Rockville, February 12-13, 1997

Format

 

NCC MERP Meeting Summary

February 12-13, 1997

Day One

The meeting was called to order at 1:45 p.m. Janet Myder was introduced as the new alternate delegate for the American Health Care Association.

Council members present included:

  • Bill Ellis (Chairman)
  • Diane Cousins (USP, Secretary)
  • David Work (NABP)
  • Dan O'Neal (ANA)
  • Joseph Cranston (AMA)
  • Susan Winckler (APhA)
  • Sharon Holston (FDA)
  • Deborah Nadzam (JCAHO)
  • Michael Cohen (Chairperson, USP Advisory Panel on Medication Errors)

The Chair, introduced the alternates:

  • Joseph Deffenbaugh (ASHP)
  • Herbert Carlin (GPIA)

Other alternates that attended along with their representatives were:

  • Kim Keller Reid (USP)
  • Jerry Phillips (FDA)

Those members absent included:

  • Andrew Smith (AARP)
  • Tom Granitir (AHA)
  • Teresa Mullin (NCSBN)
  • LeRoy LeNarz (PhRMA)
  • Charles Myers (ASHP)

The Chairman acknowledged the observers present:

  • Tom Clark (ASCP)
  • Janice Feinberg (ASCP)
  • Sue Proulx (ISMP)
  • Yvonne D'Antonio (CPMU)
  • Stacy Wiegman (ISMP)
  • Frances Kurdwanowski (ASHRM)
  • Shawn Becker (USP)
  • Ilze Mohseni (USP)
  • John Cannon (USP Intern)

The first order of business dealt with structure and membership. The request for membership by the American Society of Consultant Pharmacists was tabled at the last meeting and a membership task force was appointed to make membership recommendation to the entire Council. The Council met in closed executive session for approximately 1 hour and 20 minutes to discuss these issues.

The open meeting reconvened at 3:10 p.m. and the Chairman recapped the discussions, held in executive session, on structure, membership criteria and election of the next Chairperson. Bill Ellis announced that ASCP was accepted as a member of the Council. The Chair announced that Pricilla Shoemaker is replacing Marcia Richards as the delegate from the American Health Care Association and that Janet Myder is now the alternate from AHCA.

Diane Cousins announced that Bill H.R. 524, The Safe Medications Act of 1997, had been introduced in the House on February 4, 1997. The bill has wording similar to the previous bills except that it requires the reporting of medication-related deaths (previously "medication-error-related"). This could be interpreted to include deaths due to adverse reactions, overdoses, and possibly even chemotherapeutics, as well as medication errors. However, according to David Work there are no co-sponsors and therefore the bill will have a rough road in a Republican Congress.

The Chair put forth the question, "How should the Council respond if asked about its support or position on this bill"? The Chair pointed out that the individual member organizations will more than likely have their own responses to this bill. Several organizations appeared before Congress when the original bill was introduced including: USP, ASHP, AMA, NABP, and ISMP. All of these organizations presented statements and answered questions in relation to this type of legislation. JCAHO does not intend to mandate reporting of errors by its accredited facilities (Nadzam).

After much discussion, the Council decided that it would take no official position on this legislation but encouraged member organizations to broadcast the work of the Council in the medication error arena if any calls were received from the press. A motion was made and seconded. The motion carried unanimously.

Diane Cousins introduced the topic of intellectual property protection for the Council. According to Diane, an organization took upon itself to add abbreviations to the dangerous abbreviations list prepared by the Council and then published it under the Council's name. Discussion ensued regarding the fact that the Council may want to protect itself from any such infringement in the future. Kim Reid addressed the issue of copyrighting NCC MERP materials and will draft a statement of copyright instructions. It was moved and seconded that all NCC MERP documents will henceforth contain a copyright. The motion carried unanimously.

Presentation on Computer-based Information Systems
Susan Winckler (APhA) and Janice Feinberg (ASCP) delivered a presentation on computer-based information systems in health care delivery. Dan O'Neal (ANA) noted the risk of automating in cost-constrained environments. Eliminate an FTE to justify automation and eliminate the checks and balances on the automation.

Website for NCC MERP
The Chair introduced the possibility of the NCC MERP having its own Website. Helix, a Website owned by Glaxo, is willing to provide the space for the Council. There would be no charge to NCC MERP or to the users. A question was posed "Does it matter to Glaxo that an error involving their products may show up on our Website?" The Chair indicated that he was under the impression that this was a good will gesture on the part of Glaxo. Discussions ensued regarding what should be available on such a Website. Most members felt that the Council's press releases, list of organization members, and other medication error related events should be posted. The members were interested in determining if the Council will learn the identity of those dialing into the NCC MERP Webpage. They felt this would be important. It was moved and seconded that the Chair proceed with the effort to include the NCC MERP on Helix. The vote carried.

