Pharmacy Practice
Pharmacy Practice
3 12/06/2025
Pharmacy in Ancient Babylonia…
6 12/06/2025
Ebers Papyrus…
13 12/06/2025
In Ancient Rome
Galen (130-200A.D) was a prominent physician,
surgeon, and philosopher.
17 12/06/2025
Traditional Era
Beginning of the 20th century, pharmacists formulated
and compounded medications from natural sources.
Prescriptions were compounded by hand, using a
mortar and pestle, ingredients and dosages tailored
to individual patients.
Less than 1% of all prescriptions today are
compounded.
Pharmacists-in-training served as apprentices,
learning the trade in pharmacies rather than sitting in
a classroom.
Pharmacognosy – the knowledge of the medicinal
functions of natural products from animal, plant, or
mineral origins was a piece of the limited education
18 12/06/2025
pharmacist focused on at this time.
Scientific Era
Post WWII period, pharmaceutical
manufacturers developed and tested new
drugs and dosage forms..
21 12/06/2025
Pharmaceutical Care Era
Pharmaceutical care – expands the
mission of the pharmacy profession to
include responsibility for ensuring positive
outcomes for drug therapy.
22 12/06/2025
Additional Responsibilities
Based on the pharmacy setting
pharmacists may have specific
responsibilities.
Community Pharmacies:
Institutional Pharmacies:
23 12/06/2025
Pharmacy practice and the healthcare system
1. Medicine management
– drug development
– dispensing of medicine
– patient counseling
24 12/06/2025
2. Management of chronic conditions:
– monitoring therapeutic outcomes
– improvement in quality of life
3. Management of common diseases:
– counseling
– recommendation of line of action
25 12/06/2025
3. Promotion and support of healthy lifestyles:
– health education
– health screening
26 12/06/2025
Pharmacist interventions in the healthcare system
28 12/06/2025
2. Identifying groups of patients with special needs
Patients suffering from certain diseases, such as:
29 12/06/2025
Age groups:
30 12/06/2025
3. Achieving cost-effective patient care
Value for money and cost- effectiveness are important
original
31 12/06/2025
Medicine presentation and administration
7R
The Right medicine
At the Right dose,
In the Right form
Is administered to the Right patient,
at the Right time,
by the Right route,
using the Right technique,
32
and the Right documentation is kept 12/06/2025
Medicine safety
medicine
Proper labeling on container to include dosage regimen
Cautionary labels
May cause drowsiness.
containing preparations).
Cetirizine , Chlorpheniramine , Clemastine
34 12/06/2025
Diphenhydramine and Loratadine etc
Avoid alcoholic drink (e.g. metronidazole)
inflammatory drugs)
35 12/06/2025
Swallow whole, do not chew (e.g. enteric- coated and
36 12/06/2025
Advisory labels
externally).
Discard 4 weeks after opening (e.g. eye drops).
37 12/06/2025
Barriers to proper use of medicines
Patient confusion
Communication problems
Side-effects
Dispensing errors
Cost of medicines
Accessibility
38 12/06/2025
Drug-related problems
Sub-therapeutic dose
Drug interactions
39 12/06/2025
Adverse drug reactions
drug discontinuation
dose modification
hospital admission
40 12/06/2025
An ADR can lead to…
prolonged hospitalization
complication of diagnosis
41 12/06/2025
Adverse drug reaction monitoring and
reporting program
ADR surveillance:
monitoring occurrence.
ADR documentation:
documenting incident.
Reporting of ADRs:
reporting to national regulatory authority (e.g.
FMHACA).
The national regulatory authority undertakes
coordination and monitoring of suspected ADRs on a
local and an international level
42 12/06/2025
Pharmacists should participate in mechanisms that
43 12/06/2025
Processes of an ADR monitoring program
Monitoring
Detecting
Evaluating
Documentation
Reporting to authorities
members
44 12/06/2025
Drug interactions
the other.
Occurrence and impact of drug interactions should be evaluated on the
47 12/06/2025
Medication errors
48 12/06/2025
Medication errors…
being administered.
Time error /dose error /administration technique
error:
49 12/06/2025
Some practices to reduce medication errors during prescribing
E.g. micrograms
Names of drugs must be written clearly and not
abbreviated
50 12/06/2025
Poisoning
absorption.
