Rockville, August 13-14, 1998

Format

NCC MERP Meeting Summary

August 13-14, 1998

Day One

Dr. Deborah Nadzam, the newly elected Chairperson, called the meeting to order at 1:45 p.m.

Dr. Nadzam acknowledged the attendance of the delegates and observers. She also asked if there were any objections to taping the sessions for the purpose of getting the group's multiple views and perspectives correctly represented in the minutes. There were no objections.

Council delegates present:

Deborah Nadzam, Chairperson (JCAHO)
Diane Cousins, Secretary (USP)
Dan O'Neal (ANA)
Sharon Smith Holston (FDA)
Bill Ellis (APhA)
Thomas R. Clark (ASCP)
Teresa Mullin (NCSBN)
Nancy Rapp (ASHRM)
Alice Till (GPIA)
Andrew Heath Smith (AARP)
Michael Cohen (USP Advisory Panel on Medication Errors)

Alternates present:

Joseph Deffenbaugh (ASHP)
Marjorie Jaski (AMA)
Mary Mologne (AHA)

Other alternates that attended along with their delegates:

Herbert Carlin (GPIA)
Shawn Becker (USP)
Jerry Phillips (FDA)

Delegates absent:

Thomas Granatir (AHA)
Joseph Cranston (AMA)
LeRoy LeNarz (PhRMA)
Janet Myder (AHCA)
Charles Myers (ASHP)
David Work (NABP)

Observers present:

Robert Shapiro (NACDS)
Anthony Grasha (Observer/Presenter Univ. of Cinn.)
Greg Chenier (ISMP)
Jim Crandall (USP)
Fay Menacker (USP)
Judy McMeekin (USP)

Activities Update

Dr. Nadzam requested a roundtable update from the delegates.

USP (Diane Cousins)

Addressed the successful beta test phase for the USP MedMARx^TM Program, which started on May 11, 1998 and ended on July 31, 1998. Ms. Cousins introduced Judy McMeekin, newest staff addition to the USP MedMARx Program, and introduced Jim Crandall, Dir. External Affairs. Mr. Crandall provided information on how publicity is handled for the USP programs. He also summarized the national publicity program for the children and medicines efforts by USP. Video news releases on children and medicines and on medication errors were filmed and provided to 12,000 news outlets. Mr. Crandall suggested that this same level of publicity could be used for the Council. Additional information presented on day 2.

ASHP (Joe Deffenbaugh)

ASHP's publication on relationships between medication errors and adverse events that was sent out for comment, is now available on their website. The ASHP guidelines on the Safe Use of Automated Medication Storage and Distribution Devices were approved and published. Copies were sent to all state boards of pharmacy. The Oklahoma state board requested additional copies for a task force on revision of the statute and regulation on these devices. Dr. Henri Manasse, ASHP Executive Vice President, is part of a group of leaders (Harvard Executive Sessions) researching the issues of medical and patient safety. Dr. Manasse will be a commentator at the second Annenberg conference in November, 1998. At their annual meeting in June, ASHP featured a session on medication errors that reviewed the medication errors associated with the Denver case. Mike Cohen and Judy Smetzer of ISMP have been asked to repeat this presentation at the ASHP midyear meeting in Las Vegas in December, 1998. This midyear clinical meeting will have several sessions dealing with medication errors, including a USP MedMARx presentation and JCAHO discussions on sentinel events.

GPIA (Alice Till)

Dr. Till requested that Herb Carlin provide an update on GPIA activities. Dr. Carlin addressed concerns regarding the short time allotted for the "Rx only" placement on labels. He also expressed concern that this process may become voluntary. Dr. Carlin expressed his satisfaction that FDA has extended the timeframe for compliance. He also suggested that federal legend be removed. Dr. Till echoed Dr. Carlin's concerns. Dr. Carlin requested a tape of the ASHP session on the Denver case that moved him immensely because it was such an emotional presentation.

NCSBN (Teresa Mullin)

Commented on the good work NCC MERP is doing. She mentioned that while the NCSBN supports the work of the NCC MERP, it is impossible to mandate reporting because each board has its own state laws and regulations, and the boards of nursing are responsible to the public for safe practice. Ms. Mullin described the existence of a disciplinary data bank that captures disciplinary actions for medical errors. She applauded the fact that the Council has re-focused the problem of placing blame for errors away from the individual and onto the system.

