if safe to do so.

• record measurable observations.

• inform the person in charge of the ward.

• inform patient and next of kin/family/carers. Discussion must take place between the practitioner managing the situation and the patient’s doctor as to the appropriate timing, environment, and presence of the next of kin/family/carers to inform the patient.

• inform the Senior Nurse as soon as possible (Site Manager out of hours)

• inform the Pharmacy Manager or on call pharmacist out of hours.

• complete an Incident Report Form (Datix). As soon as the immediate situation is managed:

a) the incident must be assessed by an appropriately trained person e.g. Ward Sister/Department manager, team leader, senior nurse, senior pharmacy manager, or



consultant and any immediate action taken. The investigation and review must be completed within 30 working days of the incident. Multi-Disciplinary Team learning to prevent further incidents must be employed.

b) it is stressed that errors made, but honestly reported in a way which clearly puts the interests of patients first, will be sensitively investigated and managed in order for both the individual and the organisation to learn from the situation.

c) appropriate support for the individual(s) involved will be provided.

The line manager(s) of the individual(s) involved, must decide, following thorough and careful investigation what, if any, further action is required to be taken in relation to those involved in the incident e.g. re-training, additional training. If a student nurse is involved in a drug administration error, the personal tutor or Link Lecturer must be informed at the earliest possible opportunity. If a medical student or trainee doctor (F1 & F2, Specialist Registrar) is involved in the drug error their supervisor and Medical Education must be informed. If a pre-registration pharmacist is involved in the medication error their pre-registration tutor must be informed. Trend analysis of reported drug administration incidents [fully anonymised] will be undertaken by the Medicines Event Review Group. This will be based on reports and will be utilised (anonymously) to review and inform policy, systems review and training needs and should be disseminated for Clinical Directors for discussion and action. Datix reports are automatically fed into NRLS (http://www.patientsafety.wales.nhs.uk/home) to enable the wider NHS service to learn from incidents. 6.2.9 Reflective Practice / Clinical Supervision Medication administration incidents (including practices that have the potential to cause problems, for example, covert administration of medicines) must be discussed regularly with the professional’s clinical supervisor or mentor, in order to develop a robust understanding of their accountability. If regular, formalised mechanisms are not yet in place for practitioners, advice and support should be sought via the line management structure. 6.2.10 Self-Administration of Medicinal Products To be read in conjunction with the Health Board’s Guidelines for the Self-Administration of Inpatients’ Own Medicines. (Appendix J). Accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/Guidelines%20for%20self-administration%20of%20patients%20own%20medicines%20v1%20Final%20Website.pdf Patient Information Leaflets can be sourced at: http://howis.wales.nhs.uk/sitesplus/documents/862/PIL%20Self%20administation%20v%201%20Dec%202013.pdf Further information for self administration of insulin can be found:



http://howis.wales.nhs.uk/sitesplus/documents/862/Addendum%20Self-Administration%20Insulin%20v%201%20FInal.pdf 6.2.11 Medication for Discharge It is essential to ensure that patients and/or carers have an understanding of their prescribed medication, the potential side effects and when to take this medication. The clinical pharmacist for the ward/department has a key role in achieving these goals. If the patient is admitted using a Monitored Dosage System (MDS) (e.g. Nomad or Dosette box) and it is deemed appropriate to continue, this should be considered as part of the discharge planning assessment plans which should be made well in advance of discharge. For patients (not currently using a MDS) where medicine adherence is considered a potential problem, patients should be referred to their community pharmacist for appropriate assessment on discharge by the multi-disciplinary ward based team. A community pharmacist may undertake a Discharge Medicine Review (DMR) and assess under the Disability Discrimination Act (DDA) any reasonable adjustments to their medication to support the patient. A simple reminder sheet is often just as effective, if not more so, than a MDS; especially as an increasing number of medicines are not suitable to be used in these boxes. In preparing a simple reminder sheet it is safer to use a second set of printed pharmacy dispensing labels than transcribing of drug dosages and administration frequencies to assist patients in their understanding of their medications. In exceptional circumstances (e.g. out of hours discharge and A&E attendances) it may be necessary to transcribe a patient’s prescription. In such situations, nurses must always ensure they fully recognise their personal accountability for such practice and always ensure that checking of such transcriptions is undertaken by a second registered nurse.(NMC standards for Medicines Management). This process must be documented in the patient’s clinical record. If the patient has any medication at home that has been changed or been discontinued during their hospital stay, the nurse and pharmacist should ensure the patient understands the need to safely dispose of this medication by returning it to their Community Pharmacy. The patient should receive information about the Medication Review Services that is available from community pharmacies. Leaflets explaining this service are available from the hospital pharmacy. Where a patient has been admitted on a monitored dose system or is part of the HDUHB Medication Administration Scheme then the ward is responsible for planning discharge and liaising with the pharmacy department to make suitable arrangements are in place prior to discharge. The AWMSG provides guidance in this area: http://www.awmsg.org/awmsgonline/app/sitesearch;jsessionid=8480526369179e588fdb7eb20b04?execution=e1s1



If a patient is discharged home and requires the community nursing service to call to administer medication, the in-patient medication administration record must be faxed to the District Nurse by the discharging registered nurse and a legible photocopy sent with the patient. If a patient is discharged home outside Pharmacy department opening hours, registered Healthcare Professionals should follow the Guidelines for the Provision of Safe Patient Discharge during pharmacy out of hours. (Appendix D) 6.2.12 Complementary Therapies Healthcare Professionals must enquire whether patients are using complementary therapies when taking a medication history. If a patient or client desires to continue to use complementary therapies, the practitioner must be mindful that potential difficulties might arise, for example, the complementary medicines may:

• cause the presenting symptoms;

• mask symptoms, or

• interact with prescribed medicines.

The Pharmacy or Medicines Information Centre should be contacted for further information and advice In such situations, the practitioner, acting in the interests of the patient or client, must ensure that the relevant registered medical practitioner is aware of the patient’s full medication history and their desire to continue to use complementary therapies. Within the hospital setting, such agents must be recorded as a substance that the patient is self-administrating on the in-patient prescription chart in the normal way as other conventional medicinal products. Healthcare Professionals must understand the use of the complementary medicines and any potential adverse reactions or drug interactions before administering it to the patient. Complementary therapies are usually non-formulary and not stocked by the hospital pharmacies. The practitioner must always remain mindful of the need to respect the patient’s rights and beliefs. 6.2.13 Consent and Covert Administration of Medicines 6.2.13.1 Consent Every adult must be presumed to be able to consent to receive or to refuse medication unless there are reasons to doubt the person’s mental capacity for this decision. Wherever such circumstances arise the capacity of the patient must be formally assessed to determine his / her clinical condition at that precise time and the outcomes recorded in the health record. It must be borne in mind that capacity is variable and can change from day to day. A person will lack the necessary mental capacity to consent to or refuse medication if the assessment shows that they have an impairment or disturbance of the mind or brain which prevents the person from being able to do any of the following:

• to understand the nature and consequences of accepting or refusing the medication

• to retain the information about the medication provided by the treating staff long enough to make a decision

• to weigh up the information about the medication as part of the process of arriving at a decision.



• to communicate their decision in some way Where adult patients are capable of giving or withholding consent, no medication should be given without their agreement since failure to do so may amount to criminal battery, civil trespass, or a breach of their human rights. The exception to this principle applies to treatment authorised under Part IV of the Mental Health Act (1983) (also see part.15 of Health Board Policy No: 008, ‘Policy for Consent to Examination or Treatment’ http://howis.wales.nhs.uk/sitesplus/documents/862/008ConsenttoExaminationorTreatmentPolicyversion2signed.pdf ). Children under the age of 16 years are able to consent to or refuse medication providing they are have sufficient maturity and understanding to do so (known as Gillick competence) but the refusal of a competent child may be overridden by those with parental responsibility. Young people aged 16 or 17 years are presumed to be able to consent for themselves in the same way as an adult. The refusal of a young person can also be over-ridden by a person with parental responsibility. However, the GMC Guidance (‘0-18 years: guidance for all doctors’, 2007) acknowledges this area of law as complex and suggests that, where a competent young person refuses medication the treating doctor thinks is in their best interests, legal advice is sought. In exceptional circumstances this may involve seeking an order from the court The wishes of patients (adults) /parents/guardians who have the necessary competence to make a decision but refuse to consent to receive medication must be respected, even if this could have an adverse effect upon their condition. 6.2.13.2 Covert administration of Medicines Covert administration of medicines, usually by disguising medication in food or drink, is a complex issue that has provoked widespread concern. It engages the fundamental principles of patient autonomy and consent to treatment, set out in common and statute law and underpinned by the Human Rights Act 1988. The NMC (2008) has issued a position statement on the covert administration of medicines (9/01) and it is the principles contained in this document which form the basis of this section. Disguising medication in the absence of informed consent could be regarded as deception and will represent a breach of a person’s rights under Article 8 of the European Convention on Human Rights (1950). A clear distinction must always be made between patients or clients who have the necessary mental capacity to make a decision to refuse medication and whose refusal should be respected, and patients or clients who lack this capacity. Among people who lack this capacity, a further distinction must be made between those for whom no disguising is necessary because they are willing to take medication and others who would not be willing to take medication unless it is administered covertly. General principles to be taken into account when considering the option of covert administration of medicinal products:-

• The best interests of the patient are paramount at all times

• The medication must be considered essential for the patient’s health and well being. Effectively this should be determined through a four-stage test. 1) the patient is assessed as lacking capacity for this decision and is unwilling to take

medication unless administered covertly.



2) there is no alternative form of authority relevant to the decision about administering medication covertly (this would include a valid and applicable advance decision or an attorney or a court appointed deputy with relevant authority; see Health Board Policy No:018, ‘Guidance on the Mental Capacity Act’. http://howis.wales.nhs.uk/sitesplus/documents/862/374MentalCapacityAct2005Policy.pdf

3) the treatment is necessary and in the patient’s best interests in that it is required either to save their life, to ensure improvement or prevent deterioration in their physical or mental health.

4) that it is reasonable (i.e. an acceptable medical practice to provide this treatment to the patient.)

Covert administration of medications must not develop into a routine practice but should only be undertaken following a thorough documented individual risk and care needs assessment of the patient. Decisions to administer medication covertly must not be taken in isolation by a registered Healthcare Professional. The views and support of the multidisciplinary team and family should be sought openly and recorded in the individual care plan. The ultimate decision to administer medication covertly is the responsibility of the prescriber but must be one that has been informed and agreed by the team caring for that patient and with the involvement of relevant others. Discussions and decisions need to be documented accurately in the current care plan. Where it is practicable and appropriate health care professionals should consult and take into account the views of the person’s family and other relevant people. If agreement cannot be reached about the decision the health care professionals should consider holding a ‘best interests’ meeting or attempt some form of mediation. They should also seek advice from the Mental Capacity Act Lead Officer or the Legal Services Department. In exceptional circumstances it may be necessary to ask the Court of Protection to decide what is in the patient’s best interests. If there is no-one appropriate to consult and the decision to give or withhold the medication could have a serious impact on the patient then an Independent Mental Capacity Advocate should be instructed. Regular re-assessment of the individual patient must be undertaken, and recorded, particularly where there is evidence of temporary or fluctuating capacity. For mental health patients who are subject to the Mental Health (Wales) Measure Care and Treatment Programme Approach (CTP) re-assessment would take place as a minimum at each review date, or between reviews if necessary. Regular attempts must be made to encourage the patient to take their medication through the provision of information, explanation and encouragement, preferably by the team member who has the best rapport with the patient. Family involvement in the care process must be actively encouraged as well as that of advocates and carers.



The method of administration must be agreed with the appropriate pharmacist since adding medication to food and drink can alter its chemical properties and thereby affect its performance. HCSW often help feed the patient their food or drink; in this situation, where medicines are also given, the accountability remains with the registered Healthcare Professional who signs for administration. Where patients are lawfully detained under the Mental Health Act some forms of treatment given against the person’s wishes are authorised by law. In these cases the appropriate process must be adhered to and documented accurately. 6.2.14 Administration of Medicines as Part of Clinical Trials Under the Medicines Act 1968, statutory controls are in place governing clinical trials of medicinal products. There are a large number of legislative documents that govern clinical trials, at a European and national level. Following implementation of the Clinical Trials Directive 2001/20/EC, compliance with the principles of Good Clinical Practice became a legal requirement in the UK. This requirement was achieved through The Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument No. 1031 (SI 2004/1031). Since then, compliance with the principles of Good Clinical Practice (GCP) has become a legal requirement in the UK (GCP Directive 2005/28/EC). Before commencing clinical trials of medicinal products, the chief and/or principal investigator must ensure compliance with all regulatory and ethical requirements. Information on these requirements can be obtained from the Research and Development (R&D) Department and pharmacy department. Although not a requirement of the Clinical Trials Regulations, it is good practice to prescribe Investigational Medicinal Products (IMPs) on a prescription form (paper or electronic) or a hospital drug chart. It is essential that prescriptions for IMPs identify the clinical trial, the subject and medication required (ie using a trial-specific prescription or clinical trial sticker). When IMPs are prescribed for an in-patient, the hospital drug chart must clearly identify the clinical trial and include the words ‘Clinical Trial’. IMPs must be solely prescribed by the investigator or a qualified delegated member of the research team. The Head of Pharmacy and Medicines Management is responsible for the overall provision of the pharmacy clinical trials service, although a designated member of pharmacy staff, the Clinical Trials Pharmacist, will assume operational responsibilities for the service. Pharmacy Standard Operating Procedures for Clinical trials must be applied for all aspects of the management of IMPs. The administration of IMPs must be undertaken as for the policy for administration of routine drugs. Vigilance must be exercised to ensure that the IMP is being used according to the clinical trial protocol and that each individual involved in conducting a trial is qualified by education, training and experience to perform a specific task. All registered Healthcare Professionals administering medication within a clinical trial must check the medical records for further information. 6.2.15 Administration of unlicensed medicines or licensed medicines outside their

product licences



Valid and exceptional situations may occur when the use of unlicensed products, or licensed medicines outside their product licence, will be appropriate or essential. The products covered in this category are:-

• medicines awaiting a product licence

• medicines manufactured for export

• medicines which have been withdrawn from the UK market

• where the manufacturer does not intend to apply for an UK licence.

• unlicensed medicines prepared by a manufacturer with a ‘Specials’ Manufacturing Licence.

• licensed products where the dose, range, patient’s age, route or method of administration may be outside the licence.

The practitioner administering the medication must ensure that they have sufficient information to administer the drug safely and, wherever possible, that there is acceptable evidence for the use of that product for the intended indication. The practitioner involved with prescribing and/or administration of such products must ensure that patients are provided with adequate and appropriate information to ensure that they understand the status of the products they have been prescribed. Prescribers must complete an unlicensed medicines request form which is available from Pharmacy departments or can be accessed at: http://howis.wales.nhs.uk/sitesplus/862/page/43560 The process by which such medicinal products are controlled within the Health Board is detailed in the ‘Policy for the Use of Unlicensed and Off Label Medication’ which can be accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/Finalunlicensedmedspolicy%20Dec12%20MMG.pdf 6.2.16 Crushing of Tablets or Opening of Capsules Not all tablets and capsules can be crushed or opened as the clinical effect of the medicine may be altered or adverse reactions occur. The Pharmacy Department must be contacted for advice on individual products. The crushing of tablets or opening of capsules and subsequent administration must be carried by the registered healthcare professional only after receiving advice from the Pharmacy Department. It should be noted that crushing or opening capsules might affect the licensing status of the product. Whatever action is decided upon must be recorded on the patient's chart. Refer to the All Wales Medicines Strategy Group guidance on the following link: Primary Care Guidance: Prescribing medicines for adults who are unable to swallow oral solid dosage forms. http://www.awmsg.org/awmsgonline/app/sitesearch?execution=e2s1

The HDUHB Enteral Feeding Policy for Adults with Operational Guidelines provides procedures and information on the administration of medicines via feeding tubes and can be accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/331-EnteralFeedingPolicyforAdultsincludingOperationalGuidelines-approved.pdf 6.2.17 Enteral Syringes



Sterile purple enteral syringes must be used for the administration of all medication to be given via the enteral route (including patients who have nasogastric, gastrostomy or jejunostomy tubes) where a 5ml spoon or graduated measuring cup cannot be used (NPSA: Promoting safer measurement and administration of liquid medicines via oral and other enteral routes) The HDUHB Enteral Feeding Policy for Adults with Operational Guidelines gives further advice and can be accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/331-EnteralFeedingPolicyforAdultsincludingOperationalGuidelines-approved.pdf 6.3 Ordering and Supply of Medicinal Products

6.3.1 Responsibility of Pharmacy Department All medicinal products supplied by the Health Board will be purchased by the hospital pharmacy departments and stored within this department under appropriate and secure conditions until required for use. It is the responsibility of the pharmacist to ensure that medicinal products are supplied only under appropriate statutory, Health Board-approved conditions i.e. any of the following:

• against a written prescription by qualified medical/dental staff, or by authorised independent/supplementary prescribers, for in-patients or out-patients attending a hospital or clinic.

• against a written requisition signed by a qualified nurse in charge of the ward, department or clinic

• in accordance with the written instructions of a qualified medical or dental practitioner.

• or in accordance with the Hywel Dda University Health Board Tissue Viability and Wound Management Guidelines.

• to midwives against the midwives’ supply order authorised by the supervisor of midwives.

• against a written order from a registered ODP in theatre.

• Against a written order from a practitioner under the authority of a patient group direction / patient specific direction/HDUHB Agreed Protocol.

• against a written requisition signed by a physiotherapist, podiatrist or other recognised health care professional, where the medicinal product requisitioned is one that they are entitled to possess under the Regulations made under the Medicines Act 1968.

• In accordance with the pharmacy operated top-up system procedures. A named pharmacist will be provided for each ward as a point of contact for any issues relating to pharmacy and medicines management. This does not mean that no other member of the pharmacy team or the dispensary can be contacted but will provide the ward with a regular point of contact to discuss and address any ongoing issues/concerns. The named pharmacist will liaise with the ward on a regular, mutually agreed, timescale with the senior ward sister. This may be daily, weekly or monthly. 6.3.2 Ordering and Supply Procedures 6.3.2.1 Hospital Wards, Departments and Operating Theatres: Medicinal Products Held

in Stock



All wards or department stock lists must be reviewed regularly by the named ward pharmacist with the Senior Sister or Departmental Manager. Stocks should be reviewed regularly by the senior ward sister and named pharmacist to ensure they are appropriate to current clinical needs and best practice guidelines and the Health Board’s formulary. Stock levels will be checked by pharmacy staff at agreed intervals and replenished via the pharmacy operated top-up system. For those areas not serviced by a top-up system they will order via a process agreed with the Pharmacy department. Further supplies of stock items may be requested from the pharmacy department using the appropriate requisition. These must be used in chronological order, ideally though the use of a bound book (or similar) to ensure full audit trail is available.

