Guideline For Good Pharmacy Practice
Guideline For Good Pharmacy Practice
Contents
1. INTRODUCTION ................................................................................................................................. 3
2. PURPOSE .............................................................................................................................................. 3
3. SCOPE ................................................................................................................................................... 3
4. STRUCTURE GUIDELINES ............................................................................................................... 3
4.1Premises…………………………………………………………………………………………….3
4.2 Furniture and fixtures……………………………………………………………………………...4
4.3 Equipment…………………………………………………………………………………………4
4.4 Personnel…………………………………………………………………………………………..5
4.5 Systems……………………………………………………………………………………………6
4.6 Quality Policy………………………………………………………………………………………………………………………………………………….6
4.7 Service Policy……………………………………………………………………………………..6
4.8 Staff Training Policy……………………………………………………………………………...7
4.9 Complaints policy………………………………………………………………………………...7
4.10 Medicine Recall Policy………………………………………………………………………….7
4.11 Audit Policy……………………………………………………………………………………..7
4.12 Documentation system…………………………………………………………………………..8
5. PROCESS GUIDELINES…………………………………………………………………………….8
5.1 Procurement and inventory management…………………………………………………………8
5.2Storage management…………………………………………………………………………………...9
5.3 Disposal of unused pharmaceutical products and waste……………………………………………....9
5.4 Prescription handling…………………………………………………………………………..…9
5.5 Dispensing……………………………………………………………………………………….10
5.5.1Filling the prescription……………………………………………………………………………...10
5.6 Extemporaneous preparation…………………………………………………………………………11
5.7 Information for patient……………………………………………………………………………….11
5.8 Patient Counselling…………………………………………………………………………………..12
5.9 Proffesional Guidance……………………………………………………………………………….12
5.10 Medication Records………………………………………………………………………………..12
5.11 Patient Follow-up………………………………………………………………………………..…13
5.12 Self Care---------------------------------------------------------------------------------------------------------13
5.13Health promotion & ill health prevention--------------------------------------------------------------------13
5.14 Pharmacovigilance---------------------------------------------------------------------------------------- 13
5.15 Enhancement of professional role……………………………………………………………...14
5.16 Professional interactions……………………………………………………………………….14
6. FEEDBACK ........................................................................................................................................ 14
7. APPROVAL AND REVIEW DETAILS ............................................ Error! Bookmark not defined.
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1. INTRODUCTION
The objective of framing and implementing these GPP Guidelines for Sri Lanka is that over the next
few years, all pharmacies in Sri Lanka should achieve standards of practice laid down in this
document. It is the commitment of individual pharmacies how they achieve these standards. This has
to be through continuous education, training and perseverance of the pharmacists as well as the
professional organizations.
Even though it may seem that high level of standards has been set, the time has come for the situation
in Sri Lanka to change from a product oriented approach to a patient oriented approach with
Pharmaceutical Care the ultimate goal of pharmacy practice.
2. PURPOSE
In order to ensure the maintaining of high standards of quality assurance and the integrity of the
practices followed in community pharmacy set up, and to promote uniformity in licensing of retail
sale of products regulated under NMRA Act, the following Guidelines on to Good Pharmacy Practice
(GPP) for Medicinal Products has been adopted.
3. SCOPE
The standards set out herein apply to medicines and other products regulated under NMRA Act. At
the time of issue, this document reflected the current state of the art. It is not intended to be a barrier
to technical innovation or the pursuit of excellence or to place any restraint upon the development of
new concepts or new technologies, which have been validated and provide a level of Quality
Assurance and integrity of the distribution processes at least equivalent to those set out in this Guide.
4. STRUCTURE GUIDELINES
4.1 Premises
• The pharmacy should be easily located & identified by the public. Exterior of the pharmacy should be
maintained neat and clean. The façade should be clearly marked with the word “PHARMACY” written
in English as well as in Sinhala and Tamil language(s) of Sri Lanka.
