Rockville, November 3-4, 1998

Format
Rockville

 

NCC MERP Meeting Summary

November 3-4, 1998

Day One

Dr. Deborah Nadzam called the meeting to order at 1:40 p.m.

Dr. Nadzam welcomed Dr. John Kessler, newly elected chairperson to the Advisory Panel on Medication Errors, Dr. Sue Proulx of ISMP, and Ms. Jennifer Marcus, Project Manager of Quality Initiatives of AHA, representing their organizations for the first time. Dr. Nadzam also acknowledged the delegates and observers, and introduced Dr. Richard Croteau, Executive Director for Strategic Planning at JCAHO, and Dr. Arthur Atkinson of American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Atkinson explained that his organization (2000 members) is planning a workshop on medication errors at their annual March meeting.

Council delegates present:

  • Deborah Nadzam, Chairperson
  • Diane Cousins, Secretary (USP)
  • Dan O'Neal (ANA)
  • Sharon Smith Holston (FDA)
  • Janet Myder (AHCA)
  • Thomas R. Clark (ASCP)
  • Teresa Mullin (NCSBN)
  • Nancy Rapp (ASHRM)
  • Alice Till (GPIA)
  • Joseph Cranston (AMA)
  • John Kessler (USP Advisory Panel on Medication Errors)

Alternates present:

  • Joseph Deffenbaugh (ASHP)
  • Susan Proulx (ISMP)
  • Jennifer Marcus (AHA)
  • Linda Hanold (JCAHO)

Other alternates that attended along with their delegates:

  • Herbert S. Carlin (GPIA)
  • Shawn Becker (USP)
  • Jerry Phillips (FDA)

Delegates absent:

  • John R Combes (AHA)
  • David Work (NABP)
  • LeRoy LeNarz (PhRMA)
  • Charles Myers (ASHP)
  • Bill Ellis (APhA)
  • Michael Cohen (ISMP)
  • Andrew Heath Smith (AARP)

Observers present:

  • Robert Shapiro (NACDS)
  • Arthur Atkinson (ASCPT)
  • Irene Belder (ISMP)
  • Richard Croteau (JCAHO)
  • Jim Crandall (USP)
  • Fay Menacker (USP)
  • Judy McMeekin (USP)

Invited Guest: Dr. Richard Croteau, Executive Director for Strategic Planning at JCAHO

Dr. Croteau has been instrumental in instituting a formal policy-for Sentinel Events and Root Cause Analysis related to medication errors. Following a brief background, Dr. Croteau proceeded with his presentation on JCAHO's Sentinel Events and Root Cause Analyses. The presentation included:

  • the Sentinel Event process
  • definition of a Sentinel Event
  • standards relating to Sentinel Events
  • policies and procedures
  • examples constituting a reportable event
  • examples that are not reportable
  • legal issues and confidentiality
  • review and responses to a reported event

Comments and areas of discussion included:

  • how close JCAHO is to establishing indicator measurements
  • JCAHO is striving to reach accountability of measures
  • JCAHO is working with existing measures including medication errors and with HCFA
  • reporting will only occur when fear is abolished
  • is the work done to date moving the Council into areas of accreditation?
  • central location for reporting medication errors is needed
  • standard requirements for tracking medication errors is needed
  • need to have a system that answers to the integrity of the data

Activities Update

ASCP (Tom Clark)
Finalizing plans for ASCP meeting in Seattle. Mike Cohen will speak on medication errors. HCFA has released drug therapy guidelines and has proposed a broader definition of errors. A draft of the guidelines is on ASCP's website for comments.

AHCA (Janet Myder)
Expressed interest in the HCFA guidelines. Ms Myder is concerned with HCFA expanding into the nursing practice, that would impact on long term care facilities. Ms. Myder suggested that they would like HCFA to pay closer attention to the prevention of medication errors. Ms. Myder informed the group AHCA's website links to the NCC MERP site.

USP Advisory Panel (John Kessler)
At their October meeting, the panel worked on developing a high alert matrix for drugs causing most medication errors. The Panel is presently identifying the 18 criteria to include in the development of the scoring grid.

ISMP (Susan Proulx)
ISMP sent out an alert on Lipids problems to all hospitals. Targeted were health care pharmacists, directors of pharmacy and risk managers. Some companies are working on changing the labeling of this product. ISMP will attend the Annenberg and ASHP conference, and has added three new journals to their list; Nurse practitioners and Physicians Association.

GPIA (Alice Till)
Had nothing new to report at this time.

