Drug Safety and Risk Management

FDA has also formed a Drug Safety and Risk Management Advisory Committee during this time, provided specific training for the members and has subsequently placed selected members on Advisory Committee Panels to consider various risks or to review existing risk management programs. 

Shiraishi Y, Morita K, Nakao M, Uezono S, Chuma R, Furuya H. [The incidence of critical arrhythmia related to epinephrine under halogenated inhalational anesthesia-report of the Subcommittee on Drugs, Committee on Patient Safety and Risk Management, and Committee on Administrative Affairs Japanese Society of Anesthesiologists.] Masui 2009 58(3) 378-83. 

In the past decade there has been increased emphasis on drug safety, and more public visibility of safety problems. The volume of reports now exceeds 250 000 spontaneous reports per year, and adverse events have been highlighted in the medical sector and also in the media. In parallel, the FDA has focused more intently on this area in both NDA reviews and in the postmarketing period. This has accompanied withdrawals of a number of products, such as cisapride, phenylpropanolamine and terfenadine, and special scrutiny of products associated with particular adverse events, such as cardiac arrhythmias (torsades de Pointes ) and hepatic necrosis. The result has been an emphasis on the concept of risk management of a product. This concept, which is due to be described in forthcoming FDA recommendations, stresses the need to identify potential... 

Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy—Report of the ISPOR risk-benefit management working group. Value Health August 2010 13(5) 657-666. 

Hsu JC, Cheng CL, Ross-Degnan D et al (2015) Effects of safety warnings and risk management plan for ThiazoUdinediones in Taiwan. Pharmacoepidemiol Drug Saf 24 1026-1035... 

Conaghan PG, Day RO. Risks and benefits of drugs used in the management and prevention of gout. Drug Safety 1994 11 252-258. 

The FDA s postmarketing surveillance of drug safety in FY 2003 includes a new database on prescribed drug use (with patient idenhhes removed). The agency uses this database of marketed drugs to "make risk assessments and decisions about the most appropriate way to manage any new risk or new perspective on a previously known... 

Since late 2005, the ICH has added three more quality guidelines Q8— Pharmaceutical Development, Q9—Quality Risk Management, and QIO— Pharmaceutical Quality System. All these guidelines are intended to bolster the quality of drugs to be manufactured, steering manufacturers in the direction to improve compliance, safety, and consistency of the drugs. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

If risk management activities are used to permit the marketing of drugs that otherwise would be kept off because of serious safety concerns, and the activities are effective, the public will be better off. On the other hand, if risk minimisation tools are routinely applied to drugs that could be marketed without them, they could serve to deny access of physicians and patients to valuable and acceptably safe medicines. How the FDA will strike this balance remains to be seen. 

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