The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009

Made

Coming into Operation-: 1st October 2009

The Department of Health, Social Services and Public Safety[^f00001], makes the following Regulations in exercise of the powers conferred on it by sections 17, 18, 20(3) and (7) and 79(3) of the Health Act 2006[^f00002].

PART 1 — Preliminary

Citation and commencement

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These Regulations may be cited as the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 and shall come into operation on 1st October 2009.

Interpretation

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• (1) The Interpretation Act (Northern Ireland) 1954[^f00003] shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.

• (2) In these Regulations—

• “the 2003 Order” means the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003[^f00004];

• “the 2006 Act” means the Health Act 2006;

• “the 2009 Act” means the Health and Social Care (Reform) Act (Northern Ireland) 2009[^f00005];

• “accountable officer” means a person nominated or appointed under regulation 4;

• “the Department” means the Department of Health, Social Services and Public Safety;

• “designated body” shall be construed in accordance with regulation 3;

• “domiciliary care agency” has the meaning assigned to it by Article 2(2) of the 2003 Order;

• ...

• “general dental services” has the meaning given in Article 2(2) of the Health and Personal Social Services (Northern Ireland) Order 1972[^f00006];

• “health care” means any services designed to secure improvement in the physical and mental health and prevention, diagnosis and treatment of illness in the people of Northern Ireland;

• “hospital” shall be construed in accordance with Article 2(2) of the 2003 Order;

• “HSC Trust” means a Health and Social Care Trust established under Article 10 of the Health and Personal Social Services (Northern Ireland) Order 1991[^f00007];

• “Independent hospital” means a hospital which is not vested in the Department or managed by a HSC trust and excludes dental practices;

• “Local Intelligence Network” shall be construed in accordance with regulation 18(2);

• “misuse of drugs legislation” means the Misuse of Drugs Act 1971[^f00008] and any subordinate legislation made under that Act;

• ...

• “nursing home” shall be construed in accordance with Article 11 of the 2003 Order;

• “pilot scheme” has the meaning given in Article 3 of the Health Services (Primary Care) (Northern Ireland) Order 1997[^f00010];

• “piloted services” has the meaning given in Article 3 of the Health Services (Primary Care) (Northern Ireland) Order 1997;

• “Primary medical services performers list” means the list of persons performing primary medical services prepared in accordance with regulations made under Article 57G of the Health and Personal Social Services (Northern Ireland) Order 1972;

• “RBSO” means the Regional Business Services Organisation established under section 14 of the 2009 Act;

• “Regional Board” means the Regional Health and Social Care Board established under section 7 of the 2009 Act;

• “registered dentist” means a person who is registered in the dentists register kept under section 14 of the Dentists Act 1984[^f00011];

• “registered medical practitioner” means a person who is registered in the register of medical practitioners under Section 2(2) of the Medical Act 1983[^f00012];

• “registered pharmacist” means a person registered in the register of pharmacists maintained by the Pharmaceutical Society of Northern Ireland under Article 6 of the Pharmacy (Northern Ireland) Order 1976[^f00013];

• “registered pharmacy” means a retail pharmacy business in Northern Ireland that is for the time being entered in the register kept under section 75, (registration of premises), of the Medicines Act 1968[^f00014];

• “regular force” means the Royal Air Force, the Royal Navy, the Royal Marines or the regular army (that is, Her Majesty’s military forces other than the Army Reserve, the Territorial Army or the forces raised under the law of a British overseas territory);

• “regulatory body” means—a body referred to in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (the Professional Standards Authority for Health and Social Care); andthe Northern Ireland Social Care Council;

• “relevant activities” means activities that involve, or may involve, the management or use of controlled drugs;

• “relevant independent hospital” shall be construed in accordance with regulation 2A;

• “relevant individual” shall be construed in accordance with section 17(8)(b) of the 2006 Act;

• “relevant person” shall be construed in accordance with regulation 23;

• “relevant premises” shall be construed in accordance with regulation 20;

• “reserve force” means the Royal Air force Reserve, the Royal Auxiliary Air Force, the Royal Fleet Reserve, the Royal Naval Reserve, the Royal Marines reserve, the Army Reserve or the Territorial Army;

• “residential care home” shall be construed in accordance with Article 10 of the 2003 Order;

• “responsible body” shall be construed in accordance with regulation 22;

• “retail pharmacy business” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;

• “RQIA” means the Health and Social Care Regulation and Quality Improvement Authority[^f00016] ;

• “senior manager”, in relation to a body or undertaking means one of the individuals who play significant roles in—the making of decisions about how the whole or a substantial part of its activities are to be managed or organised; orthe actual managing or organising of the whole or a substantial part of those activities;

• “statutory provision” has the meaning assigned to it by section 1(f) of the Interpretation Act (Northern Ireland) 1954.

