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Executive Summary

SANDOZ' CLOZARIL PATIENT MANAGEMENT SYSTEM (CPMS) OPPOSED by the American Society of Hospital Pharmacists (ASHP) and the Joint Commission of Pharmacy Practitioners (JCPP) in separate letters to the company. The pharmacy groups' objections are based on the program's proposed distribution system, which would exclude pharmacies. In a Dec. 19 letter to Sandoz CEO Jacques Rejeange, ASHP Executive VP Joseph Oddis said the patient management system "would deny most ambulatory patients the benefit of contact with their individual pharmacist in obtaining Clozaril (clozapine) and related pharmaceutical services." Under the patient management system for the antipsychotic drug, scheduled for launch on Feb. 1, a visiting nurse or other qualified personnel will take patient blood samples weekly and dispense one week's supply of the drug only after results show a normal white blood cell count. The program was designed to manage the risk of agranulocytosis. Clozaril was approved Sept. 6 for the management of severely ill refractory schizophrenic patients ("The Pink Sheet" Oct. 9, p. 3). ASHP "strongly" urged Sandoz "to abandon the current plan for the CPMS." The association suggested that "Clozaril be distributed through the traditional system that allows patients the freedom and benefits associated with receiving medications from their personal pharmacists." Oddis said ASHP was concerned that an institution's ambulatory patients will not receive "adequate patient education and counseling through the proposed CPMS when product distribution is outside of the institution's control." For example, ASHP queried, if Clozaril is dispensed through Sandoz and contractee Caremark Homecare, will "unsolicited patient education/counseling be provided on an individual patient basis each time the prescription is dispensed?" The society also predicted that the caseworker delivering the medication to the patient under the proposed program will most likely be a phlebotomist. "Therefore, even if patient education/counseling is offered, in many cases, it seems probable that it will be provided by someone with no pharmacy training," ASHP said. In a Dec. 4 letter, JCPP maintained that Sandoz has not "given appropriate consideration to the public health advantages of keeping the patient's pharmacists in the Clozaril-therapy process." JCPP pointed out that "it is not too late" to correct "this proposed change in the American public's medication distribution system."

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