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Pharmacy Practice

By Dr. ABDRHMAN GAMILAssociate Professor of PharmaceuticsAl-Neelain University - Khartoum

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Institutional Pharmacy

Hospital Pharmacy

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Definition Practice of pharmacy in a hospital setting including it organizational

related facilities or services.

It is that department or division of the hospital wherein the procurement, storage, compounding, manufacturing, packaging, controlling, assaying, dispensing, distribution and monitoring of medicines through the drug therapy management for hospitalized and ambulatory patients are performed by a legally qualified, professionally competent pharmacist.

It includes responsibility for the safe and appropriate use of drugs.

Rational selection, monitoring, dosing and overall control of the therapy program

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Uniqueness of hospital

pharmacy

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Functions of hospital pharmacy

To provide and evaluate service in support of medical care pursuant to the objectives and policies of the hospital.To implement for departmental services the philosophy, objectives, policies and standards of the hospital.To provide and implement a plan with clear responsibilities and duties of the personnel.

To participate in all functions of all other departments and services of the hospital.

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Functions of hospital pharmacyTo estimate the requirements for the department and to recommend and implement policies and procedures to maintain adequate competent staff.

To provide methods by which personnel can work with other groups to interpreting the objectives of the hospital to the patient and community.

To develop and maintain an effective system for clinical and administrative records and reports.

To estimate needs for facilities, supplies and equipment and to implement a system for evaluation, control and maintenance.

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Functions of hospital pharmacy

Research activities.

Continuous education for the staff.

Educational program for the students.

To adhere to the safety program of the hospital.

Comprehensive pharmaceutical service of high quality coordinated to meet the needs of diagnostic and therapeutic department as well as nursing service to provide better patient care.

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Routine contacts of hospital pharmacist Physician specialists ( PTC), clinical round, all matters related to drug

therapy) Nursing professionals. Microbiologists. Biochemists. Physicists and radiologist Clinical pharmacologist Medical sociologist Medical dietetics Engineering Administrative staff

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Group practice

There is a need for a number of hospital pharmacists of variety of clinical pharmacy specialists to assist in the rational selection and use of drug therapy.

This will strengthen the professional role of the hospital pharmacist and give them entry to the group of professionals who make up the health care team.

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Organizational Structure The head department reports to the hospital administrator. Formulates and implements administrative and professional

polices of the pharmacy subject to the approval of the administrator.

Professional and clinical policies which have direct relationship to the medical staff, are formulated and developed through the pharmacy and therapeutics committee and are subject to administrative approval.Comprehensive job description and responsibilities in pharmacy activities and in clinical functions

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Hospital Administrator

Department of Pharmacy DirectorExecutive and administrative operations

Professional and clinical services

Research and support servicesEducational and technical services

Nuclear pharmacy division

Unit dose dispensing divisionAmbulatory &home care

I.V admixture division

Sterile products division

Drug administration divisionClinical pharmacy division

Research division

Assay & QC division

Kinetic & bioavailability lab

Manufacturing & packaging

Purchasing&inventory controlDept services division

Investigation division

Drug information division

Education& training divisionProfessional development

Residency training programComputerized operations

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Determine the level and scope of pharmacy

services.

Planning and monitoring the budget.

Developing the policy and procedures

manual.

Pharmacist Responsibilities – Director G

ENER

AL

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Pharmacist Responsibilities – Central Pharmacist 1. Ensures that established policies and procedures are followed.

2. Check for accuracy of doses prepared, IV or unit dose.3. Proper drug control, investigational drugs, laws are followed.4. Good techniques are used in compounding 5. Proper record keeping and billing

Patient medication records. Extemporaneous compounding records. IV admixture records. Investigational drug records. Monthly workload reports.

6. Maintain professional competence; drug stability & incompatibilities and drug information.7. Ensures that personnel are well trained on policies and procedures.8. Coordinate and evaluate the personnel activities.9. Keep the dispensing area neat, clean and orderly organized.10. Coordinate with the patient-care area.