56 12/06/2025
Prevention of absorption of poison…
poisoning
Flumazenil, a benzodiazepine antagonist, is used in
58 12/06/2025
Community pharmacy:
It is known as community pharmacies because they serve
59 12/06/2025
Community pharmacy…
Dispense pharmaceuticals
medical equipments
60 12/06/2025
Organization of a community pharmacy
Human resource
Pharmacists (chief/manager and others)
Pharmacy technicians,
cashier
Other support staffs
accounta
nt
cleaner
guard
1. Appearance of pharmacy
premises
64 12/06/2025
Minimum standards
4.Condition of pharmacy premises:
The walls, floors, windows, ceiling,
woodwork and all other parts of the
premises
clean and good order, repair and condition
Site of premises
65 12/06/2025
Far from areas or premises that can cause
Minimum standards
5. Construction of pharmacy premises
Prevent:
floods
entry of insects, animals or birds
66 12/06/2025
Minimum standards
6. 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
or cooling, lighting and ventilation.
Background music or other broadcasts →
67 12/06/2025
distraction
Minimum standards
7. 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
68 12/06/2025
Minimum standards
PREMISES:
Dispensary
The size of the dispensary:
volume of prescriptions dispensed and
Waiting area
Comfortable seating must be provided.
Appropriate health-related literature must be
69 provided 12/06/2025
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.
71 12/06/2025
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 to
advise patients on sensitive issues.
72 12/06/2025
Counseling area
Semi-private area
73 12/06/2025
Counseling area: Semi-private area
74 12/06/2025
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:
sensitive emotional or health care problems and
their medicines, and other related issues.
75 12/06/2025
Minimum standards
Storage areas in pharmacy
premises
Self-contained 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.
77 12/06/2025
Minimum standards
Other issues
Waste disposal → SOPs
Suitable and adequate means in written form
81 12/06/2025
Minimum standards
the latest copy of the pharmacy legislation;
Code of ethics
Good dispensing practice manual;
Good_Dispensing_manual_new_2.pdf
Pharmacopoeia (BP, USP) (where
applicable);
Others as applicable and appropriate;
Electronic access to the required
references is also acceptable in some
countries.
82 12/06/2025
Services provided by the community pharmacy
general public
Participation in the health promotion programms.
83
Ensure the quality of the product they supply 12/06/2025
1. Processing the prescription
prescription order
Checks the patient medication record before
accurately
84 12/06/2025
Processing the prescription…
history
Clarify the patient’s understanding of the intended
response
86 12/06/2025
3. Monitoring of drug utilization
87 12/06/2025
4. Extemporaneous preparations
practice guidelines
88 12/06/2025
5. Traditional and alternative medicine
supplying medicine
90 12/06/2025
7. Informing health professionals and the public
on medicines
Provide this information to other health care
91 12/06/2025
8. Health promotion
HIV-infection)
Family planning
92 12/06/2025
3.Good dispensing practice
93 12/06/2025
Assessment of the pharmaceutical sector in Ethiopia in
seconds,
On average, only 19.95% of medicines dispensed to
96 12/06/2025
Introduction…
Evaluation of prescriptions is a crucial step of the
dispensing process
Counseling patients on medications is a major part of
dispensing
Lack or improper counseling by dispensers leads to
incorrect use of medicines by patients
In correct use results in loss of efficacy or occurrence of
adverse effects.
Dispensers should be able to equip themselves with up-
to-date medicine information
97 12/06/2025
Introduction…
Dispensers need to have communication skills so as to
effectively deal with patients or health care providers.
98 12/06/2025
3.1. Principles of good dispensing practice
99 12/06/2025
Dispensing- all the activities that occur b/n the time the
request
10 12/06/2025
0
SodoHospital
prescription paper
Patient name: Kedir Mohammed
Age: 60yrs
Diagnosis:______________
Rx—Amytriptillin 25mg po 1 tab noct for 1 month
Prescriber name:_________________________________
Qualification:__________________________________
Sign:_______________________________________
Leku Hospital
prescription paper
Patient name: Berhanu Tamirat
Age: 40yrs
Diagnosis:______________
10 12/06/2025
1
Accurate preparation and labeling of drugs with
10 12/06/2025
3
Determinates of dispensing
10 12/06/2025
4
Some ways to reduce dispensing errors:
prescription
Keeping the pharmacy professionals up to date
10 12/06/2025
5
The dispensing environment should possess:
Appropriate temperature
Sufficient lighting
Humidity control
11 12/06/2025
1
Stock management
11 12/06/2025
3
Elements that insure proper stock management
A. Acquisition of drugs
Before drugs and medical supplies are issued from store to
dispensing room
store requisition/delivery (issue) form should be filled by
11 12/06/2025
4
When you receive drugs for dispensing:
products
Check that all original boxes, tins, or bottles are
11 12/06/2025
5
If products are defective:
Separate the damaged or expired stock from the
usable stock
Refuse to accept the products
body.