AMA (Joseph Cranston)
NPSF and AMA (among others) are co-sponsors of the Annenberg conference. The October issue of JAMA contains several articles on the use of computers in medicine to prevent medication errors. Dr. Cranston informed the Council that his Alternate, Marjorie Jaskie, has left the AMA. No replacement has been assigned as yet.

FDA (Sharon Smith Holston)
Reported that they were looking forward to the new commissioner, Jane Henney, who will be coming on board November 30. Ms. Holston feels that the FDA Modernization Act could be the most significant piece of legislation since 1938. Ms. Holston described the stakeholders meetings and how FDA posed questions to assist them in establishing what they should be doing and not doing to meet statutory requirements. She expressed the need for better ADE and ADR reporting system that could enhance the current MedWatch system. Ms. Holston announced that she was stepping down as Delegate to the Council, and Jerry Phillips (her Alternate) will take over the position. Mr. Phillips will be leading the newly created office, Office of Post-Marketing Drug Risk Assessment (OPDRA), which will include, epidemiology, IT support, risk assessment for PMS and medication errors.

ANA (Dan O'Neil)
Received approval from ANA, to prepare his experience with a non-punitive medication error system implemented at the Orlando Regional Healthcare System for publication. This non-punitive system increased reporting by 70 percent. Mr. O'Neil informed the Council that he would be vacating the delegate seat and his alternate, Mr. Richard Pessagno, will be replacing him effective immediately. Mr. O'Neil has accepted a position at NIH.

JCAHO (Linda Hanold)
The Annenberg conference scheduled for November 8-10 was over sold. 600+ people will be present. Some participants will have to view the proceedings on videotape. There will be several panel sessions on medication errors, and two plenary sessions. Bill Hendee, Ph.D. Chair of the organizing committee is drawing relationships from the first Annenberg conference to be presented at this conference. Don Berwick of IHI is the keynote speaker. Ms. Hanold reviewed the agenda for the conference. The conference is sponsored by AMA, JCAHO, AAAS, VA and the Annenberg Center for Health Sciences.

ASHRM (Nancy Rapp)
2,500 attended the ASHRM conference in October. There were several sessions on medication errors. ASHRM is soliciting ideas for speakers at the annual meeting in Chicago on home health issues and medication errors.

AHA (Jennifer Marcus)
The Quality Initiatives section of the AHA website now has links to the USP, NCC MERP, NPSF and ISMP websites. AHA is also working with its quality partner, the Hospital and Healthsystem Association of Pennsylvania (HAP), and the Institute for Healthcare Improvement (IHI) to launch a statewide breakthrough series in Pennsylvania on reducing medication errors.

NCSBN (Teresa Mullin)
Dr. Jennifer Bosma, who has been a real leader as executive director of NCSBN, will be leaving her post. The new executive director will be Ms. Elois Velasco. Ms. Mullin thanked Shawn Becker (USP), for presenting medication error issues to the VA State Board of Nurses. Ms. Mullin also informed the Council that she will be retiring this year, and therefore stepping down from her position as delegate to the NCC MERP. Her alternate will be attending future meetings. No replacement has been named as yet.

ASHP (Joe Deffenbaugh)
ASHP encourages pharmacists to take the lead in the medication use process. Charles Myers, Dr. Manasse, and John Santell are representing ASHP at the Annenberg conference. There will be four medication error sessions at the ASHP midyear meeting in Las Vegas, and an encore presentation of the Denver nurses case. Diane Cousins and Mike Cohen are presenting medication error information. Ken Barker's group is presenting an observation-based method for monitoring and reducing errors. Mike Cohen will moderate a pearl session on medication errors. Amy Daugherty is planning an educational session dealing with the aftermath of medication errors for ASHP's annual meeting in June 1999. ASHP's webmaster is still working on links to other organizations.

USP (Diane Cousins)
There were 55 requests for the recommendations on labeling and packaging. USP is scheduled to address the USP Nomenclature Committee meeting on lipid based products. Dr. Carlin distributed samples of labels from Marsam, to show the significance of triangles as additional prevention. Ms. Cousins introduced a book on the systems approach to medication errors she co-edited with JCAHO. Ms. Cousins contributed a chapter to the book, as did Deborah Nadzam. The Oral Dosage Form article will appear in the next issue of the Pharmacopeia Forum. It will also be on the NCC MERP homepage.

