the safe and secure handling of medicines policy · 4.7 chief pharm acist (a count ble officer fo...

DOCUMENT CONTROL:

Version 10.2 Ratified by: Clinical Quality Group

Date ratified: 1 March 2016

Name of Originator / Author Chief Pharmacist Name of Responsible Committee/Individual

Clinical Quality Group

Date Issued 17 April 2018 (removal of Forensic Service annual review document control box)

Review Date March 2019 Target Audience This policy applies to all staff involved with the

use of medicines.

The Safe and Secure Handling of

Medicines Policy

http://nww.intranet.rdash.nhs.uk/home/corporate-templates/rotherham-doncaster-and-south-humber-nhs-foundation-trust-rgb-blue/

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CONTENTS

SECTION PAGE

1. INTRODUCTION 7

2. PURPOSE 8

3. SCOPE 9

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 9

4.1

4.2

The Board of Directors

Medical Director

10

10

4.3

4.4

Clinical Governance Group

Clinical Effectiveness Committee

10

10

4.5 The Medicines Management Committee 10

4.6 Organisational Learning Forum 11

4.7 Chief Pharmacist (Accountable Officer for Controlled Drugs) 11

4.8 Trust Pharmacists 12

4.9 Pharmacy Technician 12

4.10 Prescribing responsibilities of all staff: Practitioners with prescribing, ordering, storing and administering of medicines responsibilities

12

4.10.1 Staff definitions 12

4.10.2 Medical staff 12

4.10.3 Independent prescribing 13

4.10.4 Supplementary prescribing 13

4.10.5 Non-medical prescribing (NMPs) 13

4.10.6 Prescribers responsibility 13

4.10.7 Informed Prescribing 14

4.10.8 Appointed practitioner in charge / responsible person 14

4.10.9 Assigned practitioner in charge 16

4.10.10 Non-registered healthcare staff 16

4.10.11 Bank/agency staff 16

4.10.12 Staff who administer medication 17

4.10.13 Supplying Pharmacist (community hospital) 17

5. PROCEDURE/IMPLEMENTATION 17

5.1 Medicines which fall within this policy 17

5.2 Prescribing of medicines 18

5.2.1 Medicines reconciliation 18

5.2.1.1 Allergy 19

5.2.2 Patient involvement 20

5.2.3 Source of information available to patients 21

5.2.4 Prescribing principles 21

5.2.4.1 How medicines are managed on handover between 21

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care settings

5.2.5 Prescription documentation 22

5.2.6 Initiation of treatment 24

5.2.7 Completing the prescription 24

5.2.8 Transcribing directions to administer 31

5.2.9 How the organisation is assured that medication charts are accurate

31

5.3 As required medication (prn) 31

5.3.1 Prescription 32

5.3.2 Administration 33

5.3.3 Review 33

5.3.4 Leave/Discharge 34

5.4 Take home medication (TTO) or discharge drugs 34

5.5 Outpatient prescriptions 36

5.6 FP10’s 36

5.6.1 Issuing prescription 36

5.6.2 Lost Prescriptions Pads 37

5.6.3 SOPS for managing FP10’s 37

5.7 Use of patient’s own medication 37

5.8 Prescribing homeopathic/herbal remedies 38

5.9 Above BNF maximum prescribing lines 38

5.10 Prescription for hospital staff and their families 39

5.11 Staff self-administration of medicines 39

5.12 Patient group direction 39

5.13 Ordering medication from pharmacy 40

5.13.1 Ordering stock medication 41

5.13.2 Ordering named patient medication 43

5.13.3 Receipt of stock and named patient medication 44

5.13.4 Faxing of prescriptions to pharmacy 44

5.13.5 Ordering controlled drugs 44

5.14 Transfer of medicines between ward areas 47

5.15 Out of hours pharmacy service 48

5.16 Delivery of non-controlled medicines 48

5.17 Storage of medication 48

5.17.1 Containers for storage of medication 48

5.17.2 Storage of medication on wards/departments 49

5.17.2.1 Medicines storage room ambient temperature monitoring

49

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5.17.3 Drug fridges 49

5.17.4 Siting of cupboards or trolleys 50

5.17.5 Controlled drugs cupboards 50

5.18 Custody and safekeeping of medicine 50

5.18.1 Keys for medicine cupboards, medicine trolleys and drug fridges

50

5.18.2 Keys to the controlled drugs cupboard 51

5.18.3 Re-agent cupboard keys 51

5.19 Arrangements for the administration of medicines 51

5.19.1 Medicines and the Law 51

5.19.2 Who has the authority to administer medication 53

5.19.3 Patients Self Administration of Medication 53

5.19.3.1 Inpatient services General Self Medication Scheme 53

5.19.3.2 Specific Medicinal Products 54

5.19.3.3 Patients in the Community unable to self-administer 55

5.19.4 Principles of Administration 55

5.19.5 Action prior to administering medication 55

5.19.6 Consent to treatment 56

5.19.7 Checking administration 58

5.19.7.1 Complex calculations 59

5.19.7.2 Controlled drugs 59

5.19.8 Documenting the administration of medicines 60

5.19.9 Covert administration of medicines 61

5.19.10 Medications which have specific p rescribing, administrative, storage, availability or monitoring requirements

62

5.19.10.1 Injectable Medicines 62

5.19.10.2 Clozapine 67

5.19.10.3 Lithium 67

5.19.10.4 Oral Anticoagulants 67

5.19.10.5 Cytotoxics/Cytostatics and Chemotherapy 68

5.19.10.6 Antibiotics 68

5.19.10.7 Naloxone 68

5.19.10.8 Syringe Drivers 69

5.19.10.9 Enteral feeding and administering medication 70

5.19.10.10 Medical Gases 71

5.19.10.11 Flammable Liquids 72

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5.19.10.12 Dressings 73

5.19.10.13 Insulin 73

5.20 Advice about the uses and side effects of medication 73

5.21 Side Effects Monitoring 74

5.22 Transport of Medicine 75

5.22.1 Transport within wards and departments 75

5.22.2 Transport of medicines between health service premises

75

5.22.3 Transport of medicines from the Supplying Pharmacy 75

5.22.4 Transportation by Taxi 75

5.22.5 Transport of Medicines to Patients at Home 76

5.22.6 Transport of Patients medicines by Community Staff 76

5.23 Medication Error/incidents 77

5.23.1 Definition of Medication Error 77

5.23.2 Action to take if on Error occurs 78

5.23.3 How the organization learn from medication errors 79

5.24 Disposal of Medicines which are no longer required 79

5.24.1 Disposal of non-controlled drugs 79

5.24.2 Disposal of controlled drugs 79

5.24.3 Disposal of Patient’s own Medication 80

5.24.4 Drug disposal in Community Service 81

5.25 Ward Closures 81

5.25.1 Temporary or routine ward/department closures 81

5.25.2 Permanent closure of ward/department 81

5.26 Investigation of Drug Discrepancy or loss occurring in the hospital or community

81

5.27 Removal of and disposal of unknown substances 82

5.27.1 Action if a visitor is in possession of an unknown substance

82

5.27.2 Action if a patient is in possession of an unknown substance

82

5.28 Adverse drug reaction 83

5.29 Medicine Defect Reporting 83

5.30 Drug alerts, recalls and safety notices 84

5.31 Use of unlicensed medicines 85

5.31.1 Trust Procedure for the prescribing of unlicensed medication

86

5.32 Definition of “off-label Medicines” 87

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5.33 Medicines Safety 87

5.34 Clinical Trials including pharmaceutical products 87

5.35 Contact with Pharmaceutical Industry Representation 88

5.36 New medicine related documents 88

6 Training Implication 88

7 Monitoring Arrangements 89

8 Equality Impact Assessment Screening 89

8.1 Privacy, Dignity and Respect 90

8.2 Mental Capacity Act 90

9 Links to any Associated Documents 90

10 REFERENCES 91

11 APPENDICES 93

Appendix 1 – Guidance to staff on Medicines reconciliation 94

Appendix 2 – Crushing Tablets and Opening Capsules 99

Appendix 3 – Adverse Drug Reporting 101

Appendix 4 – Guidance on High Dose Antipsychotic Prescribing 103

Appendix 5 – Pharmacy Medication Card Assurance Verification Record

105

Appendix 6 – Allergy Assessment 107

Appendix 7 – Covert Administration Care Plan 118

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1. INTRODUCTION

- The department of Health requires that NHS Trusts establish documents and maintain an effective system to ensure that medicines are handled in a safe and secure manner.

- Medicines Management focuses on optimizing the use of medicines and

is defined in the Audit Commission’s Report ‘A Spoonful of Sugar’ as ‘encompassing the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimize the contribution that medicines make to produce informed and desired outcomes of care’.

- Aspects of medicines management run throughout the organization,

across all localities and service areas, and comprehensive medicines management is crucial to the achievement of the Trust strategic and operation objective. Medicines Management involves patients, carers and all Pharmacy Services within the Trust.

- This policy has been written in accordance with:-

• The NMC Standards for medicines management (2004)

• The NMC the Code: Standards of conduct, performance and ethics for Nurses and Midwives (2008)

• The Medicines Act (1968)

• The Misuse of Drugs Act (1971)

• The Misuse of Drugs Regulations 2001

• The Safe and Secure Handling Medicines 2005 (revision to the Duthe Report, 1988)

• The Mental Health Act (1983) (amended by the Mental Health Act 2007)

• Health and safety Regulation

• Control of Substance Hazardous to Health Regulations 1988 (COSHH)

• Essential Standards of quality and Safety

• NPSA alerts and guidance

• Health and Social Care Act 2008 (Registration Requirements) Regulations 2009: Regulation 11 – Management of medicines and medical devise.

And also any amendments to the primary legislation up to and including December 2015 Policy Statement In the Trust the principles which govern the management of medicines must be applied to all the actives in which medicines or their administrative and legal control is concerned.

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The Key principles are:

• Compliance with current legislation;

• Adherence to guidance issued by the Health Departments for England, Wales, Scotland and Northern Ireland and other national guidance e.g. NPC Guide, NPSA alerts;

• Management of the risks to patients and staff arising from the use of medicines.

These principles will be applied to the management and physical handling processes involved in the initiation of treatment, prescribing, procurement, production, acquisition, storage, distribution, dispensing, preparation, administration to patients and the safe handling and disposal of any residual medicinal product. If situations occur that may require staff to go outside of policy then the chief pharmacist must be contacted who will decide whether the course of action is appropriate, and whether they can continue, or it needs further agreement, following this the chief pharmacist will then consult with the team manager and head of professional service for agreement and document the decision, this will then be taken to medicines management for ratification.

2. PURPOSE

The purpose of this policy is to set out the arrangements for managing the risks associated with medicines in all care environments; and, to enhance standards of professional practice in the safe prescribing, dispensing and administration of medicines by:

• Providing a procedural framework supporting the safe and secure use of medicines across all Trust activities. This framework is to be used to support the development of ward, department and base point specific standard operating procedures.

• Ensuring that the handling and storage of medicines within the Trust meets legal requirements.

• Creating a robust audit trail that will be monitored regularly.

• Defining the roles and limitations of staff working within the Trust in relation to medicines.

• Detailing the lines of responsibility for the investigation of medicines related incidents.

Additionally, the aims of this Policy are to ensure that:

• all patients receiving treatment requiring medication do so in the correct and proper manner;

• all precautions have been taken to ensure that the proper procedures have been followed in providing that treatment;

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• Proper procedures have been followed such that all medicines have been stored and transported to ensure that their integrity has been maintained and to minimize risks to staff, patients and the public.

The result of using the Policy (in conjunction with any other appropriate local policies) should be that the right patient /patient receives:

• The correct medication;

• In the correct dosage;

• By the correct route;

• At the right time, and

• For the right duration;

However, medicines management should not be viewed as a mechanistic task, which becomes routine, as it requires thought and the exercise of professional judgment with each practitioner being accountable for their actions and omissions.

3. SCOPE

This policy applies to those members of staff that are directly employed by the Trust and for whom the Trust has legal responsibility who are involved with the use of medicines. For those staff covered by a letter of authority/honorary contract or work experience this policy is also applicable whilst undertaking duties on behalf of the Trust or whilst working on Trust premises and forms part of their arrangements with our organisation. As part of good employment practice, agency workers are also required to abide by the Trusts policies and procedures, as appropriate, to ensure their health, safety and welfare. All staff contracted to work within the Trust who are involved with the use of medicines must familiarise themselves with the correct procedures contained within this policy. Those in charge of wards, units and clinics are responsible for ensuring that their staff, (especially new and locum staff), follow procedures in this policy, which may differ from procedures used elsewhere. Copies of the policy will be available at all inpatient and outpatient sites as well as being accessible on the Trust intranet.

4. RESPONSIBILITIES, ACCOUNTABILITES AND DUTIES

The duties and responsibilities for medicines procedures that may be held by various grades of practitioners are shown below. However, all grades of practitioners must:

• Be aware of the tasks they may or may not perform.

• Identify their training needs making their manager aware of any training deficit.

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• Maintain a personal record of all competency-based assessments.

• Report near-misses, clinical incidents and serious incidents regarding their prescribing, dispensing, storage and administration of medicines.

4.1 The Board of Directors

The Board of Directors through the Executive Medical Director and the Chief Pharmacist is responsible for Medicines Management within the Trust.

4.2 Medical Director

The Medical Director is responsible for:

• Medicines Management and Pharmacy Services lead at Board of Directors

• Medical leadership and supervision

• Signatory to Trust Patient Group Directions

4.3 Clinical Governance Group

The clinical Governance Group is responsible for:

• Establishing, auditing and maintaining effective processes for Medicines Management.

• Receiving, debating and taking action on as appropriate the Annual Report of the Accountable Officer for Controlled Drugs.

4.4 Clinical Quality Group

The Clinical Quality Group is responsible for

• Receiving, discussing and ratifying proposed medicines related policies and suggested amendments to existing policies.

• To receive audit results and ensure action plans are appropriate and robust in relation to the audit results.

• Chair of Clinical Effectiveness Committee to be a signatory to Trust Patient Group Directions.

4.5 The Medicines Management Committee

The Medicines Management Committee is responsible for:

• To develop effective medicines management policies which supports compliance with medicines legislation and good professional practice in prescribing, supplying, administering and monitoring of medicines

• To ratify and register all unlicensed medicinal products supplied or

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administered through the Trust.

• To promote safe medication practice by the systematic review of medication errors.

• To recommend to the Clinical Quality Group all documentation associated with the prescribing and administration of medicines.

• To recommend to the Clinical Effectiveness Group protocols which enable non-medical practitioners to supply and administer medicines

• To audit medicines policies and procedures and the administration of medicines as part of the annual Clinical Audit Programme.

• All medication errors/incidents will be subject to review by the Trust’s Pharmacy Team. Themes and lessons learned from Serious Incidents (Sis) will be reviewed in the Medicines Management Committee, and will inform the medicines management training and policy review.

4.6 Organisational Learning Forum

The Organisational Learning Forum is responsible for:

• Developing and managing a structured approach to active organisational learning, where lessons learned are embedded in the Trust’s culture and practice. The group will help to facilitate a fair blame (no blame) culture.

• Share lessons learnt from one service to other areas of the Trust in order that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated.

• All medication errors/incidents are subject to review by the Trust’s Pharmacy Team. Themes and lessons learned from Serious Incidents (Sis) will be reviewed in the Medicines Management Committee, and will also be shared at the Organisational Learning Forum

4.7 Chief Pharmacist (Accountable Officer for Controlled Drugs and

Medication Safety Officer)

The Chief Pharmacist is responsible, and accountable to the Trust boards for:

• Pharmacy Services

• Medicines management throughout the Trust. Ensuring timely reporting against the monitoring requirements of this policy

• Ensuring processes are in place supporting the appropriate acquisition, storage, usage and disposal of medicines across the Trust

• Providing a monthly report from the Medicines Management Committee to the Clinical Governance Group

• Providing an annual report to the Clinical Governance Group in their capacity as Accountable Officer for Controlled Drugs

• Providing a quarterly report to the Clinical Governance Group from the Pharmacy Local Intelligence Network (LIN)

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• Providing a three monthly report on medication related errors

• Signatory to Trust Patient Group Directions.

• Providing advice on the medicines management element of the Trusts Clinical Audit Programme

4.8 Trust Pharmacists

Whilst the Trust medicines are supplied through either service level agreements with the acute hospitals within the localities or via a contract with local pharmacists, these are pharmacists employed who are responsible for supporting the best use of medicines throughout the Trust including:

• The safe, effective and economic use of medicines

• Appropriate storage of medicines in clinical area

• Supporting the Trust’s Clinical Audit Programme in relation to medicines management

• Appropriate investigation of medicines related incidents

• Support staff training in relation to medicines management

• Monitor prescription cards in line with the 10 point plan

4.9 Pharmacy Technician

These staff offer a service Trust-wide, but are based within the Doncaster locality and will inspect the stocks of medicines held on the wards or in departments at any time to ensure the medicines are in date and stored/disposed of under the proper legal and environmental conditions.

4.10 Prescribing responsibilities of all staff: Practitioners with prescribing,

ordering, storing and administering of medicines responsibilities

4.10.1 Staff Definitions

Throughout the Policy, Certain specialist titles describe healthcare staff that have defined responsibilities regarding the management of medicines. In general, only staff with contracts (honorary contracts) of employment to work with the Trust are assessed as having any involvement with medicines. All nurses or practitioners who are either new or unsure about certain practices should administer in pairs.

4.10.2 Medical Staff

Medical staff are responsible for prescribing medicines for patients. They and any other authorized prescribers must comply with current legislation, national guidance and the Medicines Policy, when performing these duties. With the exception of Clozapine, which can only be initiated by a Consultant Psychiatrist, who in turn must be registered with ZTAS, all qualified doctors may prescribe licensed medication on inpatient charts, leave prescriptions (TTOs) and outpatient prescriptions.

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Off-license prescribing must be Consultant-led, unless supported by the Trust Formulary or national/local guidance such as NICE, and should be recorded in the patients clinical record.

4.10.3 Independent prescribing

Prescribing by a practitioner (e.g. doctor, dentist, nurse and Pharmacist) responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing.

• Non-medical prescribers must not prescribe unlicensed medicines.

However, medication which is licensed, but outside its licensed indications may be in exceptional circumstances prescribed by an independent non-medical prescriber, if such use is justified by current best practice (e.g. national NHS guidance or local Trust guidance). Non-medics prescribing medicines outside the terms of the product license must accept professional, clinical and legal responsibility for that prescribing. This prescribing must be carried out within their professional competence/

4.10.4 Supplementary Prescribing

Supplementary prescribing with the agreement of patients enables nurses, pharmacists and that AHPs previously identified, to make adjustments to medication based on agreed clinical management plans, thus facilitating a more flexible approach to care delivery and the development of new professional roles. The Department of Health (2004) defines supplementary prescribing as “A voluntary partnership between an independent Prescriber (a Doctor or Dentist) and a Supplementary Prescriber to implement an agree patient specific Clinical Management Plan (CMP) with the Patient’s agreement”.

4.10.5 Non-Medical Prescribers (NMPs)

NMPs are nurses, pharmacists, or certain AHPs who have satisfactorily completed the supplementary and independent prescribing course. They should only prescribe within their agreed area of expertise and competence, Please refer to the Trust’s Non-Medical Prescribing Policy.

4.10.6 Prescribers Responsibility

It is the responsibility of any authorized prescriber to:

• Write the prescription legibly and correctly

• Include all relevant details of the patient on the prescription

• Prescribe medication in accordance with the standards in the policy

• Check the patients’ medical records prior to writing any new

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prescription

• Follow local and national prescribing standards

• Pay particular attention to the accuracy of complex drug calculations

• Discuss the proposed treatment plan with the patient and their carer/relatives (subject to the patients agreement) and record a summary of this discussion in the patients records stating clearly:

• What medication is to be prescribed

• The aims of the treatment plan

• How long the medication should be taken for

• What alternative treatment plans have been discussed

• Review date and monitoring

4.10.7 Informed Prescribing

The Trust appreciates that face to face assessment, by the prescriber, of a patient prior to any prescribing decision is the ideal situation, however the reality is that in many instances this is simply not possible or in the patient’s best interest – most notably in out of hours situations, community teams where patient assessment may be by another healthcare professional (HCP) or occasions where a patient receives a repeat prescription from us as part of their on-going care. In such instances the Trust supports national and professional guidance which requires prescribers to work within their competencies and assure themselves of the patient’s health and their need for the medication prior to prescribing. This assurance may be informed by telephone conversation with the patient or their carer, the patient’s clinical notes or care plan, referral letters from other HCPs, adequate feedback from other HCPs who have assessed the patient, other sources that are considered reliable. When making such prescribing decisions, due regard should be given to the prescriber’s experience, the seriousness of the patient’s clinical condition and specific drug considerations such as potency, monitoring requirements and abuse potential. You are responsible for any prescription you sign, including repeat prescriptions for medicines initiated by colleagues, so you must make sure that any prescription you sign is safe and appropriate.

