The Vaccine Identification Standards Initiative

VISI HOME

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

Meeting Proceedings

Vaccine Identification Standards Initiative (VISI)

October 21, 1997 Atlanta, GA

BACKGROUND

The Centers for Disease Control and Prevention (CDC) hosted the initial meeting for a Vaccine Identification Standards Initiative (VISI) to improve the accuracy, efficiency, and "user-friendliness" of the transfer of essential vaccine identifying information from vaccine vials/packaging to patients' medical records. The VISI is a concerted effort by multiple partners in our immunization system: the federal government (CDC, FDA), the vaccine industry, state immunization and registry programs, non-governmental health-related organizations (e.g., AAP, AMA, All Kids Count), healthcare providers, and technical organizations (e.g., Uniform Code Council). The first meeting of the VISI convened 21 October, 1997 at CDC in Atlanta, Georgia. (See Appendix A for meeting agenda and Appendix B for participants list.)

PLENARY SESSION

Introduction

Dr. Bob Chen of CDC launched the meeting by describing the current increased diversity/complexity inherent to vaccine "exposures".  Recent changes in the immunization program include:

Formal pre-licensure evaluation of interchangeability of some vaccines is limited. Therefore, current recommendations for some (e.g., DTaP) advise using the same brand for all doses. The vaccine community relies primarily on post-marketing surveillance for detecting rare adverse events and confirming effectiveness. Accordingly, the accuracy of surveillance data is of paramount importance.

Compliance with such recommendations requires accurate record-keeping practices, especially in light of the high health plan turnover rate. The National Vaccine Childhood Injury Act of 1986 requires the recording of 1) date of vaccination; 2) manufacturer and identity of the vaccine; 3) lot number; and 4) name, address, and title of the person administering vaccine. Under the many current systems of recording, these requirements have become increasingly burdensome to providers; yet failure to maintain accurate records of immunizations will undermine the timely and appropriate administration of vaccines for children. Record inaccuracy will have deleterious effects on studies of vaccine coverage, efficacy, and safety.

New solutions to remedy the current problems in recording essential vaccine identifying information are imperative for the success of computerized immunization registries. At present, full implementation of registries may be 5-10 years away. Most private providers are not linked into registry systems. Moreover, vaccine manufacturer and lot number are not routinely captured in existing systems.

Complementary solutions to record-keeping problems may include educating both providers and recorders of vaccine information and making the entire recording system as "user-friendly" as possible.

Problems and Potential Solutions: An Overview

Dr. Bruce Weniger of CDC opened the presentation segment of the meeting with an overview of existing problems inherent to vaccine identifying information as displayed on packaging and the recording of vaccine information. A series of photographs of various vaccine packages illustrated that lot numbers can be 1) difficult to locate on vaccine packaging; 2) easily confused with manufacturers' internal control numbering; and 3) difficult to read (i.e., extremely small lettering and/or the use of embossing versus printing). Additionally, multiple lot numbers and expiration dates on packaging can be misleading. In the case of some combination vaccines that must be prepared by combining the contents of two vials by the immunization provider at the time of vaccination, the liquid vaccine, powder vaccine, and the exterior packaging (containing both) may each have uncoordinated, individual lot numbers and expiration dates (though the exterior package typically reflects the expiration date that coincides with the vaccine that expires first). Accordingly, the provider may record a lot number that does not reflect the actual vaccine administered. Vaccine identifiers (especially lot numbers) were not designed for routine manual recording for tens of millions of doses administered each year. Current identifiers were established without consideration of the needs of end-users to record them for diverse products.

Vaccine Information Panel

Several potential solutions to these problems were presented. A standard location on vaccine packaging could display a panel of the information needed for recording by immunization providers. A prototype panel emulated the "Nutrition Facts" panels currently provided on food packaging. The "Vaccine Information" prototype panel (Figure 1) utilized distinctive, bold fonts and easy-to-locate headings to detail:

-vaccine type
-manufacturer
-brand name
-National Drug Code (NDC)
-lot number
-expiration date
-volume
-doses
-storage instructions
-U.S. Government license number
-distributor
-immunization registry code

Suggestions were also made to include information that does not currently exist on packaging, including 1) a uniform "vaccine type" code (e.g., DTaP, DTaP-Hib, Hib, HepB, Hib-HepB) 2) a uniform "manufacturer" code (i.e., PMC might indicate Pasteur Mérieux Connaught); and 3) bar coding for NDC, lot number, and expiration date. Photographs of vaccine packaging illustrated that adequate space already exists to facilitate a Vaccine Information panel for many existing vaccines.

