HOSPITALSTANDARDS OF PRACTICE - 1

- Drug Distribution

- Patient Counseling

- Drug Information Service

- Drug Formulary

DRUG DISTRIBUTION

• EVERY PHARMACIST MANAGER SHALL BE RESPONSIBLE FOR:

- PURCHASING,

different companies may bring the same drug !

consider the best price “economic savings”.

consider the best brand “in case of alternatives”.

relationship with the selling company etc..

- RECEIVING,

be sure to get the bill.

be sure of quantity & price of the purchased item.

be sure of the expiry date.

be sure of the batch “lot” no.

be sure of the products integrity.

DRUG DISTRIBUTION

- STORAGE,

arrange the drugs in their place “FEFO vs. FIFO”

be aware of storage conditions “temp., light etc..”

some drugs have strict storage conditions “e.g. narcotics”.

- DISTRIBUTION,

in drug store, pharmacy, or hospital wards?

- DISPOSAL OF DRUGS IN THE PHARMACY.

once the drugs can no longer be used “expired, damaged, contaminated etc..”, the right way of disposal should be implemented.

HW#1

• Choose randomly 3 drug invoices, indicate their details, & follow the drugs journey from purchase till storage or administration.

• Example: • Drug generic: Amoxicillin. Drug brand: Moxypen.

• Quantity: 50 boxes. Price: ---- NIS.

• Selling company: ----- Batch no.: ---------

• Expiry date: ------

• Storage: suitable conditions? FEFO / FIFO? Integrity?

• Distribution: pharmacy or to wards?

DRUG DISTRIBUTION

• Pharmacy support personnel may be utilized to reduce the professional time committed to the mechanics of the drug distribution service, without reducing the professional and legal control.

Procurement of Drugs

• The purchase of all drugs shall be:

- under the supervision of a pharmacist.

- in accordance with the Formulary Standard.

• The pharmacy department shall maintain adequate records of drug purchases for:

- inventory control.

- legal requirements.

Receiving/Storage of Drugs

• Narcotic and Controlled substances shall be delivered to:

- the institution's pharmacy department directly.

- or, where applicable, to the receiving area and subsequently delivered to the pharmacy department.

• If drugs are stored in a place outside the pharmacy:

- The pharmacist manager shall be responsible to ensure the proper storage of received drugs in this area.

• The pharmacist should ensure the security of received medications:

- from the actual receiving time until it is stored properly by the pharmacy.

HW#2

• What narcotics & controlled substances are available in the hospital pharmacy? Mention dosage forms & strengths.

• Are they stored securely & how?

• Are they counted & registered by chief pharmacist in a special record (input vs. output)?

Receiving/Storage of Drugs

• All drugs within the pharmacy and throughout the hospital shall be stored under proper conditions of:

- sanitation, temperature, light, humidity, ventilation, regulation and security.

• This includes investigational drugs, patient's own medications from home, samples…

Receiving/Storage of Drugs

• The pharmacy personnel shall make regular inspections of all drugs storage areas:

i) disinfectants and drugs for external use are stored separately from internal and injectable medications.

ii) drugs requiring special environmental conditions for stability are properly stored.

iii) no outdated drugs are stocked.

iv) narcotics and controlled drugs substances are being stored with proper measures of security.

v) drugs are not being overstocked.

vi) drugs which may be required on an urgent or emergency basis are in adequate and proper supply.

HW#3

• Go to one of the hospital wards & check if the previous list (6 points) applied. If any not applied, give an example.

• Check if the list applies also in the pharmacy itself.

Drug Recall Procedure

• Some drugs may be returned to pharmacy.

• There shall be implemented drug recall procedures for:

- patient medications no longer required “discharged, stabilized, died…”

- expired / near expired medications.

- contaminated drug product “batch”.

- FDA disapproval of a previously approved drug “due to a new study, for example”.

- etc…

Drug Ordering

• The text of medication orders made by physicians shall include:

a) the patient's name, age, hospital number and location

b) the name of medication and dosage

c) route and frequency of administration

d) duration of treatment, if limited

e) name of authorized prescriber

f) date the order was written

g) the time the order was written, if deemed appropriate

h) for verbal orders, the name and signature of the person who received the order

i) if pediatric patient, weight of child

HW#4

• Check one medication order for 5 patients & examine if the previous list applies. Give examples. You can find medication orders in patients’ files in hospital wards. Ask the permission before checking patients’ files.

Drug Ordering

• The medication orders should be sent to the pharmacy department, and the original medication order should be retained on the patient's chart.

• When a patient goes to surgery:- medication orders should be cancelled automatically (HOLD drugs).