• Pharmaceutical services and products should be served from an area which is separate from the other
activities/services and products. This facilitates the integrity & quality of products, and minimizes the
risk of dispensing errors. The Pharmacist should be directly & easily accessible to public for information,
counseling, etc.
• The pharmacy environment should be clean with minimum dust and should be maintained clean as per
the cleaning schedules and Standard Operation Procedure (SOPs).
• It should be free from rodents and pests/ insects and pest control measures should be taken from time to
time.
• The pharmacy should have a constant supply of energy especially for the refrigerator(s).
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• There should preferably be a provision for drinking water to facilitate drug administration to the patients
and for use of the staff.
• The pharmacy should have a comfortable environment for ease/comfort of customers and personnel.
• The pharmacy should have a separate enclosure described as “counselling Area” for patient counselling,
storage of reference resources (e.g. books, internet access etc.).
• Counselling area should be a place where patients can talk freely with the pharmacist.
• There should be a sufficient additional space for making extemporaneous preparations, besides the
necessary equipment for doing so.
• Separate waste collection baskets/boxes should be available for the staff and for the customers.
• The products storage area should be protected from exposure to excessive light and heat.
• Temperature in the pharmacy should be maintained within the stipulated range to prevent deterioration
of medicines.
4.3 Equipment
The pharmacy should be equipped with refrigerated storage facilities (validated from time to time) and
should be available for products requiring storage at cold temperature.
The counseling area should be equipped with:
1. Reference material
2. Patient information leaflets (PILs)
3. Weight and height scale
The pharmacy should preferably be equipped with computers and appropriate software that can
1. Manage inventory
2. Manage invoicing
3. Generate timely warning for expiring medicines
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4. Archive patient medicines use records
4.4 Personnel
• The Community Pharmacy should be managed under the overall supervision of a pharmacist known as
the “responsible pharmacist, who will have the final responsibility for all the professional activities and
operations.
• All staff members including newly recruited staff should be trained as per the staff training policy of the
pharmacy.
• All activities in the Pharmacy should be carried out as per well documented guidelines and procedures,
which should have been framed by the management in consultation with the “responsible pharmacist”.
• Each staff member should have clearly assigned responsibilities, which must be performed according to
documented standard operating procedures.
• All personnel in the pharmacy must, at all times, wear a neat apron/ coat.
• All Pharmacists should additionally wear a badge prominently displaying their name and the word
“Pharmacist”.
• The license issued by the NMRA to sell medicines by retail and registration certificate(s) of the
pharmacist(s) should be displayed in a prominent place in the pharmacy in clear view of the customers
entering the pharmacy.
• All pharmacy personnel should have been adequately immunized and should be medically examined
periodically and, their health data should be available for inspection.
4.5 Systems
The pharmacy should have well defined and documented systems for each operation carried out in the
pharmacy.
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4.6 Quality Policy
• It is a general declaration of the intent of the pharmacy about the level of quality of service and products
offered to the public.
• It is the responsibility of the “responsible pharmacist” to formulate a Quality Policy and set and achieve
Quality Goals along with the management and other staff.
• Quality goals derive from the stated quality policy and they are the targets, which are set and which can
be in a stipulated period of time. Different quality goals need to be set in the various operational areas of
the pharmacy.
• The pharmacy should have a quality manual, which should state, in detail, the necessary steps to be
carried out for fulfillment of the desired quality goals. The manual should also enlist the details of the
activities, routines, distribution of responsibilities, work procedures and instructions that are necessary
for achieving the quality goals in day-to-day operations in the pharmacy. The Quality Manual should be
accessible to the staff of the pharmacy for their easy
• The “responsible pharmacist” should ensure that the quality policy and quality goals are understood,
implemented and maintained throughout the operations in the pharmacy. Timely audits should be
conducted to check the extent to which the pharmacy meets its quality goals and the outcomes should be
documented for a review to further improve the process.
• The pharmacy should have a well-documented service policy based on its customer servicing goals.
