Purpose of this workshop

1. To raise awareness about importance of adverse drug reactions(ADR) reporting.
2. To be able to differentiate between Adverse Event (AE) and ADR.
3. To be able to apply WHO-UMC & Naranjo's scales for categorising ADR.
4. To be able to fill up the CDSCO form as per Pharmacovigilance Programme of India.

Pharmacovigilance

"Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem" -WHO

This Program for International Drug Monitoring was established by WHO as a result of the thalidomide disaster detected in 1961. Pharmaceutical manufacturing companies are required by law in all countries to perform clinical trials, testing new drugs on people before they are made generally available in the market. At the end of 2010, 134 countries were part of the WHO Pharmacovigilance (PV) Programme.

The Purpose of Pharmacovigilance

• The main purpose of pharmacovigilance is to improve the patient's safety and enhance his care in terms of the use of medicines, including paramedical interventions.
• Pharmacovigilance also supports public health programs by providing reliable information for the efficient assessment of the risk-benefit profile of medicines.
• Contribute to the assessment of benefits, uses, side effects, harm, effectiveness and risk of medicines.
• Encouraging the safe, rational and more effective (including cost-effective) use of various medicines.
• Promote education, understanding and clinical training in pharmacovigilance and its effective availability to the public.Recently, pharmacovigilance has widened its horizon to include:
• Traditional and complementary medicines
• Herbals
• Biologicals
• Blood products
• Medical devices
• Vaccines

Importance of Pharmacovigilance So overall, pharmacovigilance covers the following:

• Drug monitoring
• Pharmaceutical preparations - adverse effects
• Adverse drug reaction reporting
• Product surveillance
• Postmarketing Legislation

Besides the above, many other issues are also relevant to pharmacovigilance such as follows:

• Medication errors
• Substandard medicines
• Lack of efficacy reports
• Use of medicines that are not approved for
• Case reports of acute and chronic poisoning
• Study of drug-related deaths
• Abuse and misuse of medicines
• Adverse affects of medicines with chemicals, other medicines, and food.

Pharmacovigilance has been developed by WHO solely with the intention of responding to the special needs. Over the last decade, it has been increasingly recognized that the scope of pharmacovigilance needs to be extended more , much beyond the present signals of safety concerns. Globalization, consumerism, the resulting expansion in free trade and communication across national and international borders, and increasing use of the Internet have all contributed to a change so that people can access information on all types of medicinal products. So pharmacovigilance is indeed important and the changing patterns in drug use require a shift in the approach to pharmacovigilance so that it can respond to the prevailing patterns of drug use within society in a better way.

In today's advanced age of medicines, science and technology, there has been an increasing public awareness of safety issues related to medical products. This has led to an increased importance of pharmacovigilance.

Naranjo's algorithm: Determination of ADR Probability