Controlled Drugs Guidance

The Department of Health and Royal Pharmaceutical Society of Great Britain guidance document “Safer Management of Controlled Drugs; a guide to good practice in secondary care (England)” was released in October 2007.

It is aimed at any secondary care practitioner, either hospital or community based, who processes or administers controlled drugs (CD's). The guidance was issued following the fourth report of the Shipman inquiry and is aimed at strengthening the current controlled drugs management systems and thereby minimise the risk to patients, the environment and the wider general public.

The Guidance clearly states that in all situations where they are used, CD’s should be safely denatured and disposed of securely to avoid both environmental damage and misuse.

“CD’s should be destroyed in such a way that the drug is denatured or rendered irretrievable so that it cannot be reconstituted or re-used”

It is good practice to ensure that these drugs are disposed of quickly and securely as possible to minimise the risk of drugs being accessible. In an acute environment, this may be done either on the wards or at the central pharmacy.

The Guidance clearly states that controlled drugs awaiting disposal should be regularly denatured using only authorised methods:

“Wherever practical, CD denaturing kits should be used to denature CD’s”

Unlike other methods, denaturing kits are approved for use for the disposal of both unwanted or out of date stock and small amounts of surplus doses.

Unused stock controlled drugs
Unused or out of date controlled drugs can be returned to the pharmacy for safe disposal as witnessed by an authorised person.

Unused part doses
For part-used vials, ampoules or infusion bags, it may be more practical to issue wards with a stock of denaturing kits for use by staff. In principal, unused part-doses should “be destroyed promptly and witnessed by a registered nurse”.

Even very small amounts of controlled drugs, e.g. a dosage surplus, should NEVER be put down the sink.

Whichever denaturing and disposal method is selected, it is recommended that a brief risk assessment is undertaken and a Standard Operating Procedure produced. For example, when crushing pills (a requirement of any CD destruction kit to ensure efficacy) protective equipment such as gloves and a mask should be provided.