The Vaccine Identification Standards Initiative

VISI HOME

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

Workgroup I
Conference Call Summary
May 12, 1998
3:00 P.M. - 5:00 P.M. EST

Participants

Allen, Jim

Texas Department of Health

Carvell, Del

Georgia Immunization Program

Chaitkin, Karen

Food and Drug Administration

Chen, Robert (chair)

NIP / Centers for Disease Control and Prevention

Kropas, John

Wyeth-Lederle Vaccines and Pediatrics

Krueger, Carol

Food and Drug Administration

Maher, Catherine

Merck and Co.

Rosofsky, Robert

Massachusetts Department of Public Health

Schwartz, Joshua

NIP / Centers for Disease Control and Prevention

Smith, Dinny

Texas Department of Health

Trautmann, Gene

Texas Department of Health

Weniger, Bruce

NIP / Centers for Disease Control and Prevention

Summary

Heath Level Seven (HL7) Manufacturer Code Set

Dr. Chen described the HL7 Standard Code Set MVX, a table of two and three letter abbreviations for manufacturers of vaccines. (I.e., MSD = Merck and Co.) The National Immunization Program at CDC maintains the HL7 MVX code set for use in computer communications. Callers received copies of the table before the call. Dr. Chen noted that the Vaccine Identification Standards Initiative (VISI) may use abbreviations for manufacturers of vaccines with other information to uniquely identify vaccine products. Accordingly, VISI partners need not "reinvent the wheel" to identify vaccine manufacturers via abbreviation.

Callers noted that the names of vaccine manufacturers are subject to change with mergers and acquisitions common to the industry. Questions arose regarding whether the abbreviations would be subject to change on ownership/governance transitions in the industry and whether such actions would invite confusion in the use of abbreviations. Mr. Kropas noted that the company he represents has a history of changing its name. He added that upper-level corporate management will likely need to consider the abbreviation issue since VISI is considering the prominent display of abbreviations on vaccine packaging.

According to Dr. Weniger, abbreviations for the vaccine manufacturers could be useful in the following places:

1. On vaccine packaging (i.e., on a "Vaccine Information" panel that includes essential vaccine identifying and descriptive information)

2. On peel-off sticky labels (provided with the vaccine and used to identify the vaccine in the vaccinee's medical record)

3. As an element of an intuitive "lot number"

In addition to current abbreviations, the MVX code set maintains abbreviations that are no longer in use. It refers the reader from the "inactive" abbreviation to the currently used, or "active" abbreviation elsewhere in the table. Dr. Chen suggested that for VISI, the table could be stratified into two sections: "active" abbreviations and "historical" abbreviations. This stratification may make the table easier to use.

Mr. Rosofsky asked whether the companies had approved their respective HL7 manufacturer abbreviations. HL7 authorities were not available to answer the question on the call, but subsequent communication revealed that HL7 assigned the abbreviations without the cooperation of the manufacturers. Mr. Rosofsky suggested on the call that VISI should contact every manufacturer for their approval on the selected abbreviations.

Ms. Krueger questioned whether the HL7 list included international vaccine manufacturers. It does not. She mentioned consulting the International Conference on Harmonisation (ICH), a blending of consortiums of Japan, Europe and the U.S. attempting to standardize reporting between the manufacturers and the various federal agencies. Dr. Weniger added that the World Health Organization (WHO) maintains a list of international vaccine manufacturers.

Ms. Maher questioned whether VISI intended the abbreviations to be for the manufacturers/distributors of the vaccines or for the firm that received license from the FDA for the vaccine. Ms. Krueger noted that the vaccine manufacturers are the licensees but the group should decide which firm VISI should indicate for abbreviation (i.e., manufacturer or distributor). Dr. Weniger reminded the group that the purpose of the abbreviation is to help identify the vaccine. Accordingly, the vaccine abbreviation need not identify the vaccine's marketing chain. Dr. Chen agreed that the end-user does not need such complexity. Ms. Krueger suggested that the abbreviation should be for the company encoded in the National Drug Code (NDC). There were no objections to this proposal..

Dr. Chen outlined the following points requiring future action:

1. Determine if each manufacturer approves of its HL7 abbreviation

2. Use the WHO international vaccine manufacturer list to produce additional abbreviations where needed

3. Create a table of Active U.S., Inactive U.S., and Non-U.S. manufacturers (another suggestion was to concurrently maintain a single list referring inactive abbreviations to their active counterparts)

Vaccine Type Abbreviations

Mr. Schwartz introduced a table of potential vaccine abbreviations that participants received before the call. He explained that several vaccines have abbreviations commonly associated with them. He considered such abbreviations (i.e., MMR, DTP, Hib) historical and maintained them on the potential VISI abbreviation list to avoid confusion. Vaccines without common abbreviations were abbreviated according to the following arbitrarily chosen system.

Each word in the full vaccine name will be abbreviated with a maximum of three letters, beginning with a capital letter. Subsequent letters will be written in lowercase.

For example, Hantavirus vaccine could be abbreviated in the following ways: Han, or Hnt, or any other intuitive combination of letters beginning with a capital H and having no more than three total characters.

