Rockville, May 12-13, 1997

Format

 

NCC MERP Meeting Summary

May 12-13, 1997

Day One

The meeting was called to order at 1:40 p.m.

Council members present:

  • Bill Ellis (APhA, Chairman)
  • Diane Cousins (USP, Secretary)
  • Dan O'Neal (ANA)
  • Joseph Cranston (AMA)
  • Sharon Smith Holston (FDA)
  • Andrew Smith (AARP)
  • Tom Granatir (AHA)
  • Tom Clark (ASCP)
  • Charles Myers (ASHP)
  • Teresa Mullin (NCSBN)
  • LeRoy LeNarz (PhRMA)
  • Janet Myder (AHCA)
  • Herb Carlin (GPIA)

Other alternates that attended along with their representatives:

  • Kim Keller Reid (USP)
  • Jerry Phillips (FDA)
  • Joseph Deffenbaugh (ASHP)
  • Marjorie Jaski (AMA)

Members absent:

  • Deborah Nadzam (JCAHO)
  • Michael Cohen (USP Advisory Panel on Medication Errors)

The Chairman acknowledged the observers present:

  • Mary Ann Wagner (NACDS)
  • Sue Proulx (ISMP)
  • Frances Kurdwanowski (ASHRM)
  • Shawn Becker (USP)
  • Ilze Mohseni (USP)
  • Susan Winckler (APhA)
  • Steven J. Schulte (Oregon Board of Pharmacy)

Structure and Membership

Tom Clark was announced as the delegate from ASCP. Phyliss Moret is the alternate delegate from ASCP. Bill Ellis announced that he is now the Director of the Quality Center for APhA and will represent APhA as the delegate replacing Susan Winckler. April Shaughnessy will continue as the alternate.

Election of Chairperson
The election results for Chairperson were announced by Diane Cousins, Secretary. Bill Ellis was reelected to his third year as the NCC MERP Chairperson.

Several issues arose during the balloting process that were not addressed in the Council's Rules. Discussion ensued on the need for a run-off in case of a tie vote. The membership determined that in the event of a tie vote, the two names would be submitted to the entire Council for a run-off. Regarding balloting by fax, it was determined that ballots could be faxed to the members and returned by fax in order to meet established deadlines.

Rules and Procedures
The changes to the Council's Rules and Procedures as discussed at the February meeting were incorporated into the written document and presented for discussion. Under 'Membership Characteristics', use of the term "affect" in bullet number three (3) was questioned for clarity. The discussion centered around using "effect" as opposed to "affect" in the following sentence: "Demonstrates ability to [affect or effect] national health care standards or practices." Diane Cousins reviewed the grammatical differences in the two terms and expressed her opinion that effect seemed to better reflect the desire of the Council as expressed at the last meeting, meaning, "to bring about" as opposed to affect meaning "to influence" — because many organizations can claim to influence national health care standards. Charles Myers (ASHP) felt that "affect" was appropriate. Very little discussion ensued and, bullet number three will remain as "affect".

It was next suggested that a provision was needed in the rules and regulations to conduct some of the work of the Council by teleconferencing. Dr. LeNarz was in favor of this prospect and expressed his desire to have a teleconference one or two weeks prior to each scheduled meeting of the Council. The Council membership decided that teleconferencing was an acceptable means of communication during the periods between meetings, and that a quorum was necessary if any issues were resolved by vote.

It was also pointed out that on page one of the Council's Rules and Procedures under organization category, the advisory panel dropped off the page. It should read: Chairperson, USP Advisory Panel on Medication Errors. At-Large Members as listed in the 'Category of Membership' chart should be changed to reflect two at-large positions.

The discussion relative to the request for membership by the American Society of Healthcare Risk Managers was tabled until closer to the scheduled break time, because this issue would be discussed in executive session.

Old Business

The meeting summary for February 12-13, 1997 was sent to each Council member for approval by mail ballot. Copies of the Meeting Summary from the November meeting were distributed.

Activities Update

ASHP (Charles Myers)
Activities relating to the reporting and prevention of medication errors since the February meeting include:

  1. The ASHP Annual meeting will have several poster sessions on medication errors.
  2. ASHP has revised its Web page to include a conference (chat) room for discussion of drug misadventures. The URL is www.ashp.org.

AMA (Joe Cranston)
The National Patient Safety Foundation conducted a planning meeting in February and another is scheduled for May 27th. A survey on medication management is being conducted as part of the Dept. of Geriatric Health's 'Medication Error Reduction Initiative (MERI)'. AMA' Dept. of Geriatric Health and the APhA are collaborating with HCFA on quality improvement management.