- medication orders shall be rewritten postoperatively.

• The use of standing orders shall be discouraged:- A standing order is a written instruction issued by a medical practitioner or

dentist. It authorizes a specified person or class of people (e.g. paramedics,

registered nurses) who do not have prescribing rights to administer and/or

supply specified medicines and some controlled drugs. The intention is for

standing orders to be used to improve patients’ timely access to medicines.

Medication Profiles

• The pharmacy department shall work toward developing a medication profile system for hospitalized patients.

• Medication profiles should be reviewed before dispensing the patient's medication.

• Medication profile should include ALL patients medications taken in the hospital, including:

- Regular medications.

- STAT medications.

- prn medications.

HW#5

• Get medication profiles for 5 patients (in pharmacy or wards) and mention what medications are present within, with all relevant information (dose, duration, regular or stat or prn….)

Drug Dispensing

• Dispensing shall be restricted to the pharmacist, • or authorized personnel under the direction and supervision of

the pharmacist “e.g. pharmacy assistant, pharmacy technician”.

• The pharmacist shall be responsible for:a) determining the appropriateness of the medication order before

dispensing (INDICATION, SAFETY, EFFECTIVENESS).

b) selecting auxiliary labels “e.g. keep in refrigerator” and/or cautionary statements “e.g. high alert medication”.

c) monitoring patient files, if accessible, for the detection of inappropriate drug therapy “e.g. non-selective beta-blocker may not be dispensed to a patient whose profile indicates that he/she has asthma”.

d) final check on all aspects of the completed prescription (DOSE, ROUTE & FREQUENCY OF ADMINISTRATION…).

Drug Dispensing

• A stop-order procedure:

• Shall be used when a definite number of doses or a time limitation for administration has not been stipulated by the physician on the drug order “e.g. Ibuprofen 400mg 1x3”.

• Drug specific automatic stop-order policies shall be appropriate for the type of treatment given in the hospital.

• There shall be a system to notify “alarm” the prescriber of the impending expiration of the medication order, so that appropriate patient reassessment is completed prior to rewriting the order.

Drug Dispensing

• Pharmacists shall use standardized terminology, metric units, and generic nomenclature of all drug labels to minimize confusion.

• There shall be a list of abbreviations and symbols approved by the hospital “e.g. Micrograms should be referred as mcg not µg”.

• Medication labels shall be typed or machine printed, and shall be free from erasures and strikeovers.

• Medication labels shall be firmly affixed to the container.

• Medication containers shall not be altered by anyone other than pharmacy personnel.

Drug DispensingUnit-Dose Medication System• Unit-dose systems shall dispense medications contained in,

and administered from, unit-dose packages.

• Not more than a 24-hour supply of unit dose medication shall be provided to the acute patient care area at any time.

• The medication profile shall be utilized for the individual medication doses to be scheduled, prepared, distributed and administered on a timely basis.

• Unit-dose carts or medication trays shall be used as medication storage facilities on the ward.

Drug DispensingUnit-Dose Medication System• The particular tray for a specific patient shall be labeled with

the patient's name, location and hospital number.

• The following information shall be indicated on the individual dosage package:

a) name of drug

b) strength

c) expiry date

d) lot number

UNIT DOSE CART

TRAYS

Drug Delivery

• Medication shall be delivered from the pharmacy to the ward with the least amount of delay.

• All parts of the transportation system shall protect the medication from pilferage and breakage.

• Special procedures for delivery of Narcotic and Controlled medications shall be established to ensure that the drugs are delivered promptly, intact and placed in proper storage areas.

Returned Medications

• Drugs having different lot numbers and expiry dates should not be combined in the same package.

• Medications dispensed for administration, but not used, shall be returned to the pharmacy.

• Returning drugs to stock “to be dispensed again” shall take into consideration:

a) integrity of returned drug package.

b) proper storage of the drug on the nursing care station.

Returned Medications

• The following types of medication shall be discarded:a) any opened topical medications (including ophthalmic, otic and

nasal medications).

b) opened multi-dose and single dose vials.

c) any medication handled by the patient.

d) any medications returned by ambulatory patients.

e) improperly stored medications.

f) any open or used I.V. admixtures.

g) any opened liquid medications.

Ward Stock Medications

• The pharmacy shall establish a list of ward stock medications for each ward, and that list shall be reviewed on an annual basis by the pharmacy department.

• The supply, distribution and control of ward stock medication shall be the responsibility of the pharmacy department.

• Narcotic and Controlled drugs may be provided as a special form of ward stock, and shall be stored in a secured area in accordance with legal requirements.

