Introduction: select topics in women's health.

This issue of the Journal of Pharmacy Practice is devoted to the broad spectrum of women’s health. Each article contributes to your understanding of the significant disease conditions and physiologic changes that women commonly face. Clinically important areas are summarized to present a snapshot of current controversies and advances. Topics covered include a review of Denosumab, fetal safety of a variety of drugs, triple negative breast cancer (TNBC), current guidelines for the use of hormone replacement therapy, and the potential influence of low-dose combination oral contraceptives on bone development in young women. Representing a new class of drugs, Denosumab, a monoclonal antibody, has Food and Drug Administration (FDA) approval for the treatment of osteoporosis in postmenopausal women. Denosumab is vastly different from older agents and may fill a unique niche in pharmacotherapy regimens. Drs Kira B. Harris, Kimberly L. Nealy, Delilah J. Jackson and Phillip L. Thornton of Wingate University School of Pharmacy provide multiple comparisons between Denosumab and Fosamax, the most commonly prescribed bisphosphonate, will allow you to evaluate its contribution. The United States public perceives a fear of breast cancer and not without reason, as the lifetime prevalence is estimated at 1 in 8 women. Dr Carrie L. Griffiths of North Texas Veterans Health Care System and Dr Jacqueline L. Olin of Wingate University School of Pharmacy discuss TNBC, a recently identified minority subtype. Although not common, occurring in only 20% of cases, knowledge of the pharmacotherapies used to combat TNBC provides a broad framework for approaching treatment of cancers. Numerous advances in all branches of medicine have evolved from understanding of the basic cellular pathophysiology and pharmacology derived from cancer research. A review article by Dr Ellena A. Anagnostis of Thomas Jefferson University Hospital chronicles the landmarks in our evolving knowledge of hormone replacement therapy. Always a topic of interest to practitioners and patients, this controversial topic and studies in progress are discussed as well as the potential insights revealed. Oral contraceptives, FDA approved for a myriad of conditions, are most likely to be used by women in early adulthood. Combination oral contraceptives effectively treat acne, primary dysmenorrhea, and iron deficiency anemia and provide reliable contraception, thus are ideal agents for adolescents and young women. The review article by Drs Susan Ziglar and Tracy Hunter, both of Wingate University School of Pharmacy, surveys the studies of bone development in this population and the influence of oral contraceptives to answer the question of whether very low-dose combination oral contraceptives, created to increase safety, may have untold detrimental effects on bone development in adolescents and young women. No issue on women’s health would be complete without discussing the safety of drugs used during pregnancy. Drs Shannon Williams and Heather Kehr, both of Wingate University, explain the fetal safety of antiepileptic drugs and migraine therapy through the use of pregnancy registries. Pregnancy registries, sponsored by pharmaceutical companies, nonprofit or government agencies, facilitate postmarketing surveillance of the adverse effects of drug exposure during pregnancy. Prospective registries that enroll gravid women and follow the pregnancy outcome can estimate the risk of adverse fetal effects or alternatively provide reassurance. Retrospective registries compile data on adverse events by enrolling women after delivery when the adverse outcome is apparent. As such, retrospective registries act as a compilation of case reports and no estimates of risk assessment can be determined. Prospective registries, although not as rigorous as blinded, placebo controlled studies, have provided evidence used by the FDA to change the pregnancy category classification of drugs. Drs Marilyn N. Bulloch and Dana Carroll, both of Harrison School of Pharmacy Auburn University, explore the safety of in utero drug exposure from common drugs required for seriously ill gravid women. No registries have been established for frequently used medications for sedation, pain control, hypertension, and antibiotics. Clinical decisions of fetal safety are based on case reports and animal reproductive data. I hope you find these articles thought provoking and insightful. It has been my pleasure to work with this distinguished line up of colleagues to prepare this issue for you.