Rockville, October 27-28, 1997

Format

NCC MERP Meeting Summary

October 27-28, 1997

Day One

The meeting was called to order at 1:55 p.m. Because of the delayed arrival of the Chairman, Diane Cousins, Secretary, announced the attendance of two new alternates, Mary Mologne from AHA and Mary Crellin from AHCA.

Council delegates present:

Bill Ellis (APhA, Chairman)
Diane Cousins (USP, Secretary)
Dan O'Neal (ANA)
Joseph Cranston (AMA)
Sharon Smith Holston (FDA)
Charles Myers (ASHP)
Teresa Mullin (NCSBN)
LeRoy LeNarz (PhRMA)
David Work (NABP)
Michael Cohen (USP Advisory Panel on Medication Errors)

Alternates present:

Mary C. Crellin (AHCA)
Herb Carlin (GPIA)
Mary Mologne (AHA)
Linda Hanold (JCAHO)

Other alternates that attended along with their delegates were:

Jerry Phillips (FDA)
Joseph Deffenbaugh (ASHP)

Delegates absent:

Deborah Nadzam (JCAHO)
Alice Till (GPIA)
Thomas R. Clark (ASCP)
Tom Granatir (AHA)
Andrew Smith (AARP)
Nancy Rapp (ASHRM)

The Chairman acknowledged the observers present:

Marilyn Radke (USP)
Ilze Mohseni (USP)
Shawn Becker (USP)
Bruce Gordon (Premier Hospital Alliance)

Old Business

The meeting summary for May 12-13, 1997, faxed to the members previously, was opened for discussion. Teresa Mullin (NCSBN) suggested that the date be included after "Day One" and "Day Two" on all future summaries. A motion was made to accept the summary as written, with the noted suggestion. The motion was carried and the meeting summary was adopted.

Activities Update

AMA (Joseph Cranston)
JAMA is publishing vignettes on medication errors prepared by USP staff. The AMA is very involved with the National Patient Safety Foundation (NPSF). The NPSF has a 50-member board that was established in June 1997. A vision and mission statement have been drafted and a website has been established. This group will support education and research and three RFP's have been issued for approximately $100,000. Questions were raised by the NCC MERP members regarding the interaction of NPSF and the Council. It was suggested that the Council could do targeted research in the medication error arena for the Foundation. Would it be possible for the Council to direct research by NPSF in this area. The Chairman of the Council offered to send a letter pursuing this endeavor.

ACTION ITEM: Chairman will compose a letter to the National Patient Safety Foundation regarding interaction between NPSF and the NCC MERP in areas of research, specifically directed toward medication error understanding, reporting, and prevention.

Another group has been formed called the National Patient Safety Partnership (NPSP).

ASHP (Charles Myers)
ASHP is involved with these same multidisciplinary groups described by Dr. Cranston and thinks it may be good to have a guest from these groups at the NCC MERP meetings and information about the Council should be provided to them. Ongoing communication should exist between NCC MERP and the NPSF and NPSP. ASHP through their strategic planning efforts has raised the priority of medication errors. They will continue with their NCC MERP efforts as well as collaborations with JCAHO, AMA, and IHI.

NABP (David Work)
Actions are being taken by the North Carolina Board of Pharmacy to limit the daily number of prescriptions that can be filled by a single pharmacist to 150. Pharmacists can have their license suspended and pharmacy owners can be forced to close the pharmacy for a certain period of time if they do not adhere to the new laws. NABP recognized the NCC MERP and its work in a recent resolution on prescription writing.

FDA (Sharon Smith Holston)
A planned January public meeting will address how the FDA can work with others to reduce medication errors (especially at the premarket phase of the product approval) so that products with latent defects are not approved. Many NCC MERP members are speakers at this meeting. The NCC MERP Chairperson will be a panel participant at the meeting. FDA is working with the Office of Women's Health, which will launch an initiative for taking medications properly. The project will launch in 12 cities and information and materials will be developed to support the effort.

USP (Diane Cousins)
Through the joint efforts of the California Pharmacists Association, the California Board of Pharmacy and USP, a medication error reporting effort will focus on workload issues. USP is exhibiting at the ASHRM meeting and emphasizing medication error prevention and education. The medication error reporting form is now available on the Internet. USP submitted chapters to ISMP and JCAHO for books to be published in 1998 on medication errors.

NCSBN (Teresa Mullin)
Published an article about the NCC MERP in their newsletter along with a USP medication errors reporting form.

PhRMA (LeRoy LeNarz)
Working with the FDA on the Women's Health Initiative.

ANA (Dan O'Neal)
Developed an interdisciplinary task force on pharmacotherapeutics and the role of the nurse. This task force may become the vehicle for NCC MERP advocacy.

