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1. GOOD PHARMACY PRACTICE
GUIDELINES
1

2. o Good Pharmacy Practice (GPP) is at the very heart of the
profession of pharmacy; indeed it is the very essence of the
profession.
o It expresses our covenant with the patient not only to “do no
harm‟ but also to facilitate good therapeutic outcomes with
medicines.
o GPP is the practice of pharmacy that responds to the needs of
the people who use the pharmacists’ services to provide optimal,
evidence-based care.
INTRODUCTION
*Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services, 1992 2

3. o GPP requires that a pharmacist's first concern in all settings is
the welfare of patients.
o GPP requires that the core of the pharmacy activity is to help
patients make the best use of medicines. Fundamental functions
include the supply of medication and other health-care products
of assured quality, the provision of appropriate information and
advice to the patient, administration of medication, when
required, and the monitoringof the effects of medication use.
o GPP requires that an integral part of the pharmacist's
contribution is the promotion of rational and economic
prescribing, as well as dispensing.
Requirements of good
pharmacy practice
Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services, 1992 3

4. o GPP requires that the objective of each element of pharmacy
service is relevant to the patient, is clearly defined and is effectively
communicated to all those involved.
o Multidisciplinarycollaborationamong health-care professionals
is the key factor for successfully improvingpatient safety.
o In order for the pharmacist to take decisions which are in the best
interest of the patient, the pharmacist should have access to the
essential medical and pharmaceutical information about each
patient.
Requirements of good
pharmacy practice
*Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services, 1992 4

5. The GPP guidelines have identified four main groups of activities
for which national standards should be set.
1. Activities associated with the promotion of good health,
avoidance of ill-health and achievement of health objectives.
2. Activities associated with the supply and use of medicines
3. Activities associated with self-care
4. Activities associated with influencing the prescribing and use
of medicine
GPP
Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services, 1992 5

6. o Activities associated with the promotion of good health,
avoidance of ill-health and achievement of health
objectives.
o Pharmacists should be actively involved in various health
promotion activities and should be at the forefront of
campaigns which aim to minimise the abuse or misuse of
medicines.
Activity I
6

7. o Activities associated with the supply and use of
medicines and items for the administration of medicines or
otherwise related to treatment.
o This is the profession’s core activity and encompasses a
vast range of services.
Activity II
7

8. This includes:
1. Reception of the prescription and confirmation of the integrity
of the communication
2. Assessment of the prescriptionby the pharmacist
3. Assembly of the prescribed item
4. Advice to ensure that the patient or carer receives and
understands sufficient written and oral information to derive
maximum benefit from the treatment
5. Followingup the effect of the prescribed treatments
6. Documentation of professional activities.
Activity II
8

9. o Activities associated with self-care, including advice about, and
where appropriate the supply of a medicine or other treatment for
symptoms of ailments that lend themselves to self-treatment.
o Individuals self-treat a large proportion of their problems
without consulting a health care professional, therefore
pharmacists should help people make informed choices about self-
care and support individuals by providing correct information and
interpretinginformation put forward by the individual.
o This necessitates a shift in focus to one of illness management
and self-maintenance.
Activity III
9

10. o Activities associated with influencing the prescribing and
use of medicine.
o Pharmacists need to be proactive in evaluating data on the
use of medicines they also need to identify adverse events
and medication errors and act in the best interest of the
patient.
Activity IV
10

11. o The hospital pharmacy should be managed under the overall
supervisionof a chief pharmacist, who will have the final
responsibilityfor all the professional activities and operations.
o All staff members includingnewly recruited staff should be trained
as per the staff training policy of the pharmacy.
o 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 consultationwith the chief
pharmacist.
o Each staff member should have clearly allotted responsibilities,
which must be performed accordingto documented standard
operating procedures.
Personnel
11

12. Personnel
o All personnel in the pharmacy must, at all times, wear a neat apron /
coat. All personnel should additionally wear a badge prominently
displaying their name and designation.
o All pharmacy personnel should be medically examined and
adequately immunized periodically and their health data should be
archived.
o Pharmacists working in the pharmacy should:
 Hold at least a bachelor degree in pharmacy.
 Be registered as a pharmacist with the Nepal Pharmacy Council.
 Have undergone adequate practical training in hospital pharmacy.
 Have communication skills & capabilities to give adequate and proper
advice to the patients on illness and appropriate use of medicines so as to
achieve optimal patient compliance.
12

