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USP Quality Review

No. 74, Issued May 2000

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Practitioner and Product Experience Programs Report: USP Quinquennial Meeting 2000

Diane D. Cousins, R.Ph., Vice-President Practitioner and Product Experience Division, presented the following report highlighting the endeavors and achievements of the division during USP's 2000 Quinquennial Meeting in Washington, D.C., held April 12-16.

Over the past decade, practitioner comment, collected through the USP reporting programs, has become an increasingly important part of the revision process for USP's drug information and drug standards activities. Expanded interests in new areas, including products used in animals and medication errors, stimulated the growth of USP's practitioner reporting programs. These programs demonstrated national impact by reaching far beyond the realm of standards setting to dramatically influence public health.

USP Medication Errors Reporting Program

Nine years ago USP decided to focus more intently on the problem of medication errors and what it could do to prevent them. USP learned that The Institute for Safe Medication Practices (ISMP) was seeking the support of a national organization to bring its USP Medication Errors Reporting Program to the national stage. USP agreed to coordinate the program. In September 1994, because of the favorable impact and significant accomplishments of the program, USP purchased the program from the Institute with a vision for its growth and impact. By 1995, USP saw firsthand the complexity of medication error scenarios and recognized that the role USP could play as an organization was limited by its mission as a creator of drug standards and information.

To address these myriad issues, USP spearheaded the formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) in July 1995. The Council is a working coalition of 17 organizations and federal agencies that share the common mission to promote the reporting, understanding, and prevention of medication errors. Member organizations include national practice associations of medicine, nursing, and pharmacy, the licensing boards of pharmacy and nursing, organizations of the pharmaceutical industry, the Department of Veterans Affairs, the FDA, the Joint Commission on the Accreditation of Healthcare Organizations, the American Hospital Association, and the USP as Secretariat.

The Council has produced internationally recognized work products, such as

a standardized definition of "medication error,"
an index of severity of patient harm,
a taxonomy to catalog medication errors, and
extensive recommendations for reducing errors in the prescribing, dispensing, and administration phases of the medication use process.

Currently, the Council is examining the issues of bar coding, verbal orders, and benchmarking error rates to help provide national-level direction on these important issues to the health care field.

In July 1996, an interdisciplinary group of health care practitioners was established as an Advisory Panel on Medication Errors. This Panel undertook the review of reports submitted to the USP Medication Errors Reporting (MER) Program and used that information to recommend changes in USP standards and information and to develop recommendations for action by the Coordinating Council. This year a new expert committee on Safe Medication Use will replace the ad hoc panel. This new expert committee will encompass a broader scope of responsibilities than the Advisory Panel; it will review data and provide guidance for the development of best practice solutions that will reduce and prevent medication errors.

In early 1997 USP began receiving telephone calls, almost daily from risk managers, quality assurance staff, pharmacists, and nurses, looking for some guidance on medication error reporting and analysis. They asked: How do I define "medication error"? What standardized set of data should I be capturing in my facility in order to conduct proper error analysis? Does USP have an electronic reporting mechanism that could be adopted by my facility? Can USP provide national medication error rates? What is an acceptable medication error rate, both within my facility and in comparing to other facilities? People also were looking for an effective anonymous system in the absence of any legislative protection.

In mid-1998, USP developed a nationwide database for hospitals to report medication errors called MEDMARX®. We found that hospitals were eager to submit reports if reporting could be done anonymously and in a standardized format.

MEDMARX is an Internet-accessible, anonymous reporting program that enables hospitals to voluntarily report, track, and trend data using nationally standardized data elements developed by USP, NCC MERP, and the American Society of Health-System Pharmacists. Hospitals can review not only the errors documented by other institutions but also the prevention plans developed in response to the error. MEDMARX is structured to support an interdisciplinary systems-approach to medication error reduction and fosters a non-punitive environment for reporting. USP's goal is to develop a model database for hospitals first, to ensure success of the model, then to broaden the model to other health care settings, such as ambulatory care and nursing homes, and other types of reporting, such as adverse drug events and medical errors.

