Rockville, April 1-2, 1996



NCC MERP Meeting Summary

April 1-2, 1996

Day One

The meeting convened at 1:50 p.m. on April 1, 1996.

In attendance were:

  • William Ellis (Council Chairperson)
  • Marcia Richards (AHCA)
  • Joseph Cranston (AMA)
  • Daniel O'Neal (ANA)
  • Susan Winckler (APhA)
  • Charles Myers (ASHSP)
  • Sharon Holston (FDA)
  • Alice Till (GPIA)
  • Deborah Nadzam (JCAHO)
  • David Work (NABP)
  • Teresa Mullin (NCSBN)
  • Diane Cousins (USP)
  • Michael Cohen (USP Advisory Panel on Medication Errors Chairperson)

Dale Austin (FSMB) did not attend the meeting on either day. Thomas Granatir (AHA) and Andrew Smith (AARP) were absent on April 1. The Pharmaceutical Research and Manufacturers of America did not yet advise the Council of a replacement delegate for Lawrence Gifford.

Guests were introduced and included MaryAnn Wagner of the National Association of Chain Drug Stores and Tom Clark of the American Association of Consultant Pharmacists. AMA appointed its alternate delegate, Marjorie Jaski, who was in attendance for the full meeting.

Chairperson, William Ellis, voiced a call for action, emphasizing the Council's ability to impact the writing of medication orders and prescriptions. He pointed out that broad recommendations will need the full commitment of each member organization.

Old Business

Meeting Summary for September 21, 1996
The Secretary pointed out that the only significant change to the draft summary was the FDA's proposed alternative wording for references to both USP and FDA Programs, and references to medication errors "databases" (plural) in the Council's reporting objectives. Mr. Cohen questioned the need for the wording change pointing out that FDA receives all reports from the USP Programs but FDA does not share the information and reporter names it receives with the USP or ISMP. Mr. Myers suggested that the summary be approved with the new wording and that discussions on this issue continue at a later date.

An omission was pointed out on the attendance list—Chairperson, William Ellis, was not listed among attendees.

VOTE: The meeting summary for the September 21, 1995, meeting was approved as amended.

NCC MERP Brochure

Teresa Mullin pointed out that the definition of a medication error in the draft brochure was not completely accurate. (This was noted for correction).

It was suggested that the inside page, second paragraph, should be reworded: "...has established a set of goals and objectives that will...." On the last page, it was suggested (Myers) that the word, "consonant", be stricken so that the sentence reads: "In an effort to assist the health care community, the Council agreed upon a definition of a medication error." Objection was raised (Cranston) to the term "spearheads" in the first paragraph and the suggested change reads: " ...was established to address..." The next sentence should read " The formation of the Council represents the collaboration of some of the nation's leading health care and consumer organizations to address challenges regarding the safe use of medications." The last sentence in the first paragraph should be changed to reflect the various organizations represented. It would then read: "...involvement of health care professionals, consumers, product manufacturers, standards-setters and regulators." It was pointed out (Holston) that in the second objective for reporting, the term "database" should be pluralized to be consistent with the reporting objectives of the Council. The second objective would then read: " Develop standardization or classification systems of medication error report collection, so databases will reflect reports and grading systems." It was emphasized that careful proofing of the stated objectives, goals, and definition should be done to assure consistency with the approved version.

VOTE: A motion to accept the brochure with the amended portions was seconded and carried.

Chairperson's Letter to Member Organizations
The drafted letter produced by Mr. Ellis to encourage reporting of medication errors was presented. The letter should not give the impression that there is only one program for reporting medication errors because the USP program is A national system not THE national system for reporting medication errors (Holston). It was decided that FDA and USP should meet within the next month and draft language for the letter addressing this issue to the satisfaction of both FDA and USP. It was suggested (Cohen) that FDA and USP also discuss how MedWatch information would be made available to USP, ISMP, and to the public.

There was mention (Cohen) of encouraging groups such as Premier Hospital Alliance and the State of New York to share their medication error information with USP. Other groups outside the Council also may need to receive such a letter from the Council (Nadzam). Examples offered were major journals in pharmacy, medicine, and nursing and all state departments of health (Cranston). The Council agreed that direct mailings of this letter by the Council to practitioners would be too costly. It was suggested that a paragraph be added about the scope of medication errors.

Options offered for distributing the letter included preparing the letter in camera-ready format; including a camera-ready reporting form; joint signature of the letter by Chairperson and each organization's executive; letter from the Chairperson sent to each member group and presented to members of Council organizations with a cover letter signed by organization's executive. Electronic reporting that would link a Council member's home page to a reporting Web site via internet should be considered.

A few members suggested that an additional review of the letter, once agreed upon by FDA and USP, would not be necessary if it is decided that a cover letter will be attached by each Council organization.

