§ Mr. BurstowTo ask the Secretary of State for Health, pursuant to his answer of 4 March 2002, on Medicinal Control,Official Report, columns 130–32W, whether the (a) MCA and (b) CSM have plans to publish articles relating to the inappropriate or overuse of anti-psychotic medication in care settings. [42629]
§ Ms Blears[holding answer 12 March 2002]: The Medicines Control Agency (MCA) in conjunction with its independent scientific advisory committee, the Committee on Safety of Medicines (CSM) is responsible for monitoring the safety of all marketed medicines to ensure that medicines meet acceptable standards of safety and efficacy. The nature of the clinical setting is not within the scope of CSM advice. However, if the balance of risks and benefits for a medicine when used in a particular indication or population is considered to be unfavourable MCA/CSM will not hesitate to take action to modify its use and to inform prescribers of this action.
For example the balance of risks and benefits for thioridazine in the following indications was considered unfavourable: anxiety, agitation and restlessness in the elderly, moderate to severe psychomotor agitation, violent and dangerously impulsive behaviour, mania/hypomania, and behavioural disorders and epilepsy in children. Upon advice from the CSM, in December 2000
1040W
NHS hospital admissions where there was a primary diagnosis of selected alcohol related disease, by NHS Regional Office area of treatment England, 1996–97 to 2000–01 Number of admissions Primary diagnosis (ICD10) England Northern & Yorkshire Trent Anglia & Oxford North Thames South Thames South West West Midlands North West 1996–97 F10 Mental and behavioural disorders due to alcohol 32,500 5,600 2,900 1,900 3,200 4,200 3,600 4,300 6,800 K70 Alcoholic liver disease 7,900 1,200 700 600 1,100 1,000 800 1,000 1,500 T51 Toxic effect of alcohol 2,300 500 200 200 200 300 200 200 500 1997–98 F10 Mental and behavioural disorders due to alcohol 34,400 5,400 3,700 2,100 4,100 4,900 3,500 4,300 6,500 K70 Alcoholic liver disease 9,000 1,300 800 700 1,200 1,100 1,000 1,200 1,600 T51 Toxic effect of alcohol 2,400 500 200 200 200 300 200 300 400 1998–99 F10 Mental and behavioural disorders due to alcohol 32,100 5,100 3,300 2,000 4,100 4,500 3,500 3,700 5,900 K70 Alcoholic liver disease 9,200 1,400 800 800 1,100 1,100 1,100 1,300 1,600 T51 Toxic effect of alcohol 2,000 500 200 200 200 200 300 200 300 1999–00 F10 Mental and behavioural disorders due to alcohol 32,300 5,000 3,100 3,700 6,000 2,100 5,900 3,800 2,700 K70 Alcoholic liver disease 10,100 1,400 1,000 1,300 1,900 800 1,600 1,200 900 T51 Toxic effect of alcohol 2,000 500 100 200 300 200 200 400 200 the use of thioridazine was restricted to the second line treatment of schizophrenia in adults. Health professionals were notified of this via a Dear Doctor letter and an article in the drug safety bulletin Current Problems in Pharmacovigilance. A copy of this article has been sent to the Library.