Outline
Introduction
Issues in community pharmacy
practice
Organization of a community
pharmacy
Services of the community pharmacy
Other professional service 2
1. Introduction
A community pharmacy is a premise
registered and licensed by an
appropriate government agency for the
provision of pharmaceutical services to
the general public.
Community pharmacist is the
professional who would be in direct
access to the public and whose duties
are widely sought after by the public and
patients. 3
Introduction
Community pharmacies are very
frequently the first contact with the health
system
• Local
• Ease of access
• Convenient
• Extended opening hours
• Availability of medicines
4
Introduction
Considerable proportions of
pharmacists work in this sector (FIP,
2006; B/Mariam, 2010)
• Overall = 57 %
• Western Pacific/SE Asia = 51 %
• Europe = 71 %
• Pan America = 66 %
• Africa / Eastern Mediterranean = 66 %
• Ethiopia = 19 %
5
Country Total number of
community
pharmacies
Community
pharmacy per
inhabitant
Australia 4926 3980
England 9872 5000
Estonia 523 2486
Germany 21,400 3900
Japan 49,956 2600
Kenya 611 55647
Peru 10,000 2722
United States 55,400 5380
Ethiopia 377 (FMOH, 2011) 212,202*
6
Table: Number of community pharmacies and their per capita distribution in
selected countries
2. Issues in community pharmacy
practice
o Useful additional business courses:
• management (personnel, supply
chain, finance, marketing),
• entrepreneurship
• economics
Ownership issues:
• pharmacist vs. non-pharmacist
• independent/chain
7
Issues in community …
Independent: a single
Opportunities exist to be:
an owner and run the pharmacy,
an employee working for the
owner/manager.
a part-time employee
8
Issues in community …
Ethiopia: approx. 300 independent
outlets
Chain (multiple) pharmacy: 12 to hundreds
and up to thousands of pharmacies
Are usually for profit/business corporations
with opportunities for multiple jobs:
distribution,
marketing, and
operations 9
Issues in community …
Chain pharmacy……
Organizational charts with the hierarchy
defined by position titles
Ethiopian scenario:
◦ Kenema Pharmacies (under the AA City
Administration): > 20 outlets in Addis Ababa
◦ Red Cross Pharmacies (under the ERCS):
outlets all over the country
10
Issues in community …
Globally: Example is Rite Aid in the US
◦ 3rd largest drug store in the US
◦ ranked #100 on Fortune among 500
Largest U.S. Corporations in 2011
◦ reported revenue of $26.3 billion in 2009
◦ 4703 locations all over the US and 54,600
employees
11
Issues in community …
Products sold:
human pharmaceuticals (POM, NP/OTC),
veterinary pharmaceuticals
herbal/alternative medicines,
Cosmetics and sanitary products
food items
others
Ethiopian setting: different types of retail
outlets
community pharmacies/drug stores/rural drug
vendors
(http://fmhaca.gov.et/Documents/Retail
outlets guideline.doc) 12
3. Organization of a community pharmacy
Human resource
◦ Pharmacists (chief/manager and others)
◦ Pharmacy technicians,
◦ Other support staff (cashier, accountant,
cleaner, guard).
◦ Pharmacist(s) and other staff on duty
must wear a name tag or badge
indicating his/her name and designation.
13
Minimum standards for pharmacy
premises, facilities and equipment
Appearance of pharmacy premises
Design and layout:
◦ Permit logical flow of work, effective
communication and supervision and ensure
effective cleaning and maintenance
◦ Minimize the risk of errors, cross-
contamination and anything else which would
have an adverse effect on the quality of
products. 14
Minimum standards…
◦ All parts of the premises must be maintained
in an orderly and tidy condition.
◦ The external appearance of the pharmacy
must depict a professional image.
◦ Entrances, dispensing counters and
doorways must be accessible to disabled
persons.
.
15
Minimum standards….
Security in pharmacy premises
Careful consideration must be given to the
overall security of the pharmacy.
