Depending on the drug-shortage profile, task forces might be created to determine what, if any, restrictions or interchanges are appropriate. Subsequently, the information is presented at the drug use committee and drug use and formulary review subcommittee of the P&T committee. Ultimately, the P&T committee reviews and accepts formulary recommendations and distributes communications about the [...]

During the assessment phase, the coordinator of purchasing and inventory control determines the duration and reason for the shortage. If it is determined that a short-term shortage will occur, drug quantities are ordered based on allocation by the wholesaler. If long-term shortages or unexpected emergent shortages are confirmed, the director of pharmacy delegates clinical assessments [...]

The incidence of significant drug shortages has been gradually increasing since the early 1990s. Reasons for the drug shortages have included, but are not limited to, a lack of raw materials, manufacturing difficulties, voluntary recalls, and shutdowns of manufacturing plants by the Food and Drug Administration (FDA). Also, there have been more occurrences as pharmaceutical [...]

In two open, randomized, crossover trials in healthy male volunteers, the mean AUC concentration and Cmaxwere decreased by 83% and 65%, respectively, when patients (n = 18) were given 500 mg of gefitinib alone on day 10 of a 16-day dosing regimen of 600 mg/day of rifam-picin (e.g., Rimactone®, Geneva), a potent CYP-3A4 inducer. In [...]

Ranson et al. conducted a phase I, escalating, multiple-dose trial to investigate the tolerability, pharmacokinetics, and antitumor activity of gefitinib in patients with solid malignant tumors. The study was designed to evaluate dose levels of 50, 100, 150, 225, 300, 400, 525, 700, and 925 mg/day. Additional patients could be recruited for the study if [...]

The FDA approved gefitinib based on results from the Iressa Dose Evaluation in Advanced Lung Cancer (IDEAL-2), a phase II trial that included 216 patients, of whom 142 had not responded to both platinum-based and docetaxel chemotherapies. Approximately 10% of patients in this trial achieved a response rate defined as a decrease in tumor size [...]

INTRODUCTION
Gefitinib (ZD1839, Iressa™, Astra-Zeneca) is an anilinoquinazoline that has been approved by the U.S. Food and Drug Administration (FDA) as a single-agent therapy for the treatment of patients with locally advanced or meta-static non-small cell lung cancer (NSCLC) who have not responded successfully to chemotherapies with platinum (carboplatin, cisplatin) and doce-taxel (Taxotere®, Aventis), two drugs [...]