Bar Coding

Bar coding of vaccine information will facilitate electronic scanning into medical, billing, and inventory records, and will ease the transfer of relevant information into immunization registries. Uniform code names for vaccine type and manufacturer may reduce transcription errors for those providers who continue to manually transcribe vaccine identifying information.

Peel-off Stickers

Peel-off stickers provided in the vaccine package may further reduce transcription errors. These may be printed with bar codes for NDC, lot number, and expiration date, with corresponding text and text detailing manufacturer, type, and brand name (Figure 2). Such stickers could be placed directly into patients' records.

Standard Immunization Registry Form

For users without scanning capabilities, a harmonized, nationally-uniform immunization form was suggested. Its design would accept the peel-off stickers for use by immunization registries. An additional solution is rethinking and standardization of lot numbers, potentially incorporating intelligible information on both manufacturer and vaccine type.

Error Rates

Vaccine Adverse Event Reporting System (VAERS)

Dr. Gina Terracciano, national Vaccine Adverse Event Reporting System (VAERS) Project Officer at CDC, presented data from a preliminary analysis to illustrate the magnitude of errors resulting from existing transcription methods and practices. The proportion of the 9,184 1997 (Jan.-Sep.) reports received in the VAERS database with missing lot numbers is approximately 20.2%. This percentage increased steadily from 12% in 1993. Assuming <5 VAERS reports for a particular lot number reflects an inaccurate lot number, the proportion of such reports in 1997 (Jan.-Sep.) received in the VAERS database with inaccurate lot numbers is approximately 14.3%, having increased steadily from 9% in 1992. (Note: The reported percentages for 1997 may change with subsequent follow up with 1997 reports.)

Vaccine Safety Datalink (VSD)

Dr. Frank DeStefano, Vaccine Safety Datalink (VSD) Project Director at CDC presented data from the VSD, a large-linked database study of adverse medical events and vaccination. From June 1991 to May 1994, two of the VSD HMO reporting sites administered 49,581 doses of one particular vaccine procured from one particular manufacturer. The number of missing or incorrect lot numbers reported to VSD was 9,574, or 19.3%. It should be noted that the lot numbers were reported in unedited text fields; accordingly, errors are attributable to erroneous human transcription and data entry (i.e., transposition of characters, omission of necessary characters, inclusion of superfluous characters). From a review of a sample of records, however, it appeared that the most common error in this case was due to the insertion of a hyphen in the lot number field, an error which could be avoided by standardizing the lot number formats. Dr. DeStefano noted that to ensure quality vaccine lot data in automated registries, both manufacturer and lot number must be entered into the database and transcription and data entry errors must be minimized. Dr. DeStefano also indicated that a standard format for manufacturer and lot number data might reduce existing errors rates.

The Immunization Registry and Provider Perspectives

Ms. Colleen Shields Bear, registry analyst to the Georgia Chapter of the American Academy of Pediatrics (AAP), described features of the 1996 AAP policy on immunization tracking systems. Features included documentation of immunization status, creation of effective and efficient immunization delivery steps, increase of immunization rates, decrease of immunization costs, and facilitation of immunization opportunities. She corroborated the need for standardization in vaccine data management including redefining, standardizing, and bar coding vaccine lot numbers, agreeing upon immunization record codes, and agreeing upon protocols. Ms. Bear underscored the importance of coordinating VISI efforts with practice management and billing systems vendors to eliminate duplicate data entry, implement standards into systems, coordinate efforts nationally, create "physician friendly" registries, and reduce health care costs. She indicated that 90.9% of pediatricians have computer systems; accordingly, registry dollars should be invested in vendor connectivity.

Dr. Jan Fitzgerald-Soapes, president of the Georgia Chapter of the AAP, and a practicing pediatrician, detailed the pediatric immunization process underscoring the significant proportion of time expended completing required paperwork. Dr. Fitzgerald-Soapes indicated that there are twice as many vaccines as there were five years ago. She described the atmosphere of her office as "controlled chaos," with four nurses and approximately 120 children per day to be vaccinated plus 120 more children who require attention for illness. A child's vaccination visit at two months of age requires 15-20 minutes, of which more time is spent facilitating the "paper processing assembly line," than administering injections. This hectic environment results in records that may be illegible and/or inaccurate. Dr. Fitzgerald-Soapes emphasized the need to simplify the recording process via uniform standards for vaccine information including manufacturer, vaccine type, expiration date, lot number, and removable bar codes. Dr. Fitzgerald-Soapes echoed Ms. Bear's assertion that practice management software vendors must be included in future discussions. Finally, she indicated that VISI is timely, as AAP recently passed a resolution recommending that vaccine manufacturers bar code all vaccine vials with uniform standard lot numbers and provide bar coded labels that can attach to medical records (Appendix C).

