Rockville, March 30-31, 1998

 

NCC MERP Meeting Summary

March 30-31, 1998

Day One

The meeting was called to order at 1:50 p.m. The Chairperson announced the attendance of a new alternate, Richard Pessagno (ANA).

Council delegates present:

• Bill Ellis (APhA, Chairman)
• Diane Cousins (USP, Council Secretary)
• Dan O'Neal (ANA)
• Joseph Cranston (AMA)
• Charles Myers (ASHP)
• Deborah Nadzam (JCAHO)
• Teresa Mullin (NCSBN)
• Thomas R. Clark (ASCP)
• David Work (NABP)
• Nancy Rapp (ASHRM)
• Tom Granatir (AHA)
• Michael Cohen (USP Advisory Panel on Medication Errors)
• Janet Myder (AHCA)

Alternates present:

• Herb Carlin (GPIA)
• Jerry Phillips (FDA)

Other alternates that attended along with their delegates were:

• Joseph Deffenbaugh (ASHP)
• Richard Pessagno (ANA)
• Gail Bormel (USP)

Delegates absent:

• Alice Till (GPIA)
• Sharon Smith Holston (FDA)
• LeRoy LeNarz (PhRMA)
• Andrew Smith (AARP)

The Chairperson acknowledged the observers present:

• Shawn Becker (USP)
• Marilyn Radke (USP)
• Kim Keller Reid (USP)
• Fay Menacker (USP)
• Nancy B. Mabie (USP)
• Judy Smetzer (ISMP)
• Samuel Kidder (HCFA)
• Robert Shapiro (NACDS)

Old Business

The meeting summary for October 27-28, 1997, was reviewed. A motion was made to accept the summary as written. The motion was carried and the meeting summary was accepted.

Activities Update

ANA (Dan O'Neal)

Mentioned the ANA interdisciplinary task force on pharmacotherapeutics and the role of the nurse.

NCSBN (Teresa Mullin)

A USP Medication Errors Reporting form was sent to all state boards. A letter was sent to all state boards and the NCSBN from USP to encourage reporting and prevention of medication errors. USP also encouraged the Boards to request medication error educational materials for distribution to the state's membership.

FDA (Sharon Smith Holston)

The January public meeting was very successful. Many NCC MERP members presented various aspects of medication error prevention at this meeting. Executive summaries are being prepared. Recommendations of the USP/FDA Advisory Panel on label simplification have made significant progress through FDAMA in removing cautions and other extraneous material from the labels of injectable products.

AMA (Joseph Cranston)

Resolution #506, report on scientific affairs, has gone on to the House. Thanks were extended to the NCC MERP for their letter of response and statement of position on the Oregon proposal for prescription labeling.

ASHP (Charles Myers)

ASHP took part in the FDA Public hearing on adverse drug events. ASHP Research and Education Foundation has played an active role in medication errors. ASHP has been vocal regarding the HCFA proposed recommendations. Several articles on this topic were distributed to the Council members as food for thought. ASHP has written practice standards, including one dealing with automatic dispensing units that are in the first stages of approval. They also published relationships between various terms such as ADE's, ADR's and medication errors. A call for comment has been issued, and there is no set time frame for response.

AHA (Tom Granatir)

Focusing on education and working with NPSF and JCAHO on a second Rancho Mirage conference. Hospital administrators are expressing concern about reporting sentinel eventsto JCAHO due to discoverability.

APhA (Bill Ellis)

Announcing a new awards program (Pinnacle Award) in conjunction with Healthcare Quality Alliance. Award is for outstanding accomplishments in improving the medication use process. There are 3 categories, individual, health care organization, and voluntary health agency. The award will be presented on June 23, 1998, in Washington, D.C. Check the APhA website for further details. APhA Council will review over-the-counter regulations. No results are out as yet. Herb Carlin was honored with the Remington Medal at the APhA annual meeting.

AHCA (Janet Myder)

Nothing new to report, but AHCA is also concerned with discoverability in reporting sentinel events to JCAHO.

ASCP (Tom Clark)

ASCP Research and Education Foundation is developing a White Paper on Automation in pharmacy. Copies will be presented at the next meeting.

