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

PART 2 Accountable officers

Designated Bodies

3.  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) NIAS;

(d) an Independent Hospital.

Appointment of Accountable Officers

4.—(1) A designated body shall nominate or appoint (or under regulation 5(2), or (4) jointly nominate or appoint with one or more other bodies) a fit, proper and suitably experienced person as its accountable officer.

(2) A designated body must notify the Department in writing of—

(a) any nomination or appointment by it under paragraph (1) as soon as practicable; and

(b) the removal of an accountable officer by it (whether or not under regulation 6) as soon as practicable.

(3) The Department shall publish, from time to time and in such manner as it sees fit, a list of accountable officers of designated bodies in Northern Ireland.

Persons who may be appointed as accountable officers

5.—(1) An independent hospital may only nominate or appoint a person as its accountable officer if—

(a) the person is—

(i) its registered manager, or

(ii) one of its officers or employees who is answerable to its registered manager,

and if the person is its registered manager, he must be answerable to the chief executive, chairman or managing director of the hospital; and

(b) the person does not routinely supply, administer or dispose of controlled drugs as part of his duties.

(2) Two or more independent hospitals may jointly nominate or appoint one registered manager to be the accountable officer for both or all of the hospitals if the registered manager —

(a) is registered as manager in relation to both or all of the hospitals; and

(b) does not routinely supply, administer or dispose of controlled drugs as part of his duties.

(3) Subject to paragraph (4), a designated body which is not an independent hospital may only nominate or appoint a person as its accountable officer if—

(a) the person is an officer or employee of the designated body, and—

(i) a member of the board of directors, or the management or executive committee of the designated body,

(ii) a member of the body (howsoever it may be called) that has the responsibility for the management of the designated body, or

(iii) is answerable to a person referred to in paragraph (i) or (ii); and

(b) the person does not routinely supply, administer or dispose of controlled drugs as part of his duties.

(4) Two or more designated bodies which are not independent hospitals but which are of the same type may jointly nominate or appoint one person to be the accountable officer for both or all of the bodies, if—

(a) the person satisfies paragraph (3)(a) in relation to one of the designated bodies;

(b) each designated body is satisfied that the person can properly discharge his responsibilities in relation to it; and

(c) the person does not routinely supply, administer or dispose of controlled drugs as part of his duties.

(5) In this regulation—

“registered manager”, in relation to an independent hospital, means the person who is registered under Part III of the 2003 Order as the manager of the hospital.

Removal of accountable officers

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

(a) he no longer satisfies the conditions set out in regulation 5; 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, or 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

7.—(1) A designated body shall provide its accountable officer with the funds and other resources necessary to enable him to carry out his responsibilities as its accountable officer.

(2) Those other resources may include access to and use of information systems, accommodation and staff.

Accountable officers to have regard to best practice

8.  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

9.—(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—

(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(1) (specified controlled drugs to which certain provisions of the Regulations apply) that have been returned by patients.

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

10.—(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.

11.—(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

12.—(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.

(4) In this regulation, “general medical practitioner” means a medical practitioner whose name is included in the register, (the General Practitioner Register) maintained by the General Medical Council under Article 10 of the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003 (2).

Accountable officers to ensure relevant individuals receive appropriate training etc.

13.—(1) An accountable officer shall—

(a) establish and operate, or ensure that his designated body establishes and operates; and

(b) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates,

the arrangements mentioned in paragraph (2).

(2) Those arrangements are appropriate arrangements to ensure that persons who are—

(a) as regards the designated body, relevant individuals; and

(b) involved in prescribing, supplying, administering or disposing of controlled drugs,

receive, from time to time, appropriate training to carry out their responsibilities.

(3) The accountable officer shall liaise with his designated body to ensure that arrangements are in place for the relevant individuals referred to in paragraph (2)—

(a) to receive information and, where appropriate, training on local standard operating procedures for controlled drugs when they first become involved in prescribing, supplying, administering or disposing of controlled drugs; and

(b) to be informed when any local standard operating procedures for controlled drugs are subsequently reviewed or amended.

Accountable officers to monitor and audit the management and use of controlled drug by relevant individuals, and to monitor and assess their performance

14.—(1) An accountable officer shall—

(a) establish and operate, or ensure that his designated body establishes and operates; and

(b) ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates,

the arrangements mentioned in paragraph (2).

(2) Those arrangements are appropriate arrangements—

(a) for monitoring and auditing the management and use of controlled drugs by a person who is, as regards the designated body, a relevant individual; and

(b) for monitoring and assessing the performance of persons who are, as regards the designated body, relevant individuals, in connection with the management and use of controlled drugs.

(3) The arrangements under paragraph (1) shall, where appropriate, provide for the following—

(a) recording, in accordance with regulation 15, any concerns raised in relation to the management or use of controlled drugs by a relevant individual;

(b) assessing and investigating, in accordance with regulation 16, any concerns raised regarding the management or use of controlled drugs by a relevant individual; and

(c) determining whether there are concerns in relation to the management or use of controlled drugs by a relevant individual which the designated body reasonably considers should be shared with a responsible body under regulation 25.

Accountable officers to maintain a record of concerns regarding relevant individuals

15.—(1) An accountable officer shall—

(a) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his designated body, a relevant individual; 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 recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his designated body, a relevant individual.

