Rational Use of Veterinary Drugs and Vaccines Training Manual First Edition

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RATIONAL USE OF VETERINARY DRUGS AND VACCINES TRAINING MANUAL

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RATIONAL USE OF VETERINARY
DRUGS AND VACCINES
TRAINING MANUAL
First Edition
Prepared by: - Veterinary Drug and Animal Feed Administration

and Control Authority (VDFACA), under Ministry of Livestock
and Fisheries, in collaboration with University of Gondar,
Faculty of Veterinary Medicine
December, 2016
Addis Ababa, Ethiopia
Rational Use of Veterinary Drugs and Vaccines
RATIONAL USE OF VETERINARY

DRUGS AND VACCINES
Prepared by VDFACA in collaboration with

University of Gondar, Faculty of Veterinary
Medicine
Contributors;
1. Dr. Achenef Melaku Beyene (DVM, MSc in
Veterinary Pharmacology, University of Gondar, Faculty
of Veterinary Medicine)
2. Dr. Solomon Kebede (DVM, MVSc in Tropical
Veterinary Epidemiology, Veterinary Drug and Feed
Administration and Control Authority)
3. Dr. Hailu Zeru (DVM, Veterinary Drug and Feed
Administration and Control Authority)
VDFACA II
VDFACA III
ACKNOWLEDGEMENTS
First of all, the group participated in the

preparation of this manual, would like to thank
the management of Veterinary Drug and Feed
Administration and Control Authority for allowing
us to set together for the preparation of this
manual so as to solve problems related to the
usage of veterinary drugs and vaccines. We would
also like to extend our gratitude to Gondar
University, Faculty of Veterinary Medicine for
initiation and allowing professional to work with
experts from the authority.
We are grateful to the professionals who offered

their feedback and edits on this and earlier drafts
of the manual. As this is the first attempt,
authors are happy if they got feedback from
readers or users of the manual for further
improvement.
VDFACA IV
VDFACA V
TABLE OF CONTENTS
Page
ACKNOWLEDGEMENTS ......................................................... IV
TABLE OF CONTENTS ........................................................... VI
PREFACE ............................................................................VIII
ACRONYMS ............................................................................ X
OPERATIONAL DEFINITIONS ................................................ XI
1. INTRODUCTION................................................................ 1
2. SOURCES OF DRUGS AND PROCESSES OF NEW DRUG
DEVELOPMENT ................................................................ 4
2.1 Sources of Drugs ......................................................... 4
2.2 Drug Development ....................................................... 8
3. UNDERSTANDING THE LABELING, PACKAGING AND
COMPOUNDING OF DRUGS ............................................ 12
3.1 Drug Labelling ........................................................... 12
3.2 Packaging .................................................................. 15
3.3 Compounding of drugs .............................................. 19
4. TRANSPORTATION, DISPENSING ENVIRONMENT, STOCK
MANAGEMENT AND QUALITY ASSURANCE OF
VETERINARY DRUGS ..................................................... 22
4.1 Transportation .......................................................... 22
4.2 Dispensing Environment ....................................... 23
4.3 Stock Management .................................................... 26
4.4 Quality Assurance of Veterinary Drugs in the Stock . 35
5. SYSTEMS OF MEASUREMENT AND DRUG FORMULATION
....................................................................................... 39
5.1 Systems of Measurements ......................................... 39
5.2 Drug Formulations .................................................... 44
6. STRENGTH OF SOLUTIONS ............................................ 47
6.1. Expression of strength of solutions .......................... 47
6.2 Changing the strength of solutions ........................... 50
7. DOSE CALCULATION ...................................................... 53
7.1. Weighting animal using heart girth .......................... 54
7.2. Formula to calculate dose: ....................................... 57
8. PRINCIPLES AND PROCESSES OF VETERINARY DRUGS
PRESCRIBING PRACTICE ............................................... 61
8.1 Principles of Rational Prescribing ............................. 61
8.2 Prescription process .................................................. 65
9. PRINCIPLES AND PROCESS OF VETERINARY DRUGS
DISPENSING PRACTICE .................................................. 75
9.1 Principles of Good Dispensing ................................... 75
9.2 Dispensing Process .................................................... 76
VDFACA VI
9.3 Withdrawal periods and control for residues of
veterinary drugs: ....................................................... 84
10. CONSEQUENCES OF IRRATIONAL DRUG UTILIZATION .. 86
10.1 Rational Use of Drugs ........................................ 86
10.2 Factors Influencing Rational Drug Use .............. 87
10.3 Magnitude of Irrational use of Drugs.................. 89
10.4 Impact of Irrational Use of Drugs ....................... 89
10.5 Measures to Improve Rational Drug Use ............ 90
11. DRUG RESISTANCE AS FUTURE THREAT ...................... 92
11.1 Drug Resistance ................................................. 92
11.2 Contributing Factors ......................................... 95
11.3 Mechanism of Spread ......................................... 95
11.4 Impacts of Antimicrobial Resistance ................. 97
11.5 Prevention of Drug Resistance ........................... 97
12. VACCINE STORAGE AND HANDLING .............................. 99
12.1. Vaccine Storage Temperatures ........................ 102
12.2. Vaccine Storage Equipment ............................. 104
12.3. Vaccine Inventory Control ............................... 107
12.4. Receiving and Unpacking Vaccine Shipments .. 109
12.5. Vaccine Transport to Off-Site Clinics............... 110
12.6. Temperature Monitoring During Off-Site ......... 111
12.7. Vaccine Preparation ......................................... 112
13. VETERINARY DRUG INFORMATION ............................. 113
13.1 Importance of Veterinary Drug Information .... 113
13.2. Sources of Veterinary Drug Information ............... 114
13.3. Dissemination of Veterinary Drug Information .... 116
14. NATIONAL LEGISLATIONS RELATED TO VETERINARY
DRUGS and VACCINES ................................................. 118
15. REFERENCES ............................................................... 122
16. ANNEXES ..................................................................... 126
VDFACA VII
PREFACE
The survey conducted on the use of veterinary

drugs and drug resistance in 2013 by Veterinary
Drug and Feed Administration and Control
Authority (VDFACA) indicated that irrational use
of veterinary drugs is becoming common practice
all over the country. Lack of awareness among
professionals and absence of reference materials
on the proper use of veterinary drugs and
vaccines were gaps identified during the study. It
is therefore found important to prepare training
manual that would help us to improve the
awareness of animal health and veterinary drug
professionals on rational use of veterinary drugs.
To prepare this manual a collaborative team was
formed from VDFACA and University of Gondar,
Faculty of Veterinary Medicine; and then they
produced this “Rational Use of Veterinary drugs
and vaccines” training manual with high and
exemplary commitments.
The manual contains information on how new

drugs are developed and the challenges related to
it to aware professionals to take care of drugs by
informing how much new drug development is a
long process and requires a big investment;
sessions on principles and process of prescription
and dispensing to improve the skill and attitude
of good prescribing and dispensing practices of
professionals; chapters to indicate the
transportation requirements of veterinary drugs,
dispensing environment, stock management and
quality assurance of drugs at stock so as to keep
VDFACA VIII
the drug quality; information on the
consequences of irrational drug utilization and
drug resistance as future threat; and the
importance, sources, handling and transportation
of vaccines, and use of updated veterinary drugs
information. The document also contains
different drug chemistry formulas and arithmetic
calculations which could help prescribers and
dispensers on their day to day practices to ensure
the rational use of veterinary drugs and vaccines.
It is hoped that the manual would help animal

health and veterinary drug professionals to use
veterinary drugs and vaccines rationally, and
enhance the quality of veterinary pharmaceutical
services so as to decrease the economic losses
and public health hazards due to diseases of
livestock. Professionals who are handling and
using veterinary drugs and vaccines are
encouraged to read this manual and other
references mentioned in the reference sections of
this manual for further information and
knowledge.
TERZU DAYA DEGAGA (Dr.)

Director General,
Veterinary Drugs and Animal Feed Administration
and Control Authority
VDFACA IX
ACRONYMS
AHS African House sickness
AMAs Antimicrobial Agents
AMR Antimicrobial Resistance
CBPP Contagious Bovine Peuro-pneumonia
CCPP Contagious Caprine Peuro-pneumonia
CNS Central Nervous System
DNA Deoxyribonucleic Acid
FEFO First Expire First Out
FIFO First in First Out
IBD Infectious Bursal Disease
ID No. Identification Number
IU International Unit
IV Intravenous
Kg kilogram
LSD Lumpy Skin Disease
Mg milligram
mL(ml) millilitre
NVDL National Veterinary Drugs List
oC Degree Celsius
oF Degree Fahrenheit
OTC Over the counter
POVM Prescription Only Veterinary Medicines
ppm parts per million
PPR peste des petits ruminants
SI International System Unit
STP Standard Temperature and Pressure
USP United States Pharmacopeia
VDFACA Veterinary Drug and Feed
Administration and Control Authority
of Ethiopia
VSTG Veterinary Standard Treatment Guideline
WHO World Health Organization
VDFACA X
OPERATIONAL DEFINITIONS
Active substance or ingredient: Any substance
or combination of substances used in a
finished pharmaceutical product intended
to furnish pharmacological activity or
otherwise have direct effect in the
diagnosis, cure, mitigation, treatment or
prevention of disease, or to have direct
effect in restoring, correcting or modifying
physiological functions in animals;
Adverse drug reaction: is unfavourable and
unintended effect that occurs after the use
of or exposure to veterinary drugs;
Biological product: means reagents, sera,
attenuated or killed vaccines or microbial
genetic material used for the diagnosis,
prevention or treatment of animal diseases;
Contraindication: is a condition or factor that
serves as a reason to withhold a certain
medical treatment. It is a specific situation
in which a drug, procedure, or surgery
should not be used because it may be
harmful to the patient;
Dispenser: Any person who is licensed or
authorized by the appropriate body to
dispense veterinary drugs and/or medical
supplies;
Dispensing: The act of preparing veterinary
drugs and/or medical supplies and
distributing to users with adequate
VDFACA XI
information, counselling and appropriate
follow up;
Dosage interval: is the time interval between
successive dosages;
Dosage regimen: is the schedule of doses of a
therapeutic agent including name, dose,
frequency, duration and route of
administration of the drug;
Dose: is the amount of a drug to be administered
at one time to bring a desired therapeutic
response in a patient;
Drug Interaction: is the modification of the effect
of one drug by the prior or concomitant
administration of another drugs or feed or
herbs.
Excipients: are inert substances added to the
pharmaceutical preparations either to add
the bulk of the active drug or to mask
unpleasant taste (lactose, calcium lactate,
starch and so on);
Indication: is a valid reason to use a certain
drug for the diagnosis, prophylaxis or
treatment of diseases;
Label: Any material which is printed or affixed to
a packing material which provides the
necessary information about veterinary
drugs and includes an insert (leaflet);
Loading dose: is one or a series of doses that
may be given at the onset of therapy with
VDFACA XII
the aim of achieving the target
concentration rapidly;
Maintenance doses: are series of repetitive doses
or as a continuous infusion to maintain a
steady-state concentration of a drug;
Over-the-counter veterinary drugs: veterinary
drugs that can be dispensed without
prescription;
Owner: any person who is responsible for the
patient animal and who bring it to the
veterinary clinic and purchases the
prescribed and/or over-the-counter
veterinary drugs from the veterinary
pharmacy;
Packing material: means any material that may
be used for filling, inserting or wrapping or
packing veterinary drug and includes
immediate container and other materials
for wrapping the product;
Patient animal: An animal presenting to an
authorized animal health care provider to
prevent or treat disease;
Precautions: are situations in which the drug
should be used cautiously because there
may be adverse reaction in that situation;
Pre-packaging: Repackaging of veterinary drugs
into usable quantities before they are
requested by animal owners (users);
VDFACA XIII
Prescriber: Any animal health practitioner who is
licensed or authorized by the appropriate
body to write a prescription;
Prescription only veterinary drugs: veterinary
drugs dispensed only with prescription;
Prescription: Any order for veterinary drug
written and signed by a duly licensed or
authorized animal health practitioner
issued to an animal patient in order to
collect medicine from veterinary drugs
dispensing outlet;
Regulatory body: Veterinary Drug and Feed
Administration and Control Authority of
Ethiopia and regional agriculture offices as
representatives;
Repackaging: Packing of any processed or semi-
processed medicine by a different
manufacturing company in any other way.
Shelf-life: The length of time a veterinary drug
may remain on the shelf, in the original
package and under usual environmental
conditions and retain an acceptable level of
its original potency and overall quality.
Side effects: are unwanted but often
unavoidable effects that occur at
therapeutic dose. Example: Atropine is a
pre-anaesthetic drug used to reduce
secretion but causes dryness of the mouth
as side effect;
VDFACA XIV
Stock solution: A solution of higher strength of a
veterinary drug or reagent (chemical) that
requires dilution before use.
Stock: The amount of veterinary drug and/or
medical supplies available in legal
veterinary drug retail outlets.
Vehicles are substances used to dissolve or
suspend the drug for better applicability
such as in ointments. Examples: sugar,
gum of acacia, petroleum jelly and so on.
Veterinary drug: means any substance or
mixture of substances used in the
diagnosis, treatment or prevention of
animal disease, and includes products
used to treat against internal and external
parasites and disease transmitting vectors,
biological products and sanitary items.
VDFACA XV
1. INTRODUCTION
The provision of successful animal health service

requires the availability of safe, effective and
affordable drugs of the required quality and quantity.
In addition, the available drugs must be prescribed,
presented, dispensed and used rationally. Proper
utilization of veterinary drugs involves handling,
prescribing, dispensing and delivery of drugs for the
animal species in question under the proper
supervision and involvement of veterinary
professionals.
Rational veterinary drug use is the part of Quality
Management System that guarantees the quality of
the veterinary pharmaceuticals through controlling
various activities related to storage, transportation,
distribution, prescription and dispensing. It refers to
the prescribing and delivery of the correct veterinary
drug to the right patient, in the required quantities,
for an adequate period of time and at the lowest cost,
in the package that maintains acceptable potency and
quality for the specified period, with clear veterinary
drug information counselling and appropriate follow
up. It is a complex issue demanding mainly an
integrated action of prescribers, dispensers and
owners of the animal patients. It may even extend to
the level of animal health administrators and
veterinary drug and feed administration and control
authority and policy makers. For instance, in matters
related to the development of national veterinary drug
list (NVDL) and improvement of the availability of
veterinary drugs.
Many researchers have highlighted the incidence and
prevalence of irrational drug use in developing
VDFACA 1
countries. It is also common in Ethiopia. The use of

veterinary drugs when no therapy is indicated, use of
wrong veterinary drugs for specific conditions
(incorrect diagnosis), the use of veterinary drugs with
doubtful efficacy, the use of veterinary drugs with
uncertain safety status, use of correct veterinary
drugs with incorrect route of administration, dosage,
or duration, the storage of veterinary drugs with other
materials in the institution store, absence of
refrigerators for veterinary drugs that need cold
chain, the dispensing of prescription-only veterinary
drugs at partial doses and without prescription, poor
labelling of the dispensed items, lack of animal owner
counselling, incomplete compiling and recording of
prescriptions, and charging animal owner
unreasonably high prices for the dispensed veterinary
drug are some of the practices that reflect an
irrational veterinary drug use. Such improper
utilization, eventually decreases drug’s efficacy,
promote the development of drug resistance and they
may harm the animal itself as drugs are potential
poisons and the way they are utilized makes the
difference between the ability to save and take
animals’ life. It is also a threat to human medicine
since majority of drugs used in veterinary medicine
are structurally related to human therapeutics which
may select for co-or cross-resistance.
The survey conducted on use of veterinary drugs in
2014 by Veterinary Drug and Feed Administration
and Control Authority (VDFACA) indicated that there
is dispensing of veterinary drugs with other goods in
the shops and markets, dispensing of prescription-
only veterinary drug without prescription, dispensing
of veterinary drugs by non veterinary drug
VDFACA 2
professionals in the veterinary pharmacy, dispensing

of illegal veterinary drugs and veterinary drugs
donated by nongovernmental organization with low
price and unethical practices of professionals. These
lead to the occurrence of therapeutic failure, harmful
drug effects, and drug resistance. Creating and
improving awareness about rational use of veterinary
drugs is helpful to avoid all these messes.
Therefore, this manual is issued as one means of
promoting proper use of veterinary drugs and
vaccines. It will support animal health and veterinary
drug professionals as source of information for
rational veterinary drug and vaccine use. The manual
should be supported by other reference materials
such as standard veterinary treatment guidelines,
national veterinary drug lists, and veterinary drug
formulary.
Generally, the manual is prepared to:
 Enhance knowledge, skill, and attitude of
animal health professionals on rational use of
veterinary drugs and vaccines;
 Improve awareness on the consequences of
irrational veterinary drug use;
 Encourage professionals to promote ethical
practices;
 Motivate professionals in developing and
maintaining behaviour of regularly updating
about veterinary drug
VDFACA 3
2. SOURCES OF DRUGS AND PROCESSES OF

