Review of purchases of unapproved medications by the Veterans Health Administration.

PURPOSE: Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost. METHODS: VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added. RESULTS: VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16. CONCLUSION: VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.

Label Design Affects Medication Safety in an Operating Room Crisis: A Controlled Simulation Study.

OBJECTIVE: Several factors contribute to medication errors in clinical practice settings, including the design of medication labels. The objective of this study was to quantify the impact of label design on medication safety in a realistic, high-stress clinical situation. METHODS: Ninety-six anesthesia trainee participants were randomly assigned to either the redesigned or the current label condition. Participants were blinded to the study's focus on medication label design and their assigned label condition. Each participant was the sole anesthesia provider in a simulated operating room scenario involving an unexpected vascular injury. The surgeon asked the participant to administer hetastarch to the simulated patient because of hemodynamic instability. The fluid drawer of the anesthesia cart contained three 500-ml intravenous bags of hetastarch and one 500-ml intravenous bag of lidocaine. We hypothesized that redesigned labels would help participants correctly select hetastarch from the cart. If the participants incorrectly selected lidocaine from the cart, we hypothesized that the redesigned labels would help participants detect the lidocaine before administration. RESULTS: The percentage of participants who correctly selected hetastarch from the cart was significantly higher for the redesigned labels than the current labels (63% versus 40%; odds ratio, 2.61 [95% confidence interval, 1.1-6.1]; P = 0.03). Of the participants who incorrectly selected lidocaine from the cart, the percentage who detected the lidocaine before administration did not differ by label condition. CONCLUSIONS: The redesigned labels helped participants correctly select hetastarch from the cart, thus preventing some potentially catastrophic medication errors from reaching the simulated patient.