title: Analyzing temozolomide medication errors: potentially fatal.
abstract: The EORTC-NCIC regimen for glioblastoma requires different dosing of temozolomide (TMZ) during radiation and maintenance therapy. This complexity is exacerbated by the availability of multiple TMZ capsule strengths. TMZ is an alkylating agent and the major toxicity of this class is dose-related myelosuppression. Inadvertent overdose can be fatal. The websites of the Institute for Safe Medication Practices (ISMP), and the Food and Drug Administration (FDA) MedWatch database were reviewed. We searched the MedWatch database for adverse events associated with TMZ and obtained all reports including hematologic toxicity submitted from 1st November 1997 to 30th May 2012. The ISMP describes errors with TMZ resulting from the positioning of information on the label of the commercial product. The strength and quantity of capsules on the label were in close proximity to each other, and this has been changed by the manufacturer. MedWatch identified 45 medication errors. Patient errors were the most common, accounting for 21 or 47% of errors, followed by dispensing errors, which accounted for 13 or 29%. Seven reports or 16% were errors in the prescribing of TMZ. Reported outcomes ranged from reversible hematological adverse events (13%), to hospitalization for other adverse events (13%) or death (18%). Four error reports lacked detail and could not be categorized. Although the FDA issued a warning in 2003 regarding fatal medication errors and the product label warns of overdosing, errors in TMZ dosing occur for various reasons and involve both healthcare professionals and patients. Overdosing errors can be fatal.
authors.affiliation: Faculte de pharmacie, Université de Montreal, Montreal, QC, Canada.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Letarte
authors.forename: Michael P
authors.initials: MP
authors.lastname: Gabay
authors.forename: Linda R
authors.initials: LR
authors.lastname: Bressler
authors.forename: Katie E
authors.initials: KE
authors.lastname: Long
authors.forename: Joan M
authors.initials: JM
authors.lastname: Stachnik
authors.forename: J Lee
authors.initials: JL
authors.lastname: Villano
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016208:Databases, Factual; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008508:Medication Errors / Q000401:mortality* / Q000706:statistics & numerical data; D008875:Middle Aged; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D011379:Prognosis; D012189:Retrospective Studies; D015996:Survival Rate; D000077204:Temozolomide; D014481:United States
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004364:Pharmaceutical Preparations; D003606:Dacarbazine; D000077204:Temozolomide