The nurse or ODP in charge of the area must ensure that the appropriate order form is completed and signed in full. The ward sister or department manager has responsibility for supplying accurate and up-to-date signatory lists to the Pharmacy department twice yearly. 6.3.2.2 Acute Response Team (ART) Stock The Acute Response Team should access all stock items through their stock drug cupboard in the first instance. (Carmarthenshire and Ceredigion). ART will routinely access the drugs form the pharmacy department in Withybush General Hospital. 6.3.2.3 Hospital Wards, Departments and Operating Theatres: Medicinal Products for

Individual Patients (non stock items) Inpatient All Wales Medication Administration Records will be reviewed at ward / department level by pharmacists at agreed intervals and supplies of medicinal products made for individual patients. Supplies of items required outside of the clinical pharmacist round may be requisitioned from the Pharmacy Department using the individual patient’s Inpatient All Wales Medication Administration Record by either:

(i) Sending the chart to the Pharmacy department (on site); or (ii) Transmitting a faxed copy of the prescription to the Pharmacy department (off site)

The pharmacy team must ensure that adequate supplies of medicinal products required for individual patients are available at ward / department level. Drugs labelled on an individual named-patient basis must be transferred with the patient when the patient is transferred between in-patient areas. Use of a ‘green bag’ will assist this transfer. Further stocks can be obtained from the hospital pharmacy departments, GP surgeries and Community Pharmacies. 6.3.2.4 Controlled Drugs Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities



relating to CD including ordering. Please refer to Appendix G for a full list of areas requiring a SOP. Orders for Controlled Drugs must be requisitioned in duplicate in the approved Controlled Drugs Order Book and with the printed name and signature in full of the person in charge of that area. If clinical areas have more than one CD cabinet, there must be separate order books and registers for each cabinet. The order book must be kept in a locked place and, if missing, the most senior nurse in charge must inform the acute services nurse manager or deputy, the pharmacy and report on Datix. All sections of the order book must be completed prior to orders being sent to pharmacy. Only authorised nurses, midwives or OPDs can order CDs for ward/theatre- authorisation is by the person in charge of the ward, clinic or theatre manager and an authorisation sheet for CDs should be completed, signed and sent to pharmacy. Senior pharmacists (Band 8a or above in permanent posts) may order CDs for clinical areas providing they are named on the ward or departmental list for “Persons Authorised to Order Controlled Drugs”. The CD order is to be dispensed and checked according to Hywel Dda Health Board Policy in line with an approved SOP. The Senior Pharmacist involved in completing the CD requisition must not be involved in the dispensing or checking process or receipt by the ward. Controlled drugs for ward stock may be delivered by pharmacy staff/porters or collected by ward staff (according to SOP). Both registered and unregistered staff can collect controlled drugs for ward stock provided they are official Health Board employees who are known to pharmacy staff or with a full permanent Health Board identity badge on display when collecting the drugs. Third year student nurses can collect controlled drugs from pharmacy, provided they have been deemed competent by a registered nurse in the area that they are currently working in. They must also present their student identification badge to the pharmacy department. Staff delivering controlled drugs to an area must identify the key holder immediately. On collection of Controlled Drugs from the pharmacy the messenger must sign both copies of the order; this may be done using carbon paper. The top copy of this is retained in the Pharmacy department. Controlled Drugs received into the clinical environment must be checked by the person in charge of that area and the remaining copy of the order signed. On receipt of Controlled Drugs the date, quantity of the drug received and requisition number must be entered into the Controlled Drug Register. The Controlled Drug Register is a legal document and must be indexed clearly. The Controlled Drugs Register must only be used for recording Controlled Drug receipts and issues.



Stock levels of Controlled Drugs must be checked on a daily basis by two registered Healthcare Professionals to ensure stock levels are correct against the Controlled Drugs Register. The following information must be recorded for every daily checks:

• date and time of check

• that the stock balances are correct.

• the signature of the two registered Healthcare Professionals undertaking the checks No inter ward borrowing of Controlled Drugs is allowed except for individual patients in emergencies when the duty manager must be contacted. The pharmacy department should be notified as soon as possible to ensure continued stocks. If it is necessary to use a Controlled Drug from another ward, the recipient’s name must be entered into the register of the provider ward. This entry must be signed by both nurses (one from each area) effecting the transaction. Controlled Drug registers and order books must be kept in a locked place at ward/department level for two years from the date of the last entry to comply with current legislation. 6.3.3 Emergency Supplies A range of emergency stock is held in Bronglais General Hospital, Glangwili General Hospital, Prince Philip Hospital, St David’s Hospital & Withybush General Hospital. The contents of the emergency cupboard is determined locally and reviewed regularly by the hospital pharmacy based on ward stocks, common emergencies, and the antidote list for poisoning and previous out-of-hours requests. The stock can be accessed by the Site Nurse / Night Nurse Practitioner / On-call Pharmacist. All issues must be recorded in the Emergency Stock File (held in the emergency cupboard. For personal safety, the member of staff accessing the emergency cupboard must be accompanied by another employee, wherever possible. In the event that a prescribed medicine is unavailable on the ward (non-stock item and/or individual patients’ drugs unsuitable for re-use) the following should first be checked:

• patients individual medication locker

• nurse’s station and treatment room to see if any patient’s own medicine has not been put away

• contact the hospital pharmacy (during working hours)

If the above is unsuccessful, then every effort must be made to obtain the medicine from an alternative source:

• emergency drug cupboard

• inter ward borrowing

• asking a relative to bring item from home

• on-call pharmacy service 6.3.3.1 Inter ward borrowing If a medicine has to be obtained from another ward (outside normal pharmacy working hours only) the registered Healthcare Professional requiring the medicine must take the patient’s prescription chart to the ward loaning the item and complete an Inter Ward Transfer Form (Appendix K). The form is then sent to the Pharmacy department for replacement of the stock borrowed. Pharmacy will retain the record.



6.3.4 Omitted Doses All patients must receive their medication as prescribed. An omitted dose can potentially cause patients harm through deterioration of their condition, and must be acted upon as a priority. If a dose has already been missed without an appropriately documented reason (of which unavailable is not one) it should be considered a serious incident. If a patient has an omitted dose after all the above has been followed then a code ‘5’ (‘drug not available’) should be recorded in the patient notes, the relevant clinical team contacted and a Datix incident submitted. Medication safety audits are carried out on every ward each month. The SOP for this process can be found in Appendix S. Note: where the on-call pharmacist has been contacted and has advised the nurse that there is no clinical risk if the dose is omitted until supplies can be arranged (e.g. calcium and vitamin D over the weekend) then this does not require a Datix incident submission. 6.3.5 Medicinal Products for use in Community Clinics or Family Planning Clinics

a. A designated person (who shall be a registered Healthcare Professional) will be responsible for controlling access to medicinal products and for their security in clinics

b. The said designated person may decide to delegate some of the duties, but the responsibility always remains with that designated person.

c. Each clinic site must have a written procedure to ensure the safety, security and the ordering of medicinal products. The Pharmacy department supplying the Clinic can advise on the contents and template of the procedure.

6.3.6 Medicinal Products for use by Other Hospital Department a. A designated person (who must be a registered Healthcare Professional) must ensure

that medicinal products are ordered on the appropriate order form. b. The range of medicinal products provided as stock will be agreed with the Pharmacy

Department. c. The designated person has responsibility for supplying accurate and up-to-date

signatory lists to the Pharmacy department twice yearly. 6.4 Transport of Medicinal Products This covers:

• Internal transport within a hospital site

• Transport between Transport between NHS Organisations from Pharmacy Departments (Including Community & GP practices)

• Delivery of Medicines to Patient’s Home (External Contractors - Taxi’s)

• Additional Actions for Oncology Medicines Personnel

• Community Services

Advice on the transport of Controlled Drugs is included under these subheadings

6.4.1 Internal Transport within a Hospital Site. 6.4.1.1 Stock Top-Ups These must be transported in a sealed tamper proof container which must be signed for by the ward on receipt.



The container must contain details of the stock items for checking on receipt at the ward/clinic. Discrepancies must be reported and investigated and if unresolved reported through Datix. Spot checks of the top-up delivery system to confirm accuracy of stock levels etc. will be undertaken as per Pharmacy department SOPs. 6.4.1.2 Individual Patient Dispensed Item Pharmacy will keep a record of any items dispensed for an individual in-patient. There is no requirement for a nurse/porter collecting an individual in-patient medication or ‘to take home’ (TTH) to sign for receipt (with the exception of Controlled Drugs) however staff will be requested to show a valid Health Board identity card prior to medication being issued for delivery where they are unknown to pharmacy staff. The senior ward nurse is responsible for the safe receipt and appropriate storage of any medicine dispensed for a patient on their ward. Any items received must be identified as correct and stored appropriately e.g. medicines dispensed against an in-patient drug chart will be stored in the patient’s locker or drug trolley. 6.4.1.2.1 Collection of TTH’s and Outpatient Prescriptions by Children and Young

People Pharmacy staff will follow the Royal Pharmaceutical Society guidance ‘Children collecting medicines from a pharmacy’ (accessed at: http://www.rpharms.com/unsecure-support-resources/children-collecting-medicines-from-a-pharmacy.asp ) when dealing with requests by children and young people to collect medicines for themselves or on behalf of patients. 6.4.1.3 Controlled Drugs Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including transport. Please refer to Appendix G for a full list of areas requiring a SOP. Any Controlled Drug must be signed for on receipt by the individual transferring the item to the ward and the individual responsible for its safe storage at ward level to ensure appropriate audit trails are available. 6.4.1.3.1 Collection of CD Containing TTH’s and Outpatient Prescriptions From 1 February 2008, it is a requirement to record the following information in the Controlled Drug register for Schedule 2 CDs supplied on prescription:

• whether the person who collected the drug was the patient, the patient’s representative or a healthcare professional acting on behalf of the patient

• if the person who collected the drug was a healthcare professional acting on behalf of the patient, that person’s name and address (in practice the ward)

• if the person who collected the drug was the patient or their representative, whether evidence of identity was requested (as a matter of good practice a note as to why the dispenser did not ask may be included but this is not mandatory) and whether evidence



of identity was provided by the person collecting the drug (i.e. If the person collecting is personally known to the dispenser, evidence is not required),

6.4.2 Transport between NHS Organisations from Pharmacy Departments (Including Community & GP practices)

The pharmacy department has responsibility to ensure that the individual transporting the medicine is clear on the following:

• who the medicine is to be delivered to – this ideally should be a named person.

• security of the medicine in transit Transport for the delivery of medicines must not be externally distinguishable from other vehicles. No unauthorised passengers shall be carried in vans, which deliver medicines, and the vehicles must be locked when unoccupied. Transport staff shall be trained to ensure understanding of the procedures and the need for security. This must include instruction on the action to be taken in the event of a physical threat. All medicines must be transported in tamper proof containers. This may be a heat-sealed, tagged or locked container dependent on the number and volume of items. Where medicines need to be kept between 2°C and 8°C.they must be packed in a validated cool box (carrier), wrapped in bubble wrap or similar insulation material and with previously, chilled cool packs included. A pre-printed consignment note/record of the containers to be transported at any one time will be signed for by the driver on collection of the delivery, carried by the driver and be signed by the individual accepting the delivery. It must be returned to the pharmacy department for reconciliation. Controlled Drugs must be in a separate locked/tamper proof sealed container and signed for individually on delivery. The delivery note must be returned to pharmacy for reconciliation. 6.4.3 Delivery of Medicines to Patient’s Home (External Contractors - Taxis) A named patient/patient representative must sign for receipt of the medicine unless previous arranged with the person responsible for delivery e.g. ward/pharmacy. The receipt does not need to identify all medicines within the container, only details to enable identification of the patient e.g. name and address. The named person must be advised of their responsibilities in relation to confidentiality. The signed delivery sheet must be returned to the issuing department e.g. ward or pharmacy department within 24 hrs of delivery. Any problems with delivery must be flagged up immediately (e.g. unable to deliver/delays). Community healthcare professionals may transport medication to patients (including Controlled Drugs), where patients, their carers or representatives are unable to collect them, provided the healthcare professional is conveying the medication to a patient for whom the medicinal product has been prescribed, (for example, from a pharmacy to the patient’s home)’.



However, it is considered good practice that health professionals should not routinely transport CDs in the course of their practice. This should only be undertaken in circumstances where there is no other reasonable mechanism available. All drugs should be kept out of sight during transportation 6.4.4 Additional Actions for Oncology Medicines Oncology medicines pose an additional risk to individuals and the public. In order to reduce the risk identified the following conditions and training must also be in place for a taxi service to transfer oncology medicines on a regular basis. Oncology medicines must always be packed in a second outer container that is clearly marked ‘cytotoxic’. Packing must be used to protect the enclosed medicines as appropriate. The driver must receive training provided by the pharmacy department before they are approved to carry oncology medicines. This includes the following:

• information on the type of medicine they are carrying i.e. cytotoxic

• information on the potential risks associated with the oncology medicine

• how to transport the medicines and any additional issues e.g. temperature controls, need to fasten safely in the car/van- place in the boot of the vehicle

• dealing with cytotoxic spillages.

• importance of ensuring a clear audit trail- signature on consignment notes and ensuring they are returned to the relevant pharmacy promptly.

Documentation of this training is using the Transport of Cytotoxic Medicines Form (Appendix L).

6.4.5 Personnel Staff involved in the transport of medicines will be kept to a minimum and be in a legitimate position to do so i.e. Health Board employee or Welsh Ambulance Service wherever possible, contracted Taxi drivers. All staff involved in the transport of medicines will be trained to ensure understanding of the procedures and need for security, including instruction on action to be taken in the event of physical threat. 6.4.6 Community Services It is permissible for community nurses to transport medicines (including CDs) for individual patients providing that they are:

• in uniform (unless Mental Health or Community Paediatrics)

• have identification

• can confirm the address of the patient.

All medicines must be transported in tamper proof containers. This may be a heat-sealed, tagged or locked container dependent on the number and volume of items. Where medicines need to be kept between 2°C and 8°C.they must be packed in a validated cool box (carrier), wrapped in bubble wrap or similar insulation material and with previously, chilled cool packs included. The medicines should be kept out of sight and the vehicle locked when unoccupied.



Community nursing staff may be required to transport oxygen or Entonox® in their vehicles. It is the responsibility of each healthcare professional to ensure they have appropriate insurance to cover this activity and they must also display a badge (Compressed gases) to say they are carrying Oxygen (O2) or Entonox® in the community. The cylinders must be stored securely in the boot of the vehicle. 6.5 Storage of Medicinal Products 6.5.1 General Within hospital settings, all medicinal products issued for use will be safeguarded against loss or improper use, and will be stored in a locked cupboard, trolley or other secure receptacle. Such products will be the responsibility of the nurse/registered Healthcare Professional with overall responsibility for the relevant clinical area. Within the operating theatres, intensive therapy and coronary care units, the storage of drugs in locked containers may be impracticable during operational hours. Specific departmental guidelines are required for these areas and must be drawn up and agreed by the nurse manager, pharmacist and medical staff and supported by a risk assessment. Storage arrangements should be audited at regular intervals to ensure compliance. Medicinal products must be labelled to indicate specific storage conditions. 6.5.2 Standards for storage facilities Within hospital settings, the following lockable facilities must be available for storage of: 6.5.2.1 Controlled Drugs Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including storage. Please refer to Appendix G for a full list of areas requiring a SOP.

Preparations containing drugs subject to the Misuse of Drugs Act, 1971 must be stored in a security cupboard which complies with the Misuse of Drugs (Safe Custody Regulations) 1973. There may be additional medicines (including mifepristone) for which the Health Board follows the full or partial Controlled Drug regulations. This list will be provided and updated by the pharmacy department. (Appendix M)

• Controlled Drug cupboards or cabinets must conform to British Standard reference BS1881 or otherwise be approved by the Pharmacy department.

• In areas where higher security may be required, a security cabinet that has been evaluated against the SOLD SECURE standard SS304 (www.soldsecure.com) must be used.

• It is acceptable for the Pharmacy department to store Controlled Drugs within the automated robot providing:

o a joint risk assessment with the police has been undertaken of the premises and robot.



o approval is given by the relevant Local Intelligence Network to store CDs in the automated robot.

o regular audit is undertaken to ensure robust procedures are in place and implemented.

In the patient’s home Controlled Drugs should be stored within a plastic lidded box as advised by the community nursing staff. The Controlled Drugs remain the patient’s property. A stock balance must be kept and checked at each visit. Any discrepancies should be reported to the prescriber and the relevant Community Service Manager.

6.5.3 Medicinal Products for Internal Use These must be stored in a cupboard, which complies with British Standard 2881. It is recommended that this cupboard is sub-divided by product, for example: Tablets/capsules; Oral liquids, and Small volume injections. Guidance on the shelf life of oral liquid preparations (see Appendix P) 6.5.4 Medicinal Products for External Use These must be stored in a cupboard, which complies with British Standards 2881. This includes: Topical preparations, eye/ear drops, suppositories, nasal drops, antiseptics, gargles, and mouth washes. 6.5.5 Disinfectant Cupboard Disinfectant must be stored in a separate locked cupboard. 6.5.6 Reagent Cupboard Blood and urine testing reagents must be stored in a separate locked cupboard. 6.5.7 Medicines Refrigerator Medicines requiring refrigeration will be labelled with the relevant information. Medicines must be kept in a locked refrigerator. No product other than medicines will be stored in the medicine refrigerator. It is preferable that medicine refrigerators should be wired into a switchless socket or switched spur to prevent their being turned off accidentally. If not, a cautionary notice must be placed on plugs or sockets to prevent accidental interruption of power supply. The temperature of the medication fridge must be monitored on a daily basis and recorded. The temperature should be between 2°C and 8°C. Immediate action must be taken if the temperature is not within the acceptable limits. The Standard Operating Procedure for the Medicines Refrigerators’ Temperature Checking (Appendix T) gives full details. In the community, medicines may be stored in a patient’s own refrigerator. 6.5.8 Portable Medicine Trolley/ Medicines Cupboards. Portable medicines trolleys and medicine cupboards enable the administration of medicinal products to patients. Medicinal products in current use must be kept in the trolley or medicines cupboards. Controlled Drugs are stored in the Controlled Drugs cupboard (with the exception of Oramorph® 10mg/5ml when the ward has implemented the SOP for Oramorph administration (Appendix G)).



When not in use:

• the trolley must be locked and secured by being anchored to the wall

• the cupboard must be locked. 6.5.9 Individual Patient Medication Lockers These lockable cupboards must be of a suitable standard to comply with British Standard 2881. They must be kept locked at all times. The medicines for a patient should be kept in this locker with the exception of Schedule 2 & 3 Controlled Drugs and items which need to be stored in the fridge. 6.5.10 Storage and recording of self-administration of rescue medications Certain medicines that are used for the acute relief of symptoms (e.g. GTN spray or tablets, reliever inhalers) are left in the possession of the patient to use, as required and stored safely out of sight and the reach of other people when this is appropriate. The use of these medicines should be prescribed and administration recorded on the All Wales Administration record and the following points completed:

• There has been completion of an assessment of patient competency recorded in the nursing notes.

• The drug is marked “self” alongside the prescription entry in the drug chart.

• A record of the patients self administration is made on the inpatient medication chart, so that the frequency of use is recorded

It is the responsibility of the nursing staff to ensure that patients own medication and any individually dispensed items are transferred with the patient. Any drugs remaining after a patient has been discharged must be removed immediately and returned to the pharmacy department for safe disposal/reuse as appropriate. 6.5.11 Intravenous Fluids Storage of intravenous fluids must be in a designated area away from heat, and maintained in a clean condition with correct stock rotation. Access by visitors and general public must be restricted. As it is not practicable to store these items in locked cupboards, the use of racking or dispensing units is acceptable. 6.5.12 High Risk Medicines Some medicines require increased storage controls to minimise risks in use. This includes the following (not exhaustive and may be amended as required)

• Potassium containing injections and infusions are subject to the HDUHB IV Potassium Procedures in line with NPSA recommendations: http://howis.wales.nhs.uk/sitesplus/documents/862/HDHBPotassium%20Chloride%20procedure_2_%20Oct%202013.pdf

• Epidural solutions: NPSA guidance Epidural injections and infusions (NPSA/2007/21 Issue date 28th March 2007). A HB policy is under development (LINK when approved.)



• Cytotoxics: If cytotoxics (parenteral or oral) require additional storage requirements, the pharmacy issuing will advise what additional precautions need to be taken on an individual item basis.