Ms. Cindy Skipper, a registered nurse with Promina NW Physicians Group, reiterated the day-to-day problems providers encounter. She noted that providers see twice as many patients during the same amount of time but must maintain the vaccine coverage in all. Additionally, the "old" vaccine system required only three shots; today, the number of shots continues to increase to as much as a dozen. Accordingly, recording information on these vaccinations is becoming "overwhelming." Ms. Skipper noted that nurses and assistants are making transposing and transcription errors "every day." She stressed the importance of education to enhance the probability that providers will "buy into" new standards and protocols. She commented that peel-off stickers would improve convenience and that three copies of such stickers per vaccine administration should be sufficient for record-keeping purposes.

Mr. Bill Watson of All Kids Count (AKC), a Robert Wood Johnson Foundation initiative to develop immunization registries, offered his perspective on where the country stands in registry development. Fully mature registry systems do not yet exist. Moreover, the "quality of data leaves a lot to be desired." He noted that the largest challenge to registries is enlisting the support of private providers. Accordingly, new systems must be built from the bottom up. Making the reporting process simpler and faster will enhance the registry movement's chances for success. Mr. Watson noted that we cannot afford to continue the old system of paper and that cultivating the political will to bring private and public providers together on registry enhancement issues is problematic.

Dr. Alan Hinman of The Task Force for Child Survival and Development added that agreements on core data requirements are currently being made by registries and that registries would likely cooperate with the standardization of vaccine identifiers. Accordingly, he urged that standardization proceed rapidly to circumvent future compatibility problems.

Regulatory Authority

Dr. Norman Baylor of the Food and Drug Administration (FDA) detailed requirements for vaccine packaging labeling. He noted that the FDA does not stipulate the method by which lot numbers are presented on packaging (i.e., printing versus embossing). Dr. Baylor remarked that no regulatory impediments exist to including bar coding on vaccine packaging. It should be noted, however, that a bar coding scheme would need to be reviewed by the FDA if it codes "prescribing information." Finally, Dr. Baylor indicated that regulations will not inhibit progress toward a systematic way of delivering essential vaccine information

The Vaccine Industry: Technical Issues

Mr. Ronald Filipski of Pasteur Mérieux Connaught (PMC) provided information regarding the vaccine industry's current processes and technical issues with regard to labeling of vaccines. Mr. Filipski's presentation was not intended to represent the position of the vaccine industry with regard to VISI. Vaccine manufacturers that contributed to Mr. Filipski's presentation via pre-VISI meeting conference calls included (in addition to PMC) Chiron, Merck, and Wyeth-Lederle.

Lot Numbering

Each manufacturer uses a unique system for lot numbering and unique equipment for packaging and labeling. Additionally, PMC, for example, uses different lot numbers for vaccines distributed in Europe versus those released in the United States. Mr. Filipski noted that there may be significant capital expenditure related to revamping lot numbering systems. Accordingly, manufacturers would be more interested in altering lot numbering systems if a mutual benefit could be realized. Manufacturers are, however, open to standardization that promotes "user-friendliness," or the ease-of-use of their products. Furthermore, it was noted that universal lot numbering may not address the true weaknesses inherent to the vaccine identifying information transcription and recording processes.

Bar Coding

Mr. Filipski identified problems regarding placing extended bar codes and text on small containers. First, a 6-point font is the smallest readable size that may be used for lot numbers. The ANSI lot number standard of 20 characters may be too long to fit on some labels. Making larger containers invites a cascade of problems including concerns about refrigeration, shipping, and waste disposal.

Sticky Labels

Mr. Filipski called attention to the small size of primary containers; he indicated that little room exists to apply a set of sticky labels to a primary container. Moreover, sticky labels can slow line speeds and overall capacity and add costs of two to 10 times that of regular paper labels. He also exhibited concern about providers' control of package stickers and package inserts.

Conclusions

Bar coding was considered the next logical step but concerns were raised regarding limited space on packaging, the need for a standard, the need for simplicity, and the need to have bar codes of the correct size to minimize scanning errors.

