The Savvy Consumer
Risk Management: The Consumer Holds the Trump Card

Two significant advances occurred this summer in addressing growing national concerns over medication safety and risk management. Both advances address the injury that results when consumers do not, or are unable to, manage risk appropriately. Both have important implications for the future of DTC advertising.

The first advance is the publication Managing the Risks From Medical Product Use, a report by FDA's Task Force on Risk Management. The report, one of Dr. Jane Henney's first initiatives as FDA commissioner, states that FDA believes the time is right to engage all stakeholders, including patients and the public, in reexamining the present system used to manage risks associated with medications.

The unmistakable message is that FDA takes the issue seriously. The report recognizes that patients rely on the health care system to protect them from injury, and offers a number of recommendations that view the consumer as end-user. It contains clear implications for DTC advertising.

The second advance relates to a thought-provoking dialogue organized by the National Patient Safety Foundation at the AMA, a nonprofit organization committed to improving medication safety. The two-day facilitated dialogue grew out of an emerging consensus that although the pharmaceutical industry can always improve upon preapproval clinical trials and analyses, the major problem with medication safety lies in how the consumer uses the product rather than in the product itself.

Consumers Bear the Risks
Both of those advances are positive. Finally, the industry is recognizing the consumer as the party that ultimately bears the risk and decides how to use the product.

The issue is simple. Each consumer holds-and ultimately plays-his or her own trump card.

Each consumer decides if the benefits of the product described in the DTC ad are greater than the risks that individual is personally willing to take.

When a physician prescribes a product, that consumer decides whether to stop taking it at the first sign of a side effect or continue taking the medication despite adverse symptoms. Either decision could be potentially life-threatening depending on the individual's clinical status.

The point is that many consumers suffer adverse effects from medicines because they fail to receive sufficient information and counseling that would allow them to manage the potential risks. Those risks extend far beyond adverse effects and include medication errors and drug interactions with other prescription drugs, OTC products, and natural and herbal remedies.

Answer Our Questions
It is more clear than ever that marketers must develop DTC messages from the consumer's point of view. That is, they must conceive those messages from the outset to answer the consumer's product-related questions. Those questions include:

1. How will the medicine help my specific problem?
2. What side effects might I expect?
3. How can I manage those side effects? When do I continue taking the medicine and when do I call my doctor?
4. What drug interactions must I avoid?

It is extremely encouraging that national organizations are developing steps that all stakeholders can take to make drug therapy safer. As the media and Capitol Hill decision makers focus more attention on the issue, consumers will become better informed of steps they need to take to ensure that national action plans recognize their viewpoints and needs.

What does that recognition mean for DTC advertising?

Consumers will no longer accept brief summaries written in language for health professionals on the back of the DTC ads. They will demand that consumer-friendly patient package inserts be developed instead.

Pharmaceutical companies will need to carefully evaluate how to present the risks associated with their products so that this information is more meaningful to their end-user, the consumer. The savvy product manager will explore creative ways to reinforce the product's DTC ads through complementary patient information programs.

Consumers Hold the Vote
The momentum is building. DTC advertising is entering a new era. Consumers will increasingly demand more information about how to manage their medications safely. This demand will lead to media attention and congressional support--simply because consumers hold the vote.

Consumers will reward companies that make a good faith effort to answer their questions and concerns about managing medication risks. The DTC team that builds risk management into its strategy will be a winner.

Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.

Do you have a DTC question? E-mail it to dlsmith@consumer-health.com or call (703)734-0650.

Published in Pharmaceutical Executive, July 1999. Copyrighted material; All rights reserved.