Dale and Appelbe’s Pharmacy Law and Ethics Ninth Edition
Buku ini diterbitkan Tahun 2009 oleh Pharmaceutical Press merupakan buku edisi sembilan.
Judul: Dale and Appelbe’s Pharmacy Law and Ethics Ninth Edition
Oleh: Gordon E. Appelbe, et al
Penerbit: Pharmaceutical Press
Tahun: 2009
Jumlah Halaman: 609 hal.
Penulis:
Gordon E Appelbe, LL B, PhD, MSc, BSc (Pharm), BA, FRPharmS, Hon MPS (Aus), FCPP, FPP (Hons), adalah farmasi / konsultan hukum independen. Dia memenuhi syarat sebagai apoteker pada tahun 1956 dan kemudian bekerja selama sembilan tahun di komunitas farmasi. Ia bergabung dengan staf Masyarakat Farmasi pada tahun 1965, pertama sebagai inspektur di bawah sejarah Farmasi dan kemudian, pada tahun 1971, sebagai sekretaris Komite Hukum. Dia diangkat wakil kepala Departemen Hukum pada tahun 1974 dan adalah kepala Departemen Hukum dan Kepala Inspektur 1978-1991.
Joy Wingfield, LL M, M Phil, BPharm, FRPharmS, Dip Ag Vet Pharm, FCPP, adalah Profesor Khusus Hukum dan Etika Farmasi di Universitas Nottingham dan konsultan praktik farmasi independen Dia memenuhi syarat sebagai apoteker pada tahun 1971 dan kemudian bekerja selama lima tahun di apotek masyarakat. Dia bergabung dengan staf dari Masyarakat Farmasi pada tahun 1976 sebagai inspektur
di bawah Farmasi. Dari tahun 1986 sampai 1991, dia adalah administrator senior, dan kepala kemudian Divisi Etika di Departemen Hukum, bertanggung jawab untuk hal-hal profesional dan pendaftaran. Hal ini diikuti oleh sembilan tahun sebagai asisten farmasi pengawas.
Lingkup Pembahasan:
Buku ini berusaha untuk menyediakan garis besar hukum yang mempengaruhi praktek farmasi di Inggris dalam satu volume, bersama-sama dengan memperhitungkan cara di mana farmasi Inggris telah mengembangkan dan mempertahankan standar perilaku profesional. Buku ini berharap terbukti berguna tidak hanya untuk mahasiswa farmasi, mahasiswa preregistration dan apoteker di semua cabang profesi, tetapi juga untuk orang lain di Inggris dan luar negeri yang mungkin perlu beberapa pengetahuan tentang hukum Inggris kontemporer berkaitan dengan obat-obatan dan racun, dan pengembangan etika profesional dalam farmasi Inggris.
Periode antara edisi 8 dan 9, yang mencakup akhir tahun 2004 untuk akhir tahun 2008, telah mencerminkan perubahan radikal dalam kebijakan terhadap profesional kesehatan secara keseluruhan, banyak timbul 'skandal' dari perawatan kesehatan seperti Shipman Kirim dan pertanyaan yang sama ke dalam kualitas kesehatan dan staf di rumah sakit di Bristol dan Liverpool (Alder Hey). Lebih dekat ke rumah, perubahan legislatif untuk mengaktifkan keterampilan dan pelatihan masyarakat apoteker untuk dihargai dan ini profesional untuk memberikan kontribusi yang tepat bagi kesehatan dan promosi yang
unpicking preseden lama didirikan dalam Undang-Undang Obat yang telah di tempat selama lebih dari 40 tahun. Kami memilih empat perubahan besar:
* Revisi dan memperketat Penyalahgunaan Obat Peraturan berikut Shipman Kirim;
* Revisi dan penggantian Royal Pharmaceutical Society kekuatan disiplin dan proses dengan kebugaran
untuk berlatih prosedur yang paralel orang-orang dari profesi kesehatan lainnya;
* Proposal untuk memisahkan fungsi Masyarakat dan menciptakan regulator, General Farmasi Council
(GPhC), dan profesional yang baru body kepemimpinan untuk farmasi; dan
* Proposal untuk menggantikan konsep 'control pribadi' di Obat
Bertindak dengan apoteker yang bertanggung jawab dan kemudian ke menafsirkan konsep 'pengawasan' untuk mengizinkan terlatih dan mendukung terdaftar profesional kesehatan untuk melaksanakan tugas-tugas di farmasi masyarakat, dengan tidak adanya seorang apoteker yang bertanggung jawab.