ASCP (Tom Clark)
Guidelines for long-term care pharmacy should be ready by July 1997. The activities of the NCC MERP were presented by Diane Cousins at the ASCP Annual Conference on Regulatory and Legislative Affairs.

USP (Diane Cousins)
A recent issue of the USP Quality Review highlighted insulin errors as reported through the USP Medication Errors Reporting Program. Two new medication error prevention posters were introduced, one detailing the confusion between similar drug names and the other reproduces the error-prone abbreviations as developed by the Council in its Prescription Writing recommendations. The Council members were encouraged to distribute or request the posters for any and all meetings that concern medication errors. Kim Reid described the latest USP actions regarding labeling simplification. A more complete report will be available at the next Council meeting after the USP Water and Parenterals Subcommittee has convened.

NCSBN (Teresa Mullin)
A recent meeting at national headquarters focused on a disciplinary data bank to help with medication errors.

PhRMA (LeRoy LeNarz)
Companies met with FDA to provide information on labeling issues. The FDA is interested in how the companies go about naming products. FDA was also interested in learning what thought processes exist to predict inherent medication errors in the design of packaging. Dr. LeNarz noted that the firms were cooperating in this venture.

AARP (Andrew Smith)
Working closely with AMA on National Patient Safety Foundation. AARP is interested in drugs with narrow therapeutic indices.

FDA (Sharon Smith-Holston)
FDA is in the process of considering a public meeting on the subject described by Dr. LeNarz. Through this meeting, FDA hopes to learn how to avoid bringing products to market with inherent errors in the design or packaging. The Agency is looking for scientific validity in methods to reduce error. FDA is considering the inclusion of drugs, biologics, devices and possibly veterinary drugs on the agenda for this meeting. A Call for Papers will be issued.

ANA (Dan O'Neal)
As part of a larger effort to develop indicators, medication errors keep cropping up. In the very near future, ANA will develop a position paper on the topic of medication errors as it relates to nurses.

AHA (Tom Granatir)
AHA is developing new relationships with state hospital associations (e.g., OK, NM, PA) using the results of the IHI breakthrough series.

AHCA (Janet Myder)
Educating their members is a high priority. There is a definite heightened sensitivity to medication errors. "Provider" Magazine will carry an article on medication errors by the end of the year.

USP Advisory Panel on Medication Errors (Diane Cousins for Mike Cohen)
No significant events since the last meeting of the Council.

APhA (Bill Ellis)
The prescription writing recommendations of the Council were put before the House of Delegates and referred to the BOT. The annual meeting will have a general session on the topic of medication errors.

NABP
David Work was not able to attend day one. Kim Reid discussed the fact that the Delaware State Board of Pharmacy had adapted the categorization (severity) index presented by the Council. Both the Oklahoma State Board of Pharmacy and the North Carolina State Board of Pharmacy are looking at workload issues. If errors occur when workload is high, it indicates a systems problem and not just a people problem. NC is now allowing only 150 scripts per 8 hour shift per pharmacist.

ASHRM (Fran Kurdwanowski)
This group has been publicizing the work of the Council and reprinting issues of USP Quality Review.

Chairperson (Bill Ellis)
Massachusetts Hospital Association has a Medication Error project underway. They are using the index as a pilot study. Maine Hospital Association also adopted the index. The taxonomy will be coming next but we need to move quickly or the hospitals will move on.

The Institute for Safe Medication Practices (Sue Proulx)
Reported that it will complete a national mailing in the next 2-3 weeks on the properties of magnesium sulfate. 15,000 letters will go to Directors of Nursing, Pharmacy, and Risk Management.

Copyright Issues for Council Works
Kim Reid was called on to present the copyright statements developed for use on Council recommendations, index, general statements and charts. The copyright statements were read and discussed. It was moved, seconded, and approved to accept the copyright statements as presented.

Charles Myers noted that the literature reference on the Categorization Index needs to be checked for accuracy and completeness.

Membership
The Council entered an executive session to address the issue of membership for the American Society for Healthcare Risk Management.

The open meeting resumed at 3:40 p.m. The Chair announced that ASHRM had been voted in as a regular member for a two-year period beginning 5/97 under the risk management category of membership. ASHRM was welcomed by the membership. The Chair introduced the letter from the Federation of State Medical Boards of the United States, Inc. The Council offered to re-activate the Federation's membership on the Council. The Federation declined and stated that they were unable to provide a representative to participate on the Council at this time.

Call for Reporting Programs
Tom Granatir and Janet Myder presented a summary of the results of the Call for Reporting Programs, that was issued in July 1996. The memo, summarizing the results and listing the recommendation, of April 8, 1997 was reviewed and discussed. Tom Granatir asked Diane Cousins to explain the medication error tracking system that is being explored by USP. The aspects of anonymous reporting were discussed and the group seemed to agree that it would be easier to start with anonymous reporting and change philosophy later if not getting the important information in reports. Charles Myers suggested that the Council consider each recommendation separately at the next meeting.

