The Home Office has advised that all Controlled Drugs in Schedules 2, 3 and 4 (part 1) should be denatured and, therefore, rendered irretrievable before being placed into waste containers. CD denaturing kits are widely available. More information can be found within Medicines Ethics and Practice (RPS membership required) and from Community Pharmacy England.
Where the CD is a Schedule 2 stock item, there is a legal requirement for the denaturing to be witnessed by an Authorised Witness. Contact your local CD Accountable Officer (CDAO).
It is good practice for all other CD waste to be denatured in the presence of another member of staff (preferably a registered healthcare professional).
CD waste produced on site
Organisations must obtain an Environment Agency T28 exemption certificate in order to be able to store, sort and denature CDs. Each location where CD waste is produced and subsequently denatured should register for a T28 exemption. Organisations with more than one site will need multiple exemptions.
T28 waste exemption: sort and denature controlled drugs for disposal contains further advice from the Environment Agency.
CD waste produced elsewhere
A T28 exemption certificate does not allow you to store, sort and denature waste controlled drugs:
- returned by patients or healthcare workers to a pharmacy or medical practice
- brought together at collection points or denaturing sessions
- in patients’ homes
The Environment Agency’s Regulatory Position Statement on the Denaturing of controlled drugs at a place other than the premises of production details the stated conditions that must be met in order to be able to denature CD waste produced elsewhere.
Sites that produce CD waste as part of their normal activities in addition to denaturing CD waste produced elsewhere, must obtain a T28 exemption certificate in order to be able to denature CD waste produced on site.
Disposal of patients’ own CDs
Patients’ own CD waste should be returned to the supplying pharmacy for disposal. Where this is not possible, for example patients’ own CD waste brought into hospital, they can be disposed of by the organisation. Patient consent for disposal is required.
CDs must be denatured before disposal in the correct disposal container. It is good practice for patent’s own CD waste to be denatured in the presence of another member of staff (preferably a registered healthcare professional).
Patient’s own sharps CD waste generated by a healthcare worker in a patient’s own home or a care home should be disposed of by the healthcare worker. An organisational risk assessment should be undertaken to decide if the CD should be denatured before disposal. Factors to consider include the risk of the member of staff receiving a needle stick injury whilst denaturing a CD, compared with the risk of the CD being diverted for illicit purposes. The risk assessment should be supported by a Standard Operating Procedure.
Where an organisational risk assessment deems it unsafe to denature the CD, the entire sharp containing the CD should be disposed of in the appropriate sharps bin carried by the healthcare worker.
Managing sharps contaminated with pharmaceutical waste contains further considerations on what to do when a used sharp is contaminated with CD waste.