◦ Access to a pharmacy when it is locked
◦ Control of access to medicine
Safety of pharmacy premises
◦ Working conditions
◦ Fire extinguisher
◦ Electrical equipment → safe and maintained
regularly.
◦ A safety procedure
16
Minimum standards
Condition of pharmacy premises
The walls, floors, windows, ceiling,
and all other parts of the premises
→clean and good order, repair and
condition.
Countertops, shelves and walls
→finished in a smooth, washable and
impermeable material.
Site of premises
◦ Far from areas or premises that can cause
contamination to the products and affect
health in general (e.g. public toilets, waste 17
Minimum standards….
Construction of pharmacy premises
Prevent:
◦ floods
◦ entry of insects, animals or birds
Easily cleaned and disinfected
Allows adequate lighting and air
movement
Ceiling:
◦ Should minimizes effects of high temperatures
◦ Adequate height
18
Minimum standards
Environment in pharmacy premises
Products stored according to
recommended conditions
Levels of heat, light, noise, ventilation,
etc., must exert no adverse effects on
pharmaceutical stock as well as
personnel.
Suitable and effective means of heating
19
Minimum standards…
Hygiene in pharmacy premises
Regular program for cleaning premises
Area for washing equipment and other
utensils (hot and cold tap water).
Toilet facilities must be kept clean and
in good order.
Hand-washing facilities
20
Minimum standards…
Premises
Dispensary
The size of the dispensary:
allow a safe and efficient flow of work and
effective communication and supervision
arrangement of available space and
space available elsewhere for storage of
stock.
Waiting area
Comfortable seating must be provided.
Appropriate health-related literature must be
provided
21
Minimum standards….
Ethiopian guideline: 25m² minimum for
dispensary and waiting area with
shortest side not less than 4 m.
South African guideline: a clear working
surface area of at least 90 cm by 1 m
for each pharmacist or other registered
pharmacy personnel.
22
Minimum standards….
Suitability of dispensary
The dispensary, its fittings and
equipment must be adequate and
suitable for the purpose of dispensing.
The temperature in the dispensing area
must be maintained below 25°C.
23
Minimum standards….
Counseling area
The area(s) must
◦ Be easily accessible and, where possible, be
close to the dispensary.
◦ Ensure reasonable privacy to the patient at
all times and eliminate background noise as
far as possible.
◦ Have sufficient space →appropriate
counseling and demonstration of the
correct and safe use of medicines.
24
Minimum standards….
Three types of areas may be
considered for the pharmacy, depending
on the:
◦ services offered by the pharmacy and
◦ degree of privacy required.
The models are:
◦ semi-private area
◦ separate private area and
◦ consultation area for the provision of
screening and monitoring services
25
Minimum standards
Semi-private area
◦ This area is for the provision of information
and/or advice that may occur in an area
visible to other patients.
◦ In such an area, patient counseling may
take place in a professional manner
regarding medicine use and other relevant
information,
◦ Does not provide the privacy required
26
Environmental factors
The general appearance of the pharmacy
Physical characteristics of pharmacy employees
30
Minimum standards…
Separate private area
◦ a small private room within the
pharmacy, which is in close proximity to
the dispensary.
◦ the area should be professionally
planned, tastefully and professionally
furnished and equipped,
◦ allows the pharmacist to counsel patients
on:
31
Minimum standards…
Consultation area for the provision of
screening and monitoring services
◦ an isolated area within which the pharmacist
can
consult in private with a patient and/or
perform certain screening and
monitoring services, e.g. cholesterol tests
or blood pressure monitoring ( Not
allowed in Ethiopia) 32
Minimum standards…
Storage areas in pharmacy premises
◦ independent and secure
◦ Large enough → orderly arrangement and
proper stock rotation
◦ Separate storage area for stocking
veterinary pharmaceuticals
◦ Sufficient shelving
Ethiopian guideline: 16 m² minimum for
storage with shortest side not less than 3
m. 33
Minimum standards….