Mr. Filipski concluded that solutions are available, but not without cost. He underscored the importance of involvement of the end-user in this process and the importance of end-user education. Furthermore, new standards should be compatible with individual manufacturer innovation (competition) and should accommodate technologic advances.

Commentary

Mr. Robert Rosofsky of the Massachusetts Immunization Information System commented on the existence of several problems that VISI must confront including the standardization of lot numbers and the abbreviation of vaccine names. Furthermore, Mr. Rosofsky commented on an analogy made earlier in the meeting by Ms. Bear (i.e., we need ATM banking methodologies for this initiative [networks of ATMs were successfully developed and are fully functional because monies were allocated to achieve that end]). Mr. Rosofsky noted that ATM networks were funded with private money and organized by a fairly homogeneous set of organizations (i.e., banks) and that the analogy is not totally applicable to immunization registries.

Mr. Rosofsky also responded to Mr. Filipski's statement about cost increases in improved labeling of vaccines. Mr. Rosofsky stated that any concern about the relative cost increases for labeling vaccines appropriately should not be compared to existing labeling costs. Alternatively, costs should be compared to the total cost of the vaccine dose, as well as the associated costs when children contract vaccine preventable disease, or when children immunized with questionable or problematic lots cannot be easily identified.

Bar Coding/Symbology Issues

Mr. John Terwilliger of the Uniform Code Council (UCC) stated emphatically that accuracy is not possible via manual methods of transcription. Accordingly, virtually all sellers of merchandise in the U.S. have moved away from manual keying of cash registers to scanning of bar codes on products. He noted that the National Drug Code (NDC) is presently used in text and bar code on vaccines and other drugs, an advancement that does not exist yet on some other medical products. The NDC is a worldwide unique identifier; we should use it. Furthermore, a lot number and expiration date can be represented in a separate bar code or concatenated with the NDC bar code. Mr. Terwilliger encouraged participants to think about electronics and standards for the reduction of costs and acceleration of implementation. Bar coding technology is inexpensive. The purchase of scanning equipment would not be solely for the recording of vaccine information. Physician's offices may use scanners for many other applications. Mr. Terwilliger responded to concerns about space limitations and bar codes by noting that very small bar codes (smaller than UPC symbols) are now possible. He also noted that the use of bar codes and computers may also be used by providers for risk management.

Commentary

Dr. Chen inquired about how the transition from manual systems to electronic systems would be made. Mr. Terwilliger indicated that the change would be driven by efficiency. The greatest benefit would derive when everyone is using the electronic system. Even the smallest retail stores now have scanning equipment; this shift took place over relatively few years. He reiterated that the technology is inexpensive; thus, the upgrade from manual to electronic systems is not prohibited by cost.

Health Level Seven (HL7)

Ms. Susan Abernathy of CDC described the function of the Health Level Seven (HL7) standard protocol for medical information. HL7 is an American National Standards Institute (ANSI) accredited standards developer for clinical and operational electronic data interchange. The HL7 membership comprises approximately 2,000 organizations, including vendors, consultants, international affiliates, and a few federal agencies. HL7 is currently utilized globally in 11 countries. The latest version (2.3) of HL7 includes the capacity for messages designed to transmit the recommended core data set of immunization information for registries. For immunization registries to function most effectively, certain requirements must be satisfied. Such requirements include the unique identification of all vaccines and combinations, and distinction among vaccines of the same type but with different manufacturers that have different schedules or dosages. The HL7 messages include these data. The HL7 tables representing codes for vaccines are maintained by CDC/NIP to provide the timely establishment of codes for new or combination vaccines. For providers who report to immunization registries from practice management systems, a vaccine to manufacturer linkage is advantageous for accurate reimbursement.

BREAKOUT SESSIONS

Three breakout sessions were proposed, including a "Packaging" group to discuss a standard "Nutrition Facts"-like table for vaccine packaging; an "Identifier" group to discuss standards for unique identifiers for vaccine; and a "Labels, Bar Codes, and Records" group to cover peel-off "sticky labels," bar code possibilities, and immunization records and recording processes. While no objections were raised regarding the usefulness or feasibility (save for concerns about limited space on packaging) of a "Nutrition Facts"-like table on vaccine packaging, the topic did not generate sufficient interest among meeting attendees to warrant an individual working group. Thus, two large working groups were formed around the remaining two topics.

