SOPs for Controlled Drugs in Registered Care Facilities - Northern Ireland

Guidance on Standard Operating Procedures for the Safer Management of Controlled Drugs in Registered Facilities Jul 2011

Introduction: This guidance sets out strengthened governance arrangements required in care homes for the management and use of controlled drugs as a result of the Fourth Report of the Shipman Inquiry. Section 17 and 18 of The Health Act 2006 apply in Northern Ireland and provide the basis for the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009. These identify (in regulation 9) the requirement of those using controlled drugs to have Standard Operating Procedures (SOPs) in place. These are one of the practical measures that will help to ensure good practice in the management of controlled drugs throughout the health and social care system. Legislative framework:

• The Health Act 2006
• The Misuse of Drugs (Safe Custody) Regulations 1973
• The Nursing Homes Regulations (Northern Ireland) 2005
• The Residential Care Homes Regulations (Northern Ireland) 2005
• The Children's Homes Regulations (Northern Ireland) 2005
• The Controlled Drugs (Supervision of Management and Use) Regulations (NI) 2009 Guidelines: Department for Health, Social Services and Public Safety (2006). The Use and Control of Medicines. Department for Health, Social Services and Public Safety (2010). Safer Management of Controlled Drugs - A guide to good practice in primary care (Northern Ireland). Resources: www.rqia.org.uk www.dhsspsni.gov.uk (follow the links to the pharmaceutical advice and services page on the right hand side and then the accountable officer link on the left hand side and guidance link on the left hand side.) Regulation 13 of the Nursing Homes Regulations (Northern Ireland) 2005 and Regulation 13 of the Residential Care Homes Regulations (Northern Ireland) 2005 require registered providers to make suitable arrangements for the ordering; storage; recording; handling; safekeeping; safe administration and disposal of medicines used in or for the purposes of the home. Regulation 20 of the Children’s Homes Regulations (Northern Ireland) 2005 requires registered providers to arrange for the recording; handling; safekeeping; safe administration; and disposal of any medicines received into the children’s home. These regulations apply to all medicines including controlled drugs. 2

Background: In 2009, the Department of Health Social Services and Public Safety (DHSSPS) produced a guidance document; Safer Management of Controlled Drugs, Guidance on Standard Operating Procedures for Northern Ireland. This document details which areas of the management of controlled drugs must be covered by Standard Operating Procedures, including:

• who has access to controlled drugs
• where controlled drugs are stored
• security arrangements for controlled drugs
• disposal of controlled drugs
• management of complications

• record keeping
  Definition: A standard operating procedure (SOP) is a step-by-step description of the way things are done in a particular setting. Written SOPs help to ensure the quality and consistency of the management of controlled drugs in each registered facility. They can help to identify and minimise risks and to trace the cause of any errors. This guidance document has been produced by the Regulation and Quality Improvement Authority to help you write standard operating procedures for the management of controlled drugs in your setting. An example of a SOP has been included for information, and a list of the other SOPs that need to be implemented for the management of controlled drugs is included for guidance. Written SOPs should be available in your setting for the management of controlled drugs to:

• improve your governance arrangements

• ensure your practice is in line with the regulatory frameworks

• improve clarity and consistency for all staff handling controlled drugs

• define accountability and responsibilities and clarify where responsibility
  can be delegated

• act as a training and competency assessment tool for new and existing
  staff 3

Scope of SOPs Each registered facility should have SOPs which cover the following areas of the management of controlled drugs:

• ordering, transport and receipt
• safe storage
• administration
• disposal
• record keeping
• management of errors and incidents EXAMPLE Ordering Supplies of Controlled Drugs SOP Number: CD01

Prepared by/date: Approved by/date: Review Date: Previous All paper copies of version/master copy previous version in endorsed as circulation destroyed: superseded, dated and archived: Sign: Date: Sign: Date: Objective: To ensure that the procedure for ordering controlled drugs is robust. Responsibility: The registered manager must ensure that the SOP is adhered to and updated when necessary. All staff who are trained and deemed competent in the management of medicines. Scope: This SOP must be read in conjunction with the home's policies and procedures for the management of medicines and other SOPs for the management of controlled drugs. Process: 1 Orders for controlled drugs should be made in writing to the prescriber using the home's usual ordering process and paperwork. Orders for controlled drugs may not be made through the repeat dispensing scheme. 2 A copy of the order should be retained in the home. 3 Excessive quantities of controlled drugs should not be ordered for individual patients. Prescribers will normally provide a 28 day supply of a controlled drug on each prescription. Signature list of staff that have read SOP 01 - Ordering supplies of controlled drugs I have read and understood the above SOP Print Staff Name Staff signature when Date SOP read 5

