Rockville, July 15-16, 1996



NCC MERP Meeting Summary

July 15-16, 1996

Day 1

The meeting was called to order at 1:30 P.M. on July 15, 1996.

Organizations absent: AARP (Smith), NABP (Work). In addition to the Council Chairperson, William Ellis, other members in attendance were:

  • Marcia Richards (AHCA)
  • Thomas Granatir (AHA)
  • Joseph Cranston (AMA)
  • Daniel O'Neal (ANA)
  • April Shaughnessy (APhA)
  • Charles Myers (ASHSP)
  • Sharon Holston (FDA)
  • Alice Till (GPIA)
  • Linda Hanold (JCAHO)
  • Teresa Mullin (NCSBN)
  • LeRoy LeNarz (PhRMA)
  • Diane Cousins (USP)
  • Michael Cohen (USP Advisory Panel on Medication Errors Chairperson)

The newest representative to the Council, Dr. LeRoy LeNarz, was appointed by PhRMA to replace Dr. Gifford. Also in attendance: Joseph Deffenbaugh (ASHP alternate), Jerry Phillips (FDA alternate), and Kim Keller (USP alternate). Observers present: Tom Clark (ASCP), Sue Proulx (ISMP), and Janice Feinberg (ASCP).

Old Business

The summary from April 1 and 2, 1996 was accepted with two modifications:

  • Sharon Holston's name was corrected
  • AHCA was added to attendance list

The NCC MERP brochure was approved. Twelve copies of the brochure, along with a diskette for future printings, were provided to each member for printing as necessary for promotion of the Council. Each diskette included directions for use in a MacIntosh Quark format.

The Chairperson's letter designed to encourage reporting by the organizations represented on the Council was adopted as drafted. Discussion ensued regarding how the letter should be used. Questions arose as to whether the letter could be modified to send to other organizations and/or journals/trade press. Teresa Mullin (NCSBN) indicated that she may want to get the letter endorsed by NCSBN to go out to all state boards of nursing. Tom Granatir (AHA) indicated that a jointly signed letter from the Council Chair and the CEO's of State Hospital Associations was a possibility. He agreed to send the letter to State Hospital Associations. Mr. Granatir also indicated that AHA publishes a trade journal and may be willing to donate advertising space...possibly a 1/2 page ad. Other members indicated this was also a possibility. Dan O'Neal (ANA) agreed to send the letter to state nurses associations. April Shaughnessy (APhA) agreed to coordinate sending letters to all affiliates but requested that the initial letter be addressed to John Gans. AHCA will send the letter to affiliates. Sharon Holston (FDA) noted that MedWatch forms go out with all FDA Bulletins.

ACTION ITEM: The Chairman will modify the letter to send to additional groups and modify for the trade press.

Activities Update

FDA (Sharon Holston)
September 30, 1996, FDA will host a Health Professional Organizations meeting. The single focus is medication errors. The Program includes presentations by Council members AMA, ANA, ASHP, and USP.

Chairperson Ellis
Received requests for medication error searches, and for space in trade journals.

ASHP (Charles Myers)
Professional practice standards are in draft for antineoplastic drugs, safety in all medication use systems, and automated dispensing devices. Mr. Myers also mentioned that ASHP presentations are scheduled at the medical errors conference in Rancho Mirage.

AHA (Tom Granatir)
Emphasized the high profile of the Rancho Mirage conference. Hundreds of proposals have been submitted for the two-and-a-half-day conference. This meeting has the potential of reaching other scientists. They will take a wider systems view of errors and develop a framework for understanding and managing errors.

AMA (Joe Cranston)
Still trying to get press on the Council out to membership. The AMA Patient Safety Initiative will be announced at the medical errors conference.

USP (Diane Cousins)
Ms. Cousins prepared a speech on the NCC MERP for Deborah Nadzam to present at the JCAHO liaison workshops in June. Anyone who wishes to borrow the slides from USP for a presentation on the Council is welcome to do so. USP developed a direct mail campaign that focused on medication errors. The mailing consisted of a flyer explaining the severity of medication errors and included a laminated card with similar sounding drug names that have been reported through the USP Medication Errors Reporting Program. The mailing encouraged reporting and offered information on the establishment of the NCC MERP, its mission and work to date.

