In order to bring clarity on Pharma covigilance Program of India (PvPI) towards patient safety, the Union health ministry has asked adverse drug reaction monitoring centres (AMCs) to set up causality assessment committee to a detect serious adverse event related to drugs in each of the 250 AMCs functioning across the country.
This is urgently required as this will effectively help in setting up clinical evidence between the drug and the adverse drug reaction or serious adverse event related to it in the patient.
Each existing AMC has been mandated to take the same in the interest of patient safety, informed a senior official related to the development.
Causality or related assessment suggests determination of whether there is a reasonable possibility that the product is causally related to the adverse event.
Causality assessment committee includes evaluation of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.
It should be emphasized that manufacturers should not separate out those spontaneous reports they receive into those that appear to themselves to be causally identified with drug exposure and those they consider not causally related.
A doctor in making a spontaneous report to a manufacturer is demonstrating that the observed event might be because of the drug, i.e. the physician suspects that the event is a reaction.
Many companies do causality assessments on spontaneous reports as a part of their signal analysis mechanisms.
The Indian Pharmacopeia Commission (IPC) under the Union health ministry has recently turned out with draft protocol and guidelines focused on targeted drugs and events as a part of adverse drug adverse drug monitoring exercise under PvPI so appropriate action can be made on specific drugs including adverse events or reactions.
The intensive ADR monitoring protocol which has recently been devised will be implemented in a continuous manner in view of the learnings of the projects undertaken with assistance from competent institutions.
This will help in taking regulatory decisions in a timely manner. Institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring according to the guidelines for reporting specific events in a focused manner related to a specific drug.