Compounding room
◦ Must be of suitable size (Ethiopian
guideline minimum of 9 m² size and
shortest side not less than 2.5 m.
◦ Must have a suitable bench, shelves,
washing sink
◦ Appropriate references
◦ Equipments, apparatuses, chemicals and
appropriate materials 34
Minimum standards…
Office
◦ secretarial and managerial activities with
appropriate furniture and equipments
◦ stock recording and other relevant
documents (if applicable)
◦ Telephone and other communications
technology
Staff room
◦ Cloak room
◦ Tea room
35
Minimum standards…
Other issues
Waste disposal → SOPs
◦ Suitable and adequate means in written form
Dispensing equipment and materials
◦ Adequate, suitable dispensing equipment.
◦ Maintained clean, in good repair and of suitable
material.
Common ones include:
◦ Tablets and capsules counting
equipments/apparatuses.
For compounding purposes
36
Minimum standards…
Technology: specialized software:
manage the stock of pharmaceuticals and
other supplies
fills and labels each prescription,
processes the sales transaction
checks for medication errors, for the
management of patients with particular
disease states such as diabetes
Electronic prescribing
Additionally :
automated dispensing machines,
specialized compounding and mixing
equipment 37
Minimum standards…
Reference sources
Current editions recommended:
◦ Martindale;
◦ Drug interactions reference source;
◦ a comprehensive textbook on
pharmacology/pharmacotherapy;
◦ Standard Treatment Guidelines and Essential
Drug List for the appropriate level of care.
◦ A pediatric dosing reference guide (where
applicable);
◦ A medical dictionary; 38
Minimum standards
◦ the latest copy of the pharmacy legislation;
◦ Code of ethics
◦ Good dispensing practice manual;
◦ Pharmacopoeia (BP, USP) (where applicable);
◦ Others as applicable and appropriate;
Electronic access to the required
references is also acceptable in some
countries.
39
4. SERVICES OF THE COMMUNITY
PHARMACY
The major work of community
pharmacists involves supplying
medicines to the public:
Dispensing prescriptions
◦ The supply of medicines according to:
Good dispensing practices,
Good compounding practices
Maintaining records and
40
SERVICES/dispensing
Good dispensing practices
The dispensing process is
divided into three phases,
namely:
Phase 1: Interpretation and
evaluation of
the prescription.
Phase 2: Labeling and
preparation of the 41
SERVICES/dispensing
Phase 1: Interpretation and
evaluation of the prescription
Receipt of the prescription and
confirmation of the integrity of the
communication.
◦ identifying the patient, the
prescriber,
◦ legality/authenticity of the
42
SERVICES/dispensing
Assessment of the
prescription to ensure the
optimal use of medicine.
◦ therapeutic aspects
◦ appropriateness for the individual
◦ social, legal and economic
aspects
Pharmacist interventions 43
SERVICES/dispensing
Phase 2: Labeling and preparation
of the prescribed medicine
Labeling of item(s)
Selecting or preparing the
medicine
◦ patient-ready packs/pre-packed
medicines
◦ extemporaneous preparations
◦ pharmaceutical containers
Checking 44
SERVICES/dispensing
Phase 3: Hand to the patient and
Counseling
Supply to the patient
Counseling to be done by a pharmacist
Patient information leaflet
Monitoring patient outcomes
assess the patient for signs of compliance,
effectiveness and safety of the therapy
identify areas for interventions,
intervene, revise the patient record and
record the action taken
Read: Ethiopian Good Dispensing
45
SERVICES/patient information
Patient information and advice
Patient information and advice is of
vital importance in the correct use
of medicines
It must respect patient autonomy,
improve health and enhance the
outcome of medical treatment by:
◦ empowering consumers to make informed
decisions about their treatments and take
responsibility for their own health care;
◦ improving communication between patients
and health care providers; and
◦ aiding and encouraging effective use of
46
SERVICES/patient information
Steps for counseling a patient on a
new prescription
Introduce yourself and identify the patient.