NEW DRUG DEVELOPMENT
Objectives
At the end of this session trainee should able to
• Identify major sources of drugs
• Describe how drugs are discovered and
the challenges related to it
2.1 Sources of Drugs
There are basically six sources of drugs, namely

plants, microorganisms, animals, mineral and
mineral products, synthetic or semi-synthetic
substances and engineered sources.
A. Plants:
Plants are the oldest source of drugs. Most of the
drugs in ancient times were derived from plants.
Almost all parts (leaves, stem, bark, fruits and
roots) of the plants are used to extract drugs.
There are many drugs derived from plants. About
25% of the drugs prescribed worldwide come from
plants. Of the 252 drugs considered as basic or
essential by the World Health Organisation
(WHO), 11% are exclusively of plant origin.
Chemicals obtained from plants (alkaloid,
tannins, resins, glycoside, oil, gum, mucilage,
carbohydrate and related compounds) are used
as a drug or may also be added as vehicle. Plants
will also be the potential sources for new drug
discovery in the future.
VDFACA 4
The following are some of the examples of drugs

derived from plant sources:
Leaves:
 The leaves of Digitalis purpurea are the
source of Digitoxin and Digoxin, which are
cardiac glycosides.
 Leaves of Eucalyptus give oil of Eucalyptus,
which is important component of cough
syrup.
 Tobacco leaves give nicotine.
 Leaves of Atropa belladonna gives atropine
Flowers:
 Poppy papaver somniferum gives morphine
 Rose gives rose water used as tonic.
Fruits:
 Senna pod gives anthracine, which is a
purgative (used in constipation)
 Calabar beans give physostigmine, which is
cholinomimetic agent.
Seeds:
 Seeds of Nux vomica give strychnine, which
is a CNS stimulant.
 Castor oil seeds give castor oil, which is
used as laxative.
 Calabar beans give Physostigmine, which is
a cholinomimetic drug.
Roots:
 Ipecacuanha root gives emetine, used to
induce vomiting as in accidental poisoning.
It also has amoebicidal properties.
 Rauwolfia serpentina gives reserpine, a
hypotensive agent.
VDFACA 5
Bark:
 Atropa belladonna gives atropine, which is
anticholinergic.
 Hyoscyamus niger gives hyosine, which is
also anticholinergic.
Stem:
 Chondrodendron tomentosum gives
tuboqurarine, which is skeletal muscle
relaxant used in general anaesthesia.
B. Microorganisms
Some of the fungi, moulds and bacteria are also
important sources of drugs
Table 1: Microorganism used as the source of

antibiotics
S/n Microorganism Antibiotic
1. Bacillus subtilis Bacitracin
2. Bacillus polymyxa Polymyxin
3. Streptomyces nodosus Amphotericin B
4. Streptomyces venezuelae Chloramphenicol
5. Streptomyces aureofaciens Tetracycline/chlortetracycline
6. Streptomyces erythraeus Erythromycin
7. Streptomyces griseus Streptomycin
8. Micromonospora purpureae Gentamicin
9. Cephalosporium species Cephalothin
10. Penicillium griseofulvum Griseofulvin
11. Penicillium notatum Penicillin
C. Animals: -
The drugs which are coming from animals include:
 Insulin which is extracted from pancreas,
used in treatment of Diabetes mellitus.
VDFACA 6
 Human chorionic gonadotropin (hCG)

obtained from urine of pregnant women
used for the treatment of infertility.
 Cod liver oil is used as a source of vitamin
A and D, derived from liver of cod fish.
 Anterior pituitary is a source of pituitary
gonadotropins, used in treatment of
infertility.
 Blood of animals is used in preparation of
vaccines.
 Heparin is commonly extracted from
porcine intestinal mucosa or bovine lung.
 Drugs coming from animals are not usually
pure and may contain antigens which induce
allergic reactions.
D. Minerals
Minerals (metals or non-metals) from the earth
are used to treat inorganic mineral deficiencies or
other problems in animals. Their salts are usually
used in clinical practices.
Examples:-
• Ferrous sulphate is used to treat anaemia
• Magnesium sulphate is used as purgative
(used to relieve constipation)
• Magnesium trisilicate and Aluminium
hydroxide are used as an antacid
• Iodine is antiseptic. Iodine supplements are
also used to treat Iodine deficiency.
E. Synthetic or semi-synthetic drugs
Synthetic or semi-synthetic drugs are evolved from
application of science and technology in the
VDFACA 7
laboratory. Semi-synthetic drugs are naturally

occurring substances that have been chemically
altered in the laboratory. Examples of synthetic or
semi-synthetic drugs are sulphonamides, thiazide
diuretics, apomorphine, aspirin and so on. It is more
preferable way since pure compounds can be easily
obtained and structural modifications to produce
potentially more active and safer drugs could be easily
performed.
F. Engineered drugs
Genetic engineering is the newest area of drug
development. It involves cleavage of DNA by enzyme
restriction endonucleases. The desired gene is coupled
to rapidly replicating DNA (viral, bacterial or plasmid).
The new genetic combination is inserted into the
bacterial cultures which allow production of vast
amount of genetic material (drug). The process has
both advantaged and disadvantages.
Advantages: -
 Huge amounts of drugs can be produced
 Drug can be obtained in pure form
 It is less antigenic
Disadvantages: -
 Well equipped laboratory and trained
manpower are needed
 It is not as such simple
Examples insulin, growth hormone and erythropoietin
are nowadays synthesised by genetic engineering
techniques.
2.2 Drug Development

Any drug development process must proceed
through several stages in order to produce a
product that is safe, efficacious, and has to pass
VDFACA 8
all regulatory requirements. The process of drug

development starts with understanding of the
disease and target identification and validation of
the promising drug, which will be followed by the
synthesis of novel chemical compounds (lead
compound).
Two tests will be conducted.

i. Preclinical testing which will be done on
laboratory animals or cell culture that yields
information on the biological effects of new
substance.
ii. Clinical test: The clinical development of new
drug usually takes place in steps or phases
conventionally described as clinical
pharmacology (Phase I), clinical investigation
(Phase II), clinical trials (Phase III), and post-
marketing studies (Phase IV)
 Phase I studies on healthy subjects (20 to

80) and seek to determine whether effects
observed in laboratory animals experiments
also occur in other animals or humans.
 Phase II, potential drugs are tested on
selected patients for therapeutic efficacy in
those disease states for which they are
intended
 Phase III is entered, involving a larger group
of patients in whom the new drug will be
compared with standard treatments in
terms of therapeutic outcome.
 Phase IV is monitoring the drug after market
authorisation from the regulatory body as it
VDFACA 9
is used in the larger population to catch any

unexpected serious adverse effects.
The drug development process described above

more applies for drugs used in human
medicine, for veterinary agents the process is
similar but with a few notable exceptions.
i. Since preclinical and Phase I studies are on
animals, processes are generally shorter
for veterinary drugs.
ii. Safety and efficacy must be confirmed for
each species included on the label in brand
or generic medications and in new dosage
forms.
iii. Veterinary dosage forms are generally more
diverse and complex to address differences
within and among species; weight
differences between species may reach up
to 700-fold.
Challenges in drug discovery:
•Drug discovery is a slow process
•Requires big investment
•One cannot be sure even after a very long
process and investments
Possible solutions:
– Use available drugs properly
– Provide priority for disease prevention
and eradication programs through
proper husbandry, nutrition and
vaccination
– Conducting research on identifying
problems and searching solutions
VDFACA 10
– Searching other alternatives like

improving useful ethno-veterinary
practices
VDFACA 11
3. UNDERSTANDING THE LABELING, PACKAGING

AND COMPOUNDING OF DRUGS
Objectives
After completion of this session, trainees should
be able to:
 Identify the major information on the label
of a drug
 Differentiate proper packaging systems for
storage, transport and dispensing of drugs
3.1 Drug Labelling

Label means any written, pictorial or other
descriptive material (including cartons, vials,
and leaflets), affixed to or contained in or on the
packaging, which gives information about the
veterinary drugs that is to be marketed or sold.
All finished drug products available for market
should be identified by labelling at their primary
and/or secondary packaging, as required by the
national legislation, bearing at least the following
information:
1. The statement “FOR ANIMAL TREATMENT
ONLY or FOR VETERINARY USE ONLY”
2. Trade name
3. Generic name
4. Active ingredient(s), and other
substance(s) added to formulated the
drug and their quantities
5. Withdrawal period
6. Restriction to its use
7. Batch number
VDFACA 12
8. Storage instructions and handling

precautions
9. Directions for use (dose rate, route,
duration of treatment and frequency of
application)
10. Adverse effects, cautions and
contraindications
11. Manufacturing and Expiry date
12. Net contents with clear unit of
measurement
13. The name and address of the
manufacturer or the company or person
responsible for placing the product on the
market
The labels should not be easily erased and/or

detached. Any deviation from the label makes the
information on the label invalid. READING THE
LABEL BEFORE USING A PRODUCT IS
EXTREMELY IMPORTANT! If the products
dispensed by veterinary drug professional are not
in the original labelled container, must be labelled
by him/her in the same manner that appears on
the commercial label. Following label instructions
is critical if drug residue and resistance are to be
avoided.
VDFACA 13
Veterinary Use Only 100ml

1 12
Dystosel*DS 2 shake well before using
VITAMIN E - SELENIUM INJECTION protect from freezing

3 sterile aqueous emulsion 8
for sheep and cattle 7
CONTAINTS 4 PER ML Lot 10919169
Selenium (as sodium selenite), 3 mg/mL and Ex date 15/12/2017
Vitamin E (dl-α-tocopherol acetate), 136 IU/mL
11
Benzyl alcohol, 15 mg/mL
Warning: Treated animals must not be slaughtered for use in food

5 for at least 21 days after the latest treatment with this drug. This
product must not be used in lactating dairy cattle.
DIN 00170968 6
Indications: For the prevention and treatment of white muscle disease
(nutritional myopathy) in calves and lambs.
Dosage and Administration 9
Administer the following single doses subcutaneously or
intramuscularly:
PREVENTION: Postnatal: Calves - 1 mL/45 kg body weight. Lambs,
Newborn - 0.25 mL per animal; 2 to 8 weeks of age - 0.5 mL per
animal. Prenatal: After a pregnancy of 5 months in cows and 3
months ewes - 1 mL/45 kg body weight and repeat, if necessary, at
no less than 2 week intervals for a maximum of 4 doses.
TREATMENT: Calves: 2 mL/45 kg body weight. Lambs: 0.5 mL per
animal.
Caution: This product contains the toxic substance selenium. Do not
exceed recommended dosages. Administer only to animals that are
known to be ingesting sub-normal levels of selenium. In case of an
anaphylactic reaction, administer epinephrine immediately.
10
ROGAR/STB inc 13 London.ont
N6A. 4CD
Figure 1: Examplery information on drug label;
numbers correspond with lists in the previous pages
VDFACA 14
3.2 Packaging
Packaging may be defined as the collection of

different components (example: bottle, vial,
closure, cap, ampoule, and blister) which
surround the pharmaceutical product from the
time of production until its use. The packaging of
a pharmaceutical product is aimed at ensuring
that veterinary medicines arrive safely in the
hands of users for which they are prescribed.
The packaging must protect the product against

all adverse external influences that may affect its
quality or potency, such as light, moisture,
oxygen, biological contamination and mechanical
damages. The packaging itself should not have an
adverse effect on the product (example: through
chemical reactions, leaching of packaging
materials or absorption); the product should not
also have an adverse effect on the packaging,
changing its properties or affecting its protective
function.
Containers may be referred to as primary or

secondary. Primary container is in physical
contact with the veterinary drug (for example,
bottle, blister pack, tube, syringe), whereas
secondary packaging is the immediate packaging
around the primary container (for example,
carton, and leaflets/inserts). The choice of
primary and/or secondary packaging materials
depends on the degree of protection required,
compatibility with the contents, the filling method
and cost, and the convenience of the packaging
VDFACA 15
for the user (example: size, weight, method of

opening/reclosing, legibility of printing). Both
single-dose and multi-dose containers also exist.
3.2.1 Pre-packaging
Pre-packaging is the process by which the
veterinary drug professionals transfer a
medication manually, or by means of an
automated system, from a manufacturer's
original commercial container to another type of
container in advance (before clients come to
veterinary drug retail out lets). Because original
containers may contain large amount of drugs,
repackaging of drugs into another container may
be necessary in order to dispense drugs for
animal patient owners. Such repackaging
procedure can be done at the spot or in advance.
The following guidelines are recommended in pre-
packaging of drugs:
 Pre-packaging procedures must comply
with laws and regulations.
 The pre-packaging operations and area
must be clean and separate from other
pharmacy activities.
 Only one drug product at a time should be
pre-packaged in a specific work area. No
drug products other than the one being
packaged should be present in the
immediate packaging area. Labels other
than those for the product being packaged
should not be present in the area.
 Before beginning a pre-packaging run, a
physical evaluation (colour, odour,
appearance, and markings) of the drug
VDFACA 16
product being pre-packaged should be

made to assure product integrity. The bulk
container should also be examined for
evidence of damage, contamination, and
other deleterious effects.
 All pre-packaging equipment and systems
should be operated and used in
accordance with the manufacturer's or
other established instructions. There
should be valid justification and
authorization by the supervisor for any
deviation from those instructions on the
part of the operator.
 The veterinary drug professionals must use
available data on the characteristics of all
packaging material used to protect the
integrity of the drug product. This
information should include data on the
chemical composition, light transmission,
moisture permeability, size, thickness
(alone or in laminate), recommended
sealing temperature, and storage
requirements.
 The beyond-use date applied to pre-
packaged medications should adhere to
USP standards.
An additional trained individual, other than the

packaging operator, should verify that the pre-
packaging system (drug, materials, and
machines) is in correct working order and that all
procedures have been performed properly.
VDFACA 17
Control records of all packaging operations must

be kept according to the guidelines, and include
the following information:
 Complete descriptions of the drug,
example: name, strength, dosage form,
etc
 The name of the product's manufacturer
and distributor (as applicable)
 Manufacturer's control number (lot
number)
 Expiration date of the manufacturer's
original container and the beyond-use
dating of the pre-packaged product
 Number of units pre-packaged, total
contents delivered per unit, and the
date(s) they were pre-packaged
 Initials of the operator and the veterinary
drug professionals responsible for
packing of each individual run
 Description of the packaging materials
and equipment used.
Upon completion of pre-packaging, all unused
drug stock, unused labels and finished packages
should be removed from the pre-packaging area.
The packaging equipment should then be
completely emptied, cleaned, and inspected
before commencing the next pre-packaging
operation.
3.2.2 Packaging Aids and Materials

The materials used for repackaging include: glass
bottles, plastic bottles, collapsible tubes, paper
VDFACA 18
envelops, and plastic envelops (annex 2). The

requirements of containers for packaging different
dosage forms are indicated in table 2. Paper has
the least value as the primary packaging material
in terms of maintaining the quality, safety and
stability of packaged drugs.
Table 2. Requirements for packaging materials.
Package Examples
characteristics
Tablets/capsules
Desirable Clean, dry, plastic or Blister packages, plastic
glass container with sachets, tightly sealing
tightly sealing cap or plastic or glass containers
seal with screw or snap cap
Acceptable Clean, dry container zip-lock plastic bags,
that provides glycine paper, hinged-lid
protection from dirt unsealed boxes, sifter-top
and moisture boxes, tight-top tins
Undesirable Unclean absorbent Unsealed plastic bags,
paper, cotton, paper bags, newspaper or
cardboard containers other printed paper
with no provision for
closure
Liquids (oral and topical)
Desirable Clean, dry, light- Amber or opaque bottle
resistant glass with screw cap
container with tightly
sealing cap
Acceptable Clean, dry plastic or Glass or plastic bottle with
glass container with tight-fitting cap
tight-fitting cap
Undesirable Unclean paper, Previously used liquid-
cardboard, metallic containing cartons,
plastic-lined paper bags,
plastic bags
3.3 Compounding of drugs
Compounding is any manipulation of a drug

beyond that stipulated on the drug label.
VDFACA 19
Manipulation might include mixing, diluting,

concentrating, flavouring, or changing a drug’s
dosage form. Purposes of compounding are to
enhance palatability, ease of administration, and
dispensing. During compounding, the potential
incompatibilities and practices that may interfere
with the drug’s stability, purity, and/or potency
must be considered and avoided.
Examples of compounding include:

