This study determined the involvement of women as first authors and other authors for every article published in Experimental and Clinical Psychopharmacology, Pharmacology Biochemistry and Behavior, and Psychopharmacology in 1991, 1996, 2001, and 2006. Their involvement as editors also was determined. Women's participation as authors, but not as editors, slightly increased over time. In 2006, 43% of first authors, 38% of other authors, and 24% of editors were women. The gender of subjects was examined for the same years and journals, but could not be determined for 6% and 9% of articles employing nonhuman and human subjects, respectively. In 2006, when subjects' gender could be determined, 77% of articles involving nonhuman subjects used only males, 9% only females, and 14% both males and females. In articles using human subjects in that same year, 17% involved only males, 6% only females, and 77% both males and females. Women researchers clearly make substantial contributions to the psychopharmacology literature, but are nonetheless underrepresented as editors. Findings regarding subjects indicate that there is growing recognition of the importance of gender as a determinant of drug effects, although the vast majority of nonhuman studies continue to involve only male subjects.
Introduction. Ibandronic acid 150 mg/month (Bonviva) is a bisphosphonate that was licensed in the UK in 2005 for the treatment of postmenopausal osteoporosis in women. Prescription-event monitoring (PEM) is a non-interventional observational cohort technique conducted by the Drug Safety Research Unit to monitor the safety of newly marketed drugs prescribed in general practice in England. Objective. To describe the utilization characteristics of the patients prescribed ibandronic acid based on an analysis of a completed PEM cohort and to assess, where possible, if the product is being used outside terms of license of marketing approval. Methods. An observational cohort PEM study was conducted. Exposure data were collected from dispensed prescriptions issued by general practitioners (GPs) between November 2005 and November 2007. Outcome data (event, patient demographic and selected clinical characteristics) were collected by sending questionnaires (green forms) to GPs at least six months after the drug was first prescribed for an individual patient. Summary descriptive statistics were calculated. For this study, menopause was defined by female age at 50þ years. Results. The cohort consisted of 11,034 patients, of which 9% (n ¼ 991 patients) were reported to be men. Where age was specified, 4.8% (529/11,017) were aged ,50 years, of which 0.4% (2/529) were ,20 years. A total of 398 deaths occurred (3.6% cohort). Where specified, primary indications other than postmenopausal osteoporosis were reported for 11.7% (1218/10,446) patients including 'prophylaxis' (n ¼ 715), 'osteopenia' (n ¼ 231) and 'fracture spontaneous' (n ¼ 41). The most frequently reported clinical reasons for stopping treatment were 'intolerance' (n ¼ 176) and 'dyspepsia' (n ¼ 158). There was one pregnancy, reported as the reason for stopping treatment. Where dose was specified, 99.9% of patients (8625/8637) were prescribed the approved dose of 150 mg per month. Conclusion. This study has highlighted that some clinicians are prescribing this product outside the recommended terms of the licence. Use in premenopausal women and men was reported. This study assumed natural menopause occurred when aged 50þ years, though this does not apply for surgically menopausal women. Prescribing for indications other than osteoporosis was common, but unusual dose regimens were uncommon. Drug utilization studies are important in describing populations that may not have been adequately studied in terms of risk in premarketing development programmes and are important in the postmarketing risk management of medicines.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.