Medication Error Reporting Systems and Disclosing Medication Errors to Patients and Families

1. Medication Error Reporting Systems and Disclosing Medication Errors to Patients and Families

2. Learning Objectives • Describe the differences between internal and external event reporting systems • Discuss the multidisciplinary role of tracking medication errors and disclosing those trends to patients • List the barriers to disclosing medication events to patients

3. Medication Error Reporting Systems • Error reporting systems promote the goal of providing the best possible patient care in a safe, compassionate environment by helping those involved learn about: • Potential risks • Actual errors • Causes of errors • Prevention of recurrent events • Both internal and external systems for reporting and tracking errors are necessary • Voluntary and mandatory systems each have strengths and weaknesses

4. Definitions • Adverse drug event (ADE) • Any injury resulting from medical intervention related to a drug • Preventable ADE • ADE that results from an error or equipment failure • Error • Failure of a planned action to be completed as intended • Medication error • Any preventable event that may cause or lead to inappropriate medication use or to patient harm while the medication is in the control of the health care professional, patient, or consumer • Close call or near miss • Medication error that was detected and corrected before it reached the patient • Medication error that reached the patient and did not cause harm because of chance

5. Purpose of Reporting Systems • Strong error reporting systems are invaluable in highlighting hazards related to medication use, including ADEs, medication errors, close calls, and near misses • 1999 Institute of Medicine (IOM) report, To Err Is Human, describes two primary purposes of reporting programs: • Hold providers accountable for performance and patient safety • Provide information that leads to new knowledge and improved patient safety • Some hospitals resist the IOM’s call to accountability for fear that ADEs may be publicly disclosed • Purposes of internal error reporting systems: • Improved management of individual patients • Getting timely medical advice • Providing a record of events • Obtaining immediate legal counsel Kohn LT, et al., eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.

6. Purpose of Reporting Systems (continued) • Ideally • An error is reported internally, investigated, and error reduction strategies implemented • Error reduction strategies are then reported to an external program • Purposes of external error reporting systems • Generate widespread alerts • Widely disseminate new ways to prevent errors • Uncover trends and hazards • Recommend best practices for all health care stakeholders

7. Responsibility for Reporting • The best person to report an event is the one who was involved or who found or witnessed the event • Most medication errors are reported by nurses or pharmacists • Everyone associated with health care could potentially make reports (e.g., pharmacists, physicians, nurses, dentists, techs, assistants, medical equipment vendors) • Consumers may report suspected medication errors to: • External voluntary error reporting programs • Appropriate licensing boards • Facility in which error occurred • Person(s) making the error • The facility should thoroughly investigate any reported medication error

8. Reportable Events, Conditions, and Priorities • It is essential to use clear, consistent terminology when reporting events • The word “event” is used by many organizations because the word “incident” has the connotation of being a crisis • Event has a broad connotation • Clearly define the types of events and conditions to be reported • Not knowing what to report is a barrier to reporting • The categories of conditions and events reportable to error reporting systems are: • Risk: hazardous conditions that could lead to an error • Near misses/close calls: errors that were intercepted and corrected before reaching the patient • Errors, no harm: errors that reach the patient but do not cause harm • Errors, harm: errors that reach the patient and cause harm • See textbook page 517 for more detailed information

9. Reportable Events, Conditions, and Priorities (continued) • Provide staff members with examples of adverse occurrences to minimize confusion about what is desired • Near misses and conditions that could lead to errors or “less serious” errors all provide information about the underlying system-based causes of medication errors • All of the above should be reported • Allows systems to be proactive in identifying system failures • Less devastating to report events not causing harm than to have to report harmful occurrences • Institutions should encourage personnel to report events and not to assume that the problem is already known • More complete reporting enhances the ability to learn about errors and to implement appropriate safeguards

10. Reporting Mechanisms • Staff must understand both formal and informal (alternative) methods of reporting events • Informal lines of communication help to enhance trust and confidence • Both formal and informal ways of accepting information should be part of the event reporting mechanism • Reports may be submitted by e-mail, especially for external reporting systems • The organization that maintains the reporting system should track the effectiveness and usefulness of the various systems and make adjustments if necessary • Event reporting forms with electronic formats are provided by both internal and external reporting programs