Identifier Group

The "Identifier" working group discussion was led by Dr. Bob Chen. Dr. Chen delineated the goal of the "identifier" portion of VISI as follows: Develop a single field/variable where desired specific information on vaccine type, manufacturer, and lot number can be recorded easily by both manual and automated recording systems. Several possibilities for lot number formats were presented with associated pros and cons. For example, a lot number including variables for MANUFACTURER-VAX TYPE-EXP DATE-LOT might appear as MSDMMR97AA. Such a "lot number" would not require a decoder for human comprehension on sight; however, the VAX abbreviation could become unwieldy with future combination vaccines (e.g., DTaP-Hib-HepB-IPV). A potential solution would be to simply list the number of vaccine types (e.g., pentavalent vaccine might use "5VA" for "vaccine type"). As lot numbers have historically been used for internal industrial needs, they were not designed for routine manual recording on the order of millions per year. Accordingly, Dr. Chen's suggestions for reengineering lot numbers included avoiding information unnecessary for the end-user, using an internal manufacturer "translation" table between "old" and "new" lot numbers (or using two separate lot numbers), avoiding nonsensical/logical strings to decrease transcription errors, and integrating existing standards (e.g., HL7) if possible. The industry representatives indicated that these options would be explored and that a response would be tendered at a later date.

Labels, Bar Codes, and Records Group

The Labels, Bar Codes, and Records group discussion was led by Dr. Weniger and Mr. Joshua Schwartz of CDC.

Adhesives for peel-off sticky labels

Peel-off sticky labels were considered a transitional technology for use until bar code scanning into electronic medical information systems could become standard in all immunization practices. One concern raised was whether peel-off stickers on a medical chart would be an acceptable component of a medical record (e.g., a sticker might be removed and reapplied elsewhere, improperly altering the medical record). Additionally, the adhesive might allow the sticker to fall off after some time. Alternatively, an adhesive might adhere too well and, if misapplied initially to the wrong place or the wrong record, might be impossible to reposition. An industry representative indicated that the proper adhesives could bond to paper for many years, but the adhesive does not "set up" and bond tightly until some time after initial application, permitting re-application if the sticker is initially misplaced or misaligned on a form. An informal test was performed using the peel-off sticker for the Merck hepatitis A vaccine. It was applied to paper and a few seconds later lifted off without damaging the paper.

To satisfy concern over the integrity of the medical record, one participant suggested borrowing from blood transfusion record-keeping practice: After peeling off the sticker identifying the transfusion bag and applying it into the patient's chart, the practitioner signs his or her name across the sticker and onto the record form. Any subsequent loss or repositioning would thus be detectable (and proper replacement facilitated if a label fell off).

Packaging multiple peel-off sticky labels

There was discussion about how many duplicate labels would be needed for each dose, and how to package these. In principle, up to three labels might be needed for each dose: one for the medical record (perhaps on a nationally standardized vaccine record form); a second for the patient's take-home "medical passport" or other record to document vaccination for school entry; and a third for placement on a form for mailing or faxing to the immunization registry (unless a copy of the medical record form would suffice). Multiple-dose packages and vials commonly contain up to 10 doses of vaccine, which might require 30 identical stickers. Concerns arose as to whether a sheet of labels could compete with the package insert for scarce space inside the package. One idea was to borrow from new packaging practice in the garden insecticide field in which extensive, multiple-page product warnings and instructions for consumers are placed behind a main product label that can be peeled off on one side and resealed to hold the pages or inserts. Industry representatives expressed concern about the costs of such labeling.

Loose or attached

Another issue raised was whether the peel-off sticky labels would be attached to the vial or package, or be loose. One manufacturer representative was concerned that loose sticky labels would be stored separately by staff (perhaps in a drawer) and lead to inadvertent errors in matching to the corresponding vaccine that the child received. If attached to the vial, the small size of most vials would require a label long enough to hold a bar code to attach at one end only and wrap loosely around the vial (as illustrated by the Fort Dodge brand of a unit-dose veterinary vaccine shown in the plenary session). A related issue was that many practitioners discard the cardboard packaging of multi-dose vials and save only the vaccine vial in the refrigerator. Several questions were raised:

According to one manufacturer, vials are stored unlabeled until an order is received. Stickers attached to vials might have to be printed on the manufacturing line--a scenario considered problematic by the industry representatives.

Bar coding

Other topics discussed included whether full bar coding (NDC no., lot no., exp. date) of vials (in addition to outer packaging) was practical, considering their small size, for scanning-capable clinics which did not want to save outer packages of multiple-dose vials. The Uniform Code Council representative indicated that newer, higher-density information coding had been developed that would permit the code to fit in much smaller space; but the additional cost of the hardware involved made this less practical for the short-term.