AHA (Mary Mologne)
Forming partnerships with five state hospital associations—PA, OR, FL, IN, and WV—focusing on quality initiatives; pursuing two more states.

APhA (Bill Ellis)
NCC MERP recommendations for error prevention initiatives on prescription writing and labeling and packaging have been referred to the APhA Board of Directors for adoption. Medication errors articles from Pharmacy Today have been archived on the APhA website, which links to the USP website. Should make the MedWatch form available on the website also. In March, will launch a book by Michael Cohen on medication errors.

USP Advisory Panel on Medication Errors (Mike Cohen)
Recommendations on neuromuscular blockers were forwarded to the USP anesthesia and pharmacy practice advisory panels for review. The medication errors advisory panel discussed packaging and labeling issues for this drug class and considered the use of color and label and container warnings as part of their discussions. The Panel is now developing a criteria matrix for identifying "high alert drugs". The term "high alert drugs" was favored by the Panel over the use of "dangerous drugs." The criteria should be able to be applied to both marketed and premarket drugs.

The Institute for Safe Medication Practices (Mike Cohen)
ISMP is currently providing free "consultation services" for practitioners involved in medication error litigation. ISMP is also helping facilities to perform root cause analyses. A slide program directed at consumers will be available for use by health care professionals to teach people how to avoid errors with their medications and the role they play in error prevention. ISMP continues to publish safety alerts based on reports from the USP Medication Error Reporting Program and FDA MedWatch. The safety alerts are distributed to 3,300 hospitals nationwide. ISMP hopes to identify ways to communicate with community pharmacies about medication error prevention.

New Business

The possibility of USP creating a listserv for the NCC MERP membership was proposed. The members agreed that this type of service would benefit member communications. USP agreed to provide this service for the Council and act as the list owner for maintenance and updating.

ACTION ITEM: USP will develop, and maintain a listserv for the NCC MERP membership.

Manufacturer's Accuracy Labels
Proposal by the Oregon Board of Pharmacy, Resolution proposed at NABP Region VII and VIII meeting, and Resolution #506 proposed at AMA Annual meeting Considerable discussion ensued regarding the presentation by Steven Schulte, Oregon Board of Pharmacy, to the NCC MERP at its last meeting and his subsequent proposal to the NABP. According to David Work the resolution did not pass at the national level. Apparently the Oregon Medical Association introduced the proposal as a resolution at AMA Annual meeting. Dr. Stuart Nightingale (FDA), Jerome Halperin (USP), and Dr. LeRoy LeNarz (PhRMA) spoke in opposition to this resolution on floor of the AMA House of Delegates. This proposal was referred to the AMA Council of Scientific Affairs. AMA will be seeking the opinion of the Council on this proposal. The Council opened the floor for discussion of this proposal. The following issues were raised:

colors to help identify the product but colors can be off from the real thing; both sides of the tablet/capsule should be pictured
costs of this process for pharmaceutical industry and pharmacies need to be assessed (but this point should be omitted from the NCC letter to AMA)
the proposed process includes an added step in the dispensing process that could cause other types of error
people preparing the product are not always the ones putting the labels on the product
repackagers are involved in process; these labels would have to be passed along with repackaged product possibly causing errors in distribution area
there is no data provided with the Schulte proposal to support the effectiveness of this system of labeling (should be evidence based)
efforts of NCC MERP should be focused on already successful systems, i.e., bar coding
generic drugs are a problem because the product can change from month to month and a new picture of another product may create additional confusion on the part of the patient
Schulte report was based on small number of error reports and did not measure the true extent of the problem
this system will not eliminate "wrong drug" errors
the proposed system would require an enormous number of stickers in some cases (e.g., bottles of 1000 Tylenol with Codeine are often dispensed ten at a time)
would the proposed labeling require FDA approval because it would be considered manufacturer's product labeling

It was agreed by the Council members that the proposal, in its present form, cannot be endorsed by the NCC MERP.

ACTION ITEM: Chair will draft a letter of response to AMA regarding the Council position on this proposal.

HCFA
Diane Cousins addressed a recent conversation she had with Sam Kidder of the Health Care Financing Association (HCFA) about a soon to be published proposed rule for a 2% error rate for hospitals administering Medicare and Medicaid Programs. Mary Crellin gave some additional information on this proposed rule. Mike Cohen noted that this initiative was not new and that it was not successful in the past. It does not provide focus and it boils down to the investigator and the interpretation. Some believed that this process would inhibit reporting in a facility. Several members indicated that Sam Kidder should be invited to address the Council.

ACTION ITEM: Sam Kidder will be invited to address the Council at the next meeting.

