Legal Aspects of Medicines 2nd Edition

Title Page

LEGAL ASPECTS OF MEDICINES

2nd Edition

by Bridgit Dimond

Copyright Page

Originally published by Quay Books Division, MA Healthcare Ltd, St Jude’s Church, Dulwich Road, London SE24 0PB

© MA Healthcare Limited 2011

Digital version converted and published in 2012 by

Andrews UK Limited

www.andrewsuk.com

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from the publishers

Cover design by Louise Cowburn, Fonthill Creative

Associate Publisher: Thu Nguyen

Note

Healthcare practice and knowledge are constantly changing and developing as new research and treatments, changes in procedures, drugs and equipment become available.

The author and publishers have, as far as is possible, taken care to confirm that the information complies with the latest standards of practice and legislation.

Foreword to the first edition

There are several reasons why the law on medicines has become increasingly complicated over the last few years. The creation of a European drug regulatory system (the European Medicines Agency) and the extension of prescribing privileges (and responsibilities) to wider groups of health professionals are only part of the story. Public and professional revulsion over the activities of the late Dr Shipman (who was responsible for poisoning over 200 of his patients), concerns about the increasing use of drugs for recreational purposes, and worries about the extent to which avoidable errors in prescribing lead to serious harm, have all played a role in the way our laws have been – and continue to be–shaped. Professor Dimond’s easy and accessible synthesis of the UK’s current legal framework for medicines is both appropriate and timely. It will be an essential work of reference for all of us who work in healthcare.

Professor Sir Michael Rawlins

National Institute for Health and Clinical Excellence, London WC1

August 2005

Preface to the first edition

Like the other books in this series, this monograph follows the publication of a series of articles in the British Journal of Nursing on the law relating to medicines. Those articles, revised and updated, form the basis of a concise publication covering the main concerns which arise in the law relating to medicines in the NHS and private sector.

This book is intended for all health professionals who are likely to be involved in the dispensing, administration, prescribing or supply of medication, whether in hospitals or in the community. It may also be of assistance to others, such as health service managers, patient groups and their representatives, lecturers and clinical supervisors.

Each chapter uses a situation to illustrate the relevant laws so that the law can be explained in a practical jargon-free way. The basic facts of the legal system are briefly set out in the first chapter. The book does not pretend to be encyclopaedic in its coverage; rather, it is intended to introduce readers to the basic principles which apply and the sources of law, so that they can, by following up the further reading and web sites provided, add to their knowledge. Changes in the statutory provisions and new cases will require some amendments over time. The NHS Plan (Department of Health 2000) envisaged that the old demarcations will be shattered and nurses, midwives and therapists would be able to take on a wider range of clinical tasks, including running clinics and discharging patients and pharmacists will be able to take on a new role as they shift away from being paid mainly for dispensing of individual prescriptions towards rewarding overall service. As a consequence, roles in relation to the supply and prescribing of medications and in the role of the hospital and the community pharmacist have changed ever more rapidly over recent years, and this will ultimately have a profound influence on the care of the patient and the organisation of healthcare. This book will provide a baseline on which readers can develop their knowledge and understanding of the law relating to medicines.

Preface to the second edition

Six years have now elapsed since this book was first published and many changes have taken place in the context of medicines supply administration and prescription; many a consequence of the 4th Shipman Inquiry Report. This new edition tracks these developments and also notes the changing legal context: The Mental Capacity Act 2005 implemented in 2007 has filled the gap on decision making on behalf of the mentally incapacitated adult; the Equality Act 2010 has brought the anti-discrimination legislation into one statute; new regulations cover herbal and homeopathic medicines. Within the NHS a revolution is taking place: the Health and Social Care Bill making its way through Parliament will, if enacted, fundamentally change the relationships of GPs and their consortia with the NHS Trusts and private sector providers. Pharmacists are finding that their advisory role is increasing It is hoped that this book will continue to provide a foundation upon which all those health professions involved in the supply, administration or prescribing of medicines can build their knowledge.

