Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women.

OBJECTIVE: This review aims to provide an overview of pharmacologic management for hypoactive sexual desire disorder (HSDD) in premenopausal women, with a focus on available agents. DATA SOURCES: Through a literature search on PubMed, Google Scholar, and ClinicalTrials.gov from 1999 to 2024, studies were selected using the following MeSH search terms: hypoactive sexual desire disorder, premenopause, pharmacologic management, flibanserin, bremelanotide, buspirone, bupropion, and testosterone, excluding those involving postmenopausal women or other sexual disorders. Product monographs were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Relevant English-language studies or those conducted in humans were considered. DATA SYNTHESIS: Hypoactive sexual desire disorder, characterized by a lack of motivation for sexual activity, predominantly affects women aged 45 years and older. Treatment involves a multimodal approach, including nonpharmacologic interventions such as psychotherapy and lifestyle adjustments, alongside pharmacologic options. Although bupropion and buspirone may be considered off-label treatments, flibanserin and bremelanotide are the sole medications approved by the Food and Drug Administration for generalized acquired HSDD in premenopausal women. However, caution is advised due to their limited efficacy, potential adverse effects, and transparency issues in reporting. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Hypoactive sexual desire disorder, while not life-threatening, significantly impacts well-being and relationships. Pharmacotherapy, including options like flibanserin and bremelanotide, is essential within a multidisciplinary approach. Validated tools and objective measures inform tailored premenopausal HSDD care plans and aid in striking a balance between potential risks and adverse effects while maximizing meaningful clinical benefits, including for transgender individuals. CONCLUSIONS: Clinicians must discern important distinctions between flibanserin, bremelanotide, and other agents when managing premenopausal HSDD. Further research with the most suitable clinical endpoints and consideration of patient factors are crucial before widespread adoption of flibanserin and bremelanotide. Pharmacists are encouraged to embrace this opportunity to provide premenopausal HSDD care in ambulatory and community practice settings.

Entrustable professional activities-based objective structured clinical examinations in a pharmacy curriculum.

BACKGROUND: The integration of Objective Structured Clinical Examinations (OSCEs) within the professional pharmacy program, contributes to assessing the readiness of pharmacy students for Advanced Pharmacy Practice Experiences (APPEs) and real-world practice. METHODS: In a study conducted at an Accreditation Council for Pharmacy Education (ACPE)-accredited Doctor of Pharmacy professional degree program, 69 students in their second professional year (P2) were engaged in OSCEs. These comprised 3 stations: best possible medication history, patient education, and healthcare provider communication. These stations were aligned with Entrustable Professional Activities (EPAs) and Ability Statements (AS). The assessment aimed to evaluate pharmacy students' competencies in key areas such as ethical and legal behaviors, general communication skills, and interprofessional collaboration. RESULTS: The formulation of the OSCE stations highlighted the importance of aligning the learning objectives of the different stations with EPAs and AS. The evaluation of students' ethical and legal behaviors, the interprofessional general communication, and collaboration showed average scores of 82.6%, 88.3%, 89.3%, respectively. Student performance on communication-related statements exceeded 80% in all 3 stations. A significant difference (p < 0.0001) was found between the scores of the observer and the SP evaluator in stations 1 and 2 while comparable results (p = 0.426) were shown between the observer and the HCP evaluator in station 3. Additionally, a discrepancy among the observers' assessments was detected across the 3 stations. The study shed light on challenges encountered during OSCEs implementation, including faculty involvement, resource constraints, and the necessity for consistent evaluation criteria. CONCLUSIONS: This study highlights the importance of refining OSCEs to align with EPAs and AS, ensuring a reliable assessment of pharmacy students' clinical competencies and their preparedness for professional practice. It emphasizes the ongoing efforts needed to enhance the structure, content, and delivery of OSCEs in pharmacy education. The findings serve as a catalyst for addressing identified challenges and advancing the effectiveness of OSCEs in accurately evaluating students' clinical readiness.

Survey of colleges and schools of pharmacy to determine restrictions for teaching, research, and advocacy related to contraception.

INTRODUCTION: The pharmacist's role in reproductive health is evolving. Since 46 states allow providers to refuse to provide reproductive health services, it is important to consider whether learning is impacted by institution restrictions on contraception teaching, advocacy, and research. METHODS: An electronic survey was emailed to deans of all pharmacy schools on the American Association of Colleges of Pharmacy Institutional Membership list with a request to share with faculty teaching women's health content within their curriculum. The survey collected information about contraception teaching, research, and advocacy. RESULTS: Of 145 schools contacted, 39 (27%) provided complete responses. Of these, 22 (56%) were public, not religiously-affiliated, seven (18%) were private, not religiously-affiliated, six (15%) were private, currently religiously-affiliated, and four were (10%) private, historically religiously-affiliated. All respondents taught hormonal contraception in the required curriculum and 15 (39%) taught miscarriage management/abortifacients. None reported restrictions on contraception teaching or research. One respondent cited an advocacy restriction for contraception methods due to violation of the school's beliefs, and another cited an advocacy restriction for miscarriage management/abortifacients. Respondents noted students expressed ethical questions/concerns about refusing to dispense contraception (59%), dispensing certain contraceptives (54%), dispensing to minors (46%), and dispensing all contraceptives (21%). Additionally, respondents reported pharmacists/faculty expressed ethical questions/concerns about refusing to dispense contraception (31%), dispensing to minors (21%), dispensing certain contraceptives (15%), and all contraceptives (13%). CONCLUSIONS: Overall, respondents reported no restrictions in contraception teaching and scholarship and minimal advocacy restrictions. Faculty should consider ethical questions/concerns from students, faculty, and pharmacists when teaching this material.

