PHARMACOVIGILANCE

• Definition:
• Pharmacovigilance is the pharmacological field which deals
with the Detection, Assessment, Understanding and Prevention
of unintended effects, adverse drug reaction or any other
possible Medication errors caused by pharmaceutical products.
 Aim:
• The main objectives of the Pharmacovigilance are:
• Identification and quantification of unrecognized ADRs.
• Findings sub group of patients at high risk of ADRs.
• Continue monitoring of safety of health products to promote their
safe and effective use.
• Provide timely information about the safety of health products to
patients, health-care professionals and the public.
• Promotes the systematic, rational use and assures the confidence
for the safety of health products.
• Detection of unknown safety problems as early as possible.
• Identify new information about hazards related to use of health
products.
SCOPE OF PHARMACOVIGILANCE

• Based on Adverse drug reactions and adverse events report of

new drugs Pharmacovigilance conducting advanced drug
monitoring study include:
• 1. Irrational use and Medication errors of medicine.
• 2. Traditional, Herbal and complimentary medicines
• 3. Counterfeit medicines and Substandard medicines
• 4 Biological, Blood products, vaccines and medical devices ADR
• For, the problems & challenges facing the development of a robust
PV system of India, the following proposals might be as follows:
1. Build & maintain a vigorous Pharmacovigilance system.
2. Introducing Pharmacovigilance inspections and making its reporting
mandatory.
3. Various stakeholders High-level discussions.
4. A single country-specific ADRs reporting form creating for all users.
5. Strengthen the Drug Controller General of India (DCGI) office with
trained scientific and medical assessors for PV.
6. Creating a clinical trial and post-marketing database for SUSARs /
SAEs and ADRs for detection of signal and all relevant data access from
various stakeholders.
7. Education and training of medical students, pharmacists and nurses in
the area of PV
8.List of all new drugs / indications by maintaining a standard database
for every pharmaceutical company.
 OVERVIEW
➢There have been tremendous evolutionary, : some might even say
"revolutionary," changes in the scope and depth of
Pharmacovigilance activities over the past several decades.
➢Core activities have been established: case management, signal
management, and benefit-risk management.
➢Individual case review activities that began in post-marketing have
expanded to include aggregate review and analytics, and have
extended to involve products in development and in some
companies, into preclinical studies, particularly as information
becomes available about the safety profile in animals. The goal is to
develop an understanding about how that information can inform
clinical investigators regarding the expected adverse events in the
first-in-human studies.
➢The concept of risk and its related concept, benefit-risk, has
been introduced into the evaluation paradigm.
➢The key elements involve risk identification, analysis,
mitigation and communication.
➢For Pharmacovigilance, this paradigm could also be increased
to include risk awareness at the front end, with the intent of
developing an explicit recognition and understanding of all the
therapeutic agents likely to be available in the disease treatment
or disease stage.
➢In this way, potential drug-drug interactions become readily
apparent, especially drugs-in-class and new classes of drugs
continue to come to the market over time, and benefit-risk
assessments are more likely to include relevant treatments.
• The range of risk-related mitigation and preventative activities includes
the following:
• 1. Management of adverse events identified during development or
collected in post-marketing that become included in the label;
• 2. Vetting of advertising and promotional offerings for the products that
depend on the label for its promotional statements; and
• 3. Most recently, analysis of manufacturing complaints that may be
associated with clusters of reports of adverse events, either because of
product in bona fide distribution channels that unknowingly becomes
compromised during transportation or storage, product that is diverted
and becomes compromised, or product that is counterfeit material in
origin.