The management of controlled drugs (CDs) in hospitals, although a multidisciplinary responsibility, is a key element of medicines management governance.
Controlled drugs in
hospital pharmacy
Background: legislative framework
The management of
controlled drugs (CDs) in hospitals, although a multidis-ciplinary
responsibility, is a key element of medicines management governance. It is
helpful, when considering CD issues, to understand the basic legislative
framework, and a little of why and how it has developed over the past decade.
Most CD legislation is consistent across the UK, though there are slightly
different arrangements that underpin the delivery of these requirements across
the four regions of the UK. This chapter refers predominantly to the
legislation in England.
The conviction of Dr
Harold Shipman for the murder of 15 of his patients using CDs and the
subsequent findings of the independent public inquiry, led by Dame Janet Smith,
laid much of the foundation for the Department of Health’s Safer Management of
Controlled Drugs programme. The inquiry’s Fourth Report focused on the methods
used by Shipman to divert large quantities of CDs for his own purposes, and
considered how he was able to do this for so long without detection. It
concluded that there were serious shortcomings in the systems for regulating
CDs and, in response, the government proposed a series of measures which
involved amendments to existing, as well as new, legislation.
The Department of
Health is responsible for The Health Act 2006, which applies across the UK and
with its associated regulations provides the basis for the new legislation
strengthening the governance and monitoring arrange-ments for CDs. Whilst
continuing to encourage good practice, it introduced and strengthened systems
aimed at detecting unusual or poor practice, criminal activity or risk to
patients. It is this Act that introduced the requirement for healthcare
organisations to appoint a CD accountable officer.
No one agency holds
complete responsibility for CDs or for CD legislation and it is important to
remember that the overall legislative framework which applies to all medicines
is the Medicines Act 1968, and subsequent regula-tions, which are managed by
the Medicines and Healthcare products Regulatory Agency (MHRA).
CDs are simply a
group of substances, some of which are used as medicines, that have the
potential for abuse. For this reason the Home Office has placed additional
controls on these substances through the Misuse of Drugs Act 1971. The Misuse
of Drugs Act imposes a complete ban on the possession, supply, manufacture,
import and export of CDs, except in situations allowed by regulations or by
licence. In the Act substances are divided into three classes, A, B and C; this
categorisation is linked to the maximum penalties that may be imposed in
criminal law on a person convicted of an offence under the Act. The Act also
introduced the Advisory Council on the Misuse of Drugs, a body that keeps under
review substances that are likely to be misused or constitute a social problem
in the UK and provides advice on measures to prevent misuse.
It is the Misuse of
Drugs Regulations 2001 which permit the clinical use of CDs as medicines, many
of which are extremely valuable to patient care. The Misuse of Drugs
Regulations (Northern Ireland) 2002 are broadly similar to the Misuse of Drugs
Regulations 2001. The 2001 regulations categorise CDs into five
schedules according to the level of control they need: schedule 1 CDs are
subject to the highest level of control and schedule 5 CDs are subject to the
lowest level of control. Few substances in schedule 1 are used therapeutically
and so it is schedule 2 substances used in medicinal products that are the
focus of the most stringent procedures in hospitals. Detailed information
relating to each schedule can be found using the further reading and reference
resources provided at the end of this chapter.
The controls placed
on each drug in a specific schedule relate to all aspects of medicines
management, including medicine production and supply, pos-session,
prescription, record-keeping, preservation of records and supervision of
destruction; the controls reflect a judgement balancing the therapeutic benefit
against potential harm if the substance were to be misused. Hospital pharmacy
staff play a crucial role in ensuring CDs are available for use in patient care
when clinically indicated. Strengthened controls, implemented through local
procedures, should support healthcare professionals and encourage good practice
whilst providing monitoring tools that can help to indicate when potential
misuse or misdirection might be a concern. Misuse of CDs can occur in any
aspect of their management.
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