JCAHO (Debbie Nadzam)

JCAHO is very busy with the sentinel event reporting, suggesting that health care organizaitons complete a thorough root cause analysis. Reporting to the JCAHO is not required but health care organizations are held accountable for root cause analysis. JCAHO is aware of the fear associated with discoverability and has established a task force headed by John Leech. They are committed and will work with the laws in one state at a time if that's what it takes to get protection for health care organizations. The newsletter "Sentinel Event Alert" presented sentinel event case reports on KCl problems filed with JCAHO. An explanation of the requirements for sentinel event reporting was presented.

USP Advisory Panel on Medication Errors (Mike Cohen)

The Panel is waiting for action on the neuromuscular blocking agents from USP. Two Advisory Panel subcommittees were formed, one dealing with category A and B reports and one dealing with high alert drugs. The Category A and B subcommittee looked at nomenclature and made a recommendation to USP regarding software vendors about offering alerts on screen. Another issue raised was the free flow pumps and removing the tubing from the pump that allows free flow of product. Not sure at present what recommendations will be made. Recommendations for independent checking of automatic dispensing units will also be made. The high alert subcommittee is still considering and testing the matrix for determining how serious drugs match the criteria.

GPIA (Herb Carlin)

Mentioned that the manufacturers only had 180 days to conform to the new "Rx only" instead of the legend requirement for prescription drug labeling. According to Jerry Philips the FDA is in the process of changing that requirement to a longer period of time. Dr. Carlin wants to be added to the listserv for the NCC MERP.

New Business

The NCC MERP website that was scheduled for completion by Helix had gone through the first draft stages, but the site has disappeared and so has the contact person. USP has offered to bear the costs associated with construction of an independent NCC MERP website. The organizations were asked if they wish to link to and from the NCC MERP website.

ACTION ITEM: USP will work with the Chairperson to develop the NCC MERP Website and will verify if organizations wish to link to and from the NCC MERP website. The group discussed other possible linkages to the NCC MERP website such as National Patient Safety Foundation, ISMP, etc.

Second Annenberg Conference on Preventing Errors in Healthcare

A call for papers has gone out for the Annenberg Conference with a July 1, deadline. The conference is scheduled for November 8-10, 1998. All NCC MERP organizations are encouraged to participate.

Legislative Remedies that Support Confidentiality in Reporting Medication Errors

Significant discussion ensued regarding advocacy for legislative remedies that support confidentiality in reporting medication errors. The idea of general protections for reporting should be considered. A good peer review law has been passed in Illinois, but politically it looks as though the hospital is trying to conceal something. JCAHO is prepared to work with other groups for state peer review efforts. Florida is in the middle of strengthening their peer review process. They did a survey of state laws.

One delegate raised the issue of whether sentinel event reporting requirements by JCAHO should be put on hold until peer review protection laws are passed? There's a need to move from punitive actions to address medication errors and develop ways to build medication error event information databases that openly share information. A good approach may be to look at errors we already know and institute improvements in the processes surrounding these issues. All processes should be analyzed and not just those surrounding sentinel events. To only look narrowly at one piece could backfire. It was emphasized that JCAHO should look at the sentinel events being reported as only a segment of the overall picture. There are many error reduction/prevention/education initiatives — the NCC MERP needs to be aware of what has been done already not recreate the wheel. Council may not be getting to the appropriate people within the organizations to communicate its message. Perhaps more emphasis should be placed on the North Carolina Board of Pharmacy philosophy that reporting is a mitigating circumstance while failure to report is an aggravating circumstance. All organizations have an interest in protection for reporting and no one group owns the issue. A more effective NCC MERP vehicle for getting information out to the healthcare community is necessary perhaps boldly listing the member organizations with their respective logos. This should be part of the Council's mission.

The following ideas were also mentioned:

• Contact Richard Croteau, Executive Director of Strategic Initiatives, JCAHO
• USP Advisory Panel should be utilized in a greater fashion
• Issue periodic summaries of accomplishments by the Council.
• Create an agenda for change and present 8-10 things that will change health care as we know it.
• Put out ideas and actions with all organizations' buy-in and not just under the Council name.
• Important to find out if KCl errors occurred with new black cap products. Put the question out on JCAHO forms.

ACTION ITEM: At the next meeting, Mike Cohen will present a list of items from the USP Advisory Panel on Medication Errors for the Council to consider as action items. Tom Granatir will report on the state of confidentiality in reporting of medication errors.