The meeting adjourned at 5:05 p.m.


Day 2

The meeting reconvened on Thursday, February 13, 1997 at 8:15 a.m.

Council members present included:

  • Bill Ellis (Chairman)
  • Diane Cousins (USP, Secretary)
  • Tom Clark (ASCP)
  • David Work (NABP)
  • Dan O'Neal (ANA)
  • Joseph Cranston (AMA)
  • Deborah Nadzam (JCAHO)
  • Michael Cohen (Chairperson, USP Advisory Panel on Medication Errors)

Alternates present:

  • Joseph Deffenbaugh (ASHP)
  • Herbert Carlin (GPIA)
  • April Shaughnessy (APhA)
  • Jerry Phillips (FDA)
  • Janet Myder (AHCA)

Other alternates that attended along with their representatives were:

  • Kim Keller Reid (USP)

Those members absent included:

  • Andrew Smith (AARP)
  • Tom Granitir (AHA)
  • Teresa Mullin (NCSBN)
  • LeRoy LeNarz (PhRMA)
  • Charles Myers (ASHP)

The Chairman acknowledged the observers present including:

  • Dr. Michael Victoroff (Quantum Medical Group)
  • Melinda Ray (NACDS)
  • Fran Kurdwanowski (ASHRM)
  • Yvonne D'Antonio (CPMU)
  • Sue Proulx (ISMP)
  • Stacy Wiegman (ISMP)
  • Ilze Mohseni (USP)
  • Shawn Becker (USP)
  • John Cannon (USP, Intern)

Subcommittee Reports

Taxonomy
Jerry Phillips reintroduced the classification (taxonomy) of errors draft. The classifications were again discussed by individual category with additions and deletions being proposed by the members for each section. The question was posed as to how detailed the taxonomy should be. After discussions, the group agreed that the hierarchical approach should be used for the taxonomy. The purpose of the taxonomy is to analyze the errors as reported.

ACTION ITEM: Diane Cousins (USP) and Jerry Philips (FDA) will work together on establishing a hierarchy for the taxonomy.

ACTION ITEM: Have the Taxonomy field tested.

Diane Cousins pointed out to the group that USP has been using many of the fields represented in the taxonomy for quite some time in coding the medication errors.

Dr. Michael Victoroff, President of Quantum Medical Group in Aurora, CO presented his multiaxial system taxonomy. He presented the information captured under his axis system and described in detail each axis listed below:

  • Axis 1 - The Patient
  • Axis 2 - The Outcome
  • Axis 3 - The Intervention
  • Axis 4 - The Agent
  • Axis 5 - The Nature of the Observation

After lunch discussions ensued over a letter received by Dr. Cranston (AMA) from William O. Robertson, MD, Medical Director, Washington Poison Center, and Professor of Pediatrics, University of Washington School of Medicine, regarding the identification of solid oral dosage forms. Dr. Robertson requests that the Council consider this problem and propose a solution.

The major concern appeared to be the confusion being caused over the identification of the product manufacturer. One questions put before the Council was "would using an alpha numeric code on products assist health care professionals and consumers to identify the various drug products or not?"

After discussions on this point the motion was made and seconded that the Council present a letter to USP for a PF Stimuli article to see if there is interest in the possibility of using an alpha numeric code indicating the manufacturer authorized by the Council. The motion carried.

ACTION ITEM: Diane Cousins (USP), Jerry Philips (FDA), Herb Carlin (GPIA), and Mike Cohen (USP Advisory Panel Chair) will work together on drafting a letter to the USP as a PF Stimuli Article.

Activities Update

APhA (Susan Winckler)
APhA Annual Meeting in Los Angeles in March '97 will hold its second General Session on medication errors. It will include vignettes from the TV show ER where several medication errors have been documented and discussed. An open forum will also be held on medication errors in the workplace March 9th. The APhA is sending the Council Recommendations on Prescription Writing through their House of Delegates.

USP (Diane Cousins)
A USP Quality Review presented the work of the NCC MERP. This Review generated considerable interest in the Council's activities. The USP Medication Errors Resource has been promoted through a direct mail campaign and members were asked to consider jointly marketing the product to the respective organization's membership. Diane Cousins presented the Council recommendations on prescription writing and the Council's classification index at the ASHP Annual meeting. Bill Ellis (Chair) summarized other Council activities to date. USP will present information on the National Coordinating Council for Medication Error Reporting and Prevention at the following meetings:

  • 42nd Annual Ohio Pharmaceutical Seminar, April 14-15, Columbus, OH
  • The Institute for Healthcare Improvement Meeting, March 26-27, St. Louis, MO

NABP (David Work)
NABP will urge state boards to incorporate recommendations on prescription writing into their guidelines through a resolution on the floor at the May Annual Meeting.