Acknowledgements

Once again I am extremely grateful for the thoroughness and care with which Bette Griffiths prepared the indexes and read the proofs for the first edition and thank her for her help. I would also like to pay tribute to the support and help provided to me by Helen Scott during her years as editor of the British Journal of Nursing in which publication this book took root. Her high standards, awareness, sensitivity and compassion served the journal, its contributors and readers superbly over many years and will be invaluable in her return to nursing. It is to Helen that I dedicate this book.

Glossary

Abbreviations

Table of useful web sites

Audit Commission http://www.audit-commission.gov.uk/

British National Formulary http://www.bnf.org/

Bristol Inquiry (Kennedy Report) http://www.bristol-inquiry.org.uk/

Civil Procedure Rules http://www.open.gov.uk/lcd/civil/procrules_fin/crules.htm

Commission for Racial Equality http://www.cre.gov.uk/

Department of Constitutional Affairs http://www.dca.gov.uk/

Department of Health http://www.dh.gov.uk/

Department of Health (research) http://www.dh.gov.uk/research/rd1/researchgovernance/

Department of Trade and Industry http://www.dti.gov.uk/

Domestic Violence http://www.domesticviolence.gov.uk/

Health and Safety Commission http://www.hsc.gov.uk/

Health and Safety Executive http://www.hse.gov.uk/

Health Professions Council http://www.hpc-uk.org/

Human Fertilisation and Embryology Authority http://www.hfea.gov.uk/

Human Rights http://www.humanrights.gov.uk/

Medicines and Healthcare Products Regulatory Agency http://www.mhra.gov.uk/

MIDIRS http://www.midirs.gov.uk/

National Audit Office http://www.nao.gov.uk/

National Patient Safety Agency http://www.npsa.org.uk/

National Service Framework (older people) http://www.doh.gov.uk/NSF/olderpeople/

National Treatment Agency http://www.nta.nhs.uk/

NHS http://www.nhs.uk/

NHS Direct http://www.nhsdirect.nhs.uk/

NHS Professionals http://www.nhsprofessionals.nhs.uk/

NICE http://www.nice.org.uk/

Nursing and Midwifery Council http://www.nmc-uk.org/

Open Government http://www.open.gov.uk/

Pain website http://www.pain-talk.co.uk/

Royal College of Midwives http://www.rcm.org.uk/

Royal College of Nursing http://www.rcn.org.uk/

Royal Pharmaceutical Society http://www.rpharms.com/

Shipman Inquiry http://www.the-shipman-inquiry.org.uk/reports.asp

Stationery Office http://www.hmso.gov.uk/

UK Parliament http://www.parliament.uk/

Victoria Climbie Inquiry http://www.victoria-climbie.org.uk/

1: The statutory framework for medicines

Box 1.1 Situation of ignorance

Jane has just started her training to become a registered nurse at the Roger Park Higher Education College, which is affiliated to Roger Park University. On her first week of clinical experience at Roger Park District General Hospital, she was asked by a staff nurse to give a patient her dose of painkillers. Jane is totally ignorant of the laws which apply to medicines and asks her tutor whether she was right to obey those instructions from the staff nurse. She would also like to know how she can find out about what makes a law and how she can know whether or not she is acting lawfully.

Introduction

Our laws derive from two main sources: statute law (including statutory instruments) and case law (judge-made law, also known as the common law). Increasingly, Directives and Regulations from the European Community relating to medicinal products, with which we as a member state must comply, are forming a large part of our laws on medicines.

Legislative framework for medicines

The two main sources of law on medicinal products are the Medicines Act 1968 and the Misuse of Drugs Act 1971. The Medicines Act 1968 (and its subsequent Statutory Instruments (SI)) provide a statutory framework for the manufacture, export and import and supply and control of medicines. Box 1.2 shows the basic contents of the Act and Box 1.3 sets out the classification of drugs recognised in the Act. The Misuse of Drugs Act 1971 and subsequent legislation regulates the supply of specified Controlled Drugs (CD) which are discussed in the next chapter.

These statutes have been supplemented by Statutory Instrument providing more detailed regulation.