Labeling and Packaging Recommendations for Health Care Organizations

The recommendations were discussed and debated. The final revisions were approved as follows:

The Council recommends the establishment of a systems approach to medication error reporting, understanding and prevention of medication errors in health care organizations. The organization's leaders should foster a culture and system that include the following key elements:

1. An environment that is conducive to medication error reporting through the FDA MedWatch Program and/or the USP Practitioners & Reporting Network.
2. An environment that focuses on improvement of the medication use process.
3. Mechanisms for internal reporting of actual and potential errors including strategies that encourage reporting.
4. Systematic approaches within the health care organization to identify and evaluate actual and potential causes of errors including Failure Mode and Effects Analysis (FMEA) Lieberman, P. Design Failure Mode And Effects Analysis And The Industry. Automotive Engineering (AUTE). 1990;31, and root cause analysis.
5. Processes for taking appropriate action to prevent future errors through improving both systems and individual performance.

In addition, the Council makes the following recommendations to health care organizations to reduce errors due to labeling and packaging of drug products and related devices:

1. The Council recommends that health care organizations employ machine readable coding (e.g., bar coding) in the management of the medication use process.
2. The Council recommends reevaluation of existing storage systems for pharmaceuticals by health care organizations and establishment of mechanisms to assure appropriate storage and location throughout the organization from bulk delivery to point of use. The following issues should be considered when applicable:
   • Storage and location that will help distinguish similar products from one another
   • storage and location of certain drugs, (e.g., concentrates, paralyzing agents) that have a high risk potential
   • scope, access, and accountability for floor stock medications
   • Safety and accountability of access to pharmaceuticals in the absence of a pharmacist (e.g., floor stock, eliminate access to pharmacy after hours)
   • Labeling and packaging of patient-supplied medications.
3. The Council recommends the development of policies and procedures for repackaging of medications that will clarify labeling to help avoid errors.
4. 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.
5. 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.

Labeling and Packaging Recommendations for Health Care Professionals

Topic will be addressed on Day 2.

Solid Oral Dosage Form Identification

Kim Keller Reid opened the floor for discussion of whether the draft article as written should be presented as a stimuli article in Pharmacopeial Forum (PF). Areas of discussion included:

• Should article be published in places other than the Pharmacopeial Forum (PF) of the USP.
• could put a spin on it and put out call for all missing or confusing imprints on OTC, Rx, botanicals, and nutritionals
• expand the article to cover more than prescription drugs
• try to publish the call in state pharmacy association newsletters
• some delegates had the impression that the imprinting regulation applied to OTC — according to Jerry Philips the law does not distinguish between OTC and Rx
• Is this the first time the PF has printed something from the NCC MERP?
• Because the letter is a vehicle to elicit comment, it should include questions at the end of the article that we would like the respondent to answer
• final version can go on the listserv for comment
• use "generic equivalent" instead of "generic substitute"
• need to state more about the counter points to balance the presentation
• change "patient" to "consumer" in first sentence of draft.

ACTION ITEM: Kim Reid will make necessary corrections/changes. Next draft due back within 2 weeks.

Medication Errors Taxonomy Update

Diane Cousins described the classification of errors. The utility of the taxonomy needs to be clarified. Entire document may be too detailed. Tom Clark will be addressing these issues in his instructions.

ACTION ITEM: Review and comment to Tom Clark by April 21, 1998. Tom Clark will draft cover letter and a mail ballot can be used to approve.

The days meeting adjourned at 5:00 p.m.

Day Two

The meeting reconvened on Tuesday, March 31, 1998, at 8:35 a.m.

Council delegates present:

• Bill Ellis (APhA, Chairman)
• Diane Cousins (USP, Council Secretary)
• Dan O'Neal (ANA)
• Joseph Cranston (AMA)
• Charles Myers (ASHP)
• Deborah Nadzam (JCAHO)
• Teresa Mullin (NCSBN)
• Thomas R. Clark (ASCP)
• David Work (NABP)
• Nancy Rapp (ASHRM)
• Tom Granatir (AHA)
• Michael Cohen (USP Advisory Panel on Medication Errors)

Alternates present:

• Herbert Carlin (GPIA)
• Jerry Phillips (FDA)

Other alternates that attended along with their representatives were:

• Joseph Deffenbaugh (ASHP)
• Gail Bormel (USP)

Those delegates absent:

• Alice Till (GPIA)
• Sharon Smith Holston (FDA)
• LeRoy LeNarz (PhRMA)
• Andrew Smith (AARP)

