Robust pharmacovigilance system needed to report ADRs: Prof Aziz

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With more and more new drugs coming in the market, it is high time that India needs to adopt robust pharmacovigilance system to report the Adverse Drug Reactions (ADR) both at the primary and tertiary care hospitals in the country. According to Professor Dr S A Aziz, Principal of Deccan College of Pharmacy in Hyderabad, with the patent cliff going off, there are vast numbers of new drugs coming in the markets. In view of this, there is a need for the country to adopt a new working model of pharmacovigilance embedded with the pharmacy practice programme.

As part of this, professor Aziz has proposed a new working model of pharmacovigilance to record the adverse drug reactions at tertiary care hospitals. “Pharmacovigilance plays a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines. Despite of recent implementation of a well structured pharmacovigilance programme in India in accordance with the objectives and recommendations of WHO by CDSCO, India has contributed only 2 per cent of Individual Case Safety Report(ICSR) to the global ICSR database which holds about 10 million ICSR’s. In view of this a new working model of pharmacovigilance is necessary to record and report ADRs,” observed Dr Aziz.

The new working model will adopt new software called Vigilflow. The voluntary and professionally identified drug reactions are recorded in blue and red forms respectively. Later this will be sent to well qualified and trained clinical pharmacists for further reviewing and prepare a detailed report which will be uploaded into the Vigilflow software.

Up on uploading into the Vigilflow software, an ICSR is generated which will be submitted to the Indian Pharmacopoeia Commission (IPC) and National Coordination Center (NCC) which will further assess the ICSR and send it to the world health organization Upsala monitoring center (WHO-UMC) which will further assess the clinical pharmacological aspect of the case history and the quality of the documentation of the observation. Based on its assessment it will provide information on drug safety to WHO headquarters in Geneva. This information will further propagated to regulatory bodies and researchers.

Apart from this, the ICSRs uploaded in the Vigilflow are also made available on Vigilbase where information is recorded in structured hierarchical form to allow for easy and flexible retrieval and analysis of the data.

“If we can adopt such a robust pharmacovigilance programme embedded in to the pharmacy practice in the healthcare centers, we can not only help develop safer drugs, but can also improve the quality of healthcare in the country,” opined the professor.

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