Pharmacy Law and Practice - 5th Edition - ISBN: 9780123942890, 9780123946188

Pharmacy Law and Practice

5th Edition

Authors: Jon Merrills Jonathan Fisher
eBook ISBN: 9780123946188
Paperback ISBN: 9780123942890
Imprint: Academic Press
Published Date: 1st May 2013
Page Count: 570
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Pharmacy Law and Practice, Fifth Edition provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice.

Key Features

  • Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more
  • Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together
  • The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area


MPharm students and pre-registration students, practicing pharmacists and professors of pharmacy in the UK.  Secondary audiences may include pharmacy technicians, NHS professionals and lawyers specializing in pharmacy law.

Table of Contents

  • Preface
  • Chapter 1. The National Health Service: History of the National Health Service from Conception to Latest Changes
    • Introduction
    • The National Insurance Act 1911
    • A National Health Service Begins
    • The National Health Service Act 1946
    • The National Health Service Act 1977 (Now Repealed)
    • The National Health Service Act 2006
    • Recent Changes: The NHS and Social Care Act 2012
    • Amendments to the NHS Act 2006
    • What the 2012 Act Does
    • Additional Resources
  • Chapter 2. Administration of the NHS: The New Administrative Structure of the NHS
    • Administration
    • The NHS Commissioning Board
    • Annual Mandate to the Board
    • The NHS Constitution
    • NHS Foundation Trusts
    • Monitor
    • Clinical Commissioning Groups
    • Extracts from the Health Act 2006
    • Public Health
    • NHS Walk-in Centres
    • NHS Direct
    • National Institute for Health and Care Excellence
    • Care Quality Commission
    • Special Health Authorities
    • NHS Business Services Authority
    • NHS Prescription Services
    • Health and Care Professionals Council
    • Professional Standards Authority for Health and Social Care
    • Health and Social Care Information Centre Special Health Authority
    • NHS Trusts
    • Ambulance Trusts
    • Northern Ireland
    • Scotland
    • Additional Resources
  • Chapter 3. NHS Pharmaceutical Services in the Community
    • The Duty
    • Health Professions Council Register
    • The Contract
    • Contractors Obligations
    • Terms of Service
    • Course of Treatment Packs
    • Dispensing from Bulk
    • Changes to Hours Made by the NHS CB
    • Additional Resources
  • Chapter 4. The Drug Tariff: Reimbursement and Remuneration Structure for Community Pharmacy
    • Legislative Basis
    • DT Forms Part of Pharmacy Contract
    • Monthly Changes
    • Basic Principles of Prescribing and Dispensing in NHS
    • DT Clauses
    • How Must NHS Prescription Forms Be Endorsed?
    • Prices in Part VIII
    • Part VIII Categories
    • The Blacklist and the Selected List
    • How Are Payments Made?
    • Price Control of NHS Medicines
    • Additional Resources
  • Chapter 5. Applications to Dispense NHS Scripts
    • Professional and Medicines Act Controls
    • NHS Contract Controls
    • History of Control of Entry to NHS Pharmaceutical Lists
    • The 2013 Changes
    • Problems with Terminology
    • Exercise of Functions by the CB
    • Three Types of Provider
    • The Pharmaceutical List
    • Control of Entry to Lists
    • Pharmaceutical Needs Assessment
    • Applications to NHS CB
    • Planning Law
  • Chapter 6. Rural Dispensing
    • History
    • The Current Rules
    • Applications by Doctors
    • Additional Resource
  • Chapter 7. Prescription Charges
    • The Regulations
    • Additional Resources
  • Chapter 8. The Interests of the Public
    • The NHS Constitution
    • Duty of the Secretary of State as to the NHS Constitution
    • Health and Wellbeing Boards
    • Healthwatch
    • Independent Complaints Advocacy Services
    • Patient Advocacy and Liaison Services
    • Care Quality Commission
    • The Health Service Commissioner for England
    • Public Health England
    • The Health Protection Agency
    • Public Health Observatories
    • Monitor
    • Audit Commission
    • Freedom of Information Act 2000
    • Access to Meetings
    • National Patient Safety Agency
    • Additional Resources
  • Chapter 9. Complaints and Breaches of the Terms of Service
    • Care Quality Commission
    • Extract from Complaints Regulations
    • Sanctions for Breach of Terms of Service
    • Removal or Suspension of Practitioners
    • National Disqualification
    • Extract from NHS Act 2006 as Amended
