The Fourth revised edition of Pharmacy Law & Practice by Jonathan Merrills and Jonathan Fisher is an accurate and authoritative reference source of pharmacy law. Legislation on health service provision and health professional regulation are of increasing importance to all health professionals. It is an area of great complexity, and to understand legislation it is necessary to have an appreciation of the policy context. Pharmacy law is an essential component of the pharmacy curriculum. When in practice, pharmacists must balance the needs of patients with the letter of the law.

Jon Merrills a former Deputy Chief Pharmacist at the Department of Health Jonathan Fisher QC is a barrister practicing from chambers at 18 Red Lion Court, London

Preface	p. xi
The National Health Service	p. 1
The National Insurance Act 1911	p. 1
The National Health Service Act 1946	p. 1
The National Health Service Act 1977	p. 3
New Act to consolidate NHS law	p. 3
General principles, scope and nature of the current NHS	p. 3
The National Health Services and Community Care Act 1990	p. 5
The Health Act 1999	p. 5
The Health and Social Care Act 2001	p. 5
The Health and Social Care (Community Health and Standards) Act 2003	p. 9
Advice from the health professions	p. 10
Acts of Parliament mainly concerned with the NHS	p. 11
Administration of the NHS	p. 13
Administration	p. 13
NHS Executive	p. 13
Strategic Health Authorities (SHAs)	p. 14
Provision of NHS services	p. 15
Acute Trusts	p. 15
Foundation Trusts	p. 16
Primary Care Trusts	p. 17
Establishment	p. 17
Care Trusts	p. 18
Mental Health Trusts	p. 19
Ambulance Trusts	p. 19
Effects of devolution	p. 21
The Supply of NHS Pharmaceutical Services	p. 24
The PCT's duty	p. 24
Pharmaceutical services	p. 25
Contractors obligations	p. 26
Terms of service	p. 27
Fundamental requirements of the terms of service	p. 27
The Drug Tariff	p. 41
Form and Content of the Drug Tariff	p. 41
Requirements for the supply of drugs, appliances and chemical reagents	p. 42
Requirements enabling payments to be made	p. 43
Applications to Dispense NHS Prescriptions	p. 52
Applications for NHS contract	p. 52
Duty of the PCT	p. 53
Application to PCT	p. 53
Rural Dispensing	p. 61
History	p. 61
The current rules	p. 61
Applications by doctors	p. 64
Appeal procedure	p. 65
Prescription Charges	p. 66
The Regulations	p. 66
Wales	p. 73
The Interests of the Public	p. 74
New arrangements for patient involvement	p. 74
Local Authority overview	p. 74
Independent Complaints Advocacy Services (ICAS)	p. 75
Patient Advocacy and Liaison Services (PALS)	p. 75
Patient and Public Involvement Forums	p. 76
New monitoring arrangements for healthcare quality	p. 77
The Healthcare Commission	p. 77
Access to meetings	p. 78
The Health Service Commissioner for England	p. 78
Audit Commission	p. 79
Public Health Observatories	p. 79
The Health Protection Agency	p. 80
Independent Regulator of Foundation Trusts - Monitor	p. 80
Complaints and Discipline in the NHS	p. 81
Complaints and breaches of the terms of service	p. 81
Healthcare Commission	p. 82
New arrangements for dealing with serious allegations	p. 84
Referral to Royal Pharmaceutical Society	p. 87
Retail Pharmacy	p. 88
The nature of the control	p. 88
History	p. 88
Retail pharmacy business	p. 88
Registered pharmacy	p. 89
Manufacture and Licensing of Medicinal Products	p. 95
The Medicines Act 1968 and other controls	p. 95
European Directives	p. 95
Control on Sales of Medicines	p. 107
Control of retail sales	p. 107
Prescription Only Medicines	p. 108
Wholesaling of medicines	p. 116
Advertising and sales promotion	p. 121
Monitoring and complaints	p. 126
Supplies and Deliveries	p. 128
Supply of medicines in an emergency	p. 128
Collection and delivery schemes	p. 131
Unlicensed Products	p. 133
Unlicensed products	p. 133
Reasons for using unlicensed products	p. 133
Exemptions for unlicensed medicines	p. 134
Specials	p. 134
Record keeping	p. 134
Exemption for doctors	p. 135
Exemption for pharmacists	p. 135
Extemporaneous preparation in the pharmacy	p. 137
Off-label use	p. 138
The Code of Ethics	p. 138
Traditional and Alternative Medicines	p. 139
Herbal remedies	p. 139
Licensing of herbal remedies	p. 139