Ask patient to talk with you about the
medication.
Assess the patient's understanding of
his/her disease and expected
outcomes of therapy.
Assess patient’s knowledge about the newly
48
SERVICES/patient information
COUNSELING PATIENTS ON THE USE OF
REFILL PRESCRIPTIONS
A refill counseling session
should concentrate on the
following three areas:
◦ Confirm that the patient has been
taking the correct medication and
knows the indication for its use.
◦ Ask how the patient has been taking 49
SERVICES/compounding
GOOD COMPOUNDING PRACTICE (GCP)
Definition
Compounding is the preparation of
a customized prescription
medication to meet the individual
patient needs in response to a
licensed practitioner's prescription.
50
SERVICES/compounding
Basic components of GCP
◦ Personnel
◦ Facilities
◦ Equipment
◦ Ingredients
◦ The compounding process
◦ Packaging and labeling
◦ Stability and beyond-use date
◦ Records and reports
52
SERVICES/compounding
FACILITIES
Site
Appropriate for the purpose of preparing
quality product.
Isolated from potential interruptions,
sources of contaminants of any type.
Located sufficiently away from dispensing
and counseling functions and high traffic
areas.
Service and utilities
Water (acceptable quality); electricity;
drainage system;
54
SERVICES/compounding
THE COMPOUNDING PROCESS
Validate the prescription
Check that the ingredients are available
in desired quality and quantity
Perform calculations
Identify the equipment needed
Wear the proper clothing and wash
hands.
Clean the compounding area and the
equipment
Only one prescription is compounded
at a time 57
SERVICES/compounding
SOPs shall be followed for the following
operations:
Weighing/measuring
Mixing of ingredients
Labeling the preparation
Entering information in the compounding log
Cleaning (room, equipment, containers)
Finally check before the preparation is
being dispensed
Physical characteristics
Quality tests, when appropriate
The beyond-use date 58
SERVICES/compounding
PACKAGING AND LABELING
Standard type of packaging material to
maintain the stability of the product
Patient-friendly package
Containers and closures cleaned
according to SOPs
The label on bulk preparations:
Name, strength and quantity of the product
Date of preparation
Control number
Storage condition 59
SERVICES/compounding
The label on compounded
preparations for individual patient:
◦ Name and address of the patient
◦ Name, strength and total quantity of
the preparation
◦ Control number/batch number of the
prod
◦ Beyond-use date
◦ Directions for use
◦ Storage condition
60
SERVICES/compounding
STABILITY AND BEYOND-USE DATE
Compounded drug preparations
are used immediately or stored
for a very limited time.
Stability evaluation and expiration
dating are different from
manufactured drug products 61
SERVICES/compounding
The beyond-use date is defined as that
date after which a dispensed product
should no longer be used by a patient
All the available stability information should
be consulted and a conservative estimate
be made for the product
Source of information:
expiry date of similar commercial
products
manufacturer’s literature
contacting the manufacturer
62
SERVICES/compounding
In the absence of stability information,
the following general guideline can be
used:
Solids and non-aqueous liquids prepared
from commercially available dosage forms -
25% of the remaining expiration date of the
commercial product, or 6 months, whichever is
earlier
Solids and non-aqueous liquids prepared from
bulk ingredients - up to 6 months
Water-containing formulations (prepared from
ingredients in solid form) - up to 14 days 63
SERVICES/Record keeping
Record keeping
Must be both accurate and up-
to-date.
◦ Compounding record
◦ Prescription Registration
◦ Patient medication records
◦ Stock records
◦ Health-screening related 64
SERVICES/Record keeping
Compounding record
The compounding information is
recorded on the compounding
log/compounding sheet
Content of compounding records for
products prepared on individual
prescription:
Date of preparation.
Control number
Source, batch number and expiration date of
all components 65
SERVICES/Record keeping
◦ Beyond-use date
◦ Signature or initials of pharmacist or
supportive person performing the
compounding function
Recording of the compounding
prescription
◦ Patient identifiers
◦ Diagnosis or ICD code number
◦ Description of the preparation
◦ Control number 66
SERVICES/Record keeping
Patient medication records
Patient medication records must be
developed, preferably using computer
technology.
