Rockville, July 19, 1995

Format
Rockville

 

NCC MERP Meeting Summary

July 19, 1995

The first meeting of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) was held at the United States Pharmacopeia (USP) in Rockville, Maryland on July 19, 1995. The Chairperson, William M. Ellis, called the meeting to order at 8:30 a.m. with a brief welcome and opening remarks. Jerome A. Halperin, USP Executive Vice President, addressed the Council (comments attached).

The representatives introduced themselves in the following order:

  • Susan Raetzman, American Association of Retired Persons (AARP)
  • David Work, National Association of Boards of Pharmacy (NABP)
  • Lawrence Gifford, Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Charles Myers, American Society of Health-System Pharmacists (ASHSP; observer status pending ASHP Board of Trustees approval)
  • Thomas Granatir, American Hospital Association (AHA)
  • Susan Winckler, American Pharmaceutical Association (APhA)
  • Teresa Mullin, National Council of State Boards of Nursing (NCSBN)
  • Diane Cousins, United States Pharmacopeia and Secretariat (USP)
  • Daniel O'Neal, American Nurses Association (ANA)
  • Herbert Carlin (alternate), Generic Pharmaceutical Industry Association (GPIA)
  • Michael Cohen, Chairperson, USP Advisory Panel on Medication Errors (ex officio)
  • Sharon Smith Holston, Food and Drug Administration (FDA)
  • Joseph Cranston, American Medical Association (AMA)
  • Dale Austin, Federation of State Medical Boards of U.S.

Deborah Nadzam, Joint Commission on the Accreditation of Healthcare Organizations introduced herself at a later time.

Other observers were asked to introduce themselves. The audience consisted of: FDA's alternate representative, Jerry Phillips, USP staff, the Institute for Safe Medication Practices (ISMP) Staff, the Center for Proper Medication Use/ISMP Fellow, USP Summer Interns, and an FDA summer trainee.

The Chairperson posed various rules and procedures for discussion that were based on USP Rules and Procedures. These will be voted upon at the next meeting and include the following:

  1. USP will act as the Secretariat to the Council.
  2. Alternates should be appointed from each organization.
  3. The Chairperson speaks for the Council.
  4. The Secretary will set the agenda for each meeting and topics may be introduced by any of the members of the Council.
  5. The Council may meet 2-4 times in the first year; perhaps semi-annually thereafter.
  6. Organizational letterhead to include a symbol/logo will be drafted by the Secretary and circulated prior to the next meeting for approval at the next meeting.
  7. Summaries (not minutes) of all meetings will be prepared by the Secretary and sent to all Council members for approval at the next meeting or by ballot if timeliness of topics is an issue.
  8. Observers at Council meetings who wish to speak may be recognized by the Chairperson.
  9. All meetings will be public. An agenda that includes summaries of topics may be made public. For logistical reasons, the Secretariat should be notified in advance so that individuals can be accommodated as space permits. The Council has the authority to exclude observers who have not given advance notice to the Secretariat if they cannot be accommodated.
  10. The Council can meet in executive sessions if privacy or confidentiality is an issue.
  11. Press Releases will be drafted by the Secretary in conjunction with the Chairperson and faxed to each member 48 hours prior to release for comment and content changes. If no comments or changes are received, the press release will be issued. All Council members may adapt the NCC MERP Press Release for their own use. The Secretariat should receive copies of any press releases issued by Council member organizations regarding the NCC MERP.
  12. The Council may utilize subcommittees and advisory panels in its work.

Council Composition
Discussions regarding the membership on the Council were discussed. The question, "who is the actual member of the Council, the organization or the individual representing the organization", was posed. It was determined by the Council membership that the organization is the representative and not the individual representative. It was also determined that while alternates may sit in for a member organization, it would be preferable that the representation remain consistent in having the same person attend the Council meetings.

Council membership discussions included the need for additional representation by other national organizations. The Council strongly supported the need for representation by long term care facilities.

VOTE: The Council voted to extend invitations to the American Association of Homes and Services for the Aging (AAHSA) and the American Health Care Association (AHCA) to become full voting members of the Council. These organizations represent non-profit and for-profit institutions respectively.

VOTE: The motion to invite the Institute for Safe Medication Practices to join the Council was tabled.

The Chairperson noted for the record that the National Committee for Quality Assurance (NCQA) was invited to participate on the Council but for unexplained reasons declined the invitation. The Council did not feel the need to include representation from managed care settings because those health professionals who practice in those settings were believed to be adequately represented by member organizations of the Council.

Mission of the Council
A draft mission statement was placed before the Council as follows:

To promote the reporting, understanding, and prevention of medication errors relative to professional practice, health care products, procedures, and systems through the participative and interactive involvement of national organizations and agencies.

The Council agreed to retain the word "reporting" in the mission statement because (1) reporting is in the Council's name, and (2) reports will provide the data by which to reach an understanding and develop prevention strategies. A motion was made and carried to move the position of "reporting" in the mission statement to emphasize its importance in the process of understanding and preventing medication errors. It was additionally suggested that the remainder of the original mission statement be deleted.

