Wednesday, December 3, 2014

Dale and Appelbe’s Pharmacy Law and Ethics Ninth Edition







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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