IMA-PvPI Initiative
BACKGROUND
A meeting regarding cooperation between National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) and Indian Medical Association (IMA) to promote the patient safety in the country was held on 6th January 2016 at CDSCO Hq, FDA Bhawan, New Delhi.
IPC, NCC-PvPI and Indian Medical Association (IMA) mutually agreed to work together to promote the patient safety in the country. Moreover, this cooperation will also ensure organizing Continuing Medical Educations (CMEs), disseminating PvPI information and other vital concepts of pharmacovigilance in IMA on frequent basis about the news, journals etc. A Letter of Intent for cooperation was signed between IPC, NCC-PvPI and IMA on 6th January 2016. Dr. G. N. Singh, DCG (I) & Secretary-cum-Scientific Director, IPC and Dr. S. S. Agarwal, President, IMA signed the Letter of Intent for cooperation on behalf of IPC and IMA respectively and exchanged the same.
NCC-PvPI and IMA agreed to cooperate for the following areas:
- PvPI-IMA patient safety monitoring cell to be started at IMA Head Quarter in the designated space provided by IMA.
- Organizing Continuing Medical Educations (CMEs), disseminating PvPI information/concept of Pharmacovigilance (PV) in IMA in News, Journals etc.
- IMA to identify the nodal centres for education/ advocacy and ADR monitoring and recommend to NCC-PvPI for recognition.
- Training to the nodal coordinators/medical officers.
- Development/up-gradation of Mobile app. for ADR monitoring.
- A “National Day on Patient Safety” is to be celebrated by NCC-PvPI and IMA in collaboration.
- Other areas to promote patient safety.
IMPORTANT-POINTS
To ensure safety of medicines IMA-PvPI has joined hands to promote patient safety & enhance public health.
Ø 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 Pharmacovigilance Programme of India (PvPI).
Ø As we all are well aware, that the medicines are developed over a period of several years. Efficacy and safety of a new drug are generally studied on a few thousand carefully selected and followed up trial subjects and patients according to strictly defined criteria. Medical safety is established in limited number of patients in clinical trials. For this reason only very frequent adverse reactions and mainly those depending on the drug's pharmacological properties can be observed during its clinical development. Hence, many ADRs go undetected.
Ø Once the product comes in market, a much larger, and also often polymorbid population will be exposed, which may lead to a change in the drug's 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.
Ø 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, many unknown risks can be identified and tackled.
Ø Hence, being a part of Pharmacovigilance, IMA is compiling the data of Adverse Drug Reactions (ADRs) / Adverse Event (AE) related to drugs/ vaccines/ medical devices/ blood products & Herbals for scientific study & evaluation.
Ø The ADR/AE reporting can be done for the following aspects:-
1. Known
2. Unknown
3. Serious
4. Non-serious
Ø ADR/AE reporting can help all of us in our practice to know whether a particular effect is an actually a side effect of a Drug or not and decide whether that particular ADR requires inclusion in its Pack insert/ Drug intake needs some special precautions /Production of that Drug needs to be stopped/ Benefit risk ratio assessment can be done/ Need to establish safety of medicines in special population (children, elderly & pregnant women.)
Ø IMA feels that reporting of such ADR/ AE under PvPI is the only means to know about the adverse effects of various drugs.
Ø To fulfil this purpose IMA has started IMA-PvPI ADR/AE helpline to report any ADR/AE through a Mobile No. +919717776514 from Monday till Friday from 9am to 5:30pm.
In the interest of society, IMA has taken this step as a major project towards patient safety.