 Mixing two injectable drugs in the same
syringe;
 Creating an oral suspension from crushed
tablets or an injectable solution;
 Adding flavouring to a commercially
available drug;
 Creating a trans-dermal gel for a drug
typically taken through other routes;
 Mixing two solutions for instilling into the
ear.
Procedures for Compounding of drugs:

i. Calculate quantities of ingredients end
product to 100% accuracy
ii. Produce clear labels for end products,
iii. Check each ingredient to ensure its
suitability for use,
iv. Ensure equipment and work area are
appropriate, clean and tidy
v. Personnel should be appropriately prepared
for aseptic procedure (hand washing,
appropriate clothing)
VDFACA 20
vi. Use appropriate compounding technique to

prepare product
vii. Weigh or measure correct quantity of
ingredients
viii. Undertake a visual final check for
products,
ix. Pack each compounded product in
container suitable for type, quantity,
intended use and storage requirements of
the product,
x. Attach labels securely, without obscuring
relevant information,
xi. Comply with optimal storage conditions
regarding: temperature, light, moisture,
type of container, and transport of the
product,
xii. Clean all equipment after use
xiii. Record the details
xiv. Issue items for users with appropriate
instruction for use
VDFACA 21
4. TRANSPORTATION, DISPENSING ENVIRONMENT

,STOCK MANAGEMENT AND QUALITY
ASSURANCE OF VETERINARY DRUGS
Objectives
At the end of this session trainees should be able

to:
 Identify the measures that should be taken
to take care of veterinary drugs during
transportation and at the stock and
dispensing areas
 Develop the skill and knowledge of proper
stock management
 Understand the different methods to assure
the quality of drugs at the stock and
dispensing area
4.1 Transportation
When transporting veterinary drugs in vehicles

(car), you should make sure drugs are stored
properly to prevent damage or spillage during
transport in section of the vehicle separated from
the driver, other passengers, animals or food.
They should be transported in accordance with
any product guidance, secured against theft and
unauthorised access, and accompanied by
relevant information about the products. The
product should not contaminate and is not
contaminated by other products and appropriate
environmental conditions must be maintained
(using cold chain for thermolabile products).
VDFACA 22
Transportation and storage of veterinary products

containing hazardous substances, such as toxic,
radioactive material, and other dangerous
pharmaceutical products presenting special risks
of abuse, fire or explosion (combustible or
flammable liquids, solids and pressurized gases)
should be stored in safe, dedicated and secure
areas, and transported in safe, suitably designed,
secured containers and vehicles.
4.2 Dispensing Environment
Dispensing environment must be clean, because

most medicinal products are for internal use,
making it important that they must be hygienic
and uncontaminated. The environment must also
be organized so that dispensing can be performed
accurately and efficiently. The dispensing
environment includes staff, physical
surroundings, shelf and storage areas, surfaces
used during work, equipments and packaging
materials.
It should also possess:
 Optimum temperature
 Sufficient lighting (but not direct sunlight)
 Optimum humidity
 Cold storage facilities
 Adequate number and type of shelves
 Suitably spaced to permit cleaning and
inspection
 A dispensing bench of adequate size having
a smooth, impervious working surface.
VDFACA 23
 Lockable cabinet for narcotic drugs ,

psychotropic substances and poisons
 Owner waiting area
 Dispensing aids
4.2.1 Premises and facilities

The premises on which a dispensing service is
provided would reflect the quality of service and
inspire confidence on the owner in the nature of
pharmaceutical service delivered. Therefore,
working conditions are recommended to take into
considerations the safety and health of the public
and people working on the premises.
 The walls, floors, windows, ceiling, and all
other parts of the premises should be as
per the requirement set by the regulatory
body.
 Rooms (with minimum area specified) are
required for dispensing, storing and
compounding veterinary drugs.
 Toilet with water supply and drainage
system is also a requirement.
 All parts of the premises should be
maintained in an orderly and tidy
condition.
 Pharmaceutical products should be
protected from the adverse effect of light,
freezing or other temperature extremes and
humidity.
The facility should make sure that the

equipments on the premises are adequate and
suitable for all the operations that have to be
VDFACA 24
carried out. All equipment should be kept clean

and should be checked for cleanliness prior to
each use. With the exception of non -returnable
containers, equipment must be of such material
and be kept in such good repair and condition as
to enable it to be thoroughly cleaned to prevent
any risk of contamination. Use of stainless steel
and glass is recommended.
4.2.2 Hygiene and Sanitation
 The physical surroundings must be

maintained as free of dust and dirt as
possible. Maintaining a clean environment
requires a regular routine of cleaning
shelves and a daily cleaning of floors and
working surfaces.
 There should be a regular schedule for
checking, cleaning, and defrosting the
refrigerator.
 Spills should be wiped up immediately,
especially if the liquid spilled is sticky,
sweet, or attractive to insects and flies.
 Food and drink must be kept out of the
dispensing area, with the refrigerator used
strictly for veterinary drugs only.
 Dispensing equipment used for measuring
liquids or counting tablets or capsules
should be kept clean at all times. For
example, uncoated tablets normally leave a
layer of powder on any surface they touch,
which can easily be transferred to other
tablets or capsules counted on the same
surface. This is called cross contamination
VDFACA 25
and could be dangerous if the

contaminating substance (example: aspirin
or penicillin) is one to which an animal
patient is sensitive.
 All persons engaged in dispensing should
observe high standards of personal
cleanliness and wear protective cloths that
should be laundered regularly.
 Smoking should be prohibited in any area
where veterinary drugs are dispensed, sold
or supplied. Direct contact between the
operator’s hands and the dispensed
products should be avoided.
4.3 Stock Management
Good stock management facilitates safe and effective

dispensing service. To ensure proper stock
management, the following elements are important:
 Acquisition of medicines
 Stock keeping
 Stock rotation
 Arrangement of veterinary drugs in the
dispensary
 Storage conditions
4.3.1 Acquisition of medicines

Before veterinary drugs and medical supplies are
issued from store to dispensing room, store
requisition/delivery (issue) form should be filled
by the dispenser and duly signed by authorized
personnel. It is mandatory that all veterinary
drugs found in veterinary drugs retail outlets are
obtained or collected from legal sources.
VDFACA 26
When you receive veterinary drugs for dispensing:

 Ensure that there is sufficient storage place
 Prepare and clean the areas for receiving
and storing
 Inspect packages for damaged and/or
expired products
 Check that all original boxes, tins, or
bottles are unopened and are in good
condition.
If products are defective:
 Separate the damaged or expired stock
from the usable stock
 Refuse to accept the products and note the
problem(s) on the delivery note
 Follow your facility’s procedure for
handling damaged or expired stock.
 Report quality problem to the nearest
regulatory body and fill prepaid adverse
drug event report form and send to
VDFACA.
If Products are not damaged:
 Fill issue voucher and requisition voucher
 Count the number of units for each
product received and compares to issue
voucher
 Record received item on receiving voucher,
stock card, bin card and computer (if
applicable)
 Ensure the expiry date is visibly marked on
every package or unit
 Arrange products in the storage area in
such a way to facilitate the dispensing of
VDFACA 27
the first to expire by first expiry first out

(FEFO) or first in first out (FIFO)
procedures.
4.3.2 Stock keeping

Veterinary drug should be kept within the
dispensary/or store rooms as follows:
 Follow the manufacturer or shippers
directions when stocking, and follow labels
for storage conditions
 Ensure safe custody of poisons,
 Place liquid products on the lower shelves
or on bottom of stacks
 Store products that require cold storage in
appropriate temperature controlled zones.
 Keep high security/high value products
such as narcotic drugs psychotropic
substances in appropriate secured place
 Separate damaged, expired and returned
products from the usable stock without
delay and dispose using established
disposal procedures.
 Always store all products in a manner that
facilitates FIFO policy for stock
managements.
 Report to appropriate body for
redistribution of veterinary drugs with near
expiry date
4.3.3 Stock rotation

When issuing products, it is important to follow
the FEFO and FIFO procedures, which minimize
wastage due to product expiry. Therefore:
VDFACA 28
 Periodic stock reconciliation should be

performed by comparing the actual and
recorded stocks.
 Always issue products that will expire first,
ensuring they are not too close to or past
their expiration date. The shelf life
remaining should be sufficient for the
product to be used before the expiry date.
 To facilitate FIFO and FEFO, place
products that may expire first in front of
products with a latter expiry date.
 Write expiry dates on stock cards, so that
stocks can be used before they expire.
 Supplies with no expiry or manufacture
date (example: gauze, cotton, medical gases
etc.) should be stored in the order received
and dispensed accordingly.
4.3.4 Arrangement of veterinary drugs

Veterinary drugs should be arranged on shelves
made of steel or treated wood and the shelves
should be strong and robust. Animal health
institutions and veterinary drugs retail outlets
can use one or a combination of the following
commonly used methods of veterinary drugs
arrangement:
1. Pharmacotherapeutic category
2. Alphabetical order by generic name
3. Dosage forms
In arranging veterinary drugs, the following
points should be considered:
 Each dosage form of veterinary drug is
arranged in separate and distinct areas
VDFACA 29
 Sufficient empty space should demarcate

one veterinary drug or dosage form from
another
 Put veterinary drug in well ventilated , dry
and place protected from direct sunlight and
heat
 Store liquids in a pallet on the floor or on
the lowest shelf
 Store drugs like acaricides, insecticides and
other hazardous substances in separate
room and open them in well ventilated area
 Do not store anything directly on the floor
 Always store cold-chain items in the
refrigerator
4.3.5 Storage conditions

Storage conditions can be arranged in two
classes:
i. Normal storage conditions

ii. Special storage conditions (cold storage
conditions, combustible /flammable or
secured)
i. Normal storage conditions
It is storage the storage of drugs in dry, well-
ventilated premises at temperatures of 15–25°C
or, depending on climatic conditions, up to 30 °C.
Extraneous odours, other indications of
contamination, and intense light must be
excluded. Veterinary drugs that must be stored
under defined conditions require appropriate
storage instructions. Unless otherwise specifically
stated (example: continuous maintenance of cold
VDFACA 30
storage) deviation may be tolerated only during

short-term interruptions, for example, during
local transportation.
The use of the following labelling instructions is

recommended:
On the label means
“Do not store over 30 °C” from +2 °C to +30°
“Do not store over 25 °C” from +2 °C to +25°C
“Do not store below 8 °C” from +8 °C to +25°C
“Protect from moisture” no more than 60%
relative humidity in normal storage conditions; to
be provided to the animal owner in a moisture
resistant container.
“Protect from light” to be provided to the
owner in a light-resistant container.
Unless special storage conditions are stated, it is

vital that veterinary drugs be stored in a dry,
adequately ventilated shady and cool store room.
Efforts should be made to maintain the specified
storage conditions with regard to exposure to
humidity, sunlight, heat, etc. Free air circulation
by opening windows, using fans or air
conditioners can be considered to reduce the
effects of humidity.
Some products are photosensitive and will be

damaged if exposed to light.
To protect products from sunlight:
VDFACA 31
 Shade the windows or use curtains, if they

allow the passage of direct sunlight
 Keep products in intact cartoon
 Do not store or pack products in sunlight
 Maintain trees on the premises around the
facility to help provide shade
Heat will also affect many products. It melts
ointments and creams and affects other products.
It is important to have thermometers, hygrometer
and other equipment in order to regulate the
temperature and humidity of storage areas.
ii. Special storage conditions

Some categories of veterinary drugs and supplies
require special storage conditions which can be
further classified into three as cold storage
conditions, combustible or flammable storage
conditions and secured storage.
a. Cold storage conditions

Cold storage conditions maintained by using
refrigerators and freezers for products that may
be degraded rapidly when kept at room
temperature or even at cool places, example:
vaccines, insulin
When using refrigerators and freezers:

 Refrigerators that open on the top are more
efficient than vertical ones, because hot
rises while cold air falls
 Store products that are sensitive to freezing
or very low temperatures on the upper
shelves.
VDFACA 32
 If there is enough space, place a few plastic

bottles of water in the refrigerator. This will
help maintain the temperature for a longer
period of time if the power is cut off. The
temperature ranges for different storage
conditions are shown in the following table.
 Do not keep staff food in the refrigerator.
Opening and closing the door may lower
the temperature and cause veterinary
drugs to deteriorate. Record the
temperature daily. Check that there is
enough space around the refrigerator so air
can move freely.
VDFACA 33
Table 3: Terms that relate to storage temperature

s/n Terms used Applications
1 Store frozen (deep For products such as certain
freezing)(-20oC) vaccines, need to be transported or
(40F) stored for long within a cold chain
2 Store at 0 - 4oC For product labelled store at
refrigerator temperature
3 Store at 2oC - For products which are very heat
80C(360F -460F) sensitive but must not be frozen.
This temperature is appropriate of
storing vaccines for a short period of
time.
4 Keep cool to be kept between 8-15 oC (45 -590F)
5 Store at room For product labelled to be kept
temperature between 15-25oC (59 -770F)
6 Store at ambient Store at the surrounding
temperature temperature. It means “room
temperature” or normal storage
condition, that is storage in a dry,
clean, well- ventilated area room
temperature between 15 -25 oC (59 -
770F) or up to 30, depending on
climatic conditions.
N.B: -When storing veterinary drugs, we have to

follow manufacturer’s recommendations on
storage conditions of specific products.
b. Combustible /Flammable storage conditions

Combustibles such as alcohol, ether and other
organic solvents must be stored in special or
separate rooms. An advisable precautionary
measure is to use a small, separate outbuilding
as a special store for inflammable supplies, since
it virtually guarantees that fire will not spread
throughout the store. All stores should be
equipped with fire extinguishers. A good
VDFACA 34
alternative to fire extinguishers is represented by

wooden or metal buckets filled with sand.
c. Secured storage conditions

Narcotic drugs, psychotropic substances, and
their documents should be kept in securely
locked rooms or cupboards. The keys should be
kept in a secure place and it is preferable that
only the chief of pharmacy should have access to
them.
4.4 Quality Assurance of Veterinary Drugs in

the Stock
Quality specifications comprise a set of properly

selected standards with associated methods of
analysis which are used to assess the integrity of
veterinary drugs and starting materials. The
selection of methods and procedures used in
specifications must be based on their utility for
the purpose of quality assurance of veterinary
drugs. The tests may involve simplified tests
(basic tests) or sophisticated analytical
examinations.
Because sophisticated analytical examinations
require special skills and well equipped
laboratories, simplified tests are commonly used
in dispensaries for verifying the quality of
dispensed veterinary drugs. Such tests may
usually serve to ascertain the absence of gross
degradation, contamination or damage.
Some indicators of quality problems that can be
ascertained by simplified test such as physical
VDFACA 35
inspection are show in table 4. When a product fails

the basic tests, it should not be used until its quality
is established by analytical examination. It is
important to note that the shelf-life of veterinary
drugs may be markedly shortened by improper
storage conditions. Therefore, the expiry date
information of a veterinary drug product may not
guarantee the quality of it. Any quality problem of
veterinary drug product should be reported to the
concerned body immediately.
VDFACA 36
Table 4: Common quality problem indicators for

different veterinary pharmaceutical products
Common quality Common Problem Indicators
problems
All products Broken or tripped packaging
Missing, incomplete or unreadable label(s)
Liquid products Discoloration, cloudiness, sediment, broken seal
on bottle, cracks in ampoule, bottle or vial,
dampness, or moistures in the packaging, leakage,
caking
Light sensitive Torn or ripped packaging
products
Latex products Dry, brittle or cracked
Lubricated latex Sticky packaging, discoloured products or
products lubricant, stained packaging, leakage of the
lubricant
Tablets (bolus) Discoloration, missing boluses, unusual smell,
stickiness (especially coated tablets)
Injectables Liquid does not return to suspension after
shaking sterile products
Torn or ripped packaging, missing parts, broken
or bent parts
Moisture inside the packaging or stained
packaging, Particle matter/precipitate
Foil packs Perforation(s) of packaging
Chemical Discoloration
Reagents
4.4.1 Techniques for quality drugs dispensing
The main aim of quality dispensing is to maintain

the quality of the dispensed medicines for their
specified shelf-life and ensure appropriate use of
the drugs by the patients. An important aspect of
quality dispensing concerns the packaging and
storage of drugs. The techniques that lead to
quality dispensing may be accumulated through
training and/or experience.
VDFACA 37
The most useful techniques to ensure quality in

dispensing include:
 Maintenance of records on what drugs and
products have been issued.
 Maintenance by the veterinary drug professional
of a daily list of drugs in stock to inform
prescriber which drugs are available thereby
ensuring that only these drugs are prescribed.
 A two prescription system whereby two separate
prescriptions are written one for medicines
available in the pharmacy and one for those
that are not but can be ordered which helps to
avoid rewriting of prescriptions.
 Adherence to specifications for storage
conditions.
 Adherence to specifications for containers for
repackaging
 Keep written procedures for compounding
 Dispensing only one prescription at a time
 Avoid dispensing when dizzy, in stress, etc.
 Double checking of the name, dosage form,
strength, amount to be dispensed as well as the
information on the label
 Organize medicine and therapeutic committee
at animal health institution level and participate
VDFACA 38
5. SYSTEMS OF MEASUREMENT AND DRUG

