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Posted on 07.31.01
Workshop on Communicating Risk a Success
By Pat French
Several drugs have been removed from the market in recent months. In most cases, the drugs were removed because the medical system could not manage their known and preventable side effects. This situation highlights the need for better communication about the appropriate use of prescription drugs. This spring, CERTs coordinated a workshop that drove this point home.
Together, the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), the Pharmaceutical Research and Manufacturers of America (PhRMA), and CERTs hosted the workshop, entitled "Improving Communication of Drug Risk Information to Prevent Patient Injury," at the George Watts Hill Alumni Center at UNC-Chapel Hill on April 30 and May 1, 2001.
The central theme of the workshop was that current communication methods of the government, industry, and caregivers must improve, to change the behaviors that lead to preventable patient injuries.
The workshop had two basic objectives: to survey the current status of risk communication, and to create a research agenda for communicating the risks of drugs and other medical products.
"It is problematic that despite all of the recent emphasis placed on the risk of therapeutics, very little research has focused on the optimal ways to communicate risk, to health care providers or to patients," notes Dr. Robert M. Califf, director of the CERTs Coordinating Center.
The 60 invited experts, including representatives from all 7 CERTs centers, reached several conclusions from their efforts. First, representatives from the FDA and the pharmaceutical industry expressed the desire to collaborate more in developing better approaches to communicate the risks with prescription drugs.
Second, although the attendees agreed that current ways of communicating are inadequate, and that new methods are required, there was no consensus about which method(s) should receive the highest priority. Instead, they agreed that several important factors should guide development of risk-communication methods:
- Current medical environments, particularly physicians' offices, are too busy for traditional communication methods to be effective.
- Messages about risk must be individualized and personalized. "Dear Doctor" letters must be replaced by "Dear Dr. Smith" letters that address the unique practice situations of individual physicians, caregivers, and (when appropriate) patients.
- Computers might offer an attractive technology for extending the reach of risk information while also individualizing it. Online prescribing, monitoring, and feedback; integration of patient records; and Internet-based communication are all interesting, but unproven, approaches.
- Single methods of communicating risk (such as product labeling) are ineffective and should be considered only one component of an integrated communication approach.
- Industry and government must view risk communication as a shared responsibility to improve outcomes, not as a legal process to discharge responsibility and minimize liability.
- Consumers receive massive amounts of information about effectiveness, but only minimal information about risk. If the former can be effective, so can the latter.
- The education of caregivers must change, at all levels, to give them the vocabulary and background for risk communication.
- Priorities must be set for research in risk communication, then research must be conducted. Both roles are pertinent to CERTs, but outside research also will be needed.
The attendees also identified several areas for research. The three major categories of research were: descriptive research (what is working and what isn't), etiological research (what is influencing what is happening now), and interventional research (what can be tried that will change what is happening now).
"It is both a sobering and stimulating experience to be part of this workshop," notes Dr. William Campbell, principal investigator of the UNC CERTs. "It is sobering because there are few research data to guide decisions, but also stimulating because all stakeholders agree on the critical importance of developing more effective methods of risk communication."
The group is developing a manuscript that summarizes the workshop proceedings, the proposed research agenda, and the proposed model of risk communication. They then will submit the manuscript to a peer-reviewed journal, for maximum dissemination of the information.
The Risk Communication workshop was the first in a series of three planned workshops on risk. During the next year, additional workshops will be held on the topics of risk assessment and risk management.
As Campbell says, "This clearly is an opportunity where CERTs leadership can contribute to improved pharmacotherapy and health outcomes at a national level."