Presentation of NCC MERP Communications Plan

Jim Crandall, Director of USP Office of External Affairs, presented an update on the communications plan for NCC MERP. He reported on meetings conducted with organizations public relations staff, both at USP and in Chicago, to promote the work of the Council. Deborah Nadzam hosted the meeting in Chicago, and Diane Cousins hosted the Maryland meeting. Information kits were distributed at these meetings and attendees agreed to participate and contribute. Mr. Crandall is working on an overall communications plan and will work with the Council through e-mail, phone and fax to assist with the communication efforts. Discussions included:

  • does the Council want to be recognized as the leader in medication error reporting and prevention
  • would the Council want to drive a national debate to address the issue of culture(this will need human and monetary resources)
  • the point should be made that NCC MERP is not just quantifying medication errors, but also providing solutions
  • should the lay press be allowed to address the issue, to stimulate better performance (this is time consuming)
  • it takes time for the lay press to address scientific issues
  • if the press is invited in to give their spin to the work of the Council, the position of the Council will have to be very clear — leader or communication tool
  • ultimate goal is the change from punitive to systems approach
  • should the Council develop guidelines for reporting and preventing medication errors
  • guidelines are a good idea since the Council's goal is to coordinate efforts
  • should there be a kick-off on medication awareness month

Deborah Nadzam and Jim Crandall will work together on these various issues.

Dispensing recommendations were distributed for review and discussion on Day 2.

A motion to adjourn was moved, seconded and approved.

The meeting was adjourned at 4:20 p.m.

Day Two

The meeting reconvened on November 4, 1998, at 8:45 a.m.

Council delegates present:

  • Deborah Nadzam, Chairperson
  • Diane Cousins, Secretary (USP)
  • Dan O'Neal (ANA)
  • John R. Combes (AHA)
  • Janet Myder (AHCA)
  • Thomas R. Clark (ASCP)
  • Teresa Mullin (NCSBN)
  • Nancy Rapp (ASHRM)
  • Alice Till (GPIA)
  • Joseph Cranston (AMA)
  • Bill Ellis (APhA)
  • John Kessler (USP Advisory Panel on Medication Errors)

Alternates present:

  • Joseph Deffenbaugh (ASHP)
  • Susan Proulx (ISMP)
  • Jerry Phillips (FDA)
  • Linda Hanold (JCAHO)

Other alternates that attended along with their delegates:

  • Herbert S. Carlin (GPIA)
  • Shawn Becker (USP)

Delegates absent:

  • Sharon Smith Holston (FDA)
  • David Work (NABP)
  • LeRoy LeNarz (PhRMA)
  • Charles Myers (ASHP)
  • Andrew Heath Smith (AARP)
  • Michael Cohen (ISMP)

Observers present:

  • Robert Shapiro (NACDS)
  • Arthur Atkinson (ASCPT)
  • Irene Belder (ISMP)
  • Sharon Bohrer (USP)
  • Jim Crandall (USP)
  • Fay Menacker (USP)
  • Judy McMeekin (USP)

New Business

Deborah Nadzam acknowledged all in attendance, and introduced Dr. John R. Combes, Senior Medical Advisor of The Hospital and Healthsystem Association of Pennsylvania. Dr. Combes is attending the meeting for the first time representing AHA. Dr. Combes is replacing Tom Granatir as the AHA delegate.

Dr. Combes provided a brief synopsis of his background to the Council. He has worked with AHA and The Hospital and Healthsystem Association of Pennsylvania, where he serves as senior medical advisor. Part of his role is to represent AHA's quality center, which is developing initiatives for state and local associations in Pennsylvania. The AHA is also developing a learning lab for national organizations to improve patient safety and reduce medical errors. Several initiatives are going on in Pennsylvania, one involving ISMP, where a coalition is being formed in the state to raise awareness on medication errors, and also one with Don Berwick of IHI, for developing a state specific program on breakthrough series for medication errors.

Update on NCC MERP Website

Meredith Tcherniavsky, Web Programmer for the USP Management Information Systems (MIS), provided a website usage report summary and information on what the Council will see when visiting the site. Ms. Tcherniavsky said that the visitors to the site are mostly interested in the Council's recommendations and medication errors information. Discussion points:

  • 900 users so far have visited the site
  • viewers are lingering on the site to read the contents, which is good
  • member sites need to link.
  • Solid Oral Dosage Form article is now available on the site for review
  • questions about whether the site stimulated any medication errors reports
  • feasibility of providing an area for viewers to comment

Update on Taxonomy

Joe Deffenbaugh presented a preamble for the taxonomy that will inform readers what this document entails.

Tom Clark, who worked with Jerry Phillips and Diane Cousins, presented the instructions and information document to be incorporated into the taxonomy. The taxonomy was reviewed item by item, and changes were made to cover a range of categories.

