The 37th National Immunization Conference of CDC

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Vaccine Recalls: Hepatitis A and Meningococcal Vaccines, Lessons Learned

Stephen Tannenbaum1, Diana Wahl1, Allan Leiberthal1, Marlene M. Lugg2, and Joan Bonner1. (1) Pediatrics, Southern California Permanente Medical Group, 4700 Sunset Blvd, Los Angeles, CA, USA, (2) Kaiser Permanente, 13652 Cantara St, South 1 Bldg, Panorama City, CA, USA

KEYWORD1:
Vaccine Registry
Vaccine Recall
Hepatitis A Vaccine
Meningococcal Polysaccharide Vaccine

BACKGROUND:
On December 10th, 2001, Merck & Co., Inc. initiated a vaccine recall of Hepatitis A Vaccine (VAQTA). There was a total of 40 lots affected by the recall, 8 of the adult formulation, (50U/1 ml), and 32 of the pediatric formulation, (25U/0.5 ml). On October 18th, 2002, Aventis Pasteur initiated a recall of Menomune. There were 4 lots affected. In addition, 80 lots were withdrawn from the market. The Southern California Kaiser Immunization Tracking System (KITS), contains over 20 million inoculations recorded with manufacturer lot number for current entries. KITS was used to identify, track, and outreach to the patients for revaccination .

OBJECTIVE:
Patients will be identified and revaccinated in a timely manner, using the immunization registry to evaluate and imprint an electronically triggered reminder prompt on clinic visit to the providers and patient recall letters.

METHOD:
1. KITS was queried to identify affected inoculation records.
2. The inoculation agent code was changed to enable a provider to readily identify the vaccine as a recall vaccine.
3. A provider reminder was printed at the time of every visit to facilitate identification and revaccination of all affected patients.
4. Reminder letters were sent to all affected patients.
5. The revaccination rate was assessed to determine the effect of provider reminders and patient recall interventions.

RESULT:
Over a 9 month period, 43,286 children ages 2-19 were revaccinated for hepatitis A. This represents a revaccination rate that is three times greater than baseline. Data on revaccination for the Menomune recall will be available by the time of the conference.

CONCLUSION:
The immunization registry increases the chance of identifying a patient who needs to be revaccinated. The registry is the key factor in the development of a standardized process in the event of future vaccine recall. This in turn facilitates an increase in the revaccination rate and minimizes missed opportunities for revaccination.
LEARNINGOBJECTIVES:
Participants will be able to efficiently administrate a vaccine recall using a vaccine registry.

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