USP Advisory Panel on Medication Errors (Michael Cohen)
The first meeting of the Panel was held on July 11-12, 1996. Mr. Cohen summarized the activity of the first meeting. The Panel includes representatives of pharmacy, nursing, and medicine who have current practice experience. The Panel agreed to examine medication errors from the systems perspective. The Panel will develop projects based on active review of the USP Medication Errors reports. On a personal note, Mr. Cohen mentioned the development of an Institute for Safe Medication Practices in Spain. ISMP is expanding its newsletter and the WHO and AMA are using exerpts from this publication. Mr. Cohen will be speaking on medication errors at the Federation Internationale Pharmaceutique meeting in Israel.

ANA (Daniel O'Neal)
ANA is developing a home page on the web and would like to include USP Medication Error Reporting forms.

Mr. Ellis made special note of the increase in medication errors activities reported by the Council members since the last meeting and acknowledged their efforts.

The Council Secretary discussed three letters that she received. (1) Michael O'Neil of REVCO has studied cognition errors and is interested in presenting his findings to the Council. Ms. Cousins suggested that he send a copy of the published study for the Council to review and it then can request a presentation as needed. (2) A carbon copy of a letter from Dr. Robertson (WA State Medical Society) concerned codes on solid oral dosage forms as an error prevention measure. He wants the Council to take a look at this issue. The issue will rest with AMA who is the direct recipient of the letter. (3) A letter was received from the Federation of State Medical Boards of the United States indicating that it was withdrawing its membership from the Council, citing lack of relevance to the mission of FSMB as one reason. The Chair will respond in writing to clear up any misgivings on their part and attempt to encourage reinstatement.

Subcommittee Reports

Glossary of terms in medication error definition were provided to the members and the definitions were addressed in turn.

  1. Adverse Drug Event. Accepted without change.
  2. Adverse Drug Reaction. Much discussion ensued over the definition of an ADR. Group questioned how many definitions there are for an ADR. Group decided to table this definition until it could be researched by the Secretariat.
    ACTION ITEM: The Secretary will compile the various definitions of an Adverse Drug Reaction.
  3. Consumer. Replace "purchaser" with "user", which, for the purposes of the Council, will include caregivers. Mr. Granatir reminded the Council that it may wish to reconsider inclusion of "caregiver" in the definition of a medication error at a later point in time.
  4. Diagnostic agents and Drug products. Delete "..or herbal" from parenthetical; no explicit inclusion or exclusion will be made.
  5. Health Care Services. Accepted without change.
  6. Medication Error. "Caregiver" should be given consideration for inclusion in the definition at a later date. (See definition of Consumer)
  7. Non-prescription products. Deleted.
  8. Patient. Accepted without change.
  9. Patient Harm. Use "Harm" and delete "Patient". Add comma following death. Delete "previous" and make "therapies" singular.
  10. Potential Medication Error. Deleted. See Index for Categorizing Errors
  11. Prescription products. Deleted.
  12. Preventable event. Accepted without change.
  13. Severity. Council removed this term from the Glossary and developed the Index for Categorizing Errors to address severity.

[Janice Feinberg, Pharm. D., observer from ASCP made comments as an observer: Nursing facilities regulated by HCFA build in medication pass observation into Quality Improvement Programs. One looks for significant and insignificant errors (frequency). An error rate of less than 5% is acceptable in long-term care facilities.]

Index for Categorizing Errors
Mr. Myers noted that the Council needs to agree on a scheme that will be statistically sound. He suggested that the Council should not feel bound to the definitions already available and should consider something other than "levels of severity". The established categories should be applicable beyond hospital settings.

Discussions were broad in scope and included the following:

  • Are weights assigned to the categories?
  • How to distinguish between categories based on severity of injury and resultant hospitalization?
  • The severity levels used by FDA were presented.
  • How should the categories deal with deaths that are reversed? A person may arrest and die, but be resuscitated through the use of new drugs, and/or cardioversion. In such cases, is this captured as a death or injury?
  • Some of the group preferred indexing as opposed to severity grading. Some felt that the emphasis should be focused on the error and not the outcome. First thoughts of the group included categories as follows:
    • Circumstances that have the capability of causing error
    • Errors that do not cause patient harm, because they have been intercepted
    • Errors that do not cause harm because they are clinically insignificant
    • Errors that cause harm but are remedial at the intervention
    • Errors that cause harm but are not remedial
    • Errors that result in death (cardiac arrest)

Comments: If the system is geared to look for patient outcomes, then does it focus on the amount of harm to patient and not the error.

"Clinically insignificant" in category C is difficult to define. Does it require intervention? Should life-threatening be added as a separate item or combined with F? Several Council members agreed that these categories as listed were too vague.