6.5.13 Emergency Drug Boxes and Trays These must be readily available at all times and kept in a designated area within the ward/department. Once the seal of an Emergency Drug Box is broken, the box must be returned as soon as possible to Pharmacy for replacement. 6.5.14 Flammable Cupboard There are certain areas where it will be necessary to store flammable products in specially designed cupboards. Advice can be obtained from Pharmacy. 6.5.15 Inhalation Anaesthetic Agents In all areas, such as operating theatres, stocks must be stored in a separate metal lockable cupboard. 6.5.16 Medical Gas Cylinders These must ideally be stored in purpose built medical gas stores. In operating theatres running stocks will be stored in the areas designated for this purpose. On the wards, the cylinders must be chained to the wall as detailed in NPSA alert Oxygen Safety in Hospitals (NPSA/2009/RRR006) Issue Date 29th September 2009. http://www.nrls.npsa.nhs.uk/resources/?entryid45=62811 6.6 Control of Medicinal Products It is the responsibility of the ward Sister/ Department Manager to ensure that the procedures for the control of all medicinal products are enforced. Only registered Healthcare Professionals, or other staff as delegated by Registered Healthcare Professional, are allowed access to medicinal products storage cupboards. The Controlled Drug cupboard must be kept locked when not in use. 6.6.1 Keys The keys of all the medicines cupboards (including CD cupboard must be kept on the person of the registered Healthcare Professional (RGN/ODP) at all times. When clinics and outpatient departments are closed the keys should be securely stored in a locked cabinet. In the event of loss of keys, contact the Senior Nurse/Team Leader (Duty manager/Site manager out of hours) for advice regarding spare keys. 6.6.1.1 Controlled Drugs Cupboard Keys Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CDs. Please refer to Appendix G for a full list of areas requiring a SOP.



The key for the Controlled Drugs cupboard and general keys must be kept on two distinct separate bunches. The Controlled Drug cupboard must be kept locked when not in use.

The Controlled Drug cupboard keys will be kept on the person in charge of a specified area, or their designated deputy (e.g. this may be the nurse in charge of a team). Loss of keys must be reported to the ward/department manager, the relevant Head of Nursing or deputy, the Senior Pharmacist on site (Out of hours: Duty manager/Site manager/on-call pharmacist) and reported through Datix. Specific departmental guidance has been developed for procedures within the operating theatre which must be adhered to. 6.6.2 Checking Stock-Balance of Controlled Drugs (Wards and Departments) Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including stock balance. Please refer to Appendix G for a full list of areas requiring a SOP. An example of an entry in a CD register can be seen in Appendix N

• Balance checks must be carried out at least once every 24 hours, where appropriate, by two authorised staff.

• This is the responsibility of the ward senior registered Healthcare Professional in charge although this responsibility may be delegated

• The balance check event must be recorded in the appropriate section of the Controlled Drug Register and signed by both staff carrying out the check.

• Discrepancies should be reported immediately to the senior registered Healthcare Professional in charge of the ward who will then inform the Duty Manager and Senior Pharmacist on site. A Datix incident report must be made for all discrepancies.

• The CD Register balances must be reconciled against CD cupboard stock, periodically every three – six months by a pharmacist and ward nurse.

• A monthly audit of the process of daily CD checks is undertaken by the ward sister or departmental manager and forwarded to the Senior nurse for monitoring purposes to ensure that daily 24 hour checks have been carried out and those entries are consistent with policy.

• Where discrepancies cannot be accounted for the Duty Manager and Senior Pharmacist on site must inform the police.

6.6.3 Apparent Excessive Use of a Specific Medicinal Product in Hospital In hospitals, this must be reported as soon as possible by the person identifying the situation to the ward Sister/Department manager The Senior nurse/Team leader/Departmental manager must be informed and, in consultation with the Head of Pharmacy and Medicines Management (or deputy), appropriate action must be taken to monitor and control the situation. Out of normal working hours the Site Manager must be informed.



6.6.4 Apparent Loss of Medicinal Products In hospitals, this must be reported immediately by the person identifying the loss to the ward Sister/Department manager. If the discrepancy cannot be resolved then further action will be instigated following consultation with the Head of Pharmacy and Medicines Management (or deputy). Out of normal working hours the Site Manager must be informed. All Controlled Drug discrepancies must be reported as an incident on Datix. These are reviewed by the Local Intelligence Network on a regular basis. All incidents of unaccounted Controlled Drugs will be reported to the police by the Head of Pharmacy and Medicines Management (or nominated deputy). The Accountable Officer will be notified and the incidents reviewed by the Local Intelligence Network on a regular basis. In the Community, the stock balance of Controlled Drugs must be reviewed at each visit. Any discrepancies should be reported to the prescriber and the relevant Community Service Manager. 6.6.5 Inspection of Stock, Storage Facilities and Maintenance of Records in Hospitals The security of Controlled Drugs on wards, units and departments must be checked by pharmacy staff in conjunction with the ward Sister with audit and reconciliation at least every three months (quarterly) and when managerial responsibility changes. 6.6.6 Change to Medication Container Labels Transfer of medicinal products from the original container and alteration of the medicinal product label must not be carried out by nursing staff. 6.7 Medicinal Products Brought into Hospital by Patients Specific procedures to ensure the safe use of patients’ own medicines whilst they are in-patients have been developed in accordance with current good practice.

6.7.1 Patient Admission Process If a patient brings medication that they are currently using into hospital, then they should be stored in the individual patient medication locker where provided. If individual patient medication lockers are not in use, the patient’s medication must be stored in a locked medicine cupboard or ward trolley. Care must be taken to ensure that the medication is only administered to the patient it belongs to. On admission, the Registered Healthcare Professional must encourage the patient or a responsible relative to provide all medicines used by the patient for reconciliation and identification by the medical/dental officer or pharmacist. If a medical/dental officer or pharmacist is not available the medicinal products must be placed in an individual patient medication bag and stored in a locked cupboard until identification can take place. NOTE: These medicinal products remain the property of the patient. 6.7.2 Assessment of safety of patients own medication During working hours – the pharmacist/pharmacy technician should check Patients Own Drugs (PODs) prior to their use and this will take place routinely on ward visits. Where a member of



the pharmacy staff do not attend on a daily basis, any queries or concerns should be referred to the pharmacy department. Ideally only tamper-evident preparations are acceptable e.g. tablets or capsules in blister packs, unopened liquid preparations with seal still intact. Where this would compromise patient care, partially used medication packs can be used. (e.g. ‘special’ unlicensed liquid medicines). The medication container must be clearly labelled with:

• name of patient

• name and strength of drug

• date dispensed

• name and address of supplier The patient’s own medication must not be used if:

• the medication was dispensed more than 6 months previously or when a shorter expiry has been passed

• the labelling on the medication is handwritten Where possible the medication in the container must be identified as being the same as that written on the label. The patient’s own medication must not be used if:

• the medication appears to have been transferred from another container

• there is more than one type of medication in a container The appearance of the container, label and medicine must be acceptable, i.e.:

• container should be intact and reasonably clean

• label should be legible and clean

• tablet or capsules must be clean, whole and without visible signs of deterioration Medication without a dispensing label will not routinely be used. However, in certain circumstances it they may be used if it is presented:

• In blister packing clearly marked with the product name, strength and expiry date

• A clearly identifiable drug, in an original container, marked with an expiry date. Complementary therapies should be assessed and storage as other patient’s own medication. Measures must be taken to ensure that the medication has been stored appropriately; check with the patient if possible. If in doubt, do not use the medication. DO NOT USE PATIENT’S OWN MEDICATION WHERE THERE IS ANY DOUBT AS TO THE IDENTITY, STRENGTH, STORAGE CONDITIONS, EXPIRY DATES OR SHELF LIFE OF THE MEDICATION.

6.7.3 Guidelines for Nursing Staff on the Use of Patient’s Own Medication in Hospital During evenings and weekends, it may be necessary to use Patients Own Drugs (PODs) prior to their formal assessment by the pharmacist/technician. Prior to their use, a nurse must check their suitability using the guidance in 6.7.2 above. The ward pharmacy team will also assess these drugs, on their next ward visit.



The advice of the On-Call Pharmacist can also be sought if required. If there is any doubt regarding the identity of the medication, it must not be administered. The nurse, doctor and pharmacist must then agree an appropriate course of action, dependent upon the circumstances. All medication brought into hospital remains the property of the patient, and must not be destroyed or returned to pharmacy without the patient’s permission.

When a patient is admitted to hospital and brings their own medication with them (whether prescribed or bought over the counter) the nurse will bring this to the attention of the admitting doctor. The medicines will be stored in the individual medication lockers. Inhalers, glyceryl trinitrate spray/tablets, creams and eye drops (which do not require refrigeration), can be left with the patient if appropriate (see Section 6.5.9)

Patient’s own medication will be used provided that the medication complies with the guidelines given. Patient’s own medication will be examined by a pharmacist or pharmacy technician on his/her next ward visit. The medication will be checked against the guidelines in 6.7.2.

The pharmacy team will endorse the chart with ‘patient’s own’. Patient’s own medication must only be used for the patient for whom they were originally prescribed.

Drugs which are not appropriate for continued use must be sent to pharmacy for destruction after receiving the patient’s consent. If consent is not given, this must be recorded on the nursing assessment form and further advice sought. The patient’s own medication will form part of the patient’s discharge drugs after the ward pharmacist has reviewed the TTH prescription.

It must be noted that relatives are not expected to obtain supplies of medication from the patient’s General Practitioner, if the patient’s own drugs are not available. 6.7.4 Patient’s Own Controlled Drugs Where appropriate patients’ own Controlled Drugs can be used. In such cases, Controlled Drugs must be entered in the Controlled Drugs Register under a section reserved for PATIENT’S OWN MEDICATION. The drugs must be stored in the Controlled Drugs cupboard and their suitability for in-patient use confirmed by a pharmacist on the next ward visit. Each dose administered must be recorded in the Controlled Drugs register. Patients’ own Controlled Drugs must only be used for the patient for whom they were originally prescribed. Where the patient is admitted and is receiving treatment for substance misuse the CD must be stored in the CD cupboard and administered at appropriate times. The CD must not be self administered. When the patient is discharged the CD should be returned to the patient if clinically appropriate. The drug must be signed out of the register by a registered nurse and witnessed by another suitably qualified person. If the CD is not returned to the patient it must be returned to the pharmacy for destruction with the ward pharmacist.



6.7.5 Unidentified suspected illicit substances Where a patient has brought in with them medicines that cannot be identified and there is suspicion that they are illegal substances, the patient must be asked to surrender these medicines in order to ensure continued safety of any medical intervention. The declaration form must be completed (Appendix O) (available at: http://howis.wales.nhs.uk/sitesplus/documents/862/Unidentifiable%20tablets%20Substance%20Letter%20%20February%202014%20_2_.pdf ) and the medicine removed and returned to pharmacy for safe disposal. In addition to this the guidance below should be followed:

• An entry must be made on the appropriate form by a registered nurse, noting the date and description of the substance. This must be countersigned by another nurse.

• The substance must be locked in the Controlled Drug cupboard and pharmacy informed. If it is outside normal pharmacy working hours, wait until the next time pharmacy is open. The patient’s consent must be obtained and if consent is not given this must be documented and further advice sought

• A pharmacist will attend the ward and will remove the substance from there. He/she will sign the form indicating date of removal, and a registered nurse will countersign the pharmacist’s signature.

• The substance once in pharmacy will be weighed and then locked in the pharmacy Controlled Drugs cupboard (with the expired Controlled Drugs). An entry will be made in the Controlled Drugs destruction book, noting the date the substance was taken into pharmacy, the description of the substance, the weight of the substance and the signature of the pharmacist who took it off the ward.

• The police must be informed of the substance, who will then attend to collect it for destruction. The police officer removing the substance will provide identification and sign the Controlled Drug destruction book. The police officer will not have access to the declaration form.

• NB Patient confidentiality must be maintained. 6.8 Disposal of Medicinal Products 6.8.1 Disposal of Patients’ Own Medication For medicinal products brought into hospital by the patient, which will not be required on discharge, consent must be sought from the patient or next of kin to destroy the products. Medicinal products for disposal must be sent to the Pharmacy department in a sealed container Where a patient refuses to agree to the destruction of such products, or refuses to hand over medicinal products which are contra-indicated, the risk must be explained to the patient and the responsible doctor informed. This must be documented in the patient’s records and further advice sought from the Senior nurse, Consultant or Senior Pharmacist. In the case of children, the legal guardian may give authority for the disposal of medicinal products.



In the event of patients bringing illicit drugs (or substances suspected of being illegal drugs) with them into hospital or any Health Board premises, the appropriate procedure must be followed (see 6.7.5).Contact the Pharmacy department for further advice. In respect of patients who lack mental capacity, it may be necessary to remove drugs which, although not unlawful for the patient to possess, could be dangerous to the patient. For further advice see 6.2.11 or contact the Mental Capacity Act Lead Officer. 6.8.2 Disposal of Patients’ Own Controlled Drugs Important Note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including destruction. Please refer to Appendix G for a full list of areas requiring a SOP. All Controlled Drugs which a patient has brought into hospital are the legal property of that patient. When the patient is discharged the Controlled Drug should be returned to the patient if clinically appropriate. The drug should be signed out of the register by a registered nurse and witnessed by another suitably qualified person. If the drug is not returned to the patient it should be returned to the pharmacy for destruction with a pharmacist in line with local procedures. 6.8.2.1 Substance Misuse Where a patient is admitted and is receiving treatment for substance misuse, the Controlled Drug must be stored in the CD cupboard and be administered at appropriate times. The Controlled Drug should not be self administered. When the patient is discharged the Controlled Drug must be returned to the patient if clinically appropriate. The drug should be signed out of the register by a registered nurse and witnessed by another suitably qualified person. If the drug is not returned to the patient it should be returned to the pharmacy for destruction with a pharmacist. 6.8.2.2 Unwanted Medicinal Products in the Community Under no circumstances must community Healthcare Professionals take surplus medicinal products into their possession from patients/carers or next-of-kin or make any further use of them. It is the duty of community Healthcare Professionals to advise their patients and relatives on the correct destruction/disposal of unwanted medicinal products. Unwanted medicinal products must be returned to the community pharmacist for destruction. It is not the responsibility of the community Healthcare Professional to return the medicinal products to the community pharmacy. However Community Healthcare Professionals may hold temporary possession of medicines, in exceptional circumstances, in order to return them to the Community Pharmacy for destruction with the agreement of the patient, carers or next-of-kin.



All residual contents of ampoules or vials must be sent for disposal in the appropriate container in accordance with HB Policy. 6.9 Disposal and Destruction of Medicinal Products Medicinal products prepared for use, but not administered, must be disposed of in accordance with the appropriate disposal procedure and recorded on the non-administration section of the prescription sheet In the community medicinal products should be returned to the community pharmacy for safe disposal. 6.9.1 Unwanted and out-of-date Stock Items in Hospital Ward/department stock lists must be regularly reviewed by the clinical pharmacist and ward/department manager. Stock items no longer required must be returned to the pharmacy via the top-up system. Broken containers and their contents, or contaminated medicinal products must be disposed of observing the appropriate disposal procedures. 6.9.1.1 Controlled Drugs (Stock Items) Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including disposal. Please refer to Appendix G for a full list of areas requiring a SOP. Ward stocks of Controlled Drugs for destruction (e.g. Date expired/unable to be returned to pharmacy stock for re-issue – such as opened liquids) may be written out of the ward Controlled Drugs register, countersigned by a pharmacist and the registered Healthcare Professionals charge of the ward at the time, and entered into the Controlled Drugs destruction book/register in the Pharmacy department. NB. Individual doses that are prepared and not administered/fully administered should be destroyed on the ward/department in the presence of a second person (who could be a pharmacist or registered Healthcare Professional). This includes the remains of partly used vials which in the case of small volumes should be disposed of in a sharps bin. An entry of the destruction is to be made in the Controlled Drugs register with both parties witnessing the destruction. 6.9.2 Unwanted and out-of-date non-stock items in hospital Unwanted non stock items must be returned to the pharmacy once the patient no longer requires the medication. They can be returned either via a member of the pharmacy team or through the top up system. 6.9.2.1 Controlled Drugs (Non-stock Items) Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities



relating to CD including destruction. Please refer to Appendix G for a full list of areas requiring a SOP. Schedule 1, 2 and 3 Controlled Drugs stock can only be destroyed in the presence of a person legally authorised to witness destruction. (Appendix A 1.3) When a Controlled Drug is destroyed, details of the drug must be entered in the Controlled Drugs destruction book/register in the Pharmacy department. This should include:

• the name of the Controlled Drug

• form

• strength

• quantity

• the date the drug was destroyed

• the signature of the Authorised Witness who witnessed the destruction and the professional destroying it (i.e. two signatures).

This section of the policy is in accordance with current Home Office guidance, Waste Management Regulations and Environment Agency guidance. The methods used for denaturing are in accordance with RPSGB guidance. (See - RPSGB guidance [Guidance for Pharmacists on the safe destruction of Controlled Drugs: England, Scotland and Wales. LInk) The Environment Agency (EA), which covers England and Wales, has decided that it is not in the public interest to expect pharmacies to obtain a waste management licence for denaturing CDs as this is seen by the EA as a ‘low risk’ activity. 6.9.3 Patient Controlled Analgesia/Epidurals PCAs / epidurals for patients in theatres are recorded in the theatre Controlled Drugs record book. When a patient is transferred to a ward area there is no requirement to transfer the volume balance to the ward CD register. However, wastage of PCA/epidurals must be recorded on a separate page of the ward Controlled Drugs register entitled PCA/Epidural/Infusion Waste. 6.9.4 Patient’s Own Medication no longer required. If a patient no longer requires a medication that they brought into hospital or failed to take it home, it must be returned to the Pharmacy department. 6.9.4.1 Patient’s Own Controlled Drugs Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including disposal. Please refer to Appendix G for a full list of areas requiring a SOP. A patient’s own Controlled Drugs that are for destruction must be disposed of in accordance with the Pharmacy department approved SOP. 6.9.5 Unwanted Controlled Drugs in Community Important note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities



relating to CD including disposal. Please refer to Appendix G for a full list of areas requiring a SOP. Under no circumstances should community Healthcare Professionals take surplus medicinal products that are CDs into their possession from patients/carers or next-of-kin or make any further use of them. It is the duty of community Healthcare Professionals to advise their patients and relatives on the correct destruction/disposal of unwanted CD medicinal products. Unwanted CDs should be returned to the community pharmacy for destruction. It is not the responsibility of the community Healthcare Professionals to return the medication to community pharmacy. However Community Healthcare Professionals may hold temporary possession of medicines, in exceptional circumstances, in order to return them to the Community Pharmacy for destruction with the agreement of the patient, carers or next-of-kin. All residual contents of ampoules or vials must be sent for disposal in the appropriate container. 6.9.6 Method of Destruction of Controlled Drugs Important Note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including destruction. Please refer to Appendix G for a full list of areas requiring a SOP.

• Recommended methods of destruction are provided by the Royal Pharmaceutical Society of Great Britain and include systems for denaturing. A risk assessment should be undertaken to determine the most appropriate method of denaturing within each pharmacy department.

• Small volumes e.g. part ampoules/vials or doses drawn up but not given can be destroyed on the ward by emptying into a sharps bin with the then empty container. This must be done by and witnessed by authorised ward staff (registered nurse/midwife, operating department practitioner, pharmacist, doctor or anaesthetist).

• Discontinued infusions/PCA syringes should be disposed of on the ward. This must be carried out and witnessed by authorised ward or department staff and recorded on the infusion chart.