A motion was made and approved to keep the changes and to make the taxonomy available as a twelve-month pilot (a work in progress for general use). The following comments were made on how to communicate the existence of this document:

  • communicate on website with feedback control (i.e. register).
  • have Jim Crandall send with the form to facility organizations, pharmaceutical organizations etc. for comments
  • communication is necessary for a document like this. It is a work in progress, and it may never be final because data changes
  • need system to manage the comments
  • document should be monitored for comments and reviewed in one year for inconsistencies
  • document should go out for general use as soon as possible
  • document will assist practitioners in realizing the subtleties of medication errors
  • do not request open comments (make it subtle)
  • create news release to publish on members' websites with links to USP for comments
  • member organizations may not approve this release on their website

ACTION ITEM: The Taxonomy will be placed on the NCC MERP website for members to review

Jim Crandall will send out a press release, and will develop a mechanism for dissemination by organizations to let potential users know of its availability on the web

A discussion surrounding communication of the availability of this document ensued. A time period was suggested (3-6 months), for using the document and commenting on it. Joe Deffenbaugh stated that ASHP can put notices in their newsletter letting people know where to locate the document on the website, or notices on how to acquire copies. Dr. Combes had no problems with AHA promoting the existence of the taxonomy through their newsletter, but cannot commit to making copies for distribution. The main concern of some members was whether the taxonomy would be used and how it would be used.

It was suggested that a group be identified to work on a survey for comments and other concerns. Jerry Phillips, Joe Deffenbaugh and John Combes volunteered.

ACTION ITEM: Jerry Phillips, Joe Deffenbaugh and John Combes will work with Diane Cousins on developing a six-month tool for viewers comments. Provide e-mail with comments.

Recommendations for avoiding error-prone aspects of dispensing and administration in the medication use process.

Update on Administration Recommendations

Corrections to recommendations were incorporated as agreed upon at the last meeting. In reference to previous conversations for combining these recommendations, Ms. Mullin feels that joining dispensing and administration comes across as a mixed message because nurses are never allowed to dispense. Dr. Nadzam agreed with that observation. Dr. Cranston questioned if recommendation number two applied specifically to oral medications or does it include injectables; there was agreement to modify the wording. Mr. Ellis felt that the wording "if adverse reaction occurs" is too loose. He suggested changing the wording to "establish and maintain an action plan when adverse reactions occur." Dr. Combes feels patients should always identify themselves to physicians, and perhaps that should be part of the recommendations. A discussion ensued, and corrections and additions were made. The Chairperson stated that consensus could not be reached at the present time on these recommendations These recommendations will be revisited at the March meeting.

Update on Dispensing Recommendations

Tom Clark reported that changes agreed upon at the last meeting were incorporated into the recommendations for dispensing. Dr. Cranston felt that information regarding labels is missing from the recommendations. This information is important for physicians and patients dealing with generic substitution. Also, not sure if beyond use date should be mentioned. Mr. Clark pointed out that the issue of labels had been addressed by the Council. However, he said some mention is made regarding labels in these recommendations. The group reviewed the recommendations, and asked the following questions:

  • should lot number be included as part of a record
  • does this document include preparation / dispensing — if so, it needs clarification
  • what does "external errors" mean (this was deleted after discussion)
  • should these recommendations be available for comments
  • global language for other dispensers should be added

Update on National Agenda Items

Diane Cousins presented a draft for discussion regarding the National Agenda items recommended by the USP Advisory Panel based on reports received by USP PRN. Ms. Cousins gave a brief description on each item as suggested at the last meeting. The object is to describe the nature of the problem and provide recommendations. Bill Ellis voiced concerns with how error/products implicated at high levels of injury will be received, i.e. by manufacturers. The Council needs some degree of justification/methodology for the basis of the recommendations. Dr. Combes would like to get this document out on a regular basis as soon as it is completed. Additional comments:

  • need general criteria — how much information is abstracted from the taxonomy
  • streamline description; too much analysis
  • need to move on this, and keep it short
  • make assessment of root cause analysis before recommendations
  • is there any value in the Council looking at actual reports, or should this be left up to the Advisory Panel
  • the Advisory Panel communicates with other groups at USP and is qualified to review reports and submit recommendations to NCC MERP
  • should the recommendations be posted individually on website with footnote (from Advisory Panel...)
  • need input from industry

ACTION ITEM: Jim Crandall will provide more information on promoting the National Agenda Items. Recommendations will be posted on website and messages sent to members for comments.

