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Vol 275 No 7358 p71
16 July 2005

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Consultation letter (Microsoft Word)
Draft guidance PDF (90K)


Pharmacies to make annual CD use declarations

NHS community pharmacies in England will have to make regular declarations to primary care trusts about Controlled Drugs under draft plans issued by the Department of Health last week. Private pharmacies will have to complete similar declarations and send them to the Royal Pharmaceutical Society.

The declarations will have to say whether or not CD stocks are held and will have to be accompanied by a self-assessment of any special circumstances that might explain any seemingly unusual patterns of supply.

Similar declarations and self-assessments will be required from all health care organisations that provide clinical services, including GP practices, and any relevant social care organisations.

Information gathered in this way will be combined with information from routine monitoring and reviewed annually to assess whether any additional monitoring or inspection is necessary.

In primary care, community pharmacies and GP surgeries will be subject to random inspections. In community pharmacy these will be carried out by Society inspectors, who will start to include CD inspections in a proportion of their routine pharmacy visits. Inspections in secondary care and the private and voluntary sectors will be the responsibility of the Healthcare Commission. Care homes will continue to be inspected by the Commission for Social Care Inspection.

Common standards for inspection visits have been developed by representatives of the Society, the Healthcare Commission, the CSCI, the police and the NHS in order to ensure consistency in the proposed new arrangements. The standards set out core activities that should be included in any inspection and cover such matters as safe storage and proper record keeping. Ten per cent of locations are to be inspected every year.

To maximise the effectiveness of the proposed new arrangements, the Government intends to place a statutory duty to share information about potential CD offences and system failures on inspection bodies together with health care organisations, the police, social services authorities and the National Clinical Assessment Service.

Information sharing is to be co-ordinated by primary care trusts, which will have to designate a senior staff member as an “accountable officer” responsible for monitoring the use of CDs and ensuring that appropriate action is taken if problems come to light.

A Scottish Executive spokeswoman said that the draft guidance would be considered and a decision made whether any action was necessary in Scotland. The same approach is to be taken in Wales. The DoH hopes to issue final guidance in the autumn — this consultation closes on 30 September — ready for implementation in 2006.

David Pruce, the Society’s director of practice and quality improvement, said: “The Society supports proposals to make the best use of the existing monitoring and inspection arrangements and is keen to ensure that any new arrangements support improvements in quality and practice and balance the need to strengthen controls with the need to ensure that patients can access the Controlled Drugs they clinically require.”

The draft guidance is accessible as a PDF file (90K).

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