FORMULATION
Objectives:-
At the end of this session, you should be able to
identify different systems of measurement and
their relationship as well as different formulations
of drugs.
5.1 Systems of Measurements
There are three systems of measurements

namely: metric, apothecary and household
systems.
A) Metric system
Metric system is the most commonly used system
and sometimes termed as SI unit (International
system unit). This is because of the simplicity of
the decimal system, the clarity provided by the
base units and prefixes of the SI, and the ease of
scientific and professional communications
through the use of a standardized and
internationally accepted system of weights and
other measurements. The system is used to
manufacture and label pharmaceutical products,
for prescription and administration of drugs.
The system has one primary (base) unit and set of

prefixes. Base units are meter (length), litre
(volume) and gram (weight).
VDFACA 39
Table 5: Prefix modifiers in metric system

S/n Prefix Symbol Factor number 10th Factor in Word
1,000,000,000,000,000,000
1. exa E 1018 quintillion
2. peta P 1,000,000,000,000,000 1015 quadrillion
3. Tera T 1,000,000,000,000 1012 Trillion
4. Giga G 1,000,000,000 109 Billion
5. Mega M 1,000,000 106 Million
6. killo K 1,000 103 Thousand
7. Hecto h 100 102 Hundred
8. Deca da 10 101 ten
9. Deci d 0.1 10-1 tenth
10. centi c 0.01 10-2 Hundredth
11. Milli m 0.001 10-3 Thousandth
12. micro u 0.000001 10-6 Millionth
13. Nano n 0.000000001 10-9 Billionth
14. Pico p 0.000000000001 10-12 Trillionth
15. femto f 0.000000000000001 10-15 quadrillionth
16. Atto a 0.000000000000000001 10-18 quintillionth
VDFACA 40
General Guideline
1. To convert a larger to smaller unit
multiply proportionally
a. kg to g multiply by 1000
b. Hectogram (hg) to g by 100
2. To convert smaller to larger unit divide it
proportionally
a. g to kg divide by 1000
b. g to hg by 100
3. To do mathematical calculation all unit
should be the same
Example: To subtract 64 mg from 0.12 g=
120mg-64mg= 56 mg
VDFACA 41
Exercise:
1. Convert the following into their corresponding
equivalent
a) 50 mL to cL ans=5cL
b) 100 hL to L ans=10000L
c) 800 mL to nL ans=800,000,000nL
2. Add 0.55kg, 55mg and 125g. Provide the

answer in g. Ans. 675.055g
1. A sedative liquid medication contains o.25
mg of an active ingredient per mL. How
many g of the substance will in 5 litre of
the solution?
Given= the concentration 0.25mg/mL
Total volume of the solution is 5L = 5000mL
0.25mg------1mL
?------------5000mL
0.25mg x 5000mL = 1250mg

1mL
Ans. 12.5g
Sometimes international unit is also included in

metric system. The international unit is a unit of
measurement for the amount of a substance,
based on the measured biological activity or
effect. There is an international agreement
specifying the biological effect expected with a
dose of one IU. The unit is used for vitamins,
hormones, some medications, vaccines, blood
products, and similar biologically active
substances. One IU of insulin is the biological
equivalent of about 45.5μg pure crystalline
VDFACA 42
insulin (1/22 mg exactly). 1 IU of vitamin A is the

biological equivalent of 0.3 μg retinol, or of 0.6 μg
beta-carotene. One IU of vitamin C is 50 μg L-
ascorbic acid; one IU is the biological equivalent
of 0.025 μg cholecalciferol/ ergocalciferol. One IU
is the biological equivalent of about 0.667 mg d-
alpha-tocopherol (2/3 mg exactly), or of 1 mg of
dl-alpha-tocopherol acetate. One IU represents
0.6 microgram of a standard preparation of
penicillin.
B) Apothecary system
Apothecary system is an old system of
measurement and used first by apothecaries
(early pharmacists). It is not commonly used.
However, some countries like US are still used it.
It has units for weight and volume only.
Apothecary systems of measurement

• Grain (gr) is the basic unit of weight in
apothecary system 1gr=60mg=0.06g
• Dram is the basic unit of volume in
apothecary system
• ounce (oz) is the common unit of volume in
apothecary system
• Pound (lb)=A unit of weight equal to 12
ounce, 1kg=2.2lb
C) Household system
The house hold system is derived from
apothecary system. The units of house hold
system are drop, teaspoon, tablespoon, cup,
gallon and so on.
Approximate equivalents to household measure:
VDFACA 43
– 1 teaspoon (tsp) =60 drops= 5 ml

– 1 tablespoon (tbsp) = 15 ml = 3
teaspoon
– 1 glass =1 cup = 250 ml
– 1 ounce= 2 tablespoon=30 ml
– 15 -20gtt (drops)= 1 ml
House hold system is important for clients rather
than using it in the laboratory or in scientific
works since it is not accurate.
NB: Important Relationship

For water at STP (standard temperature [23oC]
and pressure [15 psi])
1 cc = 1ml = 1g, one litre of water = 1 kg
5.2 Drug Formulations
Any drug contains one or more active ingredients

and other inactive substances such as:
excipients, vehicles, flavouring agents, or
preservatives. These inactive substances play a
role in stability of the drug, ease of
administration or they may affect other
pharmacological properties of the drug.
Pharmaceutical companies manufacture drugs in
different forms. Drug formulation can be solid,
semisolid, or liquid.
A. Solid formulations
Solid formulations are Powders, Granules,
Tablets, Capsules and Bolus.
Powder: contain one or mixture of two or more
drugs in a dried or finely pulverized form. It can
VDFACA 44
be prepared for external use or can be mixed with

food or water or reconstituted for injection by
sterile fluid.
Granules: are small aggregate of powder held
together by a binding agent. Their use is the
same as powders.
Bolus: A single, relatively large quantity of a
substance intended for therapeutic use.
Capsules: a drug formulation in which the drug
(solid or semisolid or liquid) is contained in an
external shell. The shell which may be made up
of gelatine or glycerine will dissolve in the
stomach or in the upper part of the intestine. The
capsule helps to mask unpleasant (unpalatable)
taste of the drug. The disadvantage of capsule is
that it cannot be broken, to give a divided or
lower dose to an animal.
B. Semisolid drug formulations

Semisolid drug formulations are lotions,
ointments, cream, paste or gels which are
prepared for local or oral use.
i) Lotions: are solutions or suspensions of
soothing substances to be applied to the skin.
ii) Ointment is a greasy, semisolid preparation
that contains dissolved or dispersed drug.
Antibiotics and anti-inflammatory agents can
be prepared in the form of ointments.
Common examples are eye or ear ointments.
iii) Cream is a semisolid emulsion formulated for
application to the skin or mucous membranes.
Example: Udder cream
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iv) Paste is a semisolid preparation slightly

thicker and less greasy than ointment.
C. Liquid Preparations
Liquid formulations are prepared either in the
form of solution or suspension.
1. Solution: is a homogeneous mixture of two
or more substances; prepared as syrups (water
and sugar) or injectors. It can be aqueous or
alcoholic solution depending on the solvent in it.
It doesn’t settle or precipitate if it stands still for a
long period of time. Solutions may be available in
different containers (ampoule, vial or bottle).
i. Ampoules are a small glass container
intended for single use, the neck is broken to
get the drug.
ii. Vials are glass containers with rubber
stopper for single or multiple doses.
iii. Bottles are a glass or plastic containers
with larger volume than vials.
2. Suspension is a fluid containing solid
particles that are sufficiently large for
sedimentation. It should be shacked before use.
VDFACA 46
6. STRENGTH OF SOLUTIONS
Objectives:
Upon successful completion of this chapter, the

trainees will be able to:
– Identify methods to express the strength
solutions
– Perform calculations for altering strength of
solutions
6.1. Expression of strength of solutions
Strength shows the concentration of ingredients

in a mixture or a solution containing two or more
substances. There are two important components
in expressing the strength of a solution.
1. Solute is a chemical substance dissolved in
solvent that is usually present in small
amount.
2. Solvent (diluents) is a liquid used to dissolve
other chemicals that is usually present in
large amount.
The amount of solute and solvent in a mixture
indicates its strength. There are different
methods used to express the strength of
solutions. The most commonly used methods are
parts per notation, percentage and ratio.
A) Parts-per notation
The parts-per notation is used as a measure of
the concentration of a component substance in a
mixture of substances and usually when the
concentration is very small. The most commonly
VDFACA 47
used parts-per notations are Part per million

(ppm), Parts per billion (ppb), Parts per trillion (ppt)
and part per thousand (pps).
i. Parts per million refers to a number of parts

of one substance in one million parts of the
solution. For example: 5 ppm chlorine in water
is 5 gram of Chlorine in one million gram of
water (1,000,000 mL at STP).
Exercise 1: Convert 500 ppm to gram per litre,
500ppm = 500g in 1,000,000g (1,000,000mL
at STP)
500g in 1000L (1L =1000mL)
Divide both side by 1000, will give you the
answer
Ans. 0.5g/L
Q1: Convert 10 ppm to milligram per kg,
10ppm=10g in 1,000,000g of a substance
10,000mg in 1000kg (after converting g to
mg, and g to kg respectively)
Divide both side by 1000 will give you the
answer
Ans. 10mg/kg
NB: 1 mg / kg = 1ppm; 1mm3 /litre = 1 ppm; 1 mg

/ litre = 1 ppm
i. One part per hundred is generally

represented by the percent (%) symbol and
denotes one part per 100 parts, one part in
102, and a value of 1×10−2.
VDFACA 48
ii. One part per thousand (pps) denotes one

part per 1000 parts, one part in 103, and a
value of 1×10−3.
iii. One part per billion (ppb) denotes one part
per 1,000,000,000 parts, one part in 109,
1/1,000,000,000 * 100% = 0.0000001% (or
1% = 10,000,000 ppb) and a value of
1×10−9.
iv. One part per trillion (ppt) denotes one part
per 1,000,000,000,000 parts, one part in
1012, and a value of 1×10−12.
B. Percentage (v/v, w/v, w/w)
i. Percent volume in volume (v/v): the number

of mls of a drug in 100ml of a solution (1% v/v
= 1 ml/100 ml).
ii. Percent weight in weight (w/w): the weight
in gm of a drug in 100 gm of the mixture (60%
w/w= 60 gm/100 gm).
iii. Percent weight in volume (w/v): the weight
in grams per 100ml of a solution (dextrose 5%
w/v = 5 g/100ml).
C. Ratio
Ratio is expressed as 1:1000 which means 1 unit
of a drug in 1000 unit of a solution.
VDFACA 49
Exercise
1. How many mL of ethanol exist in 500mL of
70% (v/v) ethanol solution?
70%= 70mL in 100mL
?-----------500mL
70mLx500mL = 350ml
100mL
2. How many gram of oxytetrcycline exist in
200 mL of 20% solution? Ans 40g
20%(20g) in 100mL
? ----- 200mL
20gx200mL = 40g
100mL
3. The recommended dilution concentration
of diazinon is 1:1000. How many mL of
stock solution is needed to prepare 10 litre
of the mixture?
1:1000 = 1mL in 1000mL of a solution
?--------------10,000mL (10L =
10,000mL)
10,000mLx1mL = 10ml
1000mL
6.2 Changing the strength of solutions
The strength of a solution can be changed either

by dilution or concentration. Dilution is making a
solution less concentrated for application as a
drug or laboratory reagent. This is done by
adding a solvent/diluents/, or admixture with
solutions or mixtures of lower strength.
Concentration is increasing the strength of a
solution by addition of the active ingredient
VDFACA 50
(solute), evaporation of the diluents or admixture

with solutions or mixtures of higher strength.
If the amount of active ingredient remains constant,
any change in the quantity of solution or mixture of
solids is inversely proportional to the percentage or
ratio strength that is the percentage or ratio strength
decreases as the quantity increases. Problems in
dilution or concentration are generally solved by the
following equation
(Quantity)1 × (Concentration)1 = (Quantity)2 × (Concentration)2;
Q1 × C1 = Q2 × C2
For calculating other quantity, determining the
quantity of active constituent (solute) is needed and
then calculating the quantity of the available solution
(usually concentrated or stock solution) that will
provide the needed amount of the constituent.
Example: if there is 4% of saline solution and if we
need 40 mL of 2% working solution. How many mL of
stock solution and water are needed?
Given
C1 = 4% C2 = 2%
Q1 = ? Q2 = 40mL
Q1x4%=2%x40mL = 40mLx2% = 20mL

4%
Answer = 20ml stock and 20ml water
Exercise
1. How many ml of a 20% solution are needed to
prepare 50 ml of a 5% solution? Ans. 12.5mL
2. A stock solution of 10% iodine is to be diluted to
2% solution. If 5 litre of iodine were needed, how
much water should be used for dilution? Ans. One
litre of Iodine, 4 litre of water
3. A veterinarian wants to disinfect the poultry
house using 2.5 % formalin from formaldehyde
VDFACA 51
(100%). How many mL of the stock solution is

needed to prepare a 16 litre working solution?
Answer: 400 mL
VDFACA 52
7. DOSE CALCULATION
Objective:
to perform dose calculation for proper drug
prescription and dispensing of veterinary drugs.
Dose calculation is crucial for any clinical

practice. Over dose is dangerous for the patient
and encore extra-cost. Under dose is ineffective
and promote the development of drug resistance.
Factors that affect dosage are related with the
patient or the drug. The patient factors include
body weight, species of animal, sex, age,
physiological status and pathology. Some of the
factors related with drug are type of the drug and
concentration of the active ingredient.
To calculate the dose, you should know the
standard dose (mg/kg, ml/kg, unit/kg or dilution
rate for a solution), the concentration of the
active ingredient (mg in ml or g) and the body
weight of the animal.
Figure 2: Weighing the animal by heart girth and

sensitive digital balance
VDFACA 53
7.1. Weighting animal using heart girth

With weight estimation formulas, a common tape
measure is used to determine the heart girth and
body length measurement. These measurements
are then used to calculate the animal’s weight.
The weight estimation formulas described below
are almost always more accurate than visual
observation in determining an animal’s weight.
7.1.1. Beef Cattle
1. Measure the length of body, from the point-of-

shoulder (A) to the point-of-rump or pin bone
(B).
2. Measure the circumference or heart girth (C).
Measure from a point slightly behind the
shoulder blade, down the fore-ribs and under
the body behind the elbow all the way around.
VDFACA 54
After these measurements are made in inches

– use the following formula.
3. (Heart girth X heart girth X body length) ÷ 300
= weight in pounds.
Example:
Heart girth (76”) X heart girth (76”) X body length
(66”) divided by 300 = 1,270 pounds.
76 X 76 = 5,776
5,776 X 66 = 381,216
381,216 divided by 300 = 1,270 pounds
7.1.2. Sheep and Goats

For sheep and goats, use the same method
described for beef cattle. When working with
unshorn sheep, be sure to part or compress the
wool to insure an accurate heart girth
measurement.
7.1.3. Horses
VDFACA 55
1. Measure the length of body from, from the

point-of-shoulder (A) to the point-of-rump (B).
2. Measure the circumference (heart girth) of
body (C). Measure from the base of the
withers, down under the belly, just behind the
elbow and foreleg, and all the way back
around. After these measurements are made
in inches – use the following formula.
3. (Heart girth X heart girth X body length) ÷ 330
= weight in pounds.
Example:
Heart girth (70”) X heart girth (70”) X body length
(65”) divided by 330 = 965 pounds.
70 X 70 = 4,900
4,900 X 65 = 318,500
318,500 divided by 330 = 965 pounds
Tips for increasing Accuracy and Safety

 Make certain the animal is standing
squarely on level ground.
 Have someone stand on the opposite side to
help with the girth measurment.
 Make sure the tape lays flat and is not
twisted.
 Pull the tape snug.
 When using a weigh tape, position the tape
according to the manufacturer’s directions.
 A cloth measuring tape is preferred.
 You may need to restrain the pig or some
feed may help you get the needed
measurements.
VDFACA 56
 Be calm, don’t rush in. Make sure the

animal is comfortable with the measuring
tape.
 When monitoring an animal’s weight over
time, it is best to have the same person
using the same method.
 By following a set procedure you will be
able to monitor change that can be used as
an indicator of health.
 The weight estimation formulas and weigh
tapes may be used effectively for many
animals, but are not highly accurate for
pregnant animals or those with extreme
conformational irregularities.
 Keep a record that you can refer back to
over time.
7.2. Formula to calculate dose:

i. Unit (amount) needed = body weight X dose rate
You should always notice the unit of
measurement.
Example: How many mg of Amoxicillin are needed
for a 10 kg dog if the dose is 20 mg/kg ? mg
needed = 10 kg x 20 mg/kg = 200 mg (kilograms
cancel out)
ii. Liquid dosage in ml =

