The Vaccine Identification Standards Initiative

VISI HOME

National Immunization Program / U. S. Centers for Disease Control and Prevention

Summary of Conference Call

February 20, 1998
2:00 PM - 4:00 PM EST

CALL PARTICIPANTS

Dr. Bob Chen (moderator)

National Immunization Program / CDC

Dr. Bruce Weniger

National Immunization Program / CDC

Joshua Schwartz

National Immunization Program / CDC

Suzy Feikema

National Immunization Program / CDC

Dr. Robb Linkins

National Immunization Program / CDC

Steve Sepe

National Vaccine Program Office / CDC

Gina Galliera

SmithKline Beecham Pharmaceuticals

Catherine Maher

Merck Vaccine Division

Jeffrey Seely

Merck Vaccine Division

Dr. Tom Vernon

Merck Vaccine Division

John Kropas

Wyeth-Lederle Vaccines & Pediatrics

Dr. Stephen Keith

North American Vaccine, Inc.

Patricia Hart

Promina NW Health System

Robert Rosofsky

Massachusetts Department of Public Health

Tracy Wright

Georgia Immunization Program

Jean Potiak

Georgia Immunization Program

Ellen Wild

All Kids Count

Carol Krueger

Center for Biologics Evaluation and Research / FDA

Karen Chaitkin

Center for Biologics Evaluation and Research / FDA

Elizabeth Leininger

Chiron Corporation

Brian Lee

Chiron Corporation

Tom McKenney

Chiron Corporation

Ellie Segal

Chiron Corporation

Barbara Baker

Oregon Immunization Alert

Dr. Richard Zimmerman

American Academy of Family Physicians

Jim Allen

Pharmacy Division / Texas Department of Health

Dinny Smith

Pharmacy Division / Texas Department of Health

Gene Trautmann

Pharmacy Division / Texas Department of Health

SUMMARY

VISI presentations

Joshua Schwartz, vaccine development fellow at NIP who is coordinating the VISI, informed the group about presentations about VISI which occurred since the October, 1997 face-to-face VISI meeting in Atlanta. At an FDA workshop entitled "Minimizing Medical Product Errors: A Systems Approach" on January 8, 1998, Mr. Schwartz described the VISI in the only presentation focused on vaccines. The goals and potential solutions of VISI were consonant with the key points reiterated by multiple speakers at the meeting: That better labeling of medical products is essential, and that education alone is not the answer to reducing medical product errors, and that improving systems for health delivery is essential.

VISI was also presented at the February 12, 1998 meeting of the Advisory Committee on Immunization Practices (ACIP) at CDC. The presentation generated interest in the Initiative from several of the ACIP members. Dr. Richard Clover, ACIP member from the University of Louisville in Kentucky, and Dr. Richard Zimmerman, liaison to ACIP from the American Academy of Family Physicians were identified to liaise with VISI.

Updates from interim working groups

The discussion opened with requested comments or reports from the interim working groups established at the October 21 meeting: Group 1 on "Lot Numbering" was to consider ideas for standardizing lot numbers to include intuitive characters not requiring code sheets to identify vaccine manufacturer and vaccine type. Group 2: on "Labels, Bar Codes, and Records"was to consider issues of adhesive technology, bar coding, label format, and the inclusion of peel-off identifying labels in vaccine packaging. No formal reports, however, were presented by members of either working group.

Mr. Rosofsky voiced concern regarding the nationwide use of a unified immunization form to record patients' vaccinations. He agreed that bar codes are critical for the future of vaccine information record-keeping, but suggested we avoid focusing our energy in the design of a prototype form to receive bar-coded stickers, as the future of vaccine record-keeping may be fully electronic. Ms. Hart countered this view by pointing out that many providers are far from implementing completely electronic systems. Further, a unified immunization form would be useful for simplifying vaccine data entry compared to what is used now, and it might be able to tie in to reporting to immunization registries.

Ms. Leininger questioned whether it was critical to have a standardized lot numbering format or system to identify vaccines. She noted that current lot numbering systems are intrinsic to the vaccine production/packaging process within companies and that altering this process would not be feasible.

Working group reformation, goals, responsibilities, and time lines

The discussions led to agreement that reformulating the working groups and dividing up the assigned topics would make the components of VISI more manageable. NIP staff were the only participants willing to volunteer to chair these workgroups, which were formed as follows

Group

Issues

Chairperson

I

Standardizing lot numbers; abbreviations for manufacturer and vaccine type

Dr. Bob Chen

II

Standardized national/international formats for vaccine identity (including National Drug Code usage issues), lot no., and expiration date; bar coding symbology for same: peel-off stickers

Dr. Bruce Weniger

III

Immunization record form, standardized information panel on vaccine packaging

Joshua Schwartz

Some call participants indicated their preferred working groups during the conference call. Others were asked to volunteer for one or more groups by contacting Mr. Schwartz with their preference (contact information below). Working group rosters will be circulated to VISI participants shortly. The chairs will plan necessary conference calls and meetings, specify issues for consideration, and generally coordinate communication and progress within the working groups.

