The Pharmaceutical Journal
Vol 268 No 7204 p895-899
29 June 2002

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CSM should consider implications for all patients when issuing directives

Psychopharmacologists and psychiatrists caring for people with learning disabilities have called on the Committee on Safety of Medicines to take more account of the adverse effects of changing or discontinuing drugs when issuing directives.

The call comes in a BMJ paper (2002;324:1519) that recounts the difficulties experienced by seven of 18 patients with learning difficulties who stopped taking thioridazine after the CSM restricted its use to patients diagnosed with schizophrenia because of fears about cardiovascular toxicity (PJ, 16 December 2000, p877).

Four of the seven patients had psychotic symptoms after substitution of an alternative antipsychotic, one patient was admitted to hospital suffering from neuroleptic malignant syndrome and one would not start an alternative drug. Two more patients who had been well for some time on low doses of thioridazine had acute behavioural disturbances on stopping without substitution of another drug.

The authors of the paper argue that although doctors remained free to prescribe the drug outside the changed indication, difficulties in obtaining informed consent from people with learning disabilities meant that many were reluctant to do so.

"In the culture in which we practise, it is difficult to continue prescribing thioridazine in the patient's 'best interest' in circumstances where the CSM has specifically stated that the balance of risks and benefits is unfavourable," they write.

A spokesman for the CSM said it issues advice restricting the use of a medicinal product in response to safety issues only where the risks of adverse effects outweigh the benefits for that population, and after consultation with experts in the field.

The CSM said that doctors are free to prescribe medicines outside the licensed indication if they consider it is in the patient's best interests to do so. "However, if a clinician does prescribe in this manner they are responsible for the patient's care and the consequences of the treatment."