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

Accountable officers to maintain a record of concerns regarding relevant individuals

15.—(1) An accountable officer must—

(a) establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his designated body, a relevant individual; and

(b) ensure that any body or person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates appropriate arrangements for recording concerns expressed about incidents that involved, or may have involved, improper management or use of controlled drugs by a person who is, as regards his designated body, a relevant individual.

(2) The accountable officer must ensure, as part of the arrangements under paragraph (1), that adequate records are compiled, which must include (but not be limited to), as appropriate—

(a) the date on which the concern was made known to the accountable officer;

(b) any dates on which the matters that led to the concern took place;

(c) details regarding the nature of the concern;

(d) details of the relevant individual in relation to whom the concern was expressed;

(e) details of the person who, or body which, made known the concern;

(f) details of any action taken by the designated body (or a body or person acting on behalf of, or providing services under arrangements made with, the designated body) in relation to the concern;

(g) the assessment of whether information in relation to the concern should be disclosed to another responsible body under regulation 25 or 26; and

(h) if information regarding the concern is disclosed to another responsible body under regulation 25 or 26, the details of any such disclosure, including the name of the responsible body to which the disclosure was made and the nature of the information disclosed to the body.

(3) Any record of a concern may be kept in paper or electronic format.

(4) The arrangements under paragraph (1) must include arrangements that limit access to the records to—

(a) the accountable officer and his staff; and

(b) others who need to have access for the purposes of ensuring the safe management or use of controlled drugs.