In a strategic move that involves direct participation of patients in the Pharmacovigilance Programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC) has recently launched the ambitious medicines adverse effect reporting form for consumers i.e. the patients.
Interestingly, this will be first done on pilot basis across all the 150 adverse drug reaction (ADR) centres to gauge the impact it creates among the patients and on whether they are comfortable with the module prepared by them for reporting of ADRs in future.
Once this project takes off, the IPC which acts as the national coordination centre (NCC) for the programme plans to pan it across on an active manner for better success of this initiative. Dr Kalaiselvan, principal scientific officer, IPC, informed that through this simple and user-friendly form, patients can now on easily fill and report to nearby ADR monitoring centre on any ADR issues they are facing which will be actively followed up by us for more technical information.
He said, “Patient awareness is the key to the success of the PvPI programme, so our biggest aim is to ensure that they are well tuned to the process and becomes our partner in our endeavor to ensure best ADR reporting system in the world. Through this initiative, once the patient reports an event, NCC will be responsible to forward the reported information to nearby AMC to coordinate with the patient to collect further information and keep tab on the patient. Since consumers are the important stakeholders of PvPI, their reporting will provide hands on information about adverse events.”
This form was launched during a national level conference that was held in Delhi to sensitise the patients about the adverse drug reactions and the immense importance in participating in PvPI programme directly to achieve grand success of this progamme. As of now, there are two forms available in reporting of ADRs; first one is red form for healthcare professionals and another one is blue form for consumers to report adverse events due to medicinal and health products administration.
Dr Kalaiselvan informed that since this is going to be a pilot trial, the designed form has already been communicated to all AMCs to circulate within their department. It is understood that the NCC will be revising or amending the form periodically as per the suggestions or comments received from the stakeholders, to make it better acceptable among the masses. The current version of consumer reporting form is available in English version; however NCC has already started converting the same into Hindi and regional languages.