The Controlled Drugs (Supervision of Management and Use) Regulations 2013

PART 3 Responsible bodies

Establishment and operation of local intelligence networks

14.—(1) The NHSCB must determine what are to be the local intelligence network areas for England, and those areas must together cover the whole of England.

(2) The accountable officer of—

(a) the NHSCB in respect of a local intelligence network area must establish and operate a local intelligence network for that area, which may include—

(i) any responsible body in that area,

(ii) a responsible body that has functions in relation to more than one local intelligence network area, and

(iii) different responsible bodies in different circumstances (as determined by the accountable officer);

(b) each Health Board must establish (if there is not one already) and operate a local intelligence network for its area, which may include—

(i) any responsible body in its area,

(ii) a responsible body that has functions in relation to more than one Health Board area, and

(iii) different responsible bodies in different circumstances (as determined by the accountable officer),

for the purposes mentioned in paragraph (3).

(3) Those purposes are facilitating the co-operation of responsible bodies who are members (in any particular circumstances) of the local intelligence network in connection with—

(a) the identification of cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by relevant persons;

(b) the consideration of issues relating to the taking of action in respect of such matters; and

(c) the taking of action in respect of such matters.

(4) An accountable officer who under paragraph (2) is required to operate a local intelligence network for an area (referred to in these Regulations as a “local lead CDAO”) may request—

(a) a periodic declaration and self assessment from a provider of medical, dental, nursing or midwifery services in that area who is a relevant person, which states—

(i) whether the provider uses controlled drugs at any premises from which the provider provides health care, and

(ii) if so, how controlled drugs are managed and used at those premises; and

(b) the accountable officer (P1) of a designated body in the area of the local intelligence network to provide to the local lead CDAO, on a quarterly basis (or more frequently, if there have been concerns that warrant it), an occurrence report that provides—

(i) details of any concerns that a designated body of P1 (that is in that area) has regarding the management or use of controlled drugs by any person that is as regards it a relevant individual, or

(ii) confirming that it has no such concerns,

and if the local lead CDAO does so request, P1 (unless P1 is the accountable officer of the headquarters of a regular or reserve force) must accede to that request.

Co-operation between responsible bodies

15.—(1) Each responsible body that is a member of a local intelligence network must co-operate with other members of that network in connection with—

(a) the identification of cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by individuals who are relevant persons as regards any member of the network;

(b) the consideration of issues relating to the taking of action in respect of such matters; and

(c) the taking of action in respect of such matters.

(2) In so co-operating, a responsible body may disclose to any other member of that network information that it reasonably believes it should disclose to that member, but if that information—

(a) contains confidential information that relates to and can identify a patient; and

(b) disclosure of that confidential information is not required for the purposes of consideration as mentioned in paragraph (1)(b) or taking action as mentioned in paragraph (1)(c),

the responsible body must, in so far as it is practicable to do so, remove from the information that it discloses the confidential information that relates to and can identify a patient.

(3) Where—

(a) it is determined under the arrangements mentioned in regulation 13(2)(b) that an incident, complaint or other concern requires investigation; or

(b) it is determined under the arrangements mentioned in regulation 13(2)(d) that appropriate action needs to be taken with regard to well founded concerns,

the accountable officer (P) of the responsible body that is responsible for those arrangements must notify the persons listed in paragraph (4) with appropriate details of that investigation or, as the case may be, action.

(4) Those persons are—

(a) the local lead CDAO of any local intelligence network of which P is a member in relevant circumstances (unless P is that lead CDAO), if the matter under investigation relates to the area of that local intelligence network; and

(b) any other responsible body that P considers it appropriate to notify (in circumstances where that disclosure is not covered by the arrangements mentioned in regulation 13(2)(c) or (d)).

(5) If a responsible body (RB1) has in its possession information relating to the management or use of controlled drugs that it considers to be of serious concern, it may request in writing additional information in relation to the matter from any other responsible body (RB2) which it considers may have relevant information (which need not be in the same local intelligence network as RB1).

(6) RB2—

(a) must co-operate with RB1 in relation to the serious concern (determining within a reasonable period whether or not to comply with the request for information); and

(b) in so co-operating, may disclose to RB1 information that it reasonably believes it should disclose,

but if that information contains confidential information that relates to and can identify a patient, RB2 must, in so far as it is practicable to do so, remove from the information that it discloses the confidential information that relates to and can identify a patient.

(7) In a case where, but for it not being practicable to do so, a responsible body would remove from information that it believes it should disclose under paragraph (2) or (6)(b) confidential information that relates to and can identify a patient, before disclosing that confidential information it must—

(a) determine that it is necessary to do so; and

(b) where practicable, obtain the consent of the patient (or, where appropriate, a person able to give consent on their behalf) to the disclosure.

Other actions relating to shared information

16.—(1) If information shared under regulation 15 by a responsible body with another body that is a designated body (DB) shows a concern about the inappropriate or unsafe management or use of controlled drugs by a person who is or who could become as regards DB a relevant individual (RI), paragraph (2) applies.

(2) The accountable officer of the DB may—

(a) make recommendations to any responsible body (including any DB) as to any action that the accountable officer considers that the responsible body should take in relation to RI to protect the safety of patients and the general public; and

(b) in connection with doing so, share information about the concern with that responsible body.

(3) If information is shared under regulation 15 with a local lead CDAO about a person (P) who—

(a) is a relevant person—

(i) in England, as regards the NHSCB, or

(ii) in Scotland, as regards the local lead CDAO’s Health Board; and

(b) is not providing services to a designated body as a relevant individual in the area of the local lead CDAO’s local intelligence network,

paragraph (4) applies.

(4) The local lead CDAO must take all reasonable steps to protect the safety of patients or the general public in connection with, or in connection with the possibility of, P engaging in relevant activities, including where appropriate—

(a) referral of the matter to a responsible body (for example a regulatory body or a police force); and

(b) sharing of information about P with any person or a representative of any body (including at a meeting of a local intelligence network of which that person or representative is not a part) who employs or may employ P in relevant activities.