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NICE calls for safer use of controlled drugs

Guidance clarifies CD regulation and legislation for GPs and other prescribers

Louise Prime

Friday, 15 April 2016

The National Institute for Health and Care Excellence (NICE) has called for safer use of controlled drugs (CDs), in new guidance for GPs and other health and social care professionals that pulls together and clarifies the complex legislation, regulation and current advice on CDs’ prescription and management. It said following the recommendations in its guidance should help to minimise potential harms associated with this group of medicines.

NICE pointed out that according to a 2013 review* of medicines-related safety incidents in England and Wales, the risk of death with controlled drugs was far greater than with other medications. That report had found that five commonly used controlled drugs – morphine, diamorphine, fentanyl, midazolam and oxycodone – were responsible for 113 incidents (88.4% of all those reported) leading to death and severe harm, with overdose accounting for 89 (69.5%) of the 128 incidents of serious harm.

NICE urged doctors making decisions about prescribing controlled drugs to take into account the benefits of controlled drug treatment; the risks of prescribing, including dependency, overdose and diversion; all prescribed and non‑prescribed medicines the person is taking (particularly any centrally acting agents) and whether the person may be opioid naïve; and evidence‑based sources, such as NICE and the British National Formulary (BNF), for prescribing decisions when possible. It said prescribers should document clearly the indication and regimen for the controlled drug in the person’s care record; check the person’s current clinical needs and, if appropriate, adjust the dose until a good balance is achieved between benefits and harms; discuss with the person the arrangements for reviewing and monitoring treatment; and be prepared to discuss the prescribing decision with other health professionals if further information is requested about the prescription.

NICE emphasised that doctors should prescribe only enough of a controlled drug to meet the person’s clinical needs for up to – and no more than – 30 days, but if, under exceptional circumstances, a larger quantity is prescribed, the reasons for this should be documented in the person’s care record. It added that those prescribing controlled drugs outside general practice (for example in hospital or out-of-hours) must inform the person’s GP of all prescribing decisions and record this information in the person’s care record so the GP has access to it.

NICE also called on prescribers to make sure that they advise patients using CDs how to store and dispose of them safely, and in particular whether they need to use lockable storage containers.

Chair of the guideline development group, GP Dr Tessa Lewis, said: “A great deal of work has been done recently to help ensure the safe use and management of controlled drugs at a local and national level. However, ongoing activity and vigilance is required to sustain the positive developments that have been achieved since the changes to the structure of the NHS took effect in 2012.

“In considering changes to legislation and to the NHS structure as well as relevant patient safety incidents, this guidance provides further clarity and good practice recommendations across most NHS settings and people’s own homes.

“Our aim with this guideline is to support organisations and individuals to minimise the potential harms associated with these medicines by having robust systems and processes in place for their use.”


* Cousins D, Gerrett D, Warner B. A review of controlled drug incidents reported to the NRLS over seven years. Pharmaceutical Journal, online 2013 Vol 291. DOI: 10.1211/PJ.2013.11125507.

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