    • Additional Resources
  • Chapter 10. Retail Pharmacy
    • The Nature of the Control
    • History
    • Registered Pharmacy
    • Retail Pharmacy Business (RPB)
    • Responsible Pharmacist
    • Additional Resources
  • Chapter 11. The Manufacture and Licensing of Medicinal Products
    • The Medicines Act 1968 and Other Controls
    • European Directives
    • The Medicines Act 1968
    • Human Medicines Regulations 2012
    • Medicinal Products
    • Marketing Authorisation
    • Legal Classification
    • Wholesaling by Pharmacies
    • The European Medicines Agency
    • The Advisory Machinery
    • Summary of Product Characteristics
    • Patient Information Leaflet
    • Product Information
    • Medical Devices
    • New Rules
    • Additional Resource
  • Chapter 12. Control on Sales of Medicines
    • Control of Retail Sales
    • Reclassification of Medicines
    • Injections
    • European Economic Area Health Professionals
    • Electronic Prescriptions
    • Wholesaling of Medicines
    • Records
    • ‘Pseudo’ - Wholesale Transactions
    • Additional Resources
  • Chapter 13. Emergency Supplies, Deliveries and Faxed Prescriptions
    • Supply of Medicines in an Emergency
    • Collection and Delivery Schemes
  • Chapter 14. Unlicensed Products
    • Unlicensed Products
    • Off-label Use
    • Reasons for Using Unlicensed Products
    • Exemptions for Unlicensed Medicines
    • Obtaining Unlicensed Products
    • Extemporaneous Preparation in the Pharmacy
    • Preparation of Stock
    • Guidance on the Exemption for Pharmacists
    • Specials
    • Record Keeping
    • Imports
    • Exemption for Doctors
    • Extracts from the Human Medicines Regulations 2012
    • Record-Keeping Requirements
    • Additional Resources
  • Chapter 15. Traditional and Alternative Medicines
    • Herbal Products
    • Herbal Remedies
    • Homeopathic Medicines
    • Advertising of Registered Homoeopathic Products
    • Additional Resource
  • Chapter 16. Controlled Drugs
    • General Prohibitions in the Misuse of Drugs Act 1971
    • Classes of CDs
    • Reclassification of Cannabis
    • Cultivation of Cannabis Plant
    • International Convention
    • Regulations Concerned with Misuse of Drugs
    • The Misuse of Drugs Regulations 2001
    • Possession of CDs
    • Requirements for Writing Prescriptions
    • CD Register
    • Safe Custody
    • Addicts
    • Miscellaneous Legislation Affecting CDs
    • Additional Resources
  • Chapter 17. Labelling, Leaflets, Packaging and Advertising
    • General Provisions for Labelling
    • Paracetamol Warnings
    • P and POM Products
    • Packaging Requirements: Information for Blind and Partially Sighted Patients
    • Labelling of Dispensed Medicinal Products
    • Supply by Doctors, Dentists, Nurses and Midwives
    • Pharmacists’ Own Remedies
    • Dispensed Medicines in CRCs
    • Standard Requirements for Patient Information Leaflets
    • Radiopharmaceuticals
    • Advertising and Sales Promotion
    • Adverts to the Public
    • Advertisements to Health Professionals
    • Additional Resources
  • Chapter 18. Poisons and Dangerous Substances
    • The Poisons Board
    • Poisons List
    • Listed Sellers
    • The Poisons Rules
    • Schedule I Poisons Subject to Extra Controls
    • The CHIP4 Regulations 2009
    • The Environmental Protection Act 1990
    • Medicines Returned from Domestic Premises
    • COSHH
    • Packaging Waste
    • Dangerous Substances and Explosive Atmospheres Regulations 2002
    • Food Safety Act 1990
    • The Offensive Weapons Act 1996
    • Additional Resource
  • Chapter 19. Patient Group Directions
    • What are Patient Group Directions
    • Background
    • Definition
    • Differences Between PGDs and Written Directions
    • Types of PGD
    • Information in the PGD Itself
    • The Groups Who May Supply or Administer
    • The Signatures Required
    • Independent Hospitals, Clinics and Medical Agencies
    • Arrangements for Scotland
    • Controlled Drugs
    • Radiopharmaceuticals
    • Extracts from the Human Medicines Regulations
  • Chapter 20. Non-Medical Prescribing
    • Background
    • What Is Non-Medical Prescribing?
    • Legislation
    • Independent Prescribing
    • Supplementary Prescribing
    • The Clinical Management Plan
    • Parenteral Administration by Supplementary Prescribers
    • Numbers of Non-Medical Prescribers
    • Additional Resource
  • Chapter 21. Rights of Access
    • Access to Pharmacies
    • GPhC Inspectors
    • Regulation of Investigatory Powers Act 2000
    • Directed Surveillance
    • NHS Commissioning Board
    • Local Healthwatch
