Pharmacy Law and Practice (eBook)

Cover 1
Title page 4
Copyright page 5
Table of contents 6
Preface 12
1 The National Health Service 14
The National Insurance Act 1911 14
The National Health Service Act 1946 14
The National Health Service Act 1977 16
New Act to consolidate NHS law 16
General principles, scope and nature of the current NHS 16
The National Health Services and Community Care Act 1990 18
The Health Act 1999 18
The Health and Social Care Act 2001 18
The Health and Social Care (Community Health and Standards) Act 2003 22
Advice from the health professions 23
Acts of Parliament mainly concerned with the NHS 24
2 Administration of the NHS 26
Administration 26
NHS Executive 26
Strategic Health Authorities (SHAs) 27
Provision of NHS services 28
Acute Trusts 28
Foundation Trusts 29
Primary Care Trusts 30
Establishment 30
Care Trusts 31
Mental Health Trusts 32
Ambulance Trusts 32
Effects of devolution 34
3 The Supply of NHS Pharmaceutical Services 37
The PCT’s duty 37
Pharmaceutical services 38
Contractors obligations 39
Terms of service 40
Fundamental requirements of the terms of service 40
4 The Drug Tariff 54
Form and Content of the Drug Tariff 54
Part I – Requirements for the supply of drugs, appliances and chemical reagents 55
Part 2 – Requirements enabling payments to be made 56
5 Applications to Dispense NHS Prescriptions 65
Applications for NHS contract 65
Duty of the PCT 66
Application to PCT 66
6 Rural Dispensing 74
History 74
The current rules 74
Applications by doctors 77
Appeal procedure 78
7 Prescription Charges 79
The Regulations 79
Wales 86
8 The Interests of the Public 87
New arrangements for patient involvement 87
Local Authority overview 87
Independent Complaints Advocacy Services (ICAS) 88
Patient Advocacy and Liaison Services (PALS) 88
Patient and Public Involvement Forums 89
New monitoring arrangements for healthcare quality 90
The Healthcare Commission 90
Access to meetings 91
The Health Service Commissioner for England 91
Audit Commission 92
Public Health Observatories 92
The Health Protection Agency 93
Independent Regulator of Foundation Trusts – Monitor 93
9 Complaints and Discipline in the NHS 94
Complaints and breaches of the terms of service 94
Healthcare Commission 95
New arrangements for dealing with serious allegations 97
Referral to Royal Pharmaceutical Society 100
10 Retail Pharmacy 101
The nature of the control 101
History 101
Retail pharmacy business 101
Registered pharmacy 102
11 Manufacture and Licensing of Medicinal Products 108
The Medicines Act 1968 and other controls 108
European Directives 108
12 Control on Sales of Medicines 120
Control of retail sales 120
Prescription Only Medicines 121
Wholesaling of medicines 129
Advertising and sales promotion 134
Monitoring and complaints 139
13 Supplies and Deliveries 141
Supply of medicines in an emergency 141
Collection and delivery schemes 144
14 Unlicensed Products 146
Unlicensed products 146
Reasons for using unlicensed products 146
Exemptions for unlicensed medicines 147
Specials 147
Record keeping 147
Exemption for doctors 148
Exemption for pharmacists 148
Extemporaneous preparation in the pharmacy 150
Off-label use 151
The Code of Ethics 151
15 Traditional and Alternative Medicines 152
Herbal remedies 152
Licensing of herbal remedies 152
New arrangements 153
Homeopathic medicines 156
Restrictions on sale for safety reasons 160
16 Controlled Drugs 165
Basic Provisions of the Misuse of Drugs Act 1971 165
Reclassification of Cannabis 166
International Convention 166
Regulations concerned with misuse of drugs 167
The Misuse of Drugs Regulations 2001 168
Requirements for writing prescriptions 174
Safe custody 182
Addicts 183
Drugs Act 2005 187
17 Labelling, Leaflets and Packaging 188
The main regulations 188
Standard Labelling Requirements for medicinal products for human use 189
18 Poisons and Dangerous Substances 201
The Poisons Board 201
The CHIP Regulations 2002 205
The Environmental Protection Act 1990 207
COSHH 207
Packaging waste 208
Dangerous Substances and Explosive Atmospheres Regulations 2002 208
Food Safety Act 1990 208
The Offensive Weapons Act 1996 209
19 Patient Group Directions 210
What are Patient Group Directions 210
20 Non-Medical Prescribing 223
Background 223
Legislation 224
Independent prescribing 227
21 Rights of Access 230
Access to Pharmacies 230
RPSGB Inspectors 230
Regulation of Investigatory Powers Act 2000 (RIPA) 230
Primary Care Trust 232
PPI Forums 232
NHS Counter Fraud Service 232
Police Controlled Drugs Inspectors (CDI) 233
The Healthcare Commission 233
HM Revenue and Customs 233
Health and Safety Inspectors 234
Trading Standards (Weights and Measures) 234
Disclosure of confidential information 235
22 Confidentiality 236
The Data Protection Act 1998 236
The Principles 237
Sensitive personal data 238
The subject’s rights 239
Use of personal data for research or analysis 239
Non-computerised records 240
Access to Health Records Act 1990 240
Access to Medical Records Act 1988 240
Use of anonymised data for research 240
Control of patient information under the Health and Social Care Act 2001 241
The Health Service (Control of Information) Regulations 2002 242
Patient Information Advisory Group 242
Confidentiality and children 242
Human Rights Act 1998 242
The Caldicott Review 1997 243
Caldicott Guardian 243
Department of Health Code of Practice 243
Records 244
23 Consent 246
Definition of consent 246
Basis for the consent concept 247
Consent by children 249
The law in Scotland 250
24 The European Union 251
Law-making institutions 251
Community law 252
25 The Pharmacy Profession 257
History 257
The Royal Pharmaceutical Society of Great Britain 259
The Statutory Committee of the RPSGB 263
The standards of professional conduct 267
Internet Pharmacy 274
NHS Prescription Fraud 276
26 Liability in Negligence 278
Dispensing mistakes 278
Breach of contract 278
Negligence 278
Liability as an occupier of premises 284
Criminal liability for negligent conduct 285
Corporate manslaughter 286
Corporate Manslaughter Bill 2006 287
27 Business Premises 288
Freehold premises 288
Leasehold premises 289
Planning law 304
28 Business Associations 306
The sole trader 306
Partnership 306
The limited company 310
Notification of changes after incorporation 321
29 The Sale of Goods 323
Contract for the sale of goods 323
Remedies available to the seller and buyer in default 338
Buyer’s remedies 340
Product liability 343
30 Employment Law 346
The contract of employment 346
Special categories of employee 349
Employee’s duties under the contract of employment 351
Employer’s duties under the contract of employment 354
Wages issues 358
Maternity issues 359
Insolvent employer 361
Equal pay and discrimination 362
Discrimination on the grounds of race 366
Disability discrimination 366
Bringing the employment to an end 369
Human rights at work 376
31 Human Rights 378
Human rights and privacy 378
Human rights and employment issues 381
Human rights and property interests 381
Freedom of information 382
Index 386