Pharmacy Law and Practice

5th Edition - April 19, 2013
Imprint: Academic Press
Authors: Jon Merrills, Jonathan Fisher
Language: English
Paperback ISBN:
9 7 8 - 0 - 1 2 - 3 9 4 2 8 9 - 0
eBook ISBN:
9 7 8 - 0 - 1 2 - 3 9 4 6 1 8 - 8

Pharmacy Law and Practice, Fifth Edition provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice… Read more

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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.

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The National Health Service Act 1977 (Now Repealed)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

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Pharmacy Law and Practice

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Jon Merrills

Jonathan Fisher

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