Rockville, September 21, 1995



NCC MERP Meeting Summary

September 21, 1995

The second meeting of the National Coordinating Council for Medication Error Reporting and Prevention was held at the Pooks Hill Marriott in Bethesda, MD on September 21, 1995.

All members were present as listed below:

  • William M. Ellis (Chairperson)
  • Andrew Smith (AARP)
  • Marcia Richards (AHCA)
  • Thomas Granatir (AHA)
  • Joseph Cranston (AMA)
  • Daniel O'Neal (ANA)
  • Susan Winckler (APhA)
  • Charles Myers (ASHSP)
  • Dale Austin (Federation of State Medical Boards of the United States, Inc.)
  • Sharon Holston (FDA)
  • Alice Till (GPIA)
  • Deborah Nadzam (JCAHO)
  • David Work (NABP)
  • Teresa Mullin (National Council of State Boards of Nursing, Inc.)
  • Lawrence Gifford (PhRMA)
  • Michael Cohen (USP Advisory Panel on Medication Errors)
  • Diane Cousins (USP)

Old Business

New members were welcomed by the chairperson. The American Society of Health-System Pharmacists (ASHP), which had been in an observer status, received approval of its Board to participate in the NCC MERP and became a full-voting member at this meeting. The American Health Care Association (AHCA), which was invited to join the Council following the last meeting, accepted the Council's invitation to become a member and was represented by Marcia Richards, who gave a brief overview of the AHCA. Andrew Smith replaced Susan Raetzman as the representative of the American Association of Retired Persons (AARP).

The chairperson noted that the Council had a quorum for this meeting.

VOTE: The first order of business was to approve the Meeting Summary from the meeting of July 19, 1995. A motion was made and seconded to accept the meeting summary. The motion carried after brief discussions.

VOTE: Regarding the adoption of the Rules and Procedures, the motion to accept was made and seconded and opened for discussion. It was pointed out that ASHP and AHCA should be added to the list of organizations comprising the Council. One question was posed regarding the difference between an advisory panel and a subcommittee. The differences regarding the purpose and composition were explained. The motion was carried with the amendment to include the two new organizations, ASHP and AHCA.

VOTE: A motion was made, seconded and carried for approval of the NCC MERP stationary and logo.

VOTE: A motion was made, seconded and carried for approval of the Goals of the NCC MERP. The goals now read as follows:

  1. To stimulate the development and use of medication error reporting and evaluation systems in individual health care organizations.
  2. To stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors.
  3. To examine and evaluate the causes of medication 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 relative to system modifications, practice standards and guidelines, and changes in packaging, labeling, and product identity.

VOTE: The approval of the Council's Definition of Medication Error was put to a motion and seconded. The motion was opened to discussion.

The first point of discussion was the difference between "patient" and "consumer" as presented in the definition. It was explained that the "patient" terminology referred to the use of prescription products and "consumer" to non-prescription products.

Further discussion involved a patient's "lack of understanding of the directions for use" and whether this would be considered a medication error under the Council's definition. This sparked further discussion about inclusion of the terms, "communication", "patient counseling", and "education", in the definition. A discussion ensued regarding the addition of "and use" to the last sentence as well as the word "education". These additions to the definition of medication error were moved, seconded and carried, to amend the second sentence as follows: "Such events may be related to professional practice, health care products, procedures, and systems including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

Discussion was raised as to whether the definition included a "potential" error. It was determined that such errors (i.e. errors made in the continuum from prescribing to dispensing or administration but that do not reach the patient), are an important aspect of the medication error definition. It was suggested that "may" be added to the first sentence to encompass such errors. A concern was voiced that "potential error rates" not be confused by some with "actual error rates". It was moved, seconded and carried to amend the first sentence as follows: "A medication error is any preventable event that may cause or lead to inappropriate medication use while the medication is in the control of the health care professional, patient, or consumer."

Considerable discussion ensued regarding the terminology "inappropriate medication use." It was agreed that missed doses are intended to be included as "inappropriate medication use". The use of "harmful" or the use of "improper" was suggested for insertion. It was moved, seconded and carried to insert "or patient harm" into sentence one, which now reads: "A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."

Cognitive errors relative to prescribing were also discussed but no change to the definition resulted.

The group discussed including "manufacturer" in the first sentence following the control of.... The consensus of the Council was that including manufacturer errors such as placing the incorrect product in the bottle was outside the scope of the Council's definition.

The Council's Definition of Medication Error with all amendments now reads:

"A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

Formation of a Subcommittee on Terminology
Discussion ensued regarding the difference between a medication error and an adverse drug reaction. At this point it was questioned whether a glossary of terms associated with the Council's established definition of a medication error would be necessary and helpful. It was determined that a glossary could appropriately capture some of the discussion on how the Council arrived at its definition of a medication error. A subcommittee was established to create a glossary and is comprised of the Deborah Nadzam (JCAHO), Susan Winckler (APhA) and Charles Myers (ASHP).