• Service policy statement should include issues like home delivery of products, the nature and level of
attention to be given to customers of various kinds (e.g. elderly customers, regular customers, etc.). The
service manual should state, in detail, the necessary steps to be carried out for providing each service
offered in the pharmacy.
• The manual should also enlist the details of the activities, schedules, distribution of responsibilities, work
procedures and instructions that are necessary for provision of the services in day to day operations of
the pharmacy.
Training
• Training policy should encompass the needs evolving out of service policy of the pharmacy. The policy
should prescribe the content & frequency of the training and the training resources.
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• Training policy should ensure that all personnel in the pharmacy are kept abreast of the developments in
their fields. Upgrading communication and inter-personal skills should form the core of the training
policy.
• The policy should prescribe the minimum continuing education levels to be attained by each staff
member so that the ultimate goal of pharmacy-provision of Pharmaceutical Care is achieved.
• All pharmacy personnel should be aware of Quality Policy of the pharmacy, and should be conscious
about their role of delivering health care to the customers. They should be trained & made aware of
minimal personal hygiene levels, as well as the level of hygiene to be maintained in storage and handling
of medicines.
• Availability of adequate reference resources (books, current periodicals, software, etc.) in the pharmacy
is the fundamental requirement of the training process.
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Prescription registers and Dangerous Drug Registers should be maintained as per relevant regulations and be
available for inspection.
There should also be adequate control and maintenance of documents that form a part of the pharmacist’s
quality system.
Some of the necessary documents include:
• Protocols
• Standard Operation Procedures
• Operation instructions
• Quality Manual
• Cleaning and maintenance processes and records
• Complaint records
• Audit records
• Policy documents
• Personal details
In addition, the documents required for the pharmaceutical care process should also be adequately
maintained and stored. These documents include:
• Patients’ medicine use records
• Records of counselling follow-ups.
• Prescription registers
• Dangerous Drug Registers
5. PROCESS GUIDLINES
The pharmacy should develop and maintain a safe and effective operational operation system. As far as
possible, the “responsible pharmacist” should ensure that medicines and other health care products are
readily available in the pharmacy in sufficient quantities. The operational system should be effective so that
the pharmacists’ financial interests are maintained while providing optimal health and cost benefits to the
customers.
The pharmacist should maintain a ‘products list’ where all items ‘approved’ by the pharmacy for stocking
are described.
This list may be reviewed and updated as often as necessary.
Ideally, the product lists specify the location of that product in the pharmacy.
All products received from vendors should be tallied against their invoice and checked for correctness of
quality, price, batch number and expiry date.
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Any anomalies should be brought to the notice of the supplier /s and suitable rectification got done. All such
rectification should be documented and got authenticated by an authorized representative of the vendor.
The purchase records/invoices should be maintained.
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d. Instruction to the patient
e. Refill information if any
f. Prescribed prescribers’ usual signature.
• Any ambient, confusion, shortcoming or anomalies should be brought to notice of the
prescriber.
5.5 Dispensing
5.5.1 Filling the prescription
• The medicine should be removed from the storage area, counted and invoiced. In all cases, final review
of prescription and the correctness of dispensed medicines must be personally made by the pharmacist.
• As a final step, the pharmacist should personally dispense the medicines, at which stage appropriate
counseling should be given for the patient.
• The medicines should be packed neatly so that their integrity is maintained. Any medicines requiring
special storage condition e.g. cold place (2-8◦C) must be packed in cold packs so that they remain at the
stipulated temperature till they are taken from a larger bulk pack then they should be packed in a clean,
food grade glass or plastic bottle or in a clean envelop and neatly labeled as provided under the lock.
• Appropriate counseling/guidelines must be given for the patient as recommended below under patient
information.
5.6Extemporaneous preparations
• Written standard operating procedures as well as standard formulations should be maintained for
commonly made extemporaneous preparation. Proposed adjuvants, their quantities and method of
preparation must be written down before any compounding activity is initiated. Each step should be
followed methodically and step by step record maintained.
• Batch numbers of each medicines used for compounding should be recorded. All such preparation should
preferably be compounding by the Pharmacist, only under direct supervision of a pharmacist.
