Rockville, November 18-19, 1996



NCC MERP Meeting Summary

November 18-19, 1996

Day One

The meeting was called to order at 1:50 p.m. Council members present:

  • Andrew Smith (AARP)
  • Joseph Cranston (AMA)
  • Susan Winckler (APhA)
  • Charles Myers (ASHP)
  • Sharon Holston (FDA)
  • Alice Till (GPIA)
  • LeRoy LeNarz (PhARMA)
  • Diane Cousins (USP)
  • Linda Hanold (JCAHO-alternate)
  • Barbara Newman (NCSBN-alternate)
  • Tom Poux (USP Advisory Panel on Medication Errors-alternate)
  • William Ellis (Chairperson)

Other alternates who attended with their delegates:

  • Joseph Deffenbaugh (ASHP)
  • Kim Keller Reid (USP)
  • Herbert Carlin (GPIA)
  • Sidney Kahn (PhARMA)
  • Jerry Phillips (FDA)

Those members absent:

  • Marcia Richards (AHCA)
  • Dan O'Neal (ANA)
  • David Work (NABP)
  • Tom Granatir (AHA)

The Chairperson acknowledged the observers:

  • Tom Clark (ASCP)
  • Sue Proulx (ISMP)
  • Frances Kurdwanowski (ASHRM)
  • Yvonne D'Antonio (CPMU)
  • Sandra Jung (NACDS)
  • Shawn Becker (USP)
  • Ilze Mohseni (USP)

The first order of business dealt with structure and membership—in response to a request for membership by the American Society of Consultant Pharmacists. The Council met in executive session for approximately 45 minutes.

The open meeting reconvened and the Chair explained the results of the executive session. A letter from ASCP dated October 4, 1996 ,was received by the Chair. ASCP requested a seat on the Council. The membership felt that before the Council could make a decision on new members it was necessary to set criteria for membership and to establish a structure to support the expanded membership.

ACTION ITEM: A task force has been established to provide draft criteria for membership and to propose a structure for the Council. The members of the Task Force on Membership and Structure are: William Ellis, Diane Cousins, Alice Till, Susan Winckler, and Charles Myers.

Old Business

The summary from July 15-16, 1996 was accepted with the following modifications:

  • Attendance should reflect the presence of JCAHO, FDA, and AHA on Day 1
  • Jerry Phillips (FDA alternate) should be listed as present on Days 1 and 2.

The Glossary of Terms for the medication error definition was the next agenda item opened for discussion. It was pointed out that Lexikon was misspelled on the document (Hanold). Discussion ensued regarding the various definitions available for an "adverse drug reaction". International harmonization should be considered and the ICH definition should be reflected in the glossary for the NCC MERP (Kahn). The FDA definition of an adverse drug reaction may also need to be incorporated (Holston). Discussions on the terms "patient" and "consumer" were again brought forth (Cranston and Smith).

The definition of a consumer should be changed to read: "user, including caregiver, of health care products and services."

The use of these definitions was to clarify statements made by the Council. Several members felt that the definitions were to assist in clarifying terminology for the definition of a medication error. It was discussed that the document may need a footnote indicating the purpose of the glossary.

The footnote should read: "Footnote: Operational terms for use in developing the medication error definition and other NCC MERP statements." The document should also be dated.

The name "Glossary of Terms" should be changed to "Operational Terms."

The Leape citation should be completed to reflect the entire citation.

The glossary of terms, reflecting these changes, was moved, seconded and approved.

ACTION ITEM: The ADE and ADR definitions will be evaluated by a work group prior to next meeting. Group consists of LeRoy LaNarz, Kim Reid and Alice Till.

Activities Update

Chairperson (Bill Ellis)
He reported that we had received a notice from Dan O'Neal regarding his absence at today's meeting and that ANA is developing a position on medication errors for presentation to their board of directors. Bill mentioned that he was pleased with the response and coverage of the news release from the July meeting. The responses to the call for reporting systems were addressed. All those responding will be placed on the NCC MERP mailing list.

FDA (Sharon Smith Holston)
The September 30, 1996, FDA Health Professional meeting was very successful. The Program included presentations by many of the NCC MERP members. The information on medication errors reached a varied audience. The FDA's Medical Bulletin published a call for reporting systems.

AMA (Joe Cranston)
National Patient Safety Initiative has been launched by AMA. At present fund raising is the major issue. Martin Hatlie, Esquire, contacted Joe Cranston to work with the Council. The AMA is bringing in an airline industry representative into these discussions to address how they react to errors and mishaps in the industry. Still trying to get press on the Council out to membership.