The day's meeting adjourned at 4:30 p.m.

Day 2

The meeting reconvened on Tuesday, October 28, 1997 at 8:40 a.m.

Council delegates 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)
Sharon Smith Holston (FDA)

Alternates present:

Herbert Carlin (GPIA)
Mary Crellin (AHCA)
Linda Hanold (JCAHO)
Mary Mologne (AHA)

Other alternates that attended along with their representatives were:

Joseph Deffenbaugh (ASHP)
Jerry Phillips (FDA)

Those delegates absent:

Michael Cohen (USP Advisory Panel on Medication Errors)
Deborah Nadzam (JCAHO)
Tom Granatir (AHA)
Andrew Smith (AARP)
Teresa Mullin (NCSBN)
Nancy Rapp (ASHRM)

The Chairman acknowledged the observers present:

Sue Proulx (ISMP)
Bruce Gordon (Premier Hospital Alliance)
Shawn Becker (USP)
Ilze Mohseni (USP)
Rita Calnan (USP)
Anne Paula Thompson (USP)

NCC MERP Website
The website for the NCC MERP is moving forward. Glaxo Wellcome has agreed to waive the fees and Helix has agreed to provide the service. The website will include the Council's recommendations, mission, goals, etc., and will reference articles referring to the Council. The site will also be hot linked to the USP Medication Errors Reporting Program. It was suggested that the website link with all NCC MERP member associations. This will not work for all but should be considered. A letter will be drafted to seek permission from all members to link URLs to NCC MERP website.

ACTION ITEM: Draft letter to all NCC MERP members requesting permission to link with NCC MERP Website. Also include the NPSF and other appropriate groups for possible links.

Labeling and Packaging Recommendations
The Council discussed the drafted recommendations for health care organizations and health care professionals. The Council members wanted to ensure consistency between these documents and the recommendations document for industry and regulators. The redrafted recommendations, including all corrections, additions, and deletions follow:

Recommendations of the National Coordinating Council for Medication Error Reporting and Prevention to Health Care Organizations to Reduce Errors Due to Labeling and Packaging of Drug Products and Related Devices

The Council recommends that health care organizations employ machine readable coding (e.g., bar coding) in the management of the medication use process.
The Council recommends the establishment of systems approach to medication error reporting, understanding, and prevention in health care organizations. Systems should evolve to include the following key elements:
1. an environment that is conducive to medication error reporting by focusing on improvement of the medication use process rather than on the actions of individuals.
2. mechanisms for internal reporting of actual and potential errors including strategies that encourage reporting.
3. systematic approaches within the health care organization to identify and evaluate causes of errors including failure mode and effects analysis (FMEA) and root cause analysis.
4. processes for taking appropriate action to prevent future errors through improving both system and individual performance.
5. external reporting of occurrences of actual and potential errors (through the USP and/or FDA) so that others may learn.
The Council recommends that health care organizations develop and implement, or provide access to education and training programs for health care professionals, technical support personnel, patients, and caregivers that address methods for reducing and preventing medication errors.
The Council recommends that health care organizations reevaluate existing storage systems for pharmaceuticals and the establishment of mechanisms to assure appropriate storage throughout the organization from bulk delivery to point of use.
The Council recommends guidelines for storage that will distinguish similar products from one another. The following issues should be considered when applicable: guidelines for storage that will help distinguish similar products from one another; guidelines for storage of certain drugs, (e.g., concentrates, paralyzing agents, alkylating agents) that have a high potential for risk; and control of floor stock.
The Council encourages collaboration among health care organizations, health care professionals, patients, industry, standard-setters, and regulators to facilitate design of packaging and labeling to help minimize errors

Recommendations of the National Coordinating Council for Medication Error Reporting and Prevention to Health Care Professionals to Reduce Errors Due to Labeling and Packaging of Drug Products and Related Devices

The Council encourages health care professionals to use only properly labeled and stored drug products and to read labels carefully (at least three times). When appropriate, cross check as part of the process.
The Council encourages health care professionals to report to national (FDA MedWatch and USP Practitioners' Reporting Network) and local reporting programs.
The Council encourages health care professionals to submit error-related alerts, case studies, etc., to their professional organizations for dissemination through newsletters, journals, bulletin boards, and the Internet.
The Council encourages collaboration among health care professionals, health care organizations, patients, industry, standard-setters, and regulators to facilitate design of packaging and labeling to help minimize errors.
The Council encourages health care professionals to support, and advocate for improved labeling and packaging (e.g., FDA and USP label simplification efforts). Health care professionals are encouraged to provide review and comment regarding proposed changes.
The Council encourages health care professionals to routinely educate patients and caregivers to enhance understanding and proper use of their medications and related devices.
For compounded products and admixtures, 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.
The Council encourages health care professionals to regularly participate in error prevention training programs.

