An evaluation of reproductive toxicity studies and data interpretation of N-methylpyrrolidone for risk assessment: An expert panel review.

An expert panel was assembled to evaluate reproductive toxicology study data and their application to health risk assessment to provide input on the data quality, interpretation, and application of data from three multi-generation reproductive toxicity studies of N-methylpyrrolidone (NMP). Panelists were engaged using a double-blinded, modified Delphi format that consisted of three rounds. Key studies were scored using the U.S. Environmental Protection Agency's (EPA) questions and general considerations to guide the evaluation of experimental animal studies for systematic review. The primary conclusions of the panel are that one of the studies (Exxon, 1991) is not a high-quality study due to several design flaws that includes: (1) exceedance of the maximum tolerable dose in the high dose group; (2) failure to adjust feed concentrations of NMP during the lactation period, resulting in NMP doses that were 2- to 3-fold higher than nominal levels; and/or (3) underlying reproductive performance problems in the strain of rats used. For these reasons, the panel recommended that this study should not be considered for quantitative risk assessment of NMP. Exclusion of this study, and its corresponding data for male fertility and female fecundity, from the quantitative risk assessment results in a change in the identification of the most sensitive endpoint. Instead, changes in rat fetal/pup body weight, an endpoint previously selected by EPA, was identified as an appropriate basis for human health risk assessment based on a consideration of the best available science and weight of scientific evidence supported by the NMP toxicity database.

Survey on unclaimed prescriptions in a community pharmacy.

OBJECTIVE: To quantify the number of unclaimed prescriptions, document the reasons patients did not claim prescriptions, investigate the effect of telephone contact on the pickup rate, and document the types of medications involved and the frequency of this type of non-compliance. DESIGN: A total of 549 unclaimed prescriptions were evaluated during a nine-month study. Pharmacy students contacted patients whose prescription orders had been dispensed but not claimed. Patients contacted by telephone were asked why they had not claimed their prescriptions. The types of medications involved were documented, and a follow-up check was made of the patient's profile on the pharmacy computer system to determine whether the telephone contact affected the pickup rate. RESULTS: Reasons given for not claiming the prescriptions included: transfer to another pharmacy, prescription was forgotten, the patient no longer wanted or needed the prescription because they had medication left over, or patient decided they did not need the medication. Telephone contact had minimal impact on the compliance rate of this patient group. The most common unclaimed medication categories were anti-infectives, cough and cold/allergy medications, and birth control/hormones. CONCLUSIONS: Patients cited many reasons for not picking up their medication. Follow-up telephone calls did not increase the number of prescriptions picked up by patients in this study.