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11.—(1) An accountable officer shall—
(a)establish and operate, or ensure that his designated body establishes and operates, appropriate arrangements for monitoring and auditing his designated body’s management and use of controlled drugs; and
(b)ensure that any person acting on behalf of, or providing services under arrangements made with, his designated body, establishes and operates appropriate arrangements for monitoring and auditing their management and use of controlled drugs (that is, their management and use of controlled drugs under their arrangements with the designated body, not under any other arrangements).
(2) Those arrangements shall, in particular, provide for the following—
(a)monitoring and analysing health care and private prescribing of controlled drugs through the use of data and analysis tools available from RBSO;
(b)ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has systems in place to alert the accountable officer of any complaints or concerns involving the management or use of controlled drugs;
(c)ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has an incident reporting system in place for adverse incidents involving the management or use of controlled drugs; and
(d)ensuring that the designated body (and any person acting on behalf of, or providing services under arrangements made with, the designated body) has appropriate arrangements in place for analysing and responding to adverse incidents involving the management or use of controlled drugs.
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