USP's commitment to MEDMARX is broader than merely collecting data. In April 2000, USP enrolled champion hospitals participating in MEDMARX in a long-term project to propose indicators of quality in the medication use process and to identify best practice and best process standards for the medication-use system.

The recently released Institute of Medicine report, To Err Is Human: Building a Safer Health System, focused national attention on an issue to which USP has been attuned for many years. The report has become the stimulus for a national agenda for change. Both USP's MER Program and MEDMARX are cited among the complementary national reporting systems that play a valuable role in encouraging improvements in patient safety.

USP believes that a significant obstacle to the full implementation of any national medication reporting system is the fear of disclosure of the reports in civil litigation and regulatory investigation. As part of the MEDMARX vision, USP planned to pursue legislative protection for medication error reports to our programs. In October 1999, USP began working closely with Congresswoman Morella (R-MD) to draft legislation designed to protect the confidentiality of MEDMARX data on medical mistakes when the information is collected and analyzed solely for the purpose of improving patient safety. On February 16, 2000, H.R. 3672, "The Medication Error Prevention Act of 2000," was introduced to Congress. As an incentive to report, information submitted to the programs would be treated as privileged under federal law similar to states that currently provide peer-review and quality improvement protections by state statute.

Through its work in the 2000-2005 quinquennium, the USP Practitioners' Reporting Network^SM will contribute uniquely to USP's knowledge base on medicines and other health care technologies with "actual use" data: it will look at products in various stages beyond manufacturing through distribution, storage, dispensing, administration, and use. The role of a pharmacopeia as a repository for such observations and experiences of health professionals and consumers is unparalleled in any other country today. Because interest in the structure and operation of USP's reporting programs, especially MEDMARX, has been expressed by many individuals and governments worldwide, the international adaptation of this model will be a focus for the USP in coming years, presenting opportunities for data exchange that can ultimately enrich USP standards and information, and those of other nations.

The second major effort in 1995-2000 for the USP's Practitioners' Reporting Network involved products used in animals and veterinary medicine.

Veterinary Practitioners' Reporting Program

As an organization dedicated to public health, USP recognizes the important connection between human health and animal health. The safe use of drugs, vaccines, and pesticides in food-producing animals as well as companion animals and zoo animals has implications not only for animal health but also for human health.

Although mechanisms for reporting adverse reactions have been available in human medicine for nearly 30 years, national organized reporting is a relatively new concept in veterinary medicine. The Veterinary Practitioners' Reporting Program was launched in 1994 and is presented in cooperation with the American Veterinary Medical Association (AVMA). USP reports are shared with three regulators (the USDA, the FDA, and the EPA), the manufacturer of the product, and the AVMA. The program offers the only centralized national database of reports involving all types of products used in veterinary medicine. In 1999, the program received more than 1,300 reports representing nearly one-third of the total reports received over 5 years. This astounding growth has enabled the program to have public health impact in the following three areas:

In July 1998, USP received two reports of fatalities in dogs following intravenous administration of Vitamin K1. Based on these reports and the medical literature, USP submitted a suggestion to FDA for reevaluation of dosing recommendations on the label. FDA will suggest appropriate labeling changes to product manufacturers.
For calendar year 1999, USP provided more than 980 reports on animal vaccines to the USDA, which typically receives fewer than 100 reports a year directly from veterinarians and consumers. Because current biologics regulations do not require manufacturer reporting of adverse events, USP reports play a vital role in USDA's immunovigilance activities.
In the summer of 1999, USP reports identified a pattern of often-fatal toxicosis in cats exposed to highly concentrated permethrin found in certain "spot-on" flea and tick products intended for use on dogs. In addition to an article published by USP in the Journal of the American Veterinary Medical Association, a public service campaign, which reached at least 123 TV stations and a radio audience of 7.6 million, alerted animal owners and veterinarians to the dangers of both direct application and secondary exposure for cats. The EPA, citing the USP alert in correspondence to product manufacturers, will recommend label changes to improve safe use.

In the upcoming five years, USP has three objectives for this program:

to increase reporting by large-animal practitioners,
to build collaborations with practitioner- and industry-based organizations, and
to increase feedback to the veterinary community about the trends reported to the program so that the program will continue to be a valuable repository of experiences in animal health.