• Emergency drugs shall be readily accessible and stored appropriately.

• Medication shall be stored securely on the ward, and available to authorized personnel only.

Investigational Drugs

• Investigational and emergency release drugs shall:

a) be used only under the direct supervision of the principal investigator.

b) be approved for use by the appropriate hospital committees.

c) be administered by personnel only after they have been given appropriate pharmaceutical information about the drugs.

d) be the responsibility of the pharmacy department for storage and distribution.

Administration of Medication

• Safe administration of drugs to patients:a) drugs shall be administered only upon the order of a medical authorized practitioner who has been assigned clinical privileges.

b) all medications shall be administered by appropriately licensed personnel “nurses” in accordance with laws and regulations.

c) whenever medications are added to parenteral products “bags”, proper auxiliary labeling should include:

- the name and amount of drug added,

- the date and time of the addition,

- the person who prepared the mixture,

- stability of the mixture,

- specific storage conditions,

- patient's name.

HW#6

• In one of the hospital wards, check if the previous list applies for 3 given admixtures prepared by nurses or pharmacists. Give examples.

Administration of Medication

d) medication shall be given as near the specified time as possible.

e) the patient for whom the medication is intended shall be positively identified in accordance with hospital policy “preferably 3 identifiers”:

- patient name.

- patient ID.

- patient hospital no.

f) all administered, refused or omitted medication doses shall be recorded in the patient's medical record or chart.

- Information to be recorded:

drug name, dose and route of administration, the date and time of administration, and the person administering the dose.

Administration of Medication

g) self-administration of medication by patients shall be permitted when specifically ordered by the physician.

- pharmacy shall be involved with the patient medication education program.

h) all medication errors shall be reported in specific forms.

- dispensing errors, transcription errors, administration errors…

i) adverse drug reaction reporting (Pharmacovigilance).

j) procedures for drug administration.

Patient's Own Medication

• If patients bring their own drugs into the hospital, these drugs shall not be administered unless:

- they can be identified

- written orders to administer these drugs are given by the physician.

• If the drugs the patient brought to the hospital are not to be used during hospitalization, they shall be:

- stored securely, then:

- if appropriate, returned to the patient at time of discharge.

- if inappropriate, destroyed by the pharmacy department.

In case of conflicts

• Pharmacist has responsibilities to refuse providing products or services: • for moral or religious reasons,

• or when the prescribed drug may harm the patient.

• Pharmacists shall hold the health and safety of the public to be their first consideration in the practice of their profession.

• Pharmacists who object, as a matter of conscience, to provide a particular pharmacy product or service to a patient must explain the basis of their objections.

• Objections should be conveyed to the pharmacy manager, not the patient.

In case of conflicts

• Pharmacist should inform the patient of the realistic consequences of drug use, and to respect patient autonomy.

• This requires eliciting informed consent,

• the patient possesses sufficient information and mental capacity to understand the risks and benefits of taking a particular drug,

• so the patient may voluntarily accept or reject that particular treatment.

• Pharmacist is obliged to accurately disclose the drug risks and benefits that may occur.

PATIENT COUNSELLING

• A PHARMACIST SHALL PROMOTE THE SAFE AND EFFECTIVE USE OF MEDICATION BY EDUCATING PATIENTS ABOUT THEIR DRUG THERAPY.

• The pharmacist shall monitor patient compliance to medications.

• Prior to the release of prescribed medications, the pharmacist shall verbally counsel the patient for safe and effective drug therapy.

PATIENT COUNSELLING

• Patient counseling shall provide information to the patient about:

a) confirmation of identity of the patient.

b) confirmation of identity of the medication being dispensed.

c) confirmation of prescribed dosage regimen.

d) importance of compliance and what to do if a dose is missed.

e) special storage requirements.

f) prescription refill information.

g) instruction required to achieve the intended therapeutic response which may include:

i) information regarding significant drug - drug (including non-prescription

medication) and drug - food interactions.

ii) activities to avoid.

iii) common side effects and what to do if they occur.

HW#7

• Pick a patient (from outpatient settings) & provide him counseling regarding one of his/her drugs in a private atmosphere.

• Example:

• Drug Generic: Atenolol tablets 100mg.

• Drug Brand: Normiten.

• Dose: 100mg once daily regardless of food.

• Indication: HTN.

• Expected drug side effects (important / common ones): fatigue, hypotension.

• Expected drug effectiveness: decreases BP.

• Storage of drug: in room temp. away from children.

• How to prevent / deal with side effects: routine monitoring of BP.

• What to avoid in this disease: high salt intake.

