Background: legislative framework

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.