6.9.5.1 Destruction of Patient’s Own Controlled Drugs Important Note: The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 require that there are standard operating procedures (SOP) in place for a range of activities relating to CD including destruction. Please refer to Appendix G for a full list of areas requiring a SOP.

• It should be noted that witnessed destruction as described above does not apply to previously dispensed controlled drugs brought in to hospital by a patient. However, there is a general duty of care to ensure appropriate disposal of waste medicines.

• All CDs as per Appendix G will be destroyed by a pharmacist/registered pharmacy technician and witnessed by a second pharmacist/registered pharmacy technician in



line with their SOP. At least one of the staff carrying out the procedure must be a pharmacist. A record of destruction will be made.

7. RESPONSIBILITIES 7.1 Chief Executive and Board (as commissioner/provider) Provision of resources to ensure the safe prescribing, administration, storage, transport and disposal of medicines is the responsibility of the Chief Executive and Board. It is their responsibility to ensure that guidance is consistent with the legal requirements, NHS and WG local Health Board guidance.

The leadership of the organisation should be able to monitor adherence to this policy.

Where there is non-compliance the Board is responsible for ensuring that there are appropriate actions in place to mitigate any risks identified.

7.2 Director of Nursing & Midwifery Is responsible for the implementation and review of this policy in consultation with other Healthcare professionals.

7.3 Head of Medicines Management Is responsible for the implementation and review of this policy in consultation with other Healthcare Professional.

7.4 Medical Director Is responsible for the implementation and review of this policy in consultation with other Healthcare Professional.

7.5 Senior Management Leads The Senior Nurse Managers, Senior Pharmacists, Consultants and Professional Heads of Department are responsible for the dissemination of this Policy, monitoring the implementation and auditing adherence to the Policy.

7.6 Individual staff (registered Healthcare professionals) Are responsible for making themselves aware of and implementing this policy, following the standard operating procedures and guidelines included and referring to other Health Board policies for further information. Staff must report any incidents where this policy is not adhered to.

7.7 HDUHB Medicines Management Group and Clinical Policy Review Group The Medicines Management Group (MMG) and the Clinical Policy Review Group (CPRG) are responsible for approving this policy and any subsequent amendments. 8. TRAINING Training will be organised by the Head of Nursing Acute Service and the Community Services Manager, Head of Medicines Management, Medical Director and Heads of service for other professional staff on the requirements of this policy, working with practice development leads and the HB Learning & Development team.



A record will be kept of the training and the assessment of competencies required under the policy. Elements of the policy will be reviewed with individual staff as part of their PDP, and as part of an action plan following an incident involving medication. Regular updates on the actions outlined in this policy will be provided and all staff will be expected to ensure their continued competency.

Training will be overseen by senior pharmacists and senior nurse managers and medical Clinical Leads across the Health Board working with Practice Development Leads and the Learning & Development team.

9. MONITORING/ASSURANCE This policy and procedures are monitored through Datix incident reports (including SUIs) by departmental managers and MERG, prescribing intervention audits for medicines (including antibiotics), regular ward stock checks and reviews (including Controlled Drugs), NPSA audits for high-risk medicines, Medication Safety Audits and compliance with departmental SOPs, HB Internal audits, HIW DECI Inspections and Welsh Audit Office programmes. 10. FURTHER INFORMATION National Institute for Health and Care Excellence: http://www.nice.org.uk/ All Wales Medicines Strategy Group: http://www.awmsg.org.uk/ Royal Pharmaceutical Society http://www.rpharms.com/home/home.asp General Pharmaceutical Council http://www.pharmacyregulation.org/ Health & Care Professions Council http://www.hpc-uk.org/ General Medical Council http://www.gmc-uk.org/ The Royal College of Anaesthetists http://www.rcoa.ac.uk/ Nursing & Midwifery Council http://www.nmc-uk.org Royal College of Nursing http://www.rcn.org.uk/ WG Chief Medical Officer letters http://gov.wales/topics/health/cmo/publications/cmo/?lang=en WG Chief Pharmaceutical Officer http://gov.wales/topics/health/cmo/professionals/pharmaceutical/?lang=en WG Chief Nursing Officer http://gov.wales/topics/health/cmo/professionals/officechiefnursing/?lang=en NHS Patient Safety (links to NPSA) http://www.nrls.npsa.nhs.uk/ East Anglia Medicines Information Service Retention of Pharmacy Records 5th Ed (April 2015) http://www.medicinesresources.nhs.uk/en/Communities/NHS/SPS-E-and-SE-England/Reports-Bulletins/Retention-of-pharmacy-records/

10.1 References Medicines Act 1968 Human Medicines Regulations 2012 http://www.legislation.gov.uk/uksi/2012/1916/contents/made Nursing & Midwifery Council (Standards for Medicines Management (May 2008) Safe and Secure Handling of Medicines (Revision of Duthie Report (1988) March 2005). NPSA Safety in Doses: Improving the use of Medicines in the NHS (2007-08) Medicines & Healthcare products Regulatory Agency (MHRA) Misuse of Drugs Act 1971 and its secondary legislation:

Misuse of Drugs (Safe Custody) Regulations 1973 (SI 1973 No 798) Misuse of Drugs (supply to addicts) Regulations 1997 Misuse of Drugs Regulations 2001



Controlled Drugs (Supervision of Management and Use) Regulations 2006 (www.opsi.gov.uk) Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007 The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008 Security of Drugs Liable to Misuse HM(70)1; EHC(77)38;WHN(78)56 Measures for Controlling Drugs on the Wards HM(70)36 Medicine related safety guidance

All Wales Medicines Strategy Group (AWMSG) Prescription Writing Standards) http://www.awmsg.org/docs/awmsg/medman/All%20Wales%20Prescription%20Writing%20Standards.pdf WHC (00)116 Royal Marsden Manual www.blackwellroyalmarsdenmanual.com NPSA Safe Medication practice Programme on Injectables (2007/8) http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812 GMC Good practice in prescribing and managing medicines and devices (2013) http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp NICE / NPSA Technical Patient Safety Solutions for Medicines Reconciliation on admission of adults to hospital. December 2007 NPSA Alerts NMC Standards for medicines management http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf NMC Standards of proficiency for nurse and midwife prescribers (2006) http://www.nmc-uk.org/documents/standards/nmcstandardsofproficiencyfornurseandmidwifeprescribers.pdf Trusted to Care Andrews/Butler Report http://gov.wales/docs/dhss/publications/140512trustedtocareen.pdf 11. REVIEW This Policy will be reviewed after 3 years, or sooner, as required Any queries regarding this document or any comments, views, feedback regarding its implementation in practice should be referred either to the:

• Head of Medicines Management

• Director of Nursing & Midwifery

12. GLOSSARY OF TERMS Term Definition

Adverse Drug Reaction (ADR)

An adverse drug reaction is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use, which is suspected to be related to the drug.

All Wales In-patient Medication Administration Record

For the purpose of this policy the prescription chart and All Wales In-patient Medication Administration Record are inter changeable and relate to the same document.



ART Acute Response Team (which form part of Community Services

Carer A person, usually a relative, parent, spouse, partner, child or friend, who provides regular and substantial voluntary care, often in lieu of a paid care worker, to someone who is disabled, severely or chronically ill, frail or who has a mental health problem.

Controlled Drugs

A Controlled Drug is one that is listed in Schedules 1-5 of the Misuse of Drugs Regulations 2001(and subsequent amendments). NB The Health Board may take a decision to increase the regulation requirements locally for certain substances. See Appendix M for current local requirements.

Drug related 'Patient Safety Incidents'

A patient safety incident is defined by the NPSA as: "an unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS funded healthcare."

Green Bags Green plastic bags are used to contain patient’s own medicines in order to transfer them between home (ambulance services) and hospital and between wards. This is to reduce the risk of loss of patients’ own medicines. Green bags can be obtained from the hospital pharmacy departments.

Medicinal Products

For the purpose of this document, Medicinal Products are defined as any substances or articles administered to a human being for medicinal purpose. These include drugs, dressing and wound management products, and dietary supplements (enteral and parenteral), as defined in the current British National Formulary.

MHRA Medicines and Health products Regulatory Agency

NMC Nursing and Midwifery Council

NPSA National Patient Safety Agency

NRLS National Learning and Reporting System PGD Patient Group Direction

Written instructions for the supply or administration of medicines to group of patients who may not be individually identified before presentation for treatment.

PSD Patient Specific Direction Written instructions form an independent prescriber (doctor, dentist or independent nurse prescriber) to another healthcare professional, to supply and/or administer a medicine directly to a named patient, or to several named patients.

Prescription chart For the purpose of this policy the prescription chart and All Wales In-patient Medication Administration Record are inter changeable and relate to the same document.



13. APPENDICES

A. Roles and Responsibilities of the Accountable Officer & Authorised Witness B. Pharmacist Enabling and Therapeutic Switch Guideline (Acute Sector) C. Medicines Reconciliation on Admission of Adults to Hospital SOP D. Guidelines for the Provision of Safe Patient Discharge during pharmacy out of hours. E. HCSW Competency Training (under development) F. SOP for Promoting Safer Use of Injectable Medicines G. Controlled Drugs Standard Operating Procedures H. Standard Operating Procedure for single nurse administration of morphine sulphate

(10mg/5ml) oral solution (“Oramorph®”) I. Medication Incident Reporting Trigger List J. Guidelines for the Self-administration of In-Patients’ Own Medicines

& Self Administration Of Patients Own Insulin. K. Inter Ward Transfer Form L. Transport of Cytotoxic Medicines Form M. Local Requirements for the Storage, Administration & Prescription for Controlled Drugs

in Hywel Dda UHB (Acute sector wards, clinic & departments) (including mifepristone) N. Example of entry in CD Register O. Surrender of Unidentified Tablets/Substance Form P. Shelf life of oral liquid medicines Q. Managed Entry of Medicinal Products onto the HDUHB Formulary R. Patient Group Directions Process S. SOP Medicines Safety Audit T. SOP Monitoring & Recording of Refrigerator Temperatures



APPENDIX A: THE ROLES AND RESPONISBILITES OF THE ACCOUNTABLE OFFICER 1.1 The Accountable Officer The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008, states that organisations are required to appoint accountable officers. A designated body must nominate or appoint (or under regulation 5(2) or (4) jointly nominate or appoint with one or more other bodies) a fit and proper suitably experienced person as its accountable officer. A designated body must notify the Chief Executive of HIW in writing:-

• any nomination or appointment by it in under paragraph (1) as soon as practicable; and

• the removal of an accountable officer by it (whether or not under regulation 6) as soon as practicable.

• HIW must publish, from time to time and in such manner as it sees fit, a list of accountable officers of designated bodies in Wales.

The Chief Executive may nominate senior staff as Accountable Officers who report directly to the Health Board Chief Executive and who have responsibility for Health and Safety Security or Risk Management matters in the Health Board. The Delegated Accountable Office for Hywel Dda Health Board as of March 2012 is the Director of Primary, Community and Mental Health.

1.1 Other individuals who may be nominated as accountable officers are:

(i) Royal Pharmaceutical Society Inspectors, Home Office Inspectors, police chemist inspection officers, Chief Dental Officer in the Department Of Health/Senior Dental Officer to whom authority has been designated.

(ii) Supervisors of Midwives appointed by the Local Supervising Authority. (iii) It should be noted that these individuals must be independent of the routine supply

and administration of Controlled Drugs. Accountable Officers designate should not be authorised people to witness destruction as one of the criteria for Accountable Officers is their independence from day to day management of Controlled Drugs.

1.2 Designated Bodies The following are prescribed as designated bodies for the purposes of section 17 of the 2006 Act:

• Local Health Board;

• an NHS Trust;

• Local Health Body (merged Trust & LHB )

• the Welsh Ambulance Services NHS Trust;

• a Welsh independent hospital.

1.3 Roles and Responsibilities Responsibilities of the Accountable Officer (AO) for the Hywel Dda University Health Board



(i) The AO must ensure a policy and procedures for CDs are in place. SOPs must at least cover:

• Who has access to CDs/ assigning responsibilities

• Where CDs are stored

• Security of storage and transport as per Misuse of Drugs legislation

• Disposal and destruction

• Who is alerted should incident/complications arise

• Record keeping

• Maintaining CD registers according to Misuse of Drugs legislation.

• Maintaining record of CDs returned by patients. (ii) SOPs must be reviewed/amended to reflect changes in the legislation and

impending review dates. (iii) Ensure arrangements are in place for routinely monitoring the safe use and

management of CDs in their Health Board. This includes:

• Ensure all those working with CDs are appropriately trained, according to SOPs.

• Ensure that arrangements are in place for assessing and investigating concerns, and that they are alerted to any significant findings.

• Define the relationships between the AO and existing local performance structures.

• Define the relationship between the AO and existing local groups e.g. Medicines Management Group, Clinical Governance Committees, Medicines Management Teams.

• Ensure suitable arrangements are in place for disposal of CDs.

• Check that systems are in place to identify and act on triggers, e.g. patient complaint, police intelligence, or concern raised by a healthcare professional, which ensure the AO is informed.

• There is an incident reporting system and all such reports are analysed and actioned.

(iv) Ensure the self assessment declaration, requested by HIW is completed and

returned. (v) Ensure adequate records are kept of concerns, including at least:-

• date concern made known to the Accountable Officer

• date matters of concern took place

• details of nature of concern

• details of relevant individual to whom concern expressed, and also of who made the concern known

• details of action taken by the designated body

• an assessment of whether information should be disclosed to another responsible body, and if so the name of this body and information given.

1.4 Authorised Witness Persons Currently Authorised to Witness the Destruction of Controlled Drugs These are specified in the Destruction CD guidance, Dangerous Drugs, Wales. The Controlled Drugs (Supervision of Management and Use) (Wales) Regulations 2008. A list of current persons authorised to witness the destruction of Controlled Drugs by the Accountable Officer is available for the County Lead for Medicines Management.



Appendix B: Pharmacist Enabling and Therapeutic Switch Guideline (Acute Sector) INTRODUCTION Pharmacists routinely review prescriptions for patients and work in partnership with other health care professionals to ensure optimal outcomes from drug treatment and maintain patient safety. Pharmacists often have to contact the prescriber to correct obvious errors on the prescription chart. This protocol is needed as the Medicine Act (1968) and the Human Medicines Regulation 2012 does not authorise pharmacists to change prescriptions without first contacting the prescriber. This protocol outlines amendments that pharmacists can make to the prescription chart without first contacting the prescriber. The Health Board has preferred drugs within a class which are more cost effective. This protocol also enables pharmacists to switch suitable patients to the preferred drug and ensure that prescribing reflects Health Board policy. SCOPE The policy applies to all pharmacists and provides guidance for all prescribers in the acute sector (in-patients, out-patients, community hospitals and mental health). The policy only applies to ADULT patients. AIMS The protocol aims to ensure that any changes that need to be made (for example, doses, timing of doses or where drugs have been duplicated) are made as soon as they are noted by the pharmacist and not delayed until the medical team are next on the ward to action them. The protocol aims to ensure that drugs prescribed reflect Health Board policy, ensure patients do not experience avoidable adverse effects and are the most cost effective option. OBJECTIVES The purpose of this protocol is to enable pharmacists to make minor changes to prescriptions, within the law, to facilitate the smooth running of wards, to ensure patient safety and enable prompt dispensing and administration of medication to patients. GUIDELINE

THIS GUIDELINE APPLIES TO ADULT PATIENTS ONLY Pharmacists working the Acute Sector of Hywel Dda Health Board may make amendments to a prescription, without first contacting the prescriber, in line with the Appendices attached and following Clinical Pharmacy Standard Operating Procedures.



Action to be taken when amending prescription charts: Appendix 1: Intravenous to oral switches Action see appendix Appendix 2: Switch of medicine/brand/formulation Annotate Prescription Appendix 3: Change of timing of administration Annotate Prescription Appendix 4: Alteration of dose or frequency of medication prescribed Annotate Prescription Appendix 5: Medication to be stopped on the Drug Chart Annotate Prescription Appendix 6: Other Amendments Annotate Prescription Appendix 7: Local Amendments Action see appendix 7 Appendix 8: Supporting Information for Appendices 1-6 Prescribers will be informed if a therapeutic switch is made by pharmacists by making an entry in the medical notes detailing which medication has been changed according to Health Board policy. Pharmacists should inform doctors if a prescription has been amended which had suboptimal prescribing information (dose, time etc) to educate prescribers and prevent reoccurrence. Where the medicines have been administered, the Senior Sister should be informed to enable appropriate action to be taken to prevent reoccurrence. Errors will be communicated through the line manager structure in line with organisational policies and procedures. Amendments to the Appendices will be approved by the HDHB Medicines Management Group (MMG). RESPONSIBILITIES Pharmacists are responsible for implementing the Pharmacist Enabling and Therapeutic Switch Guideline. Pharmacists are responsible for following the standard operating procedure for all therapeutic switches contained in the Pharmacist Enabling and Therapeutic Switch Guideline and referring to Health Board policies for further information. MMG are responsible for approving amendments (contained in the Appendices). TRAINING The Clinical Services Pharmacist Team Manager will provide training for all pharmacists on their clinical induction on the Pharmacist Enabling and Therapeutic Switch Guideline. A record will be kept of all pharmacists who have attended a training session and reviewed annually. Regular updates on the actions outlined in the Pharmacist Enabling and Therapeutic Switch protocol appendices will be provided. MONITORING COMPLIANCE



Incidences where this Guideline has not been followed will be reported to the appropriate Lead Clinical Services Pharmacist. Each hospital will review reported incidences at least yearly. FURTHER INFORMATION The General Pharmaceutical Council’s Code of Standards, Ethics and Performance must be followed by any pharmacist working under this policy. RELATED POLICIES The following reference sources outline the evidence for the amendments: NPC prescribing guidance. NICE & AWMSG guidance British National Formulary Hywel Dda Heath Board Formulary GLOSSARY OF TERMS



Appendices: Hywel Dda Health Board Pharmacists Enabling & Therapeutic Switch Guideline Document (Version 1) Approved HDHB Medicines Management Group December 2012

Pharmacist Enabling and Therapeutic Switching Guidelines This policy applies to ADULT patients only.

These appendices are a summary of amendments pharmacists may make to the medicine chart without contacting the prescriber. Prescribers will be informed if a therapeutic switch is made. Pharmacists will make an entry in the medical notes detailing which medication has been changed according to Health Board policy.

Pharmacists should inform doctors if a medicine charts has been amended which had incorrect prescribing information (wrong dose, time etc) to prevent the same error reoccurring.

Appendix 1

Intravenous to oral switches

Prescribed Medication

Substitution/Prescription Change

Comment Health Board Policy/ Costings

Action

Intravenous paracetamol

Oral paracetamol

Patients should not be continued on intravenous therapy when able to tolerate oral paracetamol

Annotate prescription chart

Intravenous ciprofloxacin

Oral ciprofloxacin

Applies ONLY to patients prescribed iv Ciprofloxacin because they were physically unable to take oral medication. If iv route indicated due to severity of infection, absorption problems or recommended for any other reason then patient is not suitable for pharmacist switching.