Further topics included (1) differing needs and priorities for complete vaccine information (NDC no., lot no., exp. date) between the medical record, the immunization registry, and the take-home vaccination "passport"; (2) the possible need for new studies and regulatory approval for storage time and temperature if the vaccine packaging were changed; and (3) encouraging providers to move exclusively to single-dose vials to circumvent problems with multi-dose vials (i.e., storage of multiple stickers, as well as unrelated problems such as wastage from incomplete use, contamination of subsequent doses, etc.).

CONCLUSION

Suggestions for next steps included a meeting of manufacturer representatives to discuss bar coding possibilities. A conference call with CDC was suggested. It was also suggested that draft "discussion" designs be proposed for standard peel-off labels and a uniform, harmonized immunization record form to receive these stickers (AAP suggested using its registry form as a model).

A suggestion was made to include practice management software vendors and HIS vendors in future VISI discussions. A separate meeting to convene top practice management vendors to discuss VISI issues was also recommended.

CONTACT PERSONS

Joshua G. Schwartz, MPH (email: zyc2@cdc.gov)
Bruce Weniger, MD, MPH
Robert Chen, MD, MA

Vaccine Safety and Development Activity
Epidemiology and Surveillance Division
National Immunization Program, MS (E-61)
1600 Clifton Road, NE
Atlanta, GA 30333


(return to text above citing Appendix A)

Appendix A: Agenda

Building 11 Conference Room, Corporate Square, Atlanta, GA
National Immunization Program (NIP), Centers for Disease Prevention and Control (CDC)
Tuesday, October 21, 1997

12:00 PM Welcoming Remarks

Dr. Robert T. Chen, Chief, Vaccine Safety and Development Activity (VSDA), NIP/CDC

Announcements

Mr. Joshua G. Schwartz, MPH, Vaccine Development Fellow, VSDA/NIP/CDC

Self-Introduction of Attendees

12:15 Overview of the Problems and Potential Solutions

Dr. Bruce G. Weniger, Assistant Chief for Vaccine Development, VSDA/NIP/CDC

12:30 PERSPECTIVES ON THE PROBLEMS AND POTENTIAL SOLUTIONS

12:30 Error Rates in Vaccine Adverse Events Surveillance Systems

Dr. Gina Terracciano, Vaccine Adverse Events Reporting System (VAERS), VSDA/NIP/CDC

Dr. Frank DeStefano, Vaccine Safety Datalink Project (VSD) VSDA/NIP/CDC

12:40 Immunization Providers

Dr. Jan Fitzgerald-Soapes, American Academy of Pediatrics

Ms. Cindi Skipper, RN, Promina NW Physicians Group

1:00 Immunization Registries

Mr. William Watson, Director & Ms. Kristin Saarlas, Deputy Director, All Kids Count, Task Force for Child Survival

Ms. Colleen Bear, Registry Consultant, American Academy of Pediatrics

1:20 Regulatory Authority

Dr. Norman Baylor, Associate Director, Regulatory Policy, Center for Biologics Evaluation, FDA

1:35 Vaccine Manufacturers

Mr. Ron Filipski, Pasteur-Mérieux-Connaught Vaccines

Ms. Gina Galliera, Senior Package Design and Development Engineer, SmithKline Beecham Pharmaceuticals

Dr. Denny J. Foley, Senior Director & Responsible Head, Wyeth-Lederle Vaccines and Pediatrics

Ms. Catherine M. Maher, Senior Director, Merck Vaccine Division

2:00 RELEVANT TECHNICAL ISSUES

2:00 Existing Standards for Bar Coding Small Pharmaceutical Packaging

Mr. John Terwilliger, Director, Health Care, Uniform Code Council

2:15 Data Transmission Standards for Immunization Registries

Ms. Susan Abernathy, Program Analyst, Data Management Division, NIP/CDC

2:30 INTRODUCTION OF WORKING GROUPS

Working  Group

Issue for discussion

1: "Packaging"

Standard "Nutrition Facts"-like table for vaccine packaging

2: "Identifier"

Standards for unique identifiers for vaccine

3: "Labels, Bar Codes,        and Records"

a) Peel-off labels; b) Bar coding; and c) Immunization records

**Charge for Working Groups: 1) Identify issues, concerns, ideas, pros and cons, constraints, caveats, solutions, incompatibilities for each topic. 2) Formulate a plan for action (e.g. next steps...)