ASCP (Tom Clark)

Clarified the NCC MERP minutes from the March meeting regarding the research and education foundation white paper on automation which has been published (copies were distributed). ASCP has developed a laminated card with a list of sound-alike, look-alike drugs used in geriatrics, designed to go into nursing/medical administration records and can also be distributed to pharmacists. Mr. Clark discussed the availability of a handbook "Ident-a-Drug" by the Therapeutic Research Center for drug identification codes. A copy was passed around to the delegates.

APhA (Bill Ellis)

Preparing for next year's annual meeting. Workplace issues are high on the APhA priority list for 1999.

FDA (Sharon Holston)

Announced that the FDA Modernization Act, signed by the president in November, 1997, requires that FDA plan how it would meet its statutory requirements. This was mentioned in the scope that FDA is having meetings with stakeholders to get suggestions and advice on how they can meet these requirements. The next agency-wide stakeholders meeting, will occur September 8, 1998. This process has been mandated by congress, and the completed plan is due on November 21, 1998. Ms. Holston indicated that the requirements can be found on the FDA website (www.fda.gov). Suggestions or comments can be communicated via the Internet.

AHA (Mary Mologne)

Significant progress is being made at AHA on sentinel event process. AHA and quality teams are having ongoing conversations with IHI on reducing medication errors and reproducing the breakthrough series, while looking for leadership audience.

AARP (Andrew Smith)

As a member of NPSF, Mr. Smith is reviewing abstracts for the Annenberg conference. In trying to raise awareness among activists at AARP, Mr. Smith has written a review outlining what the Council has learned about problems and causes of errors. Mr. Smith is working on a research paper on the topic of preventable medical errors and injuries especially in geriatrics. Mr. Smith believes this will stimulate AARP's interest in this field.

AMA (Marjorie Jaski)

Working on resolution 501 encouraging physicians to educate patients through written information about medication use. Prior to resolution 501A, written medication instructions for "chronic multidrug therapy" resolution had been prepared. A report entitled "physician education of their patients about prescription medicines" will go to the house of delegates and will be included in AMA's meeting of 1998. AMA is focusing energies on the creation of SCRIPT (Study of Clinically Relevant Indicators of Pharmacologic Therapy) a project with JCAHO. At the first national coalition on quality and medication use, AMA sat on steering committee of SCRIPT to ensure that medication error goals are achieved.

USP Advisory Panel on Medication Errors (Mike Cohen)

At the May panel meeting, reports received through the USP Medication Errors Reporting Program were reviewed, to establish a list of products for recommendation to the Council as part of a national agenda. They include:

Brevibloc/esmolol concentrate
Faxed orders and prescriptions
Liposomal products
IV free flow pumps
Automated dispensing systems
Contraindicated medications in automated systems

These recommendations will be addressed on day 2.

ANA (Dan O'Neal)

A stellar program on the NCC MERP and medication errors, was proposed for continuing education session at the ANA annual convention. Unfortunately it was not accepted for presentation. A white paper on Pharmacotherapeutics should be published soon. The field of nursing is much more aware of the nurses role in medication errors because of the Denver case.

ASHRM (Nancy Rapp)

This organization of 3,300 members appreciates the opportunity to work with AHA, JCAHO and other groups on the sentinel event process. Alerts from ISMP are sent to the ASHRM membership, which generate positive comment. The members are gearing up for the annual convention October 4-7, in San Diego, CA where part of the focus will be on medication errors.

JCAHO (Deborah Nadzam)

The board revised sentinel event reporting in July, extending the length of time for root cause analysis completion, from 30 to 45 days. There are systems in place for sharing root cause analysis with JCAHO by mail or online. The ORYX initiative is in motion, and JCAHO expects to receive data from hospitals and long-term care organizations by March 31, 1999. Each facility has to provide data for at least two measures. Home health care facilities must do the same by the end of this calendar year and submit data in the year 2000.