VOTE: The Council voted to adopt the mission statement as follows: To promote the reporting, understanding and prevention of medication errors.

Definition of Medication Error
For the Council to identify causes of medication errors and strategies for prevention, it drafted a working definition of medication error that will be voted upon at the next meeting.

Discussions for a definition of medication error centered around several definitions from the professional literature. It was pointed out that many articles on medication errors have definitions that were limited by the area of study, i.e., abbreviation errors, administration errors, dispensing errors. The use of the term "misadventure" and "adverse drug event" were discussed. A "preventable event" was determined to be one in which the health professional should have known better or should have anticipated the outcome.

Some representatives wanted the medication error definition to encompass cognitive errors of the prescriber. This concept met with considerable discussion about whether the Council wanted to be involved in drug and therapeutic selection issues. The USP stated that its reporting program does not capture or solicit this type of cognitive error. Capturing errors in the use of investigational drugs was of interest to the Council.

The elements for a definition of medication error were agreed upon as follows:

  1. preventable event
  2. causes or leads to inappropriate medication use
  3. the medication is in the control of a health care professional, patient, or consumer
  4. Such events include, but are not limited to, professional practice, health care products, procedures, and systems
  5. Errors occur throughout the continuum of prescribing, order communication, labeling, packaging, compounding, dispensing, distribution, administration, monitoring, and use.

Goals
The following draft goals were formulated for approval at the next meeting of the Council:

  1. To stimulate the development and use of reporting and evaluation systems in individual health care organizations/facilities;
  2. To stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors;
  3. To identify causes of medication errors as well as strategies that are expected to be successful in preventing such errors;
  4. To increase awareness of medication errors and methods of prevention throughout the health care system, which includes health care organizations/facilities, delivery systems, practitioners, manufacturers, regulators, and consumers;
  5. To recommend strategies (for reducing and preventing medication errors) relative to system modifications, practice standards and guidelines, and changes in packaging, labeling, and product identity of pharmaceuticals and medication-related devices; education; and regulatory requirements.

Formation of Subcommittees on Council Goals
To move toward development of an action plan, the Council categorized the goals based on the three elements of the Council's Mission: reporting, understanding, and prevention. Subcommittees were selected for each of the three categories. Specific objectives for reporting, understanding and preventing medication errors will be drafted by the subcommittees and reported back at the next meeting of the Council. The objectives should be outcomes-oriented and include time frames (eg., short term, intermediate and long term). The responsible organizations will be identified. Strategies should be specific and measurable. Funding for subcommittees and advisory panels (that may evolve) is not planned.

GOAL: REPORTING

  1. To stimulate the development and use of reporting and evaluation systems in individual health care organizations/facilities
  2. To stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors
  • Chair for Reporting: Lawrence Gifford (PhRMA)
  • Sharon Holston (FDA)
  • David Work (NABP)
  • Deborah Nadzam (JCAHO)
  • Diane Cousins (USP)

GOAL: UNDERSTANDING

  1. To examine the causes of medication errors
  • Chair for Understanding: Teresa Mullin (NCSBN)
  • Susan Winckler (APhA)
  • Dale Austin (FSMB)
  • Thomas Granatir (AHA)

GOAL: PREVENTION

  1. To increase awareness of medication errors and methods of prevention throughout the health care system, which includes health care organizations/facilities, delivery systems, practitioners, manufacturers, regulators, and consumers
  2. To recommend strategies relative to system modifications, practice standards and guidelines, and changes in packaging, labeling, and product identity
  • Chair for Prevention: Charles Myers (ASHP)
  • Daniel O'Neal (ANA)
  • Herbert Carlin (GPIA)
  • Michael Cohen (USP Advisory Panel)
  • Joseph Cranston (AMA)
  • Susan Raetzman (AARP)

Reports of the subcommittees should be sent to the Secretariat prior to September 7, 1995, preferably on diskette. This will allow the Secretary adequate time to capture each subcommittee's report in a consistent style for reporting to the entire Council.

Other Business

FDA requested comment on a letter from the AMA regarding the confusion caused by prefixes and suffixes used in trade names of medications. The FDA wanted feedback from the Council on the problem. The Council agreed to provide input and comment to FDA as such issues were brought to light either from the USP reporting program or from the MedWatch Program.

Information obtained from the USP reporting program database was presented briefly. The information summarized actual errors, intercepted errors, potential errors and fatalities. The drugs most commonly associated with the medication errors were listed and the most common types of errors were identified (eg., wrong drug given, overdose, similar labels). Discussion ensued and additional information will be presented at the next meeting. It was suggested that the FDA prepare a presentation of data received through the MedWatch program. The Council was interested in the changes that have occurred regarding the labeling of injectables.

The next meeting is scheduled for September 21, 1995 from 8:00 a.m. to 4:30 p.m.

Approved September 21, 1995

Meeting Date