11 12/06/2025
6
Ensure the expiry date is visibly marked on every
package or unit
Arrange products in the storage area in FEFO or FIFO
procedure.
Take note of the unit price of each drug and medical
11 12/06/2025
8
B. Stock keeping
and key
11 12/06/2025
9
Stock keeping…
Keep high security/high value products in appropriate
secured places
Separate damaged or expired products from the usable
12 12/06/2025
0
Stock keeping…
human use
Report to appropriate body for redistribution of
12 12/06/2025
1
C. Stock rotation
Pharmacotherapeutic category
Dosage forms
Coding
12 12/06/2025
3
In arranging drugs
Each dosage form is arranged in separate & distinct areas
Sufficient empty space should demarcate one drug or
dosage form from another
Put drugs in dry place protected from direct sun light and
heat
Store liquids in a pallet on the floor or on the lowest shelf
Do not store anything directly on the floor
Always store cold-chain items in the refrigerator
12 12/06/2025
4
E. Storage condition
12 12/06/2025
5
When a product label states “Protect from moisture”
relative humidity
Free air circulation by opening windows, using fans or
air conditioners
12 12/06/2025
6
Some products are photosensitive and will be damaged
if exposed to light.
To protect products from sunlight:
of direct sunlight,
Keep products in cartoon
12 12/06/2025
7
Cold storage conditions
12 12/06/2025
8
Special storage conditions
13 12/06/2025
0
All stores should be equipped with fire extinguishers.
13 12/06/2025
1
The dispenser…
13 12/06/2025
3
The dispenser…
pressure
Respect to pharmacy law and professional code of
ethics.
13 12/06/2025
4
The dispenser…
institution
Knowledge about national polices and working
guidelines
Good knowledge of societal norms and cultural values
professionals
13 12/06/2025
5
Good Dispensing Process
13 12/06/2025
6
13 12/06/2025
7
13 12/06/2025
8
13 12/06/2025
9
14 12/06/2025
0
Good Dispensing Process
14 12/06/2025
1
Step 1. Receive and validate prescription or
verbal request
Ask the patient to give his/her name and check the
14 12/06/2025
2
Check the following information on the prescription:
Patients name, sex, age, card number, address
registration number
14 12/06/2025
3
Step 1.
14 12/06/2025
4
Step 2. Understand and interpret prescription
prescriber
Confirm that the doses prescribed are in the normal range
14 12/06/2025
5
Step 2…
quantity to be issued
14 12/06/2025
6
Step 3. Prepare items for issue
dispensing process.
Do not select the prescribed drugs according to the color
or location of container.
Do not open many stock containers at the same time.
14 12/06/2025
Open and close containers once at a time.
7
Step 3
14 12/06/2025
8
Labeling of dispensed drugs should contain
14 12/06/2025
9
Labeling…
Dispensing date
15 12/06/2025
0
Labeling of dispensed medicines should be
clear, legible, tailored, and simple to understand
15 12/06/2025
3
Example of label –Clotrimazole
15 12/06/2025
4
Example of label –Gentian Violet
XYXT ሆ ስፒ ታ ል መ /ቤ ት : c.l 047362…
የመ ድ ኃኒት አጠ ቃ ቀ ም መ ረጃ
Öª ƒ u_____ c¯ ƒ ቆ ስሉ ን ይ ቀ ቡ ት
T ታ u _____ c¯ ƒ ቆ ስሉ ን ይ ቀ ቡ ት
ለ 3 ቀ ናት
ሊ ደረጉ የሚ ገባቸ ው አስፈ ላጊ ጥ ንቃ ቄ ዎ ች ፡-
1. u› õ ¾T >¨ cÉ › Ã ÅKU !!
2. c¯ ~” Ö wk ¨ <ይ ቀ ቡ ት !!
3. ŸK?L c¨ <Ò` › Ã Ò\ !!
4. S É ’ >
~” ¨ cŬ ÁM} KS Æ U M¡ „ ‹ " ÒÖ V ƒ KvKS <
Á¬ „ KA ÁT ¡ \ !!
5. ¾I S U U M¡ ƒ eKÖ ó w‰} hK˜ wKA መ ቋ[ Ø ¾Kw ƒ U !!
6. መ ድ ሃ ኒቱ ን በቁ ስሉ ላይ ብ ቻ ይ ቀ ቡ ት !!
7. የቆ ሰለዉ ቦታ በፍ ጹ ም መ ሸፈ ን የለበት ም !!
8. የል ብ ስ ቀ ለም ል ያበላሽ ይ ች ላል !!