4.10.8 Appointed Practitioner in Charge/Responsible Person (Service

Manager/Ward Manager)

This is the senior practitioner appointed to take charge of a ward or department e.g. Ward Manager or Team Leader. In the event that the person in charge is not from a professional nursing background appropriate to take on the duties and responsibilities within this policy (e.g. community team leader with a social work background), another senior member of the nursing team will undertake the role of appointed practitioner in charge with respect to controlled drugs, and may take the role of appointed practitioner in

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relation to all medicines management issues. This staff member has ultimate responsibility for:

• ensuring that this policy and other associated procedures in relation to medicines administration are being followed correctly

• the safekeeping of medicines on the ward, department or base point and will ensure their safe and appropriate storage at all times.

• ensuring that SOPs are relevant to their area of practice, are consistent with the standards of this policy and that all staff have read and signed SOPs appropriate to their role.

• ensuring that the staff performing physical security checks and stock reconciliation is appropriately rotated to ensure secure delegation is maintained.

• arranging for an appropriate investigation to take place if there are any exceptions or discrepancies.

• ensuring that unwanted medicines are disposed of in appropriate pharmaceutical waste bin prior to collection.

• ensuring that all Controlled Stationery on the ward, department or base point is held securely. Where a department is closed for any reason up to 7 days the Responsible Person will ensure that all medicines are stored in cupboards as specified in Section 5.17.

• signing for receipt of any medicines delivered to the ward or department. This process will involve checking the received stock against requisition, and patients own medication against the prescription, as well as ensuring security of storage through transit has been maintained.

• ensuring that access to medicines is restricted, by control of keys to the medicine cupboards and refrigerators, or other alternative approved storage areas. This responsibility remains with the Responsible Person even if they decide to delegate this duty.

• checking stock levels at least once every six months where a ward or department is not served by a pharmacy top-up service.

• ensuring that a running balance of Controlled Drugs is recorded after each transaction and recorded under the last entry for each medicine in the Controlled Drug Register.

• Administration of medicines. This duty may be delegated to another practitioner, but the appointed practitioner /Responsible person in charge must exercise supervision as necessary and be satisfied that the staff member to whom they have delegated the task has received relevant training.

• If a situation arises where medication, which has been prescribed has not been written in accordance with the standards in this policy, the practitioner may still administer the medication provided they are satisfied the prescription is legible and safe, and that any delay in administration would be detrimental to the patient. The prescriber must be contacted immediately and informed of the deficiencies with the prescription being re-written correctly within 24 hours.

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4.10.9 Assigned Practitioner in Charge

This is the senior practitioner on duty (i.e. team manager) who in the absence of the Appointed Practitioner in Charge/Responsible Person has been rostered as the professional in charge for that shift. Whilst in charge this person is responsible for all the duties as set out above in section 4.5.7

4.10.10 Non-Registered Healthcare Staff

These are clinical support workers, trainee and assistant practitioners, healthcare workers, support workers and nursing assistants who assist in medication duties. These staff must have the relevant training or Trust approved training, allowing them to undertake certain functions with respect to assisting with medicines administration, or administering medication in agreed circumstances, such as community homes. The following situations are suitable for support staff to administer or aid in the administration, provided the task has been delegated to them as an individual authorised for that level of administration:

• Administration of oral medication, such as in a community home or supported living

• The application or insertion of creams, ointments or drops

• Nursing a child who is using a nebuliser

• The supervision of a dependent patient to ensure their medicines are taken effectively

• Simple eye care

• Simple dressings

The Individual Authorised to administer medicines retains the responsibility to ensure that a medicine has been administered correctly; and that responsibility cannot be delegated. In line with this the individual authorised to administer will identify the correct medicine and correct patient to whom the medicine is to be administered. Practitioners in training must be given every opportunity to become proficient in medicines related activities under appropriate supervision. The supervising practitioner has responsibility for such medicine procedures at all times.

4.10.11 Bank/Agency Nursing Staff

Before administering medication, agency or bank staff should have attended mandatory training or local induction and be familiar with the policies of the Trust. Regular bank or agency registered nursing staff confident in Trust practices may administer medicines with approval of the appointed practitioner in charge. It is the responsibility of the registered nurse to report any issues regarding their competence.

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4.10.12 Staff who Administer Medication The individual authorised to administer medicines will be responsible for:

• ensuring they have an understanding of the use, action, usual dose, side effects and handling hazards of the medicine(s) being administered.

• ensuring they are certain of the identity of the patient to whom the medicine is to be administered before initiating any administration activity.

• retaining the responsibility to ensure that a medicine has been administered correctly; (this cannot be delegated). However in certain circumstances support staff may aid in the administration of medicines. In these circumstances the administrator will ensure that the support staff has sufficient training and information to aid the administration of the medicines safely.

• They have received appropriate training to administer medication, especially when given parenterally or via enteral feeding tubes.

4.10.13 Supplying Pharmacist (Community or Hospital)

Supplying pharmacists are responsible for ensuring that prescribers are always aware that a medicine they have requested is only available as an unlicensed product. Pharmacists will share the responsibility as the purchaser of the product, particularly when this involves specifying the product to be purchased. Pharmacists are responsible for ensuring that the manufacturer holds the appropriate license to manufacture and that the product complies with the product specification.

5. PROCEDURES/IMPLEMENTATION

5.1 Medicines Which Fall Within This Policy

Medicines, whether for internal or external use, will be regarded, for the purpose of the policy, as comprising the following categories:-

Controlled Drugs controlled under the provisions of the misuse of Drugs Act 1971, with stringent requirement for supply, storage and administration. All other medicines and medicinal products prepared for administration to patients and which are controlled by the Medicines Act 1968. This also includes many diagnostic agents, X-ray contrast agents and medical gases. Whilst less stringent regulations apply than in the case of Controlled Drugs, they must be treated with equal care. All complementary medicines, e.g. aromatherapy, herbal or homeopathic remedies. These products are used for therapeutic purposes and require the same safeguards as other medicines.

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Other pharmaceutical preparations. Disinfectants, reagents and other preparations are not used directly to treat patients. However, the use of these products must still be subject to agreed and approved procedures. Full attention must also be given to the requirements of current Control of Substances Hazardous to Health (COSHH) Regulations. It is important to understand that procedures listed in this document apply to all medicines used in the Trust. These include topical lotions, applications, injectable fluids, medicated dressings, dietary products and complementary medicines. Where they exist Standard Operating Procedures (SOPs) must be followed and where missing must be developed accordingly.

5.2 Prescribing of Medicines

5.2.1 Medicines Reconciliation

“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” (NICE Medicines Optimisation NG 5) and involves:

• Collecting information on medication history using the most recent and accurate sources of information to create a full and current list of medicines. Wherever possible, information should be obtained prior to admission.

• Checking or verifying this list against the current prescription, accounting for any discrepancies and actioning them appropriately.

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

Within the Trust, a medicine reconciliation document has been produced which meets the required standards, is auditable, and can be completed by suitably trained staff. Where staff carrying out the reconciliation are not medically trained and discover discrepancies between the record and what the patient is actually taking, this should be discussed with prescriber responsible for the patient within the team. When patients are referred in to a team, inpatient and community, medicines reconciliation should occur, this includes when patients have been to the acute hospital for treatment overnight. For community teams, patients should be asked about changes in medication at each visit and should be reviewed at least annually, this must be done in teams who are prescribing medication for the patient. In community settings the medicines reconciliation form should also indicate who is responsible for prescribing each medication.

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This document is to be completed at the point of admission, and referred to when prescribing medication for the patient. (For further guidance staff should refer to appendix 1).

5.2.1.1 Allergy

Assessment:

Take a history and undertake a clinical examination, using the guideline to help ascertain likelihood of it being an allergy. Appendix 6 Documenting and sharing with information with other healthcare professionals:

Record in their notes, and drug cardex as:

Drug Allergy/Hypersensitivity

None Known (NKDA)

Unable to ascertain (must be documented as soon as information is available)

If an allergy has been documented include (where information is available):

Drug Name (generic and brand if known)

Signs symptoms and severity

Date when it occurred

New Allergies identified whilst under our care:

Drug name, generic and brand, strength and formulation

A description of the reaction

Indication of the drug

Date and time of reaction

Number of doses/days prior to reaction

Route of administration

Which drug/classes of drugs to avoid in the future

Maintaining and sharing drug allergy information:

Ensure drug allergy/hypersensitivity is documented separately from adverse drug reactions so it is clearly visible.

Included in all GP referral and hospital discharge letters

Ensure medicines reconciliation is carried out in line with NICE guidance

Providing Information and Support to Patients

Discuss the persons suspected allergy with them and provide structured written information, record who gave this and when.

Ensure the person is aware of what drugs/classes of drugs they need to avoid in the future, and to advise them to check with the pharmacist before taking over the counter medication

Advise them to carry this information with them, and to share this information whenever they visit a health care professional.

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Non Specialist Management and referral to specialist services:

Consider stopping the suspected drug and advise to avoid in the future

Treat symptoms of the acute reaction; send people with a severe reaction to hospital

Document details as above

Provide person with information

Refer to a specialist drug allergy service if they have:

A suspected anaphylactic reaction

A severe non immediate cutaneous reaction e.g. Stevens-Johnson Syndrome

This should be via primary care, and be communicated in any discharge letter.

5.2.2 Patient Involvement

Patients have beliefs, attitudes and life experience which will influence their medicine taking behaviors, taking these into account and prescribing with that knowledge may have a positive effect on concordance. Concordance refers to a consultation and negotiation process between a health care professional and a patient, which has an ethos of a shared approach to decision making. Within this context it is the process of prescribing and medicine taking based on partnership, and the following three essential elements define the process: 1. Patient have enough knowledge to participate as partners

To aid this, patients must be provided with information which is:

• Tailored • Clear • Accurate • Accessible • Sufficiently detailed

2. Prescriber consultation involve patient as partner

To achieve this, patients must be: • Invited to talk about their concerns and expectations • Have their treatment regimens fully explained

3. Patients are supported in taking their medication

This will be achieved by giving patients:

• Ample opportunity to discuss their medication

• The effective sharing of information between all professionals involved in the patients care

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• Involving the patient in all reviews of their treatment regimes

5.2.3 Sources of Information to Patients (not relevant where patients receive

manufacturers patient information leaflet with medication packs

Information to patients is available in the following ways:

• From practitioners involved in their care and treatment

• From the information leaflets which are contained within the medication packs

• From the Trust pharmacy department

• Through 1:1 sessions with the specialist pharmacists employed within the Trust

• From the pharmacy information leaflets

• MIND and other independent organisations also offer information to patients around treatment and medication

• Long term outpatients will receive a complete set of patient information leaflets every three months

• Via the Trust website (Choice and medication)

5.2.4 Prescribing Principles

• The patient’s clinical record should always be checked before a new prescription is written.

• Prescribers should have access to a pharmacist who is able to provide advice on the drug treatment plan.

• Prescribers should follow local and national prescribing standards.

• Prescriptions should always carry specific patient directions and never be issued with the instruction “as directed”.

• Particular attention should be paid to checking the accuracy of complex drug calculations.

• The proposed treatment plan and the discussions with the patient or their representative regarding what the medication is, what the aims of treatment are, how long it should be taken, potential side effects, alternatives and what to do if stopping it as well as how the response to drug therapy is to be monitored should be clearly documented in the patients clinical notes.

• Patients should be provided with information on their treatment.

• Prescribers should be trained and assessed as competent before being required to prescribe.

• Where available electronic prescribing systems should be used.

• Actual and potential prescribing errors should be recorded and reviewed regularly to raise awareness of risk, and to improve practice.

5.2.4.1 How medicines are managed on handover between care settings

• Changes to medication must be documented in any correspondence

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between areas, e.g. discharge letter, clinic letter, transfer letter.

• This should include details and rationale of:

o Medication stopped

o Medication started, including review periods

o Any medication monitoring required and who is responsible

o Allergies and sensitivities

• When patients are received from any care setting medicines reconciliation must be completed (Appendix 1) where there is prescribing responsibility for the receiving team.

5.2.5 Prescription Documentation

Medicines may only be prescribed on authorised stationery

• Authorised inpatient prescription stationery Leave prescription sheet

• Discharge prescription sheet Outpatient prescriptions

• FP10 (NC)

• FP10SS FP10MDA

In community settings the prescription may come from the local acute trust or general practitioner and be followed with a • Letter of instruction (DCIS) • Medicine Administration Record (MAR) – Community Homes generated

by the supplying pharmacy

Write clearly Use capitals for the drug name - This is to be expressed as the Recommended International Non –Proprietary Name (rINN) unless:

• It is a combination product for which no rINN exists.

• It is a modified release preparation where brand substitution could potentially lead to symptomatic change.

• Use black ballpoint pen (prescribing in pencil is illegal)

• Pharmacists may use a green ballpoint pen on drug cards to ensure points of clarification or validation are clearly attributable to them. (2/14)

• Write figures clearly

• If a decimal point is used, ensure it is clearly visible (exaggerate if necessary), do not use a comma.

Date and Sign

• Use full signature

• Specify bleep number if appropriate

• Print name (in capitals)

• It is illegal to use a photocopied, doctor’s signature

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Patients Details Details that must be clearly written on the prescription are:

• Patient’s name (including aliases, or “known by”)

• Date of birth (age)

• Ward clinic name, or patient’s address

• Consultant

• Patient’s hospital number and/or NHS number (where available, exceptions may include crisis or home visits for example)

• Known allergies and sensitivities to medicines

Additional Requirements in Community Practice

Prescriptions issued in Community Practice must indicate a quantity to be supplied which should be for a period not exceeding 28 days unless:

• Treatment is being stabilized.

• The medicine is presented in a pack of more than 28 days and splitting the pack is unreasonable.

• Patients are going on holiday when, exceptionally, up to 3 months supply can be made to ensure continuity of treatment.

• For patients receiving regular medication from community teams, such as Access team and Assertive Outreach may use a repeat prescription using the Outpatient prescription form from Lloyds for a period of up to six months. A record should be made on the Trust approved form when a new prescription is issued and required.

• Patients who are under substance misuse services may receive FP10 MDA/FP10SS prescriptions, which allow repeat dispensing; these must be used as outlined in the Standard Operating Procedure for Controlled Drug Prescribing (Drug and Alcohol Business Division).

Function of the Prescription Chart

• To direct the administration of the medicine to the patient.

• To provide a permanent record of the patients treatment with medicines.

• To indicate the patient’s allergies and sensitivity to medicines.

• To facilitate the provision of the correct medicine from pharmacy.

• To assist compliance with the requirements of the Mental Health Act 1983 (amended by the Mental Health Act 2007).

• For patients currently detained under the Act, a copy of the relevant consent to treatment form (T1 to T5) must be stored with the current sheet

A well-written prescription sheet enables the rapid and accurate interpretation of the medicines required by the patient. All prescriptions must be clearly written in permanent black ink – this facilitates legible faxing and/or photocopying. It includes the following information that constitutes a legal prescription, thus permitting dispensing:

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• No more than one current prescription chart must exist at any one time for any patient. Where more items need to be prescribed more regularly than there are spaces on the sheet, then a second chart may be used, and both must be available when medication is prescribed, administered or requested from Pharmacy. In such circumstances, both prescription sheets must indicate the existence of a second sheet (i.e. 1 of 2 and 2 of 2).

• When a patient is re-admitted, including for respite care, a new

prescription sheet must be used. The prescription chart of patients transferred from one Trust unit to another may be transferred and do not require re-writing.

• When patients are transferred from other Trusts with

accompanying prescription charts, these must be re-written within 24 hours (48 hours at weekends and 72 hours at a bank holiday). In addition to the main prescription sheet there may be other charts (e.g. injectable fluid regimen, anticoagulants). The main prescription sheet must make reference to any therapy indicated on separate special charts and any other officially agreed special chart e.g. warfarin.

5.2.6 Initiation of Treatment

Only suitably authorised independent and supplementary prescribers have the authority to prescribe medicines for patients under the care of the Trust. Practitioners must not administer medicines that have not been authorised by an authorised prescriber. This authorisation must be in writing, in the form of a signed prescription (for community teams administering medication a letter of authorization), in advance of the administration of the medicine. Medical students are not permitted to prescribe medicines within the Trust. Staff may also administer medication from a Patient Group Directive, Patient Specific Direction, or agreed emergency medication

5.2.7 Completing the Prescription

• Date o To be written as dd/mm/yy.

o This indicates the date the treatment commences which may or may

not coincide with the date of admission.

o This start date must be carried forward to any rewritten prescription sheets in the future.

o Where dose or frequencies of administration are changed, this is regarded as a new prescription and must be written with a new start date.

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• Name and Form of the Medicine o The approved or generic name of the medicine must be written

clearly in CAPITAL o LETTERS. Drug names are not to be abbreviated under any

circumstances. o A medicine may have numerous brand names but only one

approved name. If the medicine is a combination of two or more medicines (with no approved name) or has unique release properties or bioavailability, then the brand name will be accepted.

o The form of a medicine must be specified – solid dose will be assumed unless otherwise stated.

o Non-approved abbreviations of the name of the medicine, e.g. “CBZ” for Carbamazepine, CPZ for Chlorpromazine, and Li for Lithium must not be used.

• With respect to tablet and capsule release characteristics only the

following abbreviations may be used with in the Trust: o EC – Enteric coated. o MR – Modified release. o LA - Long Acting o SR – Sustained Release o LAI - Long Acting Injection

Combination products: For oral medications containing more than one drug, write the approved name followed by the strength of each component, then the number of dose units, e.g. Co-amilofruse 5/40 i od.

Dose

The DOSE must be expressed in metric units. Quantities of less than 1 gram must be written as milligrams. Decimal points should not be used, for example 500mg not 0.5g so as to avoid confusion. Whenever a decimal point is necessary, the prescriber and the practitioner administering the drug must exercise great care. The terms MICROGRAM and NANOGRAM must not be abbreviated but must be printed in full and used for quantities less than one milligram. Liquid preparations should show the DOSE in milligrams/micrograms OR the strength of the preparation AND the dose in millilitres. With regards to the prescribing of insulin this must always be prescribed as units, and in line with the NPSA alert on insulin it must not be prescribed using the abbreviations U or IU Dosage Forms:

Capsule Cap Syrup Syr Suspension Susp Injection Injection

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Suppository Sup Eye Drops Gutt Eye Ointment Occ Tablet Tab

Only the following abbreviations are acceptable within the Trust: Mg - Milligram G - Gram Kg - Kilogram L - Litre Ml - Millilitre Mmol - Millimole Microgram and Nanogram must be written in full Route of an Administration This must be stated for all prescriptions and only the following abbreviations are acceptable: IM Intramuscular INH Inhalation IV Intravenous NEB Nebulisation PO Oral PR Per rectum PV Per vagina SC Subcutaneous SL Sublingual TOP Topical PEG Percutaneous All other routes of administration must be written out in full. Dosage Frequency

• For ‘as required’ (prn)medicines the frequency of administration and

indication for use must be written by the prescriber. A maximum dose within a 24-hour period must be stated, and this must include any regularly prescribed doses. Abbreviations such as 4 should not be used – 4-hourly should be written in full. (For full details staff should refer to Section 5.3 of this policy).

• For “regular medicines” the prescribing times should be in

accordance with regular medicine rounds wherever possible. • For antibiotics the prescribing times should be in accordance with

regular medicine rounds wherever possible, and equally spaced to promote effective treatment.

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• Depot injections must be prescribed with the time interval expressed

using the term “every” (e.g. every 3 weeks rather than 3-weekly, which can be misinterpreted. This can be abbreviated as 3/52). The date that the first depot injection is to be given must also be clearly stated.

• Be aware of drugs which are given at weekly intervals. For drugs

given less frequently than once daily (e.g. methotrexate, fentanyl patches, alendronate), use crosses on the prescription chart to indicate the days when the drug should not be given.