2:40-3:00 Coffee Break

3:00 MEETING OF WORKING GROUPS

4:00 RECONVENE IN PLENARY SESSION

--Reports from working groups

--Identifying resources

--Formalizing action plans

--Scheduling future conference calls and meetings

5:00-5:15 ADJOURNMENT

(return to text above citing Appendix A)


(return to text above citing Appendix B)

Appendix B: Vaccine Identification Standards Initiative

October 21, 1997 Meeting Participants

FEDERAL GOVERNMENT

Susan Abernathy
Program Analyst
Data Management Division
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
saa6@cdc.gov
Norman W. Baylor, Ph.D.
Assoc. Dir. Regulatory Policy
Office of Vaccines, Center for Biologics, FDA
1401 Rockville Pike
Bldg. 29B, Rm 1H16 HFM-400
Rockville, MD 20852
baylor@a1.cber.fda.gov
Mary Ann Bryant
Supervisory Contract Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-01)
Atlanta, GA 30333
mab1@cdc.gov
Robert T. Chen, MD, MA
Chief, Vaccine Safety and Development Activity
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
rtc1@cdc.gov
Frank DeStefano, MD, MPH
Medical Epidemiologist
Vaccine Safety and Development Activity
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
fxd1@cdc.gov
Suzy Feikema, MPH
Public Health Informatics Fellow
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
sff9@cdc.gov
Joseph Henderson
Consultant
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-52)
Atlanta, GA 30333
jfh0@cdc.gov
Robb Linkins, MPH, PhD
Acting Chief, Systems Development Branch
National Immunization Program
Data Management Division
Centers for Disease Control and Prevention
1600 Clifton Road MS E-62
Atlanta, GA 30333
rxl3@cdc.gov
Marcel E. Salive, MD, MPH
Chief, Epidemiology Branch
Division of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Food & Drug Administration
HFM-220
1401 Rockville Pike
Rockville, MD 20852-1448
Salive@a1.cber.fda.gov
Joshua G. Schwartz, MPH
Vaccine Development Fellow
Vaccine Safety and Development Activity
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
zyc2@cdc.gov
Steve Sepe, MPH
Associate Director for Policy
National Vaccine Program Office
Centers for Disease Control and Prevention
1600 Clifton Road (MS A-11)
Atlanta, GA 30333
sjs2@cdc.gov
Robert Snyder
Public Health Advisor
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-52)
Atlanta, GA 30333
ros3@cdc.gov
Gina Terracciano, DO, MPH
Medical Epidemiologist
Vaccine Safety and Development Activity
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road (MS E-62)
Atlanta, GA 30333
gxt5@cdc.gov
Bruce G. Weniger, MD, MPH
Assistant Chief for Vaccine Development
Vaccine Safety and Development Activity
National Immunization Program
Centers for Disease Control and Prevention
1600 Clifton Road, (MS E-62)
Atlanta, GA 30333
bgw2@cdc.gov

VACCINE INDUSTRY

William Bursaw
Michigan Biologic Products Institute
3500 N. M. L. King Blvd.
Lansing, MI 48909
Ronald Filipski, MBA CPP
Director, Filling, Packaging, Warehousing and Distribution
Pasteur Merieux Connaught
Route 611
P.O. Box 187
Swiftwater, PA 18370-0187
rfilipski@us.pmc-vacc.com
Dennis J. Foley, PhD
Senior Director & Responsible Head
Global Regulatory Affairs
Wyeth-Lederle Vaccines and Pediatrics
401 North Middletown Road
Pearl River, NY 10965
Gina Galliera
Senior Package Design & Development Engineer
SmithKline Beecham Pharmaceuticals
One Franklin Plaza
P.O. Box 7929
Philadelphia, PA 19101
gina.galliera@sb.com
Stephen N. Keith, MD, MSPH
Vice President, Marketing & Sales
North American Vaccine, Inc.
12103 Indian Creek Court
Beltsville, MD 20705
skeith@nava.com
John E. Kropas
Sr. Package Development Engineer
Manufacturing Services
Wyeth-Lederle Vaccines and Pediatrics
401 North Middletown Road
Pearl River, NY 10965
Catherine M. Maher
Senior Director, Marketing
Merck Vaccine Division
Merck & Co., Inc.
P.O. Box 4, WP37B-312
West Pointe, PA 19486
katie_maher@merck.com
Yvonne McHugh, Ph.D.
Associate Director, Scientific Affairs
Chiron Vaccines
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
yvonne_mchugh@cc.chiron.com
Jeffrey L Seeley
Sr. Project Packaging Engineer
Merck Manufacturing Division
Merck & Co., Inc.
P.O. Box 4, WP78A-31
West Pointe, PA 19486
Jeff_Seeley@merck.com
 

