Docket Management
Docket: 03N-0017 - Impact of Risk Management Programs on the Practice of Pharmacy; Agency Information Collection
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Dr. Gary Stein Date/Time 2003-04-14 13:41:33
Organization American Society of Health-Sysetm Pharmacists
Category Association

Comments for FDA General
5. General Comments The American Society of Health-System Pharmacists (ASHP) is pleased to provide comments on the Food and Drug Administration's (FDA's) February 12, 2003, Federal Register notice requesting comments on the agency?s survey of pharmacists to evaluate their knowledge of risk management programs, identify the barriers that pharmacists might encounter in complying with these programs, and assess the impact of these programs on pharmacy practice. ASHP is the 30,000-member national professional and scientific association that represents pharmacists who practice in hospitals (including outpatient services), health maintenance organizations, long-term care facilities, home care agencies, and other components of health care systems. ASHP has long encouraged the FDA to include practicing pharmacists in the development of programs designed to address safety issues associated with high-risk drugs. Most recently, in comments to the agency at the FDA public workshop on risk management on April 10, 2003, we noted that although the agency and ASHP have the same long-standing commitment to helping pharmacists help patients manage the risks inherent in prescription and nonprescription medication use, many of the risk-management plans that have been implemented in recent years fall short of what is needed to manage risk. They fall short because they fail to integrate collaborative patient care efforts of all health care providers who are involved in the medication use process. We also noted that there is little information available concerning the success or failure of restricted drug distribution systems that are currently being implemented. ASHP has often recommended that, if a restricted distribution system is being considered by the FDA as a condition for marketing approval, practicing pharmacists and professional pharmacist societies should be consulted before any restricted distribution requirements are imposed on the product to help determine the impact those systems may have on the safety and effectiveness of patient care. ASHP supports the FDA's proposed survey of pharmacists, and we are particularly pleased that the agency recognizes that pharmacists in health-system settings (inpatient and outpatient hospital, ambulatory clinics, long-term care facilities) could be impacted by risk management programs and are included in the survey question about practice settings. Although the FDA intends to send its survey to a random sampling of 5,000 pharmacists, we urge the agency to ensure that pharmacists in these settings are included. ASHP believes that the survey questions are appropriate, and we have only minor comments on specific questions: Question 5. Have you ever received a prescription for a medication that required a special sticker, but the sticker was missing? The colored sticker system of restricted distribution has only been implemented for a short time, but we believe that the words or forged should be added after missing. Question 7. In your opinion, how helpful is the special sticker as a communication tool between physicians (prescribers) and pharmacists? Because many health care practitioners, other than physicians, can prescribe drugs, we believe that the word physicians should be removed from this question. It should only read prescribers. The risk management program for Accutane uses only the term prescribers. ASHP also believes that the survey should contain questions regarding how pharmacists monitor patients who receive high-risk drugs through current risk management programs. We are prepared to assist the agency in developing these questions. ASHP appreciates this opportunity present its comments on the agency's proposed survey of pharmacists to the FDA. Feel free to contact me if you have any questions regarding our comments.

EC -2