Responsibility for drug-induced injury: a reference book for lawyers, the health professions and manufacturers
Gespeichert in:
| Beteiligte Personen: | , |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Amsterdam [u.a.]
Elsevier
1988
|
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=001223561&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | XII, 431 S. |
| ISBN: | 0444810056 |
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Datensatz im Suchindex
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| adam_text | RESPONSIBILITY FOR DRUG-INDUCED INJURY A REFERENCE BOOK FOR LAWYERS, THE
HEALTH PROFESSIONS AND MANUFACTURERS M.N. GRAHAM DUKES MD MA LLM
PROFESSOR OF DRUG POLICY SCIENCE, UNIVERSITY OF GRONINGEN, THE
NETHERLANDS AND BARBARA SWARTZ MA JD PROFESSOR OF LAW, TOURO COLLEGE
SCHOOL OF LAW, HUNTINGTON, NY, U.S.A. 1988 ELSEVIER AMSTERDAM * NEW YORK
* OXFORD CONTENTS INTRODUCTION 1 1. THE SIGNIFICANCE OF INJURY DUE TO
DRUGS 1 2. DEFINING DRUGS AND DRUG-INDUCED INJURY 4 3. PRACTICAL
IMPORTANCE OF DETERMINING RESPONSIBILITY 6 4. VARIATIONS IN THE CONCEPT
OF DUTY 6 5. THE QUESTION OF COMPENSATION 9 6. SOURCES OF STANDARDS 9 7.
ACKNOWLEDGEMENTS 10 SECTION A: GENERAL PRINCIPLES 11 1. CHARACTERISTICS
OF DRUG-INDUCED INJURY 13 1. THE MANY TYPES OF DRUG-INDUCED INJURY 13 2.
THE INTRINSIC NATURE OF MUCH DRUG RISK 14 3. THE NUMBER OF PARTIES
INVOLVED 15 4. BASIC PROBLEMS IN ESTABLISHING CAUSALITY 17 2. FORUM,
EVIDENCE AND PROOF 21 1. GENERAL VERSUS SPECIFIC PROOF 21 2. THE FORA
INVOLVED AND THEIR WAYS OF WORKING 22 3. THE APPROACH TO PROOF AND
EVIDENCE 24 4. THE LEVEL OF PROOF REQUIRED 24 5. STANDARDS FOR THE
ADMISSION OF EVIDENCE 25 6. ATTAINMENT OF THE AGREED STANDARD OF PROOF
28 7. THE EXPERT WITNESS 29 3. EVIDENCE AS TO A GENERAL CAUSAL LINK IN
THE COMMUNITY 31 1. EVIDENCE FROM HUMAN SUBJECTS 31 2. EVIDENCE FROM
ANIMAL AND OTHER LABORATORY STUDIES 33 4. EVIDENCE AS TO A CAUSAL LINK
IN THE INDIVIDUAL CASE 39 1. ESSENTIAL QUESTIONS TO BE ASKED 39 2. THE
PRESENCE OF DEFECT, DAMAGE OR INJURY 39 3. THE FACT THAT THE DRUG WAS
TAKEN 40 VM 4. FACTORS INDICATING A PROXIMATE CAUSAL RELATIONSHIP 41 5.