Should the categories be numerically graded? Dr. LeNarz suggested the following:

No Error = 0 (A)
No Harm = 1 (B) & 2 (C)
Harm = 3 (D) & 4 (E)
Death = 5 (F)

The group felt that not all variables would be addressed by this structure. At this point, the subject was tabled until Tuesday, Day 2.

Meeting adjourned for the day at 5:00 p.m.

Day 2

Tuesday, July 16, 1996, meeting reconvened at 8:30 a.m. Observers were reintroduced including Mary Ann Wagner from NACDS and Anna Poker, USP. NABP was the only Council member not represented on Day 2. Michael Cohen, Chairperson, USP Advisory Panel on Medication Errors, and Tom Granatir (AHA) departed after the morning session.

The Secretary introduced a drafted version of "Medication Error Index for Categorizing Errors" based on the discussions of the previous day. This topic was tabled until later in the meeting.

Call for Reporting Systems
Tom Granatir introduced the drafted survey for identifying systems presently in existence for reporting and tracking medication errors. Questions followed:

  • Will responses reflect the smallest of systems available in each and every institution? Paragraph #3 may look like an overture to do business. Change the wording "developing relationship and linkages".
  • May need to change the last line of paragraph #2. Need to be specific in wording. The letter needs to state exactly what the Council wants to capture, e.g. indicate "computer programs" if you do not want manual programs.
  • Letter is not clear what the relationship would entail? Should Council share information with respondents?
  • Focus on computer-based multisite systems.
  • In the first sentence, identify outstanding models and incorporate that language into the call.

The letter will be redrafted to address these concerns.

Recommendations for Prescription Format
Team members:

  • Kim Keller
  • Joe Cranston
  • Deborah Nadzam
  • Susan Winckler
  • David Work
  • Teresa Mullin

Eight recommendations were drafted by the team and discussed by the group.

Recommendation #1: All prescription documents should be legible and prescribers should move to a direct computer order entry system to reduce errors. Accepted without change.

Recommendation #2: Prescription orders should include a brief notation of purpose (e.g. for cough) in order to avoid misunderstandings by patients or pharmacists. Discussion:

Dr. Cranston spoke in behalf of the physician population. He noted that confidentiality is a problem for physicians with putting the purpose of the prescription on the prescription blank. This may increase liability. Physicians do not want pharmacies to have access to the patients diagnosis.

Teresa Mullin read from the AMA policies that what the group was requesting was consistent with AMA policy.

Mr. Cohen echoed the importance of including the purpose on the prescription if avoiding medication errors is our goal.

Mr. Smith thought that capturing the purpose would assist the patient as well. He liked the idea of purpose for drug on the prescription.

Mr. Myers felt that as a practice policy, the purpose should be expressed. This could improve communication between the physician and pharmacist.

Mr. Smith suggested wording to read "Except where deemed inappropriate by the prescriber." This wording was acceptable to Dr. Cranston.

Recommendation #2 approved as follows: Prescription orders should include a brief notation of purpose (e.g., for cough) unless deemed inappropriate by the prescriber.

Recommendation #3: Prescribers should not use abbreviations other than the common designations for gram, milligram, microgram, liter, milliliter, intravenous, intramuscular, and subcutaneous.

Two abbreviations that cause confusion are SC and mcg. Should Council develop a list of abbreviations that should never be used? There was strong sentiment by the prescription writing subcommittee that all abbreviations should be avoided. Some abbreviations are unavoidable—will the Council seem unrealistic and impractical in its recommendation to use no abbreviations in prescription writing? The Council supported development of a list by the USP Advisory Panel on Medication Errors of abbreviations that are especially dangerous, e.g., U and qid

Recommendation #3 approved as follows: Prescribers should avoid the use of abbreviations, including those for drug names (e.g., MOM, HCTZ) and Latin directions for use. The following abbreviations are especially dangerous: TABLE TO BE DEVELOPED BY USP ADVISORY PANEL ON MEDICATION ERRORS.

Recommendation #4: All prescription orders should be written in the metric system except for therapy where units are standard such as insulin, vitamins, etc. Units should be spelled out rather than writing "U". Accepted without change.

Recommendation #5: Prescribers should include age or weight of patient on prescriptions, when appropriate, to assure accurate therapy. Recommendation #5 approved as follows: Prescribers should include age, and when appropriate, weight of the patient on prescription or medication order.

Recommendation #6: Prescribers should not vague instructions such as "take as directed" or "PRN". Recommendation #6 approved as follows: Prescribers should not use "take as directed" or "take as needed" as the sole direction for use.

