Docket Management
Docket: 02N-0528 - Risk Management; Public Workshop
Comment Number: EC -6

Accepted - Volume 2

Comment Record
Commentor Dr. Gary Stein Date/Time 2003-04-28 14:53:48
Organization American Society of Health-System Pharmacists
Category Association

Comments for FDA General
1. General Comments The American Society of Health-System Pharmacists (ASHP) is pleased to provide comments on the Food and Drug Administration's (FDA?s) March 7, 2003, Federal Register notice requesting comments on the agency's concept papers on risk assessment and risk management. 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 commends the FDA for calling the April 9-11 public workshop to receive input on the agency's approach to risk assessment, risk management, and pharmacovigilance of prescription drugs prior to the agency issuing the risk management guidance documents that are mandated by the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 that reauthorized the Prescription Drug User Fee Act (PDUFA 3). ASHP's members are particularly interested in the guidance the agency intends to provide industry relating to premarket risk assessment and risk management programs. FDA Concept Paper on Premarketing Risk Assessment Section III(F) of this concept paper discusses how drug sponsors can minimize medication errors. Specifically, this section states: Ideally, a sponsor would conduct a risk assessment to ensure that a product's proprietary name, established name, container label, carton labeling, package insert, and/or packaging do not inadvertently contribute to medication errors. For example, a sponsor could perform a medication error prevention analysis or MEPA to . . . minimize the potential for an error through corrective action including renaming, relabeling or repackaging. The concept paper goes on to state that sponsors should assess a product's name, labeling, and packaging by obtaining first-hand information from physicians, pharmacists, nurses and consumers. This sponsor-initiated assessment would help to minimize medication errors and help speed FDA?s review of these issues. ASHP welcomes and strongly supports inclusion of this language in the FDA's anticipated guidance document relating to premarket risk assessment, and we urge the agency to quickly implement this concept. We have been encouraging FDA to do this for a long time: In September 1998, we stated at an FDA Health Professional Organization meeting that drug naming, packaging, and labeling was a critical, issue that had not been adequately addressed by the FDA, despite the fact that there had been abundant evidence that poor product design is a major contributing factor in medication errors. At a meeting in February 1999, we stated that one solution to the problem of medication errors stemming from poor package design and nomenclature is to require real-life submissions from the pharmaceutical industry prior to drug approval, and that before the FDA approves any new drug or biological product it should require manufacturers to document that it has rigorously tested all packaging, naming, and labeling for their potential to induce errors. This testing should be done using proven methods involving practicing pharmacists, physicians, and nurses in simulated work environments. In May, 1999, we commented that the FDA has an obligation to quickly review and revise its procedures to eliminate medication errors that occur due to look-alike and sound-alike names, similarities in packaging, and other labeling and packaging problems. We also noted that patients should be considered the partners of health professionals in eliminating medication errors, and they should be involved in providing input into the safety design of drug product labeling. We are pleased that the FDA concept paper includes a provision for patient/consumer input. In January 2002, in comments to the agency on its performance goals for the reauthorization of the Prescription Drug Marketing Act, we stated that the most consistent message ASHP hears from its members is that the FDA should be doing more to assure that drugs are safe for patients, and that safety issues must be anticipated through premarket evaluation. One specific, new performance goal that we recommended was for the FDA to engage pharmacists, physicians, nurses, and human factors experts in documented failure-mode-and-effects analyses of prospective product nomenclature and labeling to minimize the opportunities for sound-alike names and look-alike packaging for causing medication errors. ASHP believes that the FDA's risk assessment concept paper takes the right approach to this serious public health issue. We were particularly encouraged by the fact that a representative of the Pharmaceutical Research and Manufacturers Association (PhRMA) who commented from the floor at the April 9 session stated that PhRMA supports the FDA's goal of requiring the drug industry, rather than the agency, to undertake such premarket risk assessment. FDA Concept Paper: Risk Management Programs ASHP has a long-standing commitment to helping pharmacists help patients manage the risks inherent in prescription and nonprescription medication use, and we recognize that the FDA has the same commitment, particularly in regard to newer, higher risk drugs. Many of the risk-management plans developed by the FDA in cooperation with drug manufacturers that have been implemented in recent years fall short of what is needed to manage risk, because they lack the proper collaborative patient care efforts of all health care providers who are involved in the medication use process. We are pleased that the FDA's risk manageent concept paper addresses the need for such collaboration. First and foremost, there needs to be a fundamental reform in prescription drug labeling. Current package inserts and dear health professional letters are not adequate. Current labeling does not present information on a drug's safety, efficacy, or risks vs. benefits that is oriented toward a practice environment. ASHP suggests that the FDA, in consultation with health care practitioners, develop, as adjunct labeling for high risk drugs, a core protocol ? basically a check list -- that progresses from diagnostic workups to prescribing decisions based on the interpretation of those workups. Adherence to such a protocol would help influence practitioners? decisions to prescribe or not prescribe medications, based on patient selection criteria