• “the UK GDPR” has the same meaning as in Parts 5 to 7 of the Data Protection Act 2018 (see section 3(10) and (14) of that Act);

• (3) Where, by virtue of these Regulations, a person or body is required to ensure a matter, the requirement is to be construed as a requirement to take all reasonable steps to ensure that matter.

• (4) Where reference is made in these Regulations to arrangements to provide services, the reference is to be construed as a reference to arrangements to provide services that involve, or may involve, the management or use of controlled drugs.

PART 2 — Accountable officers

Designated Bodies

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The following are prescribed as designated bodies for the purposes of section 17 of the 2006 Act—

• (a) the Regional Board;

• (b) a HSC Trust;

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) a relevant independent hospital.

• (e) the headquarters in Northern Ireland of regular or reserve forces.

Appointment of Accountable Officers

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• (1) Each designated body shall nominate or appoint, or in a group with one or more other designated bodies shall jointly nominate or appoint, a fit, proper and suitably experienced person to be its accountable officer.

• (2) Where more than one part of an undertaking is a designated body, an aggregate of parts of that undertaking jointly appointing or nominating an accountable officer is a group of designated bodies for the purposes of this regulation, whether or not the aggregate is, or is part of, a single legal person.

• (3) All the designated bodies in a group of designated bodies that are jointly nominating or appointing an accountable officer shall be in Northern Ireland.

• (4) A person appointed under paragraph (1) (P) shall satisfy Conditions 1, 2 and 3.

• (5) Condition 1 is that P shall be—

• (a) in the case of the headquarters of regular or reserve forces, or headquarters of regular or reserve forces acting jointly, a senior officer (that is, a lieutenant colonel or a person of equivalent or superior rank) of the regular or reserve forces (and sub-paragraphs (b) to (d) do not apply in such cases);

• (b) a senior manager of P’s designated body;

• (c) where designated bodies are jointly acting—

• (i) unless head (ii) applies, a senior manager of one of the designated bodies jointly acting,

• (ii) if the designated bodies jointly acting are part of the same undertaking, a senior manager of that undertaking; or

• (d) answerable to a senior manager who satisfies sub-paragraph (b) or (c).

• (6) Condition 2 is that P shall be an officer or employee—

• (a) of the designated body that nominates or appoints P; or

• (b) if P is nominated or appointed by designated bodies jointly acting—

• (i) of one of the designated bodies jointly acting, or

• (ii) where those bodies are part of the same undertaking, of that undertaking.

• (7) Condition 3 is that P does not, or does only exceptionally, prescribe, supply, administer or dispose of controlled drugs as part of P’s duties as an employee or officer—

• (a) of P’s designated body; or

• (b) if P is nominated or appointed by designated bodies jointly acting and those bodies are part of the same undertaking, of that undertaking.

• (8) Two or more designated bodies may only jointly nominate or appoint a person to be their accountable officer if they are satisfied that P is capable of properly discharging P’s functions under these Regulations in relation to each and all of them.

• (9) A designated body of a description given in paragraph (b) or (d) of regulation 3 may only jointly nominate or appoint a person to be their accountable officer with another designated body of the same description.

• (10) Each designated body that has an accountable officer shall provide P with the funds and other resources necessary for enabling P to discharge P’s responsibilities as accountable officer (in the case of joint nominations or appointments, this obligation may be discharged through joint arrangements for provision of funds and other resources).

• (11) The other resources may include access to and use of information systems, accommodation and staff.

Persons who may be appointed as accountable officers

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Removal of accountable officers

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• (1) A designated body shall, having duly considered the matter, remove its accountable officer from office if—

• (a) he no longer satisfies condition 1, 2 or 3 set out in regulation 4(5) to (7); or

• (b) he is unfit to be an accountable officer.

• (2) A designated body (or, in the case of a joint appointment, the designated bodies that made the joint appointment, acting jointly) shall adopt a procedure (which may be part of an internal disciplinary procedure) for consideration, where it is on notice that its accountable officer has breached his duties under these Regulations, of whether or not it needs to remove him under paragraph (1)(b).

