IPC asks healthcare professionals & institutions to monitor ADRs as PvPI sounds alert on dabigartan and sertraline

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The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has directed healthcare professionals and institutions across the country to report adverse events associated with two suspected drugs – dabigartan and sertraline.

As per the alert from the PvPI, the preliminary analysis of ADRs from the PvPI database reveals that these drugs – Dabigartan and Sertraline– are associated with risks like alopecia and maculopathy respectively. While alopecia areata is a common autoimmune disorder that often results in unpredictable hair loss, maculopathy is damage to the macula, the part of the eye which provides us with our central vision.

The ADRs can be reported in the format available at its website http//www.ipc.gov.in. circulated as Suspected Adverse Drug Reactions (ADRs) Reporting Form or by PvPI helpline number – 1800-180-3024.

While dabigartan is recommended for prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation, sertraline is associated with major depressive disorders, obsessive compulsion disorders (OCD) and panic disorders.

Healthcare professionals, patients and consumers have been advised to closely monitor the possibility of ADRs associated with the use of these suspected drugs as specified in the alert. If such reactions are encountered, it needs to be reported to the NCC-PvPI for suitable action.

This comes at a time when the Union health ministry is keen on developing a system of intensive ADR monitoring to come out with concrete clinical evidence based on specific serious adverse events associated with specific approved drugs with a case in point like diabetic drug -pioglitazone.

“With the ever increasing thrust on patient safety and the evolving PV practices in the country, we are planning to strengthen the PvPI by identifying new institutions to develop them as competent AMCs and assign them to do intensive ADR monitoring besides the 250 ADR monitoring centres (AMCs) existing in the country,” according to IPC Scientific Director Dr G N Singh. There is a need to generate awareness in medical institutions to put in place effective surveillance system for detection of ADRs, he added.

CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. Since then, IPC which is NCC-PvPI has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment. CDSCO in collaboration with IPC has been co-ordinating with healthcare institutions through assessment on aspects like SOPs and causality assessment to strengthen AMCs in the country.

IPC has also set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 with focus on North Eastern (NE) states. There are currently 250 functioning ADR monitoring centres in the country (in medical colleges and corporate hospitals) as part of the PvPI.

The health ministry had in the past mandated based on the ADR monitoring protocol effective implementation of the projects related to Intensive adverse drug reaction monitoring with help from competent institutions in the country.

Based on the learnings of these projects, government will be equipped in taking regulatory decisions in a timely manner. The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been mis-spelt.

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