The Controlled Drugs (Supervision of Management and Use) Regulations 2006

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

17.—(1) An accountable officer must 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 the health service, as part of the arrangements established under paragraph (1), but subject to paragraphs (4) and (5), 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, 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;

(b) implementation of a serious untoward incident procedure;

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

(d) referral of the concerns to a police force;

(e) in a case of possible fraud in relation to the health service, referral of the concerns to—

(i) the Counter Fraud and Security Management Service Division of the NHS Business Services Authority, or

(ii) NHSScotland Counter Fraud Services (which is part of the Common Services Agency);

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

(g) if the accountable officer is an accountable officer nominated or appointed by a Primary Care Trust or Health Board, convening an incident panel, 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) 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 a police force; or

(e) implementation of a serious untoward incident procedure.

(4) In Scotland, if the accountable officer of a Health Board is aware of well-founded concerns in relation to the management or use of controlled drugs by a person who—

(a) is a relevant individual as respects the accountable officer’s Health Board, and the Health Board is an “appropriate Health Board”, as defined in regulation 2 of the 2006 Regulations (interpretation), as respects that individual;

(b) is a “practitioner” for the purposes of the 2006 Regulations (that is, a doctor, a dentist, an ophthalmic medical practitioner, an optician, a pharmacist or a pharmacist contractor(1)); and

(c) may, in a way that is related to those concerns, have failed to comply with “terms of service”, as defined in regulation 2 of the 2006 Regulations, that he has with that or another Health Board,

then subject to paragraph (5), the accountable officer for the Health Board must, as part of the arrangements established under paragraph (1), ensure that his Health Board takes a decision in relation to the possible breach of terms of service under regulation 4(1) of the 2006 Regulations (provisions relating to the start of disciplinary proceedings).

(5) In Scotland, if, arising out of arrangements under this regulation, an accountable officer becomes aware of well-founded concerns relating to a possible fraud in relation to the health service, the accounting officer must—

(a) refer the concerns to NHSScotland Counter Fraud Services (which is part of the Common Services Agency); and

(b) take advice from NHSScotland Counter Fraud Services before taking any disciplinary action against any person which could compromise any action taken by NHSScotland Counter Fraud Services as a consequence of that referral.

(1)

See the definition of “practitioner” in regulation 2 of the 2006 Regulations.