Standard dose in mg/kg X body wt in kg
Concentration of the drug in mg/ml
Example 1: How many mL of Amoxicillin are

needed for the patient above? The Amoxicillin
available is in a 100-mg/mL concentration,
VDFACA 57
20mg/kg x 10kg = 2mL

100mg/mL
Example 2: You decide to give a sheep weighing
30kg, oxytetracycline in the bottle containing
100mg/ml. the standard dose of oxytetracycline
in sheep is 10mg/kg. How many ml will be given
for this sheep?
Using the above formula 10mg/kgx30kg = 3mL

100mg/mL
Exercise: Calculate the following questions

accordingly
1. The general dose of atropine sulphate to pigs
is 0.05mg/kg of body weight and the solution
is levelled as 2.5mg/ml. How many ml of the
drug administered to the pig weighing 100 kg?
Ans. 2mL
2. In Exercise 1 above, another solution of
atropine sulphate is found in proportion of
0.1%. Calculate the amount of drug
administered to that animal? Ans. 5ml
3. If you want to administer 2ml of sodium
pentobarbital in dose rate of 1mg/kg of body
weight to the rabbit weighing 10kg. In what
concentration you may dissolve the drug? Ans.
5mg/ml
iii. Solid Dosage in bolus or tablet or capsule
= Standard dose in mg/kg X body wt in kg
Concentration of drug in mg/bolus/tablet
VDFACA 58
Exercise: the standard dose of Albendazole for cattle

is 10mg/kg, how many boluses are needed to
treat a cow weighing 240kg, where each bolus
contains 600mg of the drug per bolus.
10mg/kg x 240kg = 4 bolus
600mg/bolus
iv. Intravenous Drip Calculation

Intravenous (IV) infusions are sterile, aqueous
preparations administered intravenously in
relatively large volumes. They are used to extend
blood volume and /or provide electrolytes,
nutrients or medications.
Intravenous infusions may be continuous or
intermittent. In continuous infusions, large
volumes of fluid (250 to 1000 mL), with or without
added drug, are run into a vein uninterrupted.
Intermittent infusions are administered during
scheduled periods.
a). Continuous infusions

To calculate infusion time, use this formula:-
Infusion time = Volume of infusion in mL

Flow rate in mL/hr or mL/min
b) Intermittent Infusion
Drip rate = volume of solution mL x drops/mL =

volume in drops/minute (or ggt/min)
Time (in minutes)
Example 1: A patient animal received 260 mL of an
infusion continuously at a rate of 40 mL/minute.
What was the infusion time in minute?
260mL = 6.5 minute
40mL/min
VDFACA 59
Example 2: A medication order calls for 1000 ml of

D5W (5% dextrose) to be administered over an 8-hour
period. Using IV administration set that delivers 10
drops/ml, how many drops per minute should be
delivered to the patient animal?
8 hours = 480 minutes
X = 1000/480 = 2.1 ml/ min
2.1 X 10 = 21 drops/ minute
NB: it is possible to administer drugs together with IV

infusions however, make sure that the drug and the
fluid are compatible (didn’t react, didn’t form
precipitate). The dose calculation will be done as
described above without considering the volume of fluid
to be given.
VDFACA 60
8. PRINCIPLES AND PROCESSES OF

VETERINARY DRUGS PRESCRIBING
PRACTICE
Objectives
After completion of this session trainees should

be able to:
 Identify principles and requirements of

good prescribing practice
 Recognize the process of prescription of

veterinary drugs
8.1 Principles of Rational Prescribing
Good Prescribing Practice (GPP) is prescribing the

right veterinary drug for the right patient, in the
right dosage of the right formulation and for the
right length of time. GPP also includes not
prescribing any veterinary drug at all if it is not
needed. It requires detailed knowledge of the
patho-physiology of the diseases and clinical
pharmacology of the veterinary drugs.
The use of International Non Proprietary Names

(INN) or generic names of veterinary drugs in
prescribing is an essential component of good
prescribing practice. This is because generic
veterinary drugs are less costly, and for a generic
prescription any suitable product can be
dispensed hence avoiding delay while looking for
a specific brand.
VDFACA 61
Requirements for Good Prescribing Practice

Good prescribing practice requires:
1. Assessment of the benefit-to-risk and/or
benefit-to-cost ratio of prescribing
During prescription, professionals should
consider the following assessment tools:
i. Seriousness of the problem to be treated
ii. Appropriateness for the animal
iii. Optimal use of the veterinary drug with
respect to:
 The safety, efficacy and quality of the
veterinary drug
 Possible contraindications Example:
albendazole should not be given during early
pregnancy due to the possibility of embryo
toxicity.
 Drug-Drug interactions Example:
Oxytetracycline should not be given together
with di/trivalent cations (Ca+2, Mg+2, Al+3 or
Fe+2) due to the chelating behaviour of
oxytetracycline with these cations.
 Drug-feed interactions Example: fatty meals
facilitate the absorption of Albendazole
whereas full rumen may impair its
absorption.
 Treatment history
iv. Public health significance
The effect of the drug on consumers of products
from treated animals. Example: Nowadays,
chloramphenicol is banned from use in food-
producing animals because of its high risk in
human from consumption of products from
treated animals.
VDFACA 62
v. The cost of veterinary drug

The cost of the drug should be reasonable.
Example: Treatment of chronic bovine
tuberculosis by isozanaide is not advised because
of its high cost - to- benefit ratio.
2. Justification for veterinary drug therapy

One has to justify the need for treatment before
prescribing. The professionals should avoid
unjustifiable prescription. For example:
prescribing of broad spectrum antibiotics for all
animal patients with coughing, and prescription
of drugs based on the owner’s interest.
3. Selection of appropriate drug(s)

Once treatment is justified, to decide which
particular veterinary drug to use, the prescriber
should go through the process of:
a. Selecting the therapeutic class; example:
antibiotics for infection
b. Selecting group of veterinary drugs within the
class and selecting a particular medicine in
the group; example: Streptomycin among
Aminoglycosides
The choice of drugs should also consider
sensitivities, site of infection, feature of animal
patients such as contraindications, and
availability of the drug. Pharmacokinetics and
pharmacodynamic properties of a drug should
also be considered while choosing a drug.
4. Route of administration:
The choice of route of administration depends on
site of desired action (systemic or local), physical
VDFACA 63
and chemical property of the drug and its

formulation (solid, liquid, gas, solubility, pH,
irritancy), the rapidity with which the response is
desired (fast action, intravenous), patient’s
condition (unconscious, vomiting), the ability of
the drug to withstand the conditions of the
gastrointestinal tract (example: insulin cannot be
administered orally since it is degraded in the
gastrointestinal tract). Example: intravenous
route is preferable for severe infections such as
milk fever and cowdriosis.
5. Dosage and course of treatment

The dosage of the drug and course of treatment
may vary with characteristics of the patient (body
weight, age, species, physiological status and
pathology), the nature of the disease (chronic or
acute), and type and strength of the drug.
Example 1: A single dose of diaminazine

aceturate is given for the treatment of bovine
trypanosomosis but oxytetracycline 10% is given
from 3 to 5 days for treatment of pneumonic
pasteurellosis.
Example 2: A single dose of oxytetracycline 20%

is enough for the treatment of pneumonic
pasteurellosis but oxytetracycline 10% is given
from 3 to 5 days.
VDFACA 64
8.2 Prescription process
There are six major steps to be followed in the

prescribing process.
Defining the disease problem
Specify the therapeutic objective
Select suitable veterinary drug
Prescription writing
Give information, instruction and warning
Monitor the treatment
Figure 3: major steps in prescription process
1. Defining the diagnosis

The first step in rational treatment is defining the
patient’s problem, which is making a correct
diagnosis. To conduct correct diagnosis it should
be supported by laboratory procedures in
addition to physical examination techniques.
VDFACA 65
2. Specifying the therapeutic objectives

Once a diagnosis is made, one has to specify
his/her therapeutic objective(s), what the
prescriber wants to achieve with treatment to be
applied. For example: to cure an infectious
disease or to relief animals from non-infectious
disease like bloat. The better you define your
therapeutic objective, the easier it is to select the
suitable veterinary drug.
3. Selecting the suitable veterinary drugs

Select veterinary drugs as described above.
Selected veterinary drugs are the veterinary drugs
you have chosen to prescribe regularly, and with
which you have become familiar with their
therapeutic effects and side effects. They are your
priority choice for given indications based on the
National Veterinary Drug List, Veterinary
Formulary and the Standard Veterinary
Treatment Guideline (SVTG) for Ethiopia.
4. Prescription writing
A prescription is an important therapeutic
transaction between the prescriber and veterinary
drug consumer through a dispenser. It is a
written order of the prescriber for one or more
medication, and instructs the dispenser how to
prepare and dispense veterinary drugs and the
owner how to use them.
Prescription should be written on a standard

prescription paper, written in ink, legible, written
in generics, clear (not ambiguous), written in
English with some Latin abbreviations, and The
VDFACA 66
quantity of ingredients should be expressed in

metric system.
Table 7: Techniques to avoid confusion in writing

figures or units
Incorrect way of writing Correct way of writing
.5 mg 0.5 mg
μg mcg
1.0 mg 1 mg
500000 500,000
0.025 g 25 mg
Content of prescription paper

According to Guidelines for the control of use of
prescription paper which will be published by the
Veterinary Drug Administration and Control
Authority of Ethiopia, the content of any
prescription paper should include the following
information (Annex 1):
1. Serial number and area code and date
2. Name, level and address of the animal
health institution.
3. Owner's name and address
4. Species of the animal, breed, age, sex,
status, colour card Number and ID No
(name)
5. Type of Diagnosis
6. Name, strength, dosage form and dosage of
the drug
7. If the drug is to be compounded the type of
ingredients needed, direction for use and
how to prepare it
VDFACA 67
8. If the drug is refillable direction for refill.

9. The withdrawal period for milk, meat and
egg
10. Prescriber's name, qualification, registration
number, and signature and date on which
the prescription is written
11. Dispenser's name, qualification, registration
number, and signature and date on which
the prescription is filled.
12. Summarized directions to be followed by
prescribers and dispensers.
5. Give information, instructions and warnings

Most owners do not give the prescribed drugs
correctly to patient animals; give them
irregularly, or not at all. The most common
reasons are that symptoms have ceased, side
effects have occurred, the drug is not perceived
as effective, or the dosage schedule is
complicated for patients, particularly the elderly.
For example drugs with a short half-life or a
narrow therapeutic margin may become
ineffective or toxic if taken irregularly.
Patient adherence to treatment can be improved
in three ways: prescribe a well chosen drug
treatment; create a good veterinarian-owner
relationship; and take time to give the necessary
information, instructions and warnings.
The six points listed below summarize the
minimum information that should be given to the
owner.
1. Effects of the drug: Which symptoms will
disappear; and when; how important is it
VDFACA 68
to give the drug; what happens if it is not

given;
2. Side effects: Which side effects may occur;
how to recognize them; how long will they
remain; how serious they are; what to do if
they occur;
3. Instructions: When to take; how to take;
how to store; how long to continue the
treatment; what to do in case of problems;
4. Warnings: What not to do (driving,
machinery); maximum dose (toxic drugs);
need to continue treatment (antibiotics);
5. Next appointment: When to come back (or
not); when to come earlier; what to do with
left-over drugs; what information will be
needed;
6. Everything clear? Everything understood;
repeat the information; any more
questions.
6. Record keeping and Monitoring of the

treatment
Information containing the date of prescription,
the owner name, the animal patients name or ID
No, species, sex, age, the disease diagnosed, the
prescribed drug name, dosage strength and
dosage form and amount, the prescriber name
and initials should be recorded on the case book.
The purpose of monitoring is to check whether
the treatment has solved the patient's problem.
You should use the same criteria for monitoring
the effect, but in practice they can be condensed
VDFACA 69
into two questions: is the treatment effective? Are

there any side effects?
Was the treatment effective?

1. Yes and disease cured: Stop the treatment
2. Yes, but not yet completed: Any serious side
effects?
 No: treatment can be continued
 Yes: reconsider dosage or drug choice
3. No, disease not cured: Verify all steps:
 Diagnosis correct?
 Therapeutic objective correct?
 P-drug suitable for this patient?
 Drug prescribed correctly?
 Patient instructed correctly?
 Effect monitored correctly?
EXAMPLE: -Suppose an ox with age 5 years come

to veterinary clinic with clinical signs loss of
appetite, body condition and productivity,
intermittent fever, Anaemia, Oedema, enlarged
lymph nodes, tick infestation around some parts
of their body and direct examination of fresh
blood from ear vein and buffy coat between slide
and cover slide indicate flagellate protozoan
crossing the microscope field.
Step 1. Defining the diagnosis

Based on the clinical sign and laboratory
diagnosis the diagnosis is defined as
Trypanosomosis and tick infestation.
Step 2. Specifying the therapeutic objectives
VDFACA 70
The prescriber wants to achieve with treatment is

to cure an animal from Trypanosomosis and to
relief the animal from the ticks attack.
Step 3. Selecting the suitable veterinary drugs
you have chosen to prescribe regularly for
Trypanosomosis
 Diminazine aceturate (DIMINAVIC 2.36, YZ-
DIMINAZIN, Diminashish 2.36gm, Diminasan
2.36gm, Diminal 2.36gm, Rang tryps,
Survidium 2.36gm)
 ISOMETAMIDIUM CHLORIDE (Trypamidium
/Samorine sachet, SEMIDIUM 1000,
Trypashish, veridium, Ancomidium 125mg
 Homidium chloride (Bovidium 250mg)
 Homidium bromide (Ethidium 250mg)
you have chosen to prescribe regularly for Tick
infestation.
 Deltametrin 1% pour w/v
 Amitraz 12.5%w/v
 Diazinol 60%
 cypermethrin 2% pour –on
 ECTOPOR 020 SA Pour on
VDFACA 71
Step 4. Prescription writing
Veterinary Prescription Paper

Ser.No, 03v000638
Case No.__ 2346___
Name and level of Animal Health Institution Alem ketema veterinary
clinic (type C)_
Address Region__amahara_Zone_Semen Shoa Woreda_Merabite
Town alem ketema _Tel 01113206..
.....................................................................................................
Ser.No, 03v000638
Name and Level of Animal Health Institution Alem ketema veterinary
clinic (type C)
Address Region__amahara_Zone_Semen Shoa Woreda_Merabite
Town Alem ketema _Tel 01113206..
Owner's Name___Ato Ambereber Abrare____
Address Region_ Amahara _ Town Alem ketema Woreda_ Merabite
_Keble_03_locality_Setatit_
Species of animal _Bovine_Age_5_Sex__male_ Body
weight___250kg_
ID No.(name)_Bure___ Case No.___2346___
Diagnosis _Trypanosomosis and tick infestation__
Treatment given (name, strength, dosage Price of Each item
form, dosage and quantity of drug)
Birr Cent
3.5 mg of diminazene diacenturate/kg
Diazinon 60% 5ml dilute with 5 litre of
water
Refill______________________Withdrawal period_________________
Prescriber's Dispenser's Name___Tefera Tibebu (Dr.)
Qualification _______DVM____
Registration no.________________________________________
Signature_________________________ __________________________
Date______________________________ _________________________
* Seal over leaf
VDFACA 72
Step 5. Give information, instructions and

warnings
• The six points listed below summarize the

minimum information that should be given
to the owner.
– Instructions: When to give diazinon; how to

give diazinon; how to store; how long to
continue the treatment; what to do in case
of problems;
– Effects of the drug: Which symptoms will

disappear; and when; how important is it to
give the drug; what happens if it is not
given;
– Side effects: Which side effects may occur;

how to recognize them; how long will they
remain; how serious they are; what to do if
they occur;
– Warnings: What not to do (driving,

machinery); maximum dose (toxic drugs);
need to continue treatment (antibiotics);
– Next appointment: When to come back (or

not); when to come earlier; what to do with
left-over drugs; what information will be
needed;
– Everything clear? Everything understood;

repeat the information; any more
questions.
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7. Record keeping and Monitoring of the

treatment
Information containing
Date of prescription: O1/07/07
The owner name….. Ato ambereber abrare____
The animal patients name or ID No___ Bure ____
Species of animal _bovine_Age_5_Sex__male_
The disease diagnosed, _Trypanosomosis
The prescribed drug name, dosage strength and
dosage form and amount,3.5 mg of diminazene
diacenturate/kg, Diazinol 60%
The prescriber name and initials Tefera Tibebu (Dr.)
check whether the treatment has solved the

patient's problem. Was the treatment effective?
VDFACA 74
9. PRINCIPLES AND PROCESS OF VETERINARY