Make an entry in the patient’s medical notes noting the date and time of IV to oral change Add: Refer to HDHB IV to PO Switch Policy for Antibiotics (Updated MMG 11 2013)



Appendix 2

Switch of medicine/brand/formulation




Omeprazole tablets

Omeprazole capsules Tablets more expensive than capsules,

Dispersible formulations (Paracetamol, diclofenac, co-codamol ,lansoprazole Fastab etc)

Standard preparation

Dispersible formulations are more expensive than standard formulations and patients should be switched back once swallowing difficulties resolve

Calcium preparations Switch to formulary choice for newly initiated patients

1st line HDHB Formulary

Gaviscon Suspension Peptac/Gastrocote suspension

Cefradine/Cefaclor Cefalexin

As per HDHB Antibiotic Guidelines

Complan Shake/Fresubin Powder/Amyes Shake

Ensure Plus Milkshake/Fortisip For patients admitted from Community, only for duration of hospital stay, return to Complan/Fresubin on discharge

As per HDHB Pharmacy swap of powdered nutritional supplements (PNS) to ready made nutritional supplement (Ensure Plus) for duration of hospital stay

(Ref MMG 02 2013, 06 2013)

Patients unable to swallow tablets/capsules

Annotation of prescription chart to give liquid/suspension/mixture or crush tablets

Temazepam Zopiclone or zolpidem Introduced Aug 2013 in response to price increase for temazepam. Note exclusion criteria in additional guidance.

As per Prescribing Fact Sheet Temazepam to zopiclone or zolpidem (See Appendix 8)(Added Aug 2013)

Senna 7.5mg tablets 2 tablets Daily

Bisacodyl 5mg tablets 1 tablet Daily

Exclusions Stable palliative care patients and patients on clozapine.

Jan 2014: Senna tablets now cost £12 per 60 tablets in Primary Care, compared to bisacodyl 5mg £2.47 per

60 tablets, therefore bisacodyl preferred first-line. Constipation



See HDUHB Constipation Guidelines guideline amended (updated MMG Jan 20 14)

Nitrofurantoin 50mg capsules Nitrofurantoin 100mg MR BD for 3 days (women uncomplicated) or 7 days (complex or in men)

Nitrofurantoin can now be in patients with an estimated eGFR of more than

45ml/min/1.73m2

HDUHB Anti-infective Guidelines for Primary Care and A&E.

(Added MMG Jan 2015)



Appendix 3

Change of timing of administration




Anti-diabetic drugs Alter administration to meal times Prevent hypoglycaemia

Eye drops/inhalers/creams

Alter administration times according to when the patient usually takes the medication

Quinolones (ciprofloxacin, levofloxacin, moxifloxacin)

Alter administration times in relation to magnesium hydroxide, indigestion mixtures, iron and sucralfate

Quinolones are rapidly absorbed, taking them 2 hours before the interacting medication or 4 hours after should minimize the risk of admixture in the gut and largely avoid this interaction. Refer to individual SPC’s for further information.

Colestyramine

Alter administration time in relation to other drugs

Other drugs should be taken at least 1 hour before and 4-6 hours after colestyramine to reduce possible interference with absorption

Prednisolone oral

Alter administration to the morning for once daily dosing

Avoid alerting affect at night

Dexamethasone oral

Change time of last dose to no later than 4pm

Avoid alerting affect at night

Statins Change to night time dosing (Updated MMG Nov 2013)

Warfarin Change to time of administration agreed

As agreed with local policy

Parkinsons Disease Drugs Add specific times to prescription chart that patient should take medication

Annotate chart ‘please give at exact time stated’



Appendix 4

Alteration of dose or frequency of medication prescribed




Oral Amoxicillin qds Oral amoxicillin tds Unless part of a H.pylori regimen

Inhalers Amend to correct dose and strength if not specified, ensuring dose has not been changed since admission

Amend according to patients own drugs and/or GP records

Ciprofloxacin oral tds/qds Changed to ciprofloxacin oral bd Compliance with licensed dosage

Flucloxacillin tds Flucloxacillin oral qds Recommended frequency Exclude patients with renal impairment and Cystic Fibrosis patients

Phenytoin (NG) Suspension 100mg (90mg base) tds (15ml tds)

Phenytoin (NG) suspension 300mg (270mg base) nocte (45ml nocte)

Once daily administration of phenytoin suspension to reduce potential for interaction between NG feeds and phenytoin suspension

Drug prescribed which are not given on a daily basis, eg fentanyl patch, weekly methotrexate, weekly alendronate

Put an X in the administration signature box on the medicine chart on the days which the drug should not be given.

Ensure that these drugs are not administered more frequently than intended by the prescriber Annotate chart – give once weekly / every 72 hours.etc

Only 2.5mg of methotrexate to be used.

Simvastatin when prescribed with amiodarone/amlodipine/diltiazem

Change to 20mg NOCTE Maximum dose of simvastatin as per SPC

Paracetamol IV/PO prescribed for a patient<50kg

Cross off IV and rewrite as a separate prescription for 15mg/kg every 4-6 hours (max 60mg/kg)

(Added MMG Nov 2013)



Appendix 5

Medication to be stopped on the Drug Chart




Paracetamol Cross PRN off the in-patient chart and TTH if paracetamol based products prescribed at maximum dose on regular side

Tiotropium inhaler and nebulised Ipratropium prescribed together

Cross tiotropium off the chart for the period the patient is receiving the nebulised Ipratropium.

Statin with interacting drug Cross off statin dose while on the interacting drug

Restart as per guidance (Statins Interaction table)

See statins interaction table Note : All statins are to be stopped during fusidic acid therapy(Updated MMG Nov 2013)

Calcium preparations with bisphosphonate

‘Cross off/amend time of dose to prevent interaction’

(Updated MMG Nov 2013)

Duplication of medication Eg lansoprazole and omeprazole, Zantac and rantidine

Cross off inappropriate duplicated medication

Folic acid with methotrexate Cross off dose of folic acid on day of administration of methotrexate

As per BNF advice



Appendix 6

Other Amendments




Action

Add omitted eye drops, ear drops, inhalers or topical preparation to in-patient prescription chart or TTH from Drug History

Confirm Drug History as per SOP. Check in medical notes if omission is deliberate

(Added MMG Nov 2013)

Addition of an appropriate Proton Pump Inhibitor when a

patient is over 65 years old and on a NSAID

Addition of omeprazole 20mg daily or lanzaprazole 15-30mg daily

Check appropriateness of NSAID use (AWMSG NPI) before adding PPI.Check for contra-indications, interactions (eg omprezole with clopidogrel) and previous ADRs/allergies before adding to the prescription chart. Label the PPI and advise patients that the PPI use is only while they are taking a short course of a NSAID

As per BNF advice (1.3 & 1.3.5)

NICE Osteoarthritis CG177 (2014)

AWMSG National prescribing Indicators-

appropriate use of NSAID

Addition of an appropriate Proton

Pump Inhibitor when a patient is over 65 years

old and on a NSAID

(Added MMG Jan 2015)



Appendix 7

Local Amendments The amendments below are not applicable Health Board wide and will need local agreement




Action

Seretide evohaler 250

Seretide Accuhaler 500 Symbicort Turbohaler400/12 (Check which is preferred with local consultants)

Change newly initiated and existing patients to an accuhaler on resupply.Seretide accuhaler dose is 1 puff and evohaler is 2 puffs. Seretide evohalers are not licensed for use in COPD Patients need to be educated .Not possible to change all patients if technique not appropriate. Liaise with respiratory nurses if necessary

Note Basic NHS cost of Seretide 250 Evohaler £59.48 Seretide 500 Accuhaler £40.92 Symbicort 400/12 Turbohaler £38.00 (BNF September 2012)

Annotate prescription chart/TTH and make an entry into patient’s medical notes

Amiodarone 200mg tds (Where chart has not been annotation with information on when the dose should be reduced)

Annotation of loading scheme:- amiodarone 200mg tds for one week amiodarone 200mg bd for one week amiodarone 200mg om thereafter

If patient prescribed a amiodarone tds on chart there is a risk it may be continued tds for longer than the standard one week Exception – where cardiologist has initiated a different loading dose

Annotate prescription chart/TTH and make an entry into patient’s medical notes

Correcting / adding enoxaparin or tinzaparin dose according to body weight

Ascertain weight, calculate actual dose according to actual body weight

Exclude patients with severe renal impairment

Annotate prescription chart



Appendix 8

PRESCRIBING FACT SHEET Supporting HDHB Medicines Management 2013 -2014

Temazepam to zopiclone or zolpidem (Background information for the Pharmacists’ Enabling Protocol in Secondary Care) Temazepam tablets have been in short supply and the price increased substantially early in 2013. In 2013 Community Pharmacists were endorsing prescriptions No Cheaper Stock Obtainable. That was estimated to cost the Health Board an extra £192,000 per quarter at current levels of use. The NSCO endorsement is no longer applicable (April 2015). Prescribers were advised to review patients taking temazepam and stop them if possible or consider changing to one of the Z-drugs: zopiclone or zolpidem. NICE recommended that when prescribing hypnotic drug therapy with shorter-acting benzodiazepine hypnotics (zaleplon, zolpidem or zopiclone), the drug with the lowest purchase cost is chosen. (NICE TA77 Dec 2010) COST COMPARISON

Preparations Cost (28 tablets) (ex VAT eDT April 2015)

Temazepam 10mg tablets £13.68

Zolpidem 5mg £1.75

Zolpidem 10mg £1.57

Zopiclone 3.75mg £1.68

Zopiclone 7.5mg £1.67

Temazepam 10mg in 5ml 300ml £82.81

INCLUSION CRITERIA

• Patients who need short-term treatment with hypnotics while in hospital • Patients on temazepam 10mg or 20mg nocte at home. (Check exclusion criteria)

EXCLUSION CRITERIA

• Palliative care patients • Patients under the care of the Substance Misuse or Mental Health Teams • Patients on doses of temazepam higher than 20mg nocte (NB: These patients can be

referred to their GPs for review and gradual reduction of the hypnotic. The Pharmacy Medicines Management Teams are working with patients in GP surgeries.)



SUGGESTED DOSE EQUIVALENTS

Temazepam Zopiclone Zolpidem

10mg 3.75mg 5mg

20mg 7.5mg 10mg

Notes:

• Elderly patients are more susceptible to the adverse effects of hypnotics (next-day sedation and loss of co-ordination so the risks of treating older patients may outweigh the benefits. The half-life of hypnotics may be prolonged in elderly patients and lower doses (half to quarter adult dose) may be necessary. Monitor older patients prescribed hypnotics (especially those with dementia) closely.

• Avoid the use of hypnotics in patients with respiratory disease or severe hepatic impairment.

• If patients are started on hypnotics in hospital, do not continue hypnotics on the

discharge prescription.

• Patients who were on temazepam prior to admission: highlight change on discharge summary to GP. Maximum of 7 day supply only.

• Sleep Hygiene Advice leaflets are available. (http://www.patient.co.uk/health/insomnia-

poor-sleep http://www.rcpsych.ac.uk/expertadvice/problemsdisorders/sleepingwell.aspx)

REFERENCES

eDT Part VIIIa July 2013, April 2015 http://www.ppa.org.uk/ppa/edt_intro.htm

eMedicines Compendium http://www.medicines.org.uk/emc/

Drugdex Zopiclone, zolpidem and temazepam monographs, http://howis.wales.nhs.uk/sitesplus/878/page/31994

BNF 65 March to September 2013 http://howis.wales.nhs.uk/sitesplus/878/document/187246

Taylor D et al. The Maudsley prescribing Guidelines in Psychiatry 11th Edn: 310-313.

NICE (2005) TA77 Guidance on the use of zopiclone for the short-term management of insomnia

http://www.nice.org.uk/nicemedia/live/11530/32845/32845.pdf

AWMSG Educational Pabe ck Material to support appropriate prescribing of hypnotics and anxiolytics across Wales

http://www.awmsg.org/awmsgonline/app/sitesearch;jsessionid=352510389ef1963af58302ee0abf?execution=e1s1

If you have any questions or comments regarding this Prescribing Fact Sheet

Please contact: Sue Beach, Lead Clinical Development Pharmacist. Tel: 01554 783084 or

[email protected]



APPENDIX C MEDICINES RECONCILIATION ON ADMISSION OF ADULTS TO HOSPITAL Introduction The National Institute for Health and Care Excellence / National Patient Safety Agency (NICE / NPSA) have published guidance1 stating that all healthcare organisations that admit adult inpatients should put policies in place for medicines reconciliation on admission. This includes mental health units, and applies to elective and emergency admissions. In addition to specifying standardised systems for collecting and documenting information about current medications, policies for medicines reconciliation on admission should ensure that:

• Pharmacists are involved in medicines reconciliation within 24 hours of admission (NICE)

• The responsibilities of pharmacists and other staff in the medicines reconciliation process are clearly defined

Aim The aim of medicines reconciliation on admission to hospital is to ensure that medicines prescribed on admission correspond to those that the patient was taking before admission. The National Prescribing Centre defines medicines reconciliation as:

• collecting information on medication history (prior to admission) using the most recent and accurate sources of information to create a full and current list of medicines (for example, GP repeat prescribing record supplemented by information from the patient and/or carer), and

• checking or verifying this list against the current prescription chart in the hospital, ensuring any discrepancies are accounted for and actioned appropriately, and

• communicating through appropriate documentation, any changes, omissions and discrepancies.

Errors can occur at any stage of this process. Standard Operating Procedure for taking and recording an inpatient medication history and reconciliation TAKING A MEDICATION HISTORY 1. Where possible, all new patients should be ‘interviewed’ to obtain a complete medication

history. 2. Identify yourself to the patient and ask if they are happy for you to discuss their medicines

with them. 3. Confirm patient’s identity with the patient or by checking their identity bracelet. 4. Attach a patient’s addressograph to the pharmacy ‘medicines reconciliation’ form or

pharmacy patient profile. 5. Check patient’s allergy status: If the patient has an allergy, determine the details of any

known drug idiosyncrasies/allergies, including the drug names, strength and type of response (e.g. penicillin 250mg in 5ml– rash, anaphylaxis, erythromycin – nausea). After discussion with clinical pharmacist document these details on both the medicines



reconciliation form and the prescription chart in the RED box on the front left hand side of the inpatient chart. If no allergy is known, indicate NO KNOWN ALLERGY.

6. Use combination of the resources below to reinforce medication history. Document a

minimum of two sources of information where possible and appropriate. 7. Attach a drug history, reconciliation sticker to the prescription chart or sign appropriate

section of medication administration record. 8. If the medication history has been undertaken by a technician, he or she must liaise with the

clinical pharmacist highlighting any issues on hand-over of the ‘medicines reconciliation’ form.

SOURCES OF INFORMATION TO BE USED Patient’s Own Medication 1. Ask patient, carer or relative (if appropriate) if they have brought their own medication into

hospital. 2. Locate patient’s own medication. 3. Ask patient (carer or relative) if they are happy for their own medication to be used for his /

her use whilst in hospital. 4. Clarify if patient is taking any medication they have not brought in with them. 5. Inform patient (carer or relative) that the medication will be stored in their locked bedside

cabinet for safekeeping 6. Discuss how and when patient takes their medication at home. Use open questions to

obtain as much information as possible. Information collected should include details of:

• all regular and ‘when required’ prescribed medication (include inhalers, eye drops, topical agents, injections (e.g. hydroxocobalamin, goserelin).

• Over the Counter (OTC) product

• Herbal and other alternative medicines 7. Check if any medications have recently been stopped, started or had doses changed.

Document any issues on ‘medicines reconciliation’ form and highlight any discrepancies with those medications prescribed on the medication chart.

8. Discuss any issues the patient may have with their medication e.g. ability to open containers or understanding of why they are taking certain medications.

9. Document any relevant issues on ‘medicines reconciliation’ form. State if patient is using a Monitored Dosage System and name of patient’s regular community pharmacy.

GP Surgery letter / fax or repeat list Discuss medication with patient as described in 6.6 - 6.8 Contact GP Surgery Telephone GP Surgery and identify yourself to receptionist. Inform the receptionist you would like to confirm the medication details of one of their patients who has been admitted to hospital. Provide the patient’s name, address and date of birth to confirm identity. Ask if they could fax through a list of details or read you a list of medication. Check allergy status and details for each medication such as

• directions prescribed



• date of last issue

• acute prescriptions

• limited quantities issued e.g. for MDS or Benzodiazepines Document findings on ‘medicines reconciliation’ form and highlight any discrepancies with those medications prescribed on the medication chart. Nursing / Residential Home Medication Administration Record (MAR) Document on ‘medicines reconciliation’ record any discrepancies with those medications prescribed on the medication chart. Hospital transfer medication chart If the patient is transferred from another hospital this chart may provide a more current list of medication than the GP surgery Community Pharmacy Telephone Community Pharmacy and ask to speak to the pharmacist. Explain that you wish to confirm the medication details of one of their patients admitted to hospital. Provide the patient’s name, address and date of birth to confirm identity. Ask if they could read you a list of medication. Check allergy status (if recorded) and details for each medication such as

• directions prescribed

• date of last issue

• acute prescriptions

• limited quantities issued e.g. for MDS or Benzodiazepines Document findings on ‘medicines reconciliation’ form and highlight any discrepancies with those medications prescribed on the medication chart. MEDICATION RECONCILIATION

• The clinical pharmacist must:

• check / verify information recorded

• undertake a clinical review of medications prescribed

• document any discrepancies/interventions on the ‘medicines reconciliation’ form

• ensure discrepancies are accounted for and interventions actioned appropriately

• sign and date appropriate section of the drug history/ reconciliation sticker

• attach ‘medicines reconciliation’ form to prescription chart

• liaise with appropriate pharmacist on patient transfer 1. If any medication reconciliation issue (incorrect doses or unintentional omissions) relates to

the following ‘high alert’ drugs, report appropriately via the Health Board-wide incident reporting scheme

High alert medication Anti-arrhythmics Amiodarone, disopyramide, flecainide, mexiletine, propafenone,

quinidine Anticoagulants Warfarin, phenindione, heparins Antiepileptics Carbamazepine, sodium valproate, topiramate, oxcarbazepine,

phenytoin, ethosuximide, lamotrigine, vigabatrin, gabapentin,



phenobarbitone, pregabalin, levetiracetam, primidone, tiagabine, zonisamide

Apomorphine Ciclosporin Clozapine Corticosteroids Prednisolone, dexamethasone, hydrocortisone Cytotoxic drugs Epoietin Etanercept Insulin Immunosuppressants Azathioprine, mycophenolate Levodopa Co-Beneldopa, Co-Careldopa, Stalevo Lithium Methadone

Methotrexate Opioid analgesics (including transdermal) Tacrolimus and sirolimus

Thalidomide Reference 1 NICE / NPSA Technical Patient Safety Solutions for Medicines Reconciliation on admission of adults to hospital. December 2007 1NICE NG5 Medicines Optimisation: The safe and effective use of medicines to enable the best possible outcomes (March 2015) http://www.nice.org.uk/guidance/ng5



APPENDIX D:

Guidelines for the Provision of Safe Patient Discharge during pharmacy out of hours.

Policy Number: Supersedes: Standards For

Healthcare Services No/s

Version No:

Date Of Review:

Reviewer Name:

Completed Action:

Approved by: Date

Approved:

New Review Date:


The purpose of these guidelines is ensure the safe discharge of patients with an adequate supply of correctly labelled medication; outside of normal pharmacy opening hours.

To be read in conjunction with:

The Prescribing, Storage, Dispensing And Administration Of Medicines To Patients Acute Division Policy

Classification: Category: Freedom Of Information Status

Open

Authorised by: Job Title Signature:



Responsible Officer/Author:

Job

Title: Head of Medicines Management.

Contact Details:

Dept Base

Tel No E-mail:

Scope ORGANISATION

WIDE DIRECTORATE

DEPARTMENT ONLY COUNTY ONLY

Staff Group

Administrative/ Estates

Allied Health Professionals Ancillary Maintenance

Medical & Dental Nursing Scientific & Professional Other

CONSULTATION

Please indicate the name of the individual(s)/group(s) or committee(s) involved in the consultation process and state date agreement obtained.

