Reproductive health diagnoses of women veterans using department of Veterans Affairs health care.

BACKGROUND: Little is known regarding the reproductive health needs of women Veterans using Department of Veterans Affairs (VA) health care. OBJECTIVE: To describe the reproductive health diagnoses of women Veterans using VA health care, how these diagnoses differ across age groups, and variations in sociodemographic and clinical characteristics by presence of reproductive health diagnoses. RESEARCH DESIGN: This study is a cross-sectional analysis of VA administrative and clinical data. SUBJECTS: The study included women Veterans using VA health care in FY10. MEASURES: Reproductive health diagnoses were identified through presence of International Classification of Disease, 9th Revision (ICD-9) codes in VA clinical and administrative records. The prevalence of specific diagnosis categories were examined by age group (18-44, 45-64, ≥65 y) and the most frequent diagnoses for each age group were identified. Sociodemographic and clinical characteristics were compared by presence of at least 1 reproductive health diagnosis. RESULTS: The most frequent reproductive health diagnoses were menstrual disorders and endometriosis among those aged 18-44 years (n=16,658, 13%), menopausal disorders among those aged 45-64 years (n=20,707, 15%), and osteoporosis among those aged ≥65 years (n=8365, 22%). Compared with women without reproductive health diagnoses, those with such diagnoses were more likely to have concomitant mental health (46% vs. 37%, P<0.001) and medical conditions (75% vs. 63%, P<0.001). CONCLUSIONS: Women Veterans using VA health care have diverse reproductive health diagnoses. The high prevalence of comorbid medical and mental health conditions among women Veterans with reproductive health diagnoses highlights the importance of integrating reproductive health expertise into all areas of VA health care, including primary, mental health, and specialty care.

Patient Perceptions of Switching to a Generic Dry Powder Inhaler - Increased Understanding Through Journey Mapping.

Purpose: This qualitative study explored patients' attitudes about and perceptions of generic dry powder inhaler (DPI) substitution for the brand product and patients' views of generic product quality, efficacy, design, and usability. Methods: Forty COPD and asthma patients (36 adults, four adolescents), who were actively using a brand DPI product, participated in one of six focus groups. Participants completed a journey mapping exercise to assess attitudes and opinions about a scenario where they refill their prescription and unexpectedly receive a generic DPI instead of their brand DPI. The focus groups were audio recorded, transcribed, and analyzed thematically. Results: The hypothetical scenario of unexpectedly receiving a generic DPI elicited mixed feelings including: happiness and relief about potential cost savings, confusion, disappointment, anger, and/or frustration with the unexpected switch. Participants in most groups anticipated anxiety or hesitation in using the generic DPI due to concerns about potential differences in usability, uncertainty about correct use, and questions about efficacy. Participants across all groups said they would ask a pharmacist or healthcare provider for information or answers to their questions, and some participants said they would use online resources. When participants held the brand and generic DPI devices, most preferred the brand DPI device and found it easier, less cumbersome, or more convenient to use (due to size and weight). However, many participants reiterated that the potential reduced cost of the generic DPI would be a primary factor in their decision-making related to generic DPI substitution for their brand DPI. Conclusion: Patients experienced a mixture of positive and negative feelings when faced with an unexpected generic DPI substitution. Some patients have doubts about their ability to successfully navigate differences in generic device design, and most expressed the desire to participate in discussions and decision-making with their HCP about generic DPI sameness and substitution.

Monitoring for teratogenic signals: pregnancy registries and surveillance methods.

Pregnant women should have access to medications that have been adequately studied for use to facilitate evidence-based risk-benefit discussions with their health care providers. Pregnant women experience acute medical emergencies, have existing conditions that require continued medical treatment or may develop pregnancy-induced conditions, making drug use during pregnancy unavoidable. Drug labeling is the primary source of information about a drug's use. The safety and efficacy data found in the label is derived from well-controlled clinical trials conducted prior to a drug's approval. However, pregnant women are rarely enrolled in clinical trials unless a product is specifically indicated for a pregnancy-related condition. Consequently, information regarding a product's use during pregnancy is usually collected postapproval. Current data collection tools include pregnancy exposure registries, retrospective cohort studies, pregnancy surveillance programs, case-control studies, spontaneous reports of adverse events and case reports. Each tool has strengths and limitations in its ability to detect teratogenic signals. Combinations of different sources of data are necessary to acquire the most complete picture of potential teratogenic risk, as no single method can capture all desired data to help pregnant patients and women of child bearing potential make appropriate risk benefits decisions along with their health care providers.

Drug Information Association Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance.

The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug. These analyses allow FDA to determine that the generic drug will perform in the patient in the same way, with the same safety and efficacy profiles, as the brand name drug. Allowable differences and the precise definition of what is meant by equivalence are critical to maintaining the quality, efficacy, and safety of generic drugs. The FDA Office of Generic Drugs' (OGD's) Clinical Safety Surveillance Staff (CSSS) has developed investigative processes that complement the broader FDA safety efforts that focus on the potential impact of allowable differences and equivalence determinations for generic drugs. Two recent examples of the CSSS's processes include a clonidine transdermal system and lansoprazole oral disintegrating tablet. Ongoing efforts of the CSSS result in improvements to the FDA's review processes and the quality of generic drugs in the US market.

Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy.

To address provider struggles to provide evidence-based, rational drug therapy to pregnant women, this third Conference was convened to highlight the current progress and research in the field. Speakers from academic centers, industry, and governmental institutions spoke about: the Food and Drug Administration's role in pregnancy pharmacology and the new labeling initiative; drug registries in pregnancy; the pharmacist's role in medication use in pregnancy; therapeutic areas such as preterm labor, gestational diabetes, nausea and vomiting in pregnancy, and hypertension; breast-feeding and medications; ethical challenges for consent in pregnancy drug studies; the potential for cord blood banks; and concerns about the fetus when studying drugs in pregnancy. The Conference highlighted several areas of collaboration within the current Obstetrics Pharmacology Research Units Network and hoped to educate providers, researchers, and agencies with the common goal to improve the ability to safely and effectively use individualized pharmacotherapy in pregnancy.

FDA's proposed rule for pregnancy and lactation labeling: improving maternal child health through well-informed medicine use.

For the US Food and Drug Administration (FDA), the May 29,2008 publication of the Proposed Rule for Pregnancy and Lactation Labeling for Human Prescription Drug and Biological Products heralded both an end and a beginning. It marked an end to the labeling initiative process that produced the Proposed Rule and the beginning of FDA's second-generation approach to labeling drugs and biologics for use during pregnancy, breastfeeding, and the childbearing years. These proposed changes reflect the extensive input and feedback FDA collected from clinicians and experts, and are designed to facilitate informed counseling about and prescribing of medicines for women who are pregnant, breastfeeding, or of childbearing potential. The prescription drug label is FDA's communication tool-it is the place to clearly convey what is known about the safe and effective use of a drug in various populations. With development and implementation of the Physician Labeling Rule (PLR), FDA transformed the prescription drug label into a better communication tool in which information is better organized, clearly presented, and more easily located. The Proposed Rule for Pregnancy and Lactation Labeling is the final piece of PLR, creating a detailed and defined framework in which to present what is and is not known about the use of drugs during pregnancy and breastfeeding.