Patient medication records must
respect the patient's privacy.
The following information must be
captured in a patient medication
record:
the full name of the patient;
the address and telephone number
67
Patient medication Record…..
◦ the patient's sex;
◦ Current weight of the patient;
◦ the name of the prescriber and date of
consultation;
◦ any known allergies of the patient;
◦ idiosyncrasies or negative reactions of
the patient towards medicine;
◦ family history;
◦ the presence of other factors, e.g.
smoking, drinking, etc.
◦ chronic conditions, disease states or
68
SERVICES/Record keeping
•a list of all medicines obtained
(prescription as well as non-
prescription) by the patient at
the point of supply during the
twelve-month period
immediately preceding the69
Patient medication record
date prepared:________________
name:______________________sex: ______ date of birth: _____________
weight______
pharmacist name: _____________________________ phone:
__________________
primary physician name: ______________________ phone:
____________________
adrs (if known):_______________________________________________________
medication allergies (if known):___________________________________________
medical conditions (if any):
______________________________________________
social history: smoking : ______________alcohol drinking : ____________________
caffeinated beverages : ____________________others:
:_______________________
family medical
history:___________________________________________________
list of medications (including non-prescription and herbal products):
___________________________________________________________________
_________________________
70
MEDICATION
NAME
DOSE DIREC-
TIONS
PURPOSE
FOR USE
PRESC-
RIBER
START
DATE
STOP
DATE
REMARKS
SERVICES/SOPs
Standard operating procedures (SOPs)
A SOP is a written document that
specifies what should be done, when,
where and by whom.
help to assure the quality of the
service
help to ensure that good practice is
achieved consistently
71
Sops……
help to avoid confusion
over who does what and
clarify roles within the
pharmacy
provide advice and
guidance to locums and
part-time staff
provide useful training tools
for new members of staff 72
SERVICES/sops
an outline or summary of SOPs:
the aim or purpose of the overall
SOP
objectives – what is the
procedure trying to achieve?
scope – what areas of work are
to be covered by the procedure?
risks – are there any risks
associated with the task?
review date – to ensure that the
procedure continues to be useful 74
SERVICES/sops
The main part of the document
includes:
◦ stages of the process – describe
how the task is to be carried out step
by step
◦ responsibility – who is responsible
for carrying out each stage of the
process
◦ other useful information – is there
75
SERVICES/public health
Public health is part of the community
pharmacist’s roles:
◦ Disease prevention
◦ Health promotion
Promoting healthy lifestyles consists of
two separate areas:
◦ prescription-linked intervention
◦ involvement in public health campaigns.
Prescription-linked intervention
involves offering opportunistic
advice on public health topics to
patients that present a prescription. 76
SERVICES/public health
Promotion of healthy lifestyles will
include offering advice in the
following areas:
◦ STDs and HIV/AIDS
◦ Infectious diseases such as malaria,
URTIs and diarrheal diseases
◦ FP and child care
◦ Antimicrobial resistance
◦ CVDs, Cancer, Diabetes
Health issues: stopping smoking,
alcohol intake, nutrition advice and77
SERVICES/responding to
symptoms
Responding to symptoms and referral
Advice on appropriate OTC medicines for
symptomatic relief in the case of self-
limiting minor illnesses and common
complaints.
The sales of OTC medicines account for
between 8 and 30% of total pharmaceutical
sales in the majority of world regions.
Members of the public sometimes expect
78
SERVICES/responding…
The patient's need to ask for a particular
OTC medicine/self-medication may arise
due to several factors:
Influence of advertisements or the media.
Recommendations by friends or relatives.
Prior use for similar conditions.
Inability to go to a physician for various
reasons such as
Cost factor.
Lack of time.
Unavailability of a doctor.
