SANDOZ CLOZARIL MONITORING SYSTEM WILL USE TWO PHARMACISTS

SANDOZ CLOZARIL MONITORING SYSTEM WILL USE TWO PHARMACISTS "in most cases as an additional precaution," CEO Jacques Rejeange said in a Feb. 15 letter to American Pharmaceutical Association Exec VP John Gans. The decision to include two pharmacists "is a direct result of the helpful guidance provided by APhA and others in the JCPP [Joint Commission of Pharmacy Practitioners]," Rejeange pointed out, as well as an effort to "[enhance] the role of pharmacy within the system." The addition of pharmacists to the Clozaril Patient Monitoring System (CPMS) appears to be a conciliatory gesture towards the pharmacy community, which has objected vigorously to the distribution plan that would preclude distribution through the patient's individual pharmacist. Pharmacy organizations that have sent letters to Sandoz opposing the system include the American Society of Hospital Pharmacists, JCPP ("The Pink Sheet" Jan. 8, T&G-2), APhA and NARD. The patient monitoring system was designed to manage the risk of agranulocytosis for patients on the antipsychotic drug clozapine. Weekly blood tests are drawn by a health care professional, such as a nurse, who will dispense one week's supply of the drug conditional upon a normal white blood cell count. The CPMS program is being conducted by Caremark Homecare, under contract with Sandoz. Clozaril was approved for the management of schizophrenic patients refractory to other treatments. Sandoz launched the product Feb. 1. Under the revised system, two pharmacists will be involved in distributing Clozaril for both inpatients and outpatients. For inpatients, a Caremark pharmacist will dispense the drug to the hospital. A hospital pharmacist, in turn, will dispense the drug to the patient. Once the patient is released from the hospital, Caremark will ask the patient to identify his or her personal pharmacist, who will have a modest role as an advisor on drug-to-drug interactions. The local pharmacist, however, will not actually dispense the drug. Sandoz will give the pharmacist a one time retail fee of $25 for his or her services and provide the pharmacist with information on the patient's treatment regimen. Rejeange's letter was sent in response to a Feb. 7 letter from Gans that charged, "the rationale for CPMS is based on the economic advantages inherent in the system" rather than patient welfare. Gans noted that the estimated charge per patient for the service is $9,000 per year. APhA said the program constitutes an "artificial system of drug prescribing, distribution and monitoring, which supplants the societally sanctioned roles of pharmacists and physicians by using 'case managers' and phlebotomists." The Sandoz CEO tried to "reassure [APhA] that CPMS represents a unique approach to a unique situation...and it is extremely unlikely that we will require such a delivery system in the future." However, Caremark is reportedly seeking to build on the Clozaril experience by providing services for other drugs with special distribution needs. Caremark has also had a long-standing distribution agreement with Genentech covering the company's human growth hormone, Protropin (somatrem).