Pharmacovigilance requires strong links with regulators to ensure that authorities are well briefed on safety issues to enforce regulatory action in the future.
Post market surveillance
The value of post-market surveillance to protect consumers defines and clarifies the professional regulatory role in communicating product safety as technology continues to increase data accessibility. The cornerstone of effective post-market surveillance in monitoring and collecting surveillance data of commercialised product is to identify and document potential safety issues. Post market surveillance not only meets regulatory requirements while monitoring the safety of consumers, but also ensures continuous consumer acceptance of the products and financial viability. Implementing sound post-market surveillance system based on principles of pharmacovigilance is essential.
Post-market surveillance is a passive, multifactorial, performance-based process for health professionals, manufacturers, regulators and the public to monitor the performance during the lifecycle of a product in the open market. It is important for manufacturers and regulators to share common goals for safety surveillance keeping consumers in mind. Manufacturers must comply with the rules and regulations by taking proactive steps to ensure proper documentation and submission of reports of adverse events to the authorities. Manufacturers can implement corporate post-market surveillance program to monitor product safety with best practice efforts meeting mandatory regulatory obligations. Proper resources and expertise are also necessary to ensure ethical practices along with accurate and balanced information are used in promotional materials.
Importance of surveillance
The safety of medicine is affected by constraints placed by sponsors on the study plan and open sharing of information by clinical collaborators and sponsors. Reasonable regulatory decisions can be made for the early release of new drugs promising therapeutic advances through stronger pharmacovigilance system of post market surveillance, monitoring and reporting. Legislation governing the regulatory process for approvals should enforce pharmacovigilance after early drug release. Pharmacovigilance plays an important role in the introduction of generic medicines and safety issues or profile review of older medicines already available in the market. These considerations are likely to be more important than novel therapeutic benefits a new entity brings to an already pressed health service.
The goal of surveillance system is to identify the product use patterns or conditions responsible for adverse effects and characterize relative incidence rates compared to market penetration, units sold or other denominator-generating benchmarking data. To determine the frequency of adverse reactions or safety attributable to a product, spontaneous reports, information on utilization and extent of consumption is essential.
Assigning frontline staff with appropriate medical training to receive and document according to standardized operating procedures is important in post market surveillance. Depending on the nature of safety issue, actions like product withdrawal from the market, reformulation or recall may be initiated. All stakeholders should recognize the use of appropriately designed sensitive and effective surveillance systems.
The need for more active surveillance is becoming increasingly clear, in addition to spontaneous reporting that is indispensable for signal detection and remains a cornerstone of pharmacovigilance in the regulatory environment. Benefit-risk assessment in post-marketing has contributed to a more systematic approach in determining the merits of available medicines. Systematic medical and prescription record linkage with drug utilization studies can contribute to greater accuracy. More robust and systematic epidemiological methods in post-marketing surveillance programmes can account for spontaneous reporting limitations and help address important safety questions.
Online Course at JLI
James Lind Institute (JLI) provides an online program – Advanced PG Diploma in Clinical Research & Pharmacovigilance to better understand post market surveillance.
For more information please visit: www.jli.edu.in