JCAHO (Debbie Nadzam)
An article about the Council will be appearing in Perspectives.

AMA (Joe Cranston)
The AMA did not move forward with the prescription writing recommendations from the NCC MERP, but felt that the recommendations on prescription writing were almost identical to what AMA had already adopted in its own policy.

ASHP (Joe Deffenbaugh)
ASHP activities relating to the reporting and prevention of medication errors since the November 1996 meeting:

  • First meeting of the National Patient Safety Foundation will occur on February 21, 1997, in Chicago. ASHP has been invited to participate [USP and JCAHO will also attend].
  • ASHP is continuing discussions with the AAAS with respect to potential follow-up projects from the Examining Errors in Healthcare Conference, Rancho Mirage, CA, meeting.
  • Exploring potential follow-up projects with the JCAHO
  • Mailed copies of the following documents to hospital and health-system administrators:
    1. Top-priority actions for preventing adverse drug events in hospitals. Am J Health-Syst Pharm. 1996;53:747-751 and ASHP guidelines on preventing medication errors in hospitals. Am J Hosp Pharm. 1993; 50:305-314
    2. ASHP invited IHI Breakthrough participants to submit posters and management case studies for ASHP's June 1997 Annual Meeting in Minneapolis, MN ASHP and IHI co-sponsored a symposium on preventing adverse drug events. Am J Health-Syst Pharm. 1997; 54:171-177
    3. ASHP staff will speak on the subject of medication errors at the 42 Annual Ohio Pharmaceutical Seminar, April 14-15, Columbus, OH: The First Annual Latiolais Leadership Forum, April 13, 1997, Columbus, OH; and The IHI meeting March 26-27, 1997, St. Louis, MO.

USP Advisory Panel on Medication Errors (Mike Cohen)
Several conference calls have transpired since the last NCC MERP meeting. The Panel is still working diligently on Neuromuscular Blocking Agents (NBA). These discussion will eventually lead to recommendations. A baseline survey on NBA's will be conducted by the Panel.

FDA (Jerry Phillips)
Error Prevention Analysis is an ongoing process at FDA. Two firms have joined FDA in discussions. The simplification of labeling is moving along and may be included in the FDA Reform Package. It has been received well by the government. In the next month or so, Mr. Phillips indicated that medication error reports submitted tot he Agency will be out on the Internet. (This activity drew concern from many members of the Council. It was felt that this decision should be reviewed and discussed prior to implementation.)

ANA (Dan O'Neal)
Article appeared in AJN regarding the work of the NCC MERP and described ANA's efforts in the area of medication errors. Dan wanted to know exactly how to cite the Council when preparing documents for publication.

AHCA (Janet Myder)
Nothing significant to report at present.

It was suggested that the initial literature search presented to the Council be updated and distributed to the Council members.

ACTION ITEM: USP staff will prepare an updated search of medication errors topics in the literature prior to the next meeting.

The election of the Chairperson was again introduced for discussion. The following criteria for election of the Chairperson was moved, seconded and carried:

  1. Chairperson can be elected from the pool of delegates or alternates to the Council The term is for one (1) year with the option to renew for one (1) additional year at the pleasure of the Council.
  2. Chairperson should hold a minimum of three (3) meetings per year.
  3. Thirty (30) days from the initial written call for nominees a ballot will be sent out to all members.
  4. Ballots will be validated and counted by the current Chairperson and the Secretariat.
  5. The winner will be determined by majority vote. If more than two candidates are running for election, a plurality of votes will determine the winner.

These will be reviewed at the next meeting and added to the Rules of the Council.

Glossary
The Chairperson returned to the agenda and discussion ensued regarding the adopted glossary of terms. The definitions for Adverse Reaction and Adverse Event will be developed before the next meeting by the industry members and reviewed by the FDA.

Packaging & Labeling Recommendations
A discussion on Product Packaging and Labeling Error Prevention Strategies continued and recommendations were proposed for Industry, and Standards-setters and Regulators. These recommendations will be redrafted by the next meeting. At the May meeting, the recommendations for health care professionals/consumers and health care facilities will be discussed.

Chair Action Items
The Chairperson agreed to send letters thanking the presenters for today's meeting and also to the ASCP announcing their membership status on the Council. A response letter will also be sent to Dr. Robertson regarding the manufacturer identification concerns raised.

ACTION ITEMS: Chairperson will prepare letters for Dr. Michael Victoroff, Dr. Robertson, Tom Granitir, Janice Feinberg, Susan Winckler, and to the ASCP. The Secretary will send the appropriate ballots for the nomination and election of the next Chairperson.

The meeting adjourned at 3:30 p.m.

Meeting Date