The Pharmaceutical Journal
Vol 270 No 7248 p638
10 May 2003

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Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)

OTC statins will depend on safety profile

Patient safety is the prime consideration in any decision to make statins available over the counter, public health minister Hazel Blears said this week.

In response to a written question in the House of Commons on 6 May, Ms Blears said: "The NHS plan set out the Government’s commitment to make more medicines available over the counter. The Medicines and Healthcare products Regulatory Agency has been proactively encouraging the pharmaceutical industry to consider which medicines might be suitable to make more widely available."

Ms Blears said that any application that was made to reclassify a statin would be considered against British and European guidance and would also be subject to public consultation.

"Patient safety is the prime consideration and any application would be required to demonstrate its safety in use and that relevant patient and professional education issues have been adequately addressed."