Currently, the only varicella vaccine product available in the U.S. is the live virus sold as Varivax® (Merck). The vaccine is administered as a single injection to children between 12 months and 13 years of age and as a two- injection series to at-risk adults (see Figure 1).
Varicella virus vaccine has been in short supply since mid-2001. During this shortage, the ACIP recommends that: • vaccination of immunocompetent children age 12 to 18 months be deferred until they are between 18 months and 2 years old.
This strategy should ensure that school-aged children are immunized because they are at an increased risk of contracting varicella. The ACIP recommends further prioritizing the use of varicella virus vaccine if a severe shortage persists after vaccination deferral at age 12 to 18 months. Susceptible patients should be vaccinated, as product becomes available, in the following order: (1) health care workers, family contacts of immunocompromised patients, adolescents 13 years or older, adults, and high-risk children (including HIV-infected children, children with asthma, and children with eczema); (2) children 5 to 12 years old, especially children starting school; (3) adolescents; and (4) children 2 to 4 years old. Public health officials in each state may provide additional guidelines on the priority of varicella vaccination among school-aged children.
When administration of vaccinations has been delayed, it is important that health care providers appropriately identify patients who need “make-up” doses of vaccine. The National Childhood Vaccine Injury Act of 1986 requires that vaccine recipients have, among other requirements, documentation of the manufacturer of the vaccine, the lot number of the vaccine, and the date of administration in the permanent medical record. To quickly identify patients who have received a recalled product, it may be more efficient to have secondary documentation that links patients to products without searching through medical charts. Unless current electronic patient records systems allow capture of such data, a list documenting patient name or medical record number, vaccine manufacturer, and lot number can make it easy to identify patients who have received the recalled product.
The system does not have to be elaborate; a simple electronic spreadsheet program would be an excellent way to store the data. This same system can be used to document patients for whom a vaccine has been withheld during a shortage.
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Vaccine Information Resources
Health care providers responsible for managing immunizations must have access to evidence-based information about vaccination recommendations. The ACIP and CDC are responsible for providing this guidance. Each February the ACIP publishes General Recommendations on Immunization in Morbidity and Mortality Weekly Report (MMWR), the official publication of the CDC. Each January the recommended childhood immunization schedule is published simultaneously in the journals Pediatrics and American Family Physician (see Figure 1). When recommendations change during the year, the new ones are published in MMWR. Information about the risks and benefits of vaccines can be found on the CDC’s Web site for the National Immunization Program. These publications contain reliable information about vaccines, vaccine-related injuries, and current vaccine supplies.
During product shortages, health care providers must have up-to-date information about vaccine supplies, anticipated resolution dates, and implications for patient care. During critical shortages, the ACIP makes recommendations to the CDC on the optimal management of the vaccine shortage. The CDC then publishes these recommendations electronically and in print. Although the CDC’s publications are excellent resources for information on vaccine shortages, several other good resources for this type of information are available. The American Society of Health-System Pharmacists maintains the Drug Product Shortages Management Resource Center, an Internet page that lists current drugs and biologicals in short supply, anticipated resolution dates, and recommendations for patient care.
Another good source of vaccine shortage information is contained within the Food and Drug Administration’s (FDA’s) Web site for the Center for Biologics Evaluation and Research. This site contains a list of recalled and withdrawn products. An additional source of information is the individual manufacturer of a vaccine in short supply. Most major manufacturers of vaccines maintain a Web site where health care providers can obtain information about vaccine shortages.
Manufacturing difficulties and product discontinuations have led to extensive vaccine shortages in the past two years. The complex nature of vaccine production has impeded the ability of vaccine manufacturers to increase production to meet changing demands. Supplies of vaccines that are single-source products are especially vulnerable to such shortages. The exit of a major manufacturer from the vaccine market only serves to put more products at risk of shortage. Fortunately, most of the current shortages are anticipated to be resolved by the end of 2002. This is evidenced by the lifted restrictions on tetanus and diphtheria toxoids administration in June 2002. New and unanticipated shortages are bound to occur. Creating incentives for alternate vaccine manufacturers to enter the market might help to minimize the impact of single-manufacturer off-line periods. Certainly, rapid communication of anticipated shortages between manufacturers and CDC will serve to apprise health care providers more rapidly of the need to restrict utilization of products. Health care providers can help to ensure that enough vaccine is reserved for those who are most at risk by following evidence-based recommendations provided by the ACIP. This can be accomplished only when providers stay abreast of the most up-to-date recommendations for vaccine priority. Health care providers have the additional duty of documenting those patients who do not receive their routine immunizations because of vaccine shortages. This will help to minimize the number of patients who will needlessly suffer from vaccine-preventable disease. Buyers and purchasing agents can assist health care providers by alerting them immediately when shortages are discovered.