Activities Update

Next order of business was a round-table update from the membership on medication error related activities.

Med-use-indicators may identify process issues that could be shared. Conference on errors in health care organizations (Rancho Mirage, CA) sponsored by JCAHO may be of interest to members. AAAS has issued a call for papers.

Article appeared in American Nurse emphasizing the work of the Council and ANA's connection. Nurse Forum may expose the advanced practice nurses to the need for reporting medication errors especially from the prescribers point of view. ANA Convention will be held in Washington, DC June 14-19. American Organization of Nurse Executives would be a good point of contact for articles regarding medication errors, also NAPNE.

USP Advisory Panel Seat
The USP Advisory Panel on Medication Errors will hold its first meeting this summer. [On a personal note Mr. Cohen added that ISMP now has a web site with a section for reporting medication errors to USP; also, a biweekly subscription newsletter, Medication Safety Alert. Articles will be published in Hospital Pharmacy (systems involved in medication errors), and in American Journal of Health-Systems Pharmacists (preventing medication errors in cancer chemotherapy). The benchmarking study is completed and results will be forthcoming.]

Working on a grant for a tripartite study of systems in relation to pharmacy medication errors. North Carolina Board of Pharmacy has adopted a rule for reporting deaths—reporting is a mitigating circumstance and failure to report is considered an aggravating circumstance in Board hearings of pharmacists who err. Also, in North Carolina, both the pharmacist and the owner have been disciplined because an excessive number of scripts per day was being filled (750 Rx per day = 50 Rx per hour).

A call voiced by pharmacists to develop a support system for those involved in medication errors. The health care professional can be the victim as well as the patient.

In October 1995, ASHP held a follow-up event to the October 1994 medication errors conference. Results of the recent meeting were published as a summary with a list of six basic recommendations regarding the things that might be done in hospitals to prevent errors. Mr. Myers gave an overview of the Institute for Healthcare Improvement conferences that several members had attended.

Will look at laws that require disciplinary action on the part of the Board and look at the mitigating factors. May want to put article in Nursing Board Bulletin.

Prepared a short summary write-up on the last meeting for their journal/newsletter.

Grant on medication errors initiative. Proposals: Establishing a national patient safety institute (a foundation to develop programs to ensure patient safety). Department of geriatric health is coming up with an office certification program for physicians in community settings.

Convened the first Agency-wide working group to look at how review of applications can include an eye toward misuse with consistency from Center to Center on what is being approved.

Getting phone calls and received something from Ciba regarding study being done. Dr. Robertson from Washington State is very interested in a universal system for color coding by drug class, and for 3-digit identification codes on solid oral dosage forms. Anesthesia has had a color scheme for products for some time now. We may want to create a policy or, perhaps, this should be a topic for Council discussion.

Article appeared in The Standard summarizing the last meeting of the Council. Quality Reviews are frequently written with medication errors in mind. The Reviews educate health professionals and encourage reporting. AMA and USP collaborated on an article for physicians regarding medication error avoidance in written orders. A researcher has been selected (Purdue University—Drs. Michael Rupp and Holly Mason) to conduct the joint USP/ NABP/APhA workplace study of systems-based errors in the pharmacy ambulatory setting. USP has established its multidisciplinary medication errors advisory panel to routinely review error reports submitted to the USP Practitioners' Reporting Network, and to make recommendations to the USP Divisions of Information and Standards Development, to the Council, and to the USP reporting program. Five pharmacists, three nurses, and two physicians are represented on the Advisory Panel.

Mr. Ellis reported that Berlex is no longer a member of PhRMA which has resulted in the resignation of Dr. Lawrence Gifford. A letter was sent to PhRMA requesting that a new delegate be appointed.

Subcommittee Reports

Dr. Nadzam presented the results of the Glossary of Terms associated with the Medication Error Definition. Points for discussion were: clarify difference between a consumer and a patient; define prescription product versus non-prescription product; description of adverse event versus adverse drug reaction (i.e. Lucien Leape's or FDA's definition); for drug-related devices, add the parenthetical, "(e.g., respiratory therapy, dialysis)"; delete durable medical equipment from the list; patient harm should include death; severity levels need to be developed; delay development of classification schemes at this time; no need to define the list of terms under "other possible terms for glossary".

ACTION ITEM: This same work group will further develop the glossary and will draft severity levels for medication errors (Mr. Cohen and Mr. Phillips (FDA Alternate) volunteered to work on this also).

The subcommittee to develop a survey to help identify systems in existence for the identification, reporting, and tracking of medication errors was unable to create a draft document. To stimulate discussion, USP drafted a survey template. Points of consideration were: inclusion of long term care facilities as respondents to the survey; clarify the purpose of the survey and if it is beneficial to the Council's work; will this tool be used more in hospitals so that the data could be scientifically significant.