ACTION ITEM: These recommendations will be reviewed and approved by the Council.

The recommendations for industry and the standard-setters and regulators were again brought before the Council. The recommendation dealing with encouragement of collaborative efforts excluded health care organizations on the original documents. The Council feels that all the recommendations should reflect the same wording in this respect. It was moved, seconded, and carried that health care organizations would be added to both the industry and the standard-setters and regulators recommendations to be consistent with the other recommendations.

VOTE: Moved, seconded, and approved that the Industry and Standard-setters and Regulators Recommendations will be amended to include health care organizations in the recommendations dealing with collaborative efforts.

Medication Error Taxonomy
Discussions regarding the pilot study on the taxonomy were opened to the floor. Diane Cousins described a cover sheet that she developed in an effort to provide direction to her pilot group in use of the taxonomy. Joe Deffenbaugh noted that questions did arise regarding how best to use the data to establish where improvements could be made. His group wanted to be pointed in the right direction for identifying and implementing system improvements. Only one out of eight his facilities had a complete medication error reporting and tracking process in place; a large number did keep track of medication errors but by different means. Some of the facilities admitted that they would not use this information and most would not support reporting to a national system.

ASHRM is concerned about discoverability. Dan O'Neal will have six facilities reviewing the taxonomy. They have not done so as yet. Some facilities noted that they would need 1/2 FTE to do all the reporting out. The facilities need more experience using the taxonomy. Joe Cranston suggested a coding dictionary that is inclusive with the taxonomy. Need to look at a better description of the terms of the taxonomy. Need to allay fears that this taxonomy is a national mandatory reporting tool.

ACTION ITEM: Diane Cousins and Jerry Phillips will work together to develop a cover letter to describe what is meant by the taxonomy. Tom Clark will draft instructions. Joe Deffenbaugh will draft use of the data, and Jerry Phillips will draft the purpose of the taxonomy.

Chair's White Paper on Medication Errors
The Council members wanted an explanation of the exact purpose of this white paper and the intended audience. It was not evident from the content exactly what was intended and who would be best served by the piece. Bill Ellis explained that his purpose was to increase understanding of the issues related to medication errors. He feels that a position paper from the Council needs to be published.

Charles Myers questioned the goals. He feels that members should be encouraged to comment from their perspectives and their associations. LeRoy LaNarz agreed with this concept.

The Council felt that each issue raised had merit on it own to warrant a white paper. Mary Mologne wanted to know if the NCC MERP website could be arranged like the outline prepared for the white paper. It would be nice to have a statement or fact sheet. Does the Council think this is a valuable tool? Council feels that a position paper taking a multidisciplinary approach is what is needed. The punitive aspects of committing and reporting medication errors also needs to be addressed.

ACTION ITEM: Bill Ellis will re-address the white paper and focus a paper on reporting and possibly include the punitive issues expressed by the Council members.

Discussion of Reporting Recommendations
The memo from Tom Granatir and Janet Myder regarding recommendations for coordination of institutional and national reporting was introduced for discussion. The Council members discussed the three recommendations and the following areas needed to be implemented in combination with the recommendations:

Taxonomy project is feeding into the recommendation to develop a standard format for institutional submission of medication error information. Immunity appears to be the biggest aspect for consideration in reporting. Is that immunity from civil or criminal liability? FAA spokesperson could possibly answer the question of immunity versus confidentiality.
In developing an aggressive strategy for adoption of universal definitions the Council needs to more widely promote the definition of a medication error. The Council has done work on universal definitions.
The Council may need to approach more organizations who are responsible for risk management, quality improvement and nursing management such as NCQA (already asked to participate without success. May need to approach again.), Institute for Healthcare Improvement.

ACTION ITEM: Invite a representative from IHI after they complete their study on adverse medical events.

The FAA's Aviation Safety Reporting System was provided for the Council members. Members still feel the need for a representative from FAA to address the Council and explain how their system works for reporting malfunctions and errors, etc.

ACTION ITEM: Invite a representative from Federal Aviation Administration to present ASRS to the Council.

Scheduling of Next Meeting and Open Discussions
The need for three speakers at the next meeting was reiterated (HCFA, FAA, and IHI). A Council member suggested that the group look over the goals and objectives for possible areas of focus. It was also suggested that the Council may want to re-address the automation aspects of medication errors. The date for the next meeting was discussed. Calendars will be mailed by the Secretary for the months of February, March, and April.

Meeting adjourned at 2:45 p.m.

Meeting Date

10/27/1997 - 12:00