Updates

Update response to NCC MERP recommendations

Diane Cousins reported on approximately 2 dozen response calls from press. She also discussed a response from the Academy of Managed Care Pharmacy, who placed these recommendations on their website along with her e-mail address, which generated numerous calls requesting copies of the recommendations. All recommendations will be available on the NCC MERP website upon completion of the site.

Update on second Annenberg conference

Dr. Nadzam provided information on the call for papers for the upcoming conference. 186 abstracts were received for review and forty (40) were selected. Co-conveners are NPSF, AMA, AAAS, JCAHO, VA and the Annenberg Center. Sponsor organizations contributing financial support include: AHA, Robert Wood Johnson Foundation, Pfizer, and others. Tentative agenda is set and abstracts will round out breakout sessions on November 8-9.

Update on SCRIPT

Bill Ellis described the SCRIPT project, which grew out of the HCFA conference dating back to April 1997, and has as its main goal to develop medication use quality indicators. Previous efforts have not been as focused as this project relative to quality measures. Approximately 35 accredited organizations are involved. While evaluating performance measures and indicators, some consideration will be given to error prevention and reduction. Dr. David Bates serves as scientific advisor along with Elizabeth Chrischilles, Ph.D. from the University of Iowa as DUR scientific advisor. The group had its first successful meeting at the end of July. The program is basically a 2-year project that will require a collaborative process for developing additional measures, and a compendium. This project is looking at systems improvement and not individuals. Ms. Jaski mentioned that a coalition on medication use is still in formation. Talks have been ongoing in the area improving margins to review medications, to focus on including ambulatory care and not just hospitals. Information will be available as this project moves along.

Update on MedMARx

Diane Cousins reported on the reactions of 28 hospitals that participated in the beta test phase. Hospitals were selected for variety and geographical locations. An array of individuals were involved with the input of data including: nurses, pharmacists, quality assurance/risk managers, and clerical staff. The NCC MERP categorization index is used as part of MedMARx. Employment of the index was very positive. Some inconsistencies and questions of interpretation regarding index definitions arose. Category H, which is a near death event, in some instances was categorized as Category C (category reached the patient, but did not cause harm) because the patient recovered, indicating the need for additional education. This need also extends to the taxonomy, regarding differences in selecting types and causes of errors. Depending on the system, some testers thought there was too little information, too much information, and others just the right amount. USP is designing a reporting form that shadows the MedMARx system to provide additional standardization.

A question was raised on whether the Council should revisit the categorization index sections causing confusion. Reference was made to a poster presented at the ASHP annual meeting on interpretation of index from USP's standpoint, with examples supported with case studies on category levels. Lack of information forces a report into a different level making a category unclear. There was agreement that some changes may need to be made when more data is available. A broader grouping on severity outcomes could be used, but it is still unclear especially with medical intervention. Diane Cousins noted that the purpose of the beta testing of MedMARx was not to do analysis on trends, but to test the system for receptiveness and responsiveness. A large majority of reports in the beta testing fell into C and D categories.

HCFA Proposed Rule

The proposed rule is associated with a 2% medication error tolerance. In the absence of Dr. Sam Kidder (HCFA Consultant), Dr. Nadzam requested input of those present who were in attendance at Dr. Kidder's presentation at ASHP. Tom Clark noted that the comment period is over, and it appears that it may be a year or more before HCFA completes triage and sort out the comments. They apparently received 65,000 comments, and had to contract out for tallying the responses. Legislative Remedies that Support Confidentiality in Reporting of Medication Errors.

Mary Mologne suggested keeping an eye on revision of the house "Consumer Protection Bill," which protects "healthcare response information" for peer review. Not clear whether bill will survive congressional session. Distributed was JCAHO's draft model state legislation form, which JCAHO hopes to provide to state governments for consideration in types of protection laws. Mr. Clark mentioned the vagueness regarding the new regulation for reporting in the state of Tennessee. Tom Clark produced a copy of the final regulation from the state of Tennessee. It read as follows: "The pharmacist in charge shall report to the board any situation in which a medical or prescription order has caused serious personal injury or death". Discussion regarding the need for clarification of the regulation was heard. The regulation does not specify if incident is medication error or adverse reaction.