• Medicines that are intended to be given once only must be prescribed

in the ‘once only’ section of the prescription sheet. • For any medication where the dose varies at different times of the day,

it must be written up as two separate prescriptions. When stating the dose frequency only the following abbreviations are acceptable: Od Once a day Om/mane Each morning On/nocte Each night Bd Twice daily Tds Three times a day Qds Four times a day Prn When required MDU As directed STAT At Once AC before food PC After food Q#h every number of hours e.g. Q4h every 4 hours STAT At Once Some other abbreviation which are commonly used PGD - Patient Group Direction NKDA Not Known Drug Allergies Max Maximum eGFR Estimated glomerular filtration rate INR International Normalise ratio NICE National Institute of Clinical Excellence NSAID Non-Steroidal anti-inflammatory drug LMWH Low Molecular weight Heparin Unit in full

Prescribing Signature Each prescription item must be validated by the full signature of a registered

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medical practitioner or authorised Prescriber. The signature must be legible or the printed name of the Prescriber must be written next to the signature. Doctors’ initials or abbreviated signatures are not considered an adequate means of identification or authorisation. See Policy for Clinical Record Keeping Standards and Clinical Records Management. Letters of Instruction/Prescriptions for Community Nursing staff to administer against: Community Nursing staff may receive requests to administer medication to patients in their own home, such as antibiotics, insulin and enteral medication. These must include: • Patient Details, including NHS number • Allergy and Sensitivity status • Drug and form • Dose and rate • Frequency • Flush/Lock if appropriate • Route • Diluent as appropriate • Duration

These forms will normally be sent to community nursing services via the single point of access. Changing the Dose, Frequency or Route If changing a dose (e.g. 20mg to 10mg) the whole section must be crossed out and rewritten. If changing the route (e.g. IV to oral) the whole section must be crossed out and rewritten. If increasing the frequency of doses, the new time is to be stated on the chart and a line drawn to show when the increase is to start. Length of Treatment • Any prescription (excluding controlled drugs) is valid for a maximum

period of six months. A prescription for controlled drugs is only valid for 28 days.

• Antibiotics are issued for a maximum of 7 days unless the prescriber

indicates a specific duration of treatment. Cancellation of Treatment

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It is important that a suitable means of cancellation of the prescription is adopted, such as a bold line being drawn diagonally across the prescription. The cancellation must be dated and signed in full and all detail must remain legible. When stopping medication, the chart must be annotated clearly with a vertical line on the day of stopping and a line through the section with the drug name. The drug name and all prescribing details must remain legible, as the chart is a legal record. Sign and date the ‘stop’ box on the chart. When the ‘Stop Date’ box is used in anticipation of the treatment cancellation date, this indicates that at 12.00 midnight on the date specified the prescription must be discontinued and no further doses are to be administered. Cancellation of areas of the medicine administration record by the Prescriber, or by a designated practitioner or pharmacist, is another permitted method of indicating when the medicine should be administered and when it should be omitted. E.g. XXXX_XXXX_XXXX Amendments to prescriptions are NOT permitted. Changes to doses or frequency require cancellation of the old dose and a new entry written for the new dose. Range of Medicines Which Can Be Prescribed

Prescribing should be within the relevant district formulary: http://www.rdash.nhs.uk/about-us/public-declarations/medicines-formulary/ Any newly introduced psychotropic medicines onto the market may only be prescribed in the Trust after submission for consideration and approval by the Medicines Management Committee. Any medicines provisionally approved will be subject to a probationary period, after which time final approval will be considered. In exceptional circumstances, if an urgent request for a new medication is thought to be necessary, then a request can be made to the Chair of the Medicines Management Committee for approval. Wherever possible, Trust doctors must not prescribe or recommend medicines that are not approved for use by General Practitioners. Administering medication from a remote prescription/direction to administer

The prescribing of medicines in this way should not be routine.

http://www.rdash.nhs.uk/about-us/public-declarations/medicines-formulary/

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However, the Nursing and Midwifery Council (2008) requires a hard copy of the request prior to administration, for inpatient units staff should follow the guidance on sending the request by email using the NHS mail facility. A copy of this email should be attached to the patient’s drug card, and the prescription signed the next working day. A Pharmacist may receive a verbal order from a doctor to alter a prescription item (Medicines and Ethic Guide 2008). This only relates to Pharmacists and no other member of pharmacy staff can take a verbal order to alter a prescription. All alterations must be written clearly and signed by the pharmacist. The pharmacist must read the alteration or addition back to the doctor who must then confirm it. The doctor must sign any new prescription within 24 hours (or the next working day in the case of weekends and bank holidays). For a patient prescribed medication on a prescription and administration chart:

• The alterations and additions will be made in black ink • A pharmacy advise not will be attached to the chart requesting the

prescription to be signed by the doctor within 24 hours • If the pharmacist is on a ward or outside unit or in any situation where

the medical notes are available they must make a clear entry in indelible ink in the patient’s medical notes stating the circumstances leading to the alteration.

• If the prescription is on an outpatient prescription form the pharmacist

will annotate the prescription clearly and leave out for signing by the doctor

• Prescriptions for controlled drugs cannot be altered or ordered in

this way. This procedure is to enable the clarification of prescriptions during normal working hours and not for emergency prescribing of rapid tranquilisation in crisis situations. Community Nursing Staff (Doncaster) Where the original prescription is not available the nursing staff can accept instruction containing the same information as above from the following sources:-

• A faxed copy of the original signed prescription • A signed referral form letter or authority to administer form.

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• An email from the prescriber using the NHS number as the patient identifiable data. (not acceptable for controlled medication).

• An entry made by the prescriber on an electronic record system requiring a smart card or unique username and password which the nurse can access directly, for example TPP system (not acceptable for controlled medication).

• Entry on to the RDASH Drug sheet written by the prescriber (not acceptable for

• controlled medication) • If this identified minimum information is not present, the prescriber must

be • contacted and requested to prescribe. • If the authority is incomplete*, ambiguous or illegible to read the

instructions, the healthcare professional should not continue to administer medication until the details have been checked with the prescriber or a new authority issued.

5.2.8 Transcribing instructions to administer (Hawthorne and Hazel Ward and

Heatherwood School Deaf School) (see SOP for details).

The initial drug chart on admission to these specified services may be transcribed by a registered nurse from either the discharge paperwork accompanying the patient (i.e. discharge summary if coming from hospital) or GP letter if admitting from community). • This transcription must be checked and initialed by another

registered nurse, where only one registered nurse is present the guardian or parent can be used as the second check.

• The transcribed details are NOT a prescription and so cannot be used for further medicines supply, administration from stock medicines or for discharge unless countersigned by an appropriate prescriber.

• In schools this should be carried out at the beginning of each term, this should be checked weekly for any changes.

See 5.2.5 and 5.2.7 for the minimum data set to be transcribed specially designed drug charts are in place in these services.

5.2.9 How the organization is assured that medication charts are accurate

As part of the medicines management service, the Pharmacy Team will monitor inpatient prescription cards in line with the 10 point plan, see section 7 Monitoring and Appendix 5, an additional 5 point Antibiotic plan will look at prescribing of antibiotics, in line with Antibiotic Stewardship. and areas not covered will be expected to follow these principles.

5.3. As required medication/pro re anta (prn) The Purpose of when required medication is to treat conditions or situations that do not require regular medication.

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Before writing up any PRN medication consider the likely need for it and whether there is a better method available, such as the use of a PGD for homely remedies or the use of the once only section of the drug card.

Ensure that prescribing and use is in line with Trust guidance and policies Always remember the law of unintended consequences, when writing this form of medication, so they must be clear and unambiguous Consideration of the ability of consent and capacity should be made, in line with trust guidance. Where covert medication has been agreed and MCA 1 & “the guidance on covert PRN medication should be included. If a patient is being administered medication under the mental health act then an MCA 1 is not required. Common mistakes include: • Unintended overdoes • Being used for the wrong indication • The use of preventative inhalers • Creams or antifungal liquids e.g. nystatin or acyclovir for cold sores.

5.3.1 Prescription

A clear need must be identified for the need for PRN medication, rather than it might be needed. This should be carried out MDT. If it is out of hours and normal team medic is unavailable than consideration of the once only section of the drug card should be strongly considered. An unambiguous indication must be stated e.g. for pain, for rapid tranquilisation, if refuses regular oral medication. Clear dosage instructions must be stated • What dosage e.g. 1mg, one puff. • Suggested maximum frequency based on clinical need, ideally in hours

e.g. maximum every 4 hours. • Maximum total dose per 24 hours. • If a dosage range is written it must be clear when to use different

doses.

If you need to prescribe the same drug by two different routes, this must be written as two separate prescriptions. If you only wish it to be used a certain number of times before active review consider crossing out any additional slots on administration record. It must be reviewed at least every seven days. Take into account any regular medication the patient is taking, this should also be indicated in the total maximum 24hourly dosage where appropriate,

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guidance should be given if PRN medication may be given just before a regular dose of the medication e.g. Lorazepam. Where there is a T2/T3/Sn 62 in place this must reflect PRN medication as well. If the use of medication is going to take the total dose of that medication or class of medication above BNF limits, then this must only be written after discussion with the patient’s Consultant or their deputy and this must be clearly documented within the patient’s records. If the high- dose medication involves anti-psychotics the High-dose antipsychotics protocol must be implemented and this must be clearly recorded. A clear treatment plan should be included in the patient’s medical record, including a maximum period before review. This should include what alternatives should be considered prior to the decision to administer, in order to deliver person centred care, including unintended consequences, such as increased falls risk.

5.3.2 Administration

The use of PRN medication must be care planned

Consider is the use of medication the most appropriate way of dealing with

the issue, e.g. for agitation has talking or distraction been considered.

1. Is the prescription clear and unambiguous?

2. What regular medication has the patient already received?

3. When was the PRN last given, how much have they already been given in the last 24 hours

Explain the purpose and likely effects of the medication to the patient, and to report any problems to the nurse. Due consideration should be taken of capacity issues, where patients are unable to understand the nature of the PRN medications.

After signing to say it has been administered document in the patients care record a brief entry on why it was given and with what effect. The use of PRN should be handed over between shifts. The reason for administration must be consistent with the prescriber’s defined indication.

5.3.3 Review

PRN medication must be reviewed at a maximum of seven days in acute settings, and at patient reviews for non-acute settings allowing for bank holidays etc., by the patient’s team.

Consideration should be given as to whether it is any longer required, should it be given regularly, or is PRN still appropriate. It is suggested in the absence of good clinical reasons if a medication has not been used within seven days it should be discontinued.

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If it was written up out of hours then it should be reviewed by the regular team as soon as is practicable.

If the patient moves wards, e.g. from an open ward to a secure ward, because of significant change in the patients presentation then the PRN medication must be reviewed by the team, to assess if it is still required and if the suggested times/doses are still appropriate.

5.3.4 Leave/Discharge

When a patient is going on leave the PRN medication should be reviewed, if it is felt to be needed still then the TTO should reflect how many doses the team would like the pharmacy to issue. In most cases PRN medication will no longer be required, and the inpatient card amended accordingly.

A clear description to the patient should be given on how to use it.

Where appropriate instructions for carers or relatives should be provided, ideally in a written format.

Guidance should be included in the discharge letter on how it should be reviewed, and by whom.

5.4 Take Home Medication (TTO) or Discharge Drugs (inpatient wards only)

Prescribers are responsible for ensuring that any TTO prescriptions are written and the Nurse in Charge of the ward is responsible for these being received in pharmacy in sufficient time for the medicines to be dispensed and returned to the ward.

Ideally, this should be 24 hours prior to any period of leave or the discharge of a patient, so that the medication will be available when the patient is ready to leave. These prescriptions can be authorised in one of three ways:

• An instruction, written in ink, signed and dated by a Prescriber, on a

Trust prescription form. • A computerised prescription held on a Trust approved computerised

prescribing system, entered by a Prescriber and validated by password controlled electronic signature.

• A Patient Group Direction, approved by the Trust.

• The prescriber should prescribe every medication that the patient is taking on a regular basis (including prn medication)

• For a patient going on leave the prescription should clearly state

the number of days required, and when leave is expected to start

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• For patients who are being discharged they will usually receive a 28-day supply of medication from pharmacy. This should allow sufficient time for the discharge letter to reach the General Practitioner (GP). If for clinical reasons fewer days are supplied, e.g. risk of overdose the GP must be informed

• A Patient Information Leaflet must be supplied with each medicine.

NB: Registered nurses MUST NOT dispense drugs for patients to take home. All TTOs coming into a ward or department shall be received by a Designated Practitioner, or authorised person who must:

• Check them against the medicine card or leave card or TTO form to

confirm that all details are correct i.e. name, medicine, dose and directions

• Lock them in the medicines cupboard immediately • Report any discrepancies to the supplying pharmacy immediately

It is extremely important that the patient receives adequate information about their medicines prior to discharge. The patient should know the purpose of the medicine; how to take it, how long it is to be taken for, and what side effects they may experience. This is the responsibility of the Designated Practitioner, who may choose to involve Authorised Pharmacy Staff in this process. It is the responsibility of the Designated Practitioner who discharges the patient from the hospital to confirm with the patient that they have received adequate information. Any information communicated verbally must be backed up and supported by an appropriate leaflet. Controlled Drugs to Take Out

Controlled drugs should be ordered in the same way as TTOs and must conform to the legal requirements and be written in full, which has been personally complete by a medical practitioner in accordance with legal requirements. Controlled drugs prescriptions must be written in the Doctor’s handwriting stating:

• Patient’s name, address and unit number • The drug name (controlled Drug band name where appropriate), does

and directions

• The form (tablets, liquid)

• The total quantity to be dispensed in words and figures

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• Signed and dated by the Prescriber

The original prescription must be sent to pharmacy for dispensing along with the drug chart. Procedure for the delivery and receipt of controlled drugs for TTO purposes is detailed in Section 5.10.4.

5.5 Outpatient Prescriptions

GPs should usually be asked to prescribe all medication for outpatients. Outpatient prescriptions should be limited to urgent items, hospital only items or to initiate a new treatment that needs closer monitoring, and for patients under certain teams in order to improve concordance, such as Assertive Outreach or Early Intervention Services, or patients seen in their own homes by prescribers.

5.6 FP10 FP10 NC FP10SS and MDA

Prescribers seeing patients in the community have access to a supply of FP10’s. are written by prescribers employed by the Trust but dispensed by community rather than hospital pharmacies. Controlled stationery in relation to prescribing includes blank FP10NC FP10MDA and FP10SS prescriptions, prescription stamps, and prescription order forms. Ordering of blank prescriptions can only be undertaken by authorised personnel, and must be ordered from the appropriate, for the area, supplier.

• They are classed as controlled stationary. • Must be signed for when ordered by administrative staff. • Prescription numbers must be recorded. • Locked away securely • A record of receipt must be maintained • When issued to individual prescribers they must be signed for and a

record kept including the prescription number. • Prescribers should keep them in a manner so that they are secure

when not in use • In substance misuse services where prescription printing software is in

use, access to these systems must be secure. • Where prescriptions are spoilt, they must be marked void, before being

securely shredded, and a record made. • Prescriptions issued to prescribers must be signed for and a record

kept, it is the responsibility of the prescriber for their safe keeping

5.6.1 Issuing FP10 Prescriptions

Prescriptions once generated may be issued in one of the following ways: • Directly to the patient/Representative

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• Recorded delivery to the patients address • By staff to the pharmacy • Collection by the pharmacy staff

In all situations staff must be satisfied of the authorization of any carrier, identification must be sought. A record of all prescriptions issued must be maintained in the patient record.

5.6.2 Lost Prescription Pads

In the event of a lost or stolen prescription all prescribers should • Inform their Line Manager the same day • Complete an incident form • Inform the Chief Pharmacist or Medical Director who will alert all

pharmacies and liaise with the police and the Prescribing Pricing Authority providing as much information about serial numbers as possible.

• The prescriber will be advised to write all prescriptions in red ink for the next 2 months

If the loss occurs out of hours contact the Out of Hours on call Director and

implement the following procedure. • Notify the police • Email all pharmacies to alert them – Go into email – all groups-

Pharmacists safety alerts – Type in details – send • Staff would then follow the in hours process on the first routine working

day.

This should be done by the manager to whom this has been reported to.

5.6.3 Standard Operating Procedure for FP10’s

All areas should have a specific standard operating procedure for managing these prescriptions, which will contain the details on how these standards will be carried out. They can be found in the policies section of the web.

5.7 Use of Patient’s Own Medicines

The Trust has a duty of care to ensure that any patients own medicines used while they are under the inpatient care of the Trust are both safe and fit for purpose. It acknowledges that medicines brought in are the patient’s property and staff required the permission of the patient to dispose of their medicines. Medicines brought into hospital by a patient can be administered to them during their stay until new supplies can be obtained from pharmacy, or if they are assessed by pharmacy as being suitable for use in that:

• The medicine can be easily identified from the backing on the strip pack

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or markings on the tablet/capsule • The Medicine has not expired and appears to be in a good condition • The medicine is prescribed by an authorized prescriber and is on the

inpatient medicine card

• The patient does not object to their own supply being used

PATIENT’S OWN MEDICATION IS NOT TO BE USED IF:

• There are any doubts about the identify or quality of the medicines • The patient objects

NB: MEDICINES BROUGHT INTO HOSPITAL BY ONE PATIENT MUST NEVER BE USED FOR ANY OTHER PATIENT

5.8 Prescribing Homeopathic/Herbal Remedies

• Homeopathic and herbal medicines are subject to the licensing

Provisions of the ‘Medicines Act 1968’ although those on the market when the Act became operative (which means most of those now available), received Product Licenses without any evaluation of their efficacy, safety or quality

• There are some patients who will be on homeopathic and/or herbal

medicines and will wish to continue receiving these whilst on the inpatient wards

• Such a request should be discussed with the Responsible Prescriber who must consider the appropriateness of the therapy to both the condition of the patient and co-existing treatments

• If it is agreed that any homeopathic and herbal medicines can continue then these will be listed on the prescription card

• In the event that the patient is requesting homeopathic or herbal remedies that they have not already been taking prior to admission the Authorised Prescriber must discuss the request with the patient and only list it on the prescription card if they feel they are competent to do so

5.9 Above BNF Maximum Prescribing Limits (combined maximum)

• All prescriptions for psychotropic medications (including combinations) should usually be within BNF limits, apart from cross titrations

• Any prescribing antipsychotics above BNF maximum MUST BE

discussed in the multi-disciplinary team meeting (ideally two professionals involved in the patients care. The decision to prescribe

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must be done by a consultant.

• The rationale for the decision to prescribe above BNF maximum limits and the monitoring requirements must be documented in the patient’s records using the relevant form.

• Patients on high dose antipsychotics must be readily identifiable to the team.

Prescribing above the BNF maximum limits is an unlicensed form of prescribing and it is therefore the Consultant’s responsibility to ensure GMC and specialist colleges guidance is followed and treatment plan well documented (see appendix 4).

5.10 Prescriptions for Hospital Staff and Their Families

• Medical staff and non-medical prescribers should not prescribe for themselves or their family in line with current General Medical Council (GMC) recommendations

• FP10 (HP) prescription forms should NEVER be used by medical staff

or non-medical prescribers to prescribe for themselves or their families. These are only for use by registered outpatients to take to outside pharmacies when the hospital pharmacy is closed

5.11 Staff Self-Administration of Medicines

• On no account must any member of staff take for themselves or give to

another person medicines that has not been prescribed for them • Hospital medicine supplies are for the use of Trust patients only in

response to a prescription from a doctor or other authorized prescriber

• Staff who require treatment for minor ailments must be referred to the Occupational Health Department or purchase medicines from a local pharmacy.

5.12 Patient Group Direction

• Whilst it is necessary that all medicines administered by a practitioner are given on the authority of an authorized Prescriber, in some area certain medicines can be initiated by practitioners in accordance with a Patient Group Direction (PGD)

• This is specific and detailed written direction for the administration or

supply of named medicines, (including those classified as prescription-only), by named designated practitioners in a specific clinical situation. PGDs will be drawn up within the Trust by doctors, pharmacists and other healthcare professionals, and approved by the Medicines Management Committee. It applies to groups of patients or other patients who may not be individually identified before presentation for treatment (Crown Report 1998)

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• The contents of every Patient Group Direction must comply with that outlined by the Department of Health (March 1999) review of prescribing, supply and administration of medicines and HSC 2000/026 Patient Group Directions, giving details of which is incorporated in to The Human Medicines Regulations 2012, Further guidance is included in NICE guidance MPG2

o The condition or situation to which the protocol applies

o Characteristics of the staff authorized to take responsibility for the supply or administration of medicines under the PGD

o A description of the treatment available under the PGD

o The Management and monitoring of the PGD

• It is the responsibility of the senior Registered Nurse of each ward, department or are to ensure that if medicines are administered without a written prescription then a valid and current PGD is available to guide practitioners in their area and that the person administering the medicine has received training and is competent in working within a PGD. A list of all practitioners signed off for each PGD must be sent to pharmacy, to be kept with the original document.

• Copies of approved PGD’s must be available in each area and must

reflect accurately practice in that area

• A PGD cannot be introduced without authorization from Clinical Quality Group. Staff should refer to the Medicines management section of the clinical polices on the Trust intranet for details of existing PGDs.

• Approved PGDs will be signed by the Chief Pharmacist, Medical Director and Chair of the Clinical Quality Group.

• All original PGDs will be stored by the Pharmacy Department, along with a copy of the list of those authorised to use them.