Dis

pens

ing

Area

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1. Supervision of drug administration: Review and interprets each unit-dose and IV admixture medication order to ensure that it

is entered accurately into the system. Review each patient´s drug administration form ( missed doses, review drug charges) Confirm that administered doses are noted correctly in patient chart.( sign) Ensures that records for controlled drugs are correctly kept. Ensures that proper drug administration techniques are used. Acts as liaison between the pharmacist and nursing and medical staff. Communicate with nurses and physicians concerning medication problems. Periodically inspects the medication area on the nursing units to ensure that adequate

levels of floor stock are maintained. Ensures that drugs are procured from the dispensing area as required. Coordinate all pharmacy services on the nursing units level. Ensures that the area is neat, orderly and appropriate security levels are maintained.

Pharmacist Responsibilities – Central Pharmacist

Pati

ent

- car

e Ar

ea

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2. Direct Patient care: Identify drugs brought by the patient. Obtain patient medication histories. Assist in drug-product selection Assist physician in selecting dosage regimens and schedules, then assigns

administration times. Monitors patient total therapy ( effectiveness, side effects, toxicity, allergic reactions,

drug interaction, therapeutic outcome) Patient counseling. Participate in cardiopulmonary emergencies.

3. General responsibilities: Education to personnel staff, students, medical and nursing students. Provides drug information to the health care personnel.

Pharmacist Responsibilities – Central Pharmacist

Pati

ent

- car

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ea

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Pharmacist Responsibilities – Ambulatory Pharmacist

Dis

pens

ing

Area

1. Ensures that established policies and procedures are followed.

2. Checks for the accuracy of supportive personnel.3. Ensures that proper techniques are used in compounding.4. Adequate record keeping ( patient medication records,

investigational drug records, outpatient billing, reports and prescription files)

5. Maintain professional COMPETENCE.6. Training for the new personnel.7. Coordinate the activities of the area.8. Keep the area neat, clean and orderly organized.

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Pharmacist Responsibilities – Ambulatory Pharmacist

Pati

ent

care

Are

a1. Inspect the medication area at the nursing unit to ensure an

adequate supply of stock and proper storage.2. Identifies drugs brought by the patient into the clinic.3. Obtain patient medication records and provided to the physician.4. Assist in drug-product and entity selection.5. Assist the physician in dosage regimen and schedules.6. Monitors patient total therapy ( effectiveness, side effects, toxicity,

allergic reactions, drug interaction, therapeutic outcome)7. Patient counseling8. Prepare medications for intravenous administration.9. Provides medications for patient home care.

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Pharmacist Responsibilities – Ambulatory Pharmacist

Gen

eral

Re

spon

sibi

litie

s1. Provide drug information to staff , nursing and medical staff.

2. Coordinate activities and needs within the area,

3. Provide adequate control and proper handling following the laws.

4. Maintain professional competence.

5. Participate in cardiopulmonary emergencies.

6. Provides education on service to staff, nursing and medical students.

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Pharmacy staff

Director of the pharmacy. 7 – 12 pharmacists to each 300 beds hospital. 5- 15 technicians, helpers, clerical staff. Full-time secretary.Administrative aids: Functional organization charts. Operation manual Job description. Policy and procedures manual

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Facilities The space varies according to the hospital size. Example; hospital of 200 beds requires: Office for chief pharmacist. Separate area for inpatient and unit-dose dispensing. Outpatient services. Compounding area. Sterile admixture area. Store room. Departmental computer. Space for drug information service. Controlled medicines. Clinical pharmacy services.

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Pharmacy & Therapeutics CommitteeThe American society of health system

pharmacists state that “ the multiplicity of drugs available and the complexities

surrounding their safe and effective use make it necessary for hospital to have organized,

sound program for maximizing rational use of drug”. The pharmacy and therapeutic

committee, or equivalent, is the organizational keystone for this program“

Health system pharmacists”.

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05/02/2023

22 Pharmacy and Therapeutic Committee:- Objectives:- 1- Developing and implementing professional policies on

drug selection, procurement, evaluation, safe use and drug information.

2- Assisting in the formulation of educational programs designed to meet the needs of the staff for drug related practices.