13. Personnel
Each Pharmacist working in the pharmacy must be competent
enough to:
 Play a professional role to assess prescriptions.
 Advise patients on appropriate selection and use of OTC medicines.
 Advise patients on appropriate use of prescribed medicines.
 Check and advice on medicine-medicine and medicine-food interactions.
 Be alert for adverse drug reactions.
 Comprehend the client’s condition or illness and provide advice on proper
medication and diet.
 Assess the patient’s condition and decide when to refer him/her to the
doctor.
 Perform the role of a healthcare provider and a counselor.
13

14. Personnel
Pharmacy assistant working in the pharmacy should:
 Hold at least a Diploma in Pharmacy.
 Be registered as a pharmacy assistant with the Nepal Pharmacy
Council.
 Have undergone adequate practical training in hospital pharmacy.
 Have good communication skills
Professionalist working in the pharmacy should:
 Hold the qualification as specified by the Drug advisory committee
and recognized by that committee.
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15. Premises
o Location of pharmacy should be such that it is easily identified by
the public.
o Neat and clean environment should be maintained.
o The facade should be clearly marked with the word “PHARMACY”,
written in English as well as in Nepali.
o Should be conveniently accessible to people using prams or wheel
chairs.
o Pharmaceutical services should be served from an area which is
separate from other activities / services and medicines to facilitate
the integrity and quality of service, and minimizes the risk of
dispensing errors.
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16. Premises
o The pharmacist should be directly and easily accessible to
public for information and counseling.
o The pharmacy environment should be clean with minimum
dust and should be maintained clean as per the cleaning
schedules and SOPs.
o Pharmacy should be free from rodents and pests/insects and
pest control measures should be undertaken from time to time.
o Adequate space as recommended by the regulatory authority
is necessary, which should be enough for holding shelves of
medicines, display counter, counseling area, and sufficient for
proper movement of personnel and patients.
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17. Premises
o The pharmacy should have a telephone service and constant
supply of electricity, especially for the refrigerator(s).
o A provision for drinking water to facilitate medicine
administration to the patients and for use of the personnel.
o The pharmacy should have:
 Sufficient place for patients to stand comfortably at the dispensing
counter and for some to sit comfortably while they wait.
 Space for patient information displays, including information leaflets
/material.
 A separate enclosure described as "Counseling Area" for patient
counseling, storage of reference resources (e.g. books, internet access)
is a fundamental requirement.
17

18. Premises
o Counseling area should be a place where patients can talk freely
with the pharmacist. It should be away from the area otherwise
normally accessed by the patients and should preferably be an
enclosure with a door which can be closed for further
confidentiality. It should be well lighted with comfortable seating
for the Pharmacist and the patient / attendant.
o A compounding pharmacy should also have sufficient additional
space for making extemporaneous preparations, and the
necessary equipment for doing so.
o Separate waste collection baskets/boxes should be available for
the personnel and for the patients.
18

19. Premises
o The pharmacy should be air-conditioned and well ventilated.
o The medicine storage area should be protected from exposure
to excessive light and heat.
o Ambient temperature in the pharmacy should be maintained
within the stipulated range to prevent deterioration of various
medicines stored at room temperature conditions.
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20. Furnitures & Fixtures
o The pharmacy should have neat, well-placed shelves with
provision for storage of medicines and other items in a neat
manner, protected from dust, moisture, excessive heat and light.
o Adequate provisions should be available for storing various
medicines at prescribed temperature conditions.
o The counseling area should at least be furnished with
a. A table
b. Chairs for the pharmacist and a couple of patients.
c. Cabinet for storing Patient Medication Records (PMRs)
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21. Equipments
o The pharmacy should be equipped with refrigerated storage
facilities (validated from time to time) and should be available
for medicines requiring storage at cold temperatures.
oThe counseling area should be equipped with:
a. Reference material
b. Demonstration charts, kits and other demonstration material
c. Patient information leaflets (PILs)
d. Some basic instruments e.g. sphygmomanometer, glucometer,
thermometer and stethoscope.
e. Weight & height scale
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22. Equipments
o The pharmacy should preferably be equipped with computers
and appropriate software that can
a. Manage inventory
b. Manage invoicing
c. Generate timely warnings for expiring medicines
d. Archive patient medication records
o The computers should also be equipped to give demonstrations
to the patients and for maintaining database
o Compounding section of the pharmacy should be equipped
with appropriate apparatus required for the preparation.
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23. Quality policy
o Quality Policy (QP) is a general declaration of the intent of the
pharmacy about the quality of service and medicines offered to
the public.
o Quality goals emanate from the stated quality policy and they
are the targets which are set and which can be measured. These
expressly stated targets must be met in a stipulated period of
time.
o Different quality goals need to be set in the various operational
areas of pharmacy.
o It is the responsibility of the management and the pharmacist
to formulate a Quality Policy and set and achieve Quality Goals.
23