DRUGS DISPENSING PRACTICE
Objective

to identify principles and process of good
despising practices.
9.1 Principles of Good Dispensing
Dispensing practice, the duty of dispensers, plays

a central role in the provision of rational
veterinary drug. Dispensing refers to the process
of preparing veterinary drugs and distributing to
users with provision of appropriate information,
counselling and follow up. It may be based on a
prescription or an oral request of owner
depending on the type of veterinary drugs to be
dispensed.
Good dispensing practice ensures that the correct

veterinary drug is delivered to the right animal
patient, in the required dosage and quantities,
with clear instructions. Dispensing includes all
the activities that occur between the time the
prescription or oral request of the owner is
presented and the veterinary drugs are issued to
them. This process may take place in the animal
health institutions and community veterinary
drug retail outlets. It is often carried out by
veterinary drug professionals. No matter where
dispensing takes place or who does it, any error
or failure in the dispensing process can seriously
affect the care of the animal patient mainly with
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medical and economical consequences and public

health hazard. Therefore, the dispenser plays a
crucial role in the therapeutic process.
The quality of dispensing may be determined by

the training and supervision in which the
dispenser has received and the veterinary drug
information available to the dispenser. Veterinary
drug dispensers must have knowledge about the
veterinary drugs being dispensed (common use,
correct dose, precautions about the method of
use, common side effects, common interaction
with other medicines or feed, storage needs, good
calculation and arithmetic skills) and must have
ability to explain information clearly by the
language the owner can understand and check
whether the information is being understood.
9.2 Dispensing Process

9.2.1. Pre -dispensing Activities
Before owners arrival the dispenser should
prepare himself/herself and the dispensing
environment and facilities.
 Check the dispensing room, shelves and
dispensing desk are clean and organized
 Wear a clean and white gown
 Attach your identification tag on the gown
in such a way that it is visible to clients
 Check availability of dispensing aids
(labelling materials, packaging materials,
sufficient no of spoons etc)
 Ensure availability of updated national
veterinary drug list, rational use of
VDFACA 76
veterinary drugs manual, SVTG, veterinary

formulary, and prescription registration
book.
As clients come into the veterinary pharmacy

section, they must be made to feel attended to
and comfortable by friendly gestures, a smile,
eye–to-eye contact, a friendly welcome, politeness,
and feeling of caring.
9.2.2. Dispensing procedures

The development and use of written standard
operating procedures (SOPs) for dispensing
process will improve consistency and quality of
work. The framework for such SOP may be based
on the five major steps to be performed in the
dispensing cycle during the dispensing process.
Step 1. Receive and validate prescription or verbal

request
Upon receiving a prescription, the dispenser
should confirm the name of the owner and the
identity of the patient animal. This action is
particularly important when the clinic is dealing
with a large crowd of animals and when there is
any risk that the dispenser may mix up
prescriptions. Cross checking the name of the
owner and identifications of the animal must also
be done when issuing the drugs. Dispensers
could also accept verbal requests from
professionals and/or paraprofessionals or directly
from the owners only for OTC drugs with
justification.
VDFACA 77
Step 2. Understand and interpret prescription

 Carefully read the prescription or validate
verbal request
 Check if the prescription is legally and
currently written
 Interpret any abbreviations used by the
prescriber correctly
 Confirm that the doses prescribed are in the
normal range for the animal patient
(considering species, sex, body weight and
age)
 Identify common drug- interaction(s)
 Verify inadequately written prescription and
make necessary correction with the
prescriber’s consent.
 Perform any calculations of dose and the
quantity to be issued correctly
Step 3. Prepare items for administration or issue

Preparation of items for administration and/or
issue is the central part of the dispensing
process. This part of the process begins after the
prescription is clearly understood and the
quantity has been calculated.
 Select stock container by reading the label
and cross matching the drug name and
strength against the prescription.
 The dispenser should check the stock to
make sure that it is not expired and choose
the oldest stock (FEFO or FIFO)
 Read the container label at least twice
during the dispensing process.
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 Do not select the prescribed drugs

according to the colour or location of
container.
 Do not open many stock of containers at the
same time. This trend will lead to errors
and/or expose the drugs to air and
eventually leads to deterioration in quality.
 While counting, pouring or measuring, the
following points should be noted:
 Under and/or over measuring or
counting should be avoided
 Always use clean and sterilized syringe
and needle
 Graduated measuring cylinder and/or
flask must be used for measuring liquid
reduction. If small volume is to be
measured, small measuring cylinder or
flask has to be used.
 Appropriate weight measuring balance
should be used
 In dispensing liquid formulations:
 Must be measured in a clean vessel and
should be poured from the stock bottle
with the label kept up ward. This avoids
damage to the label by any spilled or
dripping liquid.
 Pour the measured liquid preparation
into the container/bottle and label it.
 Do not use owners own bottle
 In dispensing solid formulations:
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 Do not use fingers to count tablets or

boluses as this can lead to
contamination of drugs
 Count and put them in a labelled drug
container or pack
 Close stock containers tightly after
dispensing
 Keep the spoon or other counting
materials clean at all times
 Do not keep the spoon or other counting
materials inside the container
Step 4. Recording, documentation and reporting

Records of issues to animal patients are essential
in an efficiently run dispensary. Such records can
be used to verify the stocks used in dispensing,
and they will be required if a need arises to trace
any problems with veterinary drugs issued to
patients.
There are three different methods that can be

used to keep a record of drugs dispensed. These
are:-
 When a prescription is retained, the
dispensing staff should put initials and
annotate the prescription and either files or
enters the details into a record book.
 When the prescription is returned to the
owner of animal patient details of the drugs
dispensed must be entered into a record
book before the items are issued to the
patient.
 When computers are used in the dispensing
process the computer program should
VDFACA 80
retain the information, which can be

recalled to generate summary report.
The following information should be included into

the record book and/or computer:
 The date, name of the owner, and the
animal patient’s identity (name, ID No,
species, sex, age)
 The drug name, dosage strength and
dosage form, and the amount issued.
 The dispenser name and initials
The receipts for requisition, receiving as well as
the prescription registration book should be kept
properly. Filled prescriptions should also be kept
as a receipt. Regular reports on drug
consumption and prescribing pattern from
patient prescription registration book should be
prepared and report to the concerned veterinary
drug authority timely. Information obtained from
prescription registration book could be used for
further planning and efficient utilization of
resource.
Step 5. Administer or issue drugs to animal patient

with clear instructions and advice
For drugs to be administered at the veterinary

establishments, the owners should be informed
about withdrawal period for milk, meat, egg and
honey and not to interrupt treatment when side
effects occur or in the absence of response
without consulting the prescriber or dispenser.
(example: why the entire course of an antibiotic
treatment must be given)
VDFACA 81
In addition to these for prepared, packaged and

labelled drugs issued to owners the following
written information should also be provided.
 How much and how often to give the drug
 How long the treatment is to last
 How to give the drug
 How to store the drug (example, avoid heat,
light and dampness)
 Not to share drugs to other animals
 To keep drugs out of reach of children
 Finally, check whether the owner have
understood the information provided
9.2.3 Responsibilities of dispenser when

Supplying Veterinary Medicines
A veterinary drug professional has specific

responsibilities when supplying a veterinary
medicine in order to ensure that it is used
appropriately. The veterinary drug professional
must be present when it is handed over. In
particular, a veterinary drug professional
supplying a product classified as POVM or over
the counter (OTC) veterinary drug products must:
i. Be satisfied that the medicine is
appropriate for the animal and condition to
be treated:
As an example, the veterinary drug professional
should consider asking when the last treatment
was, Age and weight of animal, any concurrent
medication and any other disease as appropriate.
VDFACA 82
ii. Be satisfied that the person who will use

the product is competent to do so safely,
and must advise on safe administration
and any warnings or contra-indications:
For example, the dispenser should emphasize any
safety precautions:
– Directions to wear gloves or wash hands
after use
– Restrictions on children petting animals after
administration with spot-on products
– Restrictions on bathing of animals or
allowing animals to swim in water courses
after administration with spot-on products
iii. Not supply more than the minimum
amount required for the treatment
The Regulations allow veterinary drug professional
to break open packages for the purposes of
supply, except the immediate packaging of an
injectable product.
iv. Ensure that the medicine is labelled
correctly:
if the product is supplied in a container other than
the marketed pack, this container must be
suitably labelled and sufficient information
supplied to enable the product to be used safely
(this could be the SPC or the package leaflet).
v. Record and report any adverse events
involving the medicine promptly: Adverse
events should be reported to the VDFACA
using adverse effect reporting format.
VDFACA 83
9.3 Withdrawal periods and control for

residues of veterinary drugs:
Whenever antibiotics or other drugs are

administered to food producing animals either by
the veterinarian or by the owner - the veterinarian
must inform the owner about the withdrawal
periods for the drugs used, in order to avoid
residues in animals and their products (meat, milk,
eggs and honey) to be delivered for human
consumption. Such information must be given
verbally and in writing. If animals are delivered for
emergency slaughter within the withdrawal period,
information regarding the withdrawal period, as
described above, must accompany the animal to the
slaughterhouse.
Withdrawal period may be affected by different

factors
i. Route stated on the label is followed or not
Withdrawal times are only applicable if the route
stated on the label is followed. For example,
Liquamycin LP given intramuscular has a
withdrawal time of 60 hours following the last
treatment. If given intrauterine the withdrawal time
is not known.
ii. Amount Administered
Volume administered per injection site is important.
The Liquamycin LP label states “do not administer
more than 10 cc per site”. If you administer more
than 10 cc the withdrawal time is not known.
iii.Method of Treatment
Intramuscular injections require a 1.5 inch needle
to insure that the product is injected into the
muscle. If the needle is not into the muscle and the
VDFACA 84
product goes into the fat or under the skin, the

adsorption will be affected and the withdrawal time
is not known. Repeated injections in the same area
interfere with adsorption of the product. It is better
to choose a new site for each treatment.
VDFACA 85
10. CONSEQUENCES OF IRRATIONAL DRUG

UTILIZATION
Objectives

to:
• identify the magnitude and consequences
of irrational drug use
• Describe the reasons underlying irrational
use
• Discuss strategies and interventions to
promote rational use of drugs
10.1 Rational Use of Drugs
The rational use of drugs requires that patient

receive medication(s) appropriate to their clinical
needs, in doses that meet the individual
requirements for an adequate period of time, and
at the lowest cost. Rational use of drugs should
meet the following criteria:
i) Appropriate indication: - The decision to give
the drug(s) based on medical rationale and that
drug therapy is an effective and safe treatment.
ii) Appropriate drug: - The selection of drugs based
on efficacy, safety, suitability and cost
considerations.
iii) Appropriate dosage, administration and time of
treatment.
VDFACA 86
iv) Appropriate patient: - No contra-indications

exist and the likelihood of adverse reactions is
minimal, and the drug is acceptable to the owner.
v) Correct dispensing: including appropriate
information for owners about the prescribed drug
and animal condition.
v) Adherence of animal patient to treatment
On the other hand, irrational drugs use includes

use of drugs when no drug therapy is indicated
(example:- antibiotics for simple viral infections
and owners complaint), use of more medicines
than are clinically necessary, use of the wrong
drug for a specific condition (example:
inappropriate use of anti-bacterial agents for
non-bacterial infections), use of drugs with
doubtful or unproven efficacy, use of correct
drugs with incorrect route of administration,
dosages, and duration, failure to prescribe and
dispense in accordance with clinical guidelines,
and inappropriate medication by owners.
10.2 Factors Influencing Rational Drug Use
There are several factors that affect the rational

use of drugs. However, the most important
factors are:
A. Lack of information and awareness on
consequences of irrational drug use
Up to date and unbiased information on the
currently used drugs is needed for rational use of
drugs.
VDFACA 87
B. Inadequate Training and Education

In adequate training and education leads for
incorrect interpretation of the prescription,
inaccurate counting, compounding, or pouring of
drugs, unsanitary procedures, incorrect
prescribing, and profit driven attitude.
C. Poor communication between clinician and
animal owner:-
There is usually less attention to the animals and
their problem. Treatments or instructions that do
not consider the owners belief, environment, or
culture.
D. Lack of diagnostic facilities
Clinicians posted in remote areas have to face a
lot of difficulty in reaching to a precise diagnosis
due to non availability of diagnostic facilities.
This promotes poly-pharmacy and incorrect drug
prescription.
E. Demand from the owner
To satisfy the owner expectations and demand of
quick relief, veterinarians prescribe drug for every
single complaint.
F. Defective drug supply system and ineffective
drug regulation:-
Absence of well organized drug regulatory
authority and presence of large number of drugs
in the market leads to irrational use of drugs.
G. Promotional Activities of Pharmaceutical
Industries:
The lucrative promotional programmers’ of the
various pharmaceutical industries influence the
drug prescribing.
VDFACA 88
H. Unethical practices by animal health

professionals
10.3 Magnitude of Irrational use of Drugs
Data on irrational drug use show an increasing

trend worldwide, studies indicated that more
than 50% of human drugs are prescribed,
dispensed or sold inappropriately, and 50% of
patients fail to take them correctly. The problem
is so severe in veterinary medicine. Drugs not
prescribed according to standard treatment
guidelines (STGs), ineffective or unsafe drugs are
prescribed, effective and available drugs are
underused.
Many farmers access these agents and treat their

animals even in cases where use of antibiotic
(antibacterial) agents would be unnecessary.
10.4 Impact of Irrational Use of Drugs
Irrational use of drugs leads to:

A. Emergence of drug resistant organisms,
thereby rendering treatment ineffective. These
will exacerbate or prolong illness leading to
increased morbidity and mortality. Resistance
leads to search for alternative agent to treat
the infection at high price. Massive quantities
of antibiotics or antibacterial drugs used in
animals are released in the environment thus
increasing selection of the antibiotic resistant
bacterial organisms that can spread from the
VDFACA 89
animals to humans especially the bacterial

zoonoses.
B. Increase risk of unwanted effects such as
adverse drug reaction
C. False sense of security (owners)
D. Masking or confusing or delaying correct
diagnosis
E. Wastage of resources
F. Increase cost of treatment
G. Loss of faith or confidence on the profession
H. Public health hazard
10.5 Measures to Improve Rational Drug Use
The rational use of drugs can be improved by

proper diagnosis and selection of the drug which
is effective, convenient and safe; by accurate and
complete prescription and dispensing of drugs; by
Informing owners on side effects, adverse drug
reactions, dosage schedule and risk of
withdrawing the therapy is also essential;
Improve KSA of professionals; by Enhance
availability of drugs; by appropriate rule and
regulation and proper implementation.
VDFACA 90
Animal health facilities | laboratories | drug outlets|
households
Providers End Users,

Institutions
Prescribers Owners
Public or Dispensers
private Technicians Sick animals
Strategies to improve use
 Education: formal and informal trainings

 Management: Guided decision making
 Regulation: standards, guidelines and
directives enforcement
 Economic: cost sharing and incentives
Figure 4: Framework for improving veterinary

drug use
VDFACA 91
11. DRUG RESISTANCE AS FUTURE THREAT
Objectives: -

to:
• Create basic understanding about drug

resistance as obstacle to treatment and
control of infectious diseases
• Appreciate the gap between frequency of
emergence of resistant microbes and pace of
development of new drugs.
• Identify measures to prevent development of
drug resistance
11.1 Drug Resistance