Invited Guest: Dr. Anthony Grasha of the University of Cincinnati

Diane Cousins introduced Dr. Anthony Grasha, Psychologist from the University of Cincinnati, who is working on unique concepts concerning cognitive processing and how this relates to medication errors.

Dr. Grasha gave background information on the work he has been doing for 5 1/2 years in the area of cognitive psychology of human error, defined through studies of retail pharmacies. The study included pharmacists and technicians in the working environment with approximately 100 pharmacy personnel. Dr. Grasha designed a pharmacy simulation laboratory, and has just completed a survey of pharmacists and technicians on ACognitive Systems Approach.@ The results of his work with Revco, is the model that began to look at why humans fail in the context of the pharmacy environment. Dr. Grasha is working with NACDS and is seeking grants and funding to pursue this project. In his presentation, Dr. Grasha highlighted potential causes for human errors, and what his study concluded:

over simplified statements that workload impacts medication errors
personal problems in the home and family
kinds of systems needed for individuals to work properly
influences affecting proper performance i.e. regulations, policies
cognitive system bringing messages from the outside
rationale for how things are identified
tapping into the cognitive unconscious
discriminate differences

Dr. Grasha made some recommendations to what he thinks would slow down the number of medication errors:

all individuals dispensing medication should have eye checkups
use negative practice, role playing exercise
look for non-trade interventions

Update on Medication Error Taxonomy

Joe Deffenbaugh reiterated concerns raised by reviewers from ASHP regarding distinctions between taxonomy as prototype database from precursor to reporting form. Viewers (pharmacists, risk managers, quality assurance and nurses) reactions to this form was negative because of the vast amount of information, some of which they will never use. Distinction is needed on whether this is or is not a model database with predetermined fields and choices to classify information. Definitions linked to the fields for interpretation of error experience are needed for this tool to be useful. With respect to too much information in the taxonomy, concerns varied from what kind of error (wrong drug or dose selected) to what happened to the patient ( this was the main concern for risk managers). Education is needed to explain the importance of the taxonomy data and its benefits. Examples of reports would give ideas of what to look for. Strategy is needed to present this document to the public since it is finished as far as classifications. Mr. Deffenbaugh did not feel that the document was finished. In his view it is 90% there, but arriving at the final 10% would mean testing the document against medication error experiences. Dr. Nadzam feels the Council needs to determine future steps with this document. The possibility of using the taxonomy electronically as a standardized document was entertained. The taxonomy needs to look more like a reference tool. This topic will continue on day 2, time permitting.

Recommendations on Administration and Dispensing

Draft copies of recommendations on administration (D. Nadzam, T. Mullin and D. O'Neal), and recommendations on dispensing (T. Clark and B. Ellis) developed for reducing errors, were distributed for review by the Council and will be addressed on day 2.

Dr. Nadzam announced that due to the change in chairperson, the request by Michael Cohen, President of the Institute for Safe Medication Practices, for formal membership on the Council did not appear on the agenda. Copies of Mr. Cohen's letter were distributed to the voting members as well as a copy of the rules and procedures. Voting on this matter will take place on day 2 in closed session.

A motion to adjourn was moved, seconded and approved. The meeting was adjourned at 5:20 p.m. August 14, 1998.

Day Two

The meeting reconvened on August 14, 1998, at 8:45 a.m.

Council delegates present:

Deborah Nadzam, Chairperson (JCAHO)
Diane Cousins, Secretary (USP)
Dan O'Neal (ANA)
Sharon Smith Holston (FDA)
Bill Ellis (APhA)
Thomas R. Clark (ASCP)
Teresa Mullin (NCSBN)
Nancy Rapp (ASHRM)
Alice Till (GPIA)
Andrew Heath Smith (AARP)
David Work (NABP)
Michael Cohen (USP Advisory Panel on Medication Errors)

Alternates present:

Joseph Deffenbaugh (ASHP)
Marjorie Jaski (AMA)
Mary Mologne (AHA)

Other alternates that attended along with their delegates:

Herbert Carlin (GPIA)
Shawn Becker (USP)
Jerry Phillips (FDA)

Delegates absent:

Thomas Granatir (AHA)
Joseph Cranston (AMA)
LeRoy LeNarz (PhRMA)
Janet Myder (AHCA)
Charles Myers (ASHP)

