Pharmacovigilance: An Understanding

  • Added:
    Dec 05, 2012
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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.

Author's Profile

Pharmacovigilance is a broad term used to define the science of collection, documenting, monitoring, researching and evaluating information provided by healthcare professionals, patients. http://www.globalcompliancepanel.com


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