    • NHS Counter Fraud Service
    • Police Controlled Drugs Inspectors
    • The CQC
    • Her Majesty’s Revenue and Customs
    • Health and Safety Inspectors
    • Trading Standards (Weights and Measures)
    • Disclosure of Confidential Information
    • Northern Ireland Pharmacy Inspectors
    • Additional Resources
  • Chapter 22. Confidentiality
    • The Data Protection Act 1998
    • The Principles
    • Sensitive Personal Data
    • The Subject’s Rights
    • Use of Personal Data for Research or Analysis
    • Non-Computerised Records
    • Access to Health Records Act 1990
    • Access to Medical Reports Act 1988
    • Use of Anonymised Data for Research
    • Control of Patient Information Under the NHS Act 2006
    • The Health Service (Control of Information) Regulations 2002
    • The NHS Act 2006
    • Confidentiality and Children
    • The Caldicott Review 1997
    • Department of Health Code of Practice
    • Ethical Obligations Placed on Pharmacists
    • Records
    • Disclosures Required by Law
    • Additional Resources
  • Chapter 23. Consent
    • Definition of Consent
    • Basis for the Consent Concept
    • Consent by Children
    • The Law in Scotland
    • Additional Resources
  • Chapter 24. The European Union
    • The Beginnings
    • Key Dates and Treaties
    • The Schengen Agreement
    • The Introduction of the Euro
    • Law-making Institutions
    • Community Law
    • Directives Affecting Pharmacy
    • Free Movement of Professionals
    • Language Ability
    • Titles
    • Additional Resources
  • Chapter 25. The Pharmacy Profession
    • History
    • The RPS
    • The Statutory Committees of the GPhC
    • The Standards of Professional Conduct
    • Internet Pharmacy
    • NHS Prescription Fraud
    • Additional Resources
  • Chapter 26. Liability in Negligence
    • Dispensing Mistakes
    • Breach of Contract
    • Negligence
    • Liability as an Occupier of Premises
    • Corporate Manslaughter
    • Corporate Manslaughter and Corporate Homicide Act 2007
  • Chapter 27. Business Premises
    • Freehold Premises
    • Leasehold Premises
    • Planning Law
  • Chapter 28. Business Associations
    • The Sole Trader
    • Partnership
    • The Limited Company
    • Formal Requirements for Running a Company
    • Notification of Changes After Incorporation
  • Chapter 29. The Sale of Goods
    • Contract for the Sale of Goods
    • Remedies Available to the Seller and Buyer in Default
    • Buyer’s Remedies
    • Product Liability
  • Chapter 30. Employment Law
    • The Contract of Employment
    • Special Categories of Employee
    • Employee’s Duties Under the Contract of Employment
    • Employer’s Duties Under the Contract of Employment
    • Safe Working Environment
    • Employer’s Duties
    • Wages Issues
    • Maternity Issues
    • Insolvent Employer
    • Equal Pay and Discrimination
    • The Categories of Discrimination
    • Discrimination on the Grounds of Race
    • Disability Discrimination
    • Bringing the Employment to an End
    • Redundancy Awards
    • Human Rights at Work
  • Chapter 31. Human Rights
    • Human Rights and Privacy
    • Human Rights and Patient Confidentiality
    • Human Rights and Employment Issues
    • Human Rights and Property Interests
    • Freedom of Information
  • Index


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© Academic Press 2013
Academic Press
eBook ISBN:
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About the Author

Jon Merrills

Affiliations and Expertise

Parkdale House Nottingham NG7 1DE United Kingdom

Jonathan Fisher

Affiliations and Expertise

Devereaux Chambers, Temple, London, United Kingdom


"Written in plain language especially for pharmacy students and pharmacists without legal background, this reference/text examines the UK law related to pharmacy practice in a broad socio-political context and provides practical advice on how to follow regulatory guidelines… This fifth edition is completely revised in light of recent changes to the law. It offers new material on employment law, Internet pharmacies, controlled drugs, non-medical prescribing, and veterinary medicines." --Reference and Research Book News, December 2013

"This book on pharmacy law and practice describes the law rather than just listing the acts and cases that make up the law applying to community pharmacy. Many chapters further describe the law in great detail for various…areas of community pharmacy. Since new laws are always being implemented, each edition has been a complete rewrite. The previous edition was published in 2006.", December 20, 2013

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