Drug Injury: Liability, Analysis, and Prevention

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Lawyers & Judges Publishing Company, 2005 - Law - 894 pages
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If you have an involvement with the health care system, you know that drug-induced injury cases are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case. You'll want to be sure that the case you take on has merit and will prove economically sound for both you and your client. To successfully accomplish this, you need the knowledge of pharmacy and the drug manufacturing industry that the authors have carefully detailed in this book.Easy for the nonmedical professional to follow, the book is divided into three useful sections. The first section deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. The second section examines high-risk drug therapies that result in pharmaceutical litigation. You'll read about important litigation regarding drugs like Prozac, Accutane and Rezulin, as well as anabolic steroids, insulin and oral diabetic drugs, and more. Whether or not your case involves the drug cited you'll find that the theories applicable to one pharmaceutical case are often applicable to another. The third section of the book looks at the professional pharmacist and malpractice claims. It also includes appendices of FDA regulations relating to drug product liability, guidance for industry, use of risk minimization plans, and FDA pregnancy classifications.You'll find this text indispensable because it provides comprehensive information for all those affiliated with the pharmaceutical industry.New chapters: The failed system of drug warnings in America Clinical research: Testing treatments in humans FDA regulation of clinical investigations Identification of regulated solid dosage forms Evaluation of Causation in drug injury cases The role of pharmacoepidemiology and expert testimony in drug injury E-ferol disaster Drugs for asthma, allerfies and anaphylaxis: Harm from use, misuse and non-use Nephrotoxic drugs Statins and Baycol-Questionable cholesterol The Rezulin litigation Drug-induced movement disorders Ephedra The emergency department pharmacist Drug testing in the workplace
 

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Contents

The FDA and the DrugApproval Process
3
12 Clinical Studies Overview
4
13 Phases of Clinical Studies
5
A Phase 1 clinical studies
6
16 Parallel Track
7
110 Fundamentals of NDA Submissions
8
113 Additional FDAApproved Patient Labeling
9
114 The GenericDrugApproval Process
10
C Another interloper?
430
2410 End Product Testing Recommended
431
2414 Drug Interactions with Sulfonylureas
433
Nephrotoxic Drugs
437
254 Patient Groups Most Susceptible to Nephrotoxicity
438
256 Methods to Assess Renal Function and Damage
439
258 Nephrotoxic Drugs
440
C Dialysisrelated Issues
441

116 PostMarketing Surveillance
11
D MedWatch program
12
119 Applicable Statutes
13
D Drug amendments of 1962
14
120 Controlling Statute
15
The Dietary Supplement and Health Education Act of 1994 DSHEA and Related FDA Activities
17
22 Overview of DSHEA
18
23 The FDAs Role in Implementation of DSHEA
19
C Labeling of a dietary supplement
20
24 Claims Permitted under DSHEA
21
B The FDAs dietarysupplement proposal
22
C Advertising
23
A MedWatch
24
C Literature guidelines under DSHEA
25
27 Future FDA Activities Related to DSHEA
26
B Combination drug rule
27
Appendix B HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra
28
Implications for Regulation US Food and Drug Administration
31
The Pharmaceutical Industry
35
32 DirecttoConsumer Advertising DTC
37
B The FDAs requirements for the content of DTC advertisements
39
33 Marketing Abuses Fines Government Actions and Litigation
41
A Imminent loss of patent protection worth billions of dollars leads to panic in the boardroom
42
35 Summary
43
The Failed System of Drug Warnings in America
45
B Overview of the problem
46
42 Underreporting of ADEs
47
B The underreporting problem
48
C Solutions to the problem
49
43 Problems at the FDA
50
B The current and future FDA
52
44 Conclusion
54
Clinical Research Testing Treatments in Humans
59
A Phase 1
60
Not an Exact Science
61
54 Study Design
62
A Control groups
63
B Random assignment
65
D Crossover design
66
D Study procedures
67
56 ClinicalTrial Service Providers
68
C Contract research organizations
69
E Clinicaltrial site
70
F Sitemanagement organizations
71
G Institutional review board
72
Endnotes
73
FDA Compliance and Inspection Programs Governing Clinical Investigations
75
62 FDA Regulations for Clinical Investigators
76
Sponsor Regulations
77
Informed Consent
79
Institutional Review Board
81
63 Guidance for FDA Compliance Programs
83
Clinical Investigators
84
Sponsors
85
64 FDA Inspection Procedures
86
C FDAs apparent trend toward an increased use of warning letters
87
E Comments on warning letters
88
References
89
Endnotes
91
The Protection of Subjects in Clinical Research
95
73 Violations of the Rights of Human Subjects
96
Drug Studies
97
D Dangers of offlabel therapy
98
Protecting Human Subjects
99
C Institutional Review Board
100
D Informed consent
101
F Serious and unexpected adverse events
102
G Subjects responsibilities
104
I Institutional responsibilities
105
Endnotes
106
Resources for Further Reading
107
Comparison of FDA and HHS HumanSubject Protection Regulations
108
Identification of Regulated SolidDosage Forms
115
83 Accompanying Documents
116
84 Imprints and Appearance
117
85 Conceptually Imprints are Unique
122
86 Conclusion
123
HighRisk Drug Therapies Resulting in Injury and Litigation
125
Adverse Drug Reactions The Extent of the Problem
127
B ADR incidence
128
why doctors fail to report ADRs
129
E Attitudes toward ADRs
130
F Investigator fraud
131
A Categories of ADRs
132
C Claimants
133
B Selection
134
D Medication errors
135
B Exfoliative dermatitis
136
95 DrugInduced Hepatic Injury
137
The latest NSAID in the news
138
D Litigation report
139
E Aspirinsensitive rhinosinusitis or asthma
140
97 Summary and Conclusions
141
References
142
Evaluation of Medical Causation
143
103 Definition of an Adverse Effect
144
C Possible cause of adverse effect
145
A Kochs postulates
146
107 Daubert v Merrell Dow Pharmaceuticals Inc and the Evolution of Causation
147
C Scientific evidence
148
The Role of Pharmacoepidemiology and Expert Testimony
151
112 Drug Misadventures
152
C Drug interactions
153
113 Did the Drug Cause the Adverse Event?
154
115 Preventability
156
118 Grading the Strength of the Evidence
159
119 Risk Communication and Possible Actions by the FDA
160
C Patients duties
161
C How did it occur?
162
Medication Errors and Adverse Drug Reactions in Hospitalized Patients How Common Are They and Why do They Occur?
165
123 Medication Error Rates
166
125 Understanding the Normal Process for Medication Management
167
C Name of the drug
168
Intravenous IV intramuscular IM subcutaneous SC or oral PO
169
H Twentyfourhour check
170
127 Broad Classification of Medication Errors into Four Categories
171
D Administrative errors
172
C Unordereddrug error
173
1210 Those Patients at Increased Risk for Medication Errors
174
1212 Summary
175
Endnotes
176
MedicalLegal Aspects of Medication Errors
177
133 Nursing Responsibilities Following a Medication Error
178
136 Determining Culpability
179
137 When the Five Rights Go Wrong
180
D Dosing errors and children
181
E Wrong dose of intravenous medication
182
G Wrong route
183
J Wrong site
184
139 HighRisk Medications
186
B Caustic chemicals
187
C Chemotherapy medication errors
188
Potassium chloride
190
G Inducing addiction
192
1310 Treatment Errors and Adverse Drug Reactions
194
B Adverse drug reactions
195
C Negligent prescription
196
E Failure to monitor
197
Appendix A
200
Appendix B
203
Preventing Medication Errors
207
A Measurement and tracking
208
D Process improvement and process redesign
209
G SixSigma processes and what purchasers of health care know
210
A Manufacturers
211
B Healthcare systems
213
C Physician and physician extenders
216
D Pharmacists
217
E Nursing responsibilities
218
144 Summary
221
References
222
Pharmacists Errors
223
152 Why are Errors so Common?
224
153 Memorable Misfills
225
154 Lawsuits and Liability
226
155 Error Stories
227
156 How Widespread is this Problem?
229
157 The Confidence Interval
233
158 Employers Attempt Action
234
159 Inexperienced Technicians Fill Prescriptions
235
1510 Doctors Errors
237
1511 Fed Up with Doctors Handwriting
240
1512 Calling Doctors about Drug Interactions
244
1513 A Pharmacist Who has Had Enough and Will No Longer Practice Pharmacy
245
Endnotes
246
Danger at the Drugstore Some Practical Comments on Pondimin and Redux Litigation
249
B The legal issues
250
163 Overview of the Issues
251
Were the fenfluramines more harmful than helpful?
252
Litigating PPH Intermediate and BackEnd OptOut Cases
253
No optout needed
254
C Limitations on damages and the right to recover
256
E Multipleplaintiff trials
257
DietPill Litigation The FenPhenRedux Debacle A MedicalLegal Perspective
259
172 Fenfluramine and Dexfenfluramine
260
B Dosage and duration of therapy
261
B Dosage and duration of therapy
262
B Pathological findings
265
C Natural history
266
D Diagnostic studies
267
175 Cardiac Valvulopathy
268
B Pathological findings
269
C Mitralvalve regurgitation
270
H Echocardiography
271
176 Cardiac Epidemiology
272
177 Neurotoxicity
273
B Species generality
275
D Clinical experience
276
Endnotes
278
Appendix A
285
Statement of the American College of Cardiology on Recommendations for Patients Who have Used Anorectic Drugs October 18 1997
291
Diet Drugs PharmacologyInteractionsCautions
293
182 Pharmacology
294
B Effectiveness in diabetic patients
295
Metabolism Cytochrome P450
296
188 The Pharmacology of Serotonin Neurotransmission
297
B Sleep
298
1812 FenPhen Diet
299
1813 Phentermine Resin Ionamin
300
1816 Behavior
301
1819 Tricyclic Antidepressants
302
1823 Selective Serotonin Inhibitors
303
1825 5HT Receptor Agonists and Antagonists
304
1826 Summary
306
Endnotes
307
Recommended Reading
308
The Story of EFerol Adding Insult to Injury
309
193 The Fruition of EFerol
311
194 Final Exposure
312
198 Criminal Ramifications
313
199 Hospital Policy and Procedure
314
1911 LongTerm Aftermath
316
1913 The Exposure of Duty and Ethics through Litigation
317
1914 The Revelations from Litigation
320
References
323
A Plaintiffs Expert Report on the Duty of the Pharmacist in the Recall of EFerol
324
Endnotes for Appendix
331
Accutane Focus on Psychiatric Toxicity and Suicide
333
202 Mechanism of Action
334
B Psychiatric adverse events
335
205 Accutane and Depression
336
206 Accutane and Suicide in Adolescents
337
C Substanceinduced mood disorder
338
E Results
339
208 OPDRA Study
342
B Dr OConnell FDA Biological Plausibility and Risk Management 120
344
2010 Selected Abstracts from Accutane 2002 Prescribing Information
345
2011 Selections from Accutane Informed ConsentPatient Agreement
346
2013 Adverse DrugReaction Reports
347
2014 Submission of ADR Reports
348
2016 Defense of Accutane
349
2019 Retinoids Implicated in Schizophrenia
350
When Warnings are Not Enough
351
2024 RTEPrimeTime
352
Failure to Comply
353
B Therapeutic use
354
2031 Conclusion
355
Bishop v HoffmanLaRoche Inc Motion to dismiss denied
359
Memorandum on Adverse Event Report for Roaccutane
373
Review of Adverse Events Reported for Roaccutane for Children and Adolescents Aged Under 18 Years of Age
374
Antidepressants Clinical Use and Litigation
379
213 Antidepressant Overdose
380
A Prozac and suicidal ideation
381
B Paxil and suicide risk in children
382
B Stebbins v Concord Wrigley Drugs Inc et al
383
D Penelope A Carafelle et al v Brockton Oaks CVS Inc
384
A Kirk v Michael Reese Hospital
385
217 Selective Serotonin Reuptake Inhibitors and the Serotonin Syndrome
386
218 Hepatic Cytochrome P450 Drug Interactions and SSRIs
387
2111 The Omnibus Budget Reconciliation Act
388
Endnotes
389
Drugs for Asthma Allergies and Anaphylaxis Harm from Use Misuse and NonUse
391
A Young boy attacks brother after taking theophylline
392
A Lifethreatening sulfonamide reaction after Pediamycin
393
223 Vehicles Propellants Other Inert Ingredients
394
A Anaphylactic death in a medical office
396
225 Methylxanthines
397
B Permanent brain damage from double theophylline doses
398
228 Anticholinergics
399
A Diabetes after a short course of oral prednisone
401
E Massive steroids for refractory bronchitis complicating asthma
402
2210 Antitussives and Expectorants
403
B Worsening of asthma perceived as a cure with marijuana
404
E Inappropriate attribution of blame
405
Corticosteroids
409
233 Mechanism of the Toxicity
410
237 Sample Case Discussion Regarding Withdrawal of Corticosteroids
411
B Teaching tips
412
C Topical steroids
413
E Case illustration
414
B Summary
415
2311 Steroid Psychosis and Psychoactive Effects
416
2313 Warnings
417
2314 Adrenal Suppression
418
2316 SteroidInduced Avascular Necrosis
419
A Fat embolus
420
2317 An Unusual Case of SteroidInduced Avascular Necrosis
421
2319 Cushings Syndrome
422
2321 Summary
423
Recommended Reading
424
Adverse Effects of Diabetic Drugs
425
245 Hypoglycemia Low Blood Sugar
426
A Etiologies of hypoglycemia
427
247 Incidence
428
B Insulin damages babys brain pharmacist error suggested
429
E Angioedema with an ACE inhibitor
442
F Fatal hyperkalemia with medications
443
2510 Conclusions
444
DrugInduced Hepatotoxicity
445
A Hepatitis
446
263 Hepatic Drug Metabolism
447
266 NSAID Use and Hepatotoxicity
448
B Review of Duract labeling revision July 31 1996 Widmark letter
449
E Bromfenac safety summary by John Hyde PhD MD December 19 1995
450
B Clinical features and laboratory findings
451
AcetaminophenPhenytoin Interaction
452
C Bases for opinions
453
D Summary
454
B Opinions
455
2612 Other Acetaminophen Cases
457
2614 Rezulin Hepatotoxicity
459
B Discussion
460
B Clinical features and laboratory findings
461
C Liver function tests
462
B The literature
463
C Opinions
464
2619 Liability and Warning
465
Statins Including Baycol Questionable Cholesterol Control
469
273 Doubts about Benefits of Cholesterol Reduction
470
274 Adverse Reactions to Statins
472
C Rhabdomyolysis
473
F Cancer
474
277 Legal Complaints
475
C Medical malpractice
476
Endnotes
477
The Rezulin Litigation
479
A breakthrough drug for typeII diabetes?
480
C Rezulin poisons the mitochondria
481
D The range of Rezulin injuries
482
A Class effect
483
283 Warner Lamberts Reaction
485
DrugInduced Movement Disorders
489
293 Neuroleptics
491
294 Metoclopramide
492
297 Chronic Tardive and Withdrawal Akathisia
493
299 Neuroleptics
494
2911 Parkinsonism
495
2912 Neuroleptics and Other Agents
496
2913 Tardive Dyskinesia
498
2914 Neuroleptics and Other Agents
500
2915 Neuroleptic Malignant Syndrome
501
2916 Diagnostic Terminology
502
2917 Theories of Causation
503
2918 Clinical and Legal Issues in Psychiatry
504
2919 Conclusion
507
Recommended Reading
516
Pain Medications and OxyContin
517
A Diagnostic evaluation of pain
518
E The chronic pain patient
519
F Analgesics
520
H Equipotency of analgesics
521
I Hepatic side effects
522
L Goal of treatment
523
A Opinions
524
B The drugs
525
B Bases for opinions
526
E Facts of the case and summary of testimony
527
F Opinions
528
Opioids fentanyl and respiratory depression with and without additional central nervous system CNS depressants
529
H Obesityhypoventilation syndrome
530
Duragesic Fentanyl Death Discharged Patient
531
D Opinions
532
306 Pain Equilibration
533
B Experimental and clinical pain
534
C Clinical pain
535
G Goodman and Gilman discussion of morphine8
536
I Sample report
538
J Oral analgesic medication studies
539
K Dental extraction pain equivalence
540
L Conclusion
541
C Summary of opinion
542
E Materials reviewed
544
Endnotes
545
Appendix
547
PerformanceEnhancing Substances Ephedrine Anabolic Steroids Herbals and Dietary Supplements
549
B Performance enhancement and testing
551
C Antidoping code
552
312 Anabolic Steroids
553
C Other uses
554
E Psychological effects
555
H Case illustration
556
313 NonAthletic PerformanceEnhancing Substances
559
315 Amended CGMP for Dietary Supplements March 2003
561
B Why are CGMPs needed?
562
C Benefits and costs
563
Ephedra
565
B Hearing loss
566
322 Ephedra Alkaloids as Dietary Supplements
567
324 Ephedra as an Alternative to Illegal Substance Abuse
568
326 The RAND Report on Ephedra 2003
569
Weight loss
570
327 The Agency for Healthcare Research and Quality and the RAND Report
571
D Future research
572
329 Ellis and Metabolife Company Indicted for Obstruction of Justice
575
Endnotes
576
Appendix B
587
Endnotes for Appendix B
592
Recreational Drugs Alcohol Cocaine and Marijuana Forensic Issues
595
A Major Contributor to Injury
596
335 Other NonMotor Vehicle Injuries Related to Alcohol
597
336 Reaction Time Impairments and Tolerance Effect of AlcoholContribution
599
337 Adaptation Effects of Alcohol in the Central Nervous SystemTolerance
601
Extreme Alcohol LevelsTolerance
602
Alcohol
604
3310 An Unusual Case of Alcohol Hypersensitivity Reaction in Combination with Marijuana Leads to Apparent Psychotic Reaction
606
Alcohol Metabolism and Kinetics in a Malnourished Bulemic Woman Charged with the Reckless Homicide of Her Infant
609
Alcohol and Recreational Drugs
612
Urine drug testing
613
DiplomateAmerican Board of Clinical Pharmacology DPoppy seed opiate false positives
614
3313 Cocaine
615
B Metabolism and excretion
616
D Analysis
617
H Cocaine use as a cause of death
618
3314 Marijuana
619
A Effects of cannabis
620
B Marijuana in combination with alcohol and other drugs
621
C Clinical diagnosis
622
3316 Heroin and Other Opiates
624
Methadone Arrest with Brain DamageDifferentiation from Cocaine Criminal Defendant
626
3318 Prescription Drugs and Driving
627
3319 Conclusion
628
References
631
Hemophilia Holocaust Litigation Related to Blood Factor VIII and IX Products and AIDS Transmission
633
342 Challenges of Factor VIII and IX Litigation
634
343 Development of Factor VIII and IX
635
345 Response to Reported Side Effects of Factor VIII and IX
636
346 Identifying Hepatitis
637
347 AIDS Epidemic and Treatment of Hemophilia
638
348 Litigation Strategies
642
3410 History of Hepatitis Regulation
645
3411 Defending Factor VIII and IX
646
Pharmacists Pharmacy and Pharmacy Practice
649
Regulation of Pharmacy Practice
651
A OBRA 90 recognized as standard of care by appellate courts
652
B Death from multiple medications
653
353 Prescriptions
654
354 Reference Sources
655
Pharmacist Malpractice and the Infamous Courtney Case
657
A Wrong drug
658
B Wrong strength of the drug
659
D Drug review
660
E Counseling
661
G Others
662
Aminoglycoside nephrotoxicity and ototoxicity
663
363 Criminal Activity The Robert Courtney Case
664
A Vigilance
665
E Courtney case resolution
666
I Regulation of compounding
667
364 The Courtney Criminal Case
668
365 Conclusion
669
Guidelines for Injectable Medications 2004
671
Endnotes
672
Specialized Services A FullService Community Pharmacy Practice Is this Feasible Beneficial and RiskFree?
703
382 Collaborative Practice
705
384 What is a FullService Community Pharmacy?
706
385 Drug Information
707
386 Clinical Laboratory Services
708
387 Home Medical Equipment
709
388 Herbal and OTC Medications
710
3810 DiseaseState Management
711
3811 Immunizations and Vaccinations
712
3812 Documentation
713
3813 MedicalPharmaceutical Records and Documentation
714
3814 Physical Assessment and Pharmacists Diagnosis
715
3815 Facilities
717
3816 Summary
718
Nursing Home Pharmacy Pharmacology and the Elderly
721
B Dispensing medication
722
394 Chemical Restraints
723
395 OffLabel Agents
727
A Intent of OBRA restrictions on chemical restraints
728
C Ongoing monitoring
729
398 Guidelines versus Medical Practicea
730
Reference
731
The Emergency Department Pharmacist
733
403 Etiology of Drug Injury in the ED
734
A Historical Perspective
735
407 The ED Pharmacist as a Generalist
736
B The ED pharmacist and the ambulatory care interphase
737
D The ED pharmacist and the cardiology interface
738
E The ED pharmacist and neurological emergencies
739
4010 Building Layers of Defense against Drug Injury
740
B The ED pharmacist and community surveillance for adverse drug reactions
741
4012 Conclusion
742
Pharmacy Compounding Regulations
743
412 Food and Drug Administration
744
414 The Triad
745
415 Licensed Pharmacist or Physician
746
4111 Definitions
747
4114 US Pharmacopeia
749
Pharmaceutical CompoundingSterile Preparations
751
4115 Individual Drug Monographs
752
4117 Pharmacists Responsibilities
753
Endnotes
754
Appendix A
755
Appendix B Guidance for FDA Staff and Industry Compliance Policy Guides Manual
756
Appendix C List of Compounding Drugs that were Withdrawn or Removed from the Market for Safety Reasons
758
The Forensic Pharmacist
761
422 Consultant and Expert Witness
762
424 Affidavit of Consulting Pharmacologist
763
425 Interpreting Drug Levels
764
426 Malpractice Cases of Other Professionals
765
428 Utilization Review for Insurance Claims
766
4210 Workers Compensation
767
4211 Alcohol Cases
768
4214 Conclusion
769
Forensic Drug Testing
771
433 Extraction of the Drug from the Biological Matrix
773
A GCMS
774
B Quantifying a drug using the GCMS
775
C The GCMSMS
776
436 Types of Errors
778
438 Summary
779
Recommended Reading
780
Drug Testing in the Workplace
781
444 Voluntary Programs
782
445 Establishment of a Workplace Program
783
C Employee awareness training
784
A Collection
785
B Accessioning
786
C Drugs to be tested
787
E Confirmation tests
788
F Reporting and storage of samples
789
B Public interest exclusions PIE
790
B Alternate sources of drug exposure
794
C Amphetamine testing issues
796
449 Legal Aspects of Workplace Drug Testing
798
B State and federal mandates
799
The Litigation Package
800
Endnotes
801
Managed Care in Pharmacy and the Pharmaceutical Industry
805
452 Colleges of Pharmacy Continuing Education and Certification
806
454 Continuing Education
807
457 Practice Settings
808
458 Issues for Pharmacy
809
459 The Pharmaceutical Industry
810
B Manufacturer sales and marketing
811
4510 Wholesaler
812
4512 The Pharmaceutical Industry
815
4514 Pharmacy Practice Changes
816
4515 The Pharmacist Professional versus Pharmacy Business
817
4517 Summary
818
Glossary
819
The Evolution of PharmacyBenefits Managers PBMs An Overview
821
B Background
822
E The growth of mailorder pharmacy
823
462 Mail Order to Mail Service
824
C Economies of scale
825
E Managed health care
826
G Taking the lead
827
Healthcare business organizations
828
C Mergers acquisitions and alliances
829
F Intervention service
830
I Copayments
831
464 PBMs and Pharmacy Networks
832
D Utilization management
833
A The Pharmaceutical industry under pressure
834
466 Some Afterthoughts
835
The NABP Model Act and Rules Initiative toward Pharmacy Technicians
841
472 The Significance of the NABP Model Act and Model Rules Revisions
842
474 The History of US Pharmacy Technicians in Clinical Settings
843
475 A PharmacistCentered Legal and Regulatory System
844
476 Current Technician Training Education Licensing and Regulation
845
A Pharmacy technician education and training
846
477 Expanding Reliance on Pharmacy Support Personnel
847
479 National Focus on Dispensing Errors
849
4710 Previous NABP Model Act Provisions Relating to Pharmacy Technicians
850
4712 Regulation of Pharmacy Technicians under the Revised NABP Model Act
851
4713 Training Education Certification Registration and Licensing under the Revised NABP Model Act
852
4714 Elimination of Pharmacistto Technician Ratio
853
4716 ReEvaluation of a Pharmacy Technicians Legal Responsibility in Light of the Proposed Changes to the NABP Model Act
855
4717 Summary
856
Endnotes
857
Physician and Hospital Liability in Drug and MedicalDevice Litigation
861
483 OffLabel Use
863
484 Product Liability
864
486 Mass Tort Litigation
866
487 Conclusion
867
Index
869

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About the author (2005)

James O'Donnell, M.S., Pharm.D., DABCP, CNS, FACN, RPh, is a pharmacologist, pharmacist and nutritionist in Palatine, Illinois. His career has included pharmacy practice in a variety of settings, and consultations to industry, government, health care, publishing and legal fields. He is currently an assistant professor of pharmacology at the Rush Medical College in Chicago. Dr. O'Donnell is a diplomate of the American Board of Clinical Pharmacology, the founding editor-in-chief of the Journal of Pharmacy Practice, and the author of Drug Injury: Liability, Analysis, and Prevention, published by Lawyers and Judges. He consults and testifies in matters involving pharmaceuticals, medication errors, and drug injuries throughout the United States. Dr. O'Donnell received his B.S. in pharmacy from the University of Illinois, Pharm.D. from the University of Michigan, and a M.S. in clinical nutrition from Rush University.

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