Docket Management
Docket: 02N-0115 - Risk Management of Prescription Drugs; Public Hearing
Comment Number: EC -7

Accepted - Volume 1

Comment Record
Commentor Dr. Gary Stein Date/Time 2002-06-21 08:33:16
Organization American Society of Health-System Pharmacists
Category Association

Comments for FDA General
1. What improvements are needed to enhance communication about safety issues for drugs? What improvements are needed to communicate information about the efficacy of drugs? First and foremost, there needs to be a fundamental reform in prescription drug labeling. Current package inserts and ?dear health professional? letters do not adequately communicate risk information or prevention. 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 education and monitoring. Currently, most physicians and pharmacists are not systematically dealing with patients because they are not relying on the same basis of information. A standardized protocol, as we envision it, is a viable tool for drug risk management communication. It should be the basis for a collaborative drug therapy management relationship between prescribers and pharmacists that is clearly in the best interest of patients.
5. What methods should FDA be using to manage risk? What new tools can be created to better address specific drug risks? One of the ?tools? that the FDA has been relying on more and more frequently to manage the risk of new drugs is a restricted drug distribution system. 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 consigned to restricted drug distribution systems, neither the FDA nor drug manufacturers have come forward with information on how well these systems work. An analysis of current restricted drug distribution systems is warranted. 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 or omits the central oversight role of pharmacists represents an interruption in standard medication-use policies and procedures in the health-system setting. Disruptions such as these can be set-ups for error. In November of 2000, and again in January of this 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. Colored ?sticker? systems that have recently been put into place for some high-risk drugs (e.g., Accutane and Lotronex) were not designed with hospital systems in mind. The manufacturer of Accutane admitted as much in conversations with ASHP. Because of the variety of procedures and ordering systems used in hospitals by physicians to enter orders and the different procedures and systems for transmitting orders to the pharmacy, the sticker system designed for affixing to the single handwritten prescription blank for ambulatory patients just won't work in hospitals.
8. Evaluation of Risk Management Strategies and Interventions: What risk management interventions should be studied for effectiveness? What criteria should be used to judge if a risk management intervention is effective? 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. Unfortunately, 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. In its April 15 Federal Register notice, the FDA asks what risk management interventions should be studied for effectiveness. To date, we know of no restricted drug distribution system, including the yellow sticker program for Accutane, that has been studied to determine whether any of these systems are effective in reducing risks to patients. ASHP is, therefore, extremely concerned about the risk management system that was recently put into place for the renewed approval of Lotronex. As with the previous risk management program for Accutane, under the new Lotronex program, pharmacists will be asked to fill only prescriptions that display a prescribing program sticker affixed by an enrolled physician who has self-attested that he/she can diagnose and treat Irritable Bowel Syndrome and its complications, agrees to educate patients on the risks/benefits of Lotronex treatment and provide patients with medication guides, and will affix program stickers to all prescriptions for Lotronex. At the April 23, 2002, joint meeting of the FDA?s Gastrointenstinal Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science that considered the reapproval of Lotronex, members ? particularly pharmacist members ? of the Drug Safety and Risk Management Subcommittee were highly skeptical of a ?sticker? risk management program for Lotronex. These advisory committee members believed that a risk management program based on the use of colored stickers was cumbersome, outside the appropriate scope of current pharmacy practice (both inpatient and outpatient), and did not rely on the cognitive and clinical skills of pharmacists. Some members of the Gastrointestinal Drugs Advisory Committee also agreed that the colored sticker system is unmanageable. The agency certainly did not take the advice of the experts on its advisory committees when it decided to proceed with such a risk management program for Lotronex. When ASHP questioned the FDA about the renewed use of a ?sticker? risk management system for Lotronex, we were told that there is currently no alternative to such a system that would adequately inform dispensing pharmacists that the prescriber of the drug had met the required qualifications of the risk management system. It was noted that, in the future, there might be a global database of qualified prescribers that pharmacists could check to confirm a prescriber?s qualifications, but no such system currently exists. ASHP believes that, rather than unique drug product distribution schemes, the FDA, in consultation with stakeholders including pharmacists, should develop models for Dockets Management Branch (HFA-305) managing patients for whom any high-risk drug product might be indicated and prescribed that incorporate core protocols. At the April 23 advisory committee meeting about Lotronex several of the committee members advised the FDA to hold a separate risk management meeting to discuss standard ways to approach risk management for high-risk drugs. Models of risk management programs 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 serve best for provider and patient education.

EC -7