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ASHP Statement on Restricted Distribution of Prolastin

The American Society of Health-System Pharmacists (ASHP) believes that the Bayer Direct™ program for distribution of Prolastin to patients with alpha1-antitrypsin deficiency has seriously compromised the ability of pharmacists in health systems to care for their patients.

ASHP strongly objects to (1) the extremely short time allowed for patients to transition to the Bayer Direct program without the capacity for health care practitioners and patients to assess the appropriateness and practicality of this program for each patient, and (2) the exclusive distribution system for Prolastin through Express Scripts as part of the Bayer Direct program. 

ASHP believes that the healthcare needs of many patients are not being met adequately during the transition period. The letters and related communications informing health professionals that as of October 31, 1999, Prolastin would only be available from Bayer Direct were dated October 26, 1999. Many providers did not receive notification of this change until the first week in November. This short transition period was not in the best interest of patient care, as patients did not have adequate time to make arrangements for their future drug therapy. All parties would have benefited from a longer transition period and more notice of the impending change. 

The exclusive distribution system established by Bayer raises serious questions in light of the following longstanding ASHP policy: 

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: 

  • The requirements are based upon scientific evidence fully disclosed and evaluated by physicians, pharmacists, and others;  
  • There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care;  
  • 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 duplicate costs are avoided;  
  • All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients; and,  
  • The requirements do not interfere with professional practice of pharmacists, physicians, and others.

Several senior management staff members at Bayer and Express Scripts have indicated to ASHP staff in telephone conversations that the Bayer Direct program was established to address concerns related to the limited supply of Prolastin and the difficulties that some patients have had in obtaining the product. While these are problems worthy of attention, ASHP urges Bayer to reexamine this initiative and pursue options that would address these concerns while preserving the traditional drug distribution system. The standard distribution system enables all qualified pharmacists to obtain and provide needed medications and related advice for their patients. ASHP continues to believe that the optimum way for pharmacists to help patients make the best use of medications is to make those services as widely available and accessible as possible. 

In addition to numerous phone conversations with Bayer senior management, ASHP has sent a letter to David R. Ebsworth, Ph.D., executive vice president, Bayer Corporation, and is pursuing a meeting with Bayer representatives to discuss this issue and examine options to best serve patients' needs. 

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, ambulatory care centers, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. One of the largest component groups within ASHP is the Section of Home Care Practitioners, which is comprised of pharmacists who manage the infusion-related needs of patients in the home and alternate-site settings. ASHP believes that the mission of pharmacists is to help people make the best use of medications. Assisting pharmacists in fulfilling this mission is ASHP's primary objective. 

[ Please see ASHP's 2/9/2000 update to this alert about the restricted distribution of Prolastin.]