The feeling that their condition is
simple enough to be treated with OTC79
SERVICES/responding…
Skills required may be:
◦ Communication skills
◦ Clinical skills
◦ Knowledge of current OTC medication
◦ Directing/referral
What the pharmacist can do:
◦ Enquire whether the patient knows
the correct use of the medicine.
◦ Get into a conversation so that you
can ask the patient to tell you the
symptoms for which he/she wants 80
SERVICES/responding…
◦ Enquire whether the client is taking any
other medicines.
◦ Enquire whether the client suffers from
any other illness/conditions.
◦ Assist the patient in selecting an OTC
medicine suitable to his symptoms and
also check that it is not
contraindicated for the illness/condition of81
SERVICES/responding…
Inform the patient:
◦ How to take.
◦ How much to take (maximum
permissible daily dose).
◦ When to take; for how long to take
◦ Any adverse drug reactions
observed.
◦ Any side effects likely to occur.
◦ Any precautions to be taken.
◦ To see a physician if the condition
82
5. Other professional services
Retailing
Remuneration/methods of
payment:
◦ Markups on individual items and
income derived solely from the sale
of medicines,
◦ Fixed dispensing fees
Managerial skills
Financial strategy and planning
Marketing 84
Other professional services…
Pharmacies are ideally placed
to provide this service and
increase access to the service.
Effectiveness of ECs (within 72
hrs)
C/I: Confirmed pregnancy
Counseling
Appropriate use of EC
Effective, ongoing contraceptive86
Other professional services
Health screening:
◦ Body weight and height;
◦ Blood pressure;
◦ Blood glucose;
◦ Pregnancy;
◦ Cholesterol;
◦ Peak flow test;
◦ HIV
Requirements: facilities and
training
Appropriate public health
education and counseling 87
Other professional services
First aid provision
Emergency treatment of wounds; bone fractures;
burns; bleeding; foreign objects in nose, ear, eye and
respiratory system; severe diarrhea; high fever;
poisoning and snake bite; etc.
Adverse drug reaction reporting
Report suspected adverse drug reactions (ADRs) to
the regulatory body (e.g. Food, Medicines and
Healthcare Administration and Control Authority,
FMHACA)
For new drugs that have received market
authorization in the last 2 years) for which any
88
Other professional services
Nutrition advice (diabetes,
hypertension, pregnancy, etc.)
Site for training of pharmacy interns
Drug information services
◦ General public
◦ Healthcare providers
Immunization services
◦ travel,
◦ childhood,
◦ tetanus, etc.
89
Other professional services
Smoking cessation clinics
Pharmacies are recognized as being
well placed to offer a smoking-
cessation service as they are readily
accessed by the public and have a
resident healthcare professional.
Pharmacists are involved routinely in
brief interventions as part of the
90
Other professional services
Initial and follow up consultations
◦ Nicotine replacement therapy (NRT)
◦ NRT delivers nicotine in a clean form
and helps smokers to overcome
withdrawal symptoms such as irritability
and craving while avoiding the many
harmful chemicals in tobacco and the carbon
monoxide that cause serious damage.
91
Other professional services
Medication therapy management
(MTM)
Medication Therapy Management
(MTM) officially recognized by the US
Congress in the Medicare Prescription
Drug, Improvement, and
Modernization Act of 2003 (MMA
2003). 92
Medication therapy
management (MTM….
Requirements for MTM Programs are
“designed” to “optimize therapeutic
outcomes through improved medication
use” and “reduce the risk of adverse
events, including adverse drug
reactions.”
Objectives are to increase patient
adherence, prevent drug complications,
93
MTM….
◦ MTM programs are designed to
improve medication use, enhance
patient safety, and increase patient
adherence to their medication regimens
◦ A MTM program established for
targeted beneficiaries such as those
who have multiple chronic disease
94
MTM…..
Core elements for MTM
services
◦ Medication therapy review,
◦ Personal medication record,
◦ Medication-related action plan,
◦ Intervention and/or referral, and
◦ Documentation and follow-up 95