11. When to Report • Best approach is to immediately report an event whether or not it may cause serious harm • Advantages to immediate reporting: • An ADE that may not seem serious may, in fact, be serious • The supervisor can ask questions while the event is fresh in the reporter’s mind • An immediate oral report to a supervisor may be more beneficial than a hastily written report • Send final reports to risk management within 1 week of the event unless additional time is requested in the report • Report to the external voluntary reporting system after all the information is gathered • These systems have specific reporting time frames and all information may not be available

12. What Information to Report • JUST THE FACTS—include a factual description of what happened and the patient outcome • Include names of products if the event involves a problem with labeling or packaging • Include any additional patient monitoring or testing performed or medications administered as a result of the event • Include explanatory information that describes: • How the event happened • What normally happens and how risk was managed before the event • Why the event happened • At-risk behaviors • How to prevent similar events

13. What Information to Report (continued) • Figure 19-1 in the textbook provides an event reporting form with questions designed to elicit causative factors for reporting • Separate the causative and prevention portions from the factual to better protect event analysis from discovery during a lawsuit • Never include personal or professional opinions, conclusions, criticisms, accusations, admissions, or patients’ names in the report JUST THE FACTS

14. Categorizing Reports • Categorize reports according to the severity of patient outcome to help organizations monitor patient harm and prioritize their medication safety activities • Figure 19-2 in the textbook shows an index for categorizing medication errors from the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) • The NCC MERP index considers factors such as whether the patient was harmed, and if so, to what degree • All event reports are useful for learning and for change even if there was no harm to the patient • All reports should be investigated and acted upon if appropriate

15. Mandatory Reporting Programs • The IOM recommended both mandatory and voluntary reporting programs • The Institute for Safe Medication Practices (ISMP), the American Hospital Association, and the American Medical Association objected, saying mandatory reporting would stifle reporting because of heightened fear of damaged reputations and legal liability • In the United States today, both mandatory and voluntary reporting systems are in operation • Fundamentally, all reporting is voluntary • Threat of punishment will decrease likelihood of reporting • The lack of success may be less about the mandatory nature and more about the design of the reporting systems, the punitive culture, and the ineffective use of data submitted

16. Limited Success of Mandatory Programs • Usually run by the state departments of health and the licensing boards that require reporting • There is potential to generate useful data • Requirements for reporting are inconsistent • Amount of useful information and the number of reports varies • Organizations may underreport to avoid penalties, punitive actions, and legal and public scrutiny • Some practitioners are reluctant to report errors to external mandatory programs, but will report errors internally • Health systems cannot make it safe for staff to disclose errors to mandatory programs that hand down punishments • The designated reporter is charged with minimizing the organization’s exposure to liability and public distrust • Outcome-based event analysis is especially prone to hindsight bias

17. Mandatory State Programs • Less than half of the U.S. states require mandatory reporting • States are not consistent in the types of events reported, the number of events, or the requirements for reporting • Most investigate serious events • The only consistent reportable event is unanticipated death • Health professionals and health systems rarely receive feedback • Information about professionals sanctioned for errors are published by licensing boards • Health departments typically make some findings public but insulate detailed information from legal discovery • Need for research about whether safety changes are made by practitioners that would not otherwise have been made as a result of mandatory state reporting

18. Patient Safety Centers • Six states (Florida, Maryland, Pennsylvania, Oregon, Massachusetts, and New York) have created patient safety centers • The functions vary from state to state but they arose as a result of health issues such as affordability and malpractice reform • Seek to educate providers about best safety practices for patients • Have governing boards and consumers in an advisory capacity • Most of the centers operate under little or no state regulatory control • Each center submits mandatory periodic progress reports to a governing body • Most disclose findings to the public, some utilizing the Web • All but Oregon have mandatory reporting systems for serious adverse events • Table 19-1 in the textbook compares features of these patient safety centers

