In order to offer clarity in the process of reporting adverse drug reaction (ADR), union health ministry has asked 250 adverse drug reaction (ADR) monitoring centres (AMCs) to generate and report India specific ADR data on a priority basis in an effective way through intensive ADR monitoring.
The Indian Pharmacopoeia Commission (IPC) under the Union health ministry has recently come out with draft protocol and guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under Pharmacovigilance Programme of India (PvPI) so that appropriate action can be taken on specific drugs involving adverse events or reactions.
“The intensive ADR monitoring protocol which has recently been devised will be implemented in an ongoing manner based on the learnings of the projects undertaken with help from competent institutions, which may even take two years time. This will help in taking regulatory decisions in a timely manner,” explains Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.
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For this, Pharm D institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring which will follow the protocol and generate data in the stipulated columns as per the guidelines for reporting specific events in a focused manner related to a specific drug.
The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been misspelt. A case in point is of diabetic drug Pioglitazone which was suspended and then revoked due to lack of India specific data in the country for adverse reactions leading to conditions like bladder cancer. This exercise will give clear data on such cases.
Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) in collaboration with IPC has also started auditing healthcare institutions through assessment on aspects like SOPs and causality assessment in order to review the functioning of AMCs in the country.
The exercise is an initiative taken by IPC to generate awareness in medical institutions to put in place effective surveillance system for detection of adverse drug reactions. IPC is the National Coordination Centre (NCC) for PvPI.
CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010.
PvPI as of today leads with 0.82 points as per quality completeness score of Individual Case Safety Reports (ICSR) as against the global average of 0.55 accounted on a quarterly basis for a total of 150 countries including India which contribute to the global PvP database.
ICSR as part of ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
Uppsala Monitoring Centre was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO programme for international drug monitoring was transferred to Sweden. The WHO Programme for international drug monitoring is a group of more than 150 countries that share the vision of safer and more effective use of medicines. UMC has been responsible for the technical and operational aspects of the programme since 1978.