Drug resistance is the reduction in effectiveness
of a drug (antimicrobial, anthelmintic or
antineoplastic) in curing a disease or condition. It
occurs when the drug is unable to inhibit or kill
the disease causing organism due to the
development of a mechanism to cope the effect of
the drug. Resistance to antimicrobials is a
natural, biological evolutionary phenomenon but
human practices hasten it. As more
antimicrobials are used, it creates a selection
pressure on microorganisms. Susceptible ones
are killed while resistance one survive and
flourish.
The use of antibiotics in veterinary practice
started soon after it became available for the
treatment of human diseases in mid 1940s. Use
of penicillin was started before World War II to
VDFACA 92
treat mastitis. Antibiotic resistant strain of

bacteria was recognized in the late 1950s and
became evident that microorganism’s resistance
to one or more antibiotics can transfer it to other
bacteria.
The problem of antimicrobial resistance has
become common today, especially in the area of
bacterial chemotherapy. The wide spread use of
antibiotics in human and animals has been
followed by the increased emergence of bacteria
resistance to these antibiotics. A casual
relationship between increased use of antibiotics
and increased prevalence of resistant bacteria
has been demonstrated.
The acquisition of antimicrobial resistance is a
growing and serious threat to the treatment and
control of infectious diseases. Antibiotics which
have saved countless millions from the spectre of
death and disability from bacterial infections are
losing their effectiveness. The World Health
Organization stated that a post-antibiotic era in
which common infections and minor injuries
killing a patient is very real possibility for the 21st
century.
New drug development is expensive and time-
consuming. Hence, there is a declining interest of
pharmaceutical industries in antimicrobial
research and development.
Drug resistance is placing enormous challenges
on veterinarians, physicians and pharmaceutical
industries to find new products to continue the
antibiotic miracle long into the future. Every
attempt should be made today to preserve and
VDFACA 93
optimize the agents in our therapeutic

armamentarium.
Figure 5: Years of discovery of major

antimicrobial agents (it reached peak 1960s
declines after 1970)
VDFACA 94
11.2 Contributing Factors
Irrational use of drugs is the main contributing

factor for the development of drug resistance. The
important factors are knowledge, expectation,
and interaction of prescribers and owners,
economic incentives and regulatory condition.
Owner related factors are the major driving force
of inappropriate antimicrobial use. For example
many owners believe that new and expensive
drugs are more efficacious than older agents.
This leads to development of resistance against
both new and old antimicrobials. Self medication
is another major factor contributing to resistance.
Self medicated antimicrobials may be
unnecessary, inadequately dosed and may not
contain adequate amount of active drug. Owner’s
compliance with the recommended treatment is
another problem. The owner may forget to give
medication, interrupt the treatment when he/she
feels his/her animal gets better, unable to
complete the full course of the treatment; all
these factors create an ideal environment for
microbes to develop resistance.
11.3 Mechanism of Spread
Antibiotic resistance in bacteria occur in two

ways and it may be an inherent trait of the
organism in the cell wall structure that renders it
naturally resistant, or it may be acquired by
means of mutation in its own DNA or acquisition
of resistance from DNA of another source.
VDFACA 95
A) Intrinsic or inherent or natural resistance is

where microorganisms naturally or inherently
become resistant to an antibiotic due to lack of
target sites or molecules and transport system
for an antibiotic and therefore the drug does
not affect them.
B) Acquired resistance is where several
mechanisms are developed by bacteria in order to
resist an antibiotic. It occurs by either modifying
the existing genetic material or the acquisition of
new genetic material from another source.
Figure: 6. Examples of how antibiotic resistance

spreads
VDFACA 96
11.4 Impacts of Antimicrobial Resistance

Antimicrobial resistance has several impacts
including increased the costs of treatment,
increased morbidity and mortality from infectious
diseases and reduced productivity (meat, milk,
eggs, hides and skins). The consequences are
devastating particularly in young stock, which
are especially susceptible to infections. Close
contact with in the animal’s results in spread of
resistant strains making more animals at a risk
of severe illness. Once the antimicrobial drug is
recognized as resistant, clinician will switch over
to another antimicrobial agent, which may pose
financial burden to the farmers. Moreover, it may
increase the duration of treatment there by
reducing the productivity of the animal. Drug
resistance in diseases like trypanosomiasis is
highly prevalent and the impact on the economy
is huge; it prevents cultivation of large amount of
arable land. Resistance can also interfere the
control and eradication processes of diseases.
11.5 Prevention of Drug Resistance

To prevent the emergence of drug resistance,
appropriate actions should be taken by all
authorization, regulation, distribution, and use of
antimicrobials in animal and human health.
 Avoid inadequate or unduly prolonged use
of drugs
 Promote the use of appropriate dosage
regimen
VDFACA 97
 Use as much as possible rapidly acting and

selective (narrow-spectrum) antimicrobial
agents. Broad-spectrum AMAs kill large
variety of bacteria and encourage
proliferation of resistant bacteria.
 Use combination of AMAs whenever
prolonged therapy is undertaken, example
Tuberculosis.
 Avoid indiscriminate use of AMAs and use
of newer agents when already available
drugs are effective.
 Use individual full doses in combination
therapy,
 Know the sensitivity pattern and infectious
epidemiology.
 Enhancing infection prevention and control
practices
Fight against AMR requires a coordinated
approach between health and livestock sectors
on the effective use of antibiotics in humans
and animals, as well as improved infection
prevention and surveillance on the use of
antibiotics in animals.
VDFACA 98
12.VACCINE STORAGE AND HANDLING
Objectives

to:
 Identify the measures that should be taken

for proper transportation, storage and
administration of veterinary vaccines.
 Differentiate type of vaccine storage

equipment and select carefully
There are few immunization issues more

important than the appropriate storage and
handling of vaccines. The success of efforts
against vaccine-preventable diseases is
attributable in part to proper storage and
handling of vaccines. Vaccines exposed to
temperatures outside the recommended ranges
can have reduced potency and protection.
Storage and handling errors can cost a lot in
wasted vaccine and revaccination. Errors can
also result in the loss of owners’ confidence when
repeat doses are required. It is better to not
vaccinate than to administer a dose of vaccine
that has been mishandled. Vaccine management,
including proper storage and handling
procedures, is the basis on which good
immunization practices are built.
Vaccines must be stored properly from the time
they are manufactured until they are
VDFACA 99
administered. Proper maintenance of vaccines

during transport is known as the cold chain. A
proper cold chain is a temperature-controlled
supply chain that includes all equipment and
procedures used in the transport and storage and
handling of vaccines from the time of
manufacturer to administration of the vaccine.
The cold chain begins with the cold storage unit
at the manufacturing plant, extends through
transport of vaccines to the distributor and
delivery to and storage at the provider facility,
and ends with administration of vaccine to the
patient. Appropriate storage and handling
conditions must be maintained at every link in
the cold chain.
Figure 7: Cold chain flow chart
VDFACA 100
When the cold chain fails like too much exposure

to heat, cold, or light at any step in the cold chain
can damage vaccines, resulting in loss of vaccine
potency. Once lost potency cannot be restored.
Each time vaccines are exposed to improper
conditions, potency is reduced further.
Eventually, if the cold chain is not properly
maintained, potency will be lost completely, and
vaccines will be useless.
Vaccine appearance is not a reliable indicator

that vaccines have been stored in appropriate
conditions. For example, inactivated vaccines,
even when exposed to freezing temperatures, may
not appear frozen, giving no indication of reduced
or lost potency.
Figure 9: Vaccine appearance at different storage

condition
VDFACA 101
By following a few simple steps and implementing

best storage and handling practices, providers
can ensure that animals will get the full benefit of
vaccines they receive.
12.1. Vaccine Storage Temperatures

Vaccines are fragile. They must be maintained at
the recommended temperatures and protected
from light at every link in the cold chain. Most
live vaccines tolerate freezing temperatures, but
deteriorate rapidly after they are removed from
storage. Inactivated vaccines can be damaged by
exposure to temperature fluctuations (example:
extreme heat or freezing temperatures). Potency
can be adversely affected if vaccines are left out
too long or exposed to multiple temperature
excursions (out-of-range temperatures) that can
have a cumulative negative effect. It is a good
idea to post a sign on the front of the storage
unit(s) indicating which vaccines should be
stored in the freezer and which should be stored
in the refrigerator.
Freezer
Freezer is device or a part of that maintains a

temperature below the freezing point of water
usually below -20 to -18 oC. Most live vaccines
such as PPR, LSD, Sheep and goat pox, AHS,
Camel Pox, CBPP, Newcastle, and Fowl pox)
should be stored between -15°C and -20°C. The
Anthrax and IBD can be stored either in the
freezer or the refrigerator. However, storing these
vaccines in the freezer will confer longer shelf-life.
VDFACA 102
Refrigerator
Refrigerator is the device that maintains a
temperature a few degrees above the freezing
point of water (0 to 4oC). All inactivated vaccines
(example: Blackleg, Bovine pasteurella, Ovine
pasteurella, Fowl Cholera, CCPP, Inactivated
Newcastle) and diluents require refrigerator
storage temperatures between 35°F and 46°F
(2°C and 8°C), with a desired average
temperature of 40°F (5°C). It is needed to review
the manufacturers’ instruction about the specific
storage temperatures of the vaccine.
Before reconstitution with diluent, all vaccines
can be stored at refrigerator temperature between
35°F and 46°F (2°C and 8°C) for up to 72
continuous hours. Contact the institute and/or
your local or state veterinary service for guidance
before discarding any refrigerated vaccine that
cannot be used within 72 hours.
All personnel who handle or administer vaccines

should be familiar with the storage and handling
procedures for their facility. This includes not
only those who administer vaccines, but also
anyone who delivers or accepts vaccine
shipments and anyone who has access to the
unit(s) where vaccines are stored. These
procedures should be available in writing as a
reference for all staff members. It is highly
recommended to refer and follow catalogue
product guide from National Veterinary Institute.
Vaccine storage and handling training should be
provided to all new personnel who handle or
VDFACA 103
administer vaccines, including temporary staff.

Continuing education for staff is essential when
new vaccines are stocked and when there are any
changes to the storage and handling guidelines
for a particular vaccine. Immunization programs
often have good resources for staff training.
12.2. Vaccine Storage Equipment

Vaccine storage equipment should be selected
carefully, used properly, maintained regularly
(including professionally serviced when needed),
and monitored consistently to ensure the
recommended temperatures are maintained.
Freezers and Refrigerators

Using the correct freezer and/or refrigerator can
help prevent costly vaccine losses and the
inadvertent administration of compromised
vaccines. Freezers and refrigerators are available
in many different sizes, types (example: stand-
alone versus combination), and grades (example:
household, commercial, and pharmaceutical). It
is strongly recommend stand-alone freezers and
refrigerators without freezers. Studies have
demonstrated they maintain the required
temperatures better than combination units. An
alternative to stand-alone units would be to use
the refrigerator compartment of a combination
refrigerator /freezer/ unit to store refrigerated
vaccines. A separate stand-alone freezer would be
used to store frozen vaccines.
VDFACA 104
Multiple reports of incidences are available when

refrigerated vaccines have been compromised by
exposure to freezing temperatures in a
combination unit. At a minimum, a combination
refrigerator /freezer/ unit sold for home use with
separate exterior doors and thermostat controls
for each compartment is acceptable (but not
recommended).
Figure 10: -Two vaccine storage device with different

temperature settings (freezer and refrigerator)
Any freezer or refrigerator used for vaccine

storage should have its own exterior door that
seals tightly and properly, as well as thermostat
controls. It must be able to maintain the required
temperature range throughout the year. The unit
VDFACA 105
should be dedicated to the storage of biologics

and it must be large enough to hold the year’s
largest vaccine inventory without crowding
(including flu vaccine). A storage unit that is
frost-free or has an automatic defrost cycle is
preferred.
If using a combination freezer-refrigerator unit to

store vaccines, care must be taken to ensure that
the freezer is not so cold that the refrigerator
temperature drops below the recommended
temperature range. There should be separate
temperature controls (thermostats) for the freezer
and refrigerator compartments. Good air
circulation around the vaccine storage unit is
essential for proper heat exchange and cooling
functions. The unit should be in a well-ventilated
room with space around the sides and top and at
least 4 inches between the unit and a wall.
Nothing should block the cover of the motor
compartment and the unit should be level and
stand firmly with at least 1 to 2 inches between
the bottom of the unit and the floor.
A dormitory-style refrigerator is defined as a

small combination freezer/refrigerator unit that is
outfitted with one exterior door and an evaporator
plate (cooling coil), which is usually located inside
an icemaker compartment (freezer) within the
refrigerator.” In performance testing, the
dormitory-style refrigerator demonstrated
consistently unacceptable performance,
regardless of where the vaccine was placed inside
the unit. This unit also exhibited large spatial
VDFACA 106
temperature gradients confirming that there is no

“good” vaccine storage area in a dorm-style unit.
The dorm-style refrigerator is NOT recommended
for vaccine storage under any circumstance.
Figure 11: two compartment of refrigerator and

storage principle of vaccine in a fridge
12.3. Vaccine Inventory Control

A vaccine inventory should be conducted monthly
to ensure adequate supply to meet demand.
Vaccine diluents should also be included in the
inventory to ensure adequate supplies are
available. Determining factors for the amount of
vaccine and diluent ordered include: projected
VDFACA 107
demand, storage capacity, and current vaccine

supply. Vaccine coordinators should request
delivery during office hours. Each vaccine order
should be updated to reflect any period of time
the office will be closed, such as holidays or
scheduled vacation time. It is also important to
avoid overstocking vaccine supplies which could
lead to vaccine wastage or having outdated
vaccine on hand. Vaccine and diluent expiration
dates should be closely monitored. Rotate stock
so that vaccine and diluent with the shortest
expiration date are used first to avoid waste from
expiration. If the date on the label has a specific
month, day, and year, the vaccine can be used
through the end of that day. If the expiration date
on the label is a month and year, the vaccine can
be used through the end of that month.
A multi-dose vial of vaccine that has been stored

and handled properly and is normal in
appearance can be used through the expiration
date printed on the vial unless otherwise stated
in the manufacturer’s product information. Mark
a multi-dose vial with the date it is first opened.
Mark reconstituted vaccine with the date and
time it is reconstituted. The expiration date or
time might change once the vaccine is opened or
reconstituted. This information is provided in the
manufacturer’s product information. Expired
vaccine and diluent should never be used and
should be promptly removed from the storage
unit.
VDFACA 108
12.4. Receiving and Unpacking Vaccine

Shipments
Proper vaccine storage and handling is important
from the moment the vaccine arrives at the
facility. All office staff should be informed of who
to notify when a vaccine delivery has arrived. This
is extremely important for receptionists or other
front desk staff since they are often the first to
know that vaccines have been delivered. Vaccine
shipments should be inspected on arrival.
Vaccines should be stored at the proper
temperature immediately upon arrival. The
shipping container and its contents should be
examined for any evidence of damage during
transport. The contents should be cross checked
with the packing slip to be sure they match. Both
heat and cold temperature monitors/indicators
should be checked upon delivery following
instructions on the monitors for reading and
reporting. If a monitor indicates possible adverse
temperature excursion during shipping, the
monitor reading should be documented for future
reference and reported to the distributor within
the required timeframe.
Shipments sent directly by the vaccine

manufacturer are in specially designed boxes and
may not contain heat or cold temperature monitors.
The shipment date should be checked to determine
how long the package was in transit. If the interval
between shipment from the distributor and arrival
of the product at the facility was more than 48
hours, this could mean the vaccine has been
VDFACA 109
exposed to excessive heat or cold that might alter

its integrity. If there are any discrepancies with the
packing slip or concerns about the vaccine
shipment, the vaccines should be stored in proper
conditions, but segregated and marked “Do NOT
Use” until the integrity of the vaccines is
determined. Contact either the immunization
program or the vaccine manufacturer, depending
on who shipped the vaccine and the state or agency
policy.
The contents of each shipment should be

recorded on an inventory log (stock record). This
log should include the name of each vaccine, the
number of doses for each vaccine received, the
date it was received, the condition of the vaccines
upon arrival, the name of the vaccine
manufacturers, the lot numbers, the expiration
dates for each vaccine, and any action taken as a
result of a question of vaccine integrity
12.5. Vaccine Transport to Off-Site Clinics
The number of times vaccines are handled and

transported should be minimized. If vaccine
transportation to another location is required, it
is critical that vaccine potency is protected by
maintaining the cold chain at all times.
When a multi-dose vial is used, it requires that it
be used only by the provider’s office where it was
first opened. A partially used vial may be
transported to or from off-site clinics operated by
the same provider as long as the cold chain is
properly maintained. However, such a vial may
VDFACA 110
not be transferred to another provider or

transported across state lines. While there is no
defined limit to the number of times vaccine may
be transported to different clinic sites, each
transport increases the risk that vaccine will be
exposed to inappropriate storage conditions.
Diluent should travel with its corresponding
vaccine to ensure that there are always equal
numbers of vaccine vials and diluent vials for
reconstitution. Diluent should be transported at
room temperature or inside the same insulated
cooled container as the corresponding vaccine,
according to manufacturer guidelines for each
diluent. If transported inside cooled containers,
diluent must not be in direct contact with frozen
or cold packs because of the potential for
freezing. If any diluents that have been stored at
room temperature are going to be carried in the
insulated transport container, refrigerate the
diluents in advance so they do not raise the
temperature of the refrigerated vaccines.
12.6. Temperature Monitoring During Off-Site

Clinics
Vaccines should be stored at the recommended
temperatures immediately upon arrival at the
facility. Record storage unit temperatures twice
daily. If vaccine must be kept in an insulated
cooler, keep the cooler closed as much as
possible. At a minimum, record the cooler
temperature hourly.
VDFACA 111
12.7. Vaccine Preparation

Vaccine should be drawn from the vial into the
syringe at the time of administration. It is not
recommended to fill syringes in advance, for a
number of reasons. Filling a syringe before it is
needed increases the risk for administration
errors. Once in the syringe, vaccines are difficult
to tell apart. Other problems associated with this
practice are wasted vaccine and possible bacterial
growth in vaccines that do not contain a
preservative, such as vaccines supplied in single-
dose vials.
Syringes other than those filled by the
manufacturer are designed for immediate
administration and not for vaccine storage. If for
some reason more than one dose of a particular
vaccine must be pre-drawn, draw up only a few
syringes at one time (no more than 10 doses or
the contents of a single multi-dose vial). In
accordance with best practice standards, these
syringes should be administered by the person
who filled them. Any syringes prefilled by the
provider must be stored at the recommended
temperature range and used or discarded by the
end of the clinic day.
VDFACA 112
13. VETERINARY DRUG INFORMATION
Objective:
At the end of this chapter trainees should be able

to identify the importance and sources of updated
veterinary drugs information so as to use drugs
properly and disseminate appropriate
information.
13.1 Importance of Veterinary Drug

