Download Guide to Implement Pharmacovigilance System for

CAMEVET
Code:
PROCEDURE: I
Validity date:
September 21, 2016.
GUIDE TO IMPLEMENT PHARMACOVIGILANCE SYSTEM FOR VETERINARY DRUGS
Table of contents
Content
Content
1. INTRODUCTION ...................................................................................................................................... 2
2. DEFINITIONS .......................................................................................................................................... 2
3. PHARMACOVIGILANCE OBJECTIVES AND SCOPES ................................................................................. 3
4. NOTIFICATION SYSTEMS ........................................................................................................................ 4
5. CAUSES ANALYSIS................................................................................................................................... 5
6. PERIODIC SECURITY REPORT (IPS).......................................................................................................... 5
7. RESPONSIBLE FOR THE PHARMACOVIGILANCE .................................................................................... 6
8. COMMUNICATION ................................................................................................................................ 6
9. BIBLIOGRAPHY ....................................................................................................................................... 7
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GUIDE TO IMPLEMENT PHARMACOVIGILANCE SYSTEM FOR VETERINARY DRUGS
1. INTRODUCTION
Prior to the sale of a veterinary drug, pharmaceutical companies carry out clinical and preclinical trials
that allow demonstrating that products are effective for the proposed use and with a better
benefit/risk ratio for animals, the environment, operator and final consumer. All the previous is
evaluated by the government regulatory offices of each country within a normal health registration
process. However, the results obtained in clinical and preclinical trials are carried out in a limited
number of animals and often they do not reproduce all variables that can arise after the drug is in the
commercial phase, such as the interactions with drugs that are concomitantly administered, use in
animals of different breeds, body conditions and age ranges, health status, among other variables; and
also, the limited number of animals incorporated in pre-registration trials makes it little viable to
evidence adverse reactions of low presentation frequency or slow development.
Due to all the above shown, it is necessary to implement a pharmacovigilance system for veterinary
drugs, in order to identify adverse reactions soon after the drugs massive use in the market, and
therefore permanently evaluate the risk/benefit ratio and safety/efficacy profile of veterinary drugs.
2. DEFINITIONS
2.1 Pharmacovigilance:
This is the activity through which information is obtained on non-expected actions or reactions
of Veterinary Drugs, in after-sales phase, and also the scientific evaluation of reports regarding
such reactions, and the decision making regarding the standards that should be adopted
depending on the analysis of such evaluations.
2.2 Veterinary Drugs:
All substance or blends of them intended for administration to animals for the purpose of
cure, alleviation and/or prevention of diseases or its symptoms.
2.3 Adverse effects:
Unintended harmful effects that may occur after the administration of a veterinary drug in the
recommended dosage. This includes harmful side effects on animals (Adverse effects), and
also possible lack of effectiveness of drugs or adverse events on the handler, final consumer
and the environment.
2.4 Critical adverse reaction:
The one that causes death, can endanger life, causes disability or significant disability that
constitutes a congenital abnormality or birth defect, or causes permanent or prolonged
symptoms in the treated animals.
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2.5 Notification:
Action through which the authority and/or marketing holder is aware about the report
regarding a patient, person or environment that has developed an adverse event suspected to
be caused by a veterinary drug, and which is carried out through the relevant format properly
filled out by the notified in order to verify the causality.
2.6 Extra label use:
Use condition of a drug different from that authorized in labels, including different dosing
regime, intended species, use indications, among others.
3. PHARMACOVIGILANCE OBJECTIVES AND SCOPES
Pharmacovigilance objectives are:
1. Detect adverse effects and unknown interactions.
2. Detect the increased frequency of known adverse effects.
3. Identify risk factors and the possible mechanisms through which adverse effects are
generated.
4. Permanently evaluate the benefit/risk ratio and security/efficacy profile of veterinary drugs.
Pharmacovigilance scopes are:
1. Adverse reactions under authorized use conditions, i.e., following the label recommendations.
2. Adverse reactions with extra label use.
3. Alleged lack of drugs effectiveness.
4. Alleged insufficiency of established guard periods.
5. Adverse effects in people who handle the drug.
6. Adverse effects evidenced on the environment as a result of the drugs’ use and final disposal.
7. Transmission of infectious agents by drug contamination.
4. NOTIFICATION SYSTEMS:
In pharmacovigilance system different instances related to the veterinary drug use should participate,
such as:
1. Health professionals: veterinarians, chemists, pharmacist.
2. Holders of products marketing: Manufacturers or importers.
3. Animals’ owners.
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All adverse effects identified by some of the 3 levels mentioned before must be notified to the
competent authority, even if there is only a suspicion of drug implication in its presentation. In the
case of the animals’ owners, it is desirable that they notify it through a veterinarian that is responsible
for the notification objectivity.
