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Voluntary error reporting is best public policy


From the May 19 , 1999 issue

In recent years, healthcare organizations, regulatory and licensing bodies, governmental agencies, accrediting organizations and even consumers have been promoting more candid disclosure of medication errors. To that end, ISMP has been a strong and vocal proponent of establishing a non-punitive voluntary error reporting program that supports open discussion about errors. Recently, ISMP has been actively participating in various government-level public policy discussions to explore various types of reporting programs. In our discussions, we have emphasized the following:

Non-punitive and confidential voluntary reporting programs tend to provide more useful information about errors and their causes than mandatory reporting programs. A voluntary, confidential reporting program provides front-line practitioners with the opportunity to tell the complete story without fear of retribution. The depth of information contained in these stories is critical to understanding the error, and reporters often submit samples of drug labels, packages, written orders or other pertinent information to help others understand the error. This information is critical to the identification of system deficiencies that can be corrected in order to prevent future errors. Practitioners who are forced to report errors are less likely to provide this depth of information since their motivation may be adherence to a requirement, not necessarily to help others avoid the same tragedy. Further, a voluntary program encourages practitioners to report hazardous situations and errors that have the potential to cause serious patient harm. It is not possible to mandate reporting of these situations. Therefore, critical information may be lost and proactive error prevention strategies are less likely.

Potentially the greatest number of error reports may come from a non-punitive reporting program. Yet the very intent of most proposed and established mandatory reporting programs is punitive. For example, one state recently proposed, but did not implement, a mandatory reporting system designed to "identify practitioners and facilities which may present a danger to the public welfare." Even if mandatory programs offer "amnesty" or "immunity" to individuals who report errors, those who fail to report must be punished in a mandatory program. Further, the terms "amnesty" and "immunity" imply that blame and punishment is indicated when an error occurs, but practitioners will be forgiven. This concept does not support the culture change necessary to establish a truly non-punitive environment. Practitioners do not need to be forced to report errors. They just need freedom from all forms of punishment, which is possible only with a voluntary reporting program. Evidence is found in organizations with policy-driven mandatory reporting systems that practitioners will not report all detected errors if there is any fear of retribution.

While a mandatory reporting program may collect larger numbers of medication errors, it is unlikely to yield much new information beyond what can be learned from a more streamlined and effective voluntary reporting program. Too much data slows error analysis and lessens the effectiveness of subsequent prevention efforts. If data is needed for epidemiological research, USP's MedMarx or other data collection systems can provide needed volume. Further, an effective program should not require multiple reports of patient deaths and injuries in order to take action. Instead, action should be taken at the first sign of a serious problem.

While mandatory reporting programs imply that the individual at fault must report the error, analysis of serious errors always reveals multiple system failures that lie outside the direct control of involved practitioners. Who then must report the error? The drug company whose product name or label has repeatedly led to confusion? The practitioner involved? Which practitioner must report an error that started with an ambiguous prescription or a wrongly dispensed drug? By necessity, responsibility for mandatory reporting will likely fall to designated management staff, not individual practitioners. Managers may be less inclined or unable to communicate information beyond that which is required, even with statutory protection. In the end, it's likely that blame will often fall on practitioners, primarily nurses who administer the drugs involved in the errors. Similar problems have been identified with current established and proposed mandatory reporting programs. For example, the federal Safe Medical Devices Act of 1990 has not been successful in gaining practice site compliance with reporting requirements for user error with medical devices.

Finally, establishing a national mandatory medication error reporting program when an effective voluntary reporting program already exists (USP-ISMP Medication Errors Reporting Program which works in cooperation with FDA) is likely to confuse practitioners and fragment the reporting process. In-depth reporting of valuable information to an effective voluntary program may be reduced in response to establishment of a mandatory process. Through the USP-ISMP MERP, a wide scope of medication safety problems have been identified, their causes have been explored and prevention strategies have been designed. However, the program lacks sufficient influence with accrediting bodies and regulatory agencies to mandate key changes that are known to reduce serious errors. The resources required to establish a national mandatory error reporting program will be more effectively directed toward facilitating implementation of preventative actions based on the extensive knowledge we already have regarding flaws in our safety systems. It would best serve the public to focus legislation on protection of information collected through voluntary reporting and assuring that appropriate quality improvement activities occur at all levels. When errors are committed with malicious intent, licensing boards, public authorities and departments of health should handle such issues. In other situations, information from voluntary reporting programs can be shared with appropriate agencies and authorities to promote safe medication practices in all organizations.

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