9. ል ብ ስና አንሶላን ሁ ል ጊዜ ማ ጽ ዳት አለብ ዎ ት ም !!
10. መ ድ ሃ ኒቱ ን በተ ገዛ በአንድ ሳም ንት ጊዜ ዉ ስጥ መ ጠ ቀ ም አለብ ዎ ት ፡ የተ ረፈ ካለ ይ ድ ፉ ት !!
11. Ñ>
² ? ÁKð uƒ ” ¨ à ”U ¾wMi ƒ U MŸƒ Ád¾” S É ’ >ƒ › ÃÖkS < !!
12. S É H’ >
ƒ G< MÑ>² ? u^c<S Á¹ uÅ”w } ŸÉ • w` H” uT à Åር euƒ uÅ[ p“ k ´ n ³ x Áek U Ö <
!!
¾ታ ² ² Kƒ c¬ eU : ወ /ሮ ብ ዙ ነሽ ተ ሰማ
k ” : የካት ት 27፣2005 Expiry date፡ J an 2014
Q é“ ƒ uT Ã Å` c<
uƒ x à k S Ø !!
15 12/06/2025
5
Step 4. Issue drugs to patient with clear
instructions and advice
15 12/06/2025
7
Step 5. Recording, documentation and reporting
15 12/06/2025
8
Step 5…
initials
The date of dispensing
15 12/06/2025
9
Step 6 Prescription filing
16 12/06/2025
0
Step 6, cont’d.
Normal prescriptions should be filed securely for two
years and special prescriptions for 5 years.
16 12/06/2025
1
HOSPITAL PHARMACY
SERVICES
16 12/06/2025
2
INTRODUCTION
Pharmaceutical services are an essential component of
hospital care.
Effective pharmaceutical services promote:
16 12/06/2025
3
OPERATIONAL STANDARDS FOR
PHARMACY SERVICES
1. The hospital has DTC which implements measure to
promote the rational and cost effective use of
medicines
2. The hospital has a medicines formulary listing all
pharmaceuticals that can be used in the facility
The formulary is reviewed and updated every 2 year
The hospital has out patient, inpatient, emergency
pharmacies and a central medical store each directed by
a registered pharmacist
16 12/06/2025
4
OPERATIONAL STANDARDS FOR
PHARMACY SERVICES…..
4. The hospital ensures that all types of drug
transaction and patient medication related
information are properly recorded and
documented.
5. The hospital has Standard Operating Procedures
(SOPs) for all compounding procedures carried out
6. The hospital provides access to drug information to
both healthcare providers and patients in order to
optimize drug use
16 12/06/2025
5
OPERATIONAL STANDARDS FOR
PHARMACY SERVICES…..
8. The hospital has policies and procedures for
identifying and managing drug use problems,
including: monitoring ADRs, prescription
monitoring and drug utilization monitoring
16 12/06/2025
8
MEMBERSHIP OF DTC
The DTC Should be multidisciplinary including, as a
minimum:
Chief Clinical Officer, or equivalent (Chair Person)
Senior Pharmacist (Secretary)
A representative from each case team
A representative clinician from each specialty
(internal, Surgery, pediatrics, Obs/gynae)
Senior nurse representative
Representative from hospital finance department
Representatives from other services as deemed
16 12/06/2025
9 necessary
MEMBERSHIP OF DTC…
All DTC member, especially the chair and
secretary, should be given sufficient time for
their daily functions, and this should be
included in their job descriptions.
Other non-voting, non executive members may
be invited to attend DTC meetings to discuss
issues that require their particular expertise.
17 12/06/2025
0
PROCEDURE OF DTC MEETINGS
The DTC should meet at a minimum of every two
months, or more often as the need rises
Minutes should be kept of all DTC meetings
The agenda, supplementary materials and minutes
of the previous meeting should be prepared by the
secretary and distributed to members for review in
sufficient time before the meeting.
All DTC recommendations should be disseminated
to the medical staff and other concerned parties
and authorities in the hospital.
17 12/06/2025
1
ROLES AND RESPONSIBILITIES OF THE
DTC
1. To develop and maintain hospital formulary:
The hospital should have a Hospital Formulary listing all
pharmaceuticals that can be used in the facility
A participatory process should be followed to develop the
formulary involving clinical, laboratory, diagnostic imaging
and finance personnel.
The formulary should be reviewed and updated at least
annually?