Individual(s) Date(s)

Group(s) Date(s)

Committee(s) Date(s)

RATIFYING AUTHORITY (in accordance with the Schedule of Delegation)

KEY

COMMENTS/ POINTS TO NOTE

NAME OF COMMITTEE

A = Approval Required Date Approval

Obtained FR = Final Ratification

Date Equality Impact Assessment Undertaken

Group completing

Equality impact assessment

Please enter any keywords to be used in the policy search system to

enable staff to locate this policy



Document Implementation Plan

How Will This Policy Be Implemented?

Who Should Use The Document?

Nursing staff, Medical staff and pharmacists.

What (if any) Training/Financial Implications are Associated with this document?

What are the Action Plan/Timescales for implementing this policy?

Action By Whom By When



CONTENTS

Page Introduction 5 Policy statement 5 Scope 5 Aims 5 Objectives 5 Main principles 5 Roles and Responsibilities 6 Implementation 6 Training 7 Audit and Review 7 Appendices 8-9



INTRODUCTION These guidelines have been developed to support the safe discharge of patients with an adequate supply of labelled medicines; during pharmacy out of hours. The guidelines will only apply in exceptional circumstances due to individual clinical need or as a result of challenges that are presented with patient flow and any bed shortages. SCOPE These guidelines apply to registered nurses, medical teams/staff and pharmacists who are required to discharge patients outside of pharmacy opening hours. AIMS The aim of this guideline is to ensure the safe discharge of patients with an adequate supply of labelled medication during pharmacy out of hours. OBJECTIVES

• To ensure that patients are discharged safely outside of pharmacy opening hours.

• To ensure patients have an adequate supply of labelled medication.

• These guidelines are only used in EXECPTIONAL circumstances. MAIN PRINCIPLES Under normal circumstances discharge prescriptions should be written and dispensed during pharmacy opening hours. Wards should make every effort to plan for patient discharge and where possible medication can be prepared in advance. However in exceptional circumstances e.g. discharge at short notice or due to bed shortages, the discharge prescription may not have been written or dispensed. The Senior nurse on duty must be satisfied that there is a need for out of hours supply of medication on discharge. If so then the following options must be considered:

I. Does the patient have a supply at home (N.B. Please ensure patient understands any changes to usual medication and has a supply of new medication).

II. If no medication is due before pharmacy reopens and the patient is able to return to the hospital, she/he may be discharged. The prescription should then be written, sent to the pharmacy and then returned to the ward for collection by the patient.

III. Is there a local Community Pharmacy that is open then consider a WP10(HP) IV. If none of the above applies then a patient may be discharged with a labelled medication

pack. The doctor requesting discharge along with the senior nurse/ward nurse must check each item on the discharge prescription against the medication chart for accuracy of transcription. A medication pack may be either those brought into hospital by the patient (if suitable) or those issued from the A & E department or CDU. Before any medication pack is given to a patient the following checks must be made:

� Ensure the pack is correctly labelled. � The name on the prescription matches the name on the label pack. � The drug name and details on the pack corresponds to the drug name and details

on the prescription. � The route specified on the chart corresponds to the route on the pack. � Ward stock packs with no name must not be used. � The quantity of stock is sufficient to cover the supply (normally a week). � The medication has not passed its expiry date.



In all cases the nurse/doctor must ensure that the patient/carer understands

a) What the medication is for. b) How and when to take it. c) What to do if they experience any side effects. d) When to stop taking the medication and get reviewed by a doctor.

The ward nurse and the doctor requesting discharge must initial the prescription and indicate what was issued (number of tablets). The nurse must complete the out of hours discharge form and attach it to the top copy of the prescription form (white copy). The completed OOH form and the prescription form along with the administration chart and the notes must be kept on the ward for the pharmacist to review. The second copy of the prescription form should be given to the patient for their GP. If any concerns arise the on call pharmacist may be contacted for advice but please note that the on call service if an emergency service and will not result in a pharmacist attending. ROLES AND RESPONSIBILITIES Director of Therapies and Health Science, Director of Nursing and Medical Director To ensure that all appropriate healthcare professionals are informed of, and follow, the organisation’s guidelines on the Provision of Safe Patient Discharge during pharmacy out of hours. Associate Medical Directors, County Nurse To ensure that staff involved in the administration and monitoring of discharges during pharmacy out of hours, within the scope of their responsibility, have undertaken appropriate training. Ward/Department Managers/Service Managers It is the responsibility of all clinical managers to:

• Ensure that these guidelines are brought to the attention of all their staff, and that they understand and adhere to the guidance/procedure contained within.

• Ensure that all staff involved in the discharge of patients have received adequate training and are competent to carry out these guidelines.

Ward Pharmacist It is the responsibility of the ward pharmacist to

• Review the prescription the following day using the patient’s Inpatient Administration chart.

• When the review is completed the pharmacist will sign the OOH form.

• Any problems that are identified, the pharmacist must contact the responsible Consultant’s team. (If necessary the Consultant’s team must contact the patient).

• The pharmacist will complete the OOH form and then forward to the community pharmacy.

IMPLEMENTATION These guidelines will be available in all clinical areas via the Health Board Intranet, a global email will be sent to all directorate leads, general managers, medical and nursing staff and



primary care practice managers when approved. The pharmacy and medicines management team will work to raise awareness across the Health Board. TRAINING Cascade training will be provided to all wards and medical team by pharmacy and medicine management teams. AUDIT AND REVIEW Compliance with these guidelines will be monitored within six months of approval and initiation of training. This Policy will be reviewed after 3 years, or sooner, as required.



AUTHORISED NURSE MEDICATION SUPPLY AT DISCHARGE

(OUT OF HOURS).

Patient ID Label/ addressograph :

Consultant Ward

Requesting Doctor’s name and Consultant:

Date of Discharge: Time of Discharge:

Authorised nurse’s name:

Reason for Out of hours Prescription: Signature of Nurse:

Pharmacy: Signature: Date:



Checklist for checking patient’s medication.

• Is the prescription signed and dated?

• Does the prescription name match the patient’s name?

• Is there a drug name on the prescription?

• Is the frequency highlighted clearly?

• Check contents match the label and expiry has not passed.



APPENDIX E: COMPETENCIES OF HEALTHCARE SUPPORT WORKERS (Under development –please contact Mandy James, Senior Nurse, Medicines Management for further information)

APPENDIX F – PROMOTION SAFER USE OF INJECTABLE MEDICINES The procedure guidelines in the Royal Marsden Hospital Manual of Clinical Nursing Procedures (http://www.rmmonline.co.uk/rmm8/chapter/16/ss83) (8th Edition at the time of approval of this document but please refer to the current edition) have been adopted by HDUHB and should be followed when preparing and administering injectable medicines.



APPENDIX G: REQUIRED CONTROLLED DRUG STANDARD OPERATION PROCEDURE (SOP) The responsibility for establishing and maintaining a system for the security of medicines used within wards and the operating department lies with the Accountable Officer. This responsibility is delegated to senior managers of wards, theatres and pharmacy and other clinical areas that handle CDs to ensure that there are current SOPs in place that comply with current regulations. These must be signed and approved by both the senior nurse/doctor and pharmacist on site. Areas requiring a SOP for Controlled Drugs include as a minimum:

• Who has access to CDs/ assigning responsibilities

• Where CDs are stored

• Security of storage and transport as per Misuse of Drugs legislation

• Disposal and destruction

• Who is alerted should incident/complications arise

• Record keeping

• Maintaining CD registers according to Misuse of Drugs legislation.

• Maintaining record of CDs returned by patients.

WARDS The following resources are available: Royal Marsden Guidelines has a range of SOPs with covers all key areas relating to the handling of CD:

• Accountability & Responsibility

• Requisition receipt

• Storage, key holding

• Record keeping

• Stock checks

• Disposal

• Administration THEATRES Theatres due to the nature of work within a theatre department there is a need to ensure that the SOP developed for use in theatre is reflective of both legislative requirements and good practice. A SOP is designed to ensure that CDs are readily available for use by medical/nursing/ODP staff when clinically required by patients in the Health Board Operating Departments (‘Theatres’). They also aim to improve & clarify the governance of local arrangements for the safe management of CDs in Theatres by bringing current arrangements & practice into line with the (new) regulatory frameworks practice., following the publication of recent documents by the Association of Anaesthetists of Great Britain and Ireland (AAGBI), the Royal Pharmaceutical Society of Great Britain, and the Department of Health. Theatres should ensure that (at minimum) they have in place an approved and current SOP for the following;

• Ordering

• Receipt- accountability/access

• Storage

• Preparation

• Administration

• Stock checks



• Destruction PHARMACY DEPARTMENTS Pharmacy department must ensure that there are SOPs in place for all aspects of Controlled Drugs. These must be approved and current. The SOPs should cover at minimum the following:

• Ordering

• Accountability/responsibilities/access

• Receipt

• Delivery

• Storage

• Records

• Prescribing

• Destruction

These can be accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/HDUHB%20CD%20SOPs%20April%202015.pdf



Appendix H

Standard Operating Procedure For single nurse administration of morphine sulphate

(10mg/5ml) oral solution (“Oramorph®”) Applicable to areas agreed by Task and Finish Group for

Oramorph/Acute Pain Team

SOP TITLE Single nurse administration of Oral Morphine 10mg/5ml.

SOP Ref. VERSION 10 ISSUED 8.9.2014 EFFECTIVE 04.04.2012

REVIEW

AUTHOR Nia Treharne Job Title Specialist Nurse Acute Pain

Signed Date APPROVED BY Job Title Signed Date Circulated to



INTRODUCTION Currently the HDUHB policy for the prescribing, storage, dispensing and administration of medicines require that Morphine Sulphate 10mg/5ml oral solution, be treated as a Controlled Drug (Schedule 2 & 3 of Misuse of Drugs Regulation 1985) .This requires two registered nurses to account for and calculate remaining contents. Background In 2001, this regulation was updated and is now classed as a Schedule 5 - Prescription Only Medication (POM) (BNF 2014). Following a National benchmarking exercise, it was discovered that each HB decides locally on its management and the results of patient questionnaires concluded that there were significant time delay following request for this analgesia. In 2012, GGH conducted a successful pilot study which permitted the practice of one nurse signature to administer this concentration of “Oramorph” along with providing an auditable trail of the stock. AIM - improve response time between request and administration ultimately enhancing the patients overall experience of their pain control. SCOPE This procedure applies to adult patients over the age of 16years who are inpatients at HDUHB within the acute division. PROCEDURE.

1. The oral morphine solution (10mg/5ml) will be ordered, supplied, transported and received according to the Health Board policy for the supply of Controlled Drugs (CDs).

2. Stock levels to be agreed by Ward Manager and Pharmacist.

3. The bottles received from Pharmacy must be recorded in the CD register and stored in the CD cupboard.

4. One 100ml bottle of Morphine Sulphate 10mg/5ml solution is then transferred into

the medicines trolley /locked cupboard. It must be :

• Checked out of the CD cupboard and recorded in the register by 2 registered nurses. (Recorded as a transfer to the trolley/cupboard))

• Multiple trolleys to be labelled/numbered accordingly.

• Additionally, record this transfer in the dedicated “Administration Record book” and sign with two registered nurses. (eg. -transferred from CD cupboard)

5. The following details must be recorded for each dose administered :

• date, time, patient’s name, dose (in mg and ml),

• estimated remaining balance .

• RGN’s name/s signed and printed.

• A sample signature list is not required in the back of this record book. 6. The “Administration Record book” must be kept with the 100ml bottle of “Oramorph”



(10mg/5ml) inside the locked trolley/cupboard at all times. If there are multiple trolleys within an area, a separate book must be with each 100ml bottle.

7. The books are to be ordered via the Pharmacy department and are to be kept for a

minimum of 2 years following final insertion details as per HDUHB policy for CDs.

8. Following the assessment of its suitability, a single nurse may administer the prescribed dose of “Oramorph” (10mg/5ml) up to 20mg and record in the administration record book.

9. For doses above 20mgs, 2 nurses must check both the dose and the remaining

balance and record in the administration record book.

10. Administer the Oramorph using a graduated measuring cup/5ml spoon. Sterile purple enteral syringes must be used for the administration of all medication to be given via the enteral route including patients who have nasogastric, gastrostomy or jejunostomy tubes.

11. If there are discrepancies between the “Recorded (estimated) balance in the book

and the “ACTUAL” balance in the bottle, amend the volume accordingly with two RGN signatures.

• Discrepancies below 10ml must inform the ward sister and ward pharmacist within normal working hours.

• Any discrepancies greater than 10ml must be reported to the Ward sister and pharmacist along with the Senior Nurse (Site Manager out of hours) and complete an IR1 Datix form as per HDUHB policy.

12. Once the bottle is empty, a new bottle is transferred to the trolley from the CD

cupboard (as per procedure instruction point 3). Dispose of empty bottle in the sharps disposal container.

13. Once opened, the date should be recorded on the bottle since it has a 90 day shelf

life.

14. When needing to return any expired stock for destruction, please contact the pharmacy department (within working hours) and document in the ward administration record book with two RGN signatures. If the stock from the CD cupboard needs to be returned, follow CD policy.

15. A “DO NOT DISTURB” red tabard is to be worn by the administrating nurse in ward

areas in order to minimise distractions.

Deviation from practice If there are any uncertainties, continue with the above procedure but continue using two RGN signatures when completing the administration record book. This may also apply to agency bank or newly qualified/return to practice nurses. Please seek guidance from the Ward Sister, Pharmacy dept or Acute Pain Team.



Appendix I Incident – Near Miss – Hazard Reporting

Medicines

ADVERSE EVENT

Any event that has given or may give rise to actual or

possible personal injury or patient dissatisfaction

Examples

• Intravenous antibiotics administered as bolus dose

instead of via infusion.

• Medication given to wrong patient because another

patient’s drug chart was used.

• Patient discharged with wrong take home

medication.

• Rate of syringe pump was set wrongly and a patient

received the contents over a much shorter period.

• Illegible prescribing of 5 units of insulin which

resulted the patient being given 50 units.

NEAR MISS

Any event or omission that could have potentially

caused harm, but due to prompt action by a

member of staff, or simply as a result of good

fortune was prevented

Examples

• Patient prescribed drugs to which they are

allergic to, but nurse notices and does not give.

• Patient given another patient’s drugs however

the drugs were identical and caused no harm.

• Patient is nearly given another patient’s drugs,

however the nurse double checking the patient’s

identification realises the mistake and does not

give the patient the medication.

HAZARD

Anything that has the potential to cause harm

to patient’s staff, visitors and others, or affect

the services the health Board provides

Examples

• Similar drug names (i.e. oxynorm/oxycontin,

carbimazepine/carbimazole)

• Similar shape/colouring of drug packaging

• Use of unfamiliar drugs

• Interruptions/distractions whilst

prescribing/administering drugs

• Confusion between slow release and

immediate release opioids

• Insufficient training

Suspected

Adverse

Event

NO NO

YES YES YES

Attend to patient/complete online incident form

Enter as incident

Complete online incident form

Enter as Near Miss Complete online incident form

Enter as Hazard

One of the most common types of error is

medication being administered to the

wrong patient. Always ensure that you

have the correct medication chart for the

correct patient.

Please report all incidents/near misses

otherwise if they go unreported we will

be unable to learn from them.

Please ask your line manager or your local

patient safety person for feedback of any

incident that you have reported.

Near misses

(potential incidents that

were prevented)

must always be reported

Examples of incidents that must always be reported • Drug prescribed/given to patient with known allergy

• Wrong drug, route, formulation, dose/strength or frequency prescribed/given

• Omitted drugs

• Medication contra-indicated

• Expiry date wrong/omitted or passed

• Wrong label on medicine

• Wrong method of preparation/supply

• Adverse drug reaction

• Incorrect storage

• Delay or failure to monitor e.g. digoxin levels, INR

• Failure to discontinue

• Incorrect transfer of information from one drug chart to another

• Incorrect drug history taken on admission

• Illegible drug name and/or direction

• Wrong information leaflet given to patient

• Wrong information given by pharmacist

• Loss of keys or medicines



APPENDIX J Guidelines for the Self-administration of In-Patient’s Own Medicines Access at: http://howis.wales.nhs.uk/sitesplus/documents/862/Guidelines%20for%20self-administration%20of%20patients%20own%20medicines%20v1%20Final%20Website.pdf Self Administration Of Patients Own Insulin. Access at: http://howis.wales.nhs.uk/sitesplus/documents/862/Addendum%20Self-Administration%20Insulin%20v%201%20FInal.pdf



Appendix K Inter Ward Transfer Form

Ward requesting

Medicine requested

Form & Strength

Name of Patient requiring medicine

(Prescription chart must be presented)

Ward supplying

Quantity supplied

Name & signature of Registered Healthcare

Professional requesting

Name & signature of Registered Nurse supplying

Date supply made

Pharmacy Use Only:

Quantity of stock replaced Charged to Supplied to Issued by/Date



APPENDIX L

Glangwili General Hospital Pharmacy Department, Aseptic Services Transport of Cytotoxic/Biologic Medicines via Transport Provider

Journey Details:……………………….. Date:………Time ………….. From:……………………………………. To:……………………. Instructions to the driver: Please read the following and ensure you understand these instructions. If you do not, ask the pharmacy staff. When you have read and understood these instructions please sign, date and print your name in the space provided.

1. No other jobs should be undertaken whilst carrying cytotoxic/biologic medicines

2. The drivers must not remove or tamper with the consignment or its contents 3. Ensure delivery is taken directly to the correct location within the

hospital/organisation as identified on the address label 4. You must be wearing your identification card

5. You must not have passengers unless they are employees of the company and

should not carry animals in your vehicle

6. If there is a breakdown you must inform the hospital pharmacy of the delay and give an estimated time of arrival. Any prolonged delays due to traffic conditions must be communicated to the hospital.

7. In the event of an accident or spillage DO NOT attempt to recover the

consignment. Alert the emergency services to the nature of the consignment.

8. You must inform the hospital pharmacy of any loss or damage to the consignment as soon as possible on 01267 227859.

9. At all times, you must ensure compliance with all road traffic and transport laws

and any request by the Police.

10. You must have appropriate motor insurance Signature:…………………..……… Date:…………………………… Print Name:……………………….. Time…………………………….

Transport Provider:………………… Signature of Issuer……………

EMERGENCY CONTACT NUMBER – 01267 227859

TRANSPORT OF CYTOTOXIC MEDICINES GUIDELINE VERSION 1

ISSUED 20/2/15 AUTHOR A J DANIEL DATE OF REVIEW 20/2/17



Appendix M

Local Requirements for the Storage, Administration & Prescription for Controlled Drugs in Hywel Dda UHB

(Acute sector wards, clinic & departments)

Hywel Dda UHB Medicines Management Group (July 2014) agreed the storage, administration and prescription requirements for the following CD medicines listed below. This guidance covers commonly used CDs. Please check the requirements for any other CDs not listed with Pharmacy. Controlled

Drug Requisition necessary

Storage in the CD cupboard

Administration recorded in the CD ward register

Number of nurses to administer and record

Controlled Drug Prescription requirements*

Pharmacy must supervise destruction

Buprenorphine � � � Two � �

Diamorphine � � � Two � �

Fentanyl � � � Two � �

Methadone � � � Two � �

Methylphenidate � � � Two � �

Midazolam � � � Two � �

Morphine � � � Two � �

Oramorph® #

(10mg in 5ml)

� � � Two

(# See below)

� �

Oxycodone � � � Two � �

Phenobarbitone � � � Two � �

Temazepam � � � Two � �

Tramadol � � � Two � �

Zopiclone � � � One � �

Zolpidem � � � One � �

Zoleplon � � � One � �

Notes:

*Controlled Drug Prescription requirements can be found in current BNF (Guidance on prescribing-Controlled Drugs and drug dependence) # Oramorph (10mg in 5ml)- A HDdUHB Standard Operating Procedure for the Single Nurse Administration of Morphine Sulphate (10mg/5ml) oral solution has been developed. Once a ward has implemented this SOP the following requirements should be met: single nurse administration and recording in the Oramorph

® dedicated “administration record book” and storage in the designated trolley

or bay medicines cupboard.