Box 1.2 Framework set up by the Medicines Act 1968

1. An administrative system

2. A licensing system

3. Controls over the sale and supply of drugs to the public

4. Retail pharmacies

5. Packing and labelling of medicinal products

6. British Pharmacopoeia

Definition of a medicinal product

In the Medicines Act 1968 section 130, ‘medical product’ means: any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say:

a. use by being administered to one or more human beings or animals for a medicinal purpose;

b. use, in circumstances to which this paragraph applies, as an ingredient in the preparation of a substance or article which is to be administered to one or more human beings or animals for a medicinal purpose.

‘Medicinal purpose’ means one or more of the following purposes:

a. treating or preventing disease

b. diagnosing disease or ascertaining the existence, degree or extent of a physiological condition

c. contraception

d. inducing anaesthesia

e. otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating the operation of that function or in any other way.

Certain products, such as surgical ligatures and sutures, dental fillings, contact lenses and intra-uterine contraceptive devices have since 1994 been defined as medical devices and come under the Medical Devices Regulations 1994 SI 1994 No 3017 (as amended) (Dimond 2011). The term ‘medicinal product’ is also to be distinguished from food and from poisons.

Licensing

Part II of the Medicines Act 1968 and the EC Council Directives require licences to:

Sell, supply or export any medicinal product or

Procure the sale, supply or exportation of any medicinal product or

Procure the manufacture or assembly or any medicinal product (S.7(2)).

Licences are also required for manufacture and wholesale dealers and clinical trials (subject to extensive exemptions which will be considered in Chapter 26 on research into medicinal products).

Section 11 of the Medicines Act 1968 exempts a registered nurse or registered midwife from having a manufacturer’s licence in order to assemble medicinal products in the course of her profession. ‘Assemble’ means (section 132):

The enclosing of the products (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied or, where the product (with or without medicinal products of the same description) is already enclosed in a container in which it is to be sold or supplied, labelling the contained before the product is sold or supplied in it.

Manufacturing units within hospitals

Since the abolition of Crown immunity under the provisions of the NHS and Community Care Act 1990, manufacturing units in hospitals come under the licensing provisions of the Medicines Act 1968 and are subject to the Medicines Control Agency (MCA) (which has been the Medicines and Healthcare Products Regulatory Agency (MHRA) since 1 April 2003) and its inspectorate.

Section 10 provides certain exemptions where an activity takes place under the supervision of a pharmacist in a hospital. The pharmacy in a hospital can seek registration with the General Pharmaceutical Council (GPC) as a registered pharmacy, thus enabling it to provide over-the-counter medicines and a limited amount of wholesale dealing. The MCA (1992) has published guidance for NHS on the licensing requirements under the Medicines Act 1968.

Classification of medicinal products

The classification of medical products is presented in Box 1.3.

Box 1.3 Classification of medicinal products

1. Pharmacy Only Medicines

2. General Sales Medicines (GSM)

3. Prescription Only Medicines (POM)

Any procedure for dealing with medicines in hospitals or in a community home, whether residential care, nursing or mental nursing, should ensure that the specific requirements for these different classes of drugs are met, unless specified exemptions apply (e.g. Patient Group Directions (PGD), which are considered in Chapter 8).

Pharmacy Only Medicines refers to those medicinal products which can only be purchased under the supervision of a registered pharmacist or given out by a dispensing doctor (i.e. one who is authorised to dispense medicines). See below for exceptions to this rule in hospitals and health centres.

General Sales Medicine (GSM) covers drugs which are sold through a variety of outlets, for which a registered pharmacist does not have to be present. Under section 51 of the Medicines Act they are medicinal products which in the opinion of the Minister can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist. There are two Schedules to the SI 1984 No 769 (as amended) which list the classes of medicinal products coming under GSM. The regulations also list the pack sizes. If these limitations are not observed, then the medicinal product comes under the classification of Pharmacy Medicine or Perscription Only Medicines (POM).

For example, medicines for human use containing aspirin or paracetamol may only be presented for sale in separate and individual containers or packages containing not more than:

16 capsules or tablets (non-effervescent)

10 sachets (powder or granule)

30 tablets containing not more than 325 mg (effervescent tablets)

20 tablets where the amount of aspiring exceeds 325 mg but does not exceed 500 mg (effervescent tablets).

Those medicinal products which are listed under the GSM list can be sold from automatic machines provided