Controlled drugs legislation and the role of the

Controlled drugs legislation and the role of the Controlled Drugs Accountable Officer Are your CD’s under control? Susan Jolliffe, Clinical Inspector, HFEA 17 March 2017 www. hfea. gov. uk

Aim of the session • The legal framework governing controlled drugs • Criteria for a Controlled Drugs Accountable Officer (CDAO) • Role of CDAO or equivalent • HFEA regulatory requirements 2017

The Legislation • Misuse of Drugs Act 1971 • The Controlled Drugs (Supervision of Management and use) Regulations 2013

Controlled Drugs Accountable Officer Criteria • The 2013 Regulations stipulate that a CDAO for a designated body must be a “fit, proper and suitably experienced person” (set out in regulation 8(1)). A CDAO must meet three conditions: 1. Senior manager of the organisation in question, i. e. director, or reporting to one. 2. Must be an employee of the organisation concerned. 3. The CDAO should not routinely “prescribe, supply, administer or dispose of controlled drugs” as part of their duties (regulation 8(8)).

Equivalent Exemptions from 2013 regulations apply if: • fewer than 10 individuals work at the hospital. • the need to appoint an accountable officer would give rise to difficulties disproportionate to the benefits of such an appointment. Under Misuse of Drugs Regulations 2001 • Equivalent means that arrangements are in place to ensure the safe and secure management of CD’s by nominating a lead person for drug governance arrangements.

Role of CDAO or equivalent To ensure the safe and effective use of controlled drugs The Accountable Officer must ensure that; • The prescribing of controlled drugs is monitored and audited. • Adequate destruction arrangements are in place for controlled drugs. • Where there are strong grounds for concern a CDAO must share intelligence with other bodies such as the police, the NHS counter fraud service, the HFEA or registering bodies such as the General Medical Council, the Nursing and Midwifery Council, and the General Pharmaceutical Council. • ALL health care professionals have a statutory duty to report any incidents, errors or concerns, however minor, regarding the management of Controlled Drugs.

HFEA Requirements 2017 October 2014 update to the Code of Practice - Guidance Note 25 25. 21 Where controlled drugs are used, centres should be aware of the legal requirements, and have a controlled drugs accountable officer registered with the Care Quality Commission. • Does the centre have an effective CDAO or equivalent ? • Are staff trained and competent in medicines management including controlled drugs? • Are staff aware of the centre’s CD SOP? • Are controlled drugs stored, administered, recorded and disposed of correctly? • Has the process been audited?

Thank you. Any questions? www. hfea. gov. uk