Skip to main content Accessibility help
×
Hostname: page-component-586b7cd67f-2brh9 Total loading time: 0 Render date: 2024-11-25T20:09:09.776Z Has data issue: false hasContentIssue false

11 - Legal and Regulatory Responses to Avoidable Adverse Medication Events, Part I: General Principles

Published online by Cambridge University Press:  09 April 2021

Alan Merry
Affiliation:
University of Auckland
Joyce Wahr
Affiliation:
University of Minnesota
Get access

Summary

Regulatory and legal processes relevant to avoidable adverse medication events have the potential to advance the cause of patient safety but it is expecting too much to believe that these processes alone will achieve the changes that need to be made, urgently and affordably, to reduce the persistently high rate of avoidable adverse medication events. Achieving the required change will require engagement by all concerned, from politicians, through directors of hospital boards and managers and clinical leaders of hospital services to front line clinicians – and also, of necessity, regulators and the legal profession. It has been argued elsewhere that there is an ethical imperative for greater engagement in patient safety,9 and we agree.

Type
Chapter
Information
Publisher: Cambridge University Press
Print publication year: 2021

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Bowdle, TA, Jelacic, S, Nair, B, et al. Facilitated self-reported anaesthetic medication errors before and after implementation of a safety bundle and barcode-based safety system. Br J Anaesth. 2018;121(6):133845.Google Scholar
Gordon, M. When a nurse is prosecuted for a fatal medical mistake, does it make medicine safer? Health Inc. April 10, 2019. Accessed January 8, 2020. https://www.npr.org/sections/health-shots/2019/04/10/709971677/when-a-nurse-is-prosecuted-for-a-fatal-medical-mistake-does-it-make-medicine-safGoogle Scholar
Merry, AF, Brookbanks, W. Merry and McCall Smith’s Errors, Medicine and the Law. 2nd ed. Cambridge, UK: Cambridge University Press; 2017.Google Scholar
R v Prentice, R v Sullman, R v Adomako, R v Holloway [1994] QB 302.Google Scholar
Ameratunga, R, Klonin, H, Vaughan, J, Merry, A, Cusack, J. Criminalisation of unintentional error in healthcare in the UK: a perspective from New Zealand. BMJ. 2019;364:l706.Google Scholar
Webster, CS, Merry, AF, Larsson, L, McGrath, KA, Weller, J. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care. 2001;29(5):494500.CrossRefGoogle ScholarPubMed
Nanji, KC, Patel, A, Shaikh, S, Seger, DL, Bates, DW. Evaluation of perioperative medication errors and adverse drug events. Anesthesiology. 2016;124(1):2534.Google Scholar
Merry, AF, Webster, CS, Hannam, J, et al.et al. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011;343:d5543.Google Scholar
Runciman, B, Merry, A, Waltnon, M. Safety and Ethics in Healthcare: A Guide to Getting It Right. Aldershot: Ashgate Publishing; 2007.Google Scholar
Toffolutti, V, Stuckler, D. A Culture of openness is associated with lower mortality rates among 137 English National Health Service acute trusts. Health Aff (Millwood). 2019;38(5):84450.CrossRefGoogle ScholarPubMed
Studdert, DM, Mello, MM, Gawande, AA, et al. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006;354(19):202433.Google Scholar
Kachalia, A, Kaufman, SR, Boothman, R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. [Summary for patients in Ann Intern Med. 2010;153(4):I-28]. Ann Intern Med. 2010;153(4):213–21.Google Scholar
Skegg, PDG. Criminal prosecutions of negligent health professionals: the New Zealand experience. Med Law Rev. 1998;6:22046.CrossRefGoogle Scholar