Daftar Isi:
Preface to the Ninth Edition xviii
Foreword xxi
About the authors xxiii
Introduction xxiv
List of Statutes and Statutory Instruments xxix
Abbreviations and acronyms lii
1 Sources of law 1
Introduction 1
European law 1
The European institutions 2
British law 3
The courts 6
Examples of European law 8
Human rights 12
Further reading 14
2 Medicines Act 1968: Scope and administration 15
Medicinal product 16
Administration 18
Enforcement 20
Role of the Royal Pharmaceutical Society of Great Britain 21
Inspection and sampling 22
Legal proceedings 25
Summary 26
Further reading 27
3 Medicines Act 1968: The licensing system 29
Issue of licences 29
Summary 66
Further reading 67
5 Medicines Act 1968: Retail pharmacy businesses 69
The responsible pharmacist 72
Registration of pharmacy premises 73
Change of ownership 75
Premises retention fees 75
Titles, descriptions and emblems 76
Accommodation, storage, records, equipment, etc. 77
Disqualification of a retail pharmacy owner 78
Summary 78
6 Medicines Act 1968: Pharmacy Medicines 81
Pharmacy Medicine defined 82
Exemptions in cases involving another's default 82
Temporary exemptions 83
Collection and delivery arrangements – exemption 83
Summary 83
Further reading 83
7 Medicines Act 1968: General Sale Medicines 85
Conditions applying to retail sale or supply of General Sale List medicinal products for human use 85
General Sale List Medicines for human use 86
Automatic machines 87
Retail pack sizes of certain products 87
Products not to be on general sale 89
Summary 90
Further reading 90
8 Medicines Act 1968: Prescription Only Medicines 91
Prescription Only Medicines for human use 93
Exemptions from Prescription Only 94
Administration of Prescription Only Medicines 96
Radioactive medicinal products 96
Smallpox vaccine 97
Prescriptions 98
Pharmacy records 100
Particulars of prescriptions to be recorded 101
Preservation of pharmacy records 101
Labelling of dispensed medicines 101
Exemptions for hospitals, clinics, etc. 102
Exemptions for persons conducting retail pharmacy businesses 102
Summary 107
Further reading 107
9 Medicines Act 1968: Retail sale and supply: exemptions from controls for other persons 109
Hospitals and health centres 109
National Health Service bodies: medicines supplied under a Patient Group Direction 110
Doctors, dentists and veterinarians 111
Unorthodox practitioners 111
Midwives 112
Registered nurses 112
Optometrists 113
Chiropodists 114
Ambulance paramedics 115
Operators under the Ionising Radiation (Medical Exposure) Regulations 2000 (IRME) 117
Health professionals who supply or administer Prescription Only Medicines under a Patient
Group Direction in order to assist doctors or dentists in providing National Health
Service primary medical and dental services 118
Independent hospitals, clinics and agencies which supply medicines under a Patient Group
Direction 119
Police, prison and armed forces supply of medicines under a Patient Group Direction 119
Persons authorised to be sold cyanide salts under the Poisons Act 1972 120
Manufacturers of products for treatment of the hair and scalp 120
Public analysts, sampling officers and other such persons 121
National Health Service drug testing 121
Owners and masters of ships 122
Offshore installations 122
British Standards Institution 122
Statutory requirements as to medical treatment 123
Persons employed or engaged in the lawful drug treatment services 123
Licences and group authorities 123
Royal National Lifeboat Institution 123
British Red Cross Society and other such organisations 124
Dental schemes 124
Mountain rescue teams 125
Occupational health schemes 125
Aircraft commanders 125
Universities, higher education institutions or institutions concerned with research 126
Sales by licence holders 126
Veterinary drugs 126
Summary 127
10 Medicines Act 1968: Wholesale dealing 129
A person making sales by way of wholesale dealing 129
Pharmacy Medicines by wholesale dealing 130
Prescription Only Medicines by wholesale dealing 131
Wholesale dealing from a pharmacy 131
Wholesale dealing of veterinary products 132
Summary 132
11 Medicines Act 1968: Sale and supply of homoeopathic medicines for human use 133
Medicinal products at high dilutions (homoeopathic medicines) 133
Homoeopathic medicines for human use: licensing 133
Homoeopathic medicines for which general sale is permitted 133
Homoeopathic medicines for treatment according to the judgement of the seller 139
Summary 141
Further reading 141
12 Medicines Act 1968: Herbal medicines 143
Exception from registration 144
Labelling of dispensed traditional herbal medicinal products 145
Traditional herbal medicinal products not on a General Sale List 146
Exemptions from labelling 146
Transitional provisions 146
Exemption from licensing 147
Exemptions from controls on retail sale 147
Further exemption for shopkeepers 148
Exemption of `herbal practitioners' 148
Enforcement authority 149
Schedule to the Herbal Remedies Order 149
Banned herbal remedies 153
Summary 154
Further reading 155
