Small Animal Clinical Pharmacology - CYF MEDICAL DISTRIBUTION

PRINCIPLES OF GOOD PRESCRIBING PRACTICE/RESPONSIBILITIES OF COMPANION ANIMAL CLINICIANS
– the veterinarian is readily available for follow-up
evaluation in the event of adverse reactions or
failure of the treatment regimen.
This description of the VCPR is taken from the US FDA
(Extralabel Drug Use in Animals, 21 CFR Part 530, 9
December 1996) and, while directly applicable in the
USA, provides general guidance elsewhere.
● Diagnosis. An accurate diagnosis underpins each
decision to treat.
● Therapeutic plan. A plan including clear objectives
of treatment should be developed. It is useful to
consider each therapeutic intervention as an experiment
to be conducted judiciously but thoroughly.
● Drug knowledge
– The label of all drugs used should be fully understood
and the use of the drug should be consistent
with the labeled directions, unless compelling
reasons direct alternative use. In addition, veterinarians
should familiarize themselves with any
further relevant information that may allow the
drug to be used more effectively or with greater
safety.
– For example, if there is a precaution concerning
use in neonatal animals, inquiry may establish
that the drug has been universally used safely by
other practitioners in this category of animal.
– Similarly, inquiry of the literature or other practitioners
may enable dose adjustments as necessary
in the presence of specific organ dysfunctions.
Whenever collecting additional information, it is
incumbent on the inquirer to evaluate the relevance,
quality and strength of the evidence obtained
before incorporating it into a therapeutic plan.
● Client communication. The client should be involved
in the development of the plan, both to ensure
that s/he concurs with the decision to treat and the
objectives of treatment, as well as to ensure that
compliance with the dosage regimen is assured. The
risks and benefits of the plan should be discussed.
● Client consent. Particularly when using an untested
approach or extra-label program, the informed
consent of the client should be obtained.
● Client instructions
– Clear and comprehensible written instructions
should be provided to the client, outlining the
method of administration, dose rate, frequency
and duration.
– Details of product storage and disposal should be
provided.
– Other instructions should describe the expected
response to treatment, identifying any expected
side effects and encouraging the client to contact
the prescribing veterinarian if any concerns
arise.
● Follow-up. As considered appropriate, plans
for either passive (allowing the client to call if
concerned) or active (scheduled by veterinarian)
follow-up should be considered in order to determine
if the therapeutic plan is working as
expected.
● Reassessment. The success of the therapeutic plan
should be always open to objective reassessment. As
discussed earlier in this chapter, there are a multitude
of factors that can lead to variation in clinical
response to treatment. These factors (including reassessment
of the diagnosis, compliance, medication
errors and comorbidities) should be systematically
evaluated if either lack of efficacy or untoward effects
are encountered.
● Adverse events. Suspected adverse events, including
drug interactions, should be thoroughly investigated
and the manufacturer and regulatory agency
informed.
● Prescriptions. Veterinarians must be familiar with
requirements for prescription writing, particularly
the minimum labeling needs (see further information
below). In addition, the quantity of medication prescribed
should be commensurate with the needs of
the patient, the disease, the expiry date and the
potential for misuse.
● Special requirements. When prescribing drugs for
companion animals, veterinarians should be
aware of any rules and regulations of breed societies,
sporting bodies or other parties that may be
applicable.
● Containers. Products should preferably be dispensed
in their original labeled container. If this cannot be
done, then the product should preferably be dispensed
in a childproof container labeled with the
appropriate information, as for example described
below under Prescriptions.
● Record keeping. Thorough records of each case,
including the dates of consultations and treatment,
details of drug dosage regimens and identification of
the animal treated, should be maintained in a readily
retrievable system for the necessary time. For certain
scheduled or controlled drugs (particularly drugs of
addiction) there may be additional record-keeping
requirements.
● Storage of medicines. Medicines should be stored
according to appropriate legislation, but generally
this will include storage in a secure site, away from the
public. The storage conditions of each drug should be
observed and expired product removed. The flammability
of stored products should be determined and
appropriate precautionary measures implemented. In
addition to segregation of flammable and nonflammable
products, it may be necessary to have a bonded
storage area and specific fire extinguishers.
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