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11.—(1) An accountable officer (CDAO) of a provider body or a group of provider bodies must—
(a)establish and operate, or ensure that the provider body or each member of the group of provider bodies establishes and operates, appropriate arrangements for securing the safe management and use of controlled drugs by the CDAO’s provider body or group of provider bodies; and
(b)review as appropriate, or ensure that the provider body or each member of the group of provider bodies reviews as appropriate, those arrangements.
(2) A CDAO of a commissioning body or a group of commissioning bodies must ensure that any person or undertaking that provides the body or group with relevant services—
(a)establishes and operates appropriate arrangements for securing the safe management and use of controlled drugs; and
(b)reviews as appropriate those arrangements.
(3) The arrangements mentioned in paragraphs (1) and (2) must include—
(a)appropriate arrangements for compliance with the Misuse of Drugs Act 1971(1) and subordinate legislation under that Act;
(b)the following systems (which may be part of a single overarching system)—
(i)systems for recording concerns (including complaints) relating to the safe management or use of controlled drugs, and
(ii)incident reporting systems for untoward incidents relating to the safe management or use of controlled drugs; and
(c)up to date standard operating procedures in relation to the management and use of controlled drugs, which cover (amongst other matters) 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.
(4) A CDAO of a provider body or group of provider bodies must ensure that any person who—
(a)as regards that provider body or group of provider bodies is a relevant individual; and
(b)needs information on, or education or training in relation to, the standard operating procedures referred to in paragraph (3)(c),
receives, as appropriate, that information, education or training.
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