19. Pennsylvania’s Unique Program • The mandatory Pennsylvania Patient Safety Reporting System (PA-PSRS) requires the reporting of close calls, near misses, and serious adverse events by all licensed hospitals, birthing centers, and ambulatory surgical facilities • The Patient Safety Authority (PSA; an independent, nonregulatory state agency) is authorized by the PA-PSRS • PSA analyzes reports for learning purposes, keeping the information confidential and not available to the public • Whistleblowers are protected and may report anonymously • Individual health care facilities can use PA-PSRS to monitor the progress to improve safety at their facilities

20. Pennsylvania’s Unique Program (continued) • Pennsylvania uses a program subcontracted to ISMP to analyze medication-related errors and adverse drug reactions reported to the system; suggests ways to avoid future errors • New information about the sources and causes of medication errors is now available to ISMP and other safety experts • Patient Safety Advisory, published quarterly, is based on analysis of errors and near misses • The 2004 data from Pennsylvania are consistent with national data, which show the following: • Approximately one-fourth of reported medication errors involved one or more high-alert medications • Two out of three harmful events involved one or more high-alert medications

21. Voluntary Reporting Programs • Voluntary systems are generally more successful than mandatory systems because: • Reports come from frontline practitioners who can describe the conditions that led to the event and provide detailed information • Conclusions can be drawn without waiting for numerous reports • Information is immediately useful to help create a plan for improvement • There is trust between the reporters and the recipients • Systems are perceived as credible because they are independent of regulatory and accrediting bodies • A nonpunitive approach recognizes that human error is inevitable • Analysis is system or process oriented rather than outcome oriented • Error reduction efforts are not targeted at the individual but toward strengthening the system to lessen the possibility of error • Table 19-2 in the textbook lists elements identified by ISMP that encourage error reporting

22. USP-ISMP Medication Errors Reporting Program • United States Pharmacopeia (USP) operates the medication errors reporting program (MERP) in cooperation with ISMP, which receives all MERP reports, analyzes reports and aggregate data, and disseminates the findings • USP or MERP automatically passes error reports to FDA’s MedWatch • FDA focuses more on packaging, labeling, and nomenclature issues than with practice issues or health care system failures • Product-related reports are sent to manufacturers • Reporting process of medication errors to USP-ISMP is described on page 529 of the textbook, including the phone, fax, e-mail, address, and Web site • Reporters are often willing to answer questions and provide supplemental materials such as photos and redacted orders • Reporters hope that their information will lead to changes for preventing future errors and patient harm

23. USP-ISMP Medication Errors Reporting Program (continued) • MERP can: • Objectively determine causes of errors and find solutions because it is independent of other agencies • Analyze reports to provide information about the types, causes, and prevention of errors • Perform individual investigation and follow-up because it has a small number of reports • MERP cannot: • Discipline, regulate, or mandate implementation of the recommendations that come from the analysis • Determine the prevalence of medication errors • Provide the names and locations of reporters

24. Analysis of Reports to MERP • The goal at MERP is to learn from reported events or hazards, preventing them in the future, and extrapolating the system-based solutions to all health care settings • 2004 MERP data analyzing errors showed: • 57% of the submitted reports documented errors that reached the patient (see Table 19-3 for the categories of reported errors) • 13% of the errors caused temporary harm • 2% of the errors resulted in permanent harm • 1% of the errors resulted in death • 43% of the reports were from hazards that could lead to errors • Most of the errors reported to MERP in 2004 involved either the wrong drug, wrong dose, or prescribing errors • Table 19-4 in the textbook lists types of errors reported to MERP

25. MERP Documented Errors Reports Submitted to USP-ISMP Medication Errors Reporting Program in 2004

26. Analysis of Reports to MERP (continued) • Table 19-6 in the textbook enumerates the leading products involved in harmful errors in 2004, including several pharmaceutical products • Drugs not currently considered high-alert medications were among the leading products on the 2004 list, including: • Lipitor and Zocor • Phenergan • Seroquel and Serzone • Clonidine • Diflucan • Lithium • Metoprolol

