kidney toxicity risk. In all likelihood, this is a direct result of the change in clinical practice,” Mr. Katz said.
In 2004, IMF again became involved in patient education about potential adverse events associated with zoledromic acid after receiving notice of a high incidence of osteonecrosis of the jaw in patients taking the drug. A web-based survey of myeloma and breast cancer patients conducted in July 2004 by the IMF identified a time-dependent risk related to the drug (Durie et al., 2005).
Public education programs that raise public awareness and communicate tangible public benefit of improved adverse reporting systems are ways in which patient advocacy groups and even patients themselves can play a role in reducing adverse drug events (ADEs). The development of an improved infrastructure for consumer reporting will benefit from the increased input of those that the system was designed to serve.
MedWatch captures only a fraction of the adverse events that occur, leaving the total burden unknown. Alison Rein of the National Consumers League concluded that this is due, in part, to a lack of meaningful consumer engagement in this process and the fact that reporting mechanisms are divorced from routine practice. Dr. Marvin Lipman of Consumers Union stated: “For consumers to play a role, they need to be made aware of the importance of reporting adverse drug effects, not only to their physician and pharmacist, but also to a central body, the FDA.” Ms. Rein reported that MedWatch is not on the radar of most consumers and is not integrated into the health-care delivery system. She compared patient reporting within the current MedWatch system to the United Kingdom’s new yellow card system (see Table 4-1). This system is managed by the Medicines and Healthcare Products Regulatory Agency (MHRA) and performs safety surveillance. Each report, which is actually a yellow card, is acknowledged and registered upon receipt and then entered into MHRA’s Adverse Drug Reactions Database. Reports are assessed by health-care professionals in the Pharmacovigilance Group of the MHRA Post Licensing Division. This assessment includes the use of data from other sources such as pre- and postclinical trials, case reports in the medical literature, data from other drug regulatory agencies, epidemiological studies, and record linkage databases. The Committee on Safety of Medicines and its Subcommittee on Pharmacovigilance advise MHRA on potential safety issues and appropriate regulatory actions.
The yellow card system allows consumers to report online, by prepaid mail, and by phone. Translation services are available for those who are