The formulary and therapeutic committee is the authoritative body who formulates the drug list circulating in that facility, and regulates the intervention concerning drug. The P&TC should have a regulatory power and activity.

The committee should be launched by the first post in the organization. His first deputy, normally, is the chairman of the committee. The committee should be permanent and the order should point to the members and functions and activities regulating its work.

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23 Members: - Chairman – usually a physician representing the headquarter. Secretary – pharmacist; senior or drug information centre or

pharmacologist. Head of main clinical department. Hospital pharmacist. Authoritative physician and specialist. Invited specialists to participate in certain issues, also nurses when

needed with no voting privileges. -Decisions should be made by vote. -Members should not have any business relationship with

pharmaceutical distributors or manufactures. - Members should not be more than ten. - One at least should attend continuing course in clinical pharmacology.

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Pharmacy & Therapeutic CommitteeSubcommittees

Subcommittee on Antineoplastic Agents. Subcommittee on Anti-infective Agents. Subcommittee on GIT Agents. Subcommittee on Cardiovascular Agents. Subcommittee on CNS Agents. Subcommittee on Endocrinology Agents. etc.

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25 Functions of Formulary & Therapeutic Committee: - 1- Developing criteria for evaluation of drugs to be included in the

drug hospital list, preparing and maintaining the formulary list. 2- Developing policies and procedures for selection, procurement

and use of drugs.. 3- Criteria for additions and deletions from the formulary list. 4- Conducting monitoring and evaluation programs for use of drugs,

management and dispensing practices. 5- Maintain an emergency drug list, approve standard ward stock

list. 6- Standardizing prescribing practices through preparation of

treatment guidelines. 7- Provide unbiased drug information through the development of a

formulary manual. 8- Coordinate drug supply for special ongoing programs. 9- Review the leveling of drugs utilization. 10- Conduct training programs. 11- Represent the facility to drug companies’ representatives. 12- Describe the inpatient and outpatient drug schemes. 13- Coordinate drug reimbursement with the health insurance

program.

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26 Policies to be developed: -

Policies empower the committee to implement decisions. Firstly, polices developed should be approved by the chair administrator.

To request medical staff compliance. To organize its work and activities.

he criteria of formulary drug selections. The addition and deletion procedures. Meetings; on call and periodical meetings. The use of generic names. Prescribing requirement and ideal prescription. Substitution policy. Generically equivalent or therapeutically alternatives. Non-.formulary drugs, allowed or not, reimbursed or not. Rules governing the formulary and revising period. Drug use evaluation and investigational regulations. Drug promotion and company representative guidelines.

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Formulary System

Increasing number of drugs being marketed.

High competitive marketing practices

Increasing influence of biased advertising literature.

Increasing complexities untoward of the newer more

potent drugs.

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28 Hospital drug formulary: “ Hospital level selection”

The key factor for the optimum therapeutic benefit of the public sector expenditure is the rational selection of drugs.

At the hospital level this may involve forming a hospital therapeutic and formulary committee. The result of such selection is developing a hospital formulary list which differs from that of the national level in being restrictive to be used within that given hospital .The hospital formulary becomes the basis of developing a hospital formulary manual which is a concise reference book containing the basic drug information facilitating the rationality of prescribing, dispensing, patient and staff education to rationalize drug use.

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• The Formulary : A continually revised compilation of pharmaceuticals plus ancillary information that reflects the current clinical judgement of the medical staff.

• The formulary System: is a method whereby the medical staff of an institution working through the P&T committee, evaluates, appraises and selects from among the numerous available drug entities and drug products those that are considered most useful in patient care.

Only those selected are routinely available from the pharmacy

It is a control for drug cost and use.

It provides for the procurement, prescribing, dispensing and administration of drugs in their nonproprietary or proprietary names.

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Principles in utilizing Formulary system1. Appointment of pharmacy and therapeutic committee.

2. Medical staff on recommendation of P&T should be sponsored of the formulary.

3. written procedures governing polices from the P&T committee.

