Part 3 U.K.Drugs, Medicines and Pharmacies

Chapter 1U.K.Supervision of management and use of controlled drugs

17Accountable officers and their responsibilities as to controlled drugsU.K.

(1)The relevant authority may by regulations make provision for or in connection with requiring designated bodies to nominate or appoint persons who are to have prescribed responsibilities in relation to the safe, appropriate and effective management and use of controlled drugs in connection with—

(a)activities carried on by or on behalf of the designated bodies, and

(b)activities carried on by or on behalf of bodies or persons providing services under arrangements made with the designated bodies.

(2)The person who is to be so nominated or appointed by a designated body is to be known as its accountable officer.

This is subject to any regulations made by virtue of subsection (5)(e).

(3)In this Chapter “designated body” means—

(a)a body falling within any description of bodies prescribed as designated bodies for the purposes of this section, or

(b)a body prescribed as a designated body for those purposes.

(4)The descriptions of bodies, or bodies, that may be so prescribed are descriptions of bodies, or bodies, appearing to the relevant authority—

(a)to be directly or indirectly concerned with the provision of health care (whether or not for the purposes of the health service), or

(b)to be otherwise carrying on activities that involve, or may involve, the supply or administration of controlled drugs.

(5)Regulations under this section may make provision—

(a)for conditions that must be satisfied in relation to a person if he is to be nominated or appointed by a designated body as the body's accountable officer;

(b)for a single person to be nominated or appointed as the accountable officer for each of two or more designated bodies where those bodies are satisfied as to the prescribed matters;

(c)requiring a designated body that has an accountable officer to provide the officer with funds and other resources necessary for enabling the officer to discharge his responsibilities as accountable officer for the body;

(d)for ensuring that an accountable officer, in discharging his responsibilities, has regard to best practice in relation to the use of controlled drugs;

(e)for the persons required to be nominated or appointed as mentioned in subsection (1) to be known by such name as is prescribed;

(f)for making such amendments of any enactment as appear to the relevant authority to be required in connection with any provision made in pursuance of paragraph (e);

(g)for creating offences punishable on summary conviction by a fine not exceeding level 5 on the standard scale or for creating other procedures for enforcing any provisions of the regulations.

(6)The responsibilities that may be imposed on a designated body's accountable officer by regulations under this section include responsibilities as to the establishment and operation of arrangements for—

(a)securing the safe management and use of controlled drugs;

(b)monitoring and auditing the management and use of such drugs;

(c)ensuring that relevant individuals receive appropriate training and that their training needs are regularly reviewed;

(d)monitoring and assessing the performance of such individuals in connection with the management or use of such drugs;

(e)making periodic inspections of premises used in connection with the management or use of such drugs;

(f)recording, assessing and investigating concerns expressed about incidents that may have involved improper management or use of such drugs;

(g)ensuring that appropriate action is taken for the purpose of protecting patients or members of the public in cases where such concerns appear to be well-founded;

(h)where required by regulations under section 18, the sharing of information.

(7)The arrangements mentioned in subsection (6) may be arrangements established (according to the circumstances)—

(a)by the accountable officer,

(b)by the designated body (or any of the designated bodies) for which he is the accountable officer, or

(c)by a body or person acting on behalf of, or providing services under arrangements made with, the designated body (or any of the designated bodies).

(8)In subsection (6)—

(a)references to the management or use of controlled drugs are to the management or use of drugs in connection with activities carried on by a body or person within subsection (7)(b) or (c), and

(b)“relevant individual” means an individual who, whether as—

(i)a health care professional, or

(ii)an employee who is not a health care professional, or

(iii)otherwise,

is engaged in any activity carried on by a body or person within subsection (7)(b) or (c) that involves, or may involve, the management or use of controlled drugs.

(9)A designated body may confer on its accountable officer such powers as it thinks appropriate to enable him to discharge any of the responsibilities imposed on him as accountable officer for the body by regulations under this section.

(10)Nothing in subsections (5) to (7) is to be read as prejudicing the generality of subsection (1).

(11)In this section “prescribed” means prescribed by regulations under this section.

Commencement Information

I1S. 17 in force for certain purposes at Royal Assent, see s. 83