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ASHP Contacts FDA Commissioner About Pharmaceutical Companies' Restricted Distribution Systems

Jane L. Miller

ASHP recently notified Food and Drug Administration (FDA) Commissioner Jane E. Henney of its concern about the recent increase in the number of medications available to patients only through restricted, closed, or limited distribution systems. The Society recommends that FDA require pharmaceutical companies with these distribution systems ensure patients continue to receive the protective efforts of a pharmacist of their choice and that the agency consult with practicing pharmacists, professional pharmacist societies, and patient before approving the marketing of a pharmaceutical with a restricted distribution system.


November 16, 2000

Jane E. Henney, M.D.
Food and Drug Administration
Parklawn Building, Room 14-71
5600 Fishers Lane
Rockville, Maryland 20857

Dear Commissioner Henney:

I would like to take this opportunity to express the American Society of Health-System Pharmacists' (ASHP) concern over pharmaceutical manufacturers' increasing reliance on restrictive systems to distribute their products. ASHP is the 30,000-member national professional 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.

There has been a substantial increase in the number of new pharmaceuticals that are available only through restricted, closed, or limited distribution systems over the last few years. These systems often exclude individual hospital as well as community pharmacies from distributing medications and use other means of distribution to deliver medications directly to patients, either through a central mail-order pharmacy, a patient's physician, or through the manufacturer itself.

Reasons given for the use of restricted delivery systems include ensuring that the use of medications with high risks for adverse effects are monitored; that specific medications are prescribed or dispensed only by professionals with verified education and training to ensure appropriate patient selection, medication use, and patient safety; and that patients receive medications through some type of allocation process when the medications are in limited supply for various reasons, including problems with the availability of raw material or manufacturer problems in complying with good manufacturing practices. ASHP is concerned that in some cases the drug product sponsor has implied that a restricted system was mandated by the Food and Drug Administration (FDA) as a condition for approval. While we believe that this is true in some cases, in others it is not.

Cisapride (Propulsid), dofetilide (Tikosyn), alpha-1-proteinase inhibitor (Prolastin), antihemophilic factor (recombinant) (Kogenate FS), and mifepristone (Mifeprex) are examples of medications that have been placed in restricted drug distribution systems for various reasons.

ASHP knows that you understand that pharmacists in hospitals and similar health systems are professionally responsible for all medication-use matters, including medication-use safety in their settings. Therefore, pharmacists are responsible for controlling the entry of every drug product into the setting, the quality and integrity of every drug product used, and ensuring an ongoing supply of drug products for patients. Any restricted distribution or special handling procedure that disrupts that central oversight represents an interruption in standard medication-use policies and procedures in the health-system setting. Disruptions and non-standardized distribution processes are not trivial matters; they create procedural confusion for pharmacy and other hospital staff and increase the potential for mistakes.

While restricted distribution systems for individual drugs may have a safety intent, they paradoxically also represent corresponding safety threats in complex health-system settings. Pharmacists must lead, balance, and manage all the considerations (including safety considerations) about drug distribution in these settings. 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 a landscape of many different special handling processes is a frightening picture for health-system pharmacists.

ASHP is also concerned about patient confidentiality in restricted distribution systems. There is a potential for conflict between the marketing goals of manufacturers and the safety goals of the FDA and pharmacists that is inherent in patient registries and distribution systems that bypass pharmacists. This could, perhaps, even extend to manufacturers illogically contending an obligation to know the names of patients receiving all of their products. This is a slippery slope that the FDA should watch very carefully.

Because of our members' concern about patient safety and continuity of care, this issue was discussed by two of ASHP's policy-recommending councils—the Council on Professional Affairs and the Council on Legal and Public Affairs—when they met in September. The councils discussed the challenges to patients and pharmacists participating in their care presented by restricted drug distribution systems. In some systems, patients are forced to obtain their medications from a source other than their usual pharmacy, thus disrupting the traditional pharmacist-patient relationship and completeness of medication profiles that can help prevent many patient-safety risks.

The patient-pharmacist relationship should not be misinterpreted as merely a product distribution function. Overall drug therapy surveillance and management, including all the drugs the patient uses—including therapy with drug products from multiple manufacturers—is the pharmacist's role and goal. 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 impose other pharmacists into that relationship 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.

Another flaw in the restricted distribution mechanism is that, in some cases, little consideration has been given to the fact that some of these medications may be started or continued for hospitalized patients. Rarely is provision made for hospital pharmacies to acquire these drugs through their normal supplier channels that are outside of the restricted distribution system. For instance, the information made available for Tikosyn states that:

A list of all confirmed participants of a TIKOSYN educational program will be maintained. The drug will be available from a special mail order pharmacy, which will verify prescribers and hospitals against this list before TIKOSYN is shipped to patients or hospitals.

This requirement puts an unnecessary burden on hospitals, as well as physicians and patients. The former may receive patients who are taking the drug, but may not be able to continue the therapy, while the latter may have to utilize institutions that are not of their choice, merely because they have taken part in the educational program.

Often, manufacturer requirements are confusing. In the Tikosyn example, again, the approved labeling states that "TIKOSYN is distributed only to those hospitals and other appropriate institutions confirmed to have received applicable dosing and treatment initiation education programs." Some of our members have received an "Education Confirmation Form for Institutions" from the manufacturer, but there is no indication as to what institution official is supposed to confirm that staff (nurses, pharmacists, and physicians) have received the appropriate education.

In addition to the negative impact on patients, restricted drug distribution systems may affect pharmacists and their health systems through increased liability, improper use of centrally collected patient data, and provision of services for which reimbursement mechanisms do not exist.

ASHP's Council on Legal and Public Affairs and Council on Professional Affairs have recommended the following policy, which has been approved by ASHP's Board of Directors and is scheduled for ratification by our House of Delegates at our Annual meeting in June 2001:

To reiterate support for the current system of drug distribution in which prescribers and pharmacists exercise their professional responsibilities on behalf of patients; further,

To acknowledge that there may be limited circumstances in which constraints on the traditional drug distribution mechanism may be appropriate if the following principles are met:

    1. The requirements do not interfere with the continuity of care for the patient;       
    2. The requirements preserve the pharmacist-patient relationship;       
    3. The requirements are based on scientific evidence fully disclosed and evaluated by physicians, pharmacists, and others;       
    4. There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care;       
    5. The cost of the product and any associated product or services are identified for purposes of reimbursement, mechanisms are provided to compensate providers for special services, and duplicative costs are avoided;       
    6. All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients;       
    7. The requirements do not interfere with the professional practice of pharmacists, physicians, and others; further,

To strongly encourage pharmaceutical manufacturers and the Food and Drug Administration to consult with practicing pharmacists when they contemplate the establishment of a restricted distribution system for a drug product.

If a manufacturer wants a restricted distribution of a drug product, the FDA should obligate the company to ensure the ongoing protections of a pharmacist of the patient's choice. ASHP also recommends that, if a restricted distribution system is being considered by the FDA as a condition for marketing approval, practicing pharmacists, professional pharmacist societies, and patients should be consulted before any restricted distribution requirements are imposed on the product. Open hearings, at which patients and 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.

ASHP would appreciate hearing from you on this important issue. If you need further information, please call Gary Stein, Ph.D., ASHP Director of Federal Regulatory Affairs, at 301-657-3000, ext. 1316; e-mail


Henri R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President and Chief Executive Officer