Peripartum Pharmacotherapy: A Pharmacist's Guide.

Complications throughout the peripartum period may be caused by preexisting conditions or pregnancy-induced conditions and may alter pharmacotherapy management. Pharmacotherapy management during late pregnancy and delivery requires careful consideration due to changing hormones, hemodynamic status, and pharmacokinetics, and concerns for potential maternal and/or fetal morbidity. Increased maternal and fetal monitoring are often required and may lead to therapy changes. Pharmacists, as key members of the interprofessional team, can contribute essential perspective to the management of postpartum pharmacotherapy through assessment and recommendation of appropriate and judicious use of medications.

Value of pharmacy services upon admission to an orthopedic surgery unit.

BACKGROUND: In Lebanon, the role of the pharmacist remains underestimated in the medication reconciliation process, especially in surgical departments. This study aims to assess the impact of pharmacist-conducted medication reconciliation performed within 48 h of hospital admission to the orthopedic surgical department. METHODS: This was a prospective single-arm study conducted in a tertiary-care teaching hospital in Lebanon between October 2019 and April 2020. Participants were adult inpatients hospitalized for orthopedic surgeries with ≥ 1 outpatient medications. Properly trained pharmacy resident obtained the Best Possible Medication History (BPMH) and led the reconciliation process. The primary endpoint was the number of reconciliation errors (REs) identified. Descriptive statistics were used to report participants' responses and relevant findings. Linear regression was performed with the number of REs as a continuous dependent variable using backward method. Results were assumed to be significant when p was < 0.05. RESULTS: The study included 100 patients with a mean age of 73.8 years, admitted for elective (54%) or emergency (46%) surgeries. Half of the study population had ≥ 5 home medications. The mean time for taking BPMH was around 8 min. A total of 110 REs were identified in 74 patient cases. The most common discrepancies consisted of medication omission (89.1%) and the most common medications involved were antihyperlipidemic agents. Twenty-four REs were judged as clinically significant, and four as serious. The most common interventions included the addition of a medication (71.9%). Most of the relayed interventions (84.5%) were accepted. The number of home medications was the only variable significantly associated with the number of REs (ß 0.492; p < 0.001). CONCLUSION: Pharmacy-led medication reconciliation upon admission to orthopedic surgery department can reduce reconciliation errors and improve medication safety. TRIAL REGISTRATION: Retrospectively registered in the Lebanon Clinical Trials Registry (LBCTR2020124680).

Impact of pharmacist-conducted anticoagulation patient education and telephone follow-up on transitions of care: a randomized controlled trial.

BACKGROUND: There is limited published data in Lebanon evaluating the impact of supplemental education for anticoagulants use, especially DOACs, on clinical outcomes such as bleeding. The study aims to assess the impact of pharmacist-conducted anticoagulation education and follow-up on bleeding and readmission rates. METHODS: This study was a randomized, non-blinded interventional study conducted between August 2017 and July 2019 in a tertiary care teaching Lebanese hospital. Participants were inpatients ≥18 years discharged on an oral anticoagulant for treatment. Block randomization was used. The control group received the standard nursing counseling while the intervention group additionally received pharmacy counseling. Phone call follow-ups were done on day 3 and 30 post-discharge. Primary outcomes included readmission rates and any bleeding event at day 3 and 30 post-discharge. Secondary outcomes included documented elements of education in the medical records and reported mortality upon day 30 post-discharge. RESULTS: Two hundred patients were recruited in the study (100 patients in each study arm) with a mean age of 73.9 years. In the pharmacist-counseled group, more patients contacted their physician within 3 days (14% versus 4%; p = 0.010), received explicit elements of education (p < 0.001) and documentation in the chart was better (p < 0.05). In the standard of care group, patients were more aware of their next physician appointment date (52% versus 31%, p < 0.001). No difference in bleeding rates at day 3 and 30 post-discharge was observed between the groups. CONCLUSIONS: Although pharmacist-conducted anticoagulation education did not appear to reduce bleeding or readmission rates at day 30, pharmacist education significantly increased patient communication with their providers in the early days post-discharge. TRIAL REGISTRATION: Lebanon Clinical Trial Registry LBCTR2020033424 . Retrospectively registered. Date of registration: 06/03/2020.

Imipenem/cilastatin/relebactam: A new carbapenem ß-lactamase inhibitor combination.

PURPOSE: The pharmacology, pharmacokinetics, pharmacodynamics, antimicrobial activity, efficacy, safety, and current regulatory status of imipenem/cilastatin/relebactam are reviewed. SUMMARY: Imipenem/cilastatin/relebactam is a newly approved anti-infective combination of a well-established ß-lactam and a new ß-lactamase inhibitor for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and complicated intra-abdominal infections (cIAIs) caused by susceptible gram-negative bacteria in patients 18 years of age or older with limited or no alternative treatment options. The antibiotic is also indicated for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The antibiotic is active in vitro against a wide range of pathogens, including multidrug-resistant (MDR) Pseudomonas aeruginosa and carbapenem-resistant Enterobacterales (CRE) such as Klebsiella pneumoniae carbapenemase. The addition of relebactam does not restore the activity of imipenem against metallo-ß-lactamase (MBL)-producing Enterobacterales and carbapenem-resistