In this issue...
Errors In Tuberculin Skin Testing Administration
A New Risk Factor for Developing TB Disease
What Mask Do I Use?
The following article is a reprint of an article that appears in the July 30, 2004 edition of the MMWR 53(29);662-664. DTC is reprinting this recent article to highlight the importance of the issues discussed. While not reportable to DTC or VDH, during the last eight months, at least 6 instances of the types of errors described in the MMWR have been reported to DTC. These have been from all health care sectors and have involved both the intradermal administration of vaccine in place of PPD and the inadvertent administration of PPD instead of a vaccine. DTC recommends that all local health districts review storage and administration procedures for TSTs to reduce the possibility of administration errors.
Notice to Readers: Inadvertent Intradermal Administration of Tetanus Toxoid--Containing Vaccines Instead of Tuberculosis Skin Tests
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 ofTTCV 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 [opens up a new browser] 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 [opens up a new browser] or by telephone, 800-332-1088.
References
1. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12:542--50.
2. Graham D, Dan B, Bertagnoll P, et al. Cutaneous inflammation caused by inadvertent intradermal administration of DTP instead of PPD. Am J Public Health 1981;71:1040--3.
3. Institute for Safe Medication Practices. Hazard alert! Confusion between tetanus diphtheria toxoid (Td) and tuberculin purified protein derivative (PPD) led to unnecessary treatment. Huntingdon Valley, Pennsylvania: Institute for Safe Medication Practices, 2003. Available at http://www.ismp.org/msaarticles/confusionprint.htm
4. U.S. Food and Drug Administration. Mix up between Td and PPD. Rockville, Maryland: U.S. Department of Health and Human Services, U.S. Food and Drug Administration, 2003. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=17#8
5. U.S. Food and Drug Administration. FDA rules requires bar codes on drugs and blood to help reduce errors. Rockville, Maryland: U.S. Department of Health and Human Services, U.S. Food and Drug Administration, 2004. Available at http://www.fda.gov/oc/initiatives/barcode-sadr
With the advent of new therapies for the treatment of rheumatoid arthritis, a new risk factor for developing active tuberculosis disease is emerging among patients treated with this new class of drugs. The new drugs belong to a class of anti-arthritis agents known as Biologic Response Modifiers (BRM). Most of the drugs work against the tumor necrosis factor (TNF). Reports of active tuberculosis and other serious infections have been reported in persons taking the following drugs. Because of the increased risk of active disease, DTC concurs with the recommendations that patients should be fully evaluated for latent tuberculosis infection prior to the initiation of theses drugs and monitored for symptoms of active TB while undergoing treatment. If indicated, treatment for LTBI should also be initiated prior to the start of the BRM for arthritis therapy. The list below provides information on the current drugs in this class. As with any new therapies, additional agents may be added to the list.
Current Biologic Response Modifiers in Use for the Treatment of Arthritis
1. Enbrel (etanercept) - http://www.enbrel.com/index.jsp
2. Remicade (infliximab) - http://www.remicade.com/
3. Humira (adalimumab) - http://www.humira.com/
4. Kineret (anakinra) - http://www.anakinra.com/
5. Rituxan/Mab Thera (rituximab) - Still in clinical trials for arthritis - http://www.rituxan.com/rituxan/index.jsp
Coincidentally, as this edition of the AcidFast Blast was being finalized, the CDC published an article on active cases of tuberculosis associated with the use of these agents in the August 6, 2004 edition of the MMWR. Between January 2002 and August 2003, a total of 12 active TB cases associated with the use of this class of drugs were reported in California. The full text of this MMWR article can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5330a4.htm
DTC is frequently asked about appropriate masks in different situations. For healthcare workers, the appropriate mask for use when infectious and potentially infectious patients is the N95 respirator. N95 respirators are manufactured by several companies and are available in a variety of sizes. Use of the N95 respirator requires individual fit testing and also the completion of health questionnaire and possibly medical evaluation prior to fit testing.
For patients with TB who are infectious or suspected of being infectious, a standard surgical mask is all that is required. N95 respirators should not be used with patients due to the fit testing requirements and the potentially altered pulmonary function due to the TB disease process.