{
  "url": "https://openlegislation.uk/controlled-drugs-supervision-of-management-and-use-regulations-2013/regulation-13",
  "json_url": "https://openlegislation.uk/controlled-drugs-supervision-of-management-and-use-regulations-2013/regulation-13.json",
  "legislation": "uksi/2013/373",
  "legislation_title": "The Controlled Drugs (Supervision of Management and Use) Regulations 2013",
  "legislation_url": "https://openlegislation.uk/controlled-drugs-supervision-of-management-and-use-regulations-2013",
  "path": "regulation/13",
  "kind": "regulation",
  "number": "13",
  "heading": "Monitoring, assessing, investigating and taking action in relation to relevant individuals",
  "text": "(1) An Accountable Officer (CDAO) of—\n(a) a provider body or group of provider bodies must—\n(i) establish and operate; or\n(ii) ensure that the body or each member of the group of provider bodies establishes and operates,\nwith regard to any person who, as regards the body or bodies, is a relevant individual (RI) because of relevant activities carried on by it or them;\n(b) a commissioning body or group of commissioning bodies must—\n(i) establish and operate; or\n(ii) ensure that the body or each member of the group of commissioning bodies establishes and operates,\nwith regard to any person who, as regards the body or bodies, is a RI because of relevant activities provided for it or them,\nthe arrangements mentioned in paragraph (2).\n(2) Those arrangements are appropriate arrangements for—\n(a) monitoring and assessing the RI's performance in connection with the management and use of controlled drugs;\n(b) determining whether incidents or concerns that relate to the RI's performance in connection with the management and use of controlled drugs require investigation;\n(c) investigating such incidents or concerns; and\n(d) taking appropriate action with regard to well founded concerns (which may relate to incidents).\n(3) Where data in respect of a RI who prescribes controlled drugs, and associated analysis tools, are available to the CDAO's designated body through use of—\n(a) in England, ePACT2 (Electronic Prescribing Analysis and Costs), a system held by the NHSBSA; or\n(b) in Scotland, PRISMS (Prescribing Information Systems for Scotland), a system held by Public Health Scotland,\nthe arrangements under paragraph (2)(a) must include monitoring and assessing the RI's performance using that data and those tools.\n(4) An integrated care board that, for purposes connected with monitoring pharmaceutical remuneration, monitors the management or use of controlled drugs by an individual who is as regards NHS England a RI must assist the relevant CDAO of NHS England in the carrying out of the CDAO's functions under paragraph (1).\n(5) Where it is determined under the arrangements mentioned in paragraph (2)(b) that an incident or a concern requires investigation, the arrangements under paragraph (2)(c) must provide for the CDAO to do one or more of the following—\n(a) carry out the investigation themselves;\n(b) arrange for the investigation to be carried out by another officer or employee of the designated body, or one of the designated bodies, of which the CDAO is the accountable officer; or\n(c) arrange with one or more of the responsible bodies listed in paragraph (6) to carry out the investigation—\n(i) on behalf of the CDAO, or\n(ii) jointly with either the CDAO or an officer or employee as mentioned in sub-paragraph (b).\n(6) The responsible bodies listed in this paragraph are—\n(a) a designated body (that is a designated body of which the CDAO is not the accountable officer);\n(b) the CQC;\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(d) HIS;\n(e) the Scottish Counter Fraud Services;\n(f) the Care Inspectorate;\n(g) a police force; and\n(h) a regulatory body.\n(7) The arrangements under paragraph (2)(d) must include appropriate arrangements for—\n(a) determining whether information relating to incidents or concerns that relate to the RI's performance in connection with the management and use of controlled drugs needs to be shared with a responsible body; and\n(b) in a case where, following investigation, it appears to the CDAO that there are concerns (which may relate to incidents) that relate to the RI's performance in connection with the management and use of controlled drugs that are well founded, as appropriate—\n(i) requesting additional advice, support, mentoring or training for the RI from an appropriate person (for example, a prescribing advisor or a clinical governance lead),\n(ii) implementation of a procedure for dealing with serious untoward incidents,\n(iii) referral of the concerns to—\n(aa) a regulatory body,\n(bb) a police force,\n(cc) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(dd) the Scottish Counter Fraud Services, or\n(ee) if the CDAO is a CDAO of NHS England or a Health Board, an incident panel convened by the CDAO, and\n(iv) where the CDAO is a CDAO of NHS England or a Health Board, dealing with matters arising out of an incident panel, which may include (but need not be limited to)—\n(aa) ongoing monitoring of the individual,\n(bb) referral of concerns to a regulatory body,\n(cc) referral of concerns to a police force,\n(dd) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(ee) referral of concerns to the Scottish Counter Fraud Services, and\n(ff) implementation of a procedure for dealing with serious untoward incidents.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 13(3)(a) substituted (1.4.2020) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 (S.I. 2020/189), regs. 1(2)(b), 7(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 13(3)(b) substituted (1.4.2020) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 (S.I. 2020/189), regs. 1(2)(b), 7(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 13(6)(c) omitted (1.4.2020) by virtue of The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 (S.I. 2020/189), regs. 1(2)(b), 7(b)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 13(7)(b)(iii)(cc) omitted (1.4.2020) by virtue of The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 (S.I. 2020/189), regs. 1(2)(b), 7(c)(i)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Reg. 13(7)(b)(iv)(dd) omitted (1.4.2020) by virtue of The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 (S.I. 2020/189), regs. 1(2)(b), 7(c)(i)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/373/regulation/13",
    "retrieved_at": "2026-10-29T01:03:40.514066+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}