CUMULATION OF DIFFERENT ELEMENTS OF PROOF 45 6. CAUSALITY IN CASES OF
MULTIPLE DRUG THERAPY 46 7. QUESTIONS RELATING PRIMARILY TO LIABILITY 46
8. USE OF GRADED CAUSALITY SCALES 49 5. THE ASSESSMENT OF SEVERITY 51 1.
THE APPROACH TO ASSESSING SEVERITY 51 2. THE PERMANENCE OR REVERSIBILITY
OF THE CONDITION 52 3. THE STABILITY OR PROGRESSION OF THE CONDITION 53
4. THE MAXIMUM EXTENT OF THE INJURY 53 5. CLASSIFICATION OF INJURY 54 6.
THE DEGREE OF INJURY AS COMPARED TO THE PROGNOSIS OF THE CONDITION WHICH
WAS TREATED AND THE BENEFIT WHICH WAS OBTAINED 56 7. SEVERITY ASSESSMENT
IN SPECIFIC SITUATIONS 58 6. THE STATE AND AVAILABILITY OF KNOWLEDGE 65
1. THE STATE OF KNOWLEDGE 65 2. THE RELIABILITY OF SOURCES 67 3.
INACCESSIBILITY OF INFORMATION AS A PLEA OR DEFENCE 72 SECTION B:
RESPONSIBILITY OF PARTIES 75 7. INDIVIDUAL AND JOINT LIABILITY 77 1.
SOCIAL RESPONSIBILITY VERSUS LEGAL LIABILITY 77 2. JOINT AND SEVERAL
RESPONSIBILITY: THE S.M.O.N. EXAMPLE 77 3. DEFINITIONS OF DUTY 79 4.
LIMITATION OF ACTIONS 80 5. RESPONSIBILITY FOR INSURANCE , 81 8.
RESPONSIBILITY OF THE PRESCRIBER 83 1. PRINCIPLES DETERMINING THE
PRESCRIBER S RESPONSIBILITY 83 2. THE NATURE OF THE PHYSICIAN/PATIENT
RELATIONSHIP AND OF LIABILITY 84 3. THE PHYSICIAN S DUTY TO KNOW ABOUT
DRUGS 91 4. THE PHYSICIAN S GENERAL DUTY TO HIS PATIENT 97 5. THE
PHYSICIAN S DUTIES AS REGARDS PRESCRIBING 98 6. THE DUTY TO USE DRUGS
RESTRICTIVELY 100 7. THE DUTY OF CAREFUL CHOICE 104 8. THE DUTY TO
CONSULT AND TO OBTAIN CONSENT 115 9. THE DUTY TO PRESCRIBE AND RECORD
WITH CARE 127 10. THE DUTY TO EXPLAIN 130 11. THE DUTY TO ADMINISTER AND
SUPERVISE WITH SKILL 133 12. THE DUTY TO TERMINATE COMPLETED TREATMENT
137 IX 13. THE DUTY TO CONFORM WITH THE LAW 138 14. THE PHYSICIAN S
RESPONSIBILITY FOR INJURY CAUSED BY HORMONAL CONTRACEPTIVES 138 15.
INJURY DUE TO THE USE OF PLACEBO 139 16. DIVISION OF RESPONSIBILITY
BETWEEN PHYSICIAN AND PHARMACIST 141 17. THE SPECIALIST S STANDARD OF
CARE 141 18. THE ANAESTHETIST 142 19. THE DENTIST 146 20. RESPONSIBILITY
OF MEDICAL STUDENTS 148 21. THE DISPENSING PHYSICIAN 149 22. THE DOCTOR
AS AUTHOR AND PUBLISHER 149 9. RESPONSIBILITY OF THE MANUFACTURER OR
INTERMEDIATE TRADER 151 1. TYPES OF FIRMS ENGAGED IN PHARMACEUTICAL
MANUFACTURING AND TRADING 151 2. THE MANUFACTURER S FUNDAMENTAL DUTIES
152 3. DUTIES AND FAULTS: EFFICACY 153 4. DUTIES AND FAULTS: SAFETY 154
5. DUTIES AND FAULTS: QUALITY 161 6. DUTIES AND FAULTS: PACKAGING AND
SUPPLY 163 7. DUTIES AND FAULTS: INFORMATION TO OFFICIAL BODIES 164 8.
DUTIES AND FAULTS: INFORMATION TO HEALTH PROFESSIONS AND THE COMMUNITY
168 9. DUTIES AND FAULTS: WARRANTIES AND GUARANTEES 181 10. DUTIES AND
FAULTS: EXPOSURE OF NON-USERS 182 11. DUTIES AND FAULTS: RESEARCH
STANDARDS 183 12. INFLUENCE OF THE STATE OF THE ART ON DUTIES 184 13.