5.13 Ordering Medication from Pharmacy

This guidance relates to medication being ordered by staff on inpatient units, and for community teams. Where community nursing staff are administering medication in patients own homes or in special schools medication will normally be provided by:

• Requesting Hospital Team (e.g. IV antibiotics) • The patients GP via FP10 • Non-medical prescriber prescription • Dressings will be supplied by the community nursing services

In community homes the medication will be supplied by the GP via an FP10 and a local pharmacy

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5.13.1 Ordering Stock Medicines

Stock medicines are medicines, which are commonly prescribed for patients on the ward/Community bases or items required in the event of an emergency. Ward/Community team stocks are retained on the ward/unit regardless of whether they are currently prescribed for any patient.

• A list of common medicines (including those legally classified as

controlled drugs) dressings and reagents, along with the appropriate quantity to be stocked on the ward or department will be decided jointly by the Management Team or clinical lead.

• The stock list should be subject to regular 6 monthly reviews at ward or

department level. The responsible person will ensure procedures are in place to ensure all staff involved in their use is familiar with the range of stock kept on the ward or department

• For area that receives a pharmacy-based top-up service, Pharmacy Services are responsible for the ordering of medicines to maintain stock levels.

• For those areas that receive a self-listed top-up service, the individual in charge at the time is responsible for the regular completion of top-up ordering of stock medicines from the Pharmaceutical Provider

• At all other times and under all other circumstances the individual in charge of an area is responsible for the ordering of stock to maintain adequate levels through contact with the local Pharmaceutical Provider. When an item is considered to be required urgently it the responsibility of the individual in charge to communicate this to the local Pharmaceutical Provider.

Stock medicines may be ordered by:

• Supplying a written requisition from the appropriate order book or an order sheet signed by a Responsible person or Designated Practitioner

• Only one book should be in use at any one time

• Using a fax machine to send a copy of the above

• By means of the pharmacy top-up service.

• Urgent orders can be accessed from Lloyds by writing them up as patient own prescription and sending to the local pharmacy, ward staff will need to organize their own transport.

5.13.2 Ordering Named Patient Medicines

• Individual patient supplies are those medicines dispensed and labeled for a particular patient. Once the patient is discharged from the ward/unit the medicines must be returned to the pharmacy. Individual patient medicines are also known as ‘named patient medicines’

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• Individually named patient medicines are supplied for the sole use of the patient whose name appears on the label, and are not to be dispensed to any other patient

• Clozapine is always supplied as an individual patient item as all patients who receive this medication are registered on a database and have regular blood tests to monitor them for the development of agranulocytosis. Clozapine must never be administered to a patient whose name does not appear on the label

• Medicines for named patients may be ordered by:

o Submitting the patient’s prescription sheet to the Pharmacist providing clinical services to the ward or department.

o Using a fax machine to send a copy of the prescription sheet

o By means of the pharmacy top up service

o By using the electronic prescribing system (where available)

o Carriage of a requisition to the local dispensary

o In the case of Controlled Drugs through carriage of a completed Controlled Drug Requisition Book to the local pharmacy.

Community Practice

Responsibility for the ordering of medication remains with the patient, except for medications supplied via the Trust such as long acting injections or Clozapine. However, good practice would indicate that where a member of staff is responsible for administering the medication they ensure the service is aware of potential stock shortages.

In certain circumstances registered community staff may collect a patient’s medication from their pharmacy (e.g. a housebound patient with no carer support). Under those circumstances the registered staff will go directly from the dispensing pharmacy to the patient. Where patients own medication is to be kept at the team base, and issued on an intermittent basis a record must be made of medication is ordered, and issued, it is the responsibility of the team manager to check the medication against what was ordered, then record what has been issued, ideally getting the patient to sign for medication on receipt, the team should have a system to record what has been issued and when a new prescription is required. This should be recorded on the Trust approved documentation.

5.13.3 Receipt of Stock and Named Patients Medication

All medicines must be checked against the request and delivery notes which must be retained for a period of 2 years. Any discrepancies between the requested and received amount of medicines must be reported to the pharmacy department immediately.

Community Practice

Community base points should not routinely be holding non-stock items. See

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above for more detail. Community based clinics may hold patient’s dispensed stock for use in that clinic. These items must be clearly marked for the individual patients use.

5.13.4 Faxing of Prescriptions to Pharmacy

In line with locality arrangements prescriptions may be faxed to pharmacies supplying under Service Level agreement Caldicott Guidelines for sending faxes

1. Use a safe haven fax 2. Double check the number before sending 3. Tell the recipient to wait by the fax 4. Ask them to phone you when it has arrived

5.13.5 Ordering Controlled Drugs

Controlled drugs are defined by the Misuse of Drugs Act 1971 and regulated by the Misuse of Drugs Regulations 2001 (with associated amendments). Due to the nature of these drugs legislation dictates how they are to be prescribed, ordered and stored and all Trust guidance on controlled drugs is written in line with this legislation. It covers schedule 1 and 2 controlled drugs, and within the Trust Temazepam and Tramadol are to be treated as a schedule 2 Controlled Drug. In addition the following shall also be considered as Controlled Drugs for the purpose of administration:

• Schedule 3 controlled drugs such as Barbiturate. • Strong Potassium Chloride Solution BP 15%

Therefore each of these is subject to Trust regulations regarding ordering, storage, administration, destruction and recording of controlled drugs.

For full guidance staff should refer to the Trust Controlled Drugs Procedure, but the general principles are as follows: • The responsibility for ordering, receipt and storage of Controlled Drugs

is that of the Assigned Practitioner in Charge of the ward/department • Controlled drugs can only be ordered from the pharmacy by submitting

a requisition from the official Controlled Drugs Requisition Book. Ordering is restricted to an Assigned Practitioner in Charge. All Assigned Practitioners who may order Controlled Drugs must provide the supplying pharmacy department with specimen signature

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• If the Controlled Drugs are to be collected by a Designated Practitioner, the appropriate part of the Controlled Drugs Requisition Book must be signed and the medicines transported back to the ward in a sealed container

o Where appropriate a porter or messenger may deliver Controlled

Drugs in a temper evident package. The porter or messenger must sign the Controlled Drugs Requisition Book to accept responsibility for carriage of the drugs. The Designated Practitioner must receive the package and sign the Controlled Drugs Requisition Book to accept delivery after checking the contents of the package.

• The Designated Practitioner will check the contents of the container in the presence of another designated practitioner, authorised member of the pharmacy staff or an authorised employee. These two staff will check the:

o Quantity of the medication o Strength of the medication o Expiry date of the medication

NB: IF THE BOX CONTAINING THE CONTROLLED DRUGS HAS THE MANUFACTURER’S SEAL INTACT THERE IS NO NEED TO OPEN THE BOX

• Once this check has been completed the Designated Practitioner will enter the new stock into the controlled drugs register on the appropriate page. This entry will be witnessed by the second member of staff with them both signing the ‘ordered by’ and ‘received by’ section of the book.

• In the community services any patients new supplies of controlled drugs, which are to be administered by Trust staff at some time in the future should be signed, as stock, into the patient’s clinical record. This will be done by the first registered member of staff who is aware of the new stock. (e.g. diamorphine prescribed during the week in readiness for a week-end administration will be signed in by the staff mid-week when in arrives.)

• All records must be in permanent black in and retained for two years • Controlled drugs must be stored in a locked, specified CD cupboard,

which has been approved by a pharmacist and is reserved solely for the storage of controlled drugs

• Access must be limited to Designated Practitioners and authorised members of pharmacy staff

• Ward controlled drug cupboards to be inspected at a minimum of biannual intervals by an authorised member of pharmacy staff

• The order book and register are controlled stationery and as such MUST be kept under lock and key when not in use

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• Any discrepancy between the order and delivery quantity MUST be reported

o To the supplying pharmacy immediately

• Stocks of controlled drugs within wards and departments must be checked and signed for at least once a week, unless in active use, in which case they are to be checked daily.

• In the community services good practice will be to record and sign the

stock level at each administration and have it countersigned by a staff member or another person – who may be a family member.

• Any discrepancies must be reported to the line manager and an IR1 completed.

• The line manager will investigate the discrepancy and if the matter cannot be resolved the relevant pharmacy department is to be informed.

• Where an incident is due to suspected theft or burglary by a person external to the Trust, the police must be informed.

• TTO or discharge medication which contains controlled drugs is not to be recorded as ward stock

• Any controlled drugs brought in by patients must be recorded in the back of the controlled drugs book, and signed out when they are either taken back to the pharmacy or returned to the patient. This must also be documented in the patients records

• Should any ward or department be closed on either a temporary or permanent basis all controlled drugs must be returned to pharmacy

Security of Controlled Stationery The Responsible Person will ensure that all Controlled Stationery on the ward, department or base point is held securely. Any loss or theft of any item of Controlled Stationery will be reported to the Responsible Person for the ward or department and their Line Manager, and to the Trust Chief Pharmacist at the earliest opportunity. An Incident form must be completed.

5.14 Transfer of Medicines between Ward Areas

Medicines must not be transferred from a ward or department within normal pharmacy opening hours. However, it is recognized that there are occasions when medication for individual patients may not be available in clinical area stocks. This may be

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for a number of reasons including: • Urgent out of hours admissions who are prescribed non stock

medication • Changes in medications due to changes in mental/physical health

status

If the medication is urgently required the following process must be followed: 1. The nurse in charge of the clinical area will contact other clinical areas

(on site) to check if they have any available stock of medication required

2. When it is ascertained that stock is available elsewhere, a member of

staff should take the completed/signed prescription chart to the ward where the medication is to be borrowed from

3. The nurse in charge of the area should, prior to giving any medication

to the member of staff:

• Check the prescription sheet for dosage, medication, route, frequency

• Check the patient’s name on the prescription sheet • Record on the ward 24-hour report the type, dose and quantity of

medications given to another area

• Record on the ward 24-hour report the name of the member of staff collecting the medication

• The transfer of medication book should be completed

NB: Only stock medicines may be borrowed and the complete container must be transferred to the receiving ward.

4. Controlled drugs must not be borrowed except in an extreme emergency. Only one dose at a time can be issued and this must be issued

directly to the patient on the receiving ward. In these circumstances the following process must be followed:

• A nurse from the patient’s ward must visit the issuing ward with the patients prescription chart

• A record must be made in the Controlled Drugs register of the issuing ward ensuring the Controlled Drug is booked out directly to the patient in the receiving ward

• A nurse from the issuing ward must accompany the patient to

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witness the administration of medication

5.15 Out of Hours Pharmacy Services

• Outside of normal hours staff should consider

1. Local RDaSH wards/teams for non CD stock transfer first then 2. Refer to contact sheet for relevant local pharmacy supplier hours and

order via TTO paperwork and processes. No delivery service is available so requested medicines will need to be collected.

• URGENT request up to 11pm can be handled by the local pharmacy provider

• URGENT request after 11pm will handled through Lloyds wholesaler (AAH) – see contact sheet for details. This attracts a £300 callout fee.

5.16 Delivery of Non Controlled Medicines

All medicines will be delivered to wards/departments in a secure container. Where appropriate, a porter or courier may deliver medicines in a tamper evident package or locked box. A Designated Practitioner/Responsible person must receive the package or box and will:

• Check the medicines against the delivery note/order book • Sign the note and keep it (for 2 years) as a record that the supply was

complete • Lock the medicines in the medicine cupboards immediately • Report any discrepancies to the supplying pharmacy immediately

5.17 Storage of Medicines 5.17.1 Containers for Storage of Medicines

Pharmacy does not re-use plastic or glass bottles. When empty, plastic bottles may be disposed of in the normal rubbish bags. Oral, non-toxic liquids may be returned to pharmacy. Empty glass bottles may be disposed of in the usual way. Child- resistant containers (CRCs) are used routinely on discharge items. If a member of the ward staff feels that CRC’s would be difficult for the patient to open they should contact the supplying pharmacy to discuss suitable alternatives.

5.17.2 Storage of Medicines on Wards/Departments

• The Appointed Practitioner/Team Manager in Charge is responsible at all times for the safekeeping of all medicines on their ward or department

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• The design and location of all ward or department medicine storage cupboards must be approved by Authorised Pharmacy Staff and regularly monitored

• All internal and external medicines, disinfectants and re-agents must be stored in locked cupboards, trolleys attached to a wall or other secure cabinets – all reserved solely for medicinal products. The only exceptions to this requirement are medicines for clinical emergencies, intravenous fluids, flammable Fluids, Medical Gasses, sterile topical fluids, nutritional products and some bulky medicated dressings which, because of their bulk, are stored in a clean area (as agreed between the Appointed Practitioner in Charge and an authorized member of the Pharmacy Staff)

• The medicines trolley may only be removed from its fixings during medicine rounds

• The nurse in charge of the medicines round must never leave the drugs trolley unattended at any time. The nurse must not be disturbed during the medicine rounds unless there is a dire emergency. In such an emergency the trolley must be locked

• Internal medicines must be stored separately from other medicines. Under no circumstances must medicines be transferred from one container to another, nor must they be taken out of their container and left loose

• All medicines in transit must be in a sealed tamper evident container • Controlled drugs must be stored in a separate designated Controlled

Drugs Cupboard • Where cold storage of medicines is necessary a lockable, temperature

controlled/monitored medicines fridge must be made available, which must be reserved solely for the purpose.

Where the ward or department holds a supply of medicines for use in a medical emergency this will be held in a tamper evident container. This container need not be kept in a locked cupboard, but will be located in an area that is most likely to have a constant staff presence that is not obvious to the general public. On some ward areas (and subject to risk assessment) to enable timely treatment the following medicines can be exempted from locked storage

• GTN tablets and Spray for the treatment of angina pain* • Inhalers of β adreno-receptor agonist as bronchodilators* • Nicotine Replacement Therapy supplied under a PGD*

*Subject to a risk assessment an individual authorised to administer medicines may assess a patient on an inpatient area as suitable to have control of and take these medicine themselves provided the following

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conditions are met:

• The patient understands what their medicines are for and the how to take them correctly.

• Suitable safe keeping arrangements are available to prevent misuse by others

• The medicines are labeled with the patients name and instructions for use.

• A record of the dose and frequency of administration is made on the in-patient drug administration chart.

5.17.2.1 Medicines storage room ambient temperature monitoring

• Unless stated otherwise in product literature and labels the majority of medicinal products, that do not require refrigeration, can be stored under conditions of controlled room temperature without compromise to their stability and recommended shelf life. These products are usually labelled ‘do not store above 25°C’

• A maximum minimum thermometer should be placed in all rooms where

medicines are stored and the temperature of the room monitored on a daily basis (preferably at the same time each day, and what is considered to be the hottest time of the day) to ensure that medicines stored in the room are stored within the recommended limit.

• The room temperature should be recorded on ‘Daily Room Temperature

Monitoring Form’.

• If the temperature reaches above 26°C, contact pharmacy services for medicines advice with regards to opened liquids. At this temperature and for a short duration tablets, powders and capsules should be stable.

• Contact the Estates office to request 24 hour monitoring by calibrated

thermometer, to detect whether this is a short or long term situation. • Request a visit from the pharmacy team to review the options available

to mitigate against this problem if this is likely to be a long term problem. • Complete an incident form with regards to the temperature of the area,

and the medicines affected. 5.17.3 Drugs Fridges

• Medicines that require refrigeration should be stored in an approved medicines fridge, which must be used solely for the storage of medicines requiring refrigeration

• The fridge must be connected to the electricity supply in such a manner that does not allow accidental disconnection, e.g. attached by a spur to the mains electricity supply

• Medicines must never be stored in the kitchen fridge

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• The medicines fridge temperature must be checked daily and recorded on the Trust’s fridge temperature monitoring form. The temperature should be within 2C – 8C

• Pharmacy or Estates must be contacted if there is a problem (area specific)

5.17.4 Siting of Cupboards or Trolleys

Cupboards and trolleys must be sited where most convenient for staff, whilst also allowing adequate space and permitting surveillance to afford maximum security against unauthorized entry. Medicine cupboards will generally be sited where they may be subjected to higher than average humidity or temperature. Re-agent cabinets, were used, must be sited in area where testing is carried out.

5.17.5 Controlled Drugs Cupboards

No ward or department must store Controlled Drugs unless there is an appointed Practitioner in Charge responsible for their storage and use. Controlled Drug Cupboards must be reserved solely for the storage of Controlled Drugs and be secured to the wall. These cupboards may be separate from others or inside other locked medicines cupboards used to store internal medicines.

Community Services

In the community services the storage of patients own medication (including controlled drugs) remains the services user’s responsibility, except new beginnings where storage is maintained on patient’s behalf. However where appropriate, professionals should advise on good storage practice.

5.18 Custody and Safe Keeping of medicine

5.18.1 Keys for medicine Cupboards, Medicine Trolleys and Drug Fridges

• Keys for the external medicine cupboard, internal medicine cupboard,

medicine trolley, medicine refrigerator must be kept together on one key ring reserved solely for these keys. The keys must be clearly identified

• The keys must be kept on the person of a ward/team manager, in the

event of no designated practitioner being on duty in a ward or unit; the keys must be handed to a designated practitioner on a ward or unit in the near vicinity. This information must be made known to the staff on both wards

• In a community setting the keys may be held by non-nursing staff, as

long as they are authorised by the team leader. • The key must never leave the ward/unit or be left unattended. They

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should be carried by the designated practitioner at all times. The only exception being when the designated person is covering for more than one area

• No other person should have access to the medicine cupboards except

in the presence of the key holders, with the exception of authorized pharmacy staff for the purpose of stock control

• At Community team bases where a number of designated practitioners may require access to the medicine cupboards at different times a secure system must be agreed between the Assigned Practitioner in Charge and the locality pharmacist

• Keys must not be handed over to medical staff or other non-key holders • Lost keys must be reported immediately to the ward/department

manager. In the event that the keys cannot be found, all locks must be changed immediately

5.18.2 Keys to the controlled Drugs Cupboard

• The Controlled Drug Cupboard key must be kept on the person of the

Assigned Practitioner in charge or Designated practitioner nominated by them

• Responsibility remains with the Assigned Practitioner in Charge • No practitioner can have access to the Controlled Drug cupboard

except with the agreement of the Practitioner in Charge, officially holding the key. The key must not be handed over to medical staff

• Authorised pharmacy staff may have access to the Controlled Drug

cupboard key for the purpose of performing statutory checks • In the event of the person in charge being inappropriately qualified, the

key must be handed to an Assigned Practitioner in charge of a ward or department in the near vicinity. The information must be made known to staff in both the ward and department and to the manager in charge of that section.

5.18.3 Re-agent Cupboard Keys

The key to the re-agent cupboard will be kept separately and in a place designated by the Appointed Practitioner in Charge

5.19 Arrangements for the Administration of Medicines

5.19.1 Medicines and the law

• The Medicines Act (1968) controls the manufacture, distribution and importation of medicine and requires that medicines available only on

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prescription must be given as instructed by the authorised prescriber (a doctor, a dentist or a nurse or pharmacist or OHP prescriber). Changing the dose or giving prescribed medicines to a different person without the authorised prescriber’s permission is against the law.

• While the law states who can prescribe medicines it allows anyone to administer them provided they follow the authorised prescriber’s instructions.

• Non-registered practitioners may only administer medicines after receiving appropriate training and assessment at local level in accordance with local guidance.

• An epinephrine (adrenaline) injection, Glucagon, Naloxone, Aspirin, Glyceryl Trinitrate may be legally administered without a prescription for the purpose of saving life in an emergency (Medicines Act 1968). However, it remains a prescription only medicine until such time as it needs to be administered.

• The administering of a medicine authorised for a patient will occur by one of three ways:

• By an individual authorised to administer medicines

• By the Prescriber.

• By the patient or carer who meets agreed self-administration criteria.

• Where the authority to administer is of questionable legibility, incomplete, or ambiguous to the person authorised to administer, the medicine will be withheld until the instruction has been checked with the prescriber or a new authority issued.

• A single person administration system is in place with the exception of the following instances:

• Calculation of complex dose e.g. doses expressed by weight or surface area. This is for the calculation only. It should be done prior to the first dose, and any subsequent changes of treatment. The details of the calculations can be recorded in to the patients treatment goals for future reference.

• Administration to children under 16 years of age without parental consent, assessed not to be Fraser competent.

• Administration of Controlled Drugs – see section 15.9.7. In exceptional circumstances, such as lone workers in special schools it may be necessary to administer controlled drugs such as Midazolam Buccal without witnesses, In these situations the medication is the patient’s own and not stock.

• Intrathecal injections – Hospice.

o With the exception of emergency medication in the circumstances as stated above medicines can only be administered in line with a valid prescription issued by an authorised prescriber.

• The prescription must be legible, signed, dated, and written in

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black ink or on an approved electronic prescribing system. The name of the drug, dose, form, route and maximum frequency, in hours, of administration should be stated.