New arrangements	p. 140
Homeopathic medicines	p. 143
Restrictions on sale for safety reasons	p. 147
Controlled Drugs	p. 152
Basic Provisions of the Misuse of Drugs Act 1971	p. 152
Reclassification of Cannabis	p. 153
International Convention	p. 153
Regulations concerned with misuse of drugs	p. 154
The Misuse of Drugs Regulations 2001	p. 155
Requirements for writing prescriptions	p. 161
Safe custody	p. 169
Addicts	p. 170
Drugs Act 2005	p. 174
Labelling, Leaflets and Packaging	p. 175
The main regulations	p. 175
Standard Labelling Requirements for medicinal products for human use	p. 176
Poisons and Dangerous Substances	p. 188
The Poisons Board	p. 188
The CHIP Regulations 2002	p. 192
The Environmental Protection Act 1990	p. 194
COSHH	p. 194
Packaging waste	p. 195
Dangerous Substances and Explosive Atmospheres Regulations 2002	p. 195
Food Safety Act 1990	p. 195
The Offensive Weapons Act 1996	p. 196
Patient Group Directions	p. 197
What are Patient Group Directions	p. 197
Non-Medical Prescribing	p. 210
Background	p. 210
Legislation	p. 211
Independent prescribing	p. 214
Rights of Access	p. 217
Access to Pharmacies	p. 217
RPSGB Inspectors	p. 217
Regulation of Investigatory Powers Act 2000 (RIPA)	p. 217
Primary Care Trust	p. 219
PPI Forums	p. 219
NHS Counter Fraud Service	p. 219
Police Controlled Drugs Inspectors (CDI)	p. 220
The Healthcare Commission	p. 220
HM Revenue and Customs	p. 220
Health and Safety Inspectors	p. 221
Trading Standards (Weights and Measures)	p. 221
Disclosure of confidential information	p. 222
Confidentiality	p. 223
The Data Protection Act 1998	p. 223
The Principles	p. 224
Sensitive personal data	p. 225
The subject's rights	p. 226
Use of personal data for research or analysis	p. 226
Non-computerised records	p. 227
Access to Health Records Act 1990	p. 227
Access to Medical Records Act 1988	p. 227
Use of anonymised data for research	p. 227
Control of patient information under the Health and Social Care Act 2001	p. 228
The Health Service (Control of Information) Regulations 2002	p. 229
Patient Information Advisory Group	p. 229
Confidentiality and children	p. 229
Human Rights Act 1998	p. 229
The Caldicott Review 1997	p. 230
Caldicott Guardian	p. 230
Department of Health Code of Practice	p. 230
Records	p. 231
Consent	p. 233
Definition of consent	p. 233
Basis for the consent concept	p. 234
Consent by children	p. 236
The law in Scotland	p. 237
The European Union	p. 238
Law-making institutions	p. 238
Community law	p. 239
The Pharmacy Profession	p. 244
History	p. 244
The Royal Pharmaceutical Society of Great Britain	p. 246
The Statutory Committee of the RPSGB	p. 250
The standards of professional conduct	p. 254
Internet Pharmacy	p. 261
NHS Prescription Fraud	p. 263
Liability in Negligence	p. 265
Dispensing mistakes	p. 265
Breach of contract	p. 265
Negligence	p. 265
Liability as an occupier of premises	p. 271
Criminal liability for negligent conduct	p. 272
Corporate manslaughter	p. 273
Corporate Manslaughter Bill 2006	p. 274
Business Premises	p. 275
Freehold premises	p. 275
Leasehold premises	p. 276
Planning law	p. 291
Business Associations	p. 293
The sole trader	p. 293
Partnership	p. 293
The limited company	p. 297
Notification of changes after incorporation	p. 308
The Sale of Goods	p. 310
Contract for the sale of goods	p. 310
Remedies available to the seller and buyer in default	p. 325
Buyer's remedies	p. 327
Product liability	p. 330
Employment Law	p. 333
The contract of employment	p. 333
Special categories of employee	p. 336
Employee's duties under the contract of employment	p. 338
Employer's duties under the contract of employment	p. 341
Wages issues	p. 345
Maternity issues	p. 346
Insolvent employer	p. 348
Equal pay and discrimination	p. 349
Discrimination on the grounds of race	p. 353
Disability discrimination	p. 353
Bringing the employment to an end	p. 356
Human rights at work	p. 363
Human Rights	p. 365
Human rights and privacy	p. 365
Human rights and employment issues	p. 368
Human rights and property interests	p. 368
Freedom of information	p. 369
Index	p. 373
Table of Contents provided by Ingram. All Rights Reserved.

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