• (3) A person shall be presumed (unless the contrary is proved) to be unfit to be an accountable officer if he wilfully, negligently or through lack of competence breaches his duties as an accountable officer under these Regulations.

• (4) This regulation is without prejudice to any other arrangements that a designated body (or, in the case of a joint appointment, the designated bodies that made the joint appointment, acting jointly) may have for removal of its accountable officer from office as part of the arrangements under which he is employed or engaged.

Funds and other resources available to accountable officers

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Accountable officers to have regard to best practice

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In discharging his responsibilities, an accountable officer shall have regard to best practice in relation to the management and use of controlled drugs.

Accountable officers to secure the safe management and use of controlled drugs

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• (1) An accountable officer shall—

• (a) both—

• (i) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for securing the safe management and use of controlled drugs by the designated body, and

• (ii) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates appropriate arrangements for securing the safe management and use of controlled drugs by that body or person; and

• (b) both—

• (i) review, or ensure that his designated body reviews, arrangements established by him or his designated body in accordance with sub-paragraph (a)(i), and

• (ii) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body reviews arrangements established by it or him in accordance with sub-paragraph (a)(ii).

• (2) In particular, an accountable officer shall, as part of these arrangements—

• (a) establish or ensure that his designated body (and any person acting on behalf of, or providing services under arrangements made with, his designated body) establishes appropriate arrangements to comply with misuse of drugs legislation; and

• (b) ensure that his designated body (and any person acting on behalf of, or providing services under arrangements made with his designated body) has adequate and up-to-date standard operating procedures in place in relation to the management and use of controlled drugs.

• (3) The standard operating procedures shall, in particular, cover the following matters unless not applicable to his designated body—

• (a) who has access to the controlled drugs;

• (b) where the controlled drugs are stored;

• (c) security in relation to the storage and transportation of controlled drugs as required by misuse of drugs legislation;

• (d) disposal and destruction of controlled drugs;

• (e) who is to be alerted if complications arise; and

• (f) record keeping, including—

• (i) maintaining relevant controlled drugs registers under misuse of drugs legislation, and

• (ii) maintaining a record of the controlled drugs specified in Schedule 2 to the Misuse of Drugs Regulations (Northern Ireland) 2002[^f00017] (specified controlled drugs to which certain provisions of the Regulations apply) that have been returned by patients;

• (g) best practice relating to—

• (i) the prescribing, supply and administration of controlled drugs, and

• (ii) clinical monitoring of patients who have been prescribed controlled drugs.

Accountable officers to ensure adequate destruction and disposal arrangements for controlled drugs

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• (1) An accountable officer shall—

• (a) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for securing the safe destruction and disposal of controlled drugs by his designated body; and

• (b) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body, establishes and operates appropriate arrangements for securing the safe destruction and disposal of controlled drugs by that body or person.

Accountable officers to ensure monitoring and auditing of the management and use of controlled drugs by designated bodies etc.

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• (1) An accountable officer shall—

• (a) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for monitoring and auditing his designated body’s management and use of controlled drugs; and

• (b) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body, establishes and operates appropriate arrangements for monitoring and auditing their management and use of controlled drugs (that is, their management and use of controlled drugs under their arrangements with the designated body, not under any other arrangements).

• (2) Those arrangements shall, in particular, provide for the following—

• (a) monitoring and analysing health care and private prescribing of controlled drugs through the use of data and analysis tools available from RBSO;

• (b) ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has systems in place to alert the accountable officer of any complaints or concerns involving the management or use of controlled drugs;

• (c) ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has an incident reporting system in place for adverse incidents involving the management or use of controlled drugs; and

• (d) ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has appropriate arrangements in place for analysing and responding to adverse incidents involving the management or use of controlled drugs.

Powers to require declarations and self-assessments, as part of accountable officers’ monitoring and auditing arrangements or otherwise

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• (1) The accountable officer, nominated or appointed by the Regional Board, may request a periodic declaration and a self-assessment from a general medical practitioner on its primary medical services performers list or from a registered dentist providing general dental services or piloted services under a pilot scheme, which shall state—

• (a) whether he uses controlled drugs at any of the premises from which the above services are provided; and

• (b) how he manages and uses controlled drugs at those premises.

• (2) The Department may request a periodic declaration and a self-assessment from a registered pharmacy.

• (3) RQIA may request a periodic declaration and a self-assessment from a HSC Trust or any person registered with them that provides health care.