Under the Misuse of Drugs Regulations 2001, all Controlled Drugs (CDs) classified under Schedules 2, 3 or 4 (part 1) should be denatured and rendered irretrievable before disposal. Please note, this does not include Schedule 5 CDs and legally these do not have to be denatured.
The Health Act 2006 introduced the concept of an Accountable Officer who is responsible for the supervision and management of CDs in any healthcare setting where CDs are used. The Accountable Officer appoints an Authorised Witness for the destruction process at their establishment.
There is some confusion regarding which Controlled Drugs require the presence of an Authorised Witness and which do not. Below, I hope to clarify the Controlled Drug schedules that require the presence of an Authorised Witness, and outline who legally can denature these CDs as well as the difference for named patient CDs and stock CDs.
The following information describes the essential legal requirements that must be followed under the Misuse of Drugs Regulations 2001. However, in practice, local policies and guidelines may add extra steps that staff will be required to follow.
Named patient CDs
Legally, denaturing is required for all Schedule 2, 3 and 4 (part 1) Controlled Drugs that have been supplied to or brought in by named patients. These should be denatured by a registered healthcare professional, however disposal of these CDs does not require the presence of an Authorised Witness. It is good practice that this is witnessed by another member of staff who is familiar with CDs and preferably also a registered health professional.
Legally, denaturing is required for all Schedule 2, 3 and 4 (part 1) Controlled Drugs that are stock items. The presence of an Authorised Witness is required for all denaturing of Schedule 2 stock CDs legally. This is not a legal requirement for stock Schedule 3 and 4 CDs, although it is best practice to have another member of staff present for the denaturing of Schedule 3 CDs.
All Schedule 2 CDs, both named patient and stock, must be recorded in a CD register, which should be updated after denaturing. There is no need to record the disposal in the Ashtons Disposal of Unwanted Medicines Record as well as in the Controlled Drugs register as this is duplication.
Records of the disposal of lower Schedule CDs (4 part 1 and 5) can be written in the Disposal of Unwanted Medicines Record.