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COMMUNITY PHARMACY
Teshome G.
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
Counseling area
Semi-private area
27
Counseling area: Semi-private
area
28
29
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
Supplementary written
information must be used (as
appropriate).
The pharmacist must assess
each patient's ability to
understand the information
imparted.
Confidentiality of the patient
must be respected.
47
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
Problem Solving…
◦Unavailable
Strength/Dosage
◦Unavailable Medications
(limited use, short shelf life,
etc.) 51
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
PERSONNEL
Pharmacists
Pharmacy technicians
Supportive staff
Appropriate education, training,
and proficiency.
Proper maintenance, cleanliness,
and use of all equipment
Inspection and approval/rejection
of all components and 53
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
EQUIPMENT
Appropriate design, adequate
size, and suitably located to
facilitate operations.
Non-interacting, non-additive
and non-absorbing.
SOPs should be followed for
storage, inspection, calibration,
use, maintenance and cleaning55
SERVICES/compounding
INGREDIENTS
 Stored according to the
manufacturers’ directions or the
specifications on official
monographs
 Should meet official compendial
requirements
56
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
General principles for SOPs:
◦Specificity to a
pharmacy
◦Consideration of the
competence of staff
73
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
SERVICES/responding…
Further reading
 Blenkinsopp A, Paxton P,
Blenkinsopp J (2009). Symptoms
in the Pharmacy: A Guide to the
Management of Common Illness,
6th Edition, Blackwell Publishing
83
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
Emergency hormonal
contraceptives (‘morning-
after-pill’).
Emergency contraception (EC)
refers to contraceptive
methods that may be used in
the first few days after
unprotected sexual
intercourse, to prevent
85
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

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COMMUNITY PHARMACY (2017).ppt

  • 2. Outline  Introduction  Issues in community pharmacy practice  Organization of a community pharmacy  Services of the community pharmacy  Other professional service 2
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
  • 7. 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
  • 8. 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
  • 9. 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
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. 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
  • 18. 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
  • 19. 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
  • 20. 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
  • 21. 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
  • 22. 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
  • 23. 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
  • 24. 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
  • 25. 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
  • 26. 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
  • 29. 29
  • 30. Environmental factors  The general appearance of the pharmacy  Physical characteristics of pharmacy employees 30
  • 31. 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
  • 32. 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
  • 33. 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
  • 34. 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
  • 35. 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
  • 36. 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
  • 37. 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
  • 38. 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
  • 39. 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
  • 40. 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
  • 41. 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
  • 42. 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
  • 43. 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
  • 44. 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
  • 45. 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
  • 46. 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
  • 47. SERVICES/patient information Supplementary written information must be used (as appropriate). The pharmacist must assess each patient's ability to understand the information imparted. Confidentiality of the patient must be respected. 47
  • 48. 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
  • 49. 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
  • 50. 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
  • 52. 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
  • 53. SERVICES/compounding PERSONNEL Pharmacists Pharmacy technicians Supportive staff Appropriate education, training, and proficiency. Proper maintenance, cleanliness, and use of all equipment Inspection and approval/rejection of all components and 53
  • 54. 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
  • 55. SERVICES/compounding EQUIPMENT Appropriate design, adequate size, and suitably located to facilitate operations. Non-interacting, non-additive and non-absorbing. SOPs should be followed for storage, inspection, calibration, use, maintenance and cleaning55
  • 56. SERVICES/compounding INGREDIENTS  Stored according to the manufacturers’ directions or the specifications on official monographs  Should meet official compendial requirements 56
  • 57. 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
  • 58. 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
  • 59. 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
  • 60. 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
  • 61. 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
  • 62. 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
  • 63. 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
  • 64. 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
  • 65. 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
  • 66. 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
  • 67. 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
  • 68. 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
  • 69. 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
  • 70. 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
  • 71. 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
  • 72. 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
  • 73. SERVICES/sops General principles for SOPs: ◦Specificity to a pharmacy ◦Consideration of the competence of staff 73
  • 74. 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
  • 75. 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
  • 76. 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
  • 77. 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
  • 78. 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
  • 79. 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
  • 80. 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
  • 81. 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
  • 82. 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
  • 83. SERVICES/responding… Further reading  Blenkinsopp A, Paxton P, Blenkinsopp J (2009). Symptoms in the Pharmacy: A Guide to the Management of Common Illness, 6th Edition, Blackwell Publishing 83
  • 84. 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
  • 85. Other professional services Emergency hormonal contraceptives (‘morning- after-pill’). Emergency contraception (EC) refers to contraceptive methods that may be used in the first few days after unprotected sexual intercourse, to prevent 85
  • 86. 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
  • 87. 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
  • 88. 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
  • 89. 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
  • 90. 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
  • 91. 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
  • 92. 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
  • 93. 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
  • 94. 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
  • 95. 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