(2) The accountable officer shall ensure, as part of the arrangements under paragraph (1), that adequate records are compiled, which must include (but not be limited to), as appropriate—

(a) the date on which the concern was made known to the accountable officer;

(b) any dates on which the matters that led to the concern took place;

(c) details regarding the nature of the concern;

(d) details of the relevant individual in relation to whom the concern was expressed;

(e) details of the person who, or body which, made known the concern;

(f) details of any action taken by the designated body (or any person acting on behalf of, or providing services under arrangements made with, the designated body) in relation to the concern;

(g) the assessment of whether information in relation to the concern should be disclosed to another responsible body under regulation 25 or 26; and

(h) if information regarding the concern is disclosed to another responsible body under regulation 25 or 26, the details of any such disclosure, including the name of the responsible body to which the disclosure was made and the nature of the information disclosed to the body.

(3) Any record of a concern may be kept in paper or electronic format.

(4) The arrangements under paragraph (1) shall include arrangements that limit access to the records to—

(a) the accountable officer and his staff; and

(b) others who need to have access for the purposes of ensuring the safe management or use of controlled drugs.

Accountable officers to assess and investigate concerns

16.—(1) An accountable officer shall establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for—

(a) assessing concerns expressed about incidents that involved, or may have involved, the improper management or use of controlled drugs by a person who is, as regards his designated body, a relevant individual; and

(b) investigating such concerns.

(2) If, after an assessment of a concern expressed, the accountable officer decides that an investigation is needed, the accountable officer may—

(a) carry out that investigation himself;

(b) make a written request for another officer or employee of his designated body to carry out the investigation; or

(c) if appropriate, and subject to paragraph (5)—

(i) make a written request for an officer or employee (including, in the case of a designated body, an accountable officer) from any of the responsible bodies listed in paragraph (3) to carry out the investigation, or

(ii) make a written request for a number of officers or employees from any of the responsible bodies listed in paragraph (3) to form a joint investigation team to carry out the investigation.

(3) The following are responsible bodies for the purposes of section 18 of the 2006 Act and this regulation—

(a) a designated body;

(b) the Department;

(c) the Counter Fraud Unit of RBSO;

(d) the Police Service of Northern Ireland;

(e) RQIA;

(f) a regulatory body.

(4) An accountable officer may use his powers under paragraph (2)(c) to request an investigation (or a joint investigation with other responsible bodies) by the Counter Fraud Unit of RBSO into any possible fraud in relation to health care.

(5) The accountable officer shall keep, or ensure that his designated body keeps, a record of—

(a) any request made to an accountable officer from another designated body, or to another responsible body, under paragraph (2)(c) to investigate a concern that involved, or may have involved, the improper management or use of controlled drugs; and

(b) any assessment or investigation of a concern that involved, or may have involved, improper management or use of controlled drugs by a relevant individual that the accountable officer or his designated body carried out; and

(c) any notification given to another responsible body or accountable officer under regulation 25(4).

Accountable officers to take appropriate action if there are well-founded concerns

17.—(1) An accountable officer shall establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for ensuring that appropriate action is taken for the purposes of protecting patients or members of the public in cases where concerns in relation to the management or use of controlled drugs by a person who is, as regards the designated body, a relevant individual, appear to be well-founded.

(2) If there are well-founded concerns in relation to the management or use of controlled drugs by relevant individuals, or wider concerns of possible fraud in relation to health care, as part of the arrangements established under paragraph (1), the action that the accountable officer may take may include (although it need not be limited to) any of the following—

(a) requesting additional advice, support, mentoring or training from an appropriate person or body, including—

(i) a prescribing advisor,

(ii) a clinical governance lead, or

(iii) in the case of an employee, a line manager within the designated body, or

(iv) the Department;

(b) implementation of a serious adverse incident procedure;

(c) referral of the concerns to a regulatory body;

(d) referral of the concerns to the Police Service of Northern Ireland;

(e) in a case of possible fraud in relation to health care, referral of the concerns to the Counter Fraud Unit of RBSO;

(f) sharing information with, and requesting information from, other responsible bodies, in accordance with regulation 25 or 26; or

(g) requesting that an incident panel be convened by the chair of the local intelligence network (LIN), established under regulation 18(2), made up of officers from any of the bodies that are responsible bodies for the purposes of Part 4, to investigate the concern and make recommendations as mentioned in paragraph (3).

(3) An incident panel convened under paragraph (2)(g) of regulation 18(3), may recommend that the accountable officer or designated body take action that includes (although it need not be limited to) any of the following—

(a) ongoing monitoring of the relevant individual;

(b) referral of the concerns to another accountable officer;

(c) referral of the concerns to a regulatory body;

(d) referral of the concerns to the Police Service of Northern Ireland; or

(e) implementation of a serious adverse incident procedure.

Arrangements for sharing information

18.—(1) An accountable officer shall establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for ensuring the proper sharing of information, in accordance with regulation 25 or 26, by his designated body with other responsible bodies regarding the management and use of controlled drugs.

(2) The Department shall direct accountable officers to establish a network (a local intelligence network) for sharing information regarding the management and use of controlled drugs.

(3) The chair of the network may convene an incident panel, made up any of the responsible bodies, that are the responsible bodies for the purposes of Part 4.

(4) The network shall include the following types of bodies, as appropriate—

(a) the Department;

(b) the Regional Board;

(c) a HSC trust;

(d) NIAS;

(e) RQIA;

(f) the Counter Fraud Unit of RBSO;

(g) the Police Service of Northern Ireland;

(h) a regulatory body.

(1)

S.R. 2002 No. 1

(2)

S.I 2003/1250