24. Quality policy
o The pharmacy should have a quality manual, which should
describe quality policy and quality goals and should state, in
detail, the necessary steps to be carried out for fulfillment of the
desired quality goals.
o The manual should also enlist the details of the activities,
routines, roles and responsibilities, work procedures and
instructions that are necessary for achieving the quality goals in
day-to-day operations in the pharmacy.
o The quality manual should be accessible to the personnel of the
pharmacy for their easy reference.
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25. Quality policy
o All the activities mentioned in the quality manual should be
well documented, and it shall be the final responsibility of
pharmacist to ensure that the quality goals are in consonance
with the quality policy of the pharmacy.
o The pharmacist should ensure that the quality policy and
quality goals are understood, implemented and maintained
throughout the operations in the pharmacy.
o Timely audits should be conducted to check the extent to which
the pharmacy meets its quality goals and the outcomes should
be documented for review to further improve the processes..
25

26. Service strategy
o Service strategy is a statement of the nature of services provided
in the pharmacy and the standards laid down for provision of
those services.
o The pharmacy should have a well-documented service strategy
based on its goals.
o Service strategy statement should include issues like home
delivery of medicines, the nature and level of attention to be
given to patients of various kinds (e.g. elderly patients, regular
patients).
26

27. Service strategy
o The service manual, which can be a part of quality manual,
should state, in detail, the necessary steps to be carried out for
providing each service offered in the pharmacy. Promptness of
service, service time and pharmacy operation schedule form an
important part of the service policy.
o The manual should also enlist the details of the activities,
routines, delegations, work procedures and instructions that are
necessary for provision of the services in day to day operations of
the pharmacy.
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28. Workload Statistics
o Each function by the staff in an assigned is collectively called
workload for that area.
o On a monthly basis, the total workload of each section is
collected to be included into one department report.
o This report will be submitted to hospital administration.
o This reporting method will be used for adjustments of shifting as
needed from the comparative monthly statistics.
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29. Policy on Workload Statistics
o Prepare standard time for performing every activity in the
pharmacy department
o Various activities involved in drug distribution are identified and
collected in the Workload Data Reporting sheets and are available
in the manual titled “Pharmacy Services Workload Statistic".
o Computer reports (if applicable) may be obtained from the
pharmacy computer system.
o Collection of the data is performed at the beginning of each
month.
o The final monthly report will be compiled and submitted to the
Head of Pharmacy Services.
o 29

30. Activities/Procedure
1. Activate the following reports in report manually or from the
pharmacy computer to obtain printouts (inpatient/outpatient In-
charge pharmacist).
a. Number of unit drug doses processed.
b. Number of bulk doses processed.
2. Collect the following log sheets located in the Inpatient
Pharmacy areas:
a. Floor stock Inspection Log Sheet
b. Crash card inspection
c. IV section unit doses (if applicable)
d. Chemotherapy statistics (if applicable)
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31. Activities/Procedure
3. Count the number of mediation prepared (as recorded in the
following record books) for the indicated time frame:
a. Extemporaneous Compounding Log Book
4. Report the workload of the outpatient pharmacy
a. Number of single item prescription processed per month.
b. Number of multiple items prescription processed per month.
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32. Activities/Procedure
5. Indicate total workload for the following:
a. Unit Dose/ bulk Items
b. IV unit dose prepared (if applicable)
c. Extemporaneous compounded bulk items.
d. Cancer Chemotherapy doses (if applicable).
e. Pre-packaging and bulk compounding
f. Floor stock inspection.
g. Floor stock narcotic temporary sheet.
32