O’Connor, E, Coates, HM, Yardley, IE, Wu, AW. Disclosure of patient safety incidents: a comprehensive review. Int J Qual Health Care. 2010;22(5):3719.Google Scholar
Vincent, JL. Information in the ICU: are we being honest with our patients? The results of a European questionnaire. Intensive Care Med. 1998;24(12):12516.Google Scholar
Health and Disability Commissioner. Code of Health and Disability Services Consumers’ Rights. Auckland: New Zealand Government; 2004. Accessed January 3, 2020. https://www.hdc.org.nzGoogle Scholar
Quick, O. Regulating Patient Safety: The End of Professional Dominance? Cambridge, UK: Cambridge University Press; 2017. Laurie, G, Ashcroft, R, eds. Cambridge Bioethics and Law.Google Scholar
Quick, O. Regulating and legislating safety: the case for candour. BMJ Qual Saf. 2014;23(8):61418.Google Scholar
Hesketh, T, Wu, D, Mao, L, Ma, N. Violence against doctors in China. BMJ. 2012;345:e5730.Google Scholar
Studdert, DM, Mello, MM, Gawande, AA, Brennan, TA, Wang, YC. Disclosure of medical injury to patients: an improbable risk management strategy. Health Aff (Millwood). 2007;26(1):21526.CrossRefGoogle ScholarPubMed
Lamb, R. Open disclosure: the only approach to medical error. Qual Saf Health Care. 2004;13(1):35.Google Scholar
Iedema, R, Jorm, C, Wakefield, J, Ryan, C, Dunn, S. Practising open disclosure: clinical incident communication and systems improvement. Sociol Health Illn. 2009;31(2):26277.CrossRefGoogle ScholarPubMed
Finlay, AJ, Stewart, CL, Parker, M. Open disclosure: ethical, professional and legal obligations, and the way forward for regulation. Med J Aust. 2013;198(8):4458.Google Scholar
Reason, J. Managing the Risks of Organizational Accidents. London: Routledge; 1997.Google Scholar
Haines, D. The legacy of Dr. Harold Shipman. Med Leg J. 2015;83(3):115.CrossRefGoogle ScholarPubMed
Mohammed, MA, Cheng, KK, Rouse, A, Marshall, T. Bristol, Shipman, and clinical governance: Shewhart’s forgotten lessons. Lancet. 2001;357(9254):4637.CrossRefGoogle ScholarPubMed
Mohammed, MA, Rathbone, A, Myers, P, et al. An investigation into general practitioners associated with high patient mortality flagged up through the Shipman inquiry: retrospective analysis of routine data. BMJ. 2004;328(7454):14747.Google Scholar
Hamblin, R, Shuker, C, Stolarek, I, Wilson, J, Merry, AF. Public reporting of health care performance data: what we know and what we should do. N Z Med J. 2016;129(1431):717.Google Scholar
Yeung, K, Horder, J. How can the criminal law support the provision of quality in healthcare? BMJ Qual Saf. 2014;23(6):51924.CrossRefGoogle ScholarPubMed
Shafer, SL. Tattered threads. Anesth Analg. 2009;108(5):13613.Google Scholar
Klein, AA. What Anaesthesia is doing to combat scientific misconduct and investigate data fabrication and falsification. Anaesthesia. 2017;72(1):34.CrossRefGoogle ScholarPubMed
Carlisle, JB. Data fabrication and other reasons for non-random sampling in 5087 randomised, controlled trials in anaesthetic and general medical journals. Anaesthesia. 2017;72(8):94452.Google Scholar
Kharasch, ED, Houle, TT. Seeking and reporting apparent research misconduct: errors and integrity. Anaesthesia. 2018;73(1):1256.Google Scholar
Carlisle, JB. Seeking and reporting apparent research misconduct: errors and integrity – a reply. Anaesthesia. 2018;73(1):1268.CrossRefGoogle ScholarPubMed
Merry, AF, Merry, D. Ethics in research: bend it like Beauchamp. Extra Corpor Technol. 2006;38(4):31217.Google Scholar
Gargiulo, DA, Sheridan, J, Webster, CS, et al. Anaesthetic drug administration as a potential contributor to healthcare-associated infections: a prospective simulation-based evaluation of aseptic techniques in the administration of anaesthetic drugs. BMJ Qual Saf. 2012;21(10):82634.Google Scholar
