The Risk Management Mandate - Pharmaceutical Executive

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The Risk Management Mandate
FDA says every new drug needs a plan for dealing with risk.


Pharmaceutical Executive


Does It Work? Finally, the FDA concept paper implores pharma companies to test their risk management interventions and to evaluate the RMP. Individual tools should be tested to assure that they meet their intended purposes. For example, it is important that patients be able to comprehend key warnings and be motivated to engage in the advocated behaviors that will prevent harm. By using quantitative testing methods, such as studies that question consumers at shopping malls, pharma companies can assess draft communications to determine if core communication objectives are comprehended. Messages that are not well communicated can be analyzed and re-crafted.

Comprehension testing has become routine in the development of over the counter (OTC) labels. These labels are often drafted several times—changing language, placement, and graphic emphasis—to develop an easily understood label. Comprehension testing not only assesses the communication of core messages, it also allows the measurement of other outcomes, such as belief change and persuasion, the ability to problem solve and influence decisions, and the ability to analyze the impact of the communication on behavioral intentions. Testing communications before implementing them—including those directed at healthcare professionals—may not only improve the tool's utility but also may protect the company from product liability. (See "Double Test.")

Rather than advocate the need to achieve a specified level of performance, each RMP should advocate continuous quality improvement. Before the program is implemented, it may not be possible to understand the degree of noncompliance. It also may not be possible to understand the cause of system failures. Overly burdensome programs may inhibit product use by making prescribers unwilling to try the drug or by making it difficult for patients to obtain the product. These and other unintended consequences may also be assessed through a survey evaluation of the product. By examining the intermediate impacts and modifying the program to shore up the weaknesses, risk management planners can continue to improve the program.

Benefits for All Companies must propose to FDA reasonable and competent programs for the drug to be accepted for marketing. FDA cannot accept programs that are shown to be ineffective; nor is it reasonable for a program to be fully effective without some trial. Thus, companies must make a commitment to develop and achieve effective RMPs. The alternative, withdrawing the drug from the market, offers little solace to either the pharma company or the patients who need access to the medication.

Risk management provides both a challenge and opportunity for pharma companies. It forces companies to understand not only how a drug treats disease, but how it is used. It also forces companies to develop a coherent set of interventions intended to influence use. Developing such information tools and systems will benefit patients and providers by improving the safe use of medicines. It should also benefit pharma companies, not only by improving drug safety, but by building trust and support and by increasing personal responsibility for safe drug use.


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