Update on Research Agenda

The Chairperson gave an update on previous discussions by the Council on the need to develop a research agenda. Bill Ellis, Diane Cousins, and Deborah Nadzam, brainstormed on this issue to determine the scope and responsibilities required for an agenda. Discussion points included:

  • NPSF is not conducting a research agenda, but is looking for possible funding to publish research
  • at the first Annenberg conference, the need for a research agenda was mentioned, but not acted upon; not sure if it will be addressed at the upcoming conference
  • important groups like the Research Foundation and NPSF are not represented at this table
  • Medline literature search revealed that there is some research going on
  • IPA database may be better source for medication errors because they capture pharmacy and nursing journals. There is also a nursing database that could be of use (Cumulative Index for Nursing...)
  • an article published by ASHP (3/90 Fundamentals of Medication Errors Research) could be helpful, and may provide some perspective on what direction the Council should take
  • should there be a push to engage organizations such as NIH, who has the means to provide funding for this agenda, to make them aware of its needs
  • are the Council recommendations reviewed/addressed - do they really make a difference
  • American Dental Association developed demo for research agenda which is available, but they do not provide funding
  • should the Council make a strong statement that a research agenda is necessary

ACTION ITEM: Joe Deffenbaugh will do IPA search. USP will extend its literature search.

Dr. Atkinson informed the group that 35 papers that meet some criteria for research (environmental, cultural, and behavioral) found systems issues, and these issues could be placed on the website. Dr. Atkinson also added that compliance issues have been researched.

ACTION ITEMS: Work group: Linda Hanold, Joe Deffenbaugh, Deborah Nadzam, and John Kessler will work on research agenda items.

Discussion of Council Membership

A discussion regarding additional participating organizations was revisited. The Council rules and procedures were reviewed. The group reiterated its decision at the previous meeting, that organizations be invited to attend as observers prior to admittance to the Council. A suggestion was made, to avoid conveying the impression that organizations are compelled to join. It was decided to follow-up with organizations that have attended prior meetings to assess their interest, and with organizations mentioned at the last meeting. The following additional groups were considered:

  • American Association of Medical Colleges
  • American Association of Journalists
  • American College of Pharmacy
  • Medical Pharmacology and Therapeutics
  • National Associations of Chain Drug Stores (have been observing for some time)
  • MEDONA (long term care)
  • Home care/Mental health
  • Institute for Health Improvement (would be good source for consulting on research agenda)
  • ASCPT (important to include pharmacology therapeutics)
  • HCFA
  • Veterans Administration (VA)
  • Public health groups

The Council needs to prioritize the list of associations/organizations to invite. Public health organizations and consumer groups are still a priority. Bill Ellis questioned the intent of the Council to add organizations (politically correct or do they understand the scope of the problem) The Chairperson asked if the Council should attempt to provide information on the NCC MERP, or wait for feedback once organizations visit the website. The measure of effectiveness will be determined by how the word gets out. This subject will be revisited at the next meeting.

ACTION ITEM: Follow-up with consumer groups to explore their interest. Invite HCFA and VA to observe the NCC MERP proceedings.

Review of Goals and Objectives

The Council examined its goals and objectives to assess current activities, and to discuss the need for change. Bill Ellis felt the goals were not broad and the need to maximize exposure existed. Joe Cranston stated that disseminating information within member organizations is not always easy. The Council is supportive of the work Jim Crandall is doing with publicizing the efforts of the Council. Some changes in wording of the NCC MERP brochure were suggested. The following comments were made:

  • should there be a medication error prevention week to enhance awareness (this is tactic for Jim Crandall)
  • prevention week could follow NCPIE and national healthcare week, or hospital quality week
  • has there been an increase in reporting in the last year due to efforts of the Council
  • the culture in healthcare has changed in the last three years even though the difference is not seen in the reporting
  • the goal is to stop medication errors which will decrease reporting
  • how much awareness of the Council's existence is out there
  • Annenberg conference may be good place to promote NCC MERP
  • advocacy groups need to understand the work of the Council
  • should the Council lobby Capitol Hill and have a representative from congress observe meetings
  • consider a targeted mailing list

Summary

The Chairperson announced that the next meeting will take place in March 1999, with actual dates yet to be decided. Dr. Nadzam concluded and summarized action items for the next meeting as follows:

  • General Communication plan to organizations by Jim Crandall
  • Follow-up on communication plan for addressing the taxonomy
  • Work on six month survey tool for taxonomy (Joe Deffenbaugh Diane Cousins Jerry Phillips and John Combes)
  • Revisit administration and dispensing recommendations
  • Follow-up on national agenda items (add to website for comments)
  • Follow-up on research agenda ( Joe Deffenbaugh, Linda Hanold, Deborah Nadzam and John Kessler)
  • Follow-up on additional organizations as members — five organizations will be contacted
  • Goals and Objectives — what has been done, what has to be updated

The Chairperson wished all a happy new year, and a motion to adjourn was moved, seconded and approved. The meeting was adjourned.

Meeting Date