Pharmacovigilance: An Understanding
What is pharmacovigilance?
Pharmacovigilance is a broad term used to define the science of collection, documenting,
monitoring, researching and evaluating information provided by healthcare professionals,
patients, manufacturers, health care centers about the adverse effects of medications, drugs,
biological products or herbal medicines.
Aim
The main aim of pharmacovigilance is to identify new hazards associated with medicines and
to prevent harm to patients.
Emphasis
The emphasis is on detecting, alerting and preventing adverse effects of medicines. Adverse
effect is any unexpected effect of long term or short term usage of a medication even when
taken or administered in recommended dosage and in the recommended manner of
administration.
Clinical Trials and Medicines: Background
Clinical trials are conducted on sample patient groups and all the effects may not come to
light during clinical trials. Medicines are the main reason for enormous improvement control
of diseases through treatment. However, these medicines cause side effects. The extent of
these effects needs to be monitored. These side effects are not the same or to the same
degree in all individuals. However, when they are noticed, the adverse effects must be
notified to the concerned authority, so that the patients can be protected from the potential
harm that a particular medication can cause.
Characteristics of pharmacovigilance
1. To bring about improvements in clinical trails
2. Improve international collaboration to record and report adverse effects of drugs.
3. Create a common platform to report and access information about drugs causing
adverse effects
4. To set standards for monitoring adverse effects of herbal medicines
Some of the agencies that carry out pharmacovigilance are
International: WHO (World Health Organization) International Drug Monitoring Program
European Union: European Medicines Agency
USA: FDA (Food and Drug Administration) - Medwatch, RADAR (Research on Adverse Drug
events And Reports), and Public Citizen
Japan: PMDA (Pharmaceuticals and Medical Devices Agency) and MHLW (Ministry of Health,
Labor and Welfare).
Example: Pharmacovigilance results achieved by RADAR of USA
Between the years 1998 and 2007, over 30 serious cases of adverse drug or device reactions
have been reported by RADAR.
Some of the toxicities involved are biological systems and
• Thrombotic thrombocytopenic purpura (TTP)caused by ticlopidine and clopidogrel
• Thromboembolism caused by thalidomide and lenalidomide
• Hepatic failure caused by gemtuzumab and nevirapine
• Hypersensitivity caused by drug eluting coronary arterial stents
• Pure red-cell aplasia (PRCA) caused by epoetin
• Vision changes caused by amiodarone, sildenafil, and tadalafil
Adverse drug reaction reports are much higher as compared to reports regarding adverse reaction caused due to devices.