27. Impact of MERP • Early warning system • ISMP immediately sends out electronic alerts, including subscription to free e-mail alerts, when MERP indicates serious hazards • Learning • Information about error prevention is shared through educational programs, newsletters, teleconferences, and the Web • Change • Surveys and reports show information provided by ISMP is stimulating changes by individuals and organizations • Standards • Information from MERP is often shared with agencies (e.g., The Joint Commission [TJC], FDA, and state health departments) and USP’s standards and drug information database also has been impacted • Public policy • ISMP and USP use information from MERP to promote changes in public policy to enhance safety • Appendix A (pages 546–9 in the textbook) lists examples of the nationwide impact of MERP

28. FDA MedWatch • A voluntary reporting program that receives reports from health care professionals and consumers involving: • ADEs, product use errors, biologics, medical devices, nutritional products, and cosmetics • Does not accept reports involving vaccines • New products are monitored through the FDA and the pharmaceutical industry • Reporter does not need proof, only suspicion, to submit an event report • Contact information for MedWatch: • Fax: 1-800-FDA-0178 • Phone: 1-800-FDA-1088 • Internet: www.fda.gov/medwatch/report/hcp.htm

29. FDA MedWatch (continued) • FDA reviews product-related errors, but not practice-related errors, reported to MERP • Names of reporters divulged only with permission from reporter • ISMP can review reports submitted to MedWatch, but can interview the reporter only through a third party within FDA • Narrative reports submitted are not available electronically • The Adverse Event Reporting System combines required reports from manufacturers and voluntary reports from MedWatch thus creating an even broader safety program • 5% of the reported events to the FDA in 2004 were voluntary, the rest came from manufacturers • FDA’s Division of Medication Errors and Technical Support (DMETS) analyzes reports and provides feedback • DMETS investigates causes and contributing factors and offers recommendations for label or packaging revisions

30. The Joint Commission Sentinel Event Reporting Program • TJC asked accredited health care organizations in 1996 to identify and voluntarily report all sentinel events within the facility • A “sentinel event” is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof • The phrase “or the risk thereof” refers to any process variation whose recurrence would carry a significant chance of a serious adverse outcome • The sentinel event policy requires organizations to: • Investigate root causes within 45 days of becoming aware of a sentinel event • Implement strategies to prevent recurrence • Monitor the effectiveness of implementedstrategies

31. The Joint Commission Sentinel Event Reporting Program (continued) • The reporting program is not entirely voluntary • If TJC learns about an event that the health system has failed to report, the health system must conduct a root cause analysis within the specified time frame or risk being placed on “accreditation watch” status with public disclosures • No matter how the event comes to the attention of TJC, the response, time frame, and review procedure are the same • TJC provides expertise in the analysis of an event and validates that system-based changes have been made • The amount of knowledge gained from an event is lessened and the disclosure of errors is inhibited when the reporting program has the authority to mandate actions

32. The Joint Commission Sentinel Event Reporting Program (continued) • 1995–2005: the sentinel events reported to TJC included patient suicides, wrong-site surgery, operative or postoperative complications, and medication errors • 1995–2004: most common root causes of medication-related sentinel events were communication failures, inadequate orientation or training of staff, inaccurate patient assessment, staffing issues, and unavailable information • Figure 19-3 in the textbook shows the breakdown of root causes of medication errors for 1995–2005 • Figure 19-4 graphs an example of one such sentinel event

33. USP MEDMARX • Internet-based system launched in 1998 • Subscribers upload data from internal reports, track the data, and learn about errors reported by other facilities • Reporting is anonymous and standardized • Allows for data to be aggregated for comparison with demographically similar facilities • By 2005, about 800 facilities paid a fee and subscribed • USP’s Center for the Advancement of Patient Safety (CAPS) analyzes the data for the purpose of creating educational programs and products that focus on error analysis and prevention • Appendix B (pages 549–50 in the textbook) includes topics featured in the MEDMARX annual reports

34. Veterans Affairs Patient Safety Reporting System • Veterans Affairs (VA) staff can voluntarily report events or concerns on a standardized form by mail to the VA’s external Patient Safety Reporting System (PSRS; an independent complementary system, established in 2002) • Does not replace the VA’s internal reporting system; PSRS is a reporting system some staff may be more comfortable using • PSRS was jointly developed with NASA, making use of NASA’s 30 years of experience with the Aviation Safety Reporting System • PSRS guiding principles • Voluntary participation • Confidentiality protection • Nonpunitive reporting

35. Veterans Affairs Patient Safety Reporting System(continued) • Reports of events involving criminal actions, purposefully unsafe acts, and alleged or suspected patient abuse are not accepted by PSRS • These actions are not protected information • Reporters are encouraged to include identifying information so they may be contacted if clarification is needed • All identifying elements are removed once the report is declared complete, including all names and locations • Only 400 reports were received in the first 2½ years, while the internal VA system received 14,000 reports • VA facilities are immediately alerted if an alarming safety trend is identified • The source of the problem is not identified

36. Disclosure of Error Reports: Public Disclosure • Thoughts on public disclosure vary, including: • Making it mandatory for health care practitioners to divulge information • Public disclosure is necessary to encourage improvements • Disclosure of adverse events will cause error reporting to go underground, weakening the effort to ensure patient safety • The public has rights regarding disclosure of patient safety issues such as: • The right to expect steps are taken by health care organizations to deal with safety hazards • The right to be informed about unsafe conditions • The right to expect companies that make any health care products to do their part to ensure error-proof health care • The right to expect companies and providers to be held accountable for implementing safety strategies

37. Disclosure of Error Reports: Public Disclosure(continued) • The public wants evidence that health care providers value patient safety above all • Safety recommendations should be evaluated by regulatory, federal, and accrediting agencies as well as by health care purchasing groups • The reporting system should not have the power to mandate the implementation of recommendations, but they should be adopted if the efficacy and cost benefit are favorable • Public disclosure should be considered if the agencies and groups do not adopt the recommendations • To help make informed decisions, consumers can review: • An organization’s compliance with safety standards • An annual report summarizing events and actions

38. Disclosure of Error Reports: Legal Disclosure • Most states have some legal protection for information submitted to internal reporting programs operated for quality improvement purposes • The offer of confidentiality and evidentiary protection for the information submitted is one of the best incentives for reporting • Lacking federal protection of reporting information is a reason many external reporting systems and safety experts do not receive information • Protection under state law may be waived if the information is shared externally • ISMP and many other safety experts subscribe to the belief that information from external reporting systems should be privileged for purposes of governmental judicial proceedings

39. Disclosure of Error Reports: Legal Disclosure(continued) • Congress enacted the Patient Safety and Quality Improvement Act of 2005 to encourage more participation in external error reporting systems • Calls for independent patient safety organizations (PSOs) that receive, analyze, and disseminate confidential data • The PSOs are to be certified • The information PSOs receive cannot be used in civil or administrative legal proceedings, thus lessening the threat of litigation while protecting patients’ rights to legal remedies

40. Practitioners’ Perspectives on Reporting • A 2002 ISMP survey found that the majority of staff-level clinicians surveyed feel more effort is needed to promote voluntary reporting, both internally and externally • Those responding more often reported safety issues to internal rather than external programs • Table 19-7 in the textbook shows frequency of reporting medication errors or safety issues • Medication errors that caused no harm, whether or not they reached the patient, were most often reported internally • Hazards that could cause errors were not often reported internally, but were the issues most often reported to MERP • Errors associated with harm were more often reported internally • The survey found that at least half of the respondents had reported one harmful error internally, but only one in ten had reported a harmful error to MERP or MedWatch

41. Practitioners’ Perspectives on Reporting (continued) • Adverse drug reactions were reported frequently to internal programs and less frequently to MedWatch • MedWatch database may be lacking in critically important postmarketing surveillance data • Table 19-8 in the textbook lists motivations for reporting medication errors and safety issues • Survey indicated that key motivations for reporting to both internal and external programs were to enhance patient safety and avoid needless tragedies • Those surveyed felt more rewarded reporting to MERP than to MedWatch or internal programs, suggesting that more needs to be done to reward voluntary reporting