• Any illegible or ambiguous prescriptions must be brought to the attention of the prescriber, and clarified.

• For any patients who are subject to consent to treatment rules staff must check that the appropriate consent form is in place and that the treatment to be administered is recorded on the form prior to any medication being administered.

• Where possible patients should only have one prescription chart in use at any given time here this is not possible, all current prescription charts for the patient is to be marked with the total number of charts in use.

• The relevant allergy section on the prescription chart must be

always completed by the prescriber. If the patient states none: ‘none known’ is to be recorded.

5.19.2 Who has the authority to administer medication?

• Medical staff, registered nurses, and student nurses (under the supervision of a registered nurse) Health Care Assistants, who have undergone Trust approved training

• Student nurses will be given every opportunity to become proficient in the administration of drugs under the supervision of a registered nurse. The registered nurse who supervises the student remains accountable for the correct administration of the drug. Both the registered nurse and student are to sign the prescription chart.

• In community settings a non-registered member of staff may prompt a patient to take their medication or supervise them removing medicine from labeled containers which have the patients name on, or a compliance aid. Under no circumstances are untrained staff to select the medicine(s) on the patient’s behalf.

• Health Care Assistants, who have undertaken trust approved training may administer medication to patients, unsupervised, in agreed circumstances, and must follow the same rules as qualified staff. Area’s this has been agreed are Community Homes and Supported Living. Other areas wishing to utilise this must discuss this with their Service director and the Chief Pharmacist.

• Non-registered staff that are to be involved in the handling of patients medicines must undergo appropriate competency training.

5.19.3 Patient self-administration of medication

5.19.3.1 Inpatient services General Self Medication Scheme

Patients in the inpatient services may only undertake routine self-administration of their medicines where a ward has in place a specific local

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procedure approved by the Trust Chief Pharmacist, and Medical Director.

• The benefits of such an approach include:

o Helping patients achieve/maintain a great degree of independence during their stay.

o Identifying compliance issues prior to discharge.

o Improving services user’s knowledge of prescribed medicines.

o Promoting drug administration at the most appropriate time.

o Reducing wastage of primary care derived medication.

o Preventing medicine hoarding and consequent inappropriate resumption of discontinued treatment.

o Minimising delay at discharge.

Protocols and procedures can be found on the Trust website

5.19.3.2 Specific Medicinal Products

Where patients are prescribed GTN tablets and sprays for the relief of angina pain, or inhalers of β adreno-receptor agonist as bronchodilators, it is appropriate to allow the patient immediate access to the medicines when they are required. An individual authorized to administer medicines may assess a patient as suitable for this type of self-administration provided the following conditions are met:

• The patient understand what their medicines are for and the how to

take them correctly • That the self-administration of such medicines has been considered as

part of the patient’s multi-disciplinary risk assessment, and the Consultant in charge of their care is in agreement

• Suitable safe keeping arrangements are available to prevent misuse by others. In this case this does not necessarily mean in a locked cupboard

• The medicines are labeled with the patients name and instructions for use

• A record of the does and frequency of self-administered medicine is made on the in-patient drug administration chart.

Community Service Within community services it is a patients right to self-administer their own medicines if willing and able to do so. However, some patients have difficulty managing their medicines safely and sometimes Trust staff are the only people to see these patients and, therefore, can highlight the need for help.

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5.19.3.3 Patients in the community who are unable to self-administer medication

• Trust staff that are caring for or managing patients who are self-administering medication should be aware of factors which can affect a patient’s ability to self-medicate.

• Self-administration from dispensed containers may not be possible for

some patients and in such cases the advice of a community pharmacist or the patient’s GP must be sought. The most appropriate form of help can then be identified.

• If a patient requires a compliance aid such as monitored dose

container, this must be dispensed, labeled and sealed by a pharmacist. If there is a delay in allocating a pharmacist to fill a compliance aid, staff must inform the patient that Trust staff are unable to fill compliance aids due to the risk of error. This information must be clearly documented in the patient’s clinical record.

5.19.4 Principles of Administration

• The individual authorized to administer medicines will be responsible for

ensuring they have an understanding of the use, action, usual dose, side effects and handling hazards of the medicine(s) being administered.

• This person will ensure they are certain of the identity of the service

user to whom the medicine is to be administered before initiating any administration activity, in line with the trust policy on patient identification.

• The individual authorized to administer medicines will check that the authorization for administration is within this policy.

5.19.5 Action prior to administering medication

Prior to administering any medication the staff member must observe the following principles.

1. Be able to confirm the identity of the patient.

• Within an in-patient setting this will be confirming that the name

and hospital number expressed on the authorization for administration corresponds with that on the patients identity bracelet or photographic ID, ad wherever possible, verbally confirming this detail with the patient themselves.

• Within a community based setting, or where an in-patient is to wearing an identity bracelet or there is no photographic ID, this will be verbally confirming the name, address and date of birth expressed on the authorisation for administration with the patient, or where appropriate, the patient’s career.

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2. Check the consent status of the patient. 3. Check that the medicine has already been Administered 4. Check that the drug to be administered has not past it’s expire date. 5. Give the correct drug. Check the label on the drug against the

prescription. 6. Give the correct dose. If unfamiliar with the drug or dosage, verify

before administration. 7. Give the drug in the right form - Check whether tablets or liquid. 8. For oral liquid medication in non-standard doses, i.e. not multiples of

5ml, approved oral syringes MUST be used. 9. Give the drug at the correct time. It is important to give medication as it

is prescribed in order to maintain therapeutic levels of treatment. 10. Check that the drug is administered by the route specified, and that the

formulation used is appropriate to that route. Administration by enteral feeding tube is covered by the CCG policy for the Management of Patients with an Enteral Tube Insitu.

11. At no time are any medicines to be left unattended by the administering

staff member. 12. Where more than one medicine is specified for administration, they will

consider whether any of the medicines may dangerously interact with each other.

5.19.6 Consent to Treatment

Wherever possible the proposed medication should be discussed with the patient in a way which gives them the opportunity to openly ask questions and express their agreement with the treatment. “Consent” within the context of this policy is the voluntary and continuing permission of the patient to receive a particular medication.

However, for a patient to give valid consent or not, they must have capacity. Therefore, the authorised prescriber must first undertake an assessment of the patient’s capacity. This consent is based on the patient having been provided with:

• Adequate knowledge of the purpose, nature, and likely effects of the

treatment

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• Information as to any commonly known risks associated with the treatment

• Details as to the likelihood of the treatment succeeding • Information about any alternative treatments which are available

Any agreement to proceed with treatment which is given under unfair or undue pressure is not consent. (Mental Capacity Act Code of Practice 2005) It is the duty of everyone proposing to give treatment to use reasonable care and skill, not only in giving information prior to seeking a patients consent, but also in meeting the continuing obligation to provide the patient with adequate information. All discussions relating to treatment are to be recorded in the patient’s clinical records. The assessment of the patient’s capacity to give consent, or not should also be documented. Information given to the patient by a Pharmacist or other practitioner about the treatment is provided in addition to that given by the prescriber, not as an alternative. Treatment of patients who lack the capacity to consent Decisions taken on behalf of a person who may lack capacity to make a particular decision for themselves must comply with the requirements of the Mental Capacity Act 2005 and the supporting Code of Practice in that, “An act done or decision made under this act for or on behalf of a person who lacks capacity must be done, or made in his/her best interest”. (Mental Capacity Act 2005, Code of Practice, page 66) Whilst not defining best interest, the Act requires that the best interest checklist is used and the following five key principles observed before any decisions may be made on behalf of a person who lacks capacity:

• A presumption of capacity – every adult has the right to make his or

her own decisions and must be assumed to have capacity to do so unless it is proved otherwise

• The right for individuals to be supported to make their own

decisions and must be given as much help as possible before anyone concludes that they cannot make their own decisions

• That individuals must retain the right to make what might be seen as

eccentric or unwise decisions • Best interests – anything done for, or on behalf of people without the

capacity to make a particular decision must be in their best interests, and

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• Least restrictive intervention – anything done for, or on behalf of people without capacity to make a particular decision should be the least restrictive of their basic rights and freedoms

Treatment of patients detained under the Mental Health Act 1983 (amended by the Mental Health Act 2007) The Mental Health Act 1983 (amended by the Mental Health Act 2007) provides the prescriber with a 3-month period in which to develop a treatment programme to meet the patient’s needs (for patients detained under a Section of the Act which legislates for consent to treatment provision). However, even though the Act allows for treatment to be administered without the consent of the patient the prescriber should still adhere to the same principles of seeking consent as described above. NB: The 3-month period starts from when treatment or medication is first prescribed. For treatment after this 3-month period: The responsible clinician will receive notification from the Mental Health Act Administrator within their locality that the patient’s consent to treatment needs to be reviewed and on receipt of this notification the responsible clinician must: • Seek the patient’s consent for the treatment to continue beyond the 3-

month period • Record the discussion in the clinical notes including an assessment of

the patient’s ability to consent • If the patient consents to continued treatment, complete a Form T2 • If the patient refuses consent or is deemed unable to provide a reliable

consent, the responsible clinician must request a second opinion doctor (SOAD) visit from the Mental Health Act Commission

• If the SOAD agrees with the responsible clinician that treatment is necessary and should be given, the SOAD will complete a form T3

• A copy of T2/T3 will be attached to the patient’s prescription card

NB: No treatment is to be administered to any patient detained under the Mental Health Act without a check being made that there is a valid T2/T3 in place. For further details staff should refer to the Mental Health Act Code of Practice.

5.19.7 Checking Administration

It is good practice that, wherever possible, all medicines are prepared and administered in the presence of another practitioner. If this is not possible for any reason a single registered nurse may carry out administration, but NOT for the following:

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• Schedule 2 Controlled drugs (staff are to refer to the Trust Standard Operating Procedure for Controlled Drugs )

• Prior to administration, the calculation of complex doses, including weight related doses, the administration itself may be done by a single practitioner

• Rapid Tranquillisation

The purpose of the second person is as a check of the correct administration of the drug (i.e. right patient, right drug, right dose, right route and dose, and form), and that the appropriate paperwork is completed. Where the second person is a qualified professional they should also review the clinical appropriateness of the dose (this will exclude nurse assistants and pharmacy technicians for example) It is the administering nurse’s responsibility to observe the patient taking any oral medication. The following may be appropriate for counter-signatories/witnesses: • Registered nurses

• Doctors

• Pharmacists

• Pharmacy Technicians (directly employed by the Trust)

• Appropriately trained healthcare professional

• Student nurses under supervision by someone other than the first

signatory

• Nurse assistants , Health Care Assistants or Clinical Support Workers 5.19.7.1 Complex calculations

These checks, such as for syringe drivers may take place away from the place of administration, such as the District Nurse community base. These should only be done by staff competent to work out such calculations.

5.19.7.2 Controlled Drugs

A member of healthcare staff is permitted to witness specific tasks that they are competent with and sign to confirm that the task has been performed accurately and correctly. For the purposes of witnessing Controlled Drug tasks the scope of the tasks are • Receipt of controlled drugs

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• As a second person check of the correct administration of the controlled drug and ensure an accurate entry is made in the register with regard to drug, dose, dose form, quantity and resultant balance.

• Balance checks

• Destruction of controlled drugs

5.19.8 Documenting the Administration of Medicines

• Following the administration of the medicine the staff member must sign

the prescription chart/MAR sheet or make an appropriate entry on an electronic patient record system such as TPP. This signature signifies that the patient has taken/been administered the medication. Students administering medication should have their signature countersigned by the supervising practitioner.

• If any medication is not administered, the code must be recorded on the

approved administration card/prescription chart using one of the Trust’s recognised codes (see below), an entry made in the clinical records, and the prescriber informed. (If not already aware).

CODES FOR OMITTED MEDICINES AWOL - Absent without leave. O/L – Patient on authorised leave. O/S – Out of stock R – Patient has refused medication NBM – Patient is nil by mouth S/A – Patient has self-administered O – Omitted on the instruction of a Doctor V – Patient vomiting FAILURE TO RECORD THE ADMINISTRATION OR OMISSION OF A MEDICATION CONSTITUTES A MEDICATION INCIDENT AND MUST BE REPORTED.

• Following administration the individual authorised to administer will

observe the patient to monitor both the positive and negative effects of the medicine(s) administered.

• As a general principle, by disguising medication in food or drink, the

patient or patient is being led to believe that they are not receiving medication, when in fact they are. This is not acceptable as the patient has not consented to administration.

• If a patient is absent from the ward, or has missed a dose for some

other reason, the delayed dose can be administered at a later time provided the prescriber has confirmed that it is appropriate to do so. If

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this is the case the actual time of administration is to be recorded on both the prescription chart, and in the patient’s clinical records.

• Any patients who are classified ‘Nil by Mouth’ for any reason are to be

given all their prescribed medication unless specifically advised otherwise by Medical staff.

5.19.9 Covert Administration of Medicines

Covert medication refers to medication that is hidden in food or beverages. The covert administration of medication is the practice of hiding medication in food or beverages so that it will be undetected by the person receiving the medication. Pills may be crushed or medication in liquid form may be used. This practice exclusively applies to patients who are not validly consenting to treatment. It is intended to ensure that patients refusing treatment as a result of their illness will have access to effective medical treatment. The decision and plan will be detailed in the patients care plan and case notes.

Process Content of the process should include the following stages:

• Legality: If they are detained for treatment under the Mental Health Act

1983 (e.g. section 2, section 3) then covert medication can be used if this is the most appropriate and least restrictive and proportionate approach to treatment, for the treatment of their mental illness only.

• Capacity: If they are informal (or detained under the mental health act,

and refusing physical medications) patients then the patient must have an assessment of whether they can accept or refuse medication, by ward nursing staff, using the framework of the Mental Capacity Act 2005. If they have capacity then covert medication cannot be used (see mental health act for exception). If they lack capacity then the following stages need to be considered.

• Representation: Is their care, such as use of medication, decided by a

Donee, Deputy or Advance Decision? • Collaboration: Discuss within the ward multidisciplinary team for joint

decision making/evidencing rational practice. • Alternatives: Jointly explore alternatives to covert medication. • Necessity: A doctor, ward nurse and pharmacist consider the necessity

of the medication. • Advocacy: Any family or carer or advocate is consulted. If

unbefriended, advocacy from an IMHA (if detained under the Mental

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Health Act 1983) or IMCA (if managed under the Mental Capacity Act 2005) must be considered.

• Evidence: Care Plans show assessment of capacity and assessment

of need, with who was involved in these. MCA1&MCA2 forms should be used to document this.

• Administration: The method of giving the medication covertly is

generated in partnership with a pharmacist. Each dose of medication is offered normally, if refused it may then be administered covertly. The pharmacy should be contacted to generate a care plan documenting the agreed method, along with any necessary dosage changes (Appendix 7)

• Documentation: Using of covert medication, and how, is documented

explicitly on the prescription chart. • Nursing staff should request a pharmacist to complete a covert

medication care plan outlining the agreed method of administration (Appendix 7)

• Safety: Systems are in place for safe, optimal practice with a clear audit

trail of events, including evidenced reviews. • Review: Review by the ward manager and ward multidisciplinary team,

on a planned and regular basis.

Supervision: Nursing staff giving covert medication have ongoing training/clinical supervision. The pharmacy service offers support to all in-patient areas, giving advice on management with covert medication. The service can be contacted in 01302 798308.

5.19.10 Medications which have specific prescribing, administrative, storage, availability or monitoring requirements

5.19.10.1 INJECTABLE MEDICINES

This area is subject to an NPSA alert http://www.nrls.npsa.nhs.uk/resources/?entryid45=59812 Research evidence indicates that the incidence of errors in prescribing, preparing and administering injectable medicines is higher than for other forms of medicine. However, the use of injectable medication has many healthcare benefits for patients such as the improved monitoring of compliance through the use of depot injections. Within the Mental health part of the Trust the most commonly used injectable medicine is depots, and staff should refer to the Trust procedure on the

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administration of depot injections for further guidance. ADMINISTRATION OF RAPID TRANQUILISATION There is a Trust procedure in place which gives guidance on the use of rapid tranquilisation, and clinical staff employed in areas where rapid tranquilisation may be used should be familiar with its contents. For further details staff should refer to the rapid tranquilisation, Community Services, including the hospice. For medicines administered via syringe driver, staff should follow the SOP. For all other injections technical information and risk assessments can be found at: http://medusa.wales.nhs.uk/Logon.asp. This must be checked for all new medications staff are unfamiliar with. Staff administering parenteral medication must have completed approved training, and be judged competent by their line manager prior to reconstitution and administration of an injection. When administering IV antibiotics in the community the first dose must have been administered in hospital, prior to transfer in to the community. Administration of IV antibiotics to children in the community Eligibility criteria:

• All referrals for IV medication administration in the community must be

discussed with the CCN Team before planned discharge. Acceptance may be dependent upon available capacity within community resources, however wherever possible referrals will be prioritised.

• The child/young person or their carer/guardian must consent to

treatment being continued in the home environment. • Referrals must be correctly completed on the appropriate Community

Children’s Nursing Team referral form.

The CCN team reserve the right to decline a referral until the correct information is provided or if the suitability of the home environment compromises the safe administration of the prescribed medication. Referrals will not be accepted on a Friday afternoon for medication on a Monday.

• The child must be stable • A treatment review or completion date has been set and documented

by the responsible prescriber. • The child/young person must have received the first two doses of any

medication in the hospital setting prior to discharge.

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• The child/young person must have patent IV access and secure, clean,

transparent, adherent dressing applied (UK DH, 2007). • The child/young person must be discharged with the required

medication and drug chart/authorisation sheet for CCNT staff to administer the required medication in the community.

• All medication including diluents and flushes needed to complete the

course of prescribed treatment will be prescribed and provided by the referring source and enough consumables for the first week of treatment dose in the community (except sharps bin).

• The time of administration and completion of the required medication

dose must be within the operational hours of the service (Monday – Friday 09:00-17:00) On a weekend the child will need to attended the children’s observation unit at Doncaster Royal infirmary and the CCN will arrange this

• The IV medication requested must be clinically suitable for the safe administration outside of a hospital setting e.g., consideration of the risk of adverse effects and specific monitoring requirements.

• The requested medication must be on the RDaSH formulary available

on the intranet/internet. (Unless specifically requested by microbiology). Consultation with the ANP for the CCNT must be undertaken if medication outside of this list is clinically indicated.

• A clean area within the home will be available for the safe preparation

of medication and that a home assessment will be conducted by the CCN at the first home visit. Should a suitable area not be available at time of home visit the family must be made aware that the CCN/registered nurse will not be able to administer the mediation and the child will be required to return to the hospital.

Exclusion criteria:

• Eligibility criteria cannot be met. • Safeguarding concerns. • The Risk assessment completed at the first home visit highlights area of

concern. • Known allergy or risk of allergy to the medication or device. History of

previous allergic reactions to medication being prescribed or similar group of medicine.

• Administration of antibiotics via intramuscular injection. • Administration of blood or cytotoxic medication.

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• Treatment regimens exceeding once or twice daily doses will only be

considered in exceptional circumstances depending on the child’s condition and service capacity. e.g. middle day doses where child is still required to attend hospital for early morning or late evening doses

Nursing/medical responsibilities The child and family must be discharged with all the medication and equipment for 1 week. If the CCN team are not informed with enough time to co-ordinate visits or treatment sheet or referral form is not completed appropriately the child will return to the ward for the dose until these are correct. The CCN/registered children’s nurse administering medications intravenously will have successfully undertaken an IV training programme/medicines management training and annual IV update. The CCN/registered nurse will have completed competencies for the administration of IV medication and have read supporting procedure documentation. Access to injectable medicines guidance will be available at all times. The CCN/registered children’s nurse are individually responsible and personally accountable for their actions or omissions, they must adhere to the code (NMC, 2008) and have the right to refuse to administer a medication via the IV route if the NMC standards for medicine management have not been met (NMC, 2010) or if they do not feel they have the skills or are competent to deliver the medication via that route to a specific patient. The CCN/registered children’s nurse will have undertaken anaphylaxis training and will carry an anaphylaxis kit at all times when delivering IV medication. The CCN/registered children’s nurse administering the IV medication will ensure they have the knowledge and understanding of the medication to be administered prior to the home visit. The nurse must confirm: • the indication for use • recommended dose and frequency of use • method of preparation and administration • rate of administration • any special monitoring or requirements • adherence to local infection control policy • contraindications

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• side effects and potential adverse reactions and how to clinically

manage and report (MHRA yellow card scheme)

After a referral to the team has been accepted the CCN will calculate the medication dose and infusion rate with the and check with recommendations within the current BNF. The adrenaline dose will be calculated and documented within the child’s record and checked by a second registered nurse. The CCN/registered children’s nurse administering the IV medication will ensure the prescription is:

• Not for a substance to which the patient is known to be allergic or

otherwise unable to tolerate. • based, whenever possible, on the patient’s informed consent and

awareness of the purpose of the treatment. • Clearly written, typed or computer-generated and indelible. • specifies the substance to be administered, using its generic name and

its stated form, together with the strength, dosage, timing, frequency of administration, start and finish dates, route of administration, flushes and diluents as necessary and final infusion volume.