13 Veterinary medicinal products 157
Annual Veterinary Regulations 157
Registration certificates for homoeopathic veterinary medicinal products 158
Classes of veterinary medicinal product 159
Wholesale supply of veterinary medicinal products 159
Retail supply of veterinary medicinal products 160
Prescription Only Medicines for animal use 160
Prescription requirements 161
The cascade 162
Supply by veterinary surgeons 163
Supply by pharmacists 163
Supply by suitably qualified persons 163
Code of good practice 164
Records of receipt and supply for Prescription Only veterinary products 165
Records and storage by wholesalers 165
Annual audit 166
Veterinary products on the General Sale List 166
Veterinary medicines 166
Labelling requirements for veterinary medicinal products 166
Labelling of ampoules 168
Advertising of veterinary products 169
Advertising of Prescription Only Medicines 169
Exemptions for small pet animals 169
Sale of sheep dips 170
Veterinary surgeons and veterinary wholesalers 171
Summary 171
Further reading 172
14 Medicines Act 1968: Prohibitions for protection of the purchaser 173
Section 62 Orders 173
Adulteration of medicinal products 175
False or misleading advertisements or representations 176
Summary 177
15 Medicines Act 1968: Containers, packages and identification 179
Regulations and penalties 179
Definitions 180
Labelling regulations 182
Labelling of relevant medicinal products 183
General labelling provisions for relevant medicinal products for human use 183
Standard labelling requirements for relevant medicinal products for human use 183
Small containers for relevant medicinal products for human use 185
Blister packs for relevant medicinal products for human use 185
Standard labelling requirements for containers and packages for radiopharmaceuticals
for human use 185
Labelling of relevant General Sale List medicinal products 186
Labelling of relevant medicinal products for pharmacy sale only 187
Labelling of relevant Prescription Only Medicines 188
Labelling of relevant dispensed medicinal products 188
Labelling of medicinal products exempt from product marketing authorisations 189
Ingredient medicinal products 191
Contract manufacture or assembly 191
Delivery and storage 192
Clinical trials 192
Standard labelling requirements for containers and packages of homoeopathic products
for human use 192
Surgical materials 193
Labelling of animal medicines 193
Labelling of small containers for animal medicinal products 193
Leaflets 193
Child safety regulations 197
Use of fluted bottles 198
Summary 200
16 Medicines Act 1968: Pharmacopoeias and other publications 203
European Pharmacopoeia 203
British Pharmacopoeia, compendia and other publications 203
British Pharmaceutical Codex and British Veterinary Codex 204
Compliance with official standards 204
Specifications in licences 206
Summary 206
17 Misuse of Drugs Act 1971 207
Advisory Council on Misuse of Drugs 207
Class A, class B and class C drugs 208
Restrictions and exemptions 209
Supply of articles for administering or preparing Controlled Drugs 210
Provisions for preventing misuse 211
Information concerning misuse 212
Prohibitions on possession, prescribing and supply 212
Tribunals, advisory bodies and professional panels 213
Offences, penalties and enforcement 214
Scheduled substances: precursors 216
Powers of the Secretary of State 217
Regimes of control 218
Poppy-straw 220
Import and export 220
Possession and supply 221
Standard operating procedures 226
Midwives and pethidine 227
Requisitions 228
Prescriptions for Controlled Drugs 230
Marking of containers 232
Registers and records 233
Running balances 236
Furnishing of information 236
Preservation of records 237
Destruction of Controlled Drugs 237
Accountable officers 237
Addicts 238
Safe custody of Controlled Drugs 239
Summary 243
Further reading 243
18 Poisons and pesticides 245
Meaning of poison 245
Poisons Board 245
Poisons List 246
Local authorities' lists 246
Inspection and enforcement 247
Penalties and legal proceedings 249
The Poison Rules 249
Sale and supply of poisons 251
Labelling of hydrogen cyanide 252
Labelling and packaging of poisons which are `chemicals' 253
Schedule 1 poisons 253
Exemptions from Schedule 1 requirements 255
Schedule 1 poisons subject to additional restrictions (Rule 12) 255
Wholesale dealing 257
Sales exempted by the Poisons Act 257
Automatic machines 258
Controls on pesticides 258
Summary 259
Further reading 260
19 Alcohol and denatured alcohol 261
Retail sales of intoxicating liquor 261
Alcohol duty 262
Denatured alcohol 264
Scotland: sale of completely denatured alcohol and surgical alcohol 267
Summary 268
Further reading 268
20 Dangerous substances and consumer protection 269
Definitions 269
Application of the regulations and exceptions 270
Inspection and enforcement 271
Classification 271
Indications of danger 271
Indications of particular risks 272
Indications of safety precautions required 272
Packaging 272
Child-resistant closures 273
Tactile danger warnings 273
Labelling for supply 273