LEGAL PRINCIPLES UNDERLYING THE DRUG MANUFACTURER S RESPONSIBILITY FOR
PATIENT INJURY 185 14. RESPONSIBILITY OF THE MANUFACTURER OF SECONDARY
BRANDS AND-, UNBRANDED EQUIVALENTS 188 15. IDENTIFICATION OF THE
DEFENDANT MANUFACTURER 190 16. THE PHYSICIAN VERSUS THE MANUFACTURER 192
17. RESPONSIBILITY OF THE INTERMEDIATE TRADER OR LICENSEE 192 18.
RESPONSIBILITY OF INDIVIDUAL COMPANY EMPLOYEES 193 19. RESPONSIBILITY OF
PARTIES SUPPLYING DATA OR MATERIALS 194 20. RESPONSIBILITY FOR BLOOD AND
BLOOD PRODUCTS 195 21. PRODUCT RECALL AND WITHDRAWAL 195 22.
RESPONSIBILITIES OF MANUFACTURERS TO EACH OTHER 196 10. RESPONSIBILITY
OF THE DISPENSING PHARMACIST OR DRUG RETAILER 197 1. THE CHANGING ROLE
OF PHARMACY 197 2. GENERAL STANDARD OF CARE APPLICABLE TO PHARMACISTS
198 3. THE PHARMACIST S DUTY: SOURCES AND LIMITATIONS 199 4. POSITIVE
RESPONSIBILITIES OF THE PHARMACIST RELEVANT TO THE PREVENTION OF
DRUG-INDUCED INJURY 202 5. ENSURING THE QUALITY OF MEDICINES ON SALE 203
6. METICULOUS DISPENSING AND SUPPLY OF PRESCRIBED DRUGS 204 7. THE
DISCRETIONARY SALE OF DRUGS 209 8. THE EXERCISE OF DUE CONTROL ON
DANGEROUS DRUGS 210 9. PREPARATION AND MANUFACTURING OF DRUGS 210 10.
MAINTENANCE OF DRUGS IN GOOD CONDITION 211 11. THE IMPORTATION OF AND
WHOLESALE TRADE IN DRUGS 212 12. PROVISION OF INFORMATION AND ADVICE TO
THE PUBLIC 213 13. PROVISION OF INFORMATION AND ADVICE TO PHYSICIANS 214
14. THE PERFORMANCE OF CERTAIN MEDICAL TASKS 215 15. RESPONSIBILITIES OF
PHARMACY STAFF 216 16. MEDICATION CONTROL 216 17. THE UNQUALIFIED
PHARMACIST OR DRUGGIST 218 11. RESPONSIBILITY OF HOSPITALS AND
INSTITUTIONS 221 1. DUTIES AND LIABILITY OF HEALTH INSTITUTIONS 221 2.
RESPONSIBILITY OF MEDICAL STAFF 224 3. RESPONSIBILITY OF THE HOSPITAL
PHARMACIST 225 4. RESPONSIBILITY OF THE CLINICAL PHARMACOLOGIST 228 5.
RESPONSIBILITY OF THE NURSE 229 6. RESPONSIBILITY OF THE HOSPITAL FOR
DEFECTIVE PRODUCTS 234 7. RESPONSIBILITY OF THE INSTITUTION TOWARDS ITS
OWN STAFF AND TOWARDS CONTRACTORS 235 8. RESPONSIBILITY OF THE STAFF TO
THE INSTITUTION 236 12. RESPONSIBILITY OF THE PATIENT 237 1. THE
INTERPLAY OF DUTIES AND RESPONSIBILITIES 237 2. DEFINITION OF A
PATIENT S DUTIES REGARDING DRUG TREATMENT 238 3. CURRENT VIEWS ON THE
INDIVIDUAL DUTIES 239 4. LIMITS TO THE PATIENT S KNOWLEDGE, ABILITIES
AND FREEDOM OF ACTION 243 5. AN ACTIVE ROLE FOR THE PATIENT? 245 13.
RESPONSIBILITY OF GOVERNMENTS AND OFFICIAL AGENCIES 247 1. THE SCOPE OF
OFFICIAL INVOLVEMENT 247 2. DRUG REGULATORY AUTHORITIES 248 3. ANCILLARY
REGULATORY AND ADMINISTRATIVE ACTIVITIES 254 4. PROCEEDINGS AGAINST THE
STATE 255 5. RESPONSIBILITY OF INTERNATIONAL ORGANIZATIONS 255 XI
SECTION C: SPECIAL SITUATIONS 259 14. ANTE-NATAL, PRE-CONCEPTUAL AND
PERI-NATAL INJURIES 261 1. PATTERNS OF SECOND GENERATION INJURY 261 2.
THE POSSIBILITY OF PREDICTING, DETECTING AND AVOIDING INJURY 263 3.
DUTIES RELATING TO THE AVOIDANCE OF INJURY 266 4. EFFECTS ON THIRD AND
LATER GENERATIONS 268 5. LEGAL PROBLEMS OF SECOND GENERATION INJURY 268
6. RESPONSIBILITY OF THE MIDWIFE 272 15. NARCOTICS, DANGEROUS DRUGS AND
PSYCHOTROPIC SUBSTANCES 275 1. STATUTORY AND CIVIL DUTIES 275 2.
INTERNATIONAL LEGAL INSTRUMENTS 276 3. NATIONAL LEGAL MEASURES 277 4.
CLASSES OF INJURY INDUCED BY NARCOTICS AND DANGEROUS DRUGS 278 5. RISKS
OF PARTICULAR CLASSES OF DRUGS 281 6. PSYCHOTROPIC DRUGS AND THE
INTERVENING ACT 283 7. DUTIES INCUMBENT UPON PARTIES 284 8. SITUATIONS
OF CLAIM AND CONFLICT 286 9. MARIHUANA (HASHISH) AND SOFT DRUGS 287
10. ILLEGAL TRADE IN NON-NARCOTIC MEDICINES 288 16. CLINICAL
INVESTIGATION OF DRUGS 291 1. CONCEPT AND SCOPE OF CLINICAL DRUG
INVESTIGATION 291 2. FORESEEABILITY OF RISK DURING DRUG RESEARCH 295 3.
INJURY DUE TO DEPRIVATION OF TREATMENT 296 4. SOURCES OF ETHICAL AND
LEGAL STANDARDS 297 5. THE PRINCIPLE OF INFORMED CONSENT IN RESEARCH 298
6. PRINCIPLES OF ALLOCATION OF RESPONSIBILITY 300 7. THE
RESPONSIBILITIES OF THE CLINICIAN IN CHARGE . 301 8. THE
RESPONSIBILITIES OF THE SPONSOR 303 9. SPECIAL CATEGORIES OF SUBJECTS
305 10. INDEPENDENT PROSPECTIVE REVIEW 307 11. RESPONSIBILITY OF THE
STATE FOR CLINICAL INVESTIGATIONAL INJURY INVOLVING DRUGS 308 12. THE
PRINCIPLE OF COMPENSATION FOR RESEARCH INJURY 309 17. SELF-MEDICATION
311 1. THE NATURE OF SELF-MEDICATION 311 2. RISKS IN THE ABSENCE OF
FAULT 312 3. DUTIES OF PARTIES 313 4. ASSESSMENT OF THE LEGITIMACY OF
SELF-MEDICATION IN THE INDIVIDUAL CASE 314 5. THE DUTY OF THE PATIENT TO
SELF-MEDICATE RESPONSIBLY 315 XLL 6. THE CLASSES OF DISEASES AND
SYMPTOMS WHICH CAN OR CANNOT REASONABLY BE REGARDED AS PROPER MATTERS
FOR SELF-MEDICATION 317 7. TYPES OF DRUGS WHICH CAN OR CANNOT BE USED
FOR SELF-MEDICATION 319 8. THE CONTENT OF ADVERTISING AND INFORMATION
MADE AVAILABLE TO THE PUBLIC 320 9. DUTIES OF REGULATORY AUTHORITIES 322
18. NON-ORTHODOX TREATMENT 325 1. THE HISTORICAL DEVELOPMENT OF
ALTERNATIVE MEDICINE 325 2. ATTITUDES TO ALTERNATIVE MEDICINAL PRODUCTS
328 3. THE LEGAL SITUATION OF ALTERNATIVE THERAPY 329 4. INJURY DUE TO
ALTERNATIVE REMEDIES 331 5. RESPONSIBILITY OF THE ALTERNATIVE
PRACTITIONER 332 6. ALTERNATIVE MEDICINE PRACTISED BY PHYSICIANS 334 7.
QUACKERY AND CHARLATANISM IN ALTERNATIVE MEDICINE 335 8. MANUFACTURERS
AND SELLERS OF NON-ORTHODOX REMEDIES 336 19. VACCINES AND BIOLOGICALS
337 1. VACCINES AND BIOLOGICALS CONTRASTED WITH DRUGS 337 2. LIABILITY
OF GOVERNMENTS FOR STATE VACCINATION PROGRAMMES 338 3. LIABILITY OF
VACCINE MANUFACTURERS 339 4. EXISTING COMPENSATION SCHEMES FOR VACCINE
INJURY 344 SECTION D: BROAD COVERAGE OF RISK 347 20. STRICT LIABILITY
AND NO-FAULT COMPENSATION SCHEMES 349 1. COMPENSATION AS A MATTER OF
PRINCIPLE 349 2. THE NEED FOR ALTERNATIVES TO LITIGATION 351 3. STRICT
LIABILITY DISTINGUISHED FROM NO-FAULT COMPENSATION 353 4. EXAMPLES OF
COMPENSATION SCHEMES OR THE STRICT LIABILITY APPROACH 356 SELECTED
REFERENCES 363 INDEX OF CONVENTIONS, STATUTES AND REGULATIONS 391 INDEX
OF JUDICIAL AND DISCIPLINARY CASES 395 GENERAL INDEX 405
|
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| format | Book |
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| geographic | USA (DE-588)4078704-7 gnd |
| geographic_facet | USA |
| id | DE-604.BV001844797 |
| illustrated | Not Illustrated |
| indexdate | 2024-12-20T07:42:33Z |
| institution | BVB |
| isbn | 0444810056 |
| language | English |
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| publishDate | 1988 |
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| publisher | Elsevier |
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| spellingShingle | Dukes, Maurice N. G. 1930- Swartz, Barbara Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers Arzneimittelnebenwirkung (DE-588)4003134-2 gnd Rechtsvergleich (DE-588)4115712-6 gnd Gesundheitsschaden (DE-588)4157178-2 gnd Arzneimittel (DE-588)4003115-9 gnd Haftung (DE-588)4022898-8 gnd |
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| title | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers |
| title_auth | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers |
| title_exact_search | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers |
| title_full | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers M. N. Graham Dukes and Barbara Swartz |
| title_fullStr | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers M. N. Graham Dukes and Barbara Swartz |
| title_full_unstemmed | Responsibility for drug-induced injury a reference book for lawyers, the health professions and manufacturers M. N. Graham Dukes and Barbara Swartz |
| title_short | Responsibility for drug-induced injury |
| title_sort | responsibility for drug induced injury a reference book for lawyers the health professions and manufacturers |
| title_sub | a reference book for lawyers, the health professions and manufacturers |
| topic | Arzneimittelnebenwirkung (DE-588)4003134-2 gnd Rechtsvergleich (DE-588)4115712-6 gnd Gesundheitsschaden (DE-588)4157178-2 gnd Arzneimittel (DE-588)4003115-9 gnd Haftung (DE-588)4022898-8 gnd |
| topic_facet | Arzneimittelnebenwirkung Rechtsvergleich Gesundheitsschaden Arzneimittel Haftung USA |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=001223561&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT dukesmauriceng responsibilityfordruginducedinjuryareferencebookforlawyersthehealthprofessionsandmanufacturers AT swartzbarbara responsibilityfordruginducedinjuryareferencebookforlawyersthehealthprofessionsandmanufacturers |