Kim Reid introduced the principles of regulatory protection for medication error reporting as a "Peer Review" activity. Tom Granatir noted the erosion of peer review protection and that perhaps the Council should look at the airline industry model where immunity is offered for reporting.

The Chairman offered to issue a "white paper" on behalf of the Council to sensitize people on the issues surrounding reporting. The paper could be useful to deal with disincentives for reporting. A response guide may be useful. Anything produced at the national level will be welcomed at the local level. We could include a statement of philosophy and encourage anonymous reporting. At present this could be an outline but could be made into a book. Non-punitive programs were agreed to be a necessity. The paper should stress that a firm can take corrective action by properly identifying an error-prone aspect of a product. Joe Cranston mentioned that we needed to look at the cultural aspects of reporting and that we should look at the FAA model and create a cultural shift in health care. Susan Winckler brought forth a policy involving an anonymous large chain pharmacy that assesses points to the pharmacist for reporting medication errors...ten points and the pharmacist is dismissed. The entire group agreed that we need to move away from punishment for individuals and move toward the systems approach of non-punitive reporting.

ACTION ITEM: Research how the FAA handles reporting immunity through its Aviation Safety Reporting System and attempt to secure a local speaker to present these concepts to the Council.

Manufacturers' Accuracy Labels
Steven Shulte from the Oregon State Board of Pharmacy presented a proposal on Manufacturers' Accuracy Labels. Mr. Shulte indicated that an endorsement from the Council would mean a great deal to the health care community. He also stressed that the Oregon Board's effort is just one attempt to aid the pharmacist in counseling and dispensing. Questions were posed to Mr. Schulte, but no endorsement was considered at the time.

The meeting adjourned at 5:10 p.m.


Day 2

The meeting reconvened on Tuesday May 13, 1997 at 8:20 a.m.

Council members present:

  • Bill Ellis (APhA, Chairman)
  • Diane Cousins (USP, Secretary)
  • Tom Clark (ASCP)
  • David Work (NABP)
  • Dan O'Neal (ANA)
  • Joseph Cranston (AMA)
  • Charles Myers (ASHP)
  • LeRoy LeNarz (PhRMA)
  • Teresa Mullin (NCSBN)
  • Tom Granatir (AHA)
  • Andrew Smith (AARP)
  • Sharon Smith Holston (FDA)
  • Frances Kurdwanowski (ASHRM)

Alternates present:

  • Herbert Carlin (GPIA)
  • Janet Myder (AHCA)

Other alternates that attended along with their representatives were:

  • Kim Keller Reid (USP)
  • Joseph Deffenbaugh (ASHP)
  • Jerry Phillips (FDA)
  • Marjorie Jaski (AMA)

Those members absent:

  • Michael Cohen (USP Advisory Panel on Medication Errors)
  • Deborah Nadzam (JCAHO) via teleconference for taxonomy discussion only

The Chairman acknowledged the observers present:

  • Mary Ann Wagner (NACDS)
  • Sue Proulx (ISMP)
  • Shawn Becker (USP)
  • Ilze Mohseni (USP)
  • Susan Winckler (APhA)
  • Rita Calnan (USP)
  • Jackie Eng (USP)
  • Anne Paula Thompson (USP)
  • Steven J. Schulte (Oregon Board of Pharmacy)

Operational Definitions of Terms
Diane Cousins reviewed the operational terms for use by the NCC MERP. The definition for an Adverse Drug Reaction was discussed. LeRoy LeNarz and Herb Carlin commented on the causality issues relevant to industry and were agreeable to leave the parenthetical "(believed to be due to a drug)" in place. Charles Myers did not see the necessity to leave in this particular parenthetical.

VOTE: It was moved, seconded, and approved that the Council accept this definition of ADR with the correction of "man" to "human". (1 dissenting vote)

The definition now reads: "Adverse Drug Reaction: An effect (believed to be due to a drug) which is noxious and unintended and which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease, or for modification of physiological function."

The definition of "Adverse Event" was opened for discussion. Charles Myers suggested that we change the title to "Adverse Drug Event". He also suggested that the second sentence be changed to begin with "adverse drug event", and change "as well as" to "and may be caused by".

VOTE: It was moved, seconded, and approved that the Council accept this definition of ADE with the appropriate changes.

The definition now reads: "Adverse Drug Event: Any untoward medical occurrence, unfavorable sign [e.g., abnormal laboratory finding], symptom, or disease, in a patient administered a drug. Adverse drug events include adverse drug reactions, and may be caused by medication errors."