• is signed and dated by the authorised prescriber (NMC, 2010). • That the dose is appropriate for the child’s age, weight and condition. • When calculations of the dose needs to be undertaken to either prepare

or administer the medication, these should be done and checked with another qualified nurse. Following assessment of the clinical risks this will be facilitated with a two person visit for the initial visit and should there be no further changes a 1person visit thereafter. Where the doses require complex calculating or there has been a change or is small dose i.e:3.3mls. Then there will be a 2 registered nurse visit each time.

Prescribing All IV medication including diluents and flushes must be prescribed by a medical practitioner or independent nurse prescriber on the appropriate drug administration/authorisation/prescription chart which is suitable for CCN staff working in the community. The prescriber must provide clear, precise instructions regarding the medication which is to be administered in accordance with best prescribing practice guidance. Verbal orders for commencement of, or changes to IV or other medications

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must not be accepted. Supply and storage For patients being discharged from a hospital ward, the full course of antibiotics, diluents, and flushes must be prescribed and dispensed by the discharging hospital. All medication must be supplied in the original packaging and labeling to include child name, details of dose in micrograms/milligrams/grams and volume in millilitres (mL), diluent and infusion volume. The drug information sheet (package insert) must be available to ascertain displacement values. The CCN/registered children’s nurse must ensure all medicinal products are stored in accordance with individual summary of product characteristics (SPC) recommendations, when unclear seek further guidance on storage requirements from pharmacy department. Where storage at room temperature is appropriate drugs should be stored below 25 °C in a clean, dry place, out of direct sunlight and close to where the procedure is to be carried out and away from children and pets e.g. top shelf or wall mounted cupboards (RCN, 2001). Medication that needs to be kept cooler than room temperature may be stored in the top of a domestic refrigerator away from food in a rigid, airtight container e.g. plastic box with lid. The refrigerator temperature should be kept between 2 and 8°C.

5.19.10.2 CLOZAPINE

Any patients who are prescribed Clozapine will be monitored through the Clozapine

clinics, which are within each of the Trust’s localities. For further details staff should

refer to the Trust Clozapine clinic protocol, and the procedure for the initiation,

administration, and monitoring of Clozapine, or contact their local clinic.

5.19.10.3 LITHIUM

The prescribing of Lithium to patients will be done in line with the Trust Lithium guidance, and staff should refer to this for further details on treatment and monitoring, including NPSA guidance

5.19.10.4 ORAL ANTICOAGULANTS

The prescribing of oral anticoagulants should be in line with the local district policy, and can be prescribed on the locally agreed forms, which must be attached the patients drug card. Reference to this prescription must be made on the drug card.

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5.19.10.5 CYTOTOXIC/CYTOSTATIC CHEMOTHERAPY

• An increasing number of Patients will be receiving chemotherapy in the community, as the provision of care is moved from the secondary to primary sector.

• Practitioners administering these drugs must be trained and competent

to do so and should attend annual updates. They should have a written prescription stating clearly the drug name, dose rate (if appropriate), frequency and timing and route of administration and, where appropriate, a review date of the treatment. This should be signed and dated by a Prescriber.

• An assessment should be made of the suitability of the patient’s home

environment including telephone access in case of emergency/anaphylaxis.

• Cytotoxic waste must be disposed of in a cytotoxic waste bin or other

receptacle, which should be supplied by the hospital at the same time as the supply of the drug. For further information refer to the Trust’s Waste Management Policy.

5.19.10.6 ANTIBIOTICS

Authorised prescribers should follow the local Primary Care Trust’s policy for the prescribing of antibiotics. (NICE)


As a minimum when prescribing antibiotics staff must:

• Clinical Indication and compliance with local guidance • Clearly documented in patient notes and should comply community

guidance in locality for drug selection, dose and duration • Swab/culture (if indicated). Sample taken prior to initiation or in

response to empirical 1st line failure as per guideline • Review at 48/72 hour • Duration/review date/stop date and indication stated these are clearly

stated either on the drug card

5.19.10.7 NALOXONE AMPOULES 400mcg.

Naloxone injection is an antidote to opiate-induced respiratory depression, and should be available in all clinical locations where diamorphine or morphine injections are stored or administered, in line with NPSA guidance. Ward and Department • All areas where morphine or diamorphine ampoules are stock items


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must also have naloxone 400mcg ampoules as a stock item. • All areas where morphine or diamorphine ampoules are not stock items

must ensure naloxone 400mcg ampoules are prescribed as ‘prn medicines for relevant patients when diamorphine or morphine injections are prescribed.

Community

Naloxone ampoules will be a stock item at base points and available for use by community nurses when dealing with patients using diamorphine or morphine injections. Administration should be via PGD or under instruction by a medical practitioner. Naloxone prefilled syringes may be made available via the substance misuse clinics where agreed, and issued using an approved PGD

5.19.10.8 ADMINISTRATION OF MEDICATION VIA A SYRINGE DRIVER.

• Syringe drivers are used for the continuous administration of drugs over time and are used to deliver a variety of medications via a subcutaneous route.

• Accurate and effective assessment of symptoms is key to the success of the treatment regimen. This should be a regular activity carried out in collaboration with the patient, his/her carers and the GP. The practitioner should be familiar with the device used as calculating the rate of delivery can vary between different models of syringe driver.

• Education and information are essential for successful management of the patient at home and for compliance with the drug regimen.

• Patients receiving analgesia via a syringe driver require as a minimum, daily visits from the practitioner to change the syringe and access to support and advice between visits.

• Under medicines legislation, except in very restricted circumstances, mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine. The person undertaking this preparation, unless an exemption applies, must hold a manufacturer’s license.

• Regulation 20 of the Human Medicines Regulations 2012 exempts nurse and pharmacist independent prescribers as well as supplementary prescribers from these restrictions. (The manufacturing restrictions do not apply to doctors and dentists - regulation 3 refers.) It allows these prescribers to mix medicines themselves or direct others to mix. Directions must be in writing.

The list of acceptable combinations can be found in the Standard Operating Procedure:

Administration of Drugs via the CME Medical T34 Syringe Driver (12/14)

Benefits of Supplementary Prescribing for Palliative Care Syringe Driver

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Use Supplementary prescribing offers a way to offer holistic patient care through a clinical management plan (CMP) set up to support all symptomatic therapies as their need arises.

• A CMP can be put in place at the earliest opportunity, as the transfer of

care is made from the doctor to the nurse, and can include the possibility of syringe driver use even though it may not be required until a later stage.

• The agreement of the CMP with both the doctor and the patient means

there is timely opportunity for discussion of future possible treatment plans with them both and specifically the patient well in advance of need

• The development of a template CMP which is then adapted for

individuals offers a way to support timely symptomatic control as the need arises.

• The development of a template CMP means that there is less work for

individuals each time a CMP is required, and treatment strategies can relate to local or national formulary choices and treatment guidance.

• The relation of CMP choices to guidance would support stability data

available for drug doses within syringes is paramount to patient safety. Need outside of this ‘standard’ guidance through larger doses or greater product combinations would allow relevant dialogue with the doctor where necessary, and perhaps instigate the need for a specific individual CMP in a few cases. This can offer an opportunity for the doctor and nurse to reassess whether continuing care is appropriate through the CMP.

5.19.10.9 ADMINSTRATION OF MEDICATION VIA A PERCUTANEOUS

ENDOSCOPIC GASTROSTOMY (PEG) TUBE

• Patients with PEG tubes may receive medication via this route. The

tube should be flushed before and after administration of medication with recently boiled water.

• Medication should never be mixed with the feed. A chemical or physical

reaction may occur, which may adversely affect the drug, food or both. Guidance should be sought from the prescriber and acute trust, alternatively the use of NEWT guidelines www.newtguidelines.com can be used.

• Medication should be prescribed in liquid form to prevent tube

blockage. If a drug is not available in liquid form, advice must be sought from a pharmacist or medical practitioner as to whether it can be crushed and flushed down the tube

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• The policy for the Management of Patients with an Enteral Tube Insitu

should be followed at all time.

5.19.10.10 MEDICAL GASES

With respect to the safe storage of medical gases the following precautions must be observed: -

The number of cylinders held as stock in any department should be kept to a minimum.

Cylinders must be firmly secured at all times to prevent them falling over

They should be stored under cover, preferably inside and not subjected to extremes of heat

Naked lights must not be allowed within the immediate vicinity of a cylinder

No oil or grease should be applied to the cylinder or tap connector

Allow for segregation of full and empty cylinders and permit

separation of different gases within the store

Have warning notices posted prohibiting smoking and naked lights within the vicinity of the store

Allow for a strict rotation of full cylinders to enable the cylinders with the oldest filling date to be used first

The storage should be designed to prevent unauthorized access and to protect cylinders from theft

Excessive force or any tools must not be used to open or close a cylinder valve

Cylinders with damaged valves and defective equipment must be labeled appropriately and withdrawn from use

Notify the emergency services of the location and contents of the medical gas cylinder store.

Contact suppliers for more specialist advice where necessary.

The arrangements for the maintenance and repair of medical devices (which includes flow meters and oxygen regulators) within the Trust localities are as below.

Doncaster

A combination of in house and service level agreements with the Doncaster and Bassetlaw Hospitals NHS Foundation Trust.

Rotherham.

A combination of in house and service level agreements with the Rotherham NHS Foundation Trust.

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Scunthorpe

Medical Physics at Scunthorpe General Hospital, North Lincolnshire and Goole NHS Foundation Trust.

OXYGEN ADMINISTRATION

• Patients should be correctly assessed for the use of oxygen. A risk

assessment must be included in relation to safety and recorded in the clinical records. Medical grade oxygen is regarded as a drug and may only be prescribed by a doctor or appropriately qualified practitioner. The prescription should include the type of appliance to be used, the appropriate percentage of oxygen, the flow rate and the duration of administration.

• Patients and carers must be educated in the safe use of oxygen in

relation to smoking and hygiene of tubing and mask. Concentration of oxygen and duration of administration should be the minimum required for efficacy and patients and carers should be educated in its safe usage

• Safety guidelines must be adhered to and appropriate warning notices

displayed on vehicles in which oxygen cylinders are transported.

5.19.10.11 FLAMMABLE LIQUIDS

Flammable liquids are issued from pharmacy and labeled “flammable” COSHH data sheets must be available for all flammable liquids kept on the premises. The data sheets must be kept in a central point available to all staff.

To reduce the risk of combustion or explosion:-

• Keep stock levels to a minimum • Avoid spillage • Keep bottle closed. Replace the screw cap immediately after use • Keep well away from naked flame or electrical apparatus • Do not store in a refrigerator • Store all flammable liquids in a locked metal cupboard that displays an

appropriate hazard notice

ALCOHOL GEL It should be noted that as alcohol gel is also a highly flammable substance; the precautions as stated above must be followed. If nursing staff need to store alcohol gel in their car it must not be stored anywhere where it would be subject to direct sunlight. Alcohol gel must therefore be stored in nursing bags, pockets and/or in the boot of the car.

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5.19.10.12 DRESSINGS

• In Doncaster Community Nursing Staff will provide dressings in line with the Doncaster Dressings Formulary

5.19.10.13 INSULIN

• All regular and single insulin (bolus) doses are measured and

administered using an insulin syringe or commercial insulin pen device. Intravenous syringes must never be used for insulin administration.

• The term ‘units’ is used in all contexts. Abbreviations, such as ‘U’ or ‘IU’, are never used.

• When Community Nursing Staff are requested to administer insulin they must have either a prescription or letter of instruction including the brand, dose and time of each dose. Prior to administration they must assure themselves that the insulin is in date and has been stored appropriately

• All clinical areas and community staff treating patients with insulin have adequate supplies of insulin syringes and subcutaneous needles, which staff can obtain at all times.

• An insulin syringe must always be used to measure and prepare insulin for an intravenous infusion. Insulin infusions are administered in 50ml intravenous syringes or larger infusion bags. Consideration should be given to the supply and use of ready to administer infusion products e.g. prefilled syringes of fast acting insulin 50 units in 50ml sodium chloride 0.9%.

• All healthcare staff involved in prescribing administering or monitoring Insulin must undertake the on line training available at http://www.nhsiq.nhs.uk/8473.aspx

5.20 Advice about the Uses and Side Effects of Medication

• Each ward/department should have a copy of the current BNF and

access to the “BNF on line” and manufacturers summary of product characteristics (spc) (http://www.medicines.org.uk/emc.aspx) for reference.

• Before patients are commenced on a medication any advance

statement/directive must be taken into account. They should also be given the appropriate information, in a suitable format to enable them to give valid consent about their treatment.

• Where patients lack capacity they must be given the information as

soon as their capacity is regained. • With the agreement of the patient, information about any proposed

treatment regimens should be given to their carer/relative. • Further information on medicines can be obtained from Pharmacy staff.

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• Information leaflets can be obtained from the pharmacy and also the Trust intranet

• Formal teaching for staff on medicines /medicines management can be

organised through the Trust training department. • Where a Pharmacist is part of the clinical team they should be the first

point of access for information or advice on medicines within the team.

5.21 Side Effects Monitoring

The experience of adverse side effects from the medication they have been prescribed is sometimes stated by patients as the reason for their non-compliance. For this reason it is important that wherever possible there is systematic monitoring of side effects particularly when a new medication has been prescribed.

Whilst there are a number of side effect monitoring tools available for clinicians to use, as a provider of Mental Health and Learning Disability services it is recognised that a high percentage of prescribing is in relation to antipsychotic medication and “adherence with antipsychotic medication is perhaps the main determinant of relapse in schizophrenia (Robinson, et al., 2002). The tolerability or experience of side effects of a particular antipsychotic medication has been regarded as both one of the key factors predicting continued adherence (Tacchi and Scott, 2005; Lambert, et al., 2004) and crucially the experience of adverse antipsychotic side effects is commonly stated by patients as an important reason for non-adherence (Patel and David, 2007). This highlights the importance of an open and systematic discussion regarding medication-related side effects, as an acknowledgement of the risks as well as benefits of a particular treatment help to establish a collaborative approach between clinicians and patients and contribute to a therapeutic rapport. Antipsychotic side-effect rating scales have been used over the years to help identify and quantify the various side effects that can occur on these medications.” (extract from Waddell and Taylor 2008)

The Glasgow Antipsychotic Side-effect (GASS) is the method for routine side effect monitoring employed by the Trust. The GASS is validated for assessment of side effects associated with second or third generation antipsychotic medication (sometimes referred to as atypical antipsychotic medication). However, many people are prescribed first generation antipsychotic, especially as a depot injection, or have a combination of first generation and second or third generation medication. In such cases, an alternative side effect assessment such as the Liverpool University Side Effects rating Scale (LUNSERS) should be used. If you are unsure as to which assessment scale should be used you should consult with a pharmacist or consultant psychiatrist. The frequency of formal side effect assessment is guided by clinical need so should be considered:

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• If the patient (or carer) reports a change/potential change in the side effects experienced.

• If said effects/potential side effects give rise to concern. • Following initiation of new antipsychotic medication. • Following a significant increase in prescribed dose. • As a minimum, patients prescribed antipsychotics will have formal side

effect monitoring recorded at least annually.

5.22 Transport of Medicines

5.22.1 Transport within wards and departments

Medicines may only be transported by Trust staff or authorized staff of supplying Trusts. No Medicines are to be left unattended at any time during transportation.

5.22.2 Transport of medicines between health services premises

Medicines accompanying a patient who is begin transferred to another hospital or unit may be transported with the patient in the ambulance, taxi, or other form of transport. It is important that the medicines are packaged securely and labeled with the final destination.

5.22.3 Transportation of medicines from the Supplying Pharmacy

All medicines will be transported in locked tamperproof containers. On arrival at the ward/department they will be left in a designated area or room. Delivery vans carrying medicines must not be externally distinguished from other Health Service vans. Delivery vans must not carry any unauthorized passengers Delivery vans are to be locked when unoccupied. Once delivered to the ward/department the responsibility for the security of the medicines rest with the practitioner in charge who will unpack the contents, check them against the delivery note, and lock them away.

5.22.4 Transportation by Taxi

Taxis should not routinely be used for the transportation of medicines, however, if an emergency arises and there is no alternative staff should: • Use a hospital contract taxi. • Check the driver’s identification.

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• Make sure the medication is in a tamper evident container. • Contact the address to which the medication is to be delivered to let

them know what time the Taxi left with the medication, and request that they confirm receipt.

5.22.5 Transport of Medicines to Patients at Home

Discharge or leave medicines may be transported home by the patient or their carer. Patients who leave the hospital or unit before all their medicines have been dispensed should be instructed to return later to collect them. The transport of medicines to a patient’s home at other times must be authorised by the practitioner in charge of the ward/department.

5.22.6 Transport of Patients medicines by Community Staff

Medicines may be carried by community staff in relation to their role. This will include medication required for emergency treatment, to be administered via a PGD, to be administered against a prescription of letter of authorization, or similar. Where staff are going to a patients home to administer the medication, such as a long acting injection, they must have the depot card with them. Community Nurses may carry stock drugs, needed to carry out their jobs, such as dressings, adrenaline and medication for PGD’s. The security of medicines issued to Community Based/Visiting staff will be the responsibility of the individual authorized to administer or Prescriber to whom they are issued. Upon delivery all medicines will be stored away from public access and in a locked container. Except when carried on the person of the individual authorized to administer or Prescriber the container will be kept locked and out of sight at all times (e.g. in the boot of their car). Staff that are not registered nurses may deliver medication to a patient for self-administration. Staff delivering medication to a patients home should record this in the patient record, ideally getting the patient to sign for it. In the unusual event staff remove medication from the patients home; this must be signed for by the patient and a record made in their clinical record. In the event that the patient is not at home to receive the medication it is to be returned to the medicine cabinet in the team base. Under no circumstances are staff to post the medication through the patient’s letterbox.

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Staff must always endeavor to return to base at the end of their working day to return any unused medication, however in exceptional cases they may be taken home, to allow for lean working. This does not include medication such as TTO’s In these situations it must be agreed by the team manager, and the medicine must be stored securely at home out of the reach of children and others, ideally in a locked case. The medication must be kept in a locked container, such as a brief case.

5.23 Medication Errors/incidents

5.23.1 Definition of a Medication Error

A Medication error is a preventable incident associated with the user of medicines, which may put a patient at risk. Such incidents may be related to any of the steps of the medicines process of medication user e.g. Prescribing errors Omission of regularly prescribed medication Drug/does selection Route/time of administration Illegible/incomplete prescriptions Dispensing errors Wrong Drug Wrong dose Wrong quantity Wrong formulation Unavailability of dose for administration at scheduled time Dispensing out of date drug Dispensing an incorrectly formulated drug Absence of PILS in TTO medications Administration errors Administering the drug to the wrong patient Administering the wrong drug Administering the wrong dose Administering the drug at the wrong rate Administering via the wrong route Administering the drug at the wrong time Non-justifiable omission of the dose Administering an out of date drug Administering an incorrectly formulated drug Patient counseling Failure to counsel a patient on the accurate use of their medicines

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Patient Monitoring Failure to monitor the appropriate patient parameters, to ensure the safe and effective use of a drug Dispensing errors should also be reported to the Chief Pharmacist of the relevant pharmacy Errors are often made under pressure of work, or by failure to follow policies. It is essential that an atmosphere of openness prevail, so that staff who realise any mistakes feel able to report them to avoid any detrimental effects on patients

5.23.2 Action to take if an error occurs

The staff member who notices the error must:

• Maintain the patients safety • Inform the appropriate prescriber and seek advice on any action

required • Review the services user’s car plan in light of any advice given • Report the error using the Trust’s electronic reporting system giving

details of the incident, immediate action taken, and any factors which may have contributed to the error

• Report the error to the Service Manager/Matron • The relevant prescriber’s line manager (or On Call cover) is responsible

for dealing with prescribing errors concerning the patient. Errors must be discussed with the manager with the knowledge of the Prescriber. The manager should significant prescribing errors with the Prescriber and the Clinical Pharmacist. Supporting statements will be required from the staff concerned. Where system in place, local drug error tools should utilized

• Inform the patient and offer reassurance. In the event that the patient

has a condition which impairs their cognitive or intellectual functions, the Doctor in charge of their care will be consulted so that a decision can be made about informing them and/or their relatives/carers or the error.

