Dispelling a Few Myths
By the Institute for Safe Medication Practices
Now that 2016 is underway, the Institute for Safe Medication Practices (ISMP) would like to extend its sincere thanks to the many healthcare providers, consumers, advocacy groups, organizations, agencies, and companies that have allowed us to be part of their journey to reduce patient harm from medication errors. It has been both a distinct privilege and a profound responsibility to touch the lives of so many during the past year. Since becoming a charitable organization more than two decades ago, ISMP has pursued a singular mission to advance patient safety worldwide by empowering the healthcare community, including consumers, to prevent medication errors. As we were making plans for 2016, we came across several relatively common but inaccurate beliefs about ISMP held by some in the healthcare industry, beliefs that could impact our work. We would like to dispel these myths by providing some general information about ISMP. If you still have questions or are confused about our organization after reading the information that follows, we encourage you to contact us directly (ismpinfo@ismp.org).
Myth 1: ISMP is a regulatory, standards-setting, accrediting, or certifying organization.
ISMP works in an expert advisory capacity only, with neither the power to set minimum standards of care, nor the authority to certify, regulate, or accredit individuals or organizations based on any standards of care, including those associated with medication safety. While we often support the minimum standards of care required by regulatory, standards-setting, accrediting, and certifying agencies, ISMP also attempts to raise the bar by recommending alternative but practical, high-leverage strategies to improve medication safety. These strategies are based on best practices documented in the literature and learned via ISMP medication error reporting programs, on-site consulting, research, expert consensus building, and advocacy work. As such, ISMP has published guidelines, but not standards, that reflect consensus among key stakeholders associated with medication use. ISMP has also published numerous tools and self-assessments, research findings, targeted medication safety best practices, and various lists—confused drug names, drug pairs with tall man letters, high-alert medications, and error-prone abbreviations, for example—that best support safe medication practices.
ISMP has no plans to become a regulatory, standards-setting, accrediting, or certifying agency, as our sole purpose is to learn about medication errors from involved frontline clinicians so we can help prevent others from making the same errors. We believe that clinicians would be less willing to report hazards, errors, or prevention strategies to ISMP if they thought we could then require them to make specific changes they may perceive to be difficult or costly, or if we could impose sanctions or punishment if the specific changes are not implemented. Open reporting begins with trusting that the recipient of the report will not unfairly judge the clinicians involved in the event, dictate a new standard that may not be immediately feasible, and punish individuals or organizations if the standard is not met. Medication error reports are the lifeblood of ISMP, and we will continue to do everything in our power to maintain the trust we have built with reporters over the last 45 years.
Myth 2: ISMP is funded by a government agency and/or the pharmaceutical industry.
ISMP is a wholly independent, nonprofit agency funded via the direct services provided by its employees, nonrestrictive educational grants, competitive research grants, and charitable donations. We receive no funding from the government or the pharmaceutical industry, with the exception of unrestricted grants intended for a specific project or study. We accept no advertising in ISMP publications, websites, or educational programs, and we will not consider any potential source of funding that might restrict our activities or give the impression that it might influence our work in any way.
Our primary sources of funding include ISMP publications, collaborations, consulting work, educational programs, research grants, error analysis, and charitable donations. However, a large portion of our work is related to medication safety advocacy, which generates little to no income. Examples of these advocacy efforts include pro bono participation on international, national, state, and local committees or initiatives, work with consumers and clinicians who seek information about medication safety, and work associated with ISMP’s free error-reporting programs.
Myth 3: ISMP operates an external medication error-reporting program similar to mandatory external incident reporting programs.
ISMP operates three national, voluntary, medication error-reporting programs: the ISMP National Medication Errors Reporting Program (MERP), the ISMP National Vaccine Errors Reporting Program (VERP), and the ISMP National Consumer Medication Errors Reporting Program. These voluntary reporting programs differ from mandatory external reporting programs in several ways:
- The reports come directly from frontline practitioners and consumers rather than risk, quality, or safety managers.
- The narrative descriptions (and pictures) that accompany the reports offer rich content for learning compared to mandatory reports that often prompt for standard information and a succinct description of the event, but not its causes.
- Communication with the practitioners or consumers who were involved in or detected the event is possible and potentially more helpful than communication with managers screening and completing the mandatory reports.
The reports to ISMP are sent for altruistic reasons—because practitioners want to share information that will benefit others, not because there is a mandate to do so. This provides information that is far more complete and useful than what is generally captured in a mandatory external incident reporting system. ISMP error reporting programs receive narratives, submitted by reporters, about errors that are unique, actionable, and useful for learning—they want others to understand the risk, learn from the external event, and prevent similar errors.
Unlike mandatory incident reports for which direct contact with the staff involved in the events is essentially impossible, voluntary reports submitted to ISMP flow directly from the field—from physicians, nurses, pharmacists, consumers—to the program. Confidential communication channels with ISMP are direct and stay open, and many ISMP reporters are responsive to follow-up questions from ISMP that support learning.
Myth 4: Medication error reports submitted to ISMP should also be reported to the U.S. Food and Drug Administration (FDA).
ISMP shares all error reports received via our reporting programs with FDA and product manufacturers. What is not shared is the name and contact information of the reporter, location of the event, or any other identifiers unless specific permission has been granted. When ISMP receives a report, a redacted version is shared via a secured portal with ISMP clinical staff responsible for analysis. It is entered into a secure database, and if the reporter has identified him- or herself, follow-up questions are typically sent via email if further explanation is necessary for learning. In some cases, an ISMP clinician may talk directly to the reporter to learn more about the hazard or event. ISMP also sends a note via email to reporters to thank them. We also call the pharmaceutical company to discuss any product safety issues.
Once we have received the answers to any follow-up questions, or if there is no response to the questions, ISMP submits all reports to FDA within one month of receipt or immediately, as necessary, when the situation is serious and involves a regulated product. We also work with FDA regularly each week and hold formal monthly calls with its Division of Medication Error Prevention and Analysis (DMEPA) to discuss specific events or safety issues that have come to our attention.
Because of the unique and robust relationship ISMP has with FDA, we highly encourage practitioners and consumers to report all medication-related events to ISMP, which are then automatically forwarded to FDA. If the report is sent directly to FDA, ISMP may miss seeing the full report or miss seeing a very serious event or hazard that requires a rapid response, such as a national alert. Also, we would not be able to follow up with reporters in a timely manner if questions arise. However, a memorandum of understanding allows FDA to spontaneously forward select but redacted MedWatch (The FDA Safety Information and Adverse Event Reporting Program) reports to ISMP when an important issue arises.
Myth 5: ISMP staff sometimes serve as expert witnesses on behalf of defendants or plaintiffs in a civil lawsuit.
Although ISMP staff have occasionally assisted pro bono in the defense of a nurse or pharmacist facing criminal charges or potential action against their licenses after making a medication error, ISMP staff do not serve as expert witnesses in any civil lawsuit that may arise after a harmful medication error. It is not a reluctance to help that informs our policy, but rather an inability to devote time to this service without sacrificing other important functions that better support our mission.
Myth 6: Reporting hazards and errors to ISMP has little value because the organization can do little about practice- or product-related issues.
Although ISMP is a relatively small organization with roughly 30 full-time employees, our influence is deep and our reach is far when it comes to medication error prevention. We review every error report received and use the information we learn in ways to help others prevent errors. For example, since 1996, in direct response to specific hazards reported to ISMP, we have electronically issued more than 30 nationwide hazard alerts (known since 2012 as the National Alert Network) to healthcare providers. We have conducted dozens of national surveys; created lists of error-prone abbreviations and dose designations, confused drug names, and high-alert medications; and established guidelines for labels, automated dispensing cabinets, smart infusion pumps, standard order sets, timely drug administration, IV sterile compounding, IV push medications, and more. We have promoted learning via clinician and consumer websites, five newsletters (acute care, community/ambulatory care, nursing, long-term care, consumer) that reach millions of clinicians or consumers, as well as published white papers and numerous research projects. These resources have also been widely used internationally.
Because of error reports submitted to ISMP, thousands of changes have already occurred with U.S. drug product labeling and packaging, FDA regulations and guidances, official Joint Commission and U.S. Pharmacopeial Convention (USP) standards, and practice modifications. These span from 1987—when the ISMP founders convened a national committee to establish a federal requirement for potassium chloride for injection to have black caps, closures, and warning statements—to the most recent 2015 change to eliminate ratio expressions on labels of EPINEPHrine and several other medications. (The most recent change was formally requested by ISMP via an official petition to USP after receiving a report about a 16-year-old boy who died unnecessarily from an EPINEPHrine injection overdose (www.ismp.org/sc?id=1640). Error reports published in our newsletters have also served as a reputable source of information for healthcare providers to use as a risk assessment to guide proactive medication safety efforts—the reports help prevent the same errors in other healthcare settings.
The impact of some recommended interventions and changes stemming from ISMP reporting programs has been measured and found to improve safety or change risky behaviors; for others, anecdotal evidence suggests that practice and product changes have been implemented, resulting in fewer errors. While ISMP and the clinician(s) or consumer(s) who reported a specific hazard are rarely recognized as a predecessor to medication safety–related changes stemming from ISMP report(s), there is a good chance that, together, we played a role, if none other than to be a persistent impetus to change. The point is, never doubt that your reports of hazards and errors sent to ISMP are powerful drivers of change, in both the U.S. and abroad, and will continue to be a major force in the patient safety movement.
This column was prepared by the Institute for Safe Medication Practices (ISMP), an independent, nonprofit charitable organization dedicated entirely to medication error prevention and safe medication use. Any reports described in this column were received through the ISMP Medication Errors Reporting Program. Errors, close calls, or hazardous conditions may be reported online at www.ismp.org or by calling 800-FAIL-SAFE (800-324-5723). ISMP is a federally certified patient safety organization (PSO), providing legal protection and confidentiality for patient safety data and error reports it receives. Visit www.ismp.org for more information on ISMP’s medication safety newsletters and other risk reduction tools. This article appeared originally in the December 3, 2015, issue of the ISMP Medication Safety Alert!