Safety monitoring postmarketing

Postmarketing surveillance The FDA s ongoing safety monitoring of marketed drugs. 

The need to strengthen the postmarketing safety monitoring and take account of the efforts in international harmonization for the technical assessment of pharmaceutical products... 

POSTMARKETING SAFETY EVALUATION MONITORING, ASSESSING, AND REPORTING OF ADVERSE DRUG RESPONSES (ADRs)... 

The Food Additives Amendment to the Federal Food, Drag, and Cosmetic Act of 1938, which was adopted in 1958, requires that proof of safety of a new food additive be furnished by the manufacturer based on extensive scientific research. Since it is impossible to conclusively prove the safety of a new food additive through animal and clinical trials, manufacturers routinely conduct postmarketing surveillance and long-term follow-up studies to monitor adverse events. 

The astute individual healthcare practitioner is the critical link in the postmarketing surveillance of medical products. One reporter can indeed make a difference in a newly approved drug s postmarketing phase. Only through the diligence of individual practitioners, such as pharmacists, can FDA hope to monitor the adverse events associated with newly marketed products and determine their safety for patient use. 

Phase IV—Postmarketing approval trial to monitor drug safety and... 

In the evaluation of safety in the postmarketing phase, regulatory agencies are greatly more restricted in their enthusiasm for data derived from some of the methods available than from others. Indeed, the EC national agencies separately and the CPMP collectively have developed a legislative framework that is predominantly concerned with spontaneous adverse event monitoring and which is, for all practical purposes, silent on the matter of safety data collected by other methods. 

NDA requires manufacturers to submit product-labeling language, which describes the proper use, benefits, and risks of the product in question. FDA may also require, as a condition of approval of an NDA or BLA application, that postmarketing studies be conducted to monitor and confirm the safety and efficacy of a product as it is used more widely in clinical practice. In addition, all sponsors or manufacturers are required to monitor and report adverse effects, defined as health effects that may or may not be related to the drug in question. For vaccines, adverse events that occur after immunization must be reported to the Vaccine Adverse Event Reporting System. 

A fourth phase known as postmarketing surveillance should be instituted after the NDA is approved. Postmarketing surveillance refers to all of the methods used to continue monitoring drug safety and effectiveness after approval for public use.19,21 These methods often consist of reports from health care providers that describe specific rare adverse effects that were not discovered during clinical testing.24 A certain drug, for example, could cause a specific adverse effect in only 1... 

Therefore, postmarketing surveillance is conducted to examine safety and effectiveness. The terms pharmacovigilance and pharmacosurveillance studies are also used in this context. Pharmacosurveillance monitors all reports of adverse reactions and thus compiles extended safety data. Pharmacosurveillance is therefore a critical component of the overall process of ensuring all members of a target disease population receive the greatest protection from adverse reactions. 

The need for more structured monitoring of the postmarketing safety of products approved by centralised and mutual recognition routes, and for a very interactive relationship with other regions and principles for providing the WHO with pharmacovigilance information, has been set out in the following papers ... 

Various stakeholders have recognized the need to improve current pharmacovigilance practice and the opportunities that exist to expand the use of observational data in that pursuit (Berlin 2008). In 2007, the U.S. Congress passed the FDA Amendment Act, which in part mandated the "establishment of a postmarket risk identification and analysis system" that leverages observational health-care data, including administrative claims and electronic health records (EHRs), to monitor approved medicines on a periodic basis. In response, FDA established the Sentinel Initiative, an effort to create and implement a national, integrated, electronic system for monitoring medical product safety (Platt et al. 2009). 

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