Destruction of Controlled Drugs and Unknown Substances by Pharmacy Services Staff Standard Operating Procedure DOCUMENT CONTROL: Version: 1 Ratified by: Quality Assurance Sub-Committee Date ratified: 6 December 2017 Name of originator/author: Trust Pharmacist Name of responsible Medicines Management Committee committee/individual: Date issued: 9 March 2018 Review date: December 2020 Target Audience Pharmacy Services staff
1. AIM This Standard Operating Procedure (SOP) covers the destruction of RDASH requisitioned (stock Controlled Drugs (CDs) (unlabelled supply and Patient dispensed (leave/discharge), Patient Own Medicines (POM) and Unknown Substances located on wards/teams/units Trust wide, which are no longer required or have expired, and cannot be returned to the patient. 2. SCOPE Pharmacy Services staff 3. LINK TO OVERARCHING POLICY AND/OR STANDARD OPERATING PROCEDURE This SOP is overarched by the RDASH Safe and Secure Handling of Medicines Policy. It should also be used in conjunction with the RDASH Controlled Drugs Standard Operating Procedure (with the exception of St John s Hospice and DCIS Community Services). 4. PROCEDURE The Controlled Drugs covered by this policy are those covered by Schedules 2 and 3, and Morphine Sulphate solution 10mg/5ml. All Controlled Drugs should be recorded in the ward/team controlled drug register book as per policy. POMs should be recorded in the back of the register or in the Patient own Controlled Drugs Register book. Unknown substances should be recorded in the back of CD register book. Controlled drugs/unknown substances may be destroyed on the ward/team only by the authorized trained named personnel (ATNP) appointed by the Trust Accountable Officer (Appendix 1) in the presence of a second staff member (counter-signatory). All controlled drugs/unknown substances will be destroyed on the ward/team using a proprietary denaturing kit (DOOP), which can be ordered from the SLA pharmacy. The Trust Pharmacy Service will order and store these kits at the pharmacy base. The Pharmacy will have available a device to crush solid dosage forms, in such a manner that they can be dispersed in the denaturing kit. It should not release dust in to the atmosphere. At the point of the discharge or prior to this, patients own controlled drugs are destroyed, the nurse in charge may ask if an appropriate adult/patient may take the POMs home for storage (the appropriate adult must be approved by the service user and entry to this effect made in the patient s clinical records). If the POMs are no longer required they should be urged to leave them with Pharmacy for destruction rather than run any risk of misuse or misadventure. Page 2 of 7
Procedure: 1. Having received notification from the ward/team pharmacy staff should liaise with the nurse in charge to ensure prior to the visit that: Identified Stock CDs are no longer needed. Identified POM CDs are no longer needed and the patient has consented to the destruction. Unknown substances. 2. The ATNP (who will destroy those CDs/unknown substances) should liaise with the nurse in charge and set a suitable time to come to the ward/ team to carry out the CDs destruction. 3. On arrival to the ward/team the ATNP should identify himself/herself, with trust identification, and will ask the nurse in charge if it is, to go with him/her to the treatment room, and get the CDs/unknown substances to be destroyed, along with the Controlled Drug register book, having assured themselves of the safety of doing so. 4. The ATNP and counter-signatory (nurse in charge or pharmacist or RDASH pharmacy technician if nurse in charge is not able to witness the CD destruction) should get the CDs/unknown substances from the CD cupboard, then lock the cupboard back up and check CDs to be destroyed against the registry entries. 5. If multiple destructions are required, this will be done in strict rotation: a. Tablets/Capsules remove from packaging, crush and add to DOOP kit b. Ampoules - break ampoule, add glass and contents into DOOP kit c. Patches remove packaging, and backing paper, fold the patch in half adhesive side inward and add to DOOP kit. d. Liquids empty directly in to DOOP kit (no more than half full) e. Lozenges remove from packaging and add into DOOP kit. Any excess packaging, e.g. plastic stick attached to lozenge, should be cut off to save space in the kit. f. Aerosols expelled under water into a small container, solution to be emptied directly into DOOP kit g. Unknown substances remove from sealed envelope and carry out the destruction as stated above depending on the formulation of the unknown substance. 6. CDs/unknown substances will be signed out of the register as being destroyed, by the ATNP and counter-signatory. A second sheet (Appendix 2) will also be completed and kept by the trust pharmacy services. 7. The DOOP kit should not be filled more than half full. Once all CDs/unknown substances have been placed in the DOOP kit, it should be filled with water to the mark on the label, the lid tightly closed and shaken. Page 3 of 7
8. Once the liquid has formed a gel, the substances are no longer considered as controlled substances, and the container can be disposed of in the pharmaceutical waste bin on the ward/unit. 9. The ATPN and counter-signatory should then check the Controlled Drug Register against existing stock and vice versa (except in St John s Hospice due to the size/range of their CD holding) and if balance is correct then an entry should be made that the stock levels have been checked and are correct, this must then be signed and dated by both the ATNP and the counter-signatory. The relevant section from Appendix 2 should be completed accordingly: - CD cupboards/cd registers checked - Number of items checked - Stock balance and register match - Any discrepancies found: YES/NO - Additional comments/discrepancies found 10. Any discrepancies must be reported, via the IR1 system to the Accountable Officer and Ward Manager and investigated accordingly. 11. All paperwork must be kept for a period of two years from the last entry. 12. Audit a. The form (Appendix 2) will be used to periodically audit, against the trust CD register books in terms of CD destruction and reconciliation. b. The form (Appendix 2) will also be used for the CD LIN Report about how many visits to wards/teams have taken place and how many items have been destroyed. Page 4 of 7
APPENDIX 1 PHARMACY SERVICES STAFF SIGN OFF SHEET TO BE AUTHORISED FOR CONTROLLED DRUGS/UNKNOWN SUBSTANCES DESTRUCTION BY ACCOUNTABLE OFFICER PHARMACY STAFF SIGN OFF SHEET Signature below represents a sample signature & initials Declaration that named Pharmacy Services staff have read & understood the terms of the SOP ACCOUNTABLE OFFICER SIGN OFF RDASH ACCOUNTABLE OFFICER Stephen Davies Chief Pharmacist NAME/TITLE SIGNATURE INITIALS SIGNATURE DATE Page 5 of 7
APPENDIX 2 DESTRUCTION AND RECONCILIATION OF CONTROLLED DRUGS/UNKNOWN SUBSTANCES RECORD SHEET (In addition to entry in CD register book) Ward/Team: Date: Page number: CD cupboards/cd registers checked: Number of items checked: Stock balance and register match: Any discrepancies found: YES/NO Drug Name Form Strength Quantity Authorised person Signature /print Witness name signature/print Additional comments/discrepancies found: Page 6 of 7
Page number: Drug Name Form Strength Quantity Authorised person Signature /print Witness name signature/print Page 7 of 7