If you have any questions regarding these requirements, please discuss them with your local pharmacy department

Mifepristone 200mg Tablets

• Mifepristone is not a controlled drug, however, the standard operating

procedure for the supply of mifepristone for the termination of

pregnancy requires the drug to be requisitioned on a controlled drug

requisition book.

• Mifepristone details will be held in the pharmacy controlled drug

register and all issues will be subject to recording in the register.

• Mifepristone must be stored in the controlled drug cupboard

• All issues to patients must be recorded on the appropriate page of

the ward controlled drug register

• Mifepristone will be subject to same daily ward checks as all other

controlled drugs and the pharmacy 3 to 6 monthly ward CD audits.



Appendix N. Example template for recording waste in Controlled Drug Registers

[N.B: Waste of part ampoules e.g. diamorphine 2.5mg out of a 5mg ampoule should

be recorded in the relevant page of the register and not in the waste section.]



CHECKLIST FOR CONTROLLED DRUGS

CD CHECKS – 3 MONTHLY CHECKLIST

1) Check ward CD register against contents of cupboard (check each page of the CD

register)

2) Ensure any patients own drugs are accounted for and signed out of register if no

longer needed.

3) Review the current ward / department CD stock list. Ensure any updates are

communicated to senior technician – dispensary services.

4) Check that Naloxone is stored in the outer section of the CD cupboard.

5) Check stocks of concentrated potassium chloride in relevant areas. If ampoules are

used check that nurses record in the ward register the fluid to which they were

added and the dilution required.

6) Check that nursing staff are checking and signing CD stocks at least once daily.

7) Complete the CD check log for each ward that is held in pharmacy. Any comments

on the general housekeeping of the CD register should be noted including

completeness and legibility.

8) A record of the stock check should be made clearly in ink in the left hand

column of the ward CD register. Endorse as “Pharmacy Stock check” signed

and dated by pharmacy and witness.

9) Review use of the following schedule 4 and 5 drugs over the last period, noting

whether use is considered appropriate compared with prescribing: This must be

done when a new stock sheet is requested or within 1 month of the Controlled

Drugs check. This includes:

Dihydrocodeine; Codeine; Co-codamol 30/500; Co-dydramol; Diazepam;

Ketamine; Lorazepam; Zopiclone.



APPENDIX O. Surrender of Unidentified Tablets/Substance Form Accessed at: http://howis.wales.nhs.uk/sitesplus/documents/862/Unidentifiable%20tablets%20Substance%20Letter%20%20February%202014%20_2_.pdf



APPENDIX P. Shelf life of oral liquid medicines Guidance on shelf life of oral liquid medicines v1 DRAFT3

Where a manufacturer specifies an ‘in use’ shelf-life on label or container, this must be

adhered to by the ward and dispensary. On first opening the bottle, the date of opening

should be noted on the label, the expiry date calculated and also noted on the bottle.

1. Oral liquids issued as ward stock

This applies to ward stock items only, where a single container might be used on multiple

occasions for more than one patient.

Where the manufacturer does not give advice on the ’in use’ shelf-life the following advice

should be followed:

Licenced product, original pack issued to

ward

28 days

Unlicenced product*, preserved

28 days

Unlicenced product*, unpreserved

7 days preferably stored in a fridge

* Only in exceptional circumstances should an unlicenced product be supplied as stock (e.g. where regular use

and out-of-hours use is anticipated). A robust audit trail should be in place to allow identification of individual

patients receiving the product if required.

Wherever possible, original sealed packs should be supplied.

If usage is low, a smaller pack size should be sourced.

2. In-use shelf life for opened dispensary stock.

Standard practice in some hospital pharmacies is to use within 1 month of opening.

However it is recognised that a longer period is preferable for certain preparations, and

pharmacists should consider the physical and microbiological stability of a formulation.

Rationalisation of pack sizes purchased may minimise risk and wastage.

All packs should be dated on opening, and no opened pack should be kept for more than 6

months.

Karen Davies Lead Pharmacist QA&C

Dec 2014



APPENDIX Q. Procedure for the Managed Entry of New Medicinal Products to the Hywel Dda University Health Board Formulary. The Medicines Management Group (MMG) will make final recommendations on the formulary status of all formulary requests for medicinal products. Final decisions can only be made by the HDUHB Corporate Directors Group Process 1. ‘Medicinal Products’ are defined as all substances defined under the Medicines Act as being medicinal products. For the purpose of this Policy this definition may be extended to cover some products licensed as medical devices (e.g. bladder installations) which are used to treat patients and are supplied on prescription. Discussion with the Medical Devices Committee may be required to determine which committee is more appropriate to consider the application. 2. Requests for the inclusion of medicinal products onto the HDUHB Formulary will be accepted from an appropriate Consultant or General Practitioner. In addition the Tissue Viability Nurses may apply for the addition of a wound care product and Dieticians for a nutritional feed or product. 3. The applicant will discuss the specific application with the Lead Clinical Development Pharmacist. If the requested medicinal product is:

• approved by NICE or AWMSG for the indication requested then a NICE/AWMSG Implementation Plan will be completed for approval by MMG.

• due to be considered by NICE/AWMSG for the indication requested within the next 12 months it will not be considered. A non-formulary request remains available to the applicant for individual patients in the meantime

• a new preparation/strength/indication of an existing Formulary medicine. An abbreviated application may be appropriate .This will decided on an individual basis

• for the use of a medicine within a procedure not currently carried out in

HDUHB a CEAC application is required before Formulary approval can be

given. Processes can run concurrently

• for an unlicensed medicine or ‘off-label’ indication or dose. A group unlicensed form or full Formulary application may be required. This will be decided on an individual basis

• The applicant will be asked to complete an ‘Addition to HDUHB Formulary Request Form’, which is available on the HDUHB website (link). Forms must be completed fully and correctly to ensure that the application is considered promptly. The Lead Clinical Development Pharmacist can provide advice and will contact the applicant where additional information is required.

4. A ‘New Product Evaluation’ will be completed by the Lead Clinical Development Pharmacist or Lead Medicines Information Pharmacist. This evaluation will be based on the ‘STEPS’ methodology (Safety, Tolerability, Effectiveness, Price and Simplicity). In addition, a summary page will be included, where necessary with a background section, to assist non-clinicians in reaching a formulary decision. 5. A recommendation will be made to the Medicines Management Group (MMG) from the Clinical Formulary subgroup (CFsg)as to whether the medicinal product



should be approved for addition to the Formulary, any restrictions on use (primary Care, Secondary Care, Specialist Use only or Shared Care) or rejected. The rationale for the decision will also be given. The Clinical formulary subgroup minutes will be presented to the MMG meeting, which includes a summary of the discussions held in the CFsg (including the points for and against approval based on the evidence presented and whether the decision reached was unanimous or split. Financial Considerations

1. Formulary requests for medicinal products which will only be prescribed in the Acute Sector and with a net cost impact of more than £10,000 per year, will require a business case form to be completed and submitted to the Director of Finance through MMG.

2. Formulary Requests for medicinal products which be used in both Primary and Acute Care and with a net cost of more than £80, 000 per year, will require a business case form to be completed and submitted to the Director of Finance through MMG.

3. Wherever possible, the potential cost impacts of new medicines under development will be identified through an annual ‘Horizon Scanning’ report prepared by the Lead Clinical Development Pharmacist.

Note: The Director of Finance will receive a completed business case for medicines that meet the criteria defined above within 48 hours of a positive decision being made by the Clinical Formulary Subgroup. This will allow the Director of Finance 3 weeks before the MMG meeting to consider the business case submitted and make recommendations to MMG. Safety Considerations Risk Assessments for new medicines will be required as part of the formulary application process. This will partly fulfil the ‘Purchasing for Safety’ recommendation from the NPSA and allow risk reduction measures to be put in place (where appropriate) before the new medicine is in use. The MEPA (Medication Error Potential Analysis) (http://www.qcnw.nhs.uk/docs/QA%20&%20Risk%20Assessment%20of%20licensed%20Medicines%20for%20the%20NHS.pdf )and NPSA ‘Risk Assessment for Injectables’ (http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812)are recognised tools for this process. The MEPA score requires a sample of the product/packaging (or electronic proofs of the packaging) to assess fully. The assessment with be carried out by the Lead Clinical Development Pharmacist with advice from the Lead Quality Assurance Pharmacist and Lead Clinical Pharmacists or Dispensary Managers. Dissemination/Communication Following each MMG meeting:

1. Recommendations will be added to the: a. HBUHB electronic Formulary (http://hywelddahb.inform.wales.nhs.uk/ ) b. Scriptswitch® (active on GP prescribing systems across the HB) c. Hospital Pharmacy Computer system

2. Prescribing Outlook Newsletter (for Primary and Secondary Care Staff) (within 2 weeks of the meeting)



3. Applicants will be informed of the recommendations made by MMG by e-mail/letter promptly. Pharmaceutical representatives will not be informed of the outcome before the applicant.

4. The draft minutes of the MMG meeting will circulate to members within 2 weeks of the meeting

5. The outcomes of MMG will be summarised and circulated to members, County Lead Pharmacists and Prescribing Advisors within 2 days of the meeting.

6. A cumulative list of approvals/rejections will be hosted on the Pharmacy & Medicines Management website.

7. Recommendations will be presented at the GP Prescribing Leads meetings.

8. Recommendations will be discussed by hospital pharmacists with the relevant healthcare staff.

9. A summary of recommendations will be sent to Community Pharmacies in HDUHB.

10. A copy of the minutes will be sent to ABMU and Powys UHB for information.

11. A list of pending formulary applications will be posted on the Pharmacy & Medicines Management website until a final formulary decision is reached.

12. Any amendments to policies, guidelines and prescribing information will be made, checked by the Lead Clinical development Pharmacist and approved by Chair’s Action (unless MMG have directed otherwise).

NB: The HDUHB electronic Formulary is available on the Internet, so patients and other stakeholders will be able to access information about Formulary decisions. Review All requests for non-formulary medicines will be reviewed every 6 months to ensure that formulary applications are made for frequently requested items. The expenditure on all new medicinal products added to the formulary will be monitored every 6 months for 2 years (primary & Secondary Care data) for 2 years and compared against cost predictions. Exceptions and Non-formulary Requests

1. The HDUHB Formulary applies to both prescribing and recommendations to prescribe. Routine recommendations to prescribe non-formulary medicines should be discussed with the local Prescribing Advisor or the Lead Clinical Development Pharmacist. The Lead Clinical development Pharmacist will contact the relevant Consultant (or Independent non-medical prescriber) to discuss the reasons for the recommendation and determine whether a formulary application is appropriate.



2. Where a non-formulary medicine is the most appropriate choice for a patient the prescriber must complete a Non-Formulary Medicine Request form as well as a prescription and sent to the hospital Pharmacy department.

3. Approval mechanism:

Medicine cost per year Approval by less than £500 County Lead Pharmacist (or deputy) more than £500 Acute Services Clinical Lead (or deputy)

More than £2000

Urgent Acute Services Clinical Lead or Medical Director in discussion with Head of Pharmacy & Medicines Management or County Lead Pharmacist

Non-urgent

IPFR Application (http://www.wales.nhs.uk/sitesplus/862/page/70502) (N.B: the NHS list price of the medicine will be considered when calculating the cost. Discounts/ FOC or Patient Access schemes will not be taken into account.) MMG May 2015.

Drugs on the Formulary will be categorised as follows: Category Definition H = Hospital only drugs

All prescriptions are issued from the hospital medical team or are restricted to use only within the hospital Primary care prescribers should not be asked to prescribe

S = Specialist initiated drugs A specialist (Consult ant, GP with a special interest or specialist independent prescribers) should undertake the initiation and stabilisation of the medicine. Follow up prescriptions may be issued by GPs, if they agree to take on responsibility for future prescribing. Medicines for which a Shared Care protocol are included.

1st = First Line drugs Drugs recommended in both primary and secondary care

2nd = Second line drugs Alternatives, often in specific conditions (eg allergy or ADR to first-line) in primary and secondary care)

Appeals Process It is recognised there may be occasions where there is a difference of scientific opinion and/or interpretation of available data. There is also a responsibility to ensure that due process has been followed. An appeal may be lodged in writing, by the original applicant, with the Lead Clinical Development Pharmacist within 30 working days of being informed of the non-approval decision of MMG.



An appeal will be considered where:

• There has been a failure to act fairly and in accordance with the HDUHB Procedure for the Managed Entry of New Medicinal Products to the Hywel Dda University Health Board Formulary.

• A decision is contrary to the evidence submitted

• Submission of new relevant supporting data or evidence.

The appeal request and grounds will be considered at the next meeting of the MMG. Where there is still a disputed decision, an Appeals Panel will be constituted. The applicant will be informed. The Appeals Panel will consist of three members nominated by the HDUHB Medical Director, including a pharmacist, GP and hospital Consultant, none of whom have been involved in the original formulary application, discussion or decision. The acceptance of the Appeals Panel’s conclusions will be at the discretion of the HDUHB Corporate Directors Group.



Medicines has been approved

for the indication requested by

NICE or AWMSG

Application is for the use of a medicine within a

procedure not currently carried out in HDUHB a

CEAC application is required before Formulary

approval can be given. Processes can run

concurrently.

Application is for a new

preparation/strength/

indication of an existing

Formulary medicine. An

abbreviated application

may be appropriate.

Application is for an

unlicensed medicine or

‘off-label’ indication or

dose. A group unlicensed

form or full Formulary

application may be

required

Medicine is due to be

considered by

NICE/AWMSG for the

indication requested

within the next 12

months will not be

considered.

Consultant or GP helps

complete a NICE/AWMSG

Implementation Plan

MMG considers the

Implementation

Plan

NB:NICE & AWMSG

approved medicines

must be made

available within 90

days.

NICE/AWMSG Audit prepared and

published on Intranet

An electronic copy of the Formulary Application Form

(link) is completed and is sent to the Lead Clinical

Development Pharmacist.

A signed paper copy of the Form is also sent for audit

purposes

Lead Clinical Development Pharmacist & Medicines

Information complete a Formulary Evaluation and Risk

Assessment

Clinical Formulary Subgroup

Recommendation to MMG

Medicines Management Group (MMG)

Final Recommendation and Formulary

status

Final Decision

made by

Executive Board

Flowchart: Procedure for the Managed Entry of

Medicinal Products to the HDUHB Formulary

Consultant or GP considering a Formulary

Application discusses with the Lead Clinical

Development Pharmacist



APPENDIX R. Patient Group Directions Process

Patient Group Directions Process 1. INTRODUCTION The Patient Group Directions (PGD) Policy provides a governance framework and process for development, approval and review of PGDs within Hywel Dda University Health Board in line with legislation, in order to ensure that patients receive safe and appropriate care and timely access to medicines. 2. POLICY STATEMENT The HB is required to have a robust process for the development, approval and monitoring of Patient Group direction to enable patients to benefit from prompt treatment from suitably trained healthcare professionals in compliance with the legal requirements and NICE guidance. 3. SCOPE This policy applies to:

• All Health Board employees who are registered health professionals who are eligible to use Patient Group Directions.

(At August 2013 the eligible professions were: chiropodists and podiatrists, dental hygienists, dental therapists, dietitians, midwives, nurses, occupational therapists, optometrists, orthoptists, orthotists and prosthetists, paramedics, pharmacists, physiotherapists, radiographers and speech and language therapists.)

• All patients under the care of Hywel Dda University Health Board. This policy applies to all services operated by Hywel Dda University Health Board, including:

• In-patient wards, departments and clinics in the Acute Hospital Sites

• Wards, Clinics and Minor Injury Units situated in Community hospitals

• Primary Care settings including GP surgeries, Clinics, Patient’s own home

• Educational settings

• Other settings defined as appropriate within the specific PGD. Adherence to this policy is the responsibility of all staff employed by Hywel Dda University Health Board. 4. AIMS The aim of this Policy is to ensure that patients receive safe and appropriate care and timely access to medicines, through the use of PGDs, in line with legislation 5. OBJECTIVES This Policy will ensure:

• the rationale for developing a PGD is approved,

• the process for developing and approving a PGD is consistent and timely

• that appropriate training of staff is carried out

• that audit requirements for PGDs are carried out



6. AGREEMENT TO DEVELOP A PATIENT GROUP DIRECTION (PGD) Hywel Dda University Health Board Medicines Management Group (MMG) is the authorising body for the development of a PGD. The submission to MMG for authorisation of the rationale is via the PGD Working Group Initial discussions with a member of the PGD working group will streamline the process and will advise where PGDs need to be developed. The national PGD website tools (http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/PGD-Legislation-Guidance/PGD-Website-Tools/To-PGD-or-not-to-PGD-that-is-the-question/ ) are helpful when considering whether a PGD is necessary and ensuring that appropriate legislative requirements (for example, unlicensed, off-label use, controlled drugs, dosage adjustments and long-term conditions) are met. The need for PGDs may be better served by guidelines, professional exemptions or Standard Operating Procedures. A proforma is available under development. The rationale for development of a PGD must include the following points:

• the title of the PGD

• details of the proposer and other individual people who would be involved in developing and authorising the PGD

• details of the organisation delivering the service (if this organisation is not the authorising body)

• the setting where the PGD would be used

• the condition to be treated, considering patient inclusion and/or exclusion criteria

• benefits to patient care

• potential risks to patient safety

• details of medicine(s) to be supplied and/or administered, including dosage, quantity, formulation and strength, route and frequency of administration, duration of treatment and whether it is included in the local formulary

• health professional groups who would work under the PGD, including training and competency needs

• current and/or future service provisions for supplying and/or administering the medicine(s), including its position within the care pathway

• evidence to support the proposal



• resources needed to deliver the service

• a timescale for developing the PGD.

• An explanation why other options for supplying and/or administrating medicines (eg medical or non-medical independent prescribing or professional exemptions) are unsuitable.

• Demonstrate that the use of the proposed PGDs offers an advantage for patient care, without compromising patient safety

• Whether the PGD is require as part of a national initiative or programme.

• That there are clear governance arrangements and accountability.

MMG will consider the rationale for development of the PGD at the next scheduled meeting. Where there are valid reasons for development of the PGD prior to the next meeting, Chair’s Action may be requested and ratified at the next scheduled MMG meeting. The standard criteria that MMG will use to review the proposed PGD are as follows and will ensure that:

• all legal requirements have been met

• robust local processes and clear governance arrangements are in place

• the risks and benefits of all options for supplying and/or administering the medicine(s) have been explored

• the PGD will deliver effective patient care that is appropriate in a pre-defined clinical situation, without compromising patient safety

• the views of stakeholders, such as clinical groups, patients and the public, and the Health Board have been considered

• appropriate registered health professionals are available to use the PGD, and training and competency needs are addressed

• people who are developing, authorising, monitoring, reviewing and updating the PGD are identified, and training and competency needs are addressed

• the need for appropriately labelled packs and safe storage can be met

• adequate resources, such as finance, training, medicines procurement and diagnostic equipment are available for service delivery



• adequate resources are available to ensure that processes are followed within any locally agreed timeframe

• decisions are aligned with local clinical strategies. The decision of MMG will be communicated to the lead author and PGD Working Group within 7 days of MMG and the decision and the reason for the decision recorded in the MMG minutes. In the event of a rejection, the lead author and the Chair of the PGD Working group will notify the Chair of MMG 6.2 Patient Group Directions Working Group The PGD Working Group is a subcommittee of the Medicines Management Group. It is chaired by the Assistant Director of Nursing (Practice) and is a multidisciplinary group which meets are regular intervals to develop the rationale for PGDs, advise on the development of PGDs and assure the content of PGDs, prior to the approval of the final PGD by MMG

6.2.1 Objectives of the Patient Group Directions Working Group

1. Develop an annual workplan to ensure that all legislative, policy and patient safety/efficiency requirements regarding the use of PGD.PSDs within the Health Board are addressed.