STATE GOVERNMENT

Jim Allen, R.PH.
Director, Division of Pharmacy
Texas Department of Health
1100 West 49th Street
Austin, TX 78756
Del Carvell
Public Health Advisor
Family Health Branch
Georgia Immunization Program
Two Peachtree St., NW, 10.200
Atlanta, GA 30303-3186
dcc@ph.dhr.state.ga.us
Dennis D. Jones
Georgia Immunization Program
Property and Supply Supervisor
Two Peachtree St., NW, 10.200
Atlanta, GA 30303-3186
dxj@ph.dhr.state.ga.us
Sharon McKenna
Project Manager, Health Information
GA Division of Public Health
Two Peachtree Street, 3rd Floor
Annex Bldg.
Atlanta, GA 30303
smc@ph.dhr.state.ga.us
Robert Rosofsky
Director, MA Immunization Information System
Commonwealth of Massachusetts
Department of Public Health
Bureau of Communicable Disease Control
305 South Street
Jamaica Plain, MA 02130-3597
Robert.Rosofsky@state.ma.us

 

HEALTH CARE PROVIDERS

Patricia L. Hart, RN, BSN
Clinical Project Coordinator
Medical Management
Promina Northwest Health System
1791 Mulkey Road
Suite 207
Austell, GA 30106
Hart_Tricia@promina.org
Cindi Skipper, RN
Promina NW Physician’s Group
1791 Mulkey Road Suite 201
Austell, GA 30106

NON-GOVERNMENTAL HEALTH-RELATED ORGANIZATIONS

Colleen Shields Bear
Immunization Registry
Business Analyst
GA Chapter, American Academy of Pediatrics
1330 West Peachtree St., NW
Suite 500
Atlanta, GA 30309-2904
csbmag@mindspring.com
Alan R. Hinman, M.D., M.P.H.
Senior Consultant for Public Health Programs
The Task Force for Child Survival and Development
One Copenhill
Atlanta GA 30307
ahinman@taskforce.org OR arh1@cdc.gov
Celeste G. Kirschner
Director, Department of Coding and Nomenclature
American Medical Association
515 North State Street
Chicago, IL 60610
Celeste_Kirschner@ama-assn.org
Jan Fitzgerald-Soapes, MD
President
GA Chapter, American Academy of Pediatrics
1330 West Peachtree St., NW
Suite 500
Atlanta, GA 30309-2904
jsoapes@compuserve.com
Bill Watson
Director, All Kids Count
One Copenhill
Atlanta, GA 30307
wmwatson@taskforce.org
 

TECHNICAL ORGANIZATIONS

John Terwilliger
Director, Healthcare
Uniform Code Council, Inc.
8163 Old Yankee Street, Suite J
Dayton, OH 45458-1839
jterwill@mail.uc-council.org
Web site http://www.uc-council.org
 

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Appendix C:

Resolution of the American Academy of Pediatrics

(Note: This is a reproduction)

TITLE: Standardization of Vaccine Lot Numbers

SUBMITTED BY: Harry Keyserling, MD

DATE: September 8, 1997

DISPOSITION:

Whereas, national efforts to increase immunization rates through state-of-the-art
technology and computerized tracking systems are limited by the lack of
uniform standards in issuing vaccine lot number by vaccine manufacturers,
and this prevents the use of bar codes, which automates reporting of
immunization records; and

Whereas, two vaccine manufacturers could potentially use the same vaccine lot
number making difficult to trace a particular vaccine in the event of a
vaccine recall, therefore be it

RESOLVED, that the American Academy of Pediatrics shall recommend to vaccine manufacturers and the U.S. Food and Drug Administration that a uniform standard for vaccine lot numbering be established; and ensure that such lot numbers include the identity of manufacturers, the vaccine types, and are sequenced so that the potential of duplicating numbers is eliminated, and

RESOLVED, that the American Academy of Pediatrics shall further recommend that vaccine manufacturers bar code all vaccine vials with such lot numbers and provide bar coded labels that can attach to medical records.

REFER TO: Annual Chapter Forum

AUTHOR/ Harry Keyserling, MD

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Figure 1

 

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Figure 2

 

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