17 12/06/2025
2
BENEFITS OF AN EFFECTIVE FORMULARY
SYSTEM
Approved and efficacious drugs available for use:
Only the most effective and safe products
17 12/06/2025
3
BENEFITS OF AN EFFECTIVE
FORMULARY SYSTEM……
Drug therapy at lower cost:
Ineffective, high-cost drugs will not be available
Availability of most-effective drugs leads to
improved outcomes and lower cost
Reduced inventory cost
17 12/06/2025
4
BENEFITS OF AN EFFECTIVE
FORMULARY SYSTEM…..
Consistent supply of drugs:
17 12/06/2025
5
BENEFITS OF AN EFFECTIVE
FORMULARY SYSTEM……
The selection of pharmaceuticals for the
formulary should be based on:
The national drug list (List of Drugs for Ethiopia)
17 12/06/2025
6
BENEFITS OF AN EFFECTIVE
FORMULARY SYSTEM…..
During the preparation of the formulary
emphasis should be placed on:
Drug description using generic names
17 12/06/2025
7
2. To develop standard clinical/treatment
guidelines
STGs promote rational drug use and provide a bench
mark of optimum treatment for the monitoring and
audit of drug use.
The DTC should implement national STGs for use in
their own hospital
Hospital should develop their own STGs for common
clinical conditions that are not covered by national
STGs
A participatory process should be followed to develop
STGs involving clinical, laboratory and diagnostic
17 imaging personnel 12/06/2025
9
ADVANTAGES OF STGS
Health Care Providers:
Provides assistance/standardized guidance to
practitioners
especially to those with lower skill levels
Promotes high quality of care
Health Care Officials:
Provides a system for controlling costs
Provides a basis for evaluating quality of care
Provides information for forecasting and ordering
18 12/06/2025
0
ADVANTAGES OF STGS…
Patients:
Patients receive optimal drug therapy
Helps provide good outcomes
Lower cost
18 12/06/2025
1
DISADVANTAGES…??
Inaccurate guidelines will provide the wrong
information.
18 12/06/2025
2
ESTABLISHING THE GUIDELINE
Determining appropriate treatment options:
Use fewest drugs necessary
Choose cost effective treatment
Use formulary drugs
Give 1st, and when appropriate 2nd, and 3rd Line
treatment options
Provide dose, duration, contraindications, side-effects
18 12/06/2025
3
ESTABLISHING THE GUIDELINE….
Determine what information should be included in the
STG:
Clinical condition
Diagnostic criteria and exclusions
Treatment objectives
Non-drug treatment
Drugs of choice
Important prescribing information
Referral criteria
Patient education information
What to do when clinical response is poor
18 12/06/2025
4
3. To develop policies and guidelines for managing
formulary and non formulary items
Policies/guidelines for the selection,
quantification, procurement and distribution of
pharmaceuticals.
Policies/guidelines for generic substitution and
therapeutic interchange
Policies/guidelines on the use of specific
medications. For example, narcotics,
chemotherapeutic agents, highly expensive
medications, etc.
18 12/06/2025
6
4. To establish mechanisms to identify
and address drug use problems
The DTC should establish policy and procedures
for identifying and managing drug use problems
including, as a minimum:
Monitoring ADRs
Prescription monitoring
Drug utilization monitoring
Antimicrobial prescribing and use
18 12/06/2025
7
5. To establish and oversee the DIS
Each hospital should establish a drug information
service that provides information and advice to
health professionals, patients and the public
18 12/06/2025
9
6. To develop an annual action plan
The DTC should prepare an annual action plan,
describing the main tasks to be under taken in the
year with corresponding budget requirements to
cover areas such as trainings, printing, etc
19 12/06/2025
0
HOSPITAL PHARMACEUTICAL SERVICES
Clinical pharmaceutical services
Dispensing and medication use counseling
Emergency pharmacy services
Compounding of extemporaneous preparations
Drug information services
Monitoring of drug use problems
Drug supply management
Pharmaceutical waste management
19 12/06/2025
1
CLINICAL PHARMACY SERVICES
Clinical pharmacy services are patient-oriented
services developed to promote the rational use of
medicines, and more specifically:
to maximize therapeutic benefits (optimize treatment
outcomes),
minimize risk, reduce cost, and
support patient choice and decision thereby
Ensuringthe safe, effective and economic use of
drug treatment in individual patients.
19 12/06/2025
4
Functions of clinical pharmacists:
1. Provide advice to doctors, nurses and other
healthcare providers on the clinical use of
medicines, economic drug utilization and safety
2. Offer direct patient care services through, for
example, medication history taking, medicines
education and advice
3. Offer hospital managers, including clinical
managers, appropriate advice and support to enable
them to make informed decision with respect to
medicines policy, procedures and guidelines
designed to ensure safety, effectiveness and
economy in medicine use
19 12/06/2025
5
Emergency pharmacy services
Emergency pharmacy service is one of the basic
healthcare services to be provided under the
emergency service unit of a hospital.
