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Health: Drugs

Volume 716: debated on Tuesday 5 January 2010


Asked by

To ask Her Majesty's Government, further to the Written Answer by Baroness Thornton on 15 October (WA 30), how the Medicines and Healthcare products Regulatory Agency monitors the safety of benzodiazepines; and how they assess that monitoring. [HL912]

The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of all medicines in the United Kingdom and, where necessary, takes action to safeguard public health.

The Yellow Card Scheme, by which healthcare professionals and patients report suspected adverse drug reactions, enables signals of drug safety issues to be detected. In the light of evidence of dependence associated with benzodiazepine use, which emerged in the 1980s, regulatory action was taken to provide advice about limiting treatment duration, extensive warnings about the risks of dependence and advice on gradual withdrawal.

The MHRA uses other sources of data to support and clarify information from spontaneous reporting and the impact of regulatory action, including published research and drug safety studies. In evaluating these, the MHRA receives regular expert advice from its independent scientific advisory bodies, the Commission on Human Medicines and its Pharmacovigilance Expert Advisory Group.

Asked by

To ask Her Majesty's Government what plans they have for raising awareness among general practitioners of the risks of dependence on prescribed drugs. [HL913]

The department is currently conducting its review into addiction to over-the-counter and prescribed drugs, which is expected to report later in 2010. Any future advice to general practitioners will be based on the evidence and therefore we do not want to pre-empt the results of the review or any recommendations it may make at this point.

Any future guidance will build on previous advice provided to clinicians, such as guidance from the British National Formulary and National Institute for Health and Clinical Excellence in relation to safe prescribing of benzodiazepines and Z-drugs.