The appointment of alternates was addressed. All those who wish to appoint an alternate were instructed to notify the Secretariat.

Requests for Information received by the Secretariat
The Secretary reviewed correspondence received by the Council from the Institute for Healthcare Improvement (IHI). She explained that this not-for-profit organization was establishing a "Breakthrough Series" on "Reducing Adverse Drug Events and Medical Errors" and they wanted to know if the Council was on a parallel track or if any overlap was a concern. Several Council members voiced their familiarity with this group, which is associated with Harvard and is well-respected. It was suggested that the Council further explore the group while maintaining open lines of communication but not active "affiliation."

Meal Expenses
Because the meetings of the Council are open, it was decided that a policy regarding meal fares should be established. Members and alternates will be included in Council expenses paid by the Secretariat. It was agreed, however, that guests, observers, etc. will be expected to cover their own meal expense at all Council meetings.

Activities Update

Organizations described activities dealing with medication errors that would be of interest to the Council members:

MedGuide proposal is out for comment. It mentions that by the year 2000, 75% of patients will receive useful information on medication use (open hearings will be held in December).

APhA, USP and NABP are issuing an RFP on a systems-based study of medication errors in the outpatient pharmacy setting.

USP just released a curricular resource, Understanding & Preventing Medication Errors, for use in nursing schools.

ASHP with AMA and ANA will be co-hosting a meeting in October as follow up to its Conference last October on Understanding and Preventing Drug Misadventures.

Presentations to Members
Presentations were made by Sharon Smith Holston (FDA) and Diane Cousins (USP) on their respective organizations' reporting programs for medication errors and adverse events. The videotape, Reducing Medication Errors Through Failure Mode and Effects Analysis, was viewed by the Council.

New Business: Subcommittee Reports

Subcommittee on Reporting of Medication Errors
Larry Gifford (PhRMA), Chairperson

This group felt that there was a need to identify reporting systems that are presently available. The group questioned whether reports from groups that have systems established should be solicited by the Council. It was pointed out that risk assessment offices within organizations/facilities may block the reporting out of medication errors. The consequences of this posture of not reporting out of the health care facility was questioned. Incentives may be needed for people to report out. The perception is that a person is required to "turn themselves in".

In North Carolina, it has been suggested to the Board of Pharmacy that if a pharmacist reports medication errors, it will be taken into consideration and help avoid a full hearing by the Board of Pharmacy. The NC Board hopes to adopt a statement that reporting of errors is a mitigating factor in litigation; failure to report is an aggravating factor. The natural inhibition is to not get involved in reporting, however the damages of medication errors could be lessened if events were reported through a national system. JCAHO must create mechanism for reporting and its standards should require that facilities report medication errors. It would then be perceived as a mandatory requirement by those facilities receiving accreditation by JCAHO.

Individual errors are enabled by systems. JCAHO has been asked to require the actual observation of individuals involved in medication use because the observation technique does turn up medication errors for internal monitoring. Hospitals need to take a look at reports and use them as anecdotal information. It may become a strategy of the Council to have JCAHO change its guidelines.

Another strategy would be for the Council to promote the national programs that are now available (through USP and FDA). JCAHO will be willing to place an article about the Council and encourage reporting through the USP and FDA programs. A question was posed about the confusion of reporting to two national programs. FDA responded that it had no problem with practitioners reporting medication errors to USP because all such reports received at USP are shared with FDA on a regular basis. USP pointed out that medication error reporting is broader than product-related or regulatory issues. It often crosses over into practice areas.

The three objectives recommended by the Reporting Subcommittee were to:

  1. Heighten awareness of systems available to or within health care organizations. Stimulate and encourage reporting of medication errors both nationally and locally.
  2. Develop standardization or classification systems of medication error report collection, so databases will reflect reports and grading systems.
  3. Maintain systems to support and provide feedback to reporters so that appropriate prevention strategies can be developed in facilities.

VOTE: These three objectives relative to reporting were adopted by the Council.

Comments made after three objectives were finalized:

Mechanisms for feedback are necessary and important. It is important to thank reporters for their efforts. Improve dissemination of information. Consumers and patients, as well as health professionals, need to be made aware of results.

Subcommittee on Understanding Medication Errors
Teresa Mullin (NCSBN) Chairperson

The Subcommittee presented three objectives. Very little discussion ensued other than some clarifying points.