Directed by a register pharmacist who is accountable
to the emergency unit of hospital.
Service should be available 24 hours a day
The pharmacist is responsible to coordinate and
prepare emergency pharmaceutical list and
ambulance kits for the hospital.
Ensures continuous availability of these
pharmaceuticals
19 12/06/2025
6
Emergency pharmacy services:
May receive orders by words of mouth or through
telephone but should be written and documented
within 48 hours
The quantity ordered should be limited to emergency
period only
Ensure safe and correct use of medications as
medication error is significant in this service area
19 12/06/2025
7
Drug information services
All hospitals should provide drug information service
for health care professionals, patients and the public.
The service generally responds to patient-oriented
drug problems received from clinical staff or patients
But, the drug information service can also provide
education and training to health professionals and/or
the public regarding appropriate and safe drug use
19 12/06/2025
8
Drug information services….
DIC should be established in each hospital.
The center should have:
Sufficient space
Furnitures: filing cabinet, computer, printer
Telephone
Internet access
Current reference materials: books, journals, drug profiles,
formularies
19 12/06/2025
9
Drug information services…
DIC should be open during normal pharmacy
hours
Should be staffed with appropriate skilled
personnel who are trained in the provision of
drug information
20 12/06/2025
0
Monitoring of Drug Use Problems
The hospital should develop and implement a policy
for monitoring drug use and to identify drug use
problems that include:
Monitoring ADRs
Monitoring of prescription
20 12/06/2025
1
Monitoring and Reporting of ADRs
Side effects/ ADRs may range from mild to serious and
life threatening
Detection of SEs and ADRs is important to optimize
patient care and prevent harm
An important element of post marketing surveillance
20 12/06/2025
2
Monitoring and Reporting of ADRs….
Individuals susceptible to an ADR include:
Those with multiple diseases
Those on multiple drug therapy
Geriatric or pediatric patients
Those receiving medicines that are known to be associated
with serious adverse effects
Those receiving drugs with a low therapeutic index or
potential for multiple interactions
20 12/06/2025
3
Those with organ impairment that may alter drug PK
Those who have had a previous ADR
A standardized form should be used to record
and report ADRs
20 12/06/2025
4
An ADR focal person should be appointed by the DTC.
He/she is responsible to:
1. Ensure that all health professionals are involved in
detecting, assessing, managing and reporting
potential ADRs
2. Ensures that ADR report forms are readily available
in all clinical areas and that health professional are
familiar with the form and how to complete it
3. Receive ADR report forms from clinical staff
4. Investigate potential ADRs
20 12/06/2025
5
5. Analyze ADR data and compile reports
6. Provide regular reports to the DTC/and the
Hospital Management on ADRs in the facility
7. Report all ADRs to the Regulatory Body
20 12/06/2025
6
The DTC should receive regular reports from
the ADR focal person and make any necessary
decisions regarding the use of the drug in the
facility
Where necessary the hospital formulary should
be amended to take account of detected ADRs
20 12/06/2025
7
Suspected ADRs should be investigated and
managed as follows:
1. Assess suspected ADR with respect to:
a) Patient details: age, gender, organ function, height,
weight, Dx and comorbidities prior to ADR, previous
exposure to the suspected drug(s) or related drug(s)
20 12/06/2025
8
c) Comprehensive adverse reaction details:
description of the reaction;
time of onset and duration of reaction;
complications and sequelae;
treatment and outcome of treatment;
relevant investigation results or autopsy report
20 12/06/2025
9
2. Perform causality assessment to assess likelihood
of the drug causing the observed reaction.
A literature review to assess the likelihood that a
suspected ADR was caused by a particular drug and/ or
advice of other health professional may be sought
21 12/06/2025
0
3. Make recommendation on treatment
options, including possible alternative
treatments taking into consideration:
The likelihood of the suspected drug(s) causing
the reaction,
The clinical significance of the reaction
The condition of the patient,
The requirement for therapy
21 12/06/2025
5
Prescription Monitoring
Prescription issued by each Case Team should be
regularly mentioned to identify problems or
opportunities for optimizing treatment.
The DTC should establish a policy that outlines the
responsible person(s), the process and frequency with
which prescription monitoring will be conducted for
each Case Team
21 12/06/2025
8
Patients and their medicine therapy should be
monitored for:
Legality, legibility and completeness of prescription
Relative efficacy of the medication for the clinical indication
Compliance with the hospital formulary or applicable STG
The appropriate dose, route of administration, duration
Possible altered kinetics of A, D, M or E
Significance of DI
Possible drug/disease incompatibilies
Drug/laboratory test interference
Duplication of therapeutically similar drugs
21 12/06/2025
9
Drug utilization Monitoring
The purpose of drug utilization monitoring is to assess
the over all drug utilization pattern of the hospital and
identify problem areas for intervention and the impact
of interventions.
