Adverse Event Voluntary Reporting Useful, Needs Standardization, IoM Says

Adverse event reporting can remain voluntary but should become more standardized, the Institute of Medicine suggests in a report on patient safety issues.

While the IoM report noted that voluntary systems are only one of several useful methods of collecting adverse event information, they are "most effective at identifying potential adverse events or near misses," the report said.

IoM identified the collection of information on potential adverse events or "near misses" as becoming increasingly important to achieving patient safety goals.

The ¹ IoM report, titled "Patient Safety: Achieving a New Standard for Care" and produced by the institute's Committee on Data Standards for Patient Safety, was released Nov. 20.

Overall, for adverse drug events, "and probably, for other types of adverse events as well, the three approaches to event detection reviewed - automatic surveillance, chart review and voluntary reporting - complement each other," the report states.

IoM predicted that "spontaneous reporting will be important indefinitely, especially for near misses; however, use of automated triggers is likely to grow as more computerized information becomes available and automated detection becomes increasingly feasible."

As part of its proposed adverse event reporting rule, FDA would require submission of medical error "near misses," but the Pharmaceutical Research & Manufacturers of America argues the requirement would burden the agency with meaningless data (² , p. 19).

The IoM report supports the development of a standardized format for collecting adverse event data across all private and public health care institutions.

In a chapter on health care data standards, IoM expressed support for using the SNOMED (System of Nomenclature of Human and Veterinary Medicine) Clinical Terms as a standard set of medical terms for the purpose of classifying patient outcomes.

SNOMED was developed by the College of American Pathologists and is being considered by HHS as a possible vocabulary set for use department-wide.

PhRMA has expressed concern about switching from the current terminology set, MedDRA, to SNOMED for adverse event reporting.

IoM called SNOMED CT "the most well-developed concept-oriented terminology to date." Terminology and taxonomy "for patient safety events should be developed and included in SNOMED CT."

The report also suggests that some useful terms from MedDRA (Medical Dictionary for Regulatory Affairs) might be adopted into SNOMED. "Patient terms in the core terminology group should be mapped through aggregation logic to important supplemental terminologies, such as MedDRA...to facilitate automated report generation," IoM said.

HHS is undertaking a project to determine how best to standardize patient safety data collection across the department (³ (Also see "FDA Adverse Event Reporting Systems To Be Integrated By Kevric" - Pink Sheet, 2 Dec, 2002.), p. 20). FDA Commissioner McClellan has also identified improving the agency's information technology capabilities as a priority in advancing patient safety.

The recently-passed Medicare legislation includes incentives for providers to adopt e-prescribing capabilities.

IoM suggested there would be both advantages and disadvantages to using automated systems to help prevent and document adverse events because of the potential for false alarms.

"Note that it will be important to determine how much data point-of-care providers can handle, since warnings and messages may be ignored if they are too numerous, especially if their relevance is not immediately apparent," the report states.

"Therefore, although automated triggers have enormous potential and have been shown to be highly valuable, the committee recognizes that in the end they will be suitable for certain types of problems, but not others."

A similar conclusion was reached by the United States Pharmacopoeia in its annual report on adverse events submitted to the voluntary MEDMARX database. "Technology has the potential to reduce many types of errors as well as the potential to create new errors. Implement with care," the ⁴ USP report concludes.

USP focused on the potential costs and benefits of new technologies in the provider setting designed to enhance patient care. "Direct prescriber order entry, automated dispensing devices (in pharmacies and patient care areas), and sophisticated infusion devices are among the many technological advances adopted ostensibly to improve efficiency and safety during an era of abundant drug approvals, soaring drug costs, and healthcare worker shortages," the report said.

However, "technology can also introduce unforeseen errors that may not have been present previously. Therefore, healthcare facilities must adopt new technology in a deliberate, careful, and integrated manner that minimizes the introduction of new errors throughout the medication use process and that maximizes the technology available to provide alerts, safety checks, dosage calculations and decision support."

The issue of how best to prevent and track adverse events and medical errors has attracted Congress' attention. The Medicare bill directs another study by IoM under a contract with HHS on "drug safety and quality issues in order to provide a blueprint for system-wide change."

The report "will consider the nature and causes of medication errors, their impact on patients, the differences in causation, impact, and prevention across multiple dimensions of heath care delivery - including patient populations, care setting, clinicians, and institutional cultures," the bill states.

In addition, IoM will "evaluate alternative approaches to reducing medication errors in terms of their efficacy, cost-effectiveness, appropriateness in different settings and circumstances, feasibility, institutional barriers to implementation," and other factors.

The report would be used as guidance for "policy-makers and government agencies," including FDA and the Centers for Medicare & Medicaid Services, "in promoting a national agenda for medication error reduction."

IoM is directed to convene a committee including "clinicians, health services researchers, pharmacists, system administrators, payer representatives, and others" to conduct the study within 18 months.