School of Public Health of University of Washington, perceives pharmacovigilance as the best active surveillance mode to improve regulatory authorities including US FDA’s capability to identify and evaluate drug safety issues in near-real-time.
The continuous, pre-organized follow-up of persons exposed to medicines would determine rates and risks of adverse drug reactions (ADRs). The data is useful to follow-up on signals to determine the incidence and risk factors of adverse events.
“Therefore, pharmacovigilance is an important tool to assess safety of newer drugs and vaccines not just in the people who have undergone clinical trials but in an understudied population. A vibrant and committed pharmacovigilance programme would only enhance FDA’s ability to assess safety issues not easily evaluated with the spontaneous reporting system”, said Dr Andy Stergachis, representing, School of Public Health, University of Washington, Seattle, USA.
Dr Stergachis was in India as the guest of honour at the two-day DIA event on pharmacovigilance which was attended by several participants. Quoting the Report of the Safety and Surveillance Group sponsored by the Bill & Melinda Gates Foundation he said that drugs and vaccines are reaching unprecedented numbers of people in low- and middle-income countries. These products have tremendous potential to save lives and reduce suffering. But many countries in which these products will be used do not have the capacity to effectively monitor their post-marketing safety.
“Only pharmacovigilance could scale-up of medicine-centric public health programs. It would expand new drugs and vaccines pipeline launched simultaneous or exclusively in low- and middle-income countries,” he added.
“Much remains unknown about safety of drug or vaccine. Here, pharmacovigilance could undermine public confidence and weaken the real or rumoured adverse events about drugs,” he said in his presentation titled ‘Active Surveillance: Sentinel Sites’.
The need of the hour is active surveillance. Institutions designated for data collection, such as hospitals, selected for their geographic location having the medical specialty would have the ability to diagnose accurately and report high quality data. The key advantage would be that it would provide complete and more accurate facts. It would help to put in place an efficient system to access medical records, said Dr Stergachis.
Identifying five reasons for active surveillance, Dr Stergachis said that it would enable follow-up on safety signals, investigate newer products that have a limited real-world safety profile, calculate rates of risk factors for adverse events, complement other pharmacovigilance methods and also monitor pregnancy outcomes following prenatal drug exposure.
Thus, pharmacovigilance or active surveillance would generate significant developments spanning from use of databases and creation of sentinel sites. The information ensuing from such specific monitoring process would benefit-risk decision making, provide treatment guidelines and allow rational use of medicines and improved patient safety, she said.