The Chair acknowledged the observers present:

• Martin Hatlie (NPSF)
• Lucian Leape (IHI)
• Shawn Becker (USP)
• Marilyn Radke (USP)
• Kim Keller Reid (USP)
• Fay Menacker (USP)
• Nancy B. Mabie (USP)
• Judy Smetzer (ISMP)
• Samuel Kidder (HCFA)
• Robert Shapiro (NACDS)
• Rita Calnan (USP)
• Anne Paula Thompson (USP)
• Jim Crandall (USP)
• Jennifer Devine (USP)
• Sue Zmuda (USP)
• Jacqueline Eng (USP)

Continuation of Old Business

Jerry Phillips confirmed that botanicals are covered by the act requiring imprints on solid oral dosage forms as discussed at yesterday's meeting. Mike Cohen mentioned ISMP would be sponsoring a conference on Medication Errors that was convening on April 3, 1998 (20 industry representatives have registered at this time).

Labeling and Packaging Recommendations

Consumer recommendations have not been addressed by the Council. Dan O'Neal mentioned that a consumer workgroup NCPIE had already done a lot of work in this area. Mr. O'Neal posed the question as to whether the Council could endorse what NCPIE is already doing on the policies they put forward. A patient group perspective may be very different from a consumer group. Joe Cranston suggested that we solicit other consumer groups to complement AARP. Tom Granatir suggested that we should invite Consumer Coalition to observe. They have a broad base of membership. Andy Webber is a consumer advocate. The National Consumer League was mentioned with Linda Golodner as the contact. Martin Hatlie suggested the National Health Council, Stephanie Marshall as contact. Another group is the Healthcare Consumer Advocacy. Tom Granatir will circulate information about them.

ACTION ITEM: A few consumer groups will be invited to describe their organizations and observe the NCC MERP meeting. Two consumer seats are open on the NCC MERP.

The Council discussed the draft recommendations for health care professionals held over from Day 1. Recommendations were discussed and the following approved:

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 routinely educate patients and caregivers to enhance understanding and proper use of their medications and related devices. Furthermore, the Council encourages health care professionals to regularly participate in error prevention training programs and, when medication errors do occur, to actively participate in the investigation.

In addition, the Council makes the following recommendations to health care professionals to reduce errors due to labeling and packaging of drug products and related devices:

1. The Council encourages health care professionals to use only properly labeled and stored drug products and to read labels carefully (at least three times — before, during, and after use).
2. 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.
3. The Council encourages health care professionals to take an active role in reviewing and commenting on proposed regulations and standards that relate to labeling and packaging (i.e., Federal Register, and Pharmacopeial Forum).
4. The Council encourages health care professionals to report actual and potential medication errors to national (e.g., FDA MedWatch Program and/or the USP Practitioners� Reporting Network), internal, and local reporting programs.
5. The Council encourages health care professionals to share error-related experiences, case studies, etc., with their colleagues through newsletters, journals, bulletin boards, and the Internet.

Invited Guests: Martin Hatlie (NPSF) and Lucian Leape (IHI)

Presentation

Martin Hatlie, J.D., of the National Patient Safety Foundation (NPSF) of the AMA provided an update on the activities and future directions of the NPSF. He informed the Council that NPSF was independent of AMA. The mission of the NPSF is to ensure patient safety in the delivery of health care:

• Promote research on human and organizational error and prevention of avoidable patient injuries in health care
• Promote the application of knowledge to enhance patient safety
• Develop information, collaborative relationships, and educational approaches that advance patient safety
• Raise awareness and foster communications and dialogue to enhance patient safety
• Grow and develop the Foundation

The NPSF Board has met twice. In December 1997 they received a grant from the Veteran Administration and a report will be done by the middle of May 1998. The NPSF's 1998 program priorities were shaped by two fundamental objectives: (1) To give voice to the issue of patient safety and the health care community's efforts to promote it; and (2) to catalyze the development of a significant research effort. These are advanced through the following planned actions:

• Develop a prevention, education, and research agenda for patient safety
• Implement NPSF's grant program to stimulate patient safety research
• Establish the National Health Care Safety Council as a standing body of organizational design, human factors, and other experts to serve as a "technical backbone" in forming all NPSF activities Co-convene a second international policy conference at Annenberg conference center to explore issues and highlight research on patient safety and human/organizational error
• Build on previous NPSF baseline public opinion research by surveying the perceptions, attitudes, and responses of differently situated people in the health care system regarding topics such as risk, error, and blame
• Produce state-of-the-art website to facilitate the dissemination of patient safety information and the interactive transfer of knowledge
• Conduct a series of regional forums with community leaders across disciplines and constituencies to raise issues, share resources and motivate the development of local initiatives and collaborations to enhance patient safety
• Establish a clearinghouse of materials relevant to the patient safety movement
• Develop materials and educational resources to assist NPSF Board members and other leaders in the patient safety movement to network within and across their own constituencies around patient safety topics Implement special projects to examine issues of concern such as (a) systems for incident reporting of errors in health care and (b) medication use and compliance

The NPSF has three bodies, an Advisory Panel, an Interagency Panel, and a Blue Ribbon Panel. Mr. Hatlie will provide information on the Annenberg Conference to send out to the NCC MERP delegates.

Areas identified for possible collaboration between NPSF and NCC MERP:

• Identification of medication use issues
• Attendance at NPSF regional meetings which are a good way to collaborate (check NPSF website for times and places)
• Room for Council on committees and task forces, some of which may not be formed as yet

Mike Cohen and Tom Granatir agreed to create an agenda for an annual safety challenge. This would mean identifying 3-5 areas related to medication errors and disseminating the information.

Lucian Leape, M.D., representing the Institute for Healthcare Improvement (IHI), provided an update on the activities and recemmendations of IHI based on the results of its collaborative on reducing adverse drug events. Dr. Leape suggested that groups such as the NCC MERP need to come out publicly and take a stand on the issues of medication errors and blanket all the representatives to encourage agreement on the issues. As one example, for the past 35 years physicians and others have been debating the need for computerized patient records. Dr. Leape feels this would have a huge effect on patient safety. He suggests that we get this adopted now! Dr. Leape does agree that confidentiality issues do stand in the way of reporting and favors a centralized data collection effort.

USP's Development of a Medication Error Database For Hospitals

Diane Cousins furnished the Council with background information on the newly established USP MedMARx^TM Program, an anonymous, Internet-accessible, reporting, tracking, and benchmarking program for health care facilities. Terry Green, from USP's Information Technology Division, was introduced. He demonstrated how the reporting entry will look and described the various features of the Program. Considerable discussion ensued around promotion, funding, use of dat, and market research results.

Possible agenda topics for the next meeting were discussed. They included the following:

• Agenda for Action
• Creating a task force to work with the USP Advisory Panel on Medication Errors
• Update on legislative remedies and JCAHO sentinel event
• Automation needs to be considered by the Council
• Agenda for Research- work through NPSF to identify areas for research project;, publish to direct research to areas dealing with medication errors; provide NPSF with items being proposed by the Council
• Capitalize on collaboration with other groups such as IHI, ISMP, and NPSF
• Enhance the Annenberg Conference by holding a post conference. Do an inventory of what is taking place on the medication error scene. If Annenberg is every 2 years could the Council do something in the interim
• Should this Council be concerned with specific labeling errors? The USP Advisory Panel on Medication Errors can help address non-injectable recommendations to improve labeling.

Recommendations for dispensing and administration were discussed. It was agreed that a task force should be established to draft these documents. Tom Clark and Bill Ellis volunteered to initiate the draft for dispensing recommendations. Dan O'Neal, Debbie Nadzam, and Teresa Mullin volunteered to draft the recommendations for administering.

The taxonomy was once again addressed by the Council. It was determined that the Council needs to encourage the use of the taxonomy and may want to identify groups to test it. It was suggested that the taxonomy could reside on the NCC MERP website. It was also suggested that each individual organization on the Council should endorse the use of the taxonomy. More direction on how to use the taxonomy may definitely be needed. The taxonomy should be released under the banner of the NCC MERP.

The issue of physician representation on the Council was brought to the floor for consideration. No decisions at this time were addressed.

The issue of the HCFA proposal was addressed by the Council. The deadline for comment is April. It was felt that this process would be very long and that the Council would play it by ear and see what falls out of the recommendations.

Ms. Cousins announced that calendars would be sent out for the next 3-4 months. The Council agreed to meet sometime in July and October of 1998 and January/February and April of 1999. Ms. Cousins informed the Council that ballots would be sent out for selecting a new Chairperson.

Meeting adjourned at 1:45 p.m.