Observers present:

Robert Shapiro (NACDS)
Jennifer Taylor (NHC)
Greg Chenier (ISMP)
Fay Menacker (USP)
Judy McMeekin (USP)
Jim Crandall (USP)
Linda Golodner (NCL)
Joseph Valentino (USP)
Rita Calnan (USP)

New Business

NCC MERP Website

Meredith Tcherniavsky, Web Programmer for the USP Management Information Systems (MIS) introduced the NCC MERP website. The website is ready for launch on August 17, 1998. Ms. Tcherniavsky presented the various pages and links available on this new website. The group discussed additional links to the site by other organizations such as National Patient Safety Foundation, etc. The demonstration generated discussions on the following topics:

copyright issues
frequently asked questions section
need for press release to announce the website
possible organization links
should the NCC MERP meeting summaries be restricted to members, or have public access
draft documents revised electronically
user IDs and passwords

ACTION ITEMS: USP will send out user ID and password to members. NCC MERP copyright will appear on each webpage with appropriate permission to reproduce. Meeting summaries will appear only on members private page.

Presentation of NCC MERP Communications Plan

Jim Crandall, Director of the Office of External Affairs (OEA), presented a communication plan for the Council. The purpose is to raise awareness of the work of the Council. Discussion included:

reaffirm a strategic direction for the Council
emphasize the educational efforts of the Council
communicate via member organizations publications and journals
development of key message
convene a communications professionals team with counterpoints from each member organization
setup systems to get information approved in a timely manner
expanded use of publicity tools

"Solid Oral Dosage Forms" article

Diane Cousins addressed the group regarding the dissemination of the "Solid Oral Dosage Forms" article to solicit comments from practitioners. Agreement was reached on placing the article on the NCC MERP website, and sending it to organizations for publication. The member organizations were encouraged to publish the article and send their readers to the NCC MERP website for comment.

ACTION ITEM: Get each organization to put blurb in their newsletters as well as other trade press about NCC MERP activities and on soliciting comments on "Solid Oral Dosage Forms" article.

Presentation of the recommendations by the USP Advisory Panel on medication errors

Michael Cohen addressed the need for a national agenda to draw attention to the major concerns documented from medication error reports. Topics were presented by the USP Advisory Panel on Medication Errors as a possible national agenda. The Panel reviewed medication error reports received through the USP Medication Error Reporting Program to arrive at the following recommendations:

Brevibloc
At least 30 voluntary reports exist stating that the concentrated form of this drug has been accidentally injected into patients. The loading dose of this drug is commonly used in the OR. The concentrate is used for constant infusion to be given over a period of time after the loading dose. In 1990 the manufacturer chose to package the concentrate in a glass ampul, and the loading dose in a vial, which is opposite to what users are familiar with, creating a deadly potential for error. The company agreed to change the label, and apply a warning on the box, but not on the ampul. The problem still exists and the company is contemplating packaging the drug in prediluted form.
Faxed orders and prescriptions
Problems with readability of prescriptions and mistakes in transmission are the result of faxed orders and prescriptions. For example, a strand of hair, ink mark or dust particle on a faxed transmission can be misread as a decimal point or number that can lead to wrong dispensing, dosing or administration.
Liposomal drug products
Errors and deaths have occurred when practitioners have given the conventional product in place of the lipid-based product. Companies that manufacture lower dose products, have placed warning statements "do not substitute" on the box. However, this can be misread as do not substitute for generic when in fact they may be saying, do not substitute for conventional product.
IV free-flow pumps
A number of deaths have been reported, two recently in Florida, from the free flow aspects of IV pumps. Most pumps have a fail-safe mechanism, but not all.
Automated dispensing systems
Problems existing with many different types of this equipment, prompted the Panel to believe that there is a lack of check systems in place at the point-of-use and stocking in the nursing units. NABP and others have addressed the issue of automated dispensing. The Panel also feels that perhaps a JCAHO surveyor could investigate, when visiting a site, to examine the process and whether dangerous drugs exist without the proper check systems in place. There have been numerous injuries that may not have happened with these systems in place.
Contraindicated medications flagged in automated systems
Many hospital pharmacy computer systems are not capable of detecting a contraindicated medication.
Albumin dilution with sterile water
Accidental administration of Albumin solution diluted with sterile water for injection is cause for concern. The FDA and ASHP have publicized the problem through their website and publications. Facilities are still using outdated textbooks that provide outdated information. Some pharmacists and nurses are still unaware that this dilution technique can cause serious injury or death to the patient. This particular issue was not addressed by the Advisory Panel, However, Mr. Cohen was aware of numerous reports and felt it was significant enough to include.

