Risk Management: Half Empty or Half Full?

Risk management and drug safety are terms that strike foreboding into the hearts of marketers across the pharmaceutical industry. In fact, there is a misperception of these disciplines as the "Sales Prevention Department". After all, highlighting a product's risks to customers may needlessly cause alarm and discomfort, right? Well, not necessarily so. Our work at ParagonRx demonstrates there is a "sweet spot" in the design of communications and risk mitigation interventions that guides appropriate use of products AND provides reassurance to customers

The Sweet Spot

ParagonRx conducted a conjoint analysis of 514 physicians to assess their acceptance of various risk management program designs. The respondents reported a 23 % decrease in their intent to prescribe a hypothetical product with specific safety risks if it was introduced with a risk management program that was objectionable to clinicians. This will not be surprising to the "glass half empty" crowd. The surprise came when the respondents reported a 48% INCREASE in their intent to prescribe the same product if it was introduced with a risk management program that clinicians perceived to be beneficial and useful. This clearly illuminates the challenge for risk management program designers: how to create programs that effectively guide appropriate use of products in a way that is actually useful for healthcare provides and patients?

Replicable Process Instead of Opinion

Every risk management plan or benefit/risk communications plan must start with a rigorous characterization of the product risk, and many manufacturers use independent consultants to conduct this analysis to minimize the potential for bias. Methods in the next step of designing risk interventions vary widely. Too often, plans are not rigorously designed, instead being based on the opinions of experts who look at precedents to assemble a program that is "likely" to be effective. Unfortunately, there are almost no precedents that have data to demonstrate program effectiveness. In addition, an opinion-based program invites opinion-based criticism.

An alternative, more-scientific approach is to use a replicable process that includes several key methods such as:

• Assessment of the medication use process. The risks of many medications can be addressed by helping to assure that products are used only in the right patient, in the right way, at the right time. This is appropriate use. An evidence-based method (such as failure mode and effects analysis) can be used to identify where the existing process of mediation use may fail to adequately protect the patient, thus defining the points where intervention is needed and effective. [www.paragonrx.com; Guidance for Industry, Development and Use of Risk Minimization Action Plans, FDA, March 2005]

• Collaborative development with clinicians. User innovation is a highly effective means of concept development [Von Hippel E. Democratizing Innovation. The MIT Press; 2005] that taps an often-ignored resource. It is likely that points of risk in the medication use process are already adequately identified and managed by isolated but highly effective techniques innovated by some clinicians. The most advantageous way to develop interventions is to identify existing, field tested techniques that are already implemented by innovative clinicians. An evidence-based approach, such as applied ethnography (naturalistic observation of a study subject's activities), is an effective way to identify such field tested interventions.

• Designing effective education. Adults remember only a fraction of the content communicated via "flat" written communication. Thus, it is no wonder that "Dear Healthcare Provider" letters have not proven to be sufficient risk communication techniques. This discipline of effective adult learning espouses an integrated education process that includes their reading, hearing instructions, viewing pictures, and interactively participating in simulations as the optimal means of educating adults. All materials must be tested for acceptability and age-appropriate comprehension.

• Continuous improvement. Even a rigorous evidence-based process cannot guarantee a fully effective risk minimization program at the completion of the initial design process. The rigor helps to assure that the program is as good as possible, but effectiveness is assured only through a process of continual improvement that features ongoing monitoring, assessment of root causes, and program redesign using the same replicable process that was used in the initial design.

Increasing Value

Risk management, which is typically employed only to gain marketing approval or preserve market presence, is now being applied in more novel ways by pharmaceutical and biotechnology companies.

Some of these applications to realize incremental value from risk management strategies include

• Product salvage. Some compounds that had been terminated prematurely in clinical development could be revisited as candidates for introduction with a risk management program
• Reintroduction. A number of products that were withdrawn for safety concerns have been reintroduced under the auspices of a risk management program
• Complementary labeling In some circumstances, additional dosing instructions have been provided in risk management programs without the manufacturer having to conduct additional clinical trials
• Accelerated approval. Companies are now pursuing risk management as a strategy for gaining early market access for a narrow indication, using interventions to prevent use more broadly.
• Prescriber confidence-building. As noted earlier, prescribers, who are sensitive to risk, may be more inclined to prescribe a product if they have access to tools that mitigate risk.
• Barrier to competitor entry. Products with established risk management interventions may "raise the bar" for the entry of competitors without such built-in support tools.

Changing Perspective

There is currently an opportunity for our industry to change its perspective on risk management. Rather than viewing it as a regulatory burden requiring reluctant compliance, we can evolve our thinking to appreciate risk management as a tool to get the right drug to the right patient at the right time. As we succeed at that goal, we will inspire the confidence of our clinicians, their patients, regulatory agencies, and the general public - as well as convincing marketers that the glass is indeed half full.