42. Practitioners’ Perspectives on Reporting (continued) • Table 19-9 in the textbook indicates more promotion of internal over external programs • The least promoted external program was MedWatch • Results show that stakeholders in patient safety must take more time to encourage frontline practitioners to report issues, both internally and externally • Potential reasons for lack of voluntary reporting • Legal impediments • Limited knowledge of voluntary external reporting programs • 2006 IOM report recommendations • More aggressive error reporting by all stakeholders • Use of a national taxonomy for data storage and analysis • Use of aggregated information to shape national health policy

43. Disclosing Medication Errors to Patients and Families

44. Disclosing Medication Errors to Patients and Families • The public is increasingly aware of the frequency and consequences of medical errors • There is general agreement that disclosure of outcomes and errors to the patients is the ethical thing to do • Disclosure is an emotional experience for all involved • There may be a hesitancy on the part of health care organizations and practitioners to move toward a process for full disclosure to patients and families

45. What Constitutes Successful Disclosure? • TJC standards state that a successful disclosure ensures both patients and families are informed about the outcomes of medical care, especially the unanticipated outcomes • Elements of successful disclosure of unanticipated events may include: • Absence of litigation • Understanding by the patient and family that mistakes are unavoidable • Calming of the patient’s and family’s anger after an adverse outcome • Absence of media coverage • Ensuring the organization and practitioners are positively portrayed if there is media coverage • The true goal is to learn from all adverse events and to use them as opportunities for improvement

46. Patients’ Perspective • The National Patient Safety Foundation (NPSF) recommends: • Prompt explanation of how an injury occurred and the effects of the injury • The explanation should be truthful and compassionate • The explanation should include remedies available • Lack of trust in the physician makes disclosure more difficult • Patients and families know errors occur and they want the following to happen: • Systems should be developed for avoiding medical errors • Give a detailed explanation and a sincere apology if an error happens • Practitioners often distance themselves from patients and families

47. Patients’ Perspective (continued) • 2004 survey of consumers regarding medical errors found: • 92%: reporting should be required • 88%: physicians should be required to tell them if a preventable error resulting in serious harm happened in their own care • 63%: hospital reports of serious medical errors should be made public • 34%: had experienced medical errors • 28% of these respondents had been told about the error • 54%: believe the physician would be very or somewhat likely to tell them about a preventable error that resulted in serious harm • 79%: giving physicians more time to spend with patients could reduce errors • 72%: require hospitals to develop systems for avoiding errors • 72%: better trained health professionals could reduce errors • 21%: malpractice lawsuits would help reduce medical errors

48. Health Care Providers’ Perspective • Physician responses varied, from always disclose complications to disclose those that cause harm, unless the harm is trivial or the patient is unable to understand the error • Near misses should not be disclosed, preferring to handle them as the physician’s problem • Risk managers surveyed: • More than half always disclose death or serious injury due to error • Less likely to disclose preventable harm than unpreventable harm • Those who felt disclosure increased the risk of litigation were more likely to disclose unpreventable harm over preventable harm

49. Experience With a Full Disclosure Policy • The Lexington, Kentucky, VA Medical Center had lost $1.5 million in malpractice judgments • In 1987, this facility adopted a full disclosure policy with equitable compensation for actual losses due to errors • Center notifies patients and families as quickly as possible • Settlements are numerous, including some that might not have been filed without the honest disclosure • Hospital even assists in the filing of claims • Attorneys are provided with clinical information • Attorneys may negotiate a settlement on the basis of monetary losses rather than seeking a more punitive judgment • All of these actions lessen patients’ anger and desire for retribution • Result was not an overwhelming number of lawsuits • Payments for claims were moderate with the economic outcomes remaining positive more than 10 years later

50. Experience With a Full Disclosure Policy (continued) • Full disclosure to patients and families is now mandatory at all VA facilities, including: • A face-to-face meeting with the VA chief of staff, the quality manager, the quality management nurse, and the facility director • All details of the event, including names, are given • The facility emphasizes their regret and the actions being taken to prevent similar events • The VA system is unique—it is a closed system and can offer restitution such as: • Universal health coverage • Free corrective treatment • Monthly disability payments to patients • VA practitioners pay no malpractice premiums and are protected from liability