Recommendation #7: Exact dosage strengths should be specified such as milligrams rather than dosage form units such as tablets or vials. Mr. Smith noted that this would be fine for pharmacists but patients would not understand what was intended. The group pointed out that this recommendation deals with instructions to the pharmacist. Recommendation #7 approved as follows: The medication order should include drug name, exact metric weight or concentration, and dosage form.

Recommendation #8: A leading zero should always precede a decimal expression of less than one and a terminal zero should never be used after a decimal. Accepted without change.

It was suggested that a ninth recommendation be added: numbers should be expressed in Arabic rather than roman numerals. This was not accepted by the group.

Medication Error Index
The index tabled at the beginning of the meeting was reintroduced. Little discussion ensued. [Click here for the approved Medication Error Index.]

Legibility Recommendations: Discussed and sent back to subcommittee (chaired by Dan O'Neal). Questions and comments by the group included the following:

  • Include cautions about typing and mouse misuse?
  • Have any studies been done to show that automation will reduce errors?
  • Preprinted prescription blanks are unrealistic. Long term care is precluded from having preprinted orders.
  • Should the Council simply make recommendations for better communications?
  • Will handwritten communication cover transcription, in the event that handwritten communication is necessary.
  • Should the Council identify persons who should not write orders?
  • The industry should more effectively educate about new drugs.
  • Market to other health care professionals.
  • Risk managers should disseminate information on new drugs.

Does the Council need to have someone present at the next meeting to discuss computerization in health care or should a subcommittee of the Council monitor and report on the issue? There are software and system vendors at PBM level and at prescriber level. Where would Council focus?

ACTION ITEM: Conduct a literature search for errors in computerized orders. Have a guest speaker address the Council regarding computerization in health care.

The chair pointed out that at this one-year anniversary of the Council, we need to know what the group thinks we should be doing in the next year or if there are any particular priorities to be set. Discussions ensued:

A major priority should be to turn these discussions into recommendations. This group could be the seed body for USP to create products. Create a listing of programs and products that are available through the Council (Myers).

What can we hang our hat on? Keep the recommendations together and track what we have done. Need to release our successes.

Heighten awareness in reporting. Address standardization. Provide feedback. A body of recommendations should come out from this group. Council recommendations should be based on outcomes presented by USP Advisory Panel (Cousins).

Create a research agenda. After two years we should be able to address what has been done. Create a list of 1996 recommendations and then add to this year by year (Myers).

The Council may do some big things that do not necessarily result in a recommendation. The recommendations are a small piece of the pie. The Council should begin to look at other areas besides prescription writing. Allow us to address the larger issues as well (Cranston).

There is a need for Council members to become more knowledgeable about the computerization aspects (Mullin).

The Council should examine the literature and see where the gaps are in the research. Create a list of topics we want to know to know more about. If no research data exists in the literature, then a definite gap exists (Myers).

An objective of the conference, Examining Errors in Healthcare in Rancho Mirage in October will be to develop a research agenda which could benefit the Council's work (Hanold).

Each member should come prepared to discuss (a round table) what we need to know more about, and these items should then be put on the agenda. This group has to make recommendations to USP about educational prospects. How do we address the regulatory and licensing groups? How do we split up activities between FDA, NABP, NCSBN, USP, etc.? How do we decide who we need to reach? We need to brainstorm on how we are going to communicate the recommendations made to date (Myers).

To whom should we send the call for systems? — Kaiser, Humana HCA. PBM (Medco), Columbia, Intermountain, AETNA Health Care, hospital chains, pharmacy associations, long-term care groups (Richards to provide list), VA system, Indian Health Service, Department of Defense, computer vendors, American Society for Automation in Pharmacy, AHA, Owen Health Care, Premier Hospital Alliance, NY State Board of Health, etc.

To whom do we send the Recommendations for Prescription Writing? — Deans of Health Professions Schools, Press releases, state medical societies, AAMC, masters prepared professionals, AANP, etc. AMA has a web site. Hot linking is the best mode.

Should we create a task force for looking into product packaging, labeling and nomenclature? — USP has a task force on bar coding and a subcommittee on labeling changes. FDA has nothing on the table as far as proposals. In the area of OTC's, the FDA has plans to standardize this labeling. The Council may want to focus on prescription products. The NCC MERP will be a good source for commenting on FDA proposals. Kim Keller reported on the USP proposals regarding simplification of labels.

ACTION ITEM: Task Force formed: Mike Cohen, LeRoy LeNarz, Kim Keller, Diane Cousins, Charlie Myers, Alice Till, Sharon Holston. The task force will separate the nomenclature from the labeling and packaging.

Meeting adjourned at 2:50 p.m.

Meeting Date