33. Activities/Procedure
h. Time spent in Pharmacy interventions in the nursing units
i. Time spent on answering telephone call for drug inquiries
j. Time spent in different meetings
k. Drug issuing/Receiving/ordering by the pharmacy store personnel
l. Time spent on Narcotic drugs issuing/ return/ inspection
m. Time spent on inspection for expiration date
n. Time spent in Pharmacy in-services and lectures
o. Time spent on Patient counseling
p. Outpatient pharmacy workload
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34. Activities/Procedure
6. Record the total workload statistics of all areas in the pharmacy
departments in one Workload Data Reporting sheet.
7. Turn in the completed Monthly Workload Data Reporting Sheet
to the department Head.
8. The workload statistics to be announced and presented to P&T
committee.
9. Pharmacy head to approve the statistics and send it to hospital
administration.
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35. BUDGET PREPARATION
&
IMPLEMENTATION
35

36. Introduction
o Budgeting is a financial exercise to make provisions for
expenditure by consolidating the revenue resources.
o It is an exercise to give direction to the growth and progress of
the organization
o Budget is a financial statement where the revenue (income)
and expenditures are identified with value.
o It is a document that shows projected revenue and expenditure
for the ensuing budgetary period.
36

37. Introduction
o The projection is based on the past data on revenue Vs expenditure
and the new plans / schemes intended for implementation.
o Budgetary period is the time in terms of months for which the
allocated budget is approved for expenditure.
o It is also called financial period.
o The fund available out of the revenue and / or other sources is
mapped against all the heads of expenditures.
o This is done institution-wise, department-wise, program-wise with
sub-heads.
37

38. Introduction
These are called Expenditure heads like;
1. Pay and allowances of the staff
2. Office contingencies
3. Publicity and communications
4. Travel and transport including packing expenses
5. Procurement of;
 Services
 Consumables
o Linen materials like Cloths and clothing, bed-spreads, blankets,
towels etc
o Drugs, chemicals, surgical items
 Capital items like; equipment, furniture, etc
 Vehicles like; Ambulances and other transport vehicles
38

39. Introduction
o Budgeting for supply-chain-management should be done
objectively and as realistically as possible to ensure that
sufficient monetary provisions are available in advance for all the
expenditure heads.
o The demand for budget should be reasonable enough with due
justification.
o Abnormally high or low demand will badly affect the whole
financial system of the institution and may affect the quality of
service, material and supply chain system.
39

40. Introduction
o The priorities should be identified at all levels. The priority of
the institutional / organization will be on the broader scale
where as the priority of the department will be on the micro
level.
o Therefore, the person preparing the budget proposal should
start working from micro level so that the proposal becomes
broad, need based and close to reality.
o The management will consider the budget proposals received
from all the departments.
40

41. Introduction
o The available pooled fund is distributed to each department as
per the demand and priorities.
o This is further divided and allocated for each head of expenditure
within the department. This is called budget of the department.
o This allocation in the form of a statement is made available to all
the departments.
o Invariably, the needs are more than the resources. It is natural
that budget allocation may not match the demand.
o Therefore, budget received and the expenditure intended should
be judiciously balanced so that priorities do not get sacrificed and
the expenditure is limited to the essential ones only.
41

42. Knowledge required for budgeting
1. Fund sources and its nature like;
a. Revenue receipts (income) of the institution
b. Dedicated program budget like; anti malarial, Anti-TB drugs
etc
c. General (Common) budget for any utility on priority
d. Loan from financial institution and the type of loan (long
term/short term)
e. Donation like;
i. General donation
ii. Specified donation
iii. Grants from International agencies
42

43. Knowledge required for budgeting
2. Expenditure heads and expenditure under each head in the
recent past three years
3. Prioritized category of materials
4. Estimated value of the materials
5. Outstanding payments due to the creditors, if any.
6. Outstanding receipts due from the debtors, if any
7. Any major forthcoming events like; Social festivals, fairs etc
expected in the area that may warrant additional expenditure
Ex; Shivaratri, Teej etc.
43

