Segregation and Destruction of Controlled Drugs

The management of controlled drugs is reviewed during all inspections. This review examines, amongst other matters, the manner in which date-expired or damaged controlled drugs (CDs) and patient returned controlled drugs are managed at the pharmacy. To assist pharmacists and pharmacies the inspectors would like to highlight the following:

1. Storage of Controlled Drugs Prior to Disposal/Destruction

Expired or non-conforming (damaged) Schedule 2 and Schedule 3 controlled drugs must be stored in the controlled drugs safe until they are destroyed. To avoid the risk of inadvertently supplying these medicines to patients, it is essential that you:

Segregate these medicines from ‘live’/ ‘active’ stock, and,
Clearly label the medicines as ‘CDs for destruction’.

Please remember that a pharmacy is never permitted to sell or supply a medicinal product which has previously been supplied to a patient, is damaged or is out of date. Patient-returned CDs, expired CDs or damaged stock should be promptly destroyed and should not be allowed to accumulate in the controlled drugs safe as this will increase the risk for error.

2. Destruction of Controlled Drugs

The law requires the destruction of schedule 2 controlled drugs that have expired or been damaged to be witnessed by (i) A member of An Garda Síochana or (ii) a PSI inspector or other person authorised under the legislation. It also requires the pharmacy to keep a record of the witnessed destruction at the pharmacy. This record must be retained at the pharmacy for a period of two years from the date the medicines were destroyed. The record must be signed by the person who witnessed the destruction of the controlled drugs.

There are two separate registers available from the PSI to record the destruction of CDs. These registers can be ordered directly by completing this form.

2.1 The PSI Controlled Drugs Register

The PSI Controlled Drugs Register contains a separate section to record the destruction of CDs. This register should only be used to record the destruction of those CDs which were originally recorded in the register and which have been written out of the register because they have either expired or are damaged. Please refer to pages 202-204 of the controlled drugs register for step-by-step instructions on how to destroy controlled drugs and how to record this destruction.

2.2 A Controlled Drugs Destruction Record

This is a separate register. This particular register should only be used to record the destruction of of patient returned CDs and expired/non-conforming CD3 and CD4 pharmacy stock. Please refer to pages 2-3 of this register for step-by-step instructions on how to destroy controlled drugs and how to record this destruction.

Please remember that each pharmacy should have written policies and procedures in place outlining the manner in which your pharmacy manages the process for the disposal and destruction of controlled drugs.

Guidance on the disposal and destruction of controlled drugs is available in the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business.

(This was included in Issue 1, 2015 of the PSI Newsletter)

A list of CD 2, 3 and 4 products from the Health Products Regulatory Authority (HPRA) is available on the Guidance on Safe Supply of Medicines page