Docket Management
Docket: 02N-0131 - Agency Information Collection Activities: Generic FDA Rapid Response Surveys
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. John Coster Date/Time 2002-07-01 14:56:27
Organization National Association of Chain Drug Stores
Category Association

Comments for FDA General
5. General Comments The National Association of Chain Drug Stores (NACDS) is pleased to provide comments to the Food and Drug Administration on the issue of FDA rapid response surveys. NACDS supports FDA’s goals of protecting public health, and activities that will produce the most valuable information about product safety and risk management. We believe that research is an important step in alleviating problems associated with products and devices. NACDS membership consists of nearly 200 chain community pharmacy companies operating over 33,000 community pharmacies. Collectively, chain community pharmacy comprises the largest component of pharmacy practice, with over 100,000 pharmacists. The chain community pharmacy industry is comprised of approximately 20,300 traditional chain drug stores, 8,300 supermarket pharmacies and 5,500 mass merchant pharmacies. Chain operated community retail pharmacies fill over 70 percent of the 3 billion prescriptions dispensed annually in the United States. NACDS believes that effective, timely, and consistent communication with professionals and patients is important for safe drug distribution and risk management. The notice describes the survey participants as “community based health care professionals.” Presumably, this includes pharmacists, but we suggest that this be specified. However, we strongly urge that these surveys be done periodically, and not be overly burdensome to pharmacists. The best response will be achieved if there are targeted questions, and the FDA works with and through the corporate chain management structure on these types of surveys. Chain community pharmacies are the primary and most frequent point of distribution for outpatient prescription drugs in the United States. In addition, pharmacists provide an easily accessible point of contact for patients. For many years, pharmacies have used computerized systems to check for potential drug-drug, and other drug related interactions. More than likely, pharmacists will be one of the first providers to recognize adverse reactions associated with prescription drugs. It is unclear whether the FDA intends to distribute and collect surveys once a problem has been discovered, or if distribution and collection of surveys will be done randomly without regard to a particular product or problem. The voluntary nature of the survey will inevitably have some rate of non-responsiveness, which could likely limit the amount of useful information that the FDA receives. Prior to distribution of the surveys, NACDS recommends making sample surveys available for public review and comment. As the major supplier of prescription drugs, NACDS is willing to work with the FDA to assure protection of public health and safety. We believe that pharmacies can provide the rapid response being sought by the FDA regarding potential safety or other issues relating to the use of prescription drugs. We suggest that these surveys be used only periodically so that they do not lose their importance and effectiveness, and that they not are overly time consuming or burdensome for any provider. We thank you for the opportunity to comment on this important issue. If you have any questions, please feel free to contact Sybil Richard at (703) 837-4221.

EC -2