• Only medicinal quality or better grade ingredient should be used for compounding.
• The preparation area should be cleaned immediately before and after compounding. All necessary
weighing, measuring instrument must be calibrated periodically and records maintained.
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• After compounding, the product should be transferred to a suitable container and closed securely.
• The container should be appropriately labeled stating name of the preparation, date of preparation, name
of the patient, direction, quantity, a reference (batch) number generated by the pharmacy, storage
conditions and name of the pharmacy. These details must be recorded in a register or electronically for
suitable reference and retrieval as and when required.
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III. When to take the medicines and whether to take the medicines and whether to take them before,
during or after meals, etc
IV. What foods/beverages/tasks to avoid during the therapy.
V. What side effects to expect and how to manage them.
VI. What to do if one or more doses get skipped.
VII. Any other precautions.
• Appropriate discretion should be exercised while discussing the nature of illness, its cause, prognosis
(course of the disease), and the expected outcomes of the therapy.
• Patients’ counseling should ideally be done in the counseling area or where separate area is not
available – in such an area of the pharmacy where the conversation is not overheard by others.
• As far as possible, oral information given to customers should be supplemented by additional written
information (in the form of Patient Information Leaflets) about their illness and the medicines. To
reinforce the understanding and improve compliance, the patient should be asked to explain what has
been conveyed. Depending on the local needs and understanding levels of the customers, the Chief
Pharmacist should devise methods to improve patient compliance.
• A list of general and specialized healthcare professionals and facilities (including laboratories) in the
locality and the city should be maintained and made available to the customers whenever necessary.
5.9Professional guidance
Pharmacists should make all efforts to deliver pharmaceutical care to his customers.
This can be achieved by providing various professional services to the patients.
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• Pharmacists should track medications taken by such patients and regularly update the patient’s
medication history as long as the patient is under his/her care.
• The pharmacist must personally make the follow-up calls or meetings and enquire about:
I. Patient’s general condition and response to therapy.
II. General problems, adverse events encountered by the patient.
III. Dose and frequency at which medicines have been taken by the patient.
IV. Missed doses.
• Possible causes of noncompliance by the patient should be evaluated and the patients counselled
accordingly. The pharmacist should keep the patient’s prescriber updated about all the adverse events
reported by or elicited from the patient and the stated or probable reasons for the patient not
complying with the prescription/therapy.
5.14 Pharmacovigilance
• The Pharmacist should be alert to the occurrence of adverse effects (expected or unexpected) to
medicines during active conversation with the patient.
• These should be recorded in the individual Patient medicine use records. The Pharmacist should give
suitable instructions to the patient to reduce the adverse effects in the future, e.g. by advising the
patient how to take the medicine correctly, what other medicines or food to avoid, any activities that
the patient should avoid (e.g. not going out in the sun, not driving, etc.), or by consulting the
prescribing prescriber.
• Such adverse effects should be informed to the pharmacovigilance Division of NMRA as per
relevant guidelines and regulations on pharmacovigilance.
5.15 Enhancement of professional role (Development of professional competence working with other
health care providers)
• Pharmacists should keep themselves updated about the developments in their profession. They should
possess excellent communication skills to be able to work closely with other healthcare providers and
mutually share the learning.
• Pharmacists must maintain healthy relationship with other health care professionals.
• In case of any discrepancy / doubt in the prescription, the Pharmacist should contact the prescriber over
the telephone without unduly alarming the patient, & in a friendly manner, put forward the query to the
prescriber.
• Before doing so, he must doubly check & ensure that there is really an error or discrepancy in the
prescription, and also work out the alternative /solution which can be promptly suggested on inquiry
from the prescriber.
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5.16 Professional interactions (organizing professional meetings for the community’s healthcare
professionals)
Up-gradation of professional skills and improved understanding between various healthcare professionals in
the locality can be achieved through this process.
6.FEED BACK
Staff and customers may provide feedback about this document by emailing [email protected].
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