When drafting SOPs homes should make reference to the documents Safer Management of Controlled Drugs: A Guide to Good Practice in Primary Care (Northern Ireland) 2010 and Safer Management of Controlled Drugs: Guidance on Standard Operating Procedures for Northern Ireland October

2009.

SOPs are needed for every stage of the controlled drugs journey including procurement (ordering, receipt and transport); safe storage; supply; administration; destruction and guidance for dealing with an incident. Some may require multidisciplinary collaboration. The organisation will need to decide how much to include in a single SOP and may need specific SOPs for specific areas. The input of designated members of staff should be encouraged when drafting SOPs. All designated members of staff should be asked to read the SOPs and should be given training on their implementation. Staff should be asked to sign the respective SOP to show that they have understood the procedures. SOPs are working documents and should therefore be reviewed and updated on a regular basis. SOPs need to be accessible to staff at all times.

Areas to consider Ordering Details of staff with authority to order controlled drugs Details of paperwork system used in the home Transport Arrangements for It is considered good obtaining prescription practice for the home to forms from the collect prescription prescriber forms and check them against their order before forwarding them to the pharmacy for dispensing. Arrangements for the Some pharmacies will transport of supplies of deliver supplies of controlled drugs from controlled drugs to the the pharmacy to the home. The SOP should home detail the delivery arrangements and the management of delivery dockets for controlled drugs. Receipt Personnel authorised to receive CDs Checking procedure Medicines checked against order and record of receipt maintained, by a competent member of staff. Any discrepancies reported to the registered manager. Storage and management of delivery dockets Security of medicines on The staff member receipt responsible for the receipt of medicines is also responsible for the security of medicines on receipt.

Storage Specifications of CD Refer to Safe Custody cabinet Regulations Location of CD cabinet Access Key control The registered manager must ensure that key control is appropriate. Temperature Record keeping Entries in controlled The name; date; time; drugs record book made and route of in accordance with administration and dose legislation and minimum given, should be standards and best recorded in the practice guidance. controlled drug record book immediately after the medication dose has been administered. The nurse/trained carer and the witness should also verify and record the remaining stock balance and sign the controlled drug record book. Details of staff In nursing homes, if only authorised to make one member of nursing entries. staff is on duty - care staff should be trained to countersign records. Receipt, administration and disposal of all controlled drugs recorded. Retention of records Refer to appropriate legislation

Administration Authority to administer Assembly Removal from cupboard/store Preparation of dose Patient Verification of patient/treatment/ personal medication record Administration Witnessed CD record book entry Medication The entry should be administration record made at the time of entry administration by the staff member administering the medicine. It is considered good practice for the member of staff witnessing the administration to also sign the administration record Disposal/ Transfer Disposal Transport and destination Record keeping Record signed by staff member and recipient of medicine. Home leave Discharge of patient Unused portions (e.g. The entry should be ampoules, syringe made at the time of driver) disposal by the staff member disposing of the medicines and the member of staff witnessing the disposal.

Self-administration Competency assessment of patient Storage Record keeping Monitoring and review Monitoring and audit Reconciliation of Records of checks arrangements Schedule 2 & 3 maintained controlled drugs by the staff members involved at each handover of responsibility. Errors and incidents Discrepancy The registered manager must be informed if a discrepancy is noted and an investigation must be undertaken. Administration error Record keeping error Reporting of The registered manager errors/incidents must inform the relevant authorities of the outcome of the investigation, in a timely manner. Review procedures The registered manager is responsible for the review of procedures to ensure that the risk of incidents in the future is reduced and that the learning points taken from the incident are communicated with all staff in an appropriate manner. Audit of SOP SOPs up to date and Periodic review accurate