Association between tetracycline or doxycycline and hepatotoxicity: a population based case-control study.

BACKGROUND AND OBJECTIVE: An FDA Working Group, along with representatives of PhRMA and the American Association for the Study of Liver Diseases, as well as the Institute of Medicine Report 'To Err is Human: Building a Safer Health Care System' have suggested that post-marketing drug surveillance is a important method to decrease adverse drug events. While tetracyclines are known to cause hepatotoxicity, no post-marketing drug surveillance studies have examined the risk of developing hepatotoxicity with tetracyclines. Therefore, the objective of this study is to determine the difference in risk of hepatotoxicity in patients receiving doxycycline or tetracycline using California Medicaid claims. METHODS: This study used a retrospective, matched case-control study using California Medicaid claims data. The cases were defined as recipients who had at least one diagnosis of hepatotoxicity any time from 1 July 1999 to 31 December 2001. One control was identified for each case, matched on age, gender and race. Logistic regression was used to determine the adjusted odds ratio (OR) and 95% confidence intervals for current users and past users of tetracycline and doxycycline. Covariates controlled for in the analysis were age, use of other hepatotoxic drugs, renal dysfunction, pregnancy, and alcohol or illicit drug use. RESULTS: A total of 3377 cases of hepatotoxicity were identified. Current users and past users of tetracycline had a statistically significant increased risk of developing hepatotoxicity (current use OR 3.70, 95% CI 1.19-11.45; past use OR 2.72, 95% CI 1.26-5.85). Current users or past users of doxycycline did not have an increased risk of developing hepatotoxicity (current use OR 1.49, 95% CI 0.61-3.62; past use OR 1.74, 95% CI 0.99-3.06). Tetracycline was commonly used for acne, acute bronchitis and upper respiratory infections. Doxycycline was commonly used for acute bronchitis, vaginitis and acne. DISCUSSION AND CONCLUSION: Doxycycline was potentially less hepatotoxic than tetracycline. Doxycycline could potentially be a safe substitute for tetracycline, when appropriate.

Time and cost analysis of repacking medications in unit-of-use containers.

OBJECTIVES: To evaluate the effects of repacking drugs in unit-of-use containers in community pharmacies. The purpose of this study was to examine whether unit-of-use repacking reduces routine mechanical "counting and pouring" to allow more time for pharmaceutical care. DESIGN: Simulation pilot study to evaluate the differences between the existing and proposed systems. Based on the literature, four variables--optimum pack size, time savings, packaging costs, and shelving requirements--were selected for evaluation. Historical prescription data from a chain were used in determining the sample drugs and their optimum pack sizes. Workflow analysis and time study were used to estimate the time savings. Manufacturer bottles, repack bottles, and shelves were measured to determine the impact of using unit-of-use containers on storage requirements. SETTING: Three community pharmacies in a major drugstore chain in Cincinnati, Ohio. RESULTS: The 25 fastest-moving solid oral dosage forms, representing 21.6% of all drugs dispensed by the chain, were selected as the sample drugs for the study. The workflow analysis and time study revealed that 0.79 minutes could be saved per prescription if repacked drugs were used. There was an increased cost of approximately $0.05 for every repack bottle used in place of a prescription vial. It was calculated that repacking in unit-of-use containers would increase storage requirements in the pharmacy by 2.5 times if current inventory levels were maintained. CONCLUSION: Repacking drugs in unit-of-use containers is potentially an inexpensive method to increase usable time in the pharmacy that does not require an increase in personnel or the purchase of additional technology at the store level.