In a bid to handle the under reporting of drug reactions taking place in the hospitals in the country, the National Pharmacovigilance Programme (NPP) is now aggressively working towards creation of a database on adverse drug reactions (ADRs) collected from different parts of India. The key objective is to foster a culture of reporting ADRs for all medicines, besides post marketing surveillance.
The ADR database will increase patient safety. It will help create a sound regulatory framework. Further, it will also highlight the economic ramifications of drug reactions arising due to irrational use of drugs, Dr Shobha Rani R Hiremath, professor & head, department of Pharmacy Practice Al Ameen College of Pharmacy, Bangalore and coordinator, NPP, told Pharmabiz.
Under patient safety, the NPP will help increase the safe use of medication. With a regulatory framework in place, the healthcare professionals will need to document the ADRs, which could eventually lead to banning the drug or restrict/modify the instructions for use of drug on the label. In the case of economic challenges, the Programme will draw ample attention to the monetary burden on patients with prolonged hospital stay resulting out of ADRs.
The creation of a database is based on the Uppsala Monitoring Centre model. The World Health Organisation (WHO) Collaborating Centre in Uppsala, Sweden founded in 1978 after an agreement between WHO and Swedish Government is now responsible for Pharmacovigilance monitoring across the world. The data utilization helps in information exchange, education, training, research and evaluation. Although many countries have started ADR (voluntary) reporting programmes, not all reports meet requirements of WHO Uppsala Monitoring Centre. There continues to be large numbers of poor quality reports and under-reporting is still a big problem.
The government of India with the assistance of World Bank initiated the National Pharmacovigilance Programme in 2004. The Central Drugs Standard Control Organization (CDSCO) is coordinating the NPP under the aegis Director General Health Services, Ministry of Health and Family Welfare.
Under the NPP, India has 21 Pharmacovigilance centres. These include two zonal centres at All India Institute of Medical Sciences, New Delhi covering North and East. The KEM Hospital at Mumbai monitors southern and western regions in India. There are five regional Pharmacovigilance Centres at Kolkata, Pondicherry (JIPMER), Nagpur and Mumbai with two centres. There are several periphery centres including Bangalore at the Victoria Hospital, Goa, and Mysore within JSS College of Pharmacy.
The peripheral centres report to regional centres who in-turn are accountable to the zonal centres that coordinate with the CDSCO. Meeting is held once a month.
All these centres in the country have to report 30 ADRs a month. The Bangalore periphery centre is set-up by the Al Ameen College of Pharmacy's Pharmacy Practice which collects the ADRs from three medical centres including Victoria Hospital, St. Marathas and Sagar Apollo Hospital. The most common ADRs reported are about antibiotics, anti epilepsy, tuberculosis, NSAIDs and anti-cancer drugs.