Members recalled that the original intention of the survey was to gather information for the Council's purposes. The Council needs to know what is happening in the health care system at the present time relative to reporting and reporting systems. The Council needs to ensure that the groups surveyed understand the purpose of the survey, how the information will be used, and its potential to impact their practice.

A suggestion was made to send out a tickler about the survey with the letter to be sent to major organizations, and then to put out a call for survey completion by practitioners.

Thomas Granitir and Marcia Richards will serve on this subcommittee.

The meeting of April 1, 1996, adjourned at 5:00 p.m.

Day 2

The April 2, 1996, meeting resumed at 8:00 a.m. In attendance were:

  • William Ellis (Council Chairperson)
  • Marcia Richards (AHCA)
  • Joseph Cranston (AMA)
  • Daniel O'Neal (ANA)
  • Susan Winckler (APhA)
  • Charles Myers (ASHSP)
  • Sharon Holston (FDA)
  • Alice Till (GPIA)
  • Deborah Nadzam (JCAHO)
  • David Work (NABP)
  • Teresa Mullin (NCSBN)
  • Diane Cousins (USP)
  • Michael Cohen (USP Advisory Panel on Medication Errors Chairperson)
  • Andrew Smith (AARP)
  • Thomas Granatir (AHA)

Michael Cohen (USP Advisory Panel) and Charles Myers (ASHP) were absent on April 2.

New Business

Prescriptions and Medication Orders
Diane Cousins presented, "The Error-prone Aspects of Medication Orders and Prescription Writing", a module of the USP Medication Errors Education Resource. The presentation included slides and case studies based on actual medication error reports.

Discussion: The group recognized one error-reduction strategy as the employment of computerized systems. The group did not know what percentage of hospitals actually have computers that are used in the drug delivery/patient care areas. Some members felt that research needs to be done to evaluate how effectively computer entry reduces errors.

Some broad issues open for discussion were legibility, abbreviations, information systems, and types of information available to health care practitioners. The Council members provided some areas for consideration:

  • Recommend education for all health care professionals in in the area of prescription writing and types of related errors. Medical schools do not teach prescription writing (formally) to medical students.
  • Standardize abbreviations or eliminate them altogether. (This will be a difficult task)
  • Provide a list of abbreviations that should never be used.
  • Eliminate the use of Latin in prescription writing.
  • Create educational tools for consumers: Place public service ads in Wall Street Journal,Washington Post.
  • Encourage consumers to demand proper counseling on the use of their medications. Patients should feel free to talk to the physician or other health care practitioner about medications.
  • Develop video segments for consumers on how to avoid errors

A brainstorming session resulted in significant areas for future work by the Council. [See brainstorming summaries in Attachment 1.]

The Council also discussed slogans of sorts that can be used:

  • When in doubt, write it out. (directed at the prescriber to avoid abbreviations)
  • Lead don't trail. (directed at prescribers' use of zeroes)
  • When in doubt, check it out. (directed at non-prescribers' ability to understand and read the written prescription)
  • Don't wait—automate. (directed at organizations' emphasis on computers)
  • Collaborate to educate. (directed at caregivers' teaching of patients about medications)
  • Check! Check! Check! Check! (directed at ALL to emphasize checks and balances from prescriber to dispenser to nurse to caregiver to consumer.

The Council should issue press releases for both patients and health professions listing recommendations addressing these issues. Each association should take back to their members the call from the Council. The participants commented that perhaps the "When in doubt" campaign would be a good approach. Patients need to be described as a part of the health care team. Patient safety should be our primary objective.

The Council determined that it needed subcommittees to tackle issues and draft recommendations.

ACTION ITEM: Develop a prescription blank with consistent format and content to prevent medication errors within the next 45 days. Members of this subcommittee are:

  • David Work, Chair
  • Susan Winckler
  • Teresa Mullin
  • Deborah Nadzam
  • Joseph Cranston
  • Kim Keller (USP Alternate)

ACTION ITEM: Draft legibility recommendations based on information recorded during brainstorming session. A conference call will be scheduled on or before May 3. Members of this subcommittee are:

  • Daniel O'Neal, Chair
  • Charles Myers
  • Joseph Cranston

ACTION ITEM: Secretariat will draft a news release for consumers with the theme, "Be sure you can read your prescription". NOTE: Deferred until after July meeting.

ACTION ITEM: Secretariat will draft a news release for health care professionals on prescription writing. NOTE: Deferred until after July meeting.

A presentation by Kim Keller highlighted the upcoming official USP title changes for injectable products. Discussion followed.

The Chair presented the idea of developing products available from the Council, such as mailing lists, bibliography of medication errors spanning a 3-year period, a directory of what each Council organization has available on medication errors. The ideas were discussed but no decisions were forthcoming.

The meeting adjourned at 2:50 p.m. The next meeting should be scheduled for the week of July 8.

Meeting Date