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Paramedics and medicines: legal considerations

02 August 2016
Volume 8 · Issue 8

Abstract

This article will cover:

The relevant legislation relating to medicines and ambulance services

The restrictions that apply to different organisations or individuals regarding the possession of medicines

Regulations on the administration and supply of medicines

Patient Group Directions and Patient Specific Directions.

The law in relation to the possession of medicines, administration to patients and the supply of medicines is separate.

This article also provides guidance to ambulance services and ambulance clinicians on available options to ensure good patient access to medicines in England. The laws described also apply in Scotland and Wales but there are some different national processes. The law both enables and restricts access to medicines. However, it does require interpretation and a pharmacist can help with this. Where interpretation is contentious then organisations may obtain a legal opinion. Legal opinions can also differ, and can only be resolved in court.

The Joint Royal Colleges Ambulance Liaiaison Committee (JRCALC) recognise the complexity of the topic of legal considerations for medicines, and requested this article in support of its established clinical guidelines. Its intention is to assist all involved—paramedics, pharmacists, employers and governing bodies—to better interpret these complexities.

The Human Medicines Regulations 2012 (No.1916) (HMR) provides an update to the Medicines Act 1968 (c.67) and has been written to ensure that medicines are appropriately evaluated and safely manufactured. The HMR also warrants that the sale and supply of medicines is regulated in order to keep people who are prescribed or given medicines, as safe as reasonably possible. All the organisations and individuals involved in the medicines supply chain need the appropriate licence, certificate or a legal exemption from the regulatory controls. The classification of medicines is given in Table 1.

The Misuse of Drugs Act 1971 (c.38) and its regulations are intended to protect the public from the illicit use of medicines and drugs which have no current medicinal use. Exemptions under the regulations make these medicines (controlled drugs) available to defined groups of organisations and people, and this is discussed later in the article. The classification of controlled drugs is given in Table 2. Drugs controlled under the Misuse of Drugs Act are placed in 1 of 5 schedules, defined by The Misuse of Drugs Regulations 2001 (No. 3998) (MDR). The more harmful a drug can be when misused, the tighter the controls around its availability and safe storage.

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