Gargiulo, DA, Mitchell, SJ, Sheridan, J, et al. Microbiological contamination of drugs during their administration for anesthesia in the operating room. Anesthesiology. 2016;124(4):78594.Google Scholar
Loftus, RW, Koff, MD, Brown, JR, et al. The dynamics of Enterococcus transmission from bacterial reservoirs commonly encountered by anesthesia providers. Anesth Analg. 2015;120(4):82736.Google Scholar
Loftus, RW, Koff, MD, Brown, JR, et al. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015;120(4):80718.Google Scholar
Loftus, RW, Koff, MD, Birnbach, DJ. The dynamics and implications of bacterial transmission events arising from the anesthesia work area. Anesth Analg. 2015;120(4):85360.Google Scholar
Loftus, RW, Brown, JR, Patel, HM, et al. Transmission dynamics of Gram-negative bacterial pathogens in the anesthesia work area. Anesth Analg. 2015;120(4):81926.Google Scholar
Fernandez, PG, Loftus, RW, Dodds, TM, et al. Hand hygiene knowledge and perceptions among anesthesia providers. Anesth Analg. 2015;120(4):83743.Google Scholar
Weller, JM, Merry, AF. I. Best practice and patient safety in anaesthesia. Br J Anaesth. 2013;110(5):6713.Google Scholar
Cilli, F, Nazli-Zeka, A, Arda, B, et al. Serratia marcescens sepsis outbreak caused by contaminated propofol. Am J Infect Control. 2019;47(5):5824.Google Scholar
Ryan, AJ, Webster, CS, Merry, AF, Grieve, DJ. A national survey of infection control practice by New Zealand anaesthetists. Anaesth Intensive Care. 2006;34(1):6874.CrossRefGoogle ScholarPubMed
Munoz-Price, LS, Bowdle, A, Johnston, BL, et al. Infection prevention in the operating room anesthesia work area. Infect Control Hosp Epidemiol. 2019:40(1):117.CrossRefGoogle ScholarPubMed
Cole, DC, Baslanti, TO, Gravenstein, NL, Gravenstein, N. Leaving more than your fingerprint on the intravenous line: a prospective study on propofol anesthesia and implications of stopcock contamination. Anesth Analg. 2015;120(4):8617.Google Scholar
Sakuragi, T, Yanagisawa, K, Shirai, Y, Dan, K. Growth of Escherichia coli in propofol, lidocaine, and mixtures of propofol and lidocaine. Acta Anaesthesiol Scand. 1999;43(4):4769.Google Scholar
Kohn, LT, Corrigan, JM, Donaldson, MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, Institute of Medicine; 1999.Google Scholar
Wachter, RM, Pronovost, PJ. Balancing “no blame” with accountability in patient safety. N Engl J Med. 2009;361(14):14016.Google Scholar
Braithwaite, J, Wears, RL, Hollnagel, E. Resilient health care: turning patient safety on its head. Int J Qual Health Care. 2015;27(5):41820.CrossRefGoogle ScholarPubMed
Pronovost, P, Needham, D, Berenholtz, S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):272532.CrossRefGoogle ScholarPubMed
Gray, J, Proudfoot, S, Power, M, et al. Target CLAB Zero: a national improvement collaborative to reduce central line-associated bacteraemia in New Zealand intensive care units. N Z Med J. 2015;128(1421):1321.Google Scholar
Haynes, AB, Weiser, TG, Berry, WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5):4919.CrossRefGoogle Scholar
Vogts, N, Hannam, JA, Merry, AF, Mitchell, SJ. Compliance and quality in administration of a surgical safety checklist in a tertiary New Zealand hospital. N Z Med J. 2011;124(1342):4858.Google Scholar
Hannam, JA, Glass, L, Kwon, J, et al. A prospective, observational study of the effects of implementation strategy on compliance with a surgical safety checklist. BMJ Qual Saf. 2013;22(11):9407.Google Scholar
Devcich, DA, Weller, J, Mitchell, SJ, et al. A behaviourally anchored rating scale for evaluating the use of the WHO surgical safety checklist: development and initial evaluation of the WHOBARS. BMJ Qual Saf. 2016;25(10):77886.Google Scholar