For vaccines with more than one word in their full names, the character sets are concatenated.

For example Meningococcal Conjugate could be abbreviated as MenCon. Staphylococcus bacterio lysate could be abbreviated as StLys.

Combination vaccines may be conjoined with hyphens.

For example, diphtheria, tetanus, acellular pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine could be abbreviated as DTaP-HepB-Hib.

Dr. Weniger identified three issues that require resolution:

1. Should VISI maintain historical abbreviations, or should all abbreviations conform to the same defining system?

2. How specific should the abbreviations be? For example, should the various conjugates of Haemophilus influenzae type b conjugate vaccine (i.e., PRP-D, HbOC, PRT-T, PRP-OMP) be included in the abbreviation, or should all such vaccines be abbreviated as Hib?

3. What protocol should VISI use to decide the order of the antigens in abbreviations for combination vaccines?

CDC asked callers to examine the list of abbreviations and make suggestions for changes. Draft # 3 of the table (attached) reflects those changes.

Mr. Rosofsky, on noticing multiple possible abbreviations for several vaccines, agreed that the group should select a single vaccine abbreviation only for each vaccine. Further, he suggested that abbreviations be treated as case-insignificant, as that is a requirement of some computer systems. Dr. Weniger suggested that mixing upper and lowercase letters in the abbreviations improves readability for humans; for computers, either all capitals or all lowercase could be used. For this to be feasible VISI must ensure that each abbreviation is composed of a unique set of characters; no two abbreviations may be alike, irrespective of the font case. The group agreed.

Combination Vaccine Considerations

Dr. Weniger questioned whether VISI should standardize the order of antigens in combination vaccine abbreviations by the chronology of the individual antigens entering the market or by another convention. Ms. Krueger noted that historically, combination vaccines licensed by the FDA have had their antigens ordered alphabetically based on the full name of the vaccine. The group did not object to this methodology. Dr. Chen noted, however, that VISI should consider allowing the antigen order to be chosen arbitrarily, case-by-case, or by manufacturer preference. In support of that point, Ms. Maher added that Merck prefers the abbreviation Hib-HepB, for example. Ms. Maher also mentioned, on noticing the ubiquitous MMR vaccine abbreviation, that for future vaccines containing measles-mumps and rubella antigens in combination with others Merck may avoid brand-naming the vaccines with seemingly generic names. This will avoid confusion between abbreviations for vaccine types and actual vaccine brand names.

Finally, callers agreed that VISI should consult front-line immunization providers for reactions regarding which abbreviations / conventions would be most useful. They suggested the use of a focus group consisting of immunization providers to consider possible conventions (i.e., do not allow a single letter to abbreviate a singular vaccine).

Rethinking Lot Numbers

Dr. Chen reviewed VISI's challenge to make vaccine lot numbers more intuitive and "user-friendly." Strings of nonsensical numbers and letters are difficult for humans to transcribe accurately. The American Academy of Pediatrics (AAP) shares the desire to improve lot numbers. In a 1997 resolution, the AAP specifically recommended "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 the manufacturers, the vaccine types, and are sequenced so that the potential of duplicating numbers is eliminated..."

Dr. Chen explained that manufacturers could likely maintain their current lot numbering systems internally, but display new codes containing intuitive information on vaccine packaging. The manufacturers could maintain records to match the new codes to their proprietary lot numbering systems. The immunization community has a great claim to the improvement of lot numbering systems since law uniquely requires providers to record lot numbers by the millions per year.

Dr. Chen offered an example of what a new "lot number" might contain: MFX-TYP-98-AB, where MFX = a three-letter manufacturer code (possibly from the HL7 standard); TYP = a three-letter vaccine type code; a two-digit year (perhaps the year of expiration or manufacture); and a two-character lot number. The two digit year could serve to delimit the number of lots. For example, if the year used were 98, there would be 26 * 26, or 676 permutations within the two digit lot number for that year. Manufacturers could reuse these permutations in the following year, 99, but take the overall "lot number" together would be unique for years to come.

Ms. Maher said she would look into the manufacturing department at her company to determine the feasibility of maintaining "external" and "internal" lot numbering systems. She also suggested that VISI convene a teleconference with the manufacturing department experts in the industry. Dr. Chen agreed.

Dr. Chen asked the group if an alternative exists to using a two-digit year to limit the lot number length. They suggested none. A participant noted it, however, that minimizing what providers record in medical records requires the recorded information to be more accurate, because backtracking with only partial information would be difficult. Dr. Chen suggested a focus group of front-line providers to find out what sort of lot numbering and recording system would be most helpful to them.

Mr. Rosofsky suggested that whatever system is chosen, VISI should avoid redundancy in recording. The group agreed.

Dr. Chen concluded the call by asking that the manufacturers investigate the feasibility of two concurrent lot numbering systems. If manufacturers maintain a decoder for a new lot-numbering scheme, is there any reason why end-users need to see internal lot numbering on vaccine packaging?

CDC will organize another call in June with representatives from the manufacturing departments of the vaccine producers.

Contact

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

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