11.—(1) An accountable officer must—
(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 a body or person acting on behalf of, or providing services under arrangements made with, his designated body establishes and operates appropriate arrangements for monitoring and auditing the person or body’s 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 must, in particular, provide for the following—
(a)monitoring and analysing health service and private prescribing of controlled drugs through—
(i)in England, the use of ePACT (Electronic Prescribing Analysis and Costs) data (where data is available to the designated body) and analysis tools available from the Prescription Pricing Division of the NHS Business Services Authority, or
(ii)in Scotland, the use of PRISMS (Prescribing Information System for Scotland) data (where data is available to the designated body) and analysis tools available from the Healthcare Information Group of the Information Services Division of the Common Services Agency;
(b)ensuring that the designated body (and any body or 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 body or person acting on behalf of, or providing services under arrangements made with, the designated body) has an incident reporting system in place for untoward incidents involving the management or use of controlled drugs; and
(d)ensuring that the designated body (and any body or 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 untoward incidents involving the management or use of controlled drugs.