Data sheets 275
Control of substances hazardous to health 276
Summary 277
Further reading 277
21 Miscellaneous legislation affecting pharmacy 279
Data protection and freedom of information 279
Pharmacy ownership 283
Employment and anti-discrimination law 287
Consumer protection law 290
Health and safety law 293
Environmental law 295
Merchant shipping: medical scales 299
Jury service 300
Summary 300
Further reading 300
22 Pharmacy regulation and leadership 303
Council for Healthcare Regulatory Excellence 305
Changing the regulation of pharmacy 306
Legislation regulating the pharmacy profession 307
The Role of the Society and its Council 308
Entitlement to register as a pharmacist 309
Education and training 311
Application to register 311
Registration of pharmacy technicians 312
The Registers of Pharmacists and Pharmacy Technicians 312
Removal from the registers 313
Moving to different parts of the registers 314
Retention on the registers 314
Restoration to the registers 315
Fees 315
The Registration Appeals Committee 315
The Education and Continuing Professional Development Committees 317
Preregistration training 317
Registration from other countries 317
A new professional body for pharmacy 319
Royal Charter 319
Organisation of the Society 321
The national pharmacy boards 322
Branches and regions of the Society 322
Membership and special interest groups 323
Fellows and honorary members and fellows of the Society 323
Students 323
Support for pharmacists 323
Summary 324
Further reading 325
23 Professional conduct 327
The profession of pharmacy 328
Trade and profession 329
Professional ethics and law 331
Codes of ethics 332
Professional standards and guidance documents 334
Clinical governance 335
Continuing professional development and revalidation 335
Professional discipline 336
Criminal negligence 337
Professional or clinical negligence 337
Summary 339
Further reading 340
24 Fitness to practise 341
The Council for Healthcare Regulatory Excellence 342
Legislation regulating fitness to practise 343
Transitional arrangements 343
Fitness to practise processes 343
The Investigating Committee 348
The Health Committee 349
The Disciplinary Committee 350
Professional performance assessments 351
Interim orders 351
Indicative sanctions guidance 352
General Procedures of the Fitness to Practise Committees 353
Appeals 355
Availability of information about the Fitness to Practise Committees and their determinations 355
The work of the Fitness to Practise Committees 356
The former Statutory Committee 359
Cases before the Registration Appeals Committee 362
Examples of cases before the Statutory Committee and the Disciplinary Committee 362
Appeals against decisions 376
Summary 378
Further reading 379
25 Organisation of other health professions 381
Medical scandals and convergence of regulation 381
The Council for Healthcare Regulatory Excellence 382
The medical profession 383
The veterinary profession 390
The dental profession 393
Nurses, midwives and health visitors 395
Opticians 399
Healthcare and associated professions 401
Hearing aid supply 404
Regulation of practitioners of traditional medicines 405
Summary 405
Further reading 406
26 National Health Service law and organisation 407
History 407
Other legislation affecting the National Health Service 409
National Health Service policy and planning 411
National Health Service structure in Great Britain 412
Summary 434
Further reading 435
27 Legal decisions affecting pharmacy 437
The meaning of `acting in accordance with the directions of a practitioner' 437
The meaning of `by a doctor or dentist to a patient of his' under the Medicines Act 1968 439
The meaning of `person' 440
Powers of the Royal Pharmaceutical Society of Great Britain 440
The meaning of `sale by way of wholesale dealing' 443
The meaning of `shop' 444
The meaning of `supervision' 444
Use of titles and descriptions 447
Definitions of `a sample' 447
Sale of Prescription Only Medicines: offence of strict liability 448
Is dispensing a medicine on a National Health Service prescription a `sale'? 448
Importation of medicinal products from the European Community 449
Sale of prescription data: breach of confidentiality? 450
Meaning of professional assessment 451
Further reading 453
Appendices 455
1 Medicines Act 1968: Medicinal products 455
2 Medicines Act 1968: Prohibition of non-medicinal antimicrobial substances 459
3 The Medicines (Pharmacies) (Responsible Pharmacist) Regulations SI 2008
No. 2789 463
4 Medicines Act 1968: Veterinary drugs: Pharmacy and Merchants List 467
5 Misuse of Drugs Act 1971: Controlled Drugs classified for level of penalties 469
6 Misuse of Drugs Regulations 1985 (as amended): Classification of Controlled Drugs
for regimes of control 479
7 The Poisons List Order 1982 491
8 The Poisons Rules 1982 495
9 Substances and preparations dangerous to supply 511
10 Medicines Act 1968: Patient Group Directions (PGD) Schedule 7 to the Regulations
(SI 2000 No.1917 as amended) 519
Index 521
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