44. Budgeting method
Following are the different types of budgeting exercises that
are being practiced:
I. Indent based budgeting method
II. Budget Repetition method
III. Scientific logical method
44

45. Indent based budgeting method
a. Here the pharmacist compiles a master list of all needs based
on the indents received (or demand experienced).
b. He discusses with the clinician to finalize the list of
requirements
c. He quantifies them and marks them with the priority indicator
[A B C ] as per the consumption pattern.
d. The budget required for each item is calculated on the basis of
the purchase cost and quantity of each item.
e. The total of the value of all items is the budget assessed for
the year
45

46. Budget Repetition method
a. This is a lazy man's method.
b. Here either 'the materials and their quantities' of the previous
period are repeated to arrive at the required budget or the
budget figures of the previous period are repeated with or
without any variation.
c. No detail exercise is carried out to look into the individual
items and their dynamics.
d. Repetition of budget proposal is done in one or more of the
following methods;
i. Repetition based on materials and quantities of previous year
ii. Repetition of budget figures
iii. Budget made up on percentage basis
46

47. Repetition based on materials and
quantities of previous year
This is a simple method of budget assessment where the
consumption in the past three / six / twelve months is
considered to identify the items and quantify them.
The total of the value of all the items is the budget required
for the specified period.
47

48. Repetition of budget figures
This is also a lazy man's method. The budget allocation of
the previous year is blindly repeated.
Material, its volume, cost, inflation rate, projected need,
operative or inoperative services etc are blindly presumed
to be satisfactory.
This is a blind exercise and such institutions suffer with no
progress and public rapport would be equally poor.
48

49. Budget made up on percentage basis
o This is also a 'Repetition method.
o But, some 5% or 10 % or some such percent of additional
amount is added to the budget of the previous year to show
the mark up for cost escalation or additional needs but
without looking into actual needs.
o This is again an irrational method as raise in budget by few
percent will most of the time doesn't help in meeting the
needs but may result in wasteful and irrational expenditure.
o The result would be purchase of additional quantity of some
item at the discretion of the purchasing authority with no
logical justification leading to logistics failure.
49

50. Scientific logical method
a. Assessment of needs and quantification is based on ground
realities with least scope for presumption.
b. The method takes into account the various ground level and
managerial level factors. These factors are classified into
constants and variables.
c. The variable factors are tuned and fine tuned to match the
constants to fulfill the objectives.
50

51. Scientific logical method
So to say it is broad based one developed from several statistical
data like;
o Population and Demography
o Epidemiology
o Disease statistics
o Standard Treatment guidelines and Essential drugs list
o 'BIN' card and Products dynamics
o Consumption analysis
51

52. Scientific logical method
o Stocks of the previous year
o Obsolete drugs and new drugs in demand
o Sources of supply and prevailing price
o Distance of the hospital from the supply source
o Mode and cost of transportation
52

53. Scientific logical method
d. Based on these data, a small working group of pharmacists and
clinicians should prepare a master list of items required.
e. This list should be placed before the 'Therapeutic committee'.
The therapeutic committee should identify the items on
therapeutic priority basis like: VITALS, ESSENTIALS and
DESIRABLES.
f. The items are then pruned and quantified on the basis of the
consumption analysis
53

54. Scientific logical method
g. The consumption analysis is an exercise where the consumption
of the previous year / years is analyzed in the light of the Disease
statistics, the epidemic and / or endemic diseases eventualities,
Standard treatment guidelines, stocks of drugs in the stores,
instances of shortage or non-procurement of any drugs /
formulations in the previous years under consideration and
rationale of drug utilization with reference to Standard treatment
guidelines.
h. The items are then evaluated at the prevailing market price
54

55. Objectives of budgeting
A. To arrive at a budgetary provision to meet the justifiable
needs.
B. To rectify any deficiency experienced in the previous year.
C. To put forth a proposal on the administration for any
justifiable development or new needs
D. To support the administration with required information
E. To support the therapeutic team with the drugs they want
to use
F. To clear and also to recover the outstanding dues
G. To facilitate proper use of the dedicated funds if any
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56. THANK YOU
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