Information
Animal health professionals involved in

prescribing and dispensing of veterinary drugs
have the need for veterinary drugs information in
order to keep themselves up to date with
developments related to veterinary drugs and to
provide such information to owner, other animal
health professionals and to the general public.
Because of an increasing number and complexity
of veterinary drugs, the need for up-to-date
information is greater than ever. Updated
veterinary drugs information is mainly directed at
improving prescribing, dispensing and veterinary
drugs administration. On the other hand,
because counselling of owners of animal patients
on medications is an integral part of the
veterinary drugs prescribing and dispensing
process. Lack of knowledge and information by
the owners about the veterinary drugs they took
leads to incorrect use which in turn results in
loss of efficacy or occurrence of adverse effects,
drug residue and drug resistance.
VDFACA 113
The need for veterinary drugs information varies

among different types of animal health care
providers and animal owners. Both animal health
care providers and dispensers need to have well
developed information on the veterinary drug
choices and therapeutic alternatives, the generic
and brand names of each drugs, and the
indication and contraindications for use,
precautions for use, dose interval and regimen,
dosage form and strengths, route of
administration, adverse drug reactions, side
effects, drug interactions (drug-drug, drug-feed,
drug-disease interactions), duration of therapy,
formulations and storage condition of each drug.
All these information are essential for promotion

of rational veterinary drug therapy through
improving prescribing and dispensing behaviour,
veterinary drug administration and use.
It is also possible that veterinary drug

professional involved in veterinary drug
dispensing may want to write a material on
veterinary drugs, and consult animal health
administrators and policy makers on matters
related to veterinary drugs, which requires having
a thorough knowledge on them.
13.2. Sources of Veterinary Drug Information
Although basic information about veterinary

drugs is obtained through training in veterinary
profession, additional knowledge can be gained
from various sources. These sources of drug
VDFACA 114
information can be classified into primary,

secondary and tertiary.
Primary sources: provide new veterinary drug

information mainly based on research in
journals. They provide original thinking and
results of original research. Primary literature
can be found as published articles or
unpublished report that provide detail on the
research and its findings. Such sources include
veterinary journals such as the BMC Veterinary
research, the Ethiopian Veterinary Association
Journal, the ELSEVIER Journals and information
from manufacturers (labels, leaflets and
packaging). It is important to assess the
reputability of the journal and time of
publication.
Secondary sources: provide reviews of articles

that appear in primary sources. Examples
include veterinary drug information bulletins
(quarterly realising by VDFACA), Pub Med,
adverse drug reaction bulletin, veterinary medical
information and others. Secondary sources are
typically easy to access and use and to link to the
primary literature.
Tertiary sources: include standard reference

books such as Veterinary clinical pharmacology,
Merck veterinary manual, veterinary medical
dictionary, veterinary drug formulary, NVDL,
STG, and pharmacopeia. The selection of a
particular source of information depends on the
type of information required. Tertiary sources are
VDFACA 115
used first than secondary or primary sources as

they provide a broad overview of particular
subject area. It should also be remembered that
standard books are published at longer time
intervals than journals. Obtain the most current
edition available when using secondary or tertiary
sources.
Veterinary drug information supplied by the

pharmaceutical industries either in the form of
leaflets in the packages or via their
representatives is being used by many clients.
The impact of pharmaceutical industry, which
has several channels of influence, is great.
Animal health professionals should develop
critical attitudes towards information provided by
pharmaceutical industry as their information
may be biased.
13.3. Dissemination of Veterinary Drug

Information
For dissemination of veterinary drug information,

communication skills are very important for
prescribers and dispensers dealing with owners,
other animal health care professionals and
general public to convey relevant veterinary drug
information effectively and clearly, which can be
done verbally and/or in written form.
Verbal communication to veterinary drug

information must be clear and fluent by
understandable language, well-organized on
important details and with confidence done by
VDFACA 116
maintaining eye contact during face-to-face

communication. It is necessary to avoid emotion,
negligence, medical languages and unnecessary
details. Written communication of veterinary drug
information must be well-organized, readable and
clear and complete.
Adverse drug reactions reporting system is an

area of veterinary drug information that has been
given little attention yet. Obviously, veterinary
drugs not only produce the desired effects, but
also undesired effects. It is possible that
veterinary drugs produce initially unanticipated
effects (adverse or potentially useful) after their
approval for marketing. Such effects can best be
identified by veterinary drug professionals and/or
prescribers because of their close proximity with
patients. Veterinary professionals have a moral
responsibility to report adverse drug reactions to
the concerned body by using a special form
designed and distributed for this purpose by
VDFACA.
VDFACA 117
14. NATIONAL LEGISLATIONS RELATED TO

VETERINARY DRUGS AND VACCINES
Objective
At the end of this session trainees will be able to

appreciate the legislative articles related to
veterinary drugs enacting in Ethiopia.
The Ethiopian Government has, particularly since

recent past, taken the issue of livestock diseases
very seriously, which can be evidenced by the
considerable commitments in terms of budget,
material and manpower allocation to curb the
effect of these diseases on the livelihood of the
animal rearing communities and on the national
economy at large. The establishment of VDFACA
and the veterinary drugs, biologics, animal
products and by-products quality control
laboratory centre at Kaliti show how serious the
government is to address the problem of quality,
safety and efficacy of veterinary drugs and animal
feed and how committed it is to break the
deadlock on prevention and control of animal
diseases.
For enhancing the effective, efficient, environment

friendly and sustainable animal disease control
efforts, appropriate legislative provisions have
been prepared and one,’ Proclamation
No.782/2011, a Proclamation to Provide for
Veterinary Drug and Feed Administration and
Control’ has been endorsed on January 2011.
The subsidiary `Veterinary Drug and Animal Feed
VDFACA 118
Administration and Control Authority

Establishment Council of Ministers Regulation
No. 272/2012 of this Proclamation was also
issued on December 2012; to administer and
control veterinary drugs, biologics and animal
feeds in the country.
Veterinary drugs were regulated by Drug

Administration and Control Authority (DACA)
together with human medicines since 2001.
Animal feed was also under the regulation of
ministry of agriculture. But now a day’s both
veterinary pharmaceuticals and feed regulations
are transferred to the newly established
Veterinary Drug and Animal Feed Administration
and Control Authority After the endorsement of
Proclamation No. 728/2011 and issue of
Regulation No. 272/2012 by the council of
ministers.
The Authority has the powers and duties stated

under Article (20) of the proclamation. We are
now highly working to regulate the proper
production, distribution and use of veterinary
drugs to ensure quality, safety and efficacy of the
products so as to enhance the productivity and
health of the livestock population; by registering
and licensing newly produced and/or importing
pharmaceuticals and companies, re-registering,
at port and premises inspection, post-marketing
surveillance (Article 7).
Article 6(2) of the proclamation states that “any

veterinary drug shall be available for use in
VDFACA 119
accordance with the guidelines issued by the

Authority to ensure judicious use of veterinary
drugs.” Packaging and labelling; and prescription
and dispensing of veterinary drugs are also stated
under Article 9 and 10, respectively. There are
also detailed punishment sub articles about
misuse of certificates of competence and
dispensing of counterfeits and adulterates
veterinary drugs under Article 26 of the
proclamation.
The responsibility to provide training for the

appropriate organs on handling and utilization of
veterinary drugs is also given to the authority on
Article 20(12). The Authority also serves as
veterinary drug information centre; disseminate
veterinary drug information to professionals and
the public; ensure the accuracy and relevance of
information disseminated by others; and prohibit
dissemination of ambiguous or erroneous
information.
3. Veterinary drug administration and control

Authority of Ethiopia has the responsibility for
the development of guidelines, directives and
administrative regulations for quality, safe and
effective veterinary drugs availability in the
market. Due the Authority ratified “Veterinary
Drug Importer, Export and Wholesale Certificate
of Competence Issue and Control Directive”,
“Veterinary Drug Registration Guideline in
Ethiopia” “Veterinary Drug Retail Certificate of
Competence Issue and Control Directive”,
“Guideline for the Control of Use of Veterinary
VDFACA 120
Prescription Paper” and “Veterinary Drugs and

Medical Supply Promotion Control Directive” as
per the power given (Article 28(2)) to issue
necessary directives for implementation of the
proclamation and regulation. Other directives and
guidelines are also under development.
VDFACA 121
15. REFERENCES
ACVM Requirement: Labelling Veterinary

Medicines, May 2014.
Advice for Pharmacists, The Veterinary Medicines
Directorate, www.vmd.defra.gov.uk
Ahrens F. A. (1996). Pharmacology: The National
Veterinary Medical Series. Lippincott
Williams Wilkins. New York, USA.
Arizona Cooperative Extension. Estimate Animal
Weight from Body Measurement. University of
Arizona. Q65.
Bill R. L., (2006). Clinical Pharmacology and
Therapeutics for Veterinary Technician. 3rd
ed. Mosby Inc. Indiana, USA.
Brownlie, J., Peckham, C., Waage, J., Woolhouse,
M., Lyall, C., Meagher, L., Tait, J., Baylis,
M. and Nicoll, A. (2006). Infectious
diseases: preparing for the future threats.
Office of Science and Innovation, London.
DACA (2007): Drug administration and control
authority. Veterinary formulary for
Ethiopia. .Addis Abeba: Champer Printing
House,
ENSURING GOOD DISPENSING PRACTICES,
Pharmaceutical management, Management
science for health, 2012.
FMHACA (2012): Food, Medicine and Healthcare
Ethiopia, Manual for Medicines Good
Dispensing Practice, Second Edition,
www.masterprintingpressplc.com
VDFACA 122
FMHACA(2012): Food, Medicine and Healthcare

Ethiopia, Manual for Medicines Good
prescribing Practice, Second Edition,
www.masterprintingpressplc.com
Galbraith A., Bullock S. and Manias E. (2001).
Fundamentals of Pharmacology. Pearson
Education Australia Pty Limited.
Gibbs, P.G. and D.D. Householder. Estimating
Horse Body Weight with a Simple Formula.
Texas A & M University. http://smith-
tx.tamu.edu/publications/hrg012-
bodyweight
GOOD PHARMACEUTICAL STORAGE
DISTRIBUTION PRACTICES (GSDP),
(2006), United Arab Emirates, Ministry Of
Health, Drug Control Department.
Goodman Gilman’s. The Pharmacological Basis
of THERAPEUTICS., 11th ed. Mcgraw-Hill
Medical Publishing Division, New York,
USA
GUIDE TO GOOD STORAGE PRACTICES FOR
PHARMACEUTICALS, World Health
Organization Technical Report Series, No.
908, 2003.
Guidelines on packaging for pharmaceutical
products. WHO Technical Report Series,
No. 902, 2002.
Jennifer, L. D., Geof, W. S., Ronald, E. B., Lisa,
A. T., Alistair, I. W. and Jim, E. R. (2009):
Update on drugs prohibited from extralabel
use in food animals, Vet Med Today:
FARAD Digest JAVMA, Vol 235, No. 5.
VDFACA 123
Katzung B. G. (2001). Basic and Clinical

Pharmacology. 8th ed. Lange Medical
Books/McGraw-Hill. New York, USA
MANAGING FOR RATIONAL MEDICINE USE:
MEDICINE AND THERAPEUTICS INFORMATION:
Mervyn Wetzstein, BCMAFF Health Management
Veterinarian. Use and Storage of Veterinary
Drugs on the Dairy Farm.
National Veterinary Institute, (2016). Product
Catalogue, August, 2016.
National Veterinary Institute, (2016). Vaccine
Storage and Handling. Issue No1.
Document No: NVI-QMS-WI-25.
Pandit N. K. (2007). Introduction to the
Pharmaceutical Science. Lippincott
Williams Wilkins. Philadelphia, USA.
Promoting Rational Prescribing: Pharmaceutical
management, Management science for
health, 2012.
Rajdeep K. and Rajneesh P., Drug Resistance in
Food Animals - A Public Health Concern,
2010, Vol. 5 No. 1, Article 48.
Rang H.P., Dale M.M., and Ritter J.M. (1999).
Pharmacology. 4th ed. Chulirchill
Livingstone, An imprint of Harcount
Publishers Limited. Edinburgh.
Sitaram A. (2001). Antibiotic Resistance: A
Concern to Veterinary and Human
Medicine.
VDFACA 124
TEACHER’S GUIDE TO GOOD PRESCRIBING,

World Health Organization, Department of
Essential Drugs and Medicines Policy,
Geneva, Switzerland, 2001.
VDFACA, Rational Veterinary Drug use survey
study report, 2014.
Veterinary Drug and Feed Administration and
Control. Ethiopian Government
Proclamation No. 728/2011.
Waller D. G., Renwick A. G. and Hillier K. (2005).
Medical Pharmacology and Therapeutics.
2nd ed. Elsevier Sounders. London, UK.
Webster C. R. (2001). Clinical Pharmacology:
Quick Look Series in Veterinary Medicine.
Teton NewMedia. USA.
WHO (2001). WHO Global Strategy for
Containment of Antimicrobial Resistance.
Zhang R., Eggleston K., Rotimi V. and
Zeckhauser R. J. (2006). Antibiotic
resistance as a global threat: Evidence from
China, Kuwait and the United States.
BioMed Central.
VDFACA 125
16. ANNEXES
Annex I. Veterinary Prescription Paper
Ser.No, __000000
Case No.____________
Name and level of Animal Health
Institution_______________________
Address:Region______Zone______Woreda_____Town
_____Tel______
...........................................................................................
Ser.No, __000000
Name and Level of Animal Health
Institution______________________
Address Region______Zone_____Woreda_____Town Tel _____
Owner's Name______________________________________
Address:Region____Town____Woreda__Keble____locality____
Species of animal ____Age_____Sex_____ Body weight_______
ID No.______________ Case No.____________
Diagnosis _____________________________________
Treatment given (name, strength, Price of Each item

dosage form, dosage and quantity
of drug)
Birr Cent
Refill _________________________Withdrawal period_______

Prescriber's
Dispenser's
Name_________________ _________________________
Qualification____________ __ _________________________
Registration no.__________ ________________________
Signature______________ ________________________
Date________________ ______________________
* Seal over leaf
VDFACA 126
Annex 2: Instruments
VDFACA 127
VDFACA 128
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RATIONAL USE OF VETERINARY DRUGS AND VACCINES TRAINING MANUAL

Book · July 2019

The user has requested enhancement of the downloaded file.

Prepared by: - Veterinary Drug and Animal Feed Administration

RATIONAL USE OF VETERINARY

Prepared by VDFACA in collaboration with

First of all, the group participated in the

We are grateful to the professionals who offered

The survey conducted on the use of veterinary

The manual contains information on how new

It is hoped that the manual would help animal

TERZU DAYA DEGAGA (Dr.)

The provision of successful animal health service

countries. It is also common in Ethiopia. The use of

professionals in the veterinary pharmacy, dispensing

2. SOURCES OF DRUGS AND PROCESSES OF

2.1 Sources of Drugs

There are basically six sources of drugs, namely

The following are some of the examples of drugs

Table 1: Microorganism used as the source of

 Human chorionic gonadotropin (hCG)

laboratory. Semi-synthetic drugs are naturally

2.2 Drug Development

all regulatory requirements. The process of drug

Two tests will be conducted.

 Phase I studies on healthy subjects (20 to

is used in the larger population to catch any

The drug development process described above

– Searching other alternatives like

3. UNDERSTANDING THE LABELING, PACKAGING

3.1 Drug Labelling

8. Storage instructions and handling

The labels should not be easily erased and/or

Veterinary Use Only 100ml

VITAMIN E - SELENIUM INJECTION protect from freezing

Warning: Treated animals must not be slaughtered for use in food

Packaging may be defined as the collection of

The packaging must protect the product against

Containers may be referred to as primary or

for the user (example: size, weight, method of

product being pre-packaged should be

An additional trained individual, other than the

Control records of all packaging operations must

3.2.2 Packaging Aids and Materials

envelops, and plastic envelops (annex 2). The

Compounding is any manipulation of a drug

Manipulation might include mixing, diluting,

Examples of compounding include:

Procedures for Compounding of drugs:

vi. Use appropriate compounding technique to

4. TRANSPORTATION, DISPENSING ENVIRONMENT

At the end of this session trainees should be able

When transporting veterinary drugs in vehicles

Transportation and storage of veterinary products

4.2 Dispensing Environment

Dispensing environment must be clean, because

 Lockable cabinet for narcotic drugs ,