Two main methods:
1. Indicator study methods
2. Drug use evaluation (DUE) methods
22 12/06/2025
0
a) Indicator study methods
Can be developed to assess prescribing, patient
care or facility practice.
22 12/06/2025
1
Prescribing indicators
Average number of medicines per encounter
% of medicines prescribed by generic name
% of encounters with an antibiotic prescribed
% of encounters with an injection prescribed
% of medicines prescribed which are from the
essential medicines list or formulary list
22 12/06/2025
2
Patient care indicators
Average consultation time
Average dispensing times
% of medicines actually dispensed
% of medicines that are adequately labelled
% of patients who know how to take their
medicines
22 12/06/2025
3
Facility indicators
Availability of essential medicines list or formulary
Availability of STG
22 12/06/2025
4
Drug Use Evaluation Methods (DUE)
Particularly important to investigate:
Perceived overuse or underuse of medications
Problems identified by indicator studies,
High numbers of ADRs
Excessive amounts of non-formulary medicines
used
Use of high-costs medicines when less expensive
alternatives exist
Use of excessive numbers of medicines within a
22 therapeutic category 12/06/2025
6
Steps to conduct a DUE study
1) Define appropriate medicine use
2) Audit actual prescribing practice against the set
criteria
3) Analyze data, prepare report and
recommendations based on findings
4) Present report and recommendations to DTC and
relevant staff
5) Implement recommendations arising from the
study, repeat study to assess the impact
22 12/06/2025
7
Reading assignment
Pharmaceutical Waste
Management??
22 12/06/2025
8
Pharmaceutical Waste Management
Pharmaceuticals which are eligible for disposal
include the following:
All expired/damaged pharmaceuticals
All unsealed syrups or eye drops (expired or
unexpired)
All cold chain products not stored as per
manufacturers’ recommendations (e.g.: insulin,
hormones, gamma globulins and vaccines)
All bulk or loose tablets and capsules with containers
which are not sealed, properly labelled or within
broken blister pack, and
All unsealed or damaged tubes of creams, ointments,
22 12/06/2025
9 lotions and related products.
Each hospital should establish a pharmaceutical
disposal committee comprised of representatives
from:
pharmacy,
finance/audit, and
sanitation services
23 12/06/2025
0
Each hospital should establish an SOP for the
management of pharmaceutical waste
The SOP should include:
The schedule,
Methods of disposal
23 12/06/2025
1
The SOP should be approved by the hospital
DTC.
Disposal of pharmaceutical wastes should be
supported by proper documentation, including
the price of the products, for audit and other
legal requirements.
23 12/06/2025
2
Basic steps to be adhered for the disposal
of pharmaceutical wastes are:
Step 1: Pharmaceuticals that are expired/ damaged or
unfit for use should be counted, recorded and placed
segregated from the other pharmaceuticals in the
hospitals.
Step 2: List of pharmaceuticals expired or unfit for use
should be submitted to the responsible body for
disposal.
Step 3: The pharmaceuticals should be sorted out based
on the pharmaceutical dosage form and chosen
disposal method.
23 12/06/2025
3
Step 4: The pharmaceuticals should be disposed of in
accordance with the appropriate method and in the
presence of delegates from the responsible body.
Step 5: Signed and stamped certificate of disposal
format should be issued by the authorized body
entitled to dispose the drugs.
Step 6: Adjustments for each disposed drug should be
made in the available inventory management system.
23 12/06/2025
4
Hospital pharmacy and cleaning staff should be
trained/ well informed about the potential risks of
hazardous pharmaceutical wastes and their
management.
Cleaners and others handling hazardous
pharmaceutical wastes should wear protective devices
such as apron, plastic shoes, gloves, head gears, eye
glasses, and goggles.
23 12/06/2025
5
General Disposal Methods:
Return to donor or manufacturer: Whenever practical,
the possibility of returning unusable drugs for safe disposal
by the manufacturer/donor should be explored;
particularly for drugs which present disposal problems,
such as antineoplastics.
Waste immobilization/encapsulation: This involves
immobilizing pharmaceutical wastes in a solid block within
a plastic or steel drum filled to 75% capacity.
The remaining space should be filled and sealed with
cement or cement/lime mixture and water in proportions
15:15:5 by weight.
