Sunday, 10 April 2016

IMA-PvPI Pharmacovigilance Initiative

IMA-PvPI Pharmacovigilance Initiative Dear Colleague As you may be well aware, efficacy and safety of a new drug are generally studied on only a few thousand trial subjects and patients. For this reason, only frequent adverse reactions can be observed during its clinical development. Once the product has been placed on the market, a much larger, and also often polymorbid population will be exposed, which may lead to a change in the drug's hitherto known safety profile. Adverse drug reactions can then be observed more frequently, including those occurring only sporadically and independently of the pharmacological properties of the substance. These new adverse reactions, should be reported without delay as a contribution to a potentially still incomplete safety profile. If such information is consistently forwarded to the competent authorities, hitherto unknown risks can be identified and tackled. Under the IMA-PvPI initiative, Indian Medical Association (IMA) has become a nodal centre for reporting of Adverse Drug Reactions (ADR) / Adverse Events (AE) under the Pharmaco Vigilance Programme of India (PvPI). IMA is compiling the data of ADR / AE related to drugs/ vaccines/ medical devices/ blood products & Herbals. One can contact IMA-PvPI ADR/AE helpline and report any ADR/AE to Ms. Megha Joshi on Mobile No. +919717776514 from Monday till Friday from 9am to 5pm. The ADR/AE reporting can be done for the following aspects: • Known ADR/AE • Unknown ADR/AE • Serious ADR/AE • Non-serious ADR/AE ADR/AE reporting can help all of us in our practice to know whether a particular effect is actually a side effect of a drug and decide whether the continuation of that drug needs to be stopped. IMA feels that reporting of such ADR/ AE under PvPI is the only means to know about the adverse effects of various drugs. IMA has taken this step as a major project in the interest of society You are requested to kindly circulate this information extensively in your region and report all Adverse Drug Reactions / Adverse Events in your region to the IMA-PvPI helpline as per the above communication details. Dr SS Agarwal Dr KK Aggarwal National President Padma Shri & Dr BC Roy National Awardee Indian Medical Association Honorary Secretary General, IMA

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