Mandatory monitoring for side effects: the ''bundling'' of clozapine

Article Abstract:

Clozapine (trade name, Clozaril) is a drug that was released in 1990 in the US with a mandatory distribution and monitoring system; in marketing jargon, a ''bundle''. Clozapine's bundle costs $172 per week. The drug is prescribed for schizophrenia and, hence, must be taken continuously, costing $9,000 each year. The problems associated with the drug, affordable only for a few, are reviewed. Clozapine seems to control schizophrenic symptoms better than neuroleptic drugs (the conventional approach), but it can cause agranulocytosis (a dramatic lowering of the white blood cell count). This condition may develop quickly with clozapine, and has been responsible for fatalities in Europe, though not in the US. The Food and Drug Administration mandated that the white blood cell count of users must be monitored closely; in response, the drug's manufacturer, Sandoz, set up the Clozaril Patient Monitoring System (CPMS), which administers a weekly blood test to each patient. If patients do not give blood, they do not receive their next week's supply of clozapine. This is the only drug for which bundling is used, and all blood tests are performed by two private, for-profit companies, which have contracts with Sandoz. Whether CPMS is better than other resources that already exist for patient monitoring remains to be seen. Certainly, it inflates the cost of clozapine: in Europe, without the CPMS, the cost is approximately $20 per week. If effective monitoring could be performed by other agencies, the price would sink. If, however, less effective monitoring were performed, and patients began to die, at what point would the gains not justify the risk? Unfortunately, the litigious climate of the US encourages Sandoz to want to reduce its liability by a strategy such as the CPMS. At the same time, it is in the company's interest to monitor clozapine users effectively. To unbundle the drug, Sandoz would need protection against major lawsuits, possibly by federal statute. The drug could be administered and patients monitored through approved distribution centers. Bundling is likely to become more widespread as new drugs are developed, but decisions regarding new drugs should be made by health professionals, the FDA, the manufacturer, and the public (who ultimately pay for the drug), not in the context of closed discussions, as was the case for clozapine. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Economic aspects, Marketing, Sandoz Ltd.

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Clozapine - deciphering the risks

Article Abstract:

Treatment with the antipsychotic drug clozapine may cause neutropenia in some patients. Neutropenia is a decrease in blood levels of neutrophilic white blood cells. Clozapine may cause both a mild to moderate neutropenia and a more severe form called agranulocytosis. Agranulocytosis is characterized by a marked decrease in the number of granulocytes and by lesions of the throat and other mucous membranes, gastrointestinal tract and skin. Patients usually require between two to three weeks to recover from agranulocytosis and have a risk of developing serious complications. Clozapine can also cause other types of blood disorders. The cause of these side effects is not known. Metabolism of clozapine may produce a substance that is toxic to blood cell precursors or that interferes with immune system processes. Patients treated with clozapine are usually evaluated once a week for different blood disorders.

Editorial

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Clozapine-induced agranulocytosis: incidence and risk factors in the United States

Article Abstract:

The antipsychotic drug clozapine may cause agranulocytosis in some patients. Agranulocytosis is characterized by a marked decrease in the number of granulocytes and by lesions of the mucous membranes, the gastrointestinal tract and the skin. Among 11,555 patients who were treated with clozapine between Feb 1990 and Apr 1991, 73 developed agranulocytosis and two died from infectious complications of agranulocytosis. Sixty-one patients with agranulocytosis developed the condition within three months of beginning treatment with clozapine. The risk of developing agranulocytosis dropped with the duration of treatment. Older patients and women had a higher risk of developing agranulocytosis than other individuals. Patients treated with clozapine should be monitored closely for the development of agranulocytosis and other disorders.

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