Discussions:

Teresa Mullin noted that she was aware of three incidents involving a death with IV-free-flow pumps. Two were caused by lack of staff orientation. Ms. Mullin encouraged the emphasis of the systems approach. Mr. Cohen agreed that systems versus individual punitive approach was the way to go. Ms. Holston reminded the group that the devices in question are approved by FDA, and unless FDA declares an emergency stating that they can no longer be used, they will remain on the market. Ms. Mologne made the suggestion that materials managers could receive an alert with a list of the pumps available. AHA has a quality advisory on website that could be useful as part of the communication effort to publicize the list of the products highlighting the top ten most serious or common errors with short summaries as suggested by Tom Clark. ASCP could also place this list on their website with links to ISMP or others for more information. Concerns were raised as to how the Council should proceed. Choosing major issues and sharing them for example, with JCAHO, to allow their surveyors to investigate one or two of the issues, may impact change. Articles and newsletters previously written on these same subjects have not resulted in the needed changes.

The possibility of a publication bearing logos from the various member organizations was discussed. However, Dr. Nadzam suggested we exercise caution in such cases. Diane Cousins suggested that for future issues, USP and FDA databases could be checked for prevalence and severity, and that the Council should approach medication errors with the Council's mission to educate in mind. With these suggestions, work groups could be formed to identify the best approach for stating the issues. It was proposed that a standardized memo format be used when an item comes out from the Council, making it easy for the readers to understand what NCC MERP is addressing.

ACTION ITEMS: Key messages are needed on each national agenda item. Check USP, JCAHO and FDA databases for prevalence of errors to add validity to the significance of the national agenda items.

Additional discussion items:

A sense of urgency needed about these issues. National agenda needs to focus on two or three items to mount a solid effort to affect change. May need hierarchy of what items should be addressed first--all are serious, but liposomal issue is growing.
FDA can assure that new products have appropriate labeling.
Boards of pharmacy can make recommendations to be proactive.
Brevibloc use is limited in hospitals, whereas IV pumps for home care and elsewhere are constantly used.
Albumin could be one of key issues (problems with dilution and use of old texts by staff).
Drug interactions filed in computers need to be updated.
Need to draft succinct statements regarding severity and number of cases.
Press release needed right now!.
NCC MERP newsletter to state boards would be well served

ACTION ITEMS: Subgroups need to address national agenda content, target audience, and suggestions for vehicles of communication. Work via listserv before November meeting.

Mike Cohen volunteered to work with Diane Cousins to draft appropriate information to include in each agenda item. Initial paragraphs will be written and provided to the Council for reaction. Marjorie Jaski stated that a press release was needed for immediate action on these items. News of a problem deemed important by NCC MERP should be taken seriously. Deborah Nadzam inquired, whether the Council should issue an immediate statement. Sharon Holston commented that issuing a statement required precise information. Failure to do so would create additional problems when reporters call for information. It was agreed that the press release and subgroup activity would need to be done immediately and worked on simultaneously.

Acknowledgment of Consumer Organizations

Linda Golodner, President of the National Consumers League (NCL), was acknowledged by the Chairperson. Ms. Golodner informed that the NCL's concentration is in consumer fraud. They work with food safety, international sweat-shops, child labor issues, education on health choices, public policy and advocacy. NCL worked with ANA on a health care coalition. NCL recently conducted an activity survey on cardiovascular disease and did a roundtable on direct to consumer advertising. A question from the group concerned whether NCL had ever addressed medication error issues. Ms. Golodner said there is great concern regarding patient confidence in healthcare settings because of current media information. Ms. Golodner would like to see open dialogue between health professionals and consumers. She asked if there should be a way for consumers to report directly to reporting programs. Ms. Golodner felt it would be patronizing to indicate that consumers would not accurately report a medication error. Sharon Holston informed the group that while FDA does not target consumers directly, there will be an 888 toll-free number to call. An under-tapped area is to work with consumers on how to prevent medication errors.

