The Evolving Role of Pharmacists in Transgender Health Care.

Pharmacists are increasingly part of a multifaceted team providing health care to members of the often marginalized transgender (TG) community. Some pharmacists, however, may feel unprepared to care for and interact with TG individuals. By providing comprehensive, respectful, and gender-affirming support, improving physical pharmacy environments with policies and procedures, pharmacists can be trustworthy providers for TG patients. This review focuses primarily on the health issues of TG persons and the pharmacist's role in promoting health, identifying barriers to health care, and providing health care resources for TG persons. The evolution of psychiatric diagnostic criteria, access to health care, and inclusion of TG, lesbian, gay, and bisexual topics in the educational curriculum are presented. Cultural competency and diversity training that addresses gender identity and sexual orientation issues should be important interdisciplinary and interprofessional activities for all health care professional education programs. Pharmacists play a key role in the health care needs of TG persons that include appropriate laboratory monitoring, complex pharmacotherapeutic challenges, and providing unbiased gender-affirming interactions. The pharmacy's physical environment, staff training, and policies and procedures can offer unique services to TG persons.

Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.

Psychosocial, HIV, and health care management issues impacting transgender individuals.

This article reviews the varied process of transitioning and the psychosocial and quality-of-life benefits and outcomes of gender-affirmation therapeutic interventions, examines the barriers that transgender (TG) persons face in accessing health care, and describes the authors' experiences in improving access to medical services by launching a TG health care clinic and a service provider collaborative. It concludes with a summary of the burgeoning prevalence of HIV among TG people and the associated psychosocial effects. (PsycINFO Database Record

Optimal pharmacotherapy to combat the atherogenic lipid triad.

PURPOSE OF REVIEW: A lipid triad involving an atherogenic dyslipidemia characterized by moderate/high LDL-C, low HDL-C, and elevated triglyceride (TG) occurs in numerous clinical settings associated with high cardiovascular risk. This article focuses on optimizing treatment of atherogenic dyslipidemias involving this lipid triad, emphasizing niacin-based or fibrate-based therapies. RECENT FINDINGS: Niacin-based therapies comprehensively improve the atherogenic lipid profile, lead to atherosclerosis regression, and exert benefits across a spectrum of cardiovascular endpoints in studies based on limited patient numbers. Fibrates impact TG, HDL-C, and LDL-C according to lipid phenotype and underlying metabolic abnormality. In a recent meta-analysis, fibrates significantly reduced major cardiovascular events (-10%) and coronary events (-13%) across a wide range of lipid phenotypes, but had no impact on stroke, sudden death, or mortality. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial in type 2 diabetic patients similarly showed no significant effect of fenofibrate + simvastatin (vs. simvastatin) on nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death; a subgroup (17%) with marked atherogenic dyslipidemia trended toward benefit. Both niacin and fibrates attenuate vascular inflammation but the potential clinical relevance is indeterminate. SUMMARY: Optimal cardiovascular risk reduction in patients exhibiting the lipid triad requires integrated pharmacotherapy to normalize LDL-C, HDL-C, TGs, and potentially lipoprotein(a). Ongoing studies may provide definitive evidence of the impact of niacin plus statins on cardiovascular outcomes.

Niacin and fibrates in atherogenic dyslipidemia: pharmacotherapy to reduce cardiovascular risk.

Although statin therapy represents a cornerstone of cardiovascular disease (CVD) prevention, a major residual CVD risk (60-70% of total relative risk) remains, attributable to both modifiable and non-modifiable risk factors. Among the former, low levels of HDL-C together with elevated triglyceride (TG)-rich lipoproteins and their remnants represent major therapeutic targets. The current pandemic of obesity, metabolic syndrome, and type 2 diabetes is intimately associated with an atherogenic dyslipidemic phenotype featuring low HDL-C combined with elevated TG-rich lipoproteins and small dense LDL. In this context, there is renewed interest in pharmacotherapeutic strategies involving niacin and fibrates in monotherapy and in association with statins. This comprehensive, critical review of available data in dyslipidemic subjects indicates that niacin is more efficacious in raising HDL-C than fibrates, whereas niacin and fibrates reduce TG-rich lipoproteins and LDL comparably. Niacin is distinguished by its unique capacity to effectively lower Lp(a) levels. Several studies have demonstrated anti-atherosclerotic action for both niacin and fibrates. In contrast with statin therapy, the clinical benefit of fibrates appears limited to reduction of nonfatal myocardial infarction, whereas niacin (frequently associated with statins and/or other agents) exerts benefit across a wider range of cardiovascular endpoints in studies involving limited patient numbers. Clearly the future treatment of atherogenic dyslipidemias involving the lipid triad, as exemplified by the occurrence of the mixed dyslipidemic phenotype in metabolic syndrome, type 2 diabetes, renal, and auto-immune diseases, requires integrated pharmacotherapy targeted not only to proatherogenic particles, notably VLDL, IDL, LDL, and Lp(a), but also to atheroprotective HDL.

Effects of renal insufficiency and hemodialysis on the pharmacokinetics of rofecoxib.

Rofecoxib (VIOXX, Merck & Co., West Point, PA) is a COX-2-selective inhibitor that combines anti-inflammatory and analgesic efficacy with improved gastrointestinal (GI) safety. The present open-label study investigated the pharmacokinetics, safety, and tolerability of a single, oral dose of rofecoxib (50 mg) in patients with end-stage renal failure (creatinine clearance <5 mL/min/1.73 m(2)) requiring hemodialysis. Rofecoxib AUC(0-48 h), AUC(0- infinity), C(max), T(max), and t(1/2) obtained from renal failure patients on hemodialysis were not significantly different from those obtained from healthy subjects. With hemodialysis initiated 48 hours postdose, rofecoxib AUC(0-48 h) adjusted mean ratio (renal failure/healthy subjects) was 0.81, with a corresponding 90% confidence interval (CI; 0.66, 1.00). Hemodialysis per se had no clinically meaningful effect on rofecoxib pharmacokinetics: plasma rofecoxib concentration-time curves were virtually superimposable when hemodialysis was initiated at 4 or 48 hours following rofecoxib dosing, although mean rofecoxib C(max) was 18% lower during the former (325 versus 395 ng/mL; P = 0.014). Overall, rofecoxib was well tolerated in end-stage renal disease patients. In this study, end-stage renal disease and hemodialysis had little effect on rofecoxib pharmacokinetics. Although there are no clinical data to support the use of rofecoxib in patients with severe renal insufficiency (creatinine clearance, 5-30 mL/min/1.73 m(2)), these data suggest that dosage adjustment of rofecoxib is not needed for patients with impaired renal function.