Taxonomy
The taxonomy was reintroduced by Jerry Phillips and Diane Cousins. The eight categories were reviewed individually with many corrections, additions, and deletions.

The meeting reconvened at 1:15 p.m. after the lunch break.

The Council determined that the taxonomy was now ready to be tested in use. Several members agreed to investigate appropriate test sources and make them available to the Chair.

ISMP volunteered as a test site.

ACTION ITEM: The Secretary will develop a time line and distribute the taxonomy to Tom Clark, Charles Myers, Jerry Phillips, Herb Carlin, Dan O'Neal, Fran Kurdwanowski, and Janet Myder. These members will arrange for institutions including FDA and USP to use the taxonomy and results will be collated and presented at the next meeting.

Product Packaging and Labeling Prevention Strategies
The Council discussed the drafted recommendations for industry, and for regulators and standards-setters. Corrections, additions, and deletions were completed.

VOTE: These recommendations were moved, seconded, and unanimously approved. The recommendations will be sent under cover letter by the Chair to FDA, USP, PhRMA, GPIA. A Press Release will be generated after the letter has been sent.

[Click here to view the final recommendations.]

Recommendations on Labeling and Packaging from the National Coordinating Council for Medication Error Reporting and Prevention to Regulators and Standards Setters

  1. The Council recommends that FDA restrict the use of any printing on the cap and ferrule of injectables except to convey warnings.
  2. The Council recommends the use of innovative labeling to aid practitioners in distinguishing between products with very similar names, for example, the use of tall letters such as VinBLAStine and VinCRIStine.
  3. The Council recommends that FDA discourage industry from printing company logos and company names that are larger than the type size of the drug name.
  4. The Council supports the recommendations of the USP-FDA Advisory Panel on Simplification of Injection Labeling. Furthermore, the Council encourages USP/FDA to consider expansion of the concepts of simplification to apply to: package inserts; labeling of other pharmaceutical dosage forms.
  5. The Council encourages further development of FDA's error prevention analysis efforts to provide consistent regulatory review of product labeling and packaging relative to the error-prone aspects of their design.
  6. The Council encourages collaboration among regulators, standards-setters, industry, health care professionals, and patients to facilitate design of packaging and labeling to help minimize errors.
  7. The Council encourages USP/FDA to examine feasibility and advisability of use of tactile cues in container design and on critical drugs. Such cues may be in the design of the container or embedded in the label.
  8. The Council encourages the printing of the drug name (brand and generic) and the strength on both sides of injectables and IV bags, containers, and overwraps. For large volume parenterals and IV piggybacks (minibags), the name of the drug should be readable in both the upright and inverted positions.

Recommendations on Labeling and Packaging from the National Coordinating Council for Medication Error Reporting and Prevention to Industry (manufacturers of pharmaceuticals and devices)

  1. The Council recommends that industry not use any printing on the cap and ferrule of injectables except to convey warnings.
  2. The Council encourages industry to employ failure mode and effects analysis in its design of devices, and the packaging and labeling of medications and related devices.
  3. The Council encourages industry to employ machine-readable coding (e.g. bar coding) in its labeling of drug products. The Council recognizes the importance of standardization of these codes for this use.
  4. The Council encourages printing the drug name (brand and generic) and the strength on both sides of injectables, and IV bags, containers, and overwraps. For large volume parenterals and IV piggybacks (minibags), the name of the drug should be readable in both the upright and inverted positions.
  5. The Council encourages industry to support the development of continuing education programs focusing on proper preparation and administration of its products.
  6. The Council encourages industry to use innovative labeling to aid practitioners in distinguishing between products with very similar names, for example, the use of tall letters such as VinBLAStine and VinCRIStine.
  7. The Council encourages industry to avoid printing company logos and company names that are larger than the type size of the drug name.
  8. The Council encourages collaboration among industry, regulators, standards-setters, health care professionals, and patients to facilitate design of packaging and labeling to help minimize errors.

The drafted recommendations for health professionals/consumers and health care facilities will be addressed by subcommittees.

ACTION ITEM: Within the next 30 days, the Professional and Consumer recommendations will be reviewed and revised by Dan O'Neal, Tom Clark, Joe Cranston, Andrew Smith, and Sharon Smith Holston

ACTION ITEM: Within the next 30 days, the Health Care Facilities recommendations will be reviewed and revised by David Work, Janet Myder, Tom Granatir, Diane Cousins, and Teresa Mullin.

The date for the next meeting was discussed. Calendars will be mailed by the Secretary for the periods mid-August through mid-November.

Meeting adjourned at 3:30 p.m.

Meeting Date