Several conference call participants suggested that future calls should not be scheduled on Fridays.

Introduction of new prototypes and discussion

Before the call, VISI participants were faxed or mailed a new prototype Uniform Vaccine Administration Record (draft 1) form, containing a prototype bar-coded, peel-off sticky label updated from an earlier model shown in October. These were discussed, as follows.

Comments on the prototype Uniform Vaccine Administration Record

The form needs to include (1) space for the physician's name and for (2) specific allergy disclosures, and (3) a way to confirm that the patient, parent or guardian has received and read the vaccine information statements (VIS).

Consideration should be given to layout of the patient information on the form that would be flexibly compatible with printing machines used commonly to identify patients and related information embossed on credit-card-sized plastic cards. Similar space might be provided for printing doctor or clinic information similarly embossed on cards or plates.

Sections of the form that would be relevant to only some clinics or some states (e.g., vaccine source, private vs. public) should be indicated somehow, e.g., by grey shading (and explained in an accompanying legend) to provide guidance for those optional sections which may be retained, deleted, or used for another purposes at state, local, or provider discretion.

DTaP-Hib vaccine is not yet licensed for doses at 2 months and 4 months in the childhood immunization series. Thus it may be misleading to use these ages for the manual and peel-off-sticker entries of this vaccine used to illustrate use of the form for the hypothetical child, Jane Doe. Future illustrations should reflect the recommended childhood immunization schedule.

The form avoids placing data in areas of the left margin that might be punched with holes for standard 3-hole notebooks. The same should be done at the top margins for typical 2-hole, top-bound medical files.

Peel-off, bar-coded sticker

The sticker as it appears on the form would be too large to be attached to a vaccine vial. The limiting factors to reducing size further are the minimal width and size of the bar code symbology selected, and whether it would be possible to divide the necessary information into two rows of bar code. This will require some input and consultation from bar-coding symbology experts that were not available for this prototype. Although bar-coding with much higher densities of information are available, there is a tradeoff with the cost and availability of equipment to read these newer standards.

If the sticker is not physically attached to the "primary" (glass vial) or to the "secondary" (cardboard box) vaccine packaging, it could be misplaced and/or misapplied or confused with other stickers between doses from multi-dose vaccine packaging.

Ms. Baker noted that Oregon has been using bar-coded stickers supplied on waxed sheets for their immunization registry system for a year. There have been some problems with tearing of stickers on removal from the sheets. However, careful placing of the sticker pieces back together onto the receiving form has generally resulted in successful scanning.

If the scanning of bar codes directly from the vaccine packaging takes place at the provider's office, an electronic database would need to be established to store the information.

Concern was raised about the possibility and consequences of placing stickers in the wrong places on the immunization form. The thick-walled gray boxes of the same size as the stickers were designed to minimize this risk.

Discussion of new issues, ideas, concerns

Dr. Chen inquired whether vaccine manufacturers would consider providing bar code scanning equipment to immunization providers as a service to encourage the use of vaccine recording systems. Dr. Vernon (Merck) noted that the industry as a group had not discussed such an idea and that it would likely be a customer-relationship issue [not amenable to industry consensus]. He added that as long as manual data entry continues, there will be transcription errors. He inquired whether anyone had thought about analyzing the costs of a universal electronic vaccine information recording system for which every immunization provider would need to have bar code reader(s) [and computer hardware and software to capture the information].

Dr. Chen commented that it would be useful for the working groups to consider cost components and share such information with the group to determine whether it makes sense to pursue such a single solution. He also suggested expanding the role of Working Group II to include development of methods to help practitioners adopt the forthcoming standards.

Dr. Zimmerman added that the completely electronic system was an interesting idea, and that most practices already have computerized billing systems. He advised the group to think ahead, as technology is moving quickly ahead, and any new standards and computer systems proposed would likely be implemented after 1998.

Mr. Schwartz noted that an AAP representative at the October, 1997 VISI meeting claimed that over 90% of pediatricians already have computer systems. Ms. Segal added that the technology industry is developing chips to work in small appliances. Accordingly, in the future we may see bar code scanners that do not need to be connected at the time of the scan to a computer.

Mr. Rosofsky added that a cost-benefit analysis would be worthwhile and that medical practice management software generally does not collect immunization information. This is an area that needs improvement.

In conclusion, Dr. Chen asked that the working groups aim to hold monthly calls to discuss issues and findings and move the process along. The combined groups should plan to convene a second face-to-face meeting and/or a comprehensive document for endorsement within six months.

CONTACT INFORMATION

Joshua G. Schwartz, MPH           
Vaccine Development Fellow
Vaccine Safety and Development Activity
National Immunization Program, CDC (MS E-61)
1600 Clifton Road
Atlanta, GA 30333
E-mail: zyc2@cdc.gov