Safe management of controlled drugs
A controlled drug is a prescription medicine that is
subject to strict legal controls. These controls are to prevent it
from being misused, being obtained illegally or causing harm. The
law determines, for example, how these medicines are produced,
stored, prescribed and destroyed.
Legislation for managing all medicines, including controlled
drugs, lies with the UK Parliament and applies to all parts of the
In April 2013, revised regulations on
controlled drugs were introduced, as a result of the change to
the regulations, Healthcare Improvement Scotland has a more
explicit governance role in the safe management of controlled
Role of Healthcare Improvement
Maintain and publish a register of
Controlled Drugs Accountable Officers in Scotland
The Controlled Drugs Regulations 2013
require every designated body in Scotland to appoint a Controlled
Drugs Accountable Officer who is responsible for ensuring the
safe and effective use and management of controlled drugs within
the organisations which they oversee.
Healthcare Improvement Scotland must
be notified of the details of the person nominated to take on this
register of controlled drugs accountable officers
Manage the process that allows
healthcare providers who meet the specified criteria apply to be
exempt from appointing a CDAO
Independent healthcare providers that have less than 10 staff do
not need to appoint a CDAO under the Regulations
Independent healthcare providers with
more than 10 staff can apply to for this exemption if they:
- do not normally use a lot of
- would find it difficult to appoint a
suitable individual to the role
We will keep a record of organisations
that are exempt from this requirement and publish these alongside
the CDAO register.
Introduce a process of self
declaration and self assessment so that healthcare organisations
can monitor their clinical governance arrangements for controlled
During 2013/14 we undertook a
baseline review and asked healthcare organisations to complete a
self declaration and self assessment.
A report of
the findings of this review is now available.
Healthcare Improvement Scotland is
committed to promoting a joint working approach and continues to
work closely with other regulatory and inspection bodies, including
the Care Quality Commission, as well as the Scottish Government,
the Care Inspectorate, the Controlled Drugs Accountable Officers
Network in Scotland.
Controlled drugs quarterly occurrence
From July 2015 independent healthcare services
will no longer require to submit a quarterly report to their NHS
Controlled Drugs Accountable Officer (NHS CDAO).
Healthcare Improvement Scotland, in
collaboration with the controlled drugs accountable officers
network, the Care Inspectorate and key stakeholders reviewed the
processes for submitting controlled drugs e-notifications to
Healthcare Improvement Scotland and controlled Drugs quarterly
occurrence reports to NHS CDAOs.
From July 2015 Healthcare Improvement Scotland
will submit the controlled drugs quarterly occurrence
reports to NHS CDAOs on behalf of independent healthcare