Martis, WR, Hannam, JA, Lee, T, Merry, AF, Mitchell, SJ. Improved compliance with the World Health Organization Surgical Safety Checklist is associated with reduced surgical specimen labelling errors. N Z Med J. 2016;129(1441):637.Google Scholar
Ong, APC, Devcich, DA, Hannam, J, et al. A “paperless” wall-mounted surgical safety checklist with migrated leadership can improve compliance and team engagement. BMJ Qual Saf. 2016;25(12):9716.Google Scholar
van Klei, WA, Hoff, RG, van Aarnhem, EE, et al. Effects of the introduction of the WHO “Surgical Safety Checklist” on in-hospital mortality: a cohort study. Ann Surg. 2012;255(1):449.Google Scholar
Goldmann, D. System failure versus personal accountability – the case for clean hands. N Engl J Med. 2006;355(2):1213.Google Scholar
Marx, D. Patient Safety and the “Just Culture”: A Primer for Health Care Executives. New York, NY: Columbia University; 2001. Accessed January 21, 2020. https://www.psnet.ahrq.gov/issue/patient-safety-and-just-culture-primer-health-care-executivesGoogle Scholar
Cabana, MD, Rand, CS, Powe, NR, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282(15):145865.Google Scholar
Goodyear-Smith, F. Murder That Wasn't. Dunedin: Otago University Press; 2015.Google Scholar
Leslie, K, Merry, AF. Cardiac surgery: all for one and one for all. Anesth Analg. 2015;120(3):5046.Google Scholar
Weller, J, Civil, I, Torrie, J, et al. Can team training make surgery safer? Lessons for national implementation of a simulation-based programme. N Z Med J. 2016;129(1443):917.Google Scholar
Bosk, CL, Dixon-Woods, M, Goeschel, CA, Pronovost, PJ. Reality check for checklists. Lancet. 2009;374(9688):4445.Google Scholar
Webb, LE, Dmochowski, RR, Moore, IN, et al. Using coworker observations to promote accountability for disrespectful and unsafe behaviors by physicians and advanced practice professionals. Jt Comm J Qual Patient Saf. 2016;42(4):14964.Google Scholar
Cooper, WO, Guillamondegui, O, Hines, OJ, et al. Use of unsolicited patient observations to identify surgeons with increased risk for postoperative complications. JAMA Surg. 2017;152(6):5229.CrossRefGoogle ScholarPubMed
Smith, R, Hiatt, H, Berwick, D. Shared ethical principles for everybody in health care: a working draft from the Tavistock Group. BMJ. 1999;318(7178):24851.Google Scholar
Francis, R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: HMSO; 2013. Accessed January 18, 2020. https://www.midstaffspublicinquiry.com/reportGoogle Scholar
Jones, A, Kelly, D. Deafening silence? Time to reconsider whether organisations are silent or deaf when things go wrong. BMJ Qual Saf. 2014;23(9):70913.CrossRefGoogle ScholarPubMed
Walshe, K. Gosport deaths: lethal failures in care will happen again. BMJ. 2018;362:k2931.Google Scholar
Gosport War Memorial Hospital. The Report of the Gosport Independent Panel (HC1084). London: HMSO; 2018. Accessed January 3, 2020. https://www.gosportpanel.independent.gov.uk/media/documents/070618_CCS207_CCS03183220761_Gosport_Inquiry_Whole_Document.pdfGoogle Scholar
Llewellyn, RL, Gordon, PC, Reed, AR. Drug administration errors – time for national action. S Afr Med J. 2011;101(5):31920.Google Scholar
Merry, AF, Webster, CS. Medication error in New Zealand – time to act. N Z Med J. 2008;121(1272):69.Google Scholar
Orser, BA. Medication safety in anesthetic practice: first do no harm. Can J Anaesth. 2000;47(11):10512.Google Scholar
Martin, GP, Armstrong, N, Aveling, EL, Herbert, G, Dixon-Woods, M. Professionalism redundant, reshaped, or reinvigorated? Realizing the “third logic” in contemporary health care. J Health Soc Behav. 2015;56(3):37897.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×