The sealed drums are then placed at the base of a land fill
23 and are covered with fresh municipal solid waste. 12/06/2025
6
Landfill:
Place the expired or ‘unfit for use’ pharmaceuticals
directly into a land disposal and cover it with municipal
waste to prevent scavenging. It should be noted that
discarding in open, uncontrolled dumps with
insufficient isolation from water courses can lead to
pollution.
23 12/06/2025
7
Sewer:
Some liquid pharmaceuticals, e.g. syrups and
intravenous fluids, can be diluted with water and flushed
into the sewers in small quantities over a period of time
without serious public health or environmental effect.
Fast flowing water courses may likewise be used to flush
small quantities of well-diluted liquid pharmaceuticals or
antiseptics.
In this case, disposal should be done in consultation with
the hospital sanitarian/environmental health specialist.
23 12/06/2025
8
Traces of pharmaceuticals and other chemicals from
the compounding and sterile preparation (if
applicable) can be discharged directly into the
sewerage system
Burning in open containers: Pharmaceuticals should
not be disposed by burning at low temperature in open
containers, as toxic pollutants may be released into the
air.
Paper and cardboard packaging, if they are not to be
recycled, may be burnt but polyvinyl chloride must not
be.
It is strongly recommended that only very small
23 12/06/2025
9 quantities must be disposed in this way.
Incineration:
Expired solid form of pharmaceuticals are burned
using a two chamber incinerator that operates at a
minimum temperature of 850 0C.
24 12/06/2025
0
Product specific disposal methods:
1. Solids, semisolids and powders:
Medium temperature incineration should be applied
for solid forms.
If there is no incinerator, encapsulation of the drugs
before discharge to a land fill is necessary.
Solids, semisolids and powders should be removed from
their outer packages but should remain in their packaging.
The disposed drugs then should be covered by municipal
waste immediately to prevent scavenging.
24 12/06/2025
1
Pharmaceuticals classed as biodegradable
organic material in the solid or semisolid form
such as vitamins, can also be disposed of in a
landfill.
24 12/06/2025
2
2. Liquids
Pharmaceuticals that can be classified as readily
biodegradable organic materials such as liquid
vitamins can be diluted and flushed into a sewer.
Harmless solutions of different concentrations of
certain salts, amino acids, lipids or glucose may
also be disposed of in sewers.
Small quantities of other liquid pharmaceuticals
which are not controlled drugs, antineoplastics or
anti-infective can also be flushed into sewers.
24 12/06/2025
3
3. Ampoules
These should be crushed on a hard impermeable
surface (e.g. concrete or in a metal drum) and the
crushed glass should be swept up, placed in a
container, sealed and disposed of in a land fill.
Ampoules should not be burnt or incinerated as
they will explode, possibly causing injury to
operators and damage to the incinerator by
melting and clogging.
24 12/06/2025
4
4. Anti-infectives
Anti-infective drugs should not be discarded in an
untreated form. Generally they are best incinerated and
if this is not possible they can be encapsulated.
Liquid anti-infective may be diluted in water, left for
two weeks and disposed to the sewer.
Controlled substances should be rendered unusable, by
encapsulation, and then dispersed among the
municipal solid waste in a land fill or incinerated.
24 12/06/2025
5
5. Antineoplastics
These drugs should be segregated from other
pharmaceuticals and kept separately in clearly marked
containers.
They should be returned to the supplier if contract
supports; otherwise, they should be destroyed in a high
temperature incinerator of at least 1200 °C.
24 12/06/2025
6
Antineoplastics should never be disposed of in a land
fill without encapsulation or inertization.
They should never be disposed into sewers and water
courses.
Work teams handling these drugs should avoid
crushing cartons or removing the product from its
packages
24 12/06/2025
7
6. Aerosol canisters
Disposable aerosol canisters and inhalers should not
be burnt or incinerated, as high temperatures may
cause them to explode, possibly causing injury to
operators and /or damage to the incinerator.
Provided they do not contain poisonous substances,
they should be disposed of in a landfill dispersed
among municipal solid wastes.
24 12/06/2025
8
Waste types not to be incinerated
Pressurized gas containers.
Large amounts of reactive chemical waste.
Silver salts and photographic or radiographic wastes.
24 12/06/2025
9
Halogenated plastic such as polyvinyl chloride (PVC),
which is mostly used for I.V. fluids container.
Waste with high mercury or cadmium content; such as
broken thermometers, used batteries, and lead-lined
wooden panels.
Sealed ampoules or ampoules containing heavy metals
25 12/06/2025
0
THE END
THANKS!
25 12/06/2025
1