Jennifer Taylor, Ph.D., Program Associate for Government Affairs, provided information on the National Health Council (NHC). The NHC is a voluntary organization interested in patient liability and compliance issues. Dr. Taylor expressed her desire to learn more about the work of the Council to take back to her colleagues at NHC.

The presence of two consumer organizations prompted discussions on the types of organizations that could fill the open slots on the Council. Discussions regarding future participating organizations generated the following suggestions for possible members:

Intravenous Nurse Society, (INS)
National Academy of Homecare Physicians (NAHP)
National Association for Home Care (NAHC)
National Association of Medical Equipment Suppliers (NAMES)
National Association of Care Givers (NACG)

The Council may need to issue another invitation to prospective groups and include more consumer groups. It was suggested that organizations be invited to observe the meetings periodically prior to admittance to the Council.

Development of NCC MERP Research Agenda

Following Dr. Lucien Leape's suggestion that the NCC MERP develop a research agenda for patient safety, the Council explored this possibility. Deborah Nadzam, Bill Ellis, and Diane Cousins introduced areas for consideration, and suggested moving the bulk of the discussion to the next meeting. The areas for consideration included:

the true need for a research agenda in the area of medication errors
should the Council issue this agenda
does a research agenda require funding
how would it be kept current
how to keep it alive and moving

Marjorie Jaski informed the group about the "alliance on aging report" which included recent recommendations on medication errors. The report implies the importance of a research agenda for medication errors. There were inquiries on funding (i.e. who and how); ongoing means for funding; moving the NCC MERP into another level of administration; implications are more complex. The agenda could be sent to agencies to make them aware of the need for funding. Tom Clark feels the NCC MERP should go on record stating that the Council's issues are important and should be researched regardless of funding availability, which could have an impact on the funding agencies and would also allow grant requesters to cite the NCC MERP on their proposals. Questions on the role of the Council and the level of participation in the research or review of proposals was discussed. Sharon Holston feels that the Council should take the time to assess proposals if funding organizations asked for opinions. Bill Ellis indicated that the Council could comply if asked, but should be careful not to appear as self-serving or as having some other agenda.

Joe Deffenbaugh and Charles Meyers suggested that in order to get credibility on research agenda issue, there must be some science behind it. Research expertise is needed from organizations such as AAAS to provide recommendations on the likelihood of obtaining funding. Dan O'Neal suggested that it is not the responsibility of the Council to over analyze the problem, but to define what the values are and create a consensus document that can be just as powerful as a research document. Mike Cohen suggested that the NCC MERP does not have the expertise to advise the FDA or any agency if asked, regarding proper warnings. Lots of issues exist for developing a research agenda. Ms. Holston stated that ideally, applications to FDA for new drugs should include background information supporting the product. When reviewing applications, it is difficult to ask a sponsor if research was done in certain areas, because definitive research guidelines are non-existent.

The group decided that they need to have a macro assessment of the state of research. Data on causes of errors are almost non-existent especially in retail pharmacy setting. This subject will be on the agenda for the next meeting.

ACTION ITEM: Literature search needed prior to next meeting.

David Work informed the group that NABP is conducting a survey to determine:

how long should a pharmacist workday be
how long between a workday
breaks should be scheduled
threshold of 150 prescriptions filled per day

The survey is on their website asking for input on this subject.

Continuation of Taxonomy

The taxonomy was once again reviewed. The subject of ASHP's testing was continued and a determination was made that this was not a data collection tool or a reporting form, but a taxonomy classification code. The question was again brought up on how the Council should proceed with the taxonomy. Jerry Phillips reformatted the taxonomy taking out patient information, and also deleted item number 24 (description of error). Categories will remain the same. Explanation is needed on what the taxonomy is and how to use it. Tom Clark drafted a cover sheet that the Council should encourage facilities to use. A possible disclaimer, expanding the introductory section, and including the "taxonomy of medication errors instructions for use" will make the taxonomy less intimidating. A revised draft will be forthcoming.