and interaction liabilities of one medication with other drugs or disease states. This type of protocol would include proper patient counseling and provision of written patient information. ASHP believes that the development of this new paradigm is imperative for an appropriate patient care process in all settings -- and for all health care providers -- to ensure appropriate patient selection, appropriate prescribing, and appropriate patient monitoring. Currently, physicians and pharmacists often are not systematically caring for patients because they are not coming from the same basis of information. A standardized protocol, as we envision it, is a viable tool for drug risk management. It could be the basis for a collaborative drug therapy management relationship between prescribers and pharmacists that is clearly in the best interest of patients. We believe that the FDA is taking a step in the right direction when, in Section II(D) of its concept paper, it suggests as a goal for a risk management program judicious patient selection for therapy and appropriate prescribing and dispensing to the appropriate patient group. The second point that we would like to make about risk management programs relates to restricted drug distribution systems, one of the tools that the FDA has been relying on more and more frequently to manage the risk of new drugs. Increased reliance on restricted, closed, or limited drug distribution systems for new, high-risk drugs is a growing concern among ASHP's members. These systems often exclude individual hospital as well as community pharmacies from distributing medications directly to patients. While a number of drugs have been relegated to restricted drug distribution systems, neither the FDA nor drug manufacturers have come forward with information on how well these systems work. We hope that the survey of pharmacists, to find out how risk management programs affect the practice of pharmacy, that the FDA announced in the Federal Register in February will answer some of these concerns. Pharmacists are responsible for ensuring that medications are readily available for patients who need them and that these medications are being used properly. Disruptions and non-standardized distribution processes create procedural confusion for pharmacy and other hospital staff and increase the potential for mistakes. Any restricted distribution or special handling procedure that disrupts that central oversight role of pharmacists represents an interruption in standard medication-use policies and procedures in the health-system setting. In November of 2000, and again in January of last year, ASHP has drawn the FDA's attention to this issue. We have suggested that when a manufacturer implements a restricted distribution of a drug product, the FDA should obligate the company to ensure that a patient's usual pharmacist relationship is not disrupted. ASHP also 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. Open hearings, at which pharmacists can express their views concerning the design of such a system and the impact those systems may have on the safety and effectiveness of patient care, may be one mechanism to accomplish this. Pharmacists must lead, balance, and manage all the considerations (including safety considerations) about drug distribution. Any distribution process that bypasses pharmacist control or requires exceptional procedures in such settings would be contrary to the best interest of patients. ASHP's members recognize that, despite this general principle and goal of standardization, some exceptions will inevitably have to be made in a patient's best interests. An important point, however, is that these should truly be extraordinary exceptions. The prospect of multiple, unique restrictive drug distribution systems is a frightening picture for pharmacists. Deviations that are unique and that greatly differ from standard practices create obstacles in delivering and administering medications safely. The patient-pharmacist relationship should not be misinterpreted as merely a product distribution function. The pharmacist's minimum responsibility is to assess the overall appropriateness of all medications with regard to purpose, dosage, and drug/food interactions; patient education and counseling; and adherence or compliance. Patient-pharmacist relationships in which this level of care is achieved depend on mutual trust, the pharmacist's thorough awareness of the patient's overall medication use, and the pharmacist's actions to ensure the timely supply of drug products. Restricted distribution systems that limit the pharmacist's ability to develop these relationships are disruptive. Restricted drug distribution systems that involve physician-to-patient delivery prevent pharmacists from providing medication appropriateness, dosage and interaction checks, patient education and counseling, monitoring, and follow-up evaluation. Thoughtful consideration needs to be given to the fact that some of these medications may be initiated or continued for hospitalized patients. Hospital pharmacies may not be able to acquire these medications in a timely manner. This has an adverse effect on patient care and cost. Restricted distribution systems make it difficult for hospital pharmacies to acquire these drugs through their normal supplier channels. This pulls resources from hospital systems that are already stressed. ASHP believes that, rather than unique drug distribution schemes, the FDA, in consultation with stakeholders including pharmacists, should develop models for managing patients for whom any high-risk drug product might be indicated and prescribed that incorporate core protocols. These models should focus on requirements for ensuring appropriate use and monitoring, such as patient work-up and selection, provider and patient education, and patient monitoring. Such a system could answer a number of our concerns about important issues such as uniformity of procedures for patient selection, what kind of distribution systems are most supportive of continuity of care, and what kinds of approaches best serve provider and patient education. ASHP appreciates this opportunity present its comments on the FDA's proposed approach to risk assessment and risk management programs, and we look forward to commenting on the draft guidance documents the agency intends to issue this fall. Feel free to contact me if you have any questions regarding our comments.

EC -6