4. Drugs in generic names and prescribers should comply.

5. Limited number sustain the patient care and give financial benefits.

6. Polices governing purchasing, prescribing , dispensing and administration.

7. Formulary system should be available to all medical staff.

8. Quantity and quality are the pharmacist responsibility.

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31Formulating the list:-1-Classification method: Therapeutic and pharmacological actions, anatomical, chemical classification or alphabetical arrangement could be chosen..2-Data collection: Concerning annual morbidity report and the statistical information available.3-Drug information available, e.g. essential list of drugs.4- Drug consumption.5- Analyze the data: 6- Arranging orderly the prevalent diseases. 7-Define the drug of choice for each disease. The dosage pattern. 8-Calculate the quantity of each drug required.

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329-Setting priorities according to ABC / VEN. ( Vital, Essential ,Non-essential)

10-Conduct drug class reviews and draft the formulary:

11-Classify the drugs obtained.

12- Implement the formulary either class by class or totally.

After finishing selection, drafting the formulary and widely disseminated, the deleted drugs could be eliminated and the new drugs could be added.

13-Reviewing the formulary periodically and cautiously. Evaluation and monitoring of drugs by group facilitates the improvement.

14-Endorsement by the chief of the organization.

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33 Methods to promote formulary adherence:-

16- Take action on non-formulary drugs available

17- Provide easy access to the formulary list.

18- Involve the medical staff in preparing the list and committee decisions.

19- Provide lists for therapeutic substitution when a prescribed drug is out of stock.

20- Design a request form for the use and addition of the drugs out of the list.

21-Prohibiting the distribution of drug samples of non-formulary drugs.

22- Filing the committee activities.

23- Shortly disseminate and develop the hospital drug manual.

24- The list should be open for additions and deletions

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34 Results required from the formulary: - The formulary should be designed to maximize the use of resources. Limited to conserve

resource, as there is no way to stock all drug in the national formulary. Therefore the number of drugs is limited.

Formulary in generic names, rationalize the practice, concentrate on drug of choice for prevalent diseases, assures the balance of safety, toxicity, effectiveness and cost of a chosen drug and avoids duplication of unnecessary alternatives.

A formulary classified in therapeutic groups allow formulary manual development to provide unbiased information resulting in improved prescribing, dispensing and appropriate use of drugs .

Provide good quality drugs and eliminate unsafe and ineffective drug and newly introduced drugs of questionable efficacy drugs.

Decrease the inpatient hospital stay . Leveling the list by medical occupation position, allow improved prescribing and restriction

and limitation of use of certain drugs to certain specialties and certain wards and professional level verify the patient safety and health.

Excluded approved products may be supplied to meet exceptional needs. The formulary should provide an important objective of selection in establishing a drug

supply system that satisfies the health needs of certain community and respond positively to the exceptional circumstances.( Taylor & Harding-2001 ) .

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Inventory management Generally assigned to senior pharmacy technician. Every hospital pharmacy should maintain sufficient inventory without shortage.

Purchasing Ordering Receiving and storage. Daily monitoring Special handling of certain substances.

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Purchasing

The specifications and standards for all requirements should be established by the pharmacist and approved by the FTC.

Competitive bidding is the professional practice.o Manufacturer .o Whole seller o Prime vendor

IV solutions may have special supply procedures. Contracts

The goal is to obtain high quality at the lowest cost.

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ordering

Ordering may be according to the stock using a software computer program.

Using a bar-cod scanner

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Receiving and storage

Once the order received it should be checked against the invoice. Any discrepancies should be noted and solved. Then the inventory control technician cam make the entry to the

records. The stock is then stored in shelves or refrigerator according to

the storage conditions stated.

Food material should no be kept aside

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Daily monitoring

Storage conditions. Checked and documented. Storage area; clean and dust-free. Out-of-stocks. Checking expiration date of the rotating inventory as FEFO. Checking the unit dose cart. Checking the nurse stock. Software computer program and out-of-stock reports. Checking and Monitoring the narcotics and control drugs. Checking for drug recalls.

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Hospital Medication Order ( Prescription) and order Entry. Medication order is a format that differs

from the common prescription. Could be delivered to the pharmacy via

nurse, personal, computer system, pneumatic tube or fax.