2. Manage the process of developing, reviewing and quality assuring PGD/PSDs

on behalf of the Health Board.

3. Make recommendations to MMG regarding the organisational requirements/approval of PGD/PSDs.

4. Maintain a database of approved PGD/PSDs and competent/approved users.

5. Ensure appropriate initial and ongoing training and competence assessments

are developed and available to support the safe use of PGD/PSDs in the Health Board

6. Develop and maintain a network across Health Board Healthcare

Professionals and Services to ensure that appropriate advice concerning PGD/PSDs use is readily available to respond to patient or service needs.

6.2.2 Membership of the Patient Group Directions Working Group Assistant Director of Nursing (Practice) or nominated deputy (Chair) Primary Care Nursing Practice Development Team representative Child Health Nursing Service representative Occupational Health representative Unscheduled Care Service representative Immunization and Vaccination Team representative



Senior Pharmacist (or nominated deputy) from each County Pharmacy Team Primary Care Prescribing Advisor representative Additional members will be co-opted to support PGD/PSD development in their service (for example, physiotherapy, radiography, Bowel Screening Team) Secretarial support will be provided from within the Nursing and Midwifery Directorate. 6.2.3 Meetings of the Patient Group Directions Working Group Meetings will be held monthly at venues across the HB. Videoconferencing facilities will be made available whenever possible. The meeting will be quorate when at least 3 members are present. 6.2.4 Reporting Arrangements of the Patient Group Directions Working Group A report containing the minutes and outcomes of the Patient Group Directions Working Group meetings will be presented at each MMG meeting. 6.3 Flow chart for developing a PGD/PSD See Appendix 1 6.4 Flow chart for reviewing an existing PGD/PSD See Appendix 2 6.5 Flow chart for the Process for Executive Sign-Off of PGDs See Appendix 3 . 7. RESPONSIBILITIES Responsibility of each practitioner working under the PGD 7.1. Supply or administration under the PGD

• Checks for drug and any other allergies before administration or supply under the PGD and consider course of action.

• Checks for potential interactions between current medications and the medicine being supplied under the PGD, referring to the current British Formulary

• Ensures that the patient understands how to take their medicine and understands what further action they must take should they experience any problems whilst taking the medicine.

• Recognises the need for a medical opinion and makes the referral as appropriate.

• Supplies medication for patient self-administration in accordance with the guidelines contained in the PGD having assessed the patients need



• Ensures an appropriately labelled medicine pre-pack is supplied to the patient, including completion of patient name and date which will need to be handwritten onto the label.

• Ensures that no quantity of medicine is removed or taken from the pack i.e. only original pack sizes are supplied.

• Provides appropriate advice to patients and staff and makes adequate written notes of all examinations, treatment, advice and referral for medical support.

• Provides the patient with the information defined within the PGD 7.2. Statement of Competency

• Agrees to and signs the statement by a practitioner agreeing to act under the PGD

• Ensures their specimen signature is currently held by the designated manager.

• Works within the limits set by the PGD and their own clinical competence.

• Is responsible for their own education/recertification and to be up to date with current best practice. This should be demonstrated by maintenance of a portfolio or continuing professional development (CPD) as laid down by the relevant professional body of the practitioner.

• Provides evidence of any compulsory training including annual updates or reviews.

• Keeps up to date with respect to all medicines listed under the PGD Failure to comply with any of the above will result in the practitioner’s name being removed from the authorised list. 7.3 Responsibility of Co-ordinator

• Ensures that annual audits of the PGD are undertaken

• Ensures the PGD is reviewed every 2 years (unless review is required earlier e.g. informed by audit or following significant changes to the medicine SPC or practice.)

• Includes pharmacists and clinicians in the review processes.

• Submits all PGD amendments to the PGD sub-group of the MMG for approval, along with all related audit reports

• Ensure handover of PGD co-ordination occurs if leaves post. 7.5 Responsibility of the Line Manager

• Ensures that the practitioners authorised to work under the PGD have completed the signed agreement to act under the PGD (see appendix 3 – template)

• Confirms by signing the agreement document that authorised practitioners have fulfilled the training requirements and achieved an acceptable standard of competency.

• Ensures that there is an up to date list of specimen signatures of all currently employed registered practitioners in the department working under the PGD. This list should be available to the PGD sub-group of the MMG on request.



• Ensures that only the currently approved PGD is available in the clinical areas and that there is full document control.

• Undertake audits, as instructed by the Co-ordinator, of all registered practitioners working under the PGD at the specified intervals.

• Picks up Co-ordinator role of PGD if Co-ordinator leaves post. 7.6 Responsibility of the Health Board (Executive Lead: Director of Nursing & Midwifery Hywel Dda University Health Board)

• To ensure that a register of PGDs/PSDs operational within the Health Board is maintained.

• A register of all employees operating the PGDs/PSDs is maintained

• That audit requirements are met. 8. TRAINING The training requirements for practitioners operating the PGD/PSD will be defined within each PGD/PSD and should be audited a regular intervals. The training definitions should include: Qualifications

• Include professional title/grade/band

• Specify current employment Specialist qualifications

• Successful completion of specified courses

• Any other relevant training or qualifications. (including working at Band X in xxxx area for xxx [specify period]

Specialist competencies

• Specify competencies with evidence of annual updates as required.

• Specify mandatory training such as CPR/life support/anaphylaxis competencies with evidence of annual updates as required.

• Specify experience or competencies for working under the PGD

• Actively partaking in annual Individual Performance Review Continuing professional development (CPD) requirements

• All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence.

• To reinforce and update knowledge and skills in this area of practice, with particular reference to changes and national directives.

• Practitioners should be aware of any changes to the recommendations for the medicine listed.

• Training needs will be identified through the Individual Performance Review process, and updates undertaken as required.



9. IMPLEMENTATION Annual audit of the PGD is a legal requirement. Audit must inform the review of a PGD and any audit reports must be submitted to the PGD Working Group with revised or re-submitted PGDs. Following the introduction of the PGD, and within one year, a sample of notes of those patients who have had supply/administration under the PGD will be audited. The aim would be for each practitioner to have a minimum of 5 records assessed during this time. Any registered practitioner who does not have their work audited within this time due to absence or annual leave or lack of opportunity to administer under this PGD will have his or her work audited separately e.g. by following up notes from specific clinics. The designated manager in consultation with a designated pharmacist, and the author will carry out this audit. The designated manager will ensure that all registered practitioners working under the PGD will have their work audited. The following areas must be audited:

• Reason for administering or supplying /not administering or supplying under the PGD

• Standard of written records and signature

• History of allergy recorded in notes

• Receipt of information including leaflet(s) by patients

• PGDs for antibiotics must be subjected to an external audit (legal requirement)

Audits could include:

• Clinical records such as date and time administered/supplied

• Clinical data such as correct indication/dose of medicine

• Signature/name of staff who administered or supplied the medication, and also, if relevant, signature/name of staff who removed/discontinued the treatment

• Details of any adverse drug reaction and actions taken including documentation in the patient’s medical record

• Referral arrangements (including self-care)

• Pharmaceutical information such as records of batch number and expiry dates.

The results will highlight areas of best practice as well as areas of concern. The results will be reviewed by the Clinical Governance Manager and Community Nursing Services Manager Nursing who together will provide recommendations for any changes in the PGD or its practice as necessary. The audit results will also form the basis of an ongoing training and development programme. Audit results will also need to be submitted to the PGD Working Group when a PGD is reviewed and updated. FURTHER INFORMATION RPharmS Medicines, Ethics & Practice http://www.rpharms.com/support/mep.asp (members only)



NHS PGD website http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/?id=512054 NICE MPG2 Patient Group Directions http://www.nice.org.uk/guidance/mpg2 MHRA Patient Group Directions: Who Can Use Them? https://www.gov.uk/government/publications/patient-group-directions-pgds/patient-group-directions-who-can-use-them RCN Patient Group Directions. Guidance and Information for Nurses. July 2004 Medicines Matters. A Guide to current mechanisms for the prescribing, supply and administration of medicines. DH NHS Modernisation Agency March 2005 RPSGB Fitness to Practise and Legal Affairs Directorate Fact Sheet: Ten. Patient Group Directions Nov 2004 MeReC Briefing. Patient Group Directions (March 2004) 23:1-8. For more information, visit the national PGD website http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/ that provides some useful information about PGDs as well as a forum for sharing knowledge. Further reading (also used as reference documents for this guidance) can be accessed via the PGD website. Patient Group Directions in the NHS: Medicines and Healthcare Products Regulatory Agency (MHRA): Link [This links to guidance for the legislative framework for development, implementation and review of PGDs in the NHS Department of Health Medicines Matters: A guide to current mechanisms for the prescribing, supply and administration of medicines: July 2006 Link [This document includes definitions of Patient Specific Directions and Patient Group Directions as well as information on independent and supplementary prescribing.] “To PGD or not to PGD” flowchart on the PGD website. [This is a flow chart to aid decision making on whether a PGD is appropriate.] National Prescribing Centre March 2004 Patient Group Directions: A practical guide and framework of competencies for all professionals using Patient Group Directions Link [This document not only sets out the legislation in practice but also features Frequently Asked Questions about PGDs Royal Pharmaceutical Society of Great Britain: PGD Resource Pack for Pharmacists Link Royal College of Nursing: PGDs – Guidance and Information for Nurses Link



Appendix 1 FLOW CHART PROCESS FOR THE DEVELOPMENT OF A NEW PGD

AUTHORS

DOCTOR NURSE PHARMACIST

Initial enquiry received by PGD Group

or member

Rationale for development agreed with lead

Doctor/ Pharmacist, Practitioner and Co-

ordinator identified for MMG approva.l Chair

of via PGD Sub Group sends rationale for

consideration by MMG.

Draft PGD circulated to PGD Sub Group

members for their comments (QA

process)

SUBMIT TO PGD SUBGROUP FOR

DISCUSSION AND APPROVAL

FINAL PGD AND COMPLETED AMENDMENT FORM

Comments to be returned to Co-ordinator

for PGD amendment and alteration

ADN PA to circulate Draft

PGD for Quality Assurance

(QA) to Group Members via Amendment form

DRAFT PGD READY

Ensure author of

PGD has the correct

template

MMG approves the

rationale for developing

the PGD

PGD SUBGROUP AND

AUTHORS INFORMED OF

DECISION

PGD Developed: Co-ordinator agreed, who then co-ordinates

comments/amendments between the lead Doctor, Nurse and

Pharmacist

MMG for FINAL

RATIFICATION

Invite author(s) if any issues

need clarification or are

controversial

APPROVED

TO ADN PA TO INITIATE

ELECTRONIC SIGN-OFF OF

RESPONSIBLE OFFICERS

PROCEDURE

If the lead nurse or pharmacist

sits on the PGD group then they

only need to comment once

Not Approved



Appendix 2 Flow chart for reviewing an existing PGD/PSD

PROCESS FOR REVIEW OF PATIENT GROUP DIRECTIONS (PGDs)

PGD REVIEW COMMENCES 6 MONTHS BEFORE EXPIRY DATE

AGREED TIMEFRAME WITH CO-ORDINATOR

ADN(P) PA

CO-ORDINATOR OF THE PGD TO BE

CONTACTED

PGD TO BE UPDATED BY CO-ORDINATOR

AND SENT TO ADN(P) PA FOR CIRCULATION TO PGD GROUP FOR QA PROCESS



Appendix 3 Flow chart for the Process for Executive Sign-Off of PGDs

PROCESS FOR EXECUTIVE SIGNATURE OF PATIENT GROUP

DIRECTIONS (PGDs)

PGD APPROVED BY HDHB PGD SUB GROUP

PGD SENT TO EXECUTIVES FOR APPROVAL AND

CONFIRMATION FOR USE OF THEIR ELECTRONIC

SIGNATURE WITHIN PGD

ADN(P) PA TO EMBED

SIGNAUTRE INTO WORD VERSION OF PGD AND PDF

BEFORE CIRCULATING TO SPECIFIC GROUPS

ELECTRONIC SIGNATURES ARE KEPT ON ADN(P) PA

COMPUTER AND ARE PASSWORD PROTECTED

ONCE PGD HAS BEEN PUT

INTO PDF FORMAT, SIGNATURES TO BE

REMOVED FROM WORD VERSION OF PGD

PDF VERSION OF PGD TO BE SENT TO GROUP

MEMBERS/OH/SPECIFIC PEOPLE BY ADN(P) PA

ADN(P) PA TO FILE ELECTRONIC AND HARD

COPY FINAL VERSION OF PGD AND COPY

CONFIRMATORY EMAIL FROM EXECS FOR AUDIT

TRAIL



APPENDIX S Medicines Safety Audit SOP

Standard Operating Procedure for the Medication Safety Audits

In light of the Trusted to Care (2014) report there is an expectation that all HBs undertake

medication safety audits.

Process

Data collection • Undertaken 1st

, 2nd

, or 3rd

Tuesday of each month

• Minimum of 10 patients per ward will be reviewed (or where less

than 10 patients present, all patients on the ward) by the

pharmacy teams.

• Data quality assured by pharmacy teams

Importing of

data

• Information sent to CPDN by third week of the month

• Data imported by the 1st

day of the following month

Sign off Data ready to be reviewed and signed off by Ward Sister (Ward Sister

signing off that they have viewed the data but are not accountable for its

accuracy).

See Table 1 for accountability/responsibilities



Appendix 1


Table 1: Accountability & Responsibilities:

Question Who is held to

account for the

results and

actions?

Expectation Report to:

Q2 Is the medicine allergy status documented on the

drug chart (including no known allergies)?

Medical teams

Develop action

plans for areas for

improvement and

monitor progress

TO BE CONFIRMED

All the results to be reported to:

• Medicine Mgt Group

• Clinical Effectiveness and

Audit Committee

Q3 Is the VTE risk assessment documented on the

medication chart?

Q4 Was medicines reconciliation undertaken within

24 hours of admission?

Pharmacy Develop action

plans for areas for

improvement and

monitor progress

Pharmacy

Prescribing Work

stream (every 3

months)

Q5 Has the patient had any unintentional medication

doses omitted in the last 24 hours?

Nursing

Develop action

plans for areas for

improvement and

monitor progress

SNMT (every three

months)

Q6 Indicate the number of missed doses in the

previous 24 hours according to the reason (non-

administration code) in the boxes below: Code

Number of doses

• Q6a Code 2 - Patient not on ward

• Q6b Code 3 - Patient unable to receive

medicines/ or no access

• Q6c Code 4 - Patient refused medicine

• Q6d Code 5 - Medicine unavailable

• Q6e Code 6 - See notes

• Q6f No code documented (blank box)


Q7 Indicate if any of the missed doses in the

previous 24 hours were any of the following:

• Q7a Anticoagulant

• Q7b Insulin

• Q7c Opiate

• Q7d Anti Infective

• Q7e Critical time medicines (see local policy)

Medical

teams/Pharmacy

and nursing

(depending on the

circumstances).

Develop action

plans for areas for

improvement and

monitor progress

Medical: TO BE

CONFIRMED

Pharmacy:

Prescribing Work

stream

Nursing: SNMT


APPENDIX T Medicines Refrigerators’ Temperature Checking Procedure

Medicines Refrigerators’ Temperature Checking

Procedure

Procedure Number:

Issued following approval

Supersedes: List document

Numbers Classification Select Clinical/

Corporate/Employment

Version No:

Date of EqIA:

Approved by: Date

Approved: Date made

active: Review Date:

1


This procedure aims to ensure that medicines which require refrigeration are stored correctly and that this can be demonstrated.

Scope

This procedure covers all wards, departments and clinics where medicines are stored in refrigerators. Staff who are involved in the administration and storage of medicines (nursing staff, pharmacy staff) and staff involved in maintaining refrigerators should follow this procedure. Staff training will be in-house by the ward sister or departmental manager.

To be read in conjunction

with: Appendix to Medicines Policy

Owning Committee/

Group Medicines Management Group


REVIEWS & UPDATES

Version

no:

Summary of Amendments:

Date

Approved:

1 New Procedure

GLOSSARY OF TERMS

Term Definition


14. AIM OF PROCEDURE The aim of the procedure is to ensure that medicines which require refrigeration are stored correctly and that this can be demonstrated. 15. OBJECTIVES

• Staff are trained in the importance of maintaining control of the temperature of medicines, maintenance and monitoring of the equipment used.

• Set out standards for daily refrigerator temperature monitoring

• Reporting mechanisms for temperature excursions.

• Standards for regular maintenances of refrigerators. 16. SCOPE This procedure covers all wards, departments and clinics where medicines are stored in refrigerators. Staff who are involved in the administration and storage of medicines (nursing staff, pharmacy staff) and staff involved in maintaining refrigerators should follow this procedure. Staff training will be in-house by the ward sister or departmental manager. 17. PROCEDURE FOR MEDICINES REFRIGERATORS Ward, clinic and departmental actions:

1. Only medicines should be stored in the designated medicines refrigerator. Nutritional supplements must be sorted in a separate refrigerator.

2. Fridges must be kept locked when not in use, and the key kept with the nurse in charge of the ward.

3. The refrigerator should be hard wired into a fused spur or at least ensure the socket or plug is clearly labelled with ‘Do not switch off’.

4. The refrigerator should not be overloaded with stock; there should be space for the air to circulate around the internal space. Medicines should not be in contact with the sides of the refrigerator. It is particularly important to ensure that the medicines do not freeze as this may be potentially more detrimental to it’s stability.

5. The temperature should be between 2 and 8°C; with an optimum target range temperature of 4-5°C.

6. The thermometers used to monitor the refrigerators will vary; if a maximum-minimum thermometer is used, it must be reset after recording the temperature.

7. The temperature of all medicines refrigerators should be checked and recorded daily by nursing staff. See Appendix ... for the Medicines Refrigerator Monitoring Chart.


8. Any other deviations outside the recommended temperature range (e.g. the door is left open or ajar) should be recorded on the monitoring sheet and reported to the nurse in charge.

9. In the event that the temperature is out side of the normal range (2 and 8°C), the nurse in charge of the ward must be informed immediately. The nurse in charge must contact the Estates department for immediate action.

10. For any out of hours problems – the stock must be quarantined in another fridge with all details on the bags etc e.g. what time was problem encountered, temp etc and contact on call pharmacy if there was a requirement for new stock . (N.B: Some medicines can still be used after storage outside the recommended temperature range, but as this constitutes use outside of the product license (i.e. unlicensed use) but this use must be authorised by the Pharmacy department. A shorted expiry date may be assigned.)

Maintenance Actions 1. All medicines refrigerators must conform to the All Wales specification. (link....). The

refrigerators must be purchased via the NHS Wales Shared Services Partnership-Procurement Services

2. All refrigerator monitoring systems should be maintained and calibrated according to the manufacturers’ instructions. (Estates to advise on frequency)

3. Refrigerators should not be placed next to heat sources or direct sunlight.

18. REFERENCES Draft WG Advice following Andrews’ Report (2014)


APPENDIX 1 Recording sheet

Daily Fridge Temperature Checklist. Name of Ward Hospital.

Temperature recorded

Signature of Nurse

Date Reported to Estates Department

Please note Temperature target range is between 2-8°C. Estates Contact Number: Pharmacy Contact Number: