Avoidable Patient Harm and Resulting Liability
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Avoidable Patient Harm and Resulting Liability What would it take to improve our insight into the cost of avoidable patient harm? Medications are the most frequent cause of adverse events in clinical settings. Some of the most devastating drug-related injuries include Steven-Johnson Syndrome, drug-related liver injury or bone marrow failure. These events, however rare, are among those that are very expensive to treat and often leave long-lasting damage. The substantial consequences of adverse drug events are hospital admissions and readmissions, prolonged hospital stay, additional therapeutic interventions and increased demand on staff. For the patient, in addition to all the misery and pain they suffer, adverse drug events mean time away from work, loss of income and additional medical expenses.
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Avoidable Patient Harm and Resulting Liability
- 1. AVOIDABLE PATIENT HARM VERONIKA VALDOVA VERACUITY, LLC
- 2. AVOIDABLE PATIENT HARM VERONIKA VALDOVA VERACUITY, LLC
- 3. AVOIDABLE PATIENT HARM VERONIKA VALDOVA VERACUITY, LLC Reduced visibility of Adverse Drug Events (ADEs) makes it difficult for physicians to adjust their prescribing practices, which extends occurrence of preventable error- related injuries, with associated liability risk.
- 4. Boeing RB-29A Superfortress 44-61999 “Over Exposed!” Crashed 03 Nov 1948 at Bleaklow, High Peak, Derbyshire, UK
- 5. 5 In 2000, Samantha Reckis (age 7) developed Toxic Epidermal Necrolysis after taking Children’s Motrin. In 2013, she was awarded $140 million in settlement. In 2016, The U.S. Supreme Court said that it will not hear Johnson & Johnson’s appeal and the verdict remained intact. (The National Trial Lawyers) “More calls in the U.S. to poison control centers are related to acetaminophen than any other drug. These account for more than 100,000 calls, with 56,000 emergency room visits, 2,600 hospitalizations, and 458 deaths. Over 40% of the cases of acute liver failure in the United States are from acetaminophen.” (Levin Law) Jasmin Bindom reached settlement against McNeil, the maker of Tylenol. Pliva v Mensing VERONIKA VALDOVA Steven-Johnson Syndrome Bone marrow failure Drug-related liver injury Drug-related patient injury
- 6. TO ERR IS HUMAN PREVENTABLE ADVERSE DRUG EVENTS To Err is Human 380,000 to 450,000 preventable ADEs annually (IoM, 2007) In 1996, incremental cost of an ADE was $5857 (Bates, 1997) 400,000 ADEs x incremental cost $5857 per ADE Estimated cost of preventable ADEs was $3.5 billion a year Institute of Medicine. 2000. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press.
- 7. BECKER’S HOSPITAL REVIEW COST OF ADVERSE DRUG EVENTS Becker’s Hospital Review 2015 $4.7 billion in reported costs of ADRs $25 billion in true costs if unreported ADRs are considered Becker’s Hospital Review. May 5, 2015. https://www.beckershospitalreview.com/hospital- management-administration/a-new-era-of-drug-safety-using-adverse-events-big-data-to-improve- outcomes-and-decrease-healthcare-costs.html
- 8. U.S. HEALTH CARE SPENDING NON-OPTIMIZED RX DRUG THERAPY The Cost of Non-Optimized Therapy 2018 Total U.S. health care spending reached $3.5 trillion • of which hospital care was $1.1 trillion • physician and clinical services were $694 billion • retail prescription drugs cost $333.4 billion. The cost of non-optimized prescription drug therapy, i.e. treatment failure and a new medical problem is estimated at $528 billion (Watanabe, 2018) Centers for Medicare and Medicaid Services. National Health Expenditures 2017 Highlights. CMS 2018; Watanabe JH, McInnis T, Hirsch JD. Cost of prescription drug-related morbidity and mortality. Ann Pharmacother 2018;1060028018765159
- 9. Veronika Valdova Batel Marques F, Penedones A, Mendes D, Alves C. A systematic review of observational studies evaluating costs of adverse drug reactions. Clinicoecon Outcomes Res. 2016;8:413-26. Published 2016 Aug 24. doi:10.2147/CEOR.S115689 • 31 Observational studies published from 1995 to 2015 included • All included studies had a low risk of bias (comparable to a well-performed randomized trial) • Validated methods to measure ADE-associated costs needed • Large methodological heterogeneity in measuring ADE-related morbidity and associated costs • Highest estimated cost €40,273.08 involved pediatric population in intensive care unit • Evidence suggests increased frequency and severity of ADRs • Profound lack of knowledge in outpatient setting • Costs due to ADEs may be steadily rising
- 10. Veronika Valdova • Evaluation of the economic impact of preventable ADRs in the USA and Europe • The associated healthcare costs include new hospital admissions, prolonged length of inpatient stay and additional therapeutic interventions • Research on economic impact of ADRs very limited and methodologically heterogenous • The costs due to preventable ADRs: • €2,851 to €9,015 (inpatient setting) • €174 to €8,515 (outpatient setting) • Impact of preventable ADRs on length of stay was 9.2 days (outpatient) / 6.1 days (inpatient) There are no published studies that would focus on the cost of preventable ADRs D Formica, J Sultana, PM Cutroneo, S Lucchesi, R Angelica, S Crisafulli, Y Ingrasciotta, F Salvo, E Spina & G Trifirò (2018) The economic burden of preventable adverse drug reactions: a systematic review of observational studies, Expert Opinion on Drug Safety, 17:7, 681-695, DOI: 10.1080/14740338.2018.1491547
- 11. First ever black hole image released, 2019 Research that quantifies the cost of patient harm due to adverse drug events
- 12. Patient Harm & Resulting Liability Legal concepts LAWSUITS AGAINST HEALTHCARE PROFESSIONALS •Diagnostic errors •Errors of omission •Errors of commission •Errors of communication •Errors of context LAWSUITS AGAINST THE PHARMACEUTICAL & MEDICAL DEVICES INDUSTRY •Inadequate warning on the label •Defectively manufactured product •Defectively designed product (devices)
- 13. Wyeth v. Levine Wyeth v. Levine (2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.
- 14. How do I know there is a problem with IV push vs. IV drip? route of administration stated , 424,013, 41% unknown , 340,023, 32% blank , 284,539, 27% Percentage of products with Route of administration stated (FAERS Q1 2019) route of administration stated unknown blank
- 15. Patient Harm & Resulting Liability Legal concepts LAWSUITS AGAINST HEALTHCARE PROFESSIONALS •Diagnostic errors •Errors of omission •Errors of commission •Errors of communication •Errors of context LAWSUITS AGAINST THE PHARMACEUTICAL & MEDICAL DEVICES INDUSTRY •Inadequate warning on the label •Defectively manufactured product •Defectively designed product (devices)
- 16. Criminal & Civil liability GSK pleaded guilty to manufacture and distribution of certain adulterated drugs made at GSK’s manufacturing facility at Cidra, Puerto Rico. The affected drugs were Kytril, Bactroban, Paxil CR and Avandamet. DOJ (2010): GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant
- 20. How do I know there is a problem with a specific product when very few products are unambiguously identified? NDC value stated (non-10-digit format), 331,525, 32% NDC value stated (10-digit format), 9, 0% NDC value blank , 717,041, 68% Count and Percentage of products that include NDC # (FAERS Q1 2019) NDC value stated (non-10-digit format) NDC value stated (10-digit format) NDC value blank
- 21. Patient Harm & Resulting Liability Legal concepts LAWSUITS AGAINST HEALTHCARE PROFESSIONALS •Diagnostic errors •Errors of omission •Errors of commission •Errors of communication •Errors of context LAWSUITS AGAINST THE PHARMACEUTICAL & MEDICAL DEVICES INDUSTRY •Inadequate warning on the label •Defectively manufactured product •Defectively designed product (devices)
- 22. Guvenoz v. Target Corp, Inc. Generic version of DARVOCET (Dextropropoxyphene) caused cardiac arrest, brain injury and death and was pulled from the market.
- 23. Is Compliance with Submission Timelines Enough? Limitations of FAERS Data Data Quality (duplicated reports, insufficient information) Causality assessment (temporal relationship, dechallenge, rechallenge, biological plausibility, alternative explanations) Verification of information Rates of occurrence
- 24. Patient Harm & Resulting Liability Legal concepts LAWSUITS AGAINST HEALTHCARE PROFESSIONALS •Diagnostic errors •Errors of omission •Errors of commission •Errors of communication •Errors of context LAWSUITS AGAINST THE PHARMACEUTICAL & MEDICAL DEVICES INDUSTRY •Inadequate warning on the label •Defectively manufactured product •Defectively designed product (devices)
- 25. David Belk: Malpractice statistics. True Cost of Healthcare, 2018.
- 28. Pharmacogenomic considerations PAROXETINE • The highest inhibitory constant for the CYP450 2D6 isoenzyme of all antidepressants • Potent inhibitor of 3A4 with multiple 3A4 substrate interactions • The highest known affinity for the serotonin transporter of any currently used antidepressant.
- 29. The Garden of Earthly Delights by Hieronymus Bosch
- 30. What would it take to improve our insight into the cost of avoidable patient harm? • Data quality • Attention to information requirements • Modern data collection methods • Novel biomarkers • Epidemiological indicators • Data verification • Communication • Analytical outputs