• Others: ----------------------

PATIENT COUNSELLING

• Patient medication counseling shall be provided in an atmosphere of confidentiality and privacy.

• The pharmacist is encouraged to provide appropriate written supplemental information with each new prescription.

• Where the prescribed order is for a medical device or some other health care item, the pharmacist must supply complete instruction for proper usage.

• If the patient refuses to participate in patient counseling, the pharmacist should document the refusal in a record.

PATIENT COUNSELLING

• Where prescribed medication is being released for delivery off premises, • the pharmacist shall make all reasonable attempts to contact the

patient directly.

• Where prescribed medication is being released to a person acting as an agent for the patient, • the pharmacist shall provide the required counseling information

through the agent.

• or obtain the necessary information to contact the patient directly.

• The pharmacist shall document the occurrence of drug consultation in a permanent record in the patient's chart.

PATIENT COUNSELLING

• Persons qualified to provide patient counseling regarding prescription medications:

• licensed pharmacist,

• pharmacy student or intern under direct supervision of a licensed pharmacist.

• The pharmacist shall use any reasonable means in counseling patients or agents with language or communication disabilities.

• The pharmacist shall evaluate the patient's understanding of the counseling information provided,

• through appropriate questioning and/or follow-up.

DRUG INFORMATION SERVICE• A PHARMACIST SHALL PROVIDE ACCURATE, UNBIASED, PERTINENT

DRUG INFORMATION.

• All drug information requests must be handled by:

• licensed pharmacist,

• pharmacy student or intern under the direct supervision of a licensed pharmacist.

• The pharmacist shall select from the current drug literature:

• evidence-based updated reference sources, which will meet the drug information needs of the specific area of practice.

• The pharmacist shall evaluate and analyze relevant drug and therapeutic information contained in the current drug literature.

HW#8

• What drug information sources are available in the hospital pharmacy (electronic & hard copies).

DRUG INFORMATION SERVICE• The pharmacist shall use professional expertise and judgment

in processing drug information requests:

a) obtaining the necessary background information, so that the request is received in a complete and understandable form.

b) interpreting the drug information request.

c) systematically and thoroughly conducting a literature search.

d) evaluating the literature in an accurate, unbiased manner.

e) formulating a relevant, coherent and informative response.

f) communicating the response in a verbal and/or written form.

DRUG INFORMATION SERVICE• The pharmacist should contribute to the drug literature.

• The drug information service shall provide current information on the assessment, management and the prevention of drug poisoning.

• The pharmacist shall be aware of more extensive (external) sources of information and the procedures necessary to access them.

DRUG INFORMATION SERVICE• Drug information services shall be available 24 hours a day,

7 days a week.

• If pharmacy staff is not available after regular working hours,

• drug information shall be provided by a pharmacist "on-call".

• The pharmacist must make arrangements in advance for the provisions of drug information services during his absence.

• The pharmacist should contribute to the education of health care personnel “seminar programs, newsletters or bulletins ”.

DRUG FORMULARY

• A PHARMACIST WHO PRACTICES IN A HEALTH CARE FACILITY SHALL PRACTICE IN ACCORDANCE WITH A FORMULARY ESTABLISHED AND APPROVED BY THE FACILITY.

• The minimum requirement for the hospital Formulary: • written list of selected drug products approved for use within the hospital.

• The pharmacist shall have a knowledge of which products are considered interchangeable.

• The pharmacist shall participate in the development and management of a hospital formulary system, • based on both therapeutic and economic considerations of drug use.

• The hospital Formulary shall receive approval from the appropriate hospital committee.

• The Formulary shall be specific to each institution.

DRUG FORMULARY

• The drug products shall be classified according to:

• pharmacologic-therapeutic use.

• Information shall be provided on:

• available dosage forms,

• available dosage strengths,

• unit-of-issue “mg, ml, tablet, vial etc..”

DRUG FORMULARY

• A formal, published hospital formulary shall also contain:

• information on formulary use and administration.

• regulations governing the prescribing of drugs in the hospital.

• relevant pharmacy policies and procedures controlling drug distribution.

• cross-index of selected drug products according to generic and trade name. The pharmacy department shall encourage the prescribing of drugs by generic name.

• information on special aspects of drug use.

DRUG FORMULARY

• There shall be policies for the approval and subsequent provision of drugs not included in the formulary.

• The formulary shall be available to all healthcare professionals,

• prescribing, dispensing or administering medications.

• There shall be policies for the approval of automatic substitution of specific drugs by the pharmacy department.

• The pharmacy department shall be responsible for the supervision and control of the hospital formulary system throughout the hospital.

• The hospital formulary shall be continuously updated according to the specific needs of the hospital.