Docs' Input Sought for Survey on Two-dimensional Vaccine Bar Codes

Alternative Technology Could Facilitate Adverse Event Reporting

April 20, 2011 02:40 pm News Staff

Two-dimensional bar codes, or data matrices, may someday complement traditional linear bar codes found on vaccine vials and syringes, allowing FPs and other vaccine providers to simply scan and upload information identifying the vaccine's manufacturer, national drug code, expiration date and lot number to their electronic health record, or EHR; practice management and billing; or other computer system.

If implemented, such a technological breakthrough could permit physicians to more easily meet the National Childhood Vaccine Injury Act, or NCVIA, requirement(www.in.gov) that vaccine administrators report certain adverse events related to identified childhood vaccines, while reducing the potential for clerical errors. It also could offer clinicians a means to manage their vaccine inventories more efficiently and accurately.

The question is, will physicians be willing to invest in the technology required to implement such a system? To find out, RTI International -- a not-for-profit research organization under contract with the CDC -- is surveying primary care physicians about their use of EHRs and other computer systems, vaccines they provide, and vaccination reporting patterns. Physicians who take the 10-minute, online survey through May 27 will be entered in a drawing to win one of 10 Apple iPads.

The FDA said in draft guidance issued to vaccine manufacturers in August 2010 that the agency thinks health care providers may wish to invest in the technology, which would require a hand-held or tabletop scanner, because it could allow them to address NCVIA reporting requirements more effectively. Those requirements dictate that the following information be recorded in a vaccine recipient's permanent medical record or in a permanent office log or file:

  • the date the vaccine was administered,
  • the manufacturer of the vaccine,
  • the lot number of the vaccine, and
  • the name, address and title of the person administering the vaccine.

"Manual data entry of this information requires rigorous procedures to ensure accurate records, as not all this information is encoded" in the currently used linear bar code, the FDA said. "Such manual entry of data may decrease medical practice efficiency as well as increase practice costs, may affect patient safety, and may potentially expose patients to unnecessary or duplicative vaccinations in the event that this information is incorrectly recorded.

"In addition, clerical recording errors can diminish the value of information available for mandatory adverse event reporting. Furthermore, inaccurate recording of a lot number may delay or misdirect FDA's investigation of an adverse event."

The American Academy of Pediatrics and the Association of Immunization Managers, or AIM, have advocated for years that two-dimensional bar codes be implemented. In comments(www.immunizationmanagers.org) it provided to the FDA last November, AIM said data matrix bar coding would improve the efficiency of vaccine ordering and inventory management in addition to reducing providers' reporting burden and the potential for errors.

If the new bar codes are implemented by vaccine manufacturers, physicians who do not use an EHR will not have to change their recording practices because the required information still will be printed on vaccine labels, the CDC said.


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