USP (Diane Cousins)
Received lots of response to her presentation on the Council and medication error reporting at the FDA meeting. The USP Standard published the Index and recommendations on prescription writing from the last NCC MERP meeting. A USP Quality Review presented the issues surrounding the continuing saga of KCl errors. Council members were asked to publicize this continuing tragedy by reprinting or citing the Quality Review. The USP Medication Errors database has been changed to reflect the newly established NCC MERP medication error index.

JCAHO (Linda Hanold)
The Rancho Mirage meeting turned out to be an excellent meeting on medication errors. It emphasized the need for a different kind of reporting system. It opened a lot of doors. Human factors were discussed at length. The panel sessions were very enlightening. The research agenda will depend on opportunities to collaborate. JCAHO made an announcement of its efforts to capture the root cause analysis of medication errors.

APhA (Susan Winckler)
As a result of the US News and World Report article about pharmacist error rates, APhA is doing a survey on workplace issues. Several articles highlighting the issues have been written and a survey on the workplace errors is being developed. Issues involving quality of worklife, practice isolation, workflow, and environment (label printers next to telephone creating noise barrier) as distractions for the pharmacist will be studied.

ASHP (Charles Myers)
November issue of ASHP Newsletter published the NCC MERP recommendations.

USP Advisory Panel on Medication Errors (Tom Poux)
A review of the November meeting was presented. The issues relating to neuromuscular blocking agents were discussed. The Advisory Panel will submit recommendations for incorporation into the USP General Chapters where appropriate. A survey will be developed to learn more about neuromuscular blocking agent protocols and errors.

Actions that may reduce errors were relayed to the Council, including:

  • Hazard warnings
  • Restrict the use
  • Proper Storage
  • Standard orders
  • Model protocols

Require resuscitation equipment whenever neuromuscular blocking agents are used Packaging and labeling (unique design or tactile design)

The Council agreed that the meeting summaries of the Advisory Panel on Medication errors should be shared with all Council members.

Subcommittee Reports

Jerry Phillips presented the classification (taxonomy) of errors draft. The classifications were discussed by individual category and considerable discussion ensued. The group wanted to incorporate a drug class such as: VA Classifications and AHFS Classifications. Because of the lateness of the hour, the Chair determined that the taxonomy issues should receive additional thought and discussion and so it was tabled until the next day.

The meeting adjourned for the day at 5:10 p.m.

Day 2

The meeting reconvened on Tuesday, November 19, 1996. All members and observers from Day 1 returned and the new observers were introduced including Rita Calnan and Nancy Best (USP), Jeffrey Winn (Eli Lilly), and Larry Futers (Canadian Standards Association).

The Chair circulated an article in the day's issue of USA Today about medication errors and offered to submit a letter to the editor regarding the NCC MERP and its efforts.

ACTION ITEM: Chair will prepare a letter to the editor of USA Today in response to the article.

The Chair noted that a change was made to the Recommendations to Correct Error-Prone Aspects of Prescription Writing. The common error noted for the abbreviation of micrograms needed clarification. The new version now reads "Mistaken for "mg" (milligrams) resulting in overdose".

Taxonomy issues were again brought to the floor for discussion. In fairness to Jerry Philips it was pointed out that this initial draft of classification of errors was not reviewed by the entire committee. However, it was felt that the input from the Council was significant. Thus each section will be reviewed and then sent back to the committee for formalizing.

The Council members focused on adding to the personnel involved section—to be inclusive of all disciplines. The setting's section was enhanced to include outpatient facilities, long term care, corrections facilities, schools, the prescribers' office, etc. Risk factors, systems, and causes were discussed and various inclusions were made. Diane Cousins will work with Jerry Phillips on the redraft. It will be presented at the next meeting.

ACTION ITEMS: USP and FDA will review 100 reports before February 1, 1997, to test the classification of errors.

New Business

Product Packaging, Labeling, and Nomenclature
Diane Cousins (USP) presented errors regarding labeling and packaging that were received through the USP's reporting program; Dr. Jeffrey Winn (invited by PhRMA), labeling manager from Eli Lilly, presented the manufacturer's perspective of design, reviews, and approvals of product packaging and labeling (in particular, new proposals specific to Insulin); Jerry Phillips (FDA) presented an overview of labeling regulations and current proposals in the Agency; and Herb Carlin (GPIA) spoke to the generic labeling issues.

A brainstorming session followed covering four specific areas of discussion: healthcare institutions, industry, regulatory and standards setters, and health professionals and consumers. After the brainstorming each specific area broke out for further discussions. The groups returned and presented conclusions to the entire Council. Each group chose a designated individual to draft the summaries of each breakout session and return them to the Secretariat no later than December 31, 1996.

Computer-based Information Systems in Health Care Delivery
Susan Winckler (APhA) agreed to forego her presentation until the next meeting. The Council was instructed to review articles on software and prepare for discussion at the next Council meeting.

The meeting adjourned at 3:30 p.m.

Meeting Date