The three objectives recommended by the Understanding Subcommittee were to:

  1. Assess current knowledge of medication errors through ongoing efforts (e.g. literature search) to gather data associated with scope of problems, types of errors, causes/sources of errors, and impact on patients and on health system costs.
  2. Develop a mechanism to identify gaps in research that hinder the knowledge of understanding medication errors.
  3. Sponsor research in an effort to expand knowledge regarding medication errors, the causes, and effectiveness of the interventions.

VOTE: These three objectives relative to understanding were adopted by the Council.

Subcommittee on Preventing Medication Errors
Charles Myers (ASHP), Chairperson

Standardization throughout the continuum from prescribing through administration and use was an issue that received comment around the table. The question arose as to whether all hospitals should have the same standards. Dr. Cranston believed the AMA would not be opposed to some type of standardization, however it would not go so far as to standardize the drugs that could be selected. It was suggested that the Council foster standardization of those aspects of the continuum that have been targeted as prone to medication errors. There was consensus for the idea of focusing on the systems solutions to medication errors.

In discussing the benefits of on-line information systems for error prevention, the term "on-line systems" was questioned — are we talking about computerized information systems or patient specific information such as "smart cards?" Some felt the Council should encourage the development of computerized patient records to provide access to patient information and data by all members of the health care team.

The six objectives recommended for medication error prevention were to:

  1. Foster standardization of error-prone aspects of drug prescribing, delivery, and administration.
  2. Encourage a reliance on systems-based solutions to enhance the safety of medication use and to minimize potential for human error.
  3. Explore the potential for computer-based information systems in the prevention of medication errors.
  4. Increase awareness of the need for distinctive packaging, labeling and nomenclature of products associated with actual or potential medication errors.
  5. Educate consumers/patients regarding strategies to prevent medication errors for prescription or non-prescription medications.
  6. Educate health care professionals regarding strategies to prevent medication errors.

Although some discussion ensued regarding whether to combine the education of consumers and health care professionals under one heading, it was agreed that they should remain separate.

VOTE: These six objectives relative to prevention were adopted by the Council.

Action Items

The members expressed a need to raise the level of awareness regarding the Council, especially among the member associations. Each association was encouraged to get the word out and publish information about its participation on the Council.

If the ANA could receive information by November, it would be helpful in reaching the multiple nursing organizations represented by ANA.

PhRMA expressed that its group of trademark attorneys was happy to learn of the broad issues that the Council would address and that the Council was not limiting its focus to naming issues. PhRMA has a task force on patient information and the Council's objectives will be taken back to that group.

NABP indicated that it would publish items in their newsletter. Information received by the middle of November would be published in the January quarterly newsletter.

AHCA has a 2-page newsletter and regulatory letter. They would be happy to publish an article in their magazine.

ASHP offered to the Council presentation time on theprogram at the ASHP Annual Meeting in June '96.

Dr. Cranston will approach the editors of AMA Journal to request space.

The JCAHO recommended that the NCC MERP get a booth at the National Forum on Quality. If too late, can try at other meetings.

The question arose regarding a budget for the Council for such things as exhibiting at meetings. It was suggested that the Council's member associations pick up costs associated with exhibiting or secure an alternate source of funding. The Council will look into specific funding for these types of activities. The production of a video spot for educational purposes was suggested.

The Council will develop a letter to mail to numerous health care organizations providing information on the Council and encouraging reporting through the toll-free numbers.

The group agreed that the best way to establish credibility is to do something. Preparing a short list of goals to set into motion is a good start.

A survey for distribution to the membership of Council organizations will be developed by Tom Granatir and Susan Winckler to help the Council substantiate systems presently in existence for identifying, reporting, and tracking medication errors.

A brochure describing the Council was an area of interest. It was determined that USP would take the lead on this and prepare a draft and mock-up of a brochure prior to the next meeting. Once developed, artwork for the brochure will be sent to all member associations for each group to print, thus reducing costs for any one organization.

USP will also prepare lists of reported concerns regarding nomenclature, labeling, and packaging as reported through its Practitioners' Reporting Network.

A stock article that could be released to all health care and consumer publications regarding the goals and objectives etc. of the Council will be drafted by the Chairperson. The interdisciplinary approach to this major problem of medication errors will be emphasized. Reporting mechanisms will be referenced. Accomplishments of the Council will be summarized. Additionally, the article will make an appeal for information on systems that work effectively.

Prior to adjournment, it was announced that calendars would be sent to all members to establish a date for the next meeting. Lots of organizational meetings occur in the Fall.

It was pointed out that the momentum should not be lost even if the Council is unable to meet in the next two months. It was decided that the group should not be split up to accomplish meetings but that the group should continue to work as a complete unit.

Approved April 1, 1996

Meeting Date