CDC and the Food and Drug Administration (FDA) have been notified about
the potential for inadvertent administration of tetanus toxoid–containing
vaccines (TTCVs) instead of tuberculin purified protein derivative (PPD) (Tubersol®,
Aventis-Pasteur, Swiftwater, Pennsylvania; Aplisol®, Parkedale Pharmaceuticals,
Rochester, Michigan) used for tuberculosis skin tests (TSTs). The Vaccine
Adverse Event Reporting System (VAERS), a passive surveillance system jointly
operated by CDC and FDA,1 detected clusters of medication errors
in at least two states. These findings, along with another previously reported
investigation involving the same error,2 suggest the need for health-care
providers to take additional steps to minimize the risk for inadvertent intradermal
injections of TTCVs.
In April 2004, five reports of medication error involving tetanus toxoid
(TT) from a health-care provider were identified. Patients were vaccinated
on three different dates; all experienced local reactions without complications.
Another cluster reported to VAERS in June 2003 involved an undisclosed number
of patients; a health-care provider confused tetanus and diphtheria toxoids
(Td) vaccine for adult use (adsorbed) with PPD and administered Td intradermally.
Patients with adverse reactions to these administrations had skin reactions
interpreted as positive TSTs, which resulted in treatment with isoniazid (INH).
Review of the lot numbers on products thought to be PPD revealed they were
Td. Affected patients were identified and retested with PPD; all TSTs were
negative. INH was discontinued, and no adverse reactions were observed.
As of March 2004, approximately 100 patients had been identified in
reports of TTCV administration instead of PPD. A total of 21 states have reported
both clusters and single cases. Vaccines substituted mistakenly for PPD include
Td (n = 13 reports), TT (n = 12), and diphtheria and tetanus toxoids, (DT)
adsorbed (n = five). For reports of Td, TT, and DT, products involved included
those manufactured by Aventis-Pasteur and Wyeth (Collegeville, Pennsylvania)
and vaccines from other unspecified manufacturers. CDC and FDA have initiated
a full review of adverse events caused by inadvertent administration of vaccines
and PPD products reported to VAERS and the FDA MedWatch Program. A preliminary
review indicates that multiple vaccines other than TTCVs have been involved.
Similarities in packaging of PPD and TTCVs might have contributed to
the medication errors.3,4 Both products require refrigeration and
often are stored side by side. Lack of availability of Td in single-dose syringes,
resulting in provider purchase of multiple-dose vials, was cited as a contributing
factor to medication error in one cluster. Conversely, at least eight reports
have been documented of inadvertent substitution for vaccine products, resulting
in intramuscular administration of PPD (FDA, unpublished data, 2004).
Health-care providers should consider ways to prevent vaccine misadministration.
As more vaccines and combination products become available, the potential
for medication errors might increase. Possible measures to prevent misadministration
should include pharmacy dispensing of vaccines when feasible, physical separation
of products, careful visual inspection and reading of labels, preparation
of PPD for patient use only at time of testing, and improved record keeping
of lot numbers of vaccines and other injectable products. Prevention of such
errors through barcode scanning technology is the goal of a recent FDA rule
requiring individual drug packages to have identifying barcodes.5 For
health-care facilities that possess such technology, package scanning could
help prevent errors made during pharmacy dispensing of products or during
vaccine or PPD administration. In addition, the Product
Identification Guide for Routine Vaccines is a helpful resource for
distinguishing commonly used vaccine products; the guide can be ordered from
the California Department of Health Services, telephone 619-594-5933. Adverse
events associated with inadvertent vaccine administration can be reported
to VAERS at http://www.vaers.org or by telephone, 800-822-7967.
Adverse events after PPD administration can be reported to the FDA MedWatch
program at http://www.fda.gov/medwatch or by telephone, 800-332-1088.
References: 5 available
Inadvertent Intradermal Administration of Tetanus Toxoid–Containing Vaccines Instead of Tuberculosis Skin Tests. JAMA. 2004;292(10):1171. doi:10.1001/jama.292.10.1171