Deadlines to notify:
1. Sales holders that receive information regarding suspicious of adverse effects must notify it
within 15 working days to the competent authority in the following cases:
a. Suspected critical adverse reactions on the animals.
b. Suspected adverse effects on people that handle the product.
c. Possible transmission of infectious agents.
All these adverse effects are classified as “Diligent”
In these cases, the notification is made through an official harmonized notification form (FOAN),
which should be available on CAMEVET website. The official form must be filled out in all its
fields, and it is essential to identify the professional responsible for the notification.
2. Adverse effects not included in the prior item are considered “Non-diligent”, and it is not
mandatory to report them individually or within a defined period, but they can be reported to
the competent authority through the Periodic Security Report (IPS).
3. Animal owners or natural persons that show adverse effects related to the veterinary drugs
use, and also health professionals that detect or which are informed about adverse effects
arising from the veterinary drug use must notify the health entity and/or marketing holder,
through an abbreviated form named Harmonized Notification Form for Natural Person (FANP).
5. CAUSES ANALYSIS
Regardless of the adverse effect notification means, the product marketing holder must evaluate
the causality between the drug administration and the notified adverse effect. Conclusions
obtained after the causality analysis must be sent to the competent authority of the relevant
country.
It is not possible to identify the causality when it is a single and isolated case. Instead, if there is a
common denominator in several adverse effects notified, it is possible to establish a behavior
pattern and take the measures concerning the involved drug.
The cause analysis is performed using the ABMON methodology, which comprises five categories:
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Category A: Very likely
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Category B: Possible
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Category M: Insufficient data (non-classifiable or non-evaluable).
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Category O: Non-conclusive
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Category N: Improbable
If results of causality analysis determine the existence of an adverse effect pattern associated to
the drug use, and depending on the conditions in which adverse effects have appeared and their
severity, corrective actions may be established in order to improve its security/effectiveness
profile, such as:
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Inclusion of use warnings or precautions in the graphic label.
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Changes of authorized use conditions (indications, dose, schedule, target species, guard
periods, among others).
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Suspension of the drug registration until the security/efficacy problems are solved.
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Request to perform post-registration studies.
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Cancellation of health registration.
6. PERIODIC SECURITY REPORT (IPS)
The IPS aims to notify adverse effects within a specific period of time, and includes evidenciable
events both inside the country and also events identified in other countries where it is marketed.
If the drug has not been marketed in any country in the world, an abbreviated IPS is acceptable.
Submission frequency to the competent authority:
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Every six months from registration until the effective sales in the country.
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Every six months in the 2 years following the drug effective sales.
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Annually in the 2 following years.
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Triennially since the last annual report.
7. RESPONSIBLE FOR THE PHARMACOVIGILANCE
All companies performing sales must have a professional responsible for the pharmacovigilance
system (PRFV), which must be proposed and accepted by the relevant competent authority.
PRFV responsibilities are:
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Establish and maintain the pharmacovigilance system.
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Notify the suspected adverse effects to the competent authority.
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Prepare the Periodic Security Reports (IPS).
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Ensure a rapid and concrete response to any request of information by the competent
authority.
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Provide the competent authority any relevant information for the benefit/risk balance
evaluation.
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Train the company staff in topics related to pharmacovigilance.
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Plan post-registration studies in order to identify and study possible security issues.
8. COMMUNICATION
The competent authority must ensure that both the health professionals and the general public are
informed of the critical security problems, important changes in sales authorizations, and suspensions
that affect health registrations due to pharmacovigilance reasons.
The competent authority must publish periodic pharmacovigilance reports, preferably through the
web platform.
The information distribution on the veterinary drugs’ effectiveness and safety seeks to support their
appropriate use and should be considered a public health activity.
9. BIBLIOGRAPHY
VICH GL24: Pharmacovigilance of veterinary drugs. Management of adverse events reports.
Guideline 2001/82/CE: Establishes a community code regarding veterinary drugs.
Volume 9B of the European Community: Pharmacovigilance guide of veterinary use drugs
SENASA Argentina: Notification Form for Pharmacovigilance System.
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