All medication orders entered into the computer by the hospital pharmacist.

Types of medication orders:• Admitting order.• Stat order• Daily and continuation order.• Standing order.• Discharge order.

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Admitting order• Written by the physician upon patient admission and it contains:- Name and demographic data.- Medications taken before.- Diagnosis.- Request for laboratory investigations.- Radiological examination.- Instructions for the nursing staff.- Medication order including dose, dose intervals and administration.- Dietary requirements.- Allergies.- Home med and bedside medications.

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Stat order ( Emergency order)

• An order being sent electronically to the pharmacy.• It should have the priority in dispensing.• Delivered to the patient by the pharmacy technician.

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Daily and continuation order

Written by the physician in daily or at least weekly basis

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Standing order

The same set of medications for each patient who

receives a similar treatment or surgery.

Physician may sign this preprinted order and may add

or delete some items.

Postoperative orders are good example.

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Discharge order

Order including all medications, doses and instructions

to take-home.

May continue for one week or maximum one month

until follow-up visit.

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Computerized Prescriber Order Entry CPOEBenefits - Immediate access to patient medical records.- Streamlined work-flow process.- Enhance coordination of patient care.- Clear communication with other health care professionals.- End result improves patient care and safety.Drawbacks:- High initial cost.- Need time for training.- Resistance from the prescribers to embrace changes.

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CPOE – cont.

For the pharmacy:- Efficient medication order completion.- Simplification of inventory ordering and posting of patient

charges.- Improvement of medication safety

- Safeguard medication filling and dispensing.- Error checking functions, duplication, incorrect doses- Reduce medication errors.

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Inpatient Distribution Systems

1- A complete floor-stock System.

2- Individual prescription medication for each patient.

3- Combination of 1 & 2.

4- Unit-dose dispensing system.

Systems 1, 2 and 3 are considered poor drug control methods.

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Floor-stock Floor-stock is an inventory of frequently prescribed drugs that is stored

on the patient care unit rather than delivered by a unit dose cart. May be free or charge. Predetermined list kept on each nursing unit. Topping-up by the pharmacy and record the consumption and cost. For more expensive drug the charge may be via bar-code, removable

label or pre-stamped pharmacy requisition form.

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Individual Patient Medications All medications dispensed by the pharmacy, kept in the nurse

cabinet and administered to each patient in doses as instructed

by the physician.

Control through pharmacy prepackaged form.

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Mixed system Floor-stock is carried out and the charges were included in the nursing

and other services charges.

Individual patient drugs kept in the nursing cabinet and charges are

recorded in the pharmacy upon dispensing.

Control and follow-up of storage conditions are the pharmacy

responsibility.

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Unit Dose Distribution System It is the standard practice in developed hospitals 12 – 72 hours supply prepacked for each patient-care unit. Then administered by the nurse to the patient. Inpatient distribution system is composed of:

- Unit dose.- IV admixture.- TPN services.

The pharmacist maintain the inventory of the floor stock drugs and narcotic sent to each unit.

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Unit dose –cont. Definition:

An amount of a drug prepackaged for a single administration.

That is to say an amount of a medication in a particular dosage

form that is ready for administration to a particular patient at a

particular time.

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Unit dose cont. General information on the label:- Generic or brand name of the drug- Strength of the dose.- Bar code of the product- Manufacturer name and lot number.- Expiration date.

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Unit dose cont. Unit dose cart: A movable cart that contains removable

cassette drawers that house medications. Each cassette drawer is labeled with

specific patient, patient bar code and room number.

Medications are generally for 24 hours -exchange in the morning by pharmacy.

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Unit dose –cont. Benefits: Streamlined work flow.

Decreased medication errors.

Increased medication security.

Reduced medication wastage.

increased cost effectiveness.

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Unit dose –cont. Repackaging medication into unit dose

1- heat-sealed ziplock bags.

2- adhesive sealed bottles.

3- blister pack.

4- heat- sealed strips.

5- Plastic or glass cups.

6- heat-sealed aluminum cups.

7- plastic syringes for liquids labelled for oral use only.

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Unit dose cont. Processing medication order:

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