ACTION ITEMS: Leave taxonomy content as is, expand introduction and create instruction sheet. Tom Clark will redraft cover letter.

Steering committee closed session

The steering committee had a closed session to review and subsequently vote on the request for admittance to the Council by the Institute for Safe Medication Practices (ISMP). Upon resumption of the meeting, the announcement was made that ISMP was unanimously approved as an at-large member.

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

Administration subcommittee (Teresa Mullin, Dan O'Neal and Debbie Nadzam)

Recommendations from work groups focusing on administration and dispensing of drugs were presented for review. It was suggested that the recommendations should be combined. Continuity of format in wording, use of medication versus drugs, and overlapping information was addressed. Suggestions raised that global recommendations may be something to consider. A statement to foster the culture for reducing medication errors, may need to be in every recommendation. Should there be a set of recommendations for users/public of medication products. NCPIE and FDA currently have recommendations in place aimed at consumers. The group concluded that the focus for healthcare professionals should be process improvement and the focus for consumers is information and application. Because many reference books available are outdated, a separate recommendation was suggested to focuses on the need for current reference material.

Administering medication by checks and balances, and creating redundancy was suggested. It was suggested by Deborah Nadzam that the NCC MERP logo indicating the checks on prescriber, dispenser, administrator and caregiver could be promoted. Consensus is needed to have policies and procedures for overriding automated dispensing systems. ASHP guidelines were suggested as reference. Diane Cousins proposed for consideration, not administering any drugs that are not properly labeled, and labeling or identifying all tubing to allow appropriate administration. Changes to the recommendations were tentatively agreed upon.

ACTION ITEM: Subcommittee will revise and take into consideration the 1993 ASHP guidelines for medication use.

Dispensing: Tom Clark and Bill Ellis presented the drafted recommendation on dispensing Issues with dispensing include: access to current information (could be computerized), should NCC MERP provide a set of organization wide medication use policies incorporating the recommendations, which groups would be using them, evaluation of systems to ensure dispensing is needed, but there should be a validation process with built in checks that should be exercised whenever a prescription is filled. The issue of robotics was mentioned as another dimension, however, the element of human error still applies when these automated devices are filled for dispensing. Changes were recommended as follows:

#1 ok as is
#2 tweak wording to avoid misinterpretation
#3 ok, but add-new employees should be oriented in dispensing process and in medication errors
#4 ok as is
#5 ok as is
#6 tweak wording and give emphasis to higher risk medication
#7 mention all pharmacy employees
#8 incorporate in template
#9 current information available to staff

Recommendations should include: Diane Cousins suggestion of not using unless properly labeled concept and including auxiliary labels wherever necessary.

ACTION ITEMS: Subcommittee will redraft and resubmit recommendations by Sept. 15, 1998 The Council agreed that the two recommendations on administration and dispensing should remain separate.

The Chairperson opened discussion about possibly changing the next NCC MERP meeting to coincide with Rancho Mirage Annenberg meeting. Council members will provide comments regarding possible change via listserv:

Dr. Nadzam concluded the meeting by summarizing action items as follows:

User IDs password to be sent out to members
Go to directors of communications to make them aware of Jim Crandall=s call to setup meeting.
The article on solid oral dose form will be something for communications group to address
Need a statement of problems for agenda items- FDA, USP and JCAHO will be asked to provide database information to help asses nature and extent of problems
Press release will be drafted. The Council will decide which of the agenda items to use first
Taxonomy classification will remain as is, but the introduction and instructions for possible use will be enhanced
E-mail on November meeting e-mail will be sent regarding possible date change to coincide with Annenberg meeting
Review the severity classification

Topics for next agenda:

communications plan
national agenda items
taxonomy uses
rewording of recommendations on administration and dispensing
exploration of research agenda
membership issues
revisit goals and education efforts of NC
MERP
Richard Croteau, M.D., of JCAHO will present the JCAHO sentinel event policy

A motion to adjourn was moved, seconded and approved. The meeting was adjourned at 2:52 p.m.

Meeting Date

08/13/1998 - 12:00