• If it is a dispensing error the Trust Chief Pharmacist or nominated

deputy will investigate and supporting statements will be require from all staff concerned in the event that the patient, relative or carer are dissatisfied with the outcome of the incident, the Trust’s Complaints procedure will be followed.

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• The team manager may wish to use the EDMET tool (LINK) to assess the error with the person concerned.

5.23.3 How the organization learns from medication errors

All medication errors/incidents will be subject to review by the Trust’s Pharmacy Team. Themes and lessons learned from serious incidents (Sis) will be reviewed in the Medicines Management Committee and will inform the medicines management training and policy review Themes and lessons learned from Serious Incidents (Sis) will also be shared at the Organisation Learning Forum

5.24 Disposal of Medicines which are no Longer Required

When disposing of medicines it is important to make the distinction between controlled and non-controlled drugs as different criteria’s apply and no pharmaceutical waste is to be disposed of using a sink or sluice

5.24.1 Disposal of non-controlled drugs

Any medicines, which are no longer required by the ward or department, are to be disposed of in the pharmaceutical waste bin, provided for the purpose.

5.24.2 Disposal of controlled drugs

• Controlled drugs must not be returned by wards or departments • Where they are no longer required, they must be removed by

Authorized Pharmacy Staff. Upon removal of the controlled drug, the authorised member of the Pharmacy staff will enter the appropriate stock balance and sign the Controlled Drugs Register. The transaction must be witnessed by a designated practitioner who will also sign the register. The drugs must remain securely stored in the CD cupboard prior to their removal.

• Any controlled drug removed from the ward or department by

Authorised Pharmacy staff must be returned to the pharmacy department where an appropriate entry will be made into the pharmacy Controlled Drug Register.

Care Homes

Where community Nurses are supporting the care of a patient in a care home i.e. maintaining a syringe driver and the patient dies, the following process must be followed: • All medications are to remain a the care home for 7 days • If the Care Home is a residential home, then the home makes

arrangements for them to be collected by or taken to their pharmacy for

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destruction.

If the Care Home is a nursing home, it is the responsibility of the home to destroy and dispose of them.

5.24.3 Disposal of patient’s own medication

Any medication brought into hospital by a patient is their property and as such cannot be destroyed without their permission. In the event that the patient agrees to the destruction of the medication it is to be placed in the pharmaceutical waste bin. If the patient/carer refuses to agree to the disposal of the medicines they can either:

• Be recorded in the patient’s clinical records and held in a sealed bag in

a separate section of the medicines cupboard from all other stock until they can be returned to the patient on discharge.

Or if the patient insists:

• Be returned home. However, the patient and or their carer/relative

must be advised that as the treatment regime will be reviewed whilst the patient is on the ward, it is likely that the supplied discharge medication will be different, and this poses a real risk that the wrong medication may be taken in future

If there are safety concerns in relation to the medication being returned home the nurse in charge consultation with the Consultant in charge of the patients care may make a decision to refuse to return the medicines and have them destroyed. For the safe disposal of any medicines staff should refer to the guidelines issued by their supplying pharmacy.

5.24.4 Drug disposal in Community Services

Community staff will advise patients or their carers to return unwanted drugs to their community pharmacists. Normal practice would be that community staff should not remove medicines from a patient’s home. Disposal of unwanted medicines is the responsibility of the patient, their carer or the person responsible for clearing the house. Where a patient has their medicines ordered and/or delivered by their community pharmacy, staff may support patients by contacting that pharmacy to arrange for removal. In exceptional circumstances, following a risk assessment and in line with maintaining a duty of care to the patient, where a patient (or other resident) is considered to be at risk, medicines may be removed. Staff should:

• Contact the principal prescriber of the medicines, to alert them to the

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risk and allow arrangements to be made for future prescribing – this may be the patient’s GP or specialist

• Obtain consent from the patient or their carer for the removal of the medicines

• Remove the unwanted medicines directly to the nearest available community pharmacy for appropriate disposal. A record of what has been removed should be made, and the patient/carers signature obtained, using the approved form.

• Where consent has not been obtained and the risk is considered high, contact your line manager for further advice

This should be documented (to include the basis of the risk and names/quantities of medicines removed) and discussed with the line manager at the earliest opportunity and within 24 hours

5.25 Ward Closures 5.25.1 Temporary or routine ward/department closures

Where a ward or department is closed for any reason for up to 7 days the Responsible Person will ensure that all medicines are appropriately stored in cupboards as specified in this policy The individual in charge at the time of such a closure will be responsible for ensuring the keys are stored in a secure place which has been agreed as suitable between the Responsible Person and the Trust Lead Pharmacist. Wherever possible, the doors to the ward or department will be kept locked during the period of closure.

5.25.2 Permanent closure of a ward/department

The Management Team will be responsible for notifying the Trust Chief Pharmacist of the permanent closure. The Trust Chief Pharmacist will then be responsible for arranging the return and credit of disposal (as appropriate) of all medicines stocked on the ward or department. Relevant registers will be stored as per Trust Records Management policy.

5.26 Investigation of Drug Discrepancy or Loss Occurring in the Hospital or

Community

It is acknowledged that in the community setting prescribed drugs are owned by the patient; however the following will apply throughout the Trust.

• Any knowledge or suspicion of drug loss or discrepancy of drugs, for

which the staff member is responsible for administering and recording the balance of, must be reported immediately to the Responsible Person and their line manager. Discretion must apply in all instances

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• Where an incident is due to suspected theft or burglary by a person external to the Trust, staff will refer to the Security Manager and the Police must be informed.

• In all cases an incident form should be completed as per trust incident

reporting policy.

5.27 Removal of and disposal of unknown substances

Unknown substance may be illicit in nature and in accordance with its duties under the Misuse of Drugs Act. The Trust does not knowingly permit the use of or dealing in illicit substances on its premises. In the event that staff become aware of someone on the premises having an unknown substance on them they should follow the guidance as detailed below:

5.27.1 Action if a visitor is in possession of an unknown substance

If any visitors are seen to be in possession of a suspected illicit substance they will be asked to leave the premises If any visitor is seen or suspected to have passed illicit substances to a patient or other visitor they will be asked to leave. The nurse in charge of the ward will then consult with the Modern Matron about the need to report the matter to the Police , and bar any further visits by the person concerned (please refer to the Trust ‘Guidance for Nursing staff when incidents of drug misuse are encountered on Trust premises’ See 5.7.2 in the policy.

5.27.2 Action if a patient is in possession of an unknown substance

In the event that it is a patient who is suspected to have illicit substances on them the nurse in charge of the ward will discuss their suspicions with them and ask that they voluntarily hand over the substance for destruction. This discussion must be held in the company of another staff member and this staff member must witness the actions of the nurse in charge once the substance has been handed over. The illicit substance will be:

• Placed in an envelope • The envelope will be labeled with a reference number linking it to the

entry in the controlled drugs register • The envelope will be sealed and both the nurse in charge and the

witnessing staff member will sign and date across the sealed flap of the envelope

• This envelope will then be locked in the ward controlled drug cupboard

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• An entry will be made in the controlled drug register under the heading of unidentified substance

• In order to maintain patient confidentially their name will not be

documented in the controlled drug register • Pharmacy are to be notified of the illicit substance on the next working

day, and they will make arrangements for the removal and safe disposal of the substance

• If staff involved in the removal of illicit substances from a patient have

reason to suspect that the quantity involved is great than of personal use, advice should be sought from the Service Matron as to the need for the matter to be reported to the Police

NB: Under no circumstances will any suspected illicit substances be returned to the patient If the patient refused to hand over the illicit substance for destruction they are to be place on 1:1 nursing observation and the matter discussed with the Modern Matron and the patient’s Consultant. All actions taken are to be recorded in the patient’s clinical record or in the event of a visitor, on the ward 24-hour report.

5.28 Adverse drug reactions

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Prescribers, pharmacist and nurses are urged to help by reporting adverse reactions to the Medicines and Healthcare Products Regulatory Agency (MHRA) on pre-paid yellow forms, which are available in the BNF or on the BNF website (http://www.bnf.org/). The BNF also provides further detail on the type of medicines and type of reactions, which should be reported. (staff can also refer to appendix 3 for further details) If the reporter of the adverse effect is not the lead clinician, they must be made aware of the problem, and the patients record updated accordingly

5.29 Medicine Defect Reporting

Medicines may be considered defective for two principal reasons. • Physical defects caused by damage or contamination noted by an

individual handling the medicine at any point in the Medicines Trail. • Efficacy defects caused by reactions that in the judgment of a

professional caring for the patient(s) concerned indicate an unexpected response

Within the Trust the following procedure applies when a defect is found or is suspected in any medicine:

http://www.bnf.org/

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• Inform the supplying pharmacy who will advise on all reporting, recording and investigating on the defect

• Retain any remaining product and any associated products or

equipment (e.g. administration sets, infusion devices etc.) and clearly mark it “Defective: not for use”

• Notify the Chief Pharmacist who is responsible for formally reporting all

defective medicines to the authorities, the manufacturer concerned, and other wards and departments as necessary. In addition to this the Chief Pharmacist is also responsible for:

• The retention of suspected defective medicines for analysis, return

or impounding. • Recall to the Pharmacy Department of all potentially defective

medicines. • The dissemination of information relating to potentially defective

medicines within the Trust.

• Complete an electronic IR1 report, recording details of the product and defect

• If the product has been administered to a service, inform the doctor

responsible for the patient and record the defects in the patients clinical record

• Report the incident to the Appointed Practitioner in Charge

Suspected defective medicinal products are notifiable by doctors and pharmacists to: The adverse Incident Centre, MHRA, 2/2G Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

5.30 Drug alerts, recalls and safety notices

The Medicines Control Agency and the Medical Devices Agency are responsible for notifying Health Authorities and Trusts of product defects, which may have implications on a wider, sometimes national, scale. Such notification will then be circulated to Trust units by their supplying pharmacy. All such notifications received must be immediately brought to the attention of the assigned practitioner in charge, or member of healthcare staff in charge of the unit. The staff member in charge must follow the instructions received regarding the identification and withdrawal of the defective product and bring any withdrawn medicines to the attention of the ward/unit pharmacist or other authorised pharmacy staff.

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A record of the action taken must be made in the ward/unit 24-hour report. 5.31 Use of unlicensed medicines

• In the UK no medicine can be marketed for human use without a Product License (PL) granted by the Licensing Authority (Department of Health). The PL specifies the indications for which a product may be used and also the dose, and route of administration etc. Licensing arrangements are determined by the Medicines Act 1968 and implemented through the Medicines and Healthcare products Regulatory Agency (MHRA). Under the Consumer Protection Act of 1987 the manufacturer of a drug, which has a UK product license is liable for damages if the product is defective.

• Unlicensed medicines fall into 5 broad categories:

• Products derived from licensed medicines and prepared by the

NHS or commercial unit with a “specials” manufacturing licence or prepared in a hospital pharmacy department under a Medicines Act exemption, e.g. the manufacture of a suspension from tablets

• Or capsules or special low-dose formulations for children • Products, whose licence has been abandoned, suspended,

revoked or not renewed • Products for which a licence has yet to be granted, but which are

available and licensed outside the UK • Medicines used outside the terms of their Product Licence, e.g. for

an unlicensed indication, via an unlicensed route, or at an unlicensed dosage

• Unlicensed medicines undergoing clinical trials

• Prescribers have a duty in common law to take reasonable care and to

act in a way consistent with the practice of a responsible body of their peers of similar professional standing. In using an unlicensed medicine the Prescriber must act responsibly and with reasonable care and skill. Not to meet these standards lays the Prescriber open to claims of negligence liability.

The responsibility for use of unlicensed medicines lies with the Prescriber. Mechanisms must be in place to ensure that a Prescriber knows when a medicine prescribed/supplied is unlicensed and that he/she is aware of his/her responsibilities. Most common drugs have product licenses, however, there are two circumstances where a Prescriber may wish to use an ‘unlicensed drug’:

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• A product awaiting a UK product license • A product that has been withdrawn from UK market

5.31.1 Trust Procedure for the prescribing of unlicensed medication

Unlicensed medicinal products are only to be used when no pharmaceutically equivalent licensed product or suitable alternative licensed product is available for use at the time the patient requires it. Prescribers who carry overall clinical responsibility for patients may use unlicensed medicines in the course of their practice. However by their nature the effects of an unlicensed medicine may be less well known than a licensed product. Health care professionals are reminded of their duty always to act in the best interest of their patient. In the case of an unlicensed medicine this may mean refusing to administer an unlicensed medicine where they have grounds to believe it may be unsafe. When prescribing two or more medicinal products together for the purpose of administering them to meet the needs of a particular patient this product becomes unlicensed. This is now legally allowed PROVIDING that controlled drugs are not included. However, MHRA have issued a statement that non-medical prescribers are unlikely to be prosecuted for the purposes of palliation even though this product is not legal. Should any Prescriber within the Trust wish to prescribe an ‘unlicensed drug’ they must firstly make an initial application to the Chair of the Medicines Management Committee. If it is felt therapeutically justified then the proposal should be taken to the Trust’s Medical Director, Director of Nursing and Chief Executive for approval. Authorised pharmacy staff will advise the Prescriber (and/or the assigned practitioner in charge) of the unlicensed nature of the medicines. Where such unlicensed use is not common practice, or is deemed to constitute a significant risk, this must be recorded in the patient’s clinical record by the Trust Prescriber or pharmacist. Prescribers must consider carefully the use of unlicensed medicines and only use this form of therapy when the benefits outweigh the risks. Prescribers must obtain consent to treatment and inform the patient of the medicines license status. The patient must also be informed that the effects of an unlicensed product will be less well understood than those of a licensed product. Prescribers must inform their medical colleagues (especially General Practitioners) of the medicine’s licence status prior to any transfer of the patient.

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5.32 Definition of “Off -Label Medicines”

The Summary of Product Characteristics (SPC) lists: indications, dose ranges, methods of administration and age restrictions as granted by the marketing authorisation for each medicine licensed for use within the UK. Any use not in accordance with the SPC is considered “off-label”, or an unlicensed use. This policy also applies to products used outside their product license “off label use”, or herbal or homeopathic products. Off label prescribing should only be carried out by senior prescribers within their area of competence, and should be supported either by trust or national guidance.

5.33 Medicines Safety

The Medicines and Healthcare products Regulatory Agency (MHRA) issue a regular monthly electronic bulletin bringing information and clinical advice about the safe use of medicines. It is intended for all healthcare professionals who work in the UK – doctors, pharmacists, nurses, dentists, allied health professionals, and coroners. The MHRA is the government agency which is responsible for ensuring that medicines and medical devises work and are acceptably safe In addition, the National Patients safety Agency (NPSA) issue regular patient safety incident data and reports, with alerts, directives, tools and guidance, to improve patient and medication safety. Within service Provision, the Director of Service provision will be responsible for ensuring that NPSA, NICE and other national alerts/guidance are actioned appropriately. All staff (including self-employed staff contracted to work within Trust provided services) will follow best practice detailed in MHRA and NPSA alerts and reports.

5.34 Clinical trials including pharmaceutical products

• Anyone considering conducting a clinical trial must refer to the MHRA

guidelines Description of the Medicines for Human Use (Clinical Trials) Regulations 2004

• Any Clinical trial within the Trust can only be undertaken after careful

consideration and approval from the Medicines Management Committee

• If the trial is sponsored by a pharmaceutical company it must comply

with the guidelines on compensation issued by the Associated of the British Pharmaceuticals Industry.

• Any patient who is to be involved in the trial must give informed consent

in line with the Mental Capacity Act (2005)

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• Supplies of the drug will be issued by pharmacy as agreed in the trial protocol

• Pharmacy will supervise the use of the medicine in the trial

5.35 Contact with Pharmaceutical Industry Representative

The Trust Medicines Management Committee (MMC) has decided that RDaSH staff will not be permitted to meet with representatives or agents of the pharmaceutical industry on Trust premises or during normal working hours. This decision has been made as the Medicines Management Committee does not consider such meetings to be an appropriate use of Trust resources. The MMC believes that it is important that Trust staff should focus their NHS time on clinical and patient-focused activities as well as planning and management activities designed to serve the Trust’s immediate and long-term goals. The MMC do not consider that meeting with sales representatives of the pharmaceutical industry service is in the interest of patients, clinicians or the Trust. It is recognised that there may be research opportunities or other collaborative arrangements where interaction with the pharmaceutical industry can be mutually beneficial to the NHS but this should be organized in a planned way through the appropriate research governance procedures. Also, the MMC recognizes that there may be opportunities for other planned collaborative work with the pharmaceutical industry that specifically serves the Trust’s educational, training or other goals. Such specific and planned projects should be cleared with MMC on a case by case basis and the representatives of the Pharmaceutical industry have strict codes (ABPI Code of Practice) by which they must abide. In line with this code they should:

• Not enter any patient areas • Never have access to patient’s clinical records • Never directly promote their products to patients or carers

Individual educational and CPD activities should continue to be discussed and arranged through the usual channels of appraisal, supervision ad job planning.

5.36 New medicine related documents

All new and updated polices, guidelines, protocols PGDs and PSDs relating to medicines must go through the Medicines Management Committee and on to the Clinical Effectiveness committee for approval, unless exempted by the Chief Pharmacist.

6. TRAINING IMPLICATIONS

The Training Needs Analysis (TNA) for this policy can be found in the

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Training Needs Analysis document which is part of the Trust’s Mandatory Risk Management Training Policy located under policy section of the Trust website.

7. MONITORING ARRAGEMENTS

Area for monitoring Monitoring

process

Who by Reported to Frequency

How medicines are

prescribed

Pharmacy

10 point plan

Pharmacy

Team

Medicines Management

Committee

Monthly

How the trust make sure

all prescription charts are

accurate

Pharmacy

10 point plan

Pharmacy

Team


Committee

Monthly

How the side effects of

medication are

monitored (inpatient)

Pharmacy

10 point plan

Pharmacy

Team


Committee

Monthly

How the organization

learns from medication

errors

Review

medicines

related serious

incidents

Pharmacy

Team


committee/Organisation

Learning Forum

Quarterly

How Medication is

administered, including

patient identification

Pharmacy

10 point plan

Pharmacy

Team


Committee

Monthly

Patient self-

administration

Audit of Policy Chief

Pharmacist

Clinical Quality Group

/Medicines Management

Committee

Annually

How a patients

medicines are managed

on handover between

care settings

Pharmacy

10 point plan

Pharmacy

Team


Committee

Monthly

How drugs are disposed

of safely

Site visits,

Contract

monitoring

Pharmacy

Team

Chief Pharmacist Ongoing

Compliance with national

standards for medicines

management

Clinical Audit

(POMH UK)

Chief

Pharmacist

Clinical Quality

Group/Medicines

Management Committee

As results

become

available/

annually

Staff training as identified

in the Training Needs

analysis

Report Head of

Learning and

Development

HR & OD Quarterly/

Annually

In addition, the Chief Pharmacist provides an annual report to the Board of Directors in their capacity

as Accountable Officer for Controlled Drugs.

8. EQUALITY IMPACT ASSESSMENT SCREENING

The completed Equality Impact Assessment for this Policy has been published on the Equality and Diversity webpage of the RDaSH website

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8.1. Privacy, Dignity and Respect

The NHS constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for ALL (2008), Lord Darzi’s review of the NHS, identifies the need to organize are around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the Trust is required to articulate its intent to deliver care with privacy and dignity that treats all service uses with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

Indicate how this will be met

No issues have been identified in relation to this policy

See attached EIA statement.

8.2. Mental Capacity Act

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the Court

Therefore, the Trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act. For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act 2005 to ensure that the interest of an individual whose capacity is in question can continue to make as many decisions for themselves as possible

Indicate How this will be Achieved.

All individuals involved in the

implementation

of this policy should do so in

accordance with the Guiding Principles of the Mental Capacity Act 2005 (Section 1)

9. LINKS TO ANY ASSOCIATED DOCUMENTS

• Risk Management Strategy • Patient Safety Strategy • Medicines Management Strategy • Guidelines for nursing staff on the use of Section 62 Procedure for the

searching of a person or their property • Controlled Drugs procedure

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• Rapid tranquilisation policy and guidelines for inpatients • Patient Identification Policy • PGDS – a list of authorised PGD’s can be found on the Trust Intranet

under clinical policies • Procedure for the administration of long acting injections • Non-Medical Prescribing Policy (Supplementary Prescribing) and Trust

authorisation and sign off protocol • Policy and Procedure for the Safe and Secure Handling of Medicines in

Trust day care settings • Incident Reporting Policy • Policy for the Management of Serious Incidents • Policy and Procedure Relating to the Handling of Formal Complaints • Policy on the Development of Information For Patients • Guidance for nursing staff when incidents of drug misuse are

encountered on Trust premises • Policy for Health Record Keeping Standards and Health Records

Management • Safe Haven Policy (from October 2012) • Standards Operating Procedures, a list of authorised supporting SOP’s

can be found on the Clinical policies section of the Trust website

• Counter Fraud Bribery and Corruption Policy 10. REFERENCES

Care Quality Commission (2010) Essential standards of quality and safety. Audit Commission Report (2001) A Spoonful of Sugar – Medicines Management in NHS Hospitals. British Medical Association, Royal Pharmaceutical Society of Great Britain (most recent edition) British National Formulary. Consumer Protection Act of 1987. Control of Substances Hazardous to Health Regulations (2002) Crown Report 1998

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Department of Health (1999) Review of Prescribing, Supply and Administration of Medicines. Department of Health (2004) Mechanisms for Nurse and Pharmacist Prescribing and Supply of Medicines. Department of Health (2007) Safer Management of Controlled Drugs: A Guide to Good Practice in Secondary Care. Department of Health (2015) Code of Practice Mental Health Act 1983. Department of Health (2015) Reference Guide to the Mental Health Act 1983. The Duthie Report (1988). General Medical Council (2013) Good Practice in managing medicines and devices Manchester Mental Health and Social Care Trust (2008) Medicines Policy 4th Edition Medicines for Human Use (Clinical Trials) Regulations 2004. Mental Capacity Act 2005. Misuse of Drugs Regulations 2001. National Institute for Health and Clinical Excellence 2015 NG5 Medicines Optimisation. National Institute for Health and Clinical Excellence 2014 CG183 Allergy. National Institute for Health and Clinical Excellence 2015 NG15 Antimicrobial Stewardship. National Institute for Health and Clinical Excellence 2013 MPG 2 Patient Group directions. National Patient Safety Agency (2007) Promoting Safer Use of Injectable Medicines. Nursing and Midwifery Council 2015 Standards for Medicines Management. Nursing and Midwifery Council (2015) The Code: standards of conduct, performance and ethics for Nurses and Midwives. Nursing and Midwifery Council (2015) Standards of Proficiency for Nurse and Midwife Prescribers. Nursing and Midwifery Council (2008) Mental Health Act Manual Eleventh Edition.

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Royal Pharmaceutical Society of Great Britain (2008) Medicines Ethics and Practice, A Guide for Pharmacists and Pharmacy Technicians. The Medicines Act 1968. The Misuse of Drugs Act 1971. The Royal Marsden NHS Foundation Trust (2004) Clinical Nursing Procedures 6th Edition. The Association of the British Pharmaceutical Industry Code of Practice (2006) The Human Medicines Regulations 2012. Royal College of Psychiatrists (2007) Use of Licensed Medicines for Unlicensed applications in Psychiatric Practice. The Stationery Office (2007) Mental Capacity Act 2005 Code of Practice. Waddell L. and Taylor M. - A new self-rating scale for detecting atypical or second- generation antipsychotic side effects - Psychopharmacol 2008; 22; 238 DOI: 10.1177/0269881107087976.

11. APPENDICES

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Appendix 1

Guidance to staff on Medicines Reconciliation

Introduction

• In 2015 NICE published guidance NG5 Medicines Optimisation that states when patients move between care settings, and the receiving team have prescribing/administration roles then Medicines reconciliation should occur.

• Medicines reconciliation will help ensure that all intended medication is given, all unintended medication is avoided and the information transferred is accurate and contemporaneous

Aims of the Medicines Reconciliation Process

• To obtain, and verify, an accurate medication history for all patients on

admission to a service. • To maintain a contemporaneous record of current medicines and the reasons

for addition, discontinuation or alteration of the patient’s medicines during the inpatient stay.

• To provide accurate information of current medicines prescribed, including any changes, upon transfer of care e.g. to the GP upon discharge.

• Definition of Medicines Reconciliation. • The National Prescribing Centre defines Medicines Reconciliation as:

o 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

o Checking or verifying this list against the current inpatient prescription/summary care record and administration record in the hospital, ensuring any discrepancies are accounted for and actioned appropriately, and

o Communicating through appropriate documentation, any changes, omissions and discrepancies

• In the community the reconciliation process should also indicate clearly who is responsible for prescribing the medication.

Summary of Roles and Responsibilities

Role of the prescriber (to include medical staff and Non-Medical Prescribers)

• To take a full, accurate medication history at the point of assessment on

admission to the team.

• To communicate with the patient/carer with regard to their usual medicines to ensure there are no discrepancies between the information obtained from the information sources and the patient/carer.

• To establish an allergy status and record this on the medication chart and on

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the alert sheet in the medical notes as per Trust policy.

• Only prescribe once the medication history is complete and accurate as doing so without this information is potentially hazardous.

• To complete and document the Medication History with the information obtained.

• To document the reason(s) for any alteration in dose/frequency or for discontinuation of medication on admission on the Medication History.

• To maintain an accurate, contemporaneous record for the addition/discontinuation/alteration of any medicines during the patient’s inpatient stay.

• To document any changes/discontinuations/additions of medicines on the patient’s discharge summary sheet.

Role of the pharmacist

• To verify that the Medicines Reconciliation Process has been undertaken by

the prescriber as soon as possible after the patient’s admission to hospital.

• To ensure the medication history appears complete and clinically coherent.

• To ensure the medication written on the current inpatient prescription and administration record matches that of the medication history, where appropriate.

• To ensure any discrepancies are documented appropriately on the Treatment

Sheet.

• To clarify any undocumented discrepancies with the prescriber.

• To endorse the Treatment Sheet that the medication history is complete and clinically coherent.

• To confirm and document allergy status, where appropriate.

Role of the pharmacy technician • To facilitate the Medicines Reconciliation Process by establishing a

medication history using appropriate resources in collaboration with a pharmacist.

• To record any additional information obtained on the Treatment Sheet.

• To inform the pharmacist, or prescriber where appropriate, of any discrepancies detected.

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• To confirm and document allergy status, where appropriate

Role of the Nursing Staff • To highlight to a member of the medical or pharmacy team if they recognise

any discrepancies between the inpatient prescription and administration record or and the patient’s regular medication.

• To ensure any information obtained is documented on the Treatment Sheet.

• To ensure allergy status has been confirmed and documented on the front of the inpatient prescription and administration record prior to administration of any medicines (unless in an emergency situation).

• To ensure any medicines prescribed are appropriate, after considering any

allergy status.

Role of Community Team members (Key Worker) • To take a full, accurate medication history at the point of assessment on

admission to the team, for the patients under their care. • To highlight to a member of the medical or pharmacy team if they recognise

any discrepancies between what the record shows and what the patient is actually taking.

• To ensure any information obtained is documented in the patient record.

• To ensure allergy status has been confirmed and documented in the patient

record, prior to medication being administered. • To ensure any medicines prescribed are appropriate, after considering any

allergy status.

The Medicines Reconciliation Process Allergy Status

• The prescriber retains the principal responsibility for ascertaining allergy status of any patient for whom they prescribe. However, it is the responsibility of every person involved in the medication process – prescribing, dispensing or administration – to take every practical step to establish the allergy status of the patient. The only exception to this is in an emergency situation where this information is unobtainable and the risk of not treating the patient outweighs the risk of having the information needed to make a fully informed decision. It must be recognised that prescribing / administering medicines without establishing allergy status is potentially hazardous.

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Sources of information

• Obtaining a full, accurate medication history requires access to one or more of the following sources:

o Referral letter from primary care o Repeat prescription sheet from the patient o Electronic medication record from the GP practice o GP surgery o Community pharmacy o Nursing Home Medication Administration Record (MAR sheet) / care

home /residential home o Patient’s relative / carer o Transfer from another unit / hospital o Recent hospital discharge letter / prescription chart o Patient’s Own Drugs o Patient

• In addition to using the sources listed above to identify prescribed medicines,

the patient, relative or carer should be questioned with regards to over the counter medicines and alternative therapies they may be taking.

• It is important to establish if there are any discrepancies between the

information obtained independently to the patient and the information that the patient delivers. Ideally, more than one information source should be used to obtain an accurate medication history.

Recording the Medication History

• Once the medication history has been established, all of this information must

be transferred onto the Trusts approved medicines reconciliation document, irrespective of whether the medicine will be continued during the admission. This document will form part of the patient’s notes to record any changes in medication therapy during the inpatient stay. Where the patient has an electronic prescription, the Medication History should be filed in the appropriate place in the medical notes.

Recording the Medication History on admission

• Complete the Medication History with:

o Date of admission o Source of information using appropriate codes o Full name of the medicine and the formulation (e.g. tablet, capsule,

modified release preparation) o Dose, frequency and route o Sign and date the entry. o If any of the patient’s current medication is to be discontinued or

altered on admission (for example, if the reason for admission is medication related), this should be documented with the reason for discontinuation / alteration and the entry signed and dated.

o Who is responsible for prescribing the medication

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Recording the Medication changes during a patient episode

• Patients who have a written Medicine Prescription and Administration record: • All medicines that are started on the admission must also be entered onto the

Medication History Sheet and the indication for treatment should be indicated. • All medicines that are discontinued / altered during the course of the patient’s

episode should have the reason for this recorded either on the Drug Treatment Sheet adjacent to the Medication in question, and the entry signed and dated, or recorded in the patients clinical record.

Communicating Medication changes at discharge or transfer

• All significant changes to the medication that has occurred during a period of

care, this includes outpatients settings, including medicines stopped on admission, must be recorded on the discharge summary, including allergy and sensitivity status, with reasons for those changes. This information is obtained from the Medication History Sheet and, where applicable, the electronic prescribing system

• The Medication History Sheet will be filed in the patient’s medical record. • A discussion about sending a copy of the discharge letter, to the patients

community pharmacy, should be had with the patient

Frequency of review

This should occur on admission to teams and wards, and in the case of community teams this should be updated each time medication is changed, and at least annually at the point of their annual review.

Reference NG 5 Medicines Optimisation

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Appendix 2 Crushing Tablets and Opening Capsules

Crushing tablets, opening capsules and altering the preparation of the medication falls outside the Drug Product Licence. In these circumstances the Prescriber and Practitioner are liable for any adverse effects resulting from administering of medication in this manner. Tablets you must never crush:

• Enteric Coated Tables (also abbreviated to EC) are formulated to pass through the stomach intact before they begin to dissolve. The enteric coating may be being used to protect the stomach against local toxicity e.g. aspirin EC, or it may be being used to ensure the medicine is released at the correct site for absorption or action e.g. Bisacodyl¹.

Therefore, crushing enteric coated tablets may increase toxicity or reduce effectiveness.

• Modified Release Tablets (M/R) are designed to release their contents over an extended period, typically 12 to 24 hours. If the tablets are crushed the medicines will be absorbed in a much shorter period, perhaps 1-2 hours. This may lead to increased toxicity as a full day’s dose is absorbed in that 1-2 hours period. Modified release tablets are also described as:

o Slow Release or SR o Extended Release or XL o Long Acting or LA o Retard o Slow or Slo o Perlonget

• Buccal or Sublingual tablets are designed to avoid the gastro intestinal

tract. Consequently crushing tablets and administering orally may be counterproductive, as the drug may not be absorbed effectively.

• Tablets that may be toxic when crushed. When crushing tablets, powder will

always be generated. A number of drugs will be potentially toxic to the person crushing the tablets by inhalation of the powder. In addition there is always the risk of sensitisation or anaphylaxis in susceptible individuals. Furthermore, if the device used for crushing is not properly cleaned the potential to contaminate other preparations exists.

Therefore the following must never be crushed:

• Cytotoxic drugs such as melphalan, busulphan, methotrexate • Antibiotics such as penicillin’s, erythromycins • Prostaglandin analogues such as misoprostol (which is part of Arthrotec) • Hormone preparations

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¹ Enteral Feeding tubes include Nasogastric (NG), Percutaneous Gastrostomy (PEG), and Percutaneous Jejunal (PEJ) tubes. The medicines listed are common examples and do not constitute an exhaustive list. You should consult the relevant section of the current BNF. If you are in any doubt consult a Pharmacist. In addition, some medicines have a bitter taste; these may or may not be coated. Crushed medication may therefore produce an unpleasant product for the patient to take orally for example. In the event of any medication being administered using a different method e.g. crushing, splitting capsules as advised by the Pharmacist or Medical Practitioner, Must be recorded in the Patient’s Clinical records. Information should include date, person advising change, drug name and reasons for administering medication not in accordance with its summary of product characteristic and name and designation of person administering the medication.

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Appendix 3 Adverse Drug Reporting

Adverse Drug Reaction Reporting and Yellow Card Scheme The Yellow Card Scheme for spontaneous reporting of suspected adverse drug reactions (ADRs) was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. Adverse Drug Reactions should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) by completing a yellow card. Who Can Report? Until recently adverse drug reaction reporting using the yellow card scheme was only available to healthcare professionals such as doctors, pharmacists, coroners and nurses. In October 2005 the Yellow Card Scheme was opened up to patients and their carers. What should be reported? An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use that is suspected to be related to the drug. For intensively monitored medicines (identified by ▼) report all suspected reactions. For established drugs and herbal remedies report all serious adverse reactions in adults; report all serious and minor reactions in children (under 18). Serious reactions include those that are:

• fatal • life threatening • disabling • incapacitating • result in or prolonged hospitalisation • and / or are medically significant requiring intervention • congenital abnormalities

If in doubt about the seriousness of a reaction please report it. Areas of Special Interest Although all adverse reactions with medicines are monitored there are a number of areas of particular interest, as listed below:

• Children • The elderly • Delayed drug effects • Congenital abnormalities • Herbal remedies – it is important to monitor all herbal products to ensure their

safety.

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It would be helpful to report the ingredients, source or supplier. Where to find a Yellow Card A paper version of the Yellow Card is included in:

• British National Formulary • Nurse Prescriber Formulary • Monthly Index of Medical Specialties (MIMS)

Alternatively down load a copy from the MHRA web site http://medicines.mhra.gov.uk Patient Details Provide one of the following, patient’s initials, age, sex, weight if known, local identifier. Do not identify the patient by date of birth or name of patient. In order to help identify the Patient in any future correspondence also include their initials and a local identification number, which will identify them in the case of any future correspondence. This does not breach any confidentiality agreements between the health care professional and the patient. Copy of Yellow Card in Patients Notes It is vital that a copy of the Yellow Card Report is included in the patients clinical record. It is also recommended that a copy be sent to the GP for future Drug Alerts Medicines and Healthcare Products Regulatory Agency (MHRA) Drug Alerts are cascaded directly to the Trust Pharmacists and they are responsible for ensuring that the advised action is taken, which may necessitate the removal of the affected pharmaceuticals from pharmacy stock.

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Appendix 4

Guidance on High Dose Antipsychotic Prescribing*

Current evidence does not justify the routine use of high-dose antipsychotic medication in

general adult mental health services, either with a single agent or combined antipsychotics.

Calculating the level of antipsychotic dose*

The Consensus Working Group recommends the following definition for high dose: a total daily dose of

a single antipsychotic which exceeds the upper limit stated in the British National Formulary or a total

daily dose of two or more antipsychotics which exceeds the BNF maximum using the percentage

method, including PRN medication.

i.e. Olanzapine 15mg plus Aripiprazole 20mg

((15/20) x 100) + (( 20/30)x100) = ~142%

*recommendations adapted from CR 138 (RCPSYCH 2006)

Considering prescribing

Use of high dose of antipsychotics should only be considered in individual cases

• as a carefully monitored therapeutic trial and where evidence-based strategies have failed

• involve an individual risk–benefit assessment by a fully trained psychiatrist. (Consultant only)

• in consultation with the wider clinical team and the patient and a patient advocate, if available, and if the patient wishes their presence

• taking full account of possible contraindications and drug interactions to high dose, for the drug(s) in the patient

Having decided to prescribe

Having decided explicitly to prescribe high dose of antipsychotics

• the decision should be documented in the case notes to include as a minimum

• risks and benefits of the strategy

• define the length of trial, not less than 6 weeks but not more than 3 months.

• expected outcome and schedule for monitoring

• Conduct baseline ECG to exclude cardiac contraindications, including long QT syndromes. This must be repeated after a few days and then every 1–3 months in the early stages of high-dose treatment (the frequency being determined as clinically indicated).

• Baseline U&E’s, repeated after a week are required as abnormal electrolyte levels can pre dispose patients to ECG abnormalities.

• The use of PRN medication should be kept under regular review. Staff administering PRN should be aware of its potential to raise the total daily dose of antipsychotic above the high-dose threshold.

Prescribers should be able to readily identify patients on high dose antipsychotics within the team

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When used in the context or Rapid Tranquilisation.

• If high-dose antipsychotic treatment has been used, it is particularly important that the routine monitoring of a sedated patient is carried out, with particular attention to regular checks of pulse, blood pressure, respiration, temperature and hydration, in line with the rapid tranquilisation policy.

• ECGs should be carried out frequently during dose escalation, if and when possible, if unable due to patient factors this should be documented and a risk benefit assessment carried out.

• During acute violence or emergency tranquilisation avoid parenteral antipsychotics if possible, but if used, ECG monitoring or regular ECGs should be performed, but see above

Patients subject to T2 or T3 regulations

• In line with CQC guidance high dose prescribing must be explicitly acknowledged on the form, with a cumulative maximum dose of antipsychotic stated

* These Guidance notes must be read in conjunction with other Trust guidance on medicines, and along with

NICE guidance, including guidance on the use of ECG’s.

Andrew Houston, On behalf of the Medicines Management Committee

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Appendix 5

Pharmacy Medication Card Assurance Verification Record

Ward:

Name:

D.O.B:

Silverlink No /Hospital No:

Date of admission:

Points (details are indicative of review but not exhaustive) Yes/No

Allergy status

(patient’s allergy status is consistently and legibly recorded on all drug charts)

Medicines reconciliation

(medicines reconciliation has been completed and forms part of the patient record)

Dose

(all prescribed doses and routes of administration are unambiguous and congruent with SPC)

Time of does

(timings for doses are unambiguous and congruent with SPC)

Side effects

(there is evidence of baseline and periodic ADR assessment/enquiry consistent with changes to medication)

Interactions

(all significant drug interactions have been considered and co-prescribing is intentional with a clear rational recorded)

Form T2/T3

(MHA documentation is complete, in date and supports current prescribing)

PGD

(administration of medicine under PGD is clearly recorded and has been without risk

Monitoring

(Monitoring arrangements are in place to support safe use of medicines and establish their effectiveness

Indication for prescribing each drug

(it should be clear from the clinical record or care plan the purpose of prescribing each medication)

Patient information

(it should be clear that the patient has had the opportunity

PRN instructions & maximum dose

(all psychotropic medicines prescribed prn should have clear directions to include rational for administration admin route,

minimum time lapse between doses, maximum single and daily dose.

Medicines card complete

(all drug cards must be a complete record of prescribing and administration of medicines, all prescriptions to be signed, there

should be no gaps in the administration record)

Patient seen: Y/N Interventions/outcomes:

Reviewer’s

Name…………………………………………...

Verification: Yes No

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Signature/date/time…………………………………………

Standard Operating Procedure for filling in assurance form

This is the SOP for filling in this form or spreadsheet, not for the checking and intervention process as a whole.

1. For each patient a form must be filled in, for each visit, alternatively enter the information directly in to the data collection tool spreadsheet, stored on the K Drive

2. Attach patient PID sticker or fill in patient details

3. For each point indicate that you have verified it either yes or no.

4. If all 10 points are verified then:

a. Sign date and time form. b. Apply green sticker to all cards for that patient. c. Make entry in medical records that card is verified.

5. If unable to verify:

a. Give details of any interventions you have carried out in the free

text box, including outcomes (if this then allows you to verify, see 4)

b. Apply red sticker to all appropriate cards c. Make entry in the notes, including what is required to be done to

verify that prescription card d. Make note to follow up as appropriate. e. Sign Date and Time Form

6. Upload details from each reviewed record to ‘Pharmacist 10 point plan’

database on Pharmacy K drive Antibiotic 5 point plan

Clinical Indication and compliance with local guidance

Swab/culture (if indicated). Sample taken prior to initiation or in response to empirical 1st line failure as per guideline

Review at 48/72 hour

Duration/review date/stop date and indication stated these are clearly stated either on the drug card

Record of administered doses. Drug cards will be checked against the 5 standards, the results entered on the spreadsheet on the K Drive.

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Appendix 6

Allergy Assessment

When assessing a potential allergy the following tool should be used (NICE CG183)

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Name: DOB: Unit Number Ward

Authority to Administer 1

MHA2 MCA2

MCA1/2 completed:

Review Date: 1. See table for authority to administer for individual drugs

2. MHA – Mental Health Act MCA - Mental Capacity Act

Pharmacist Name and Signature: 1. Attach Copy to Medication Card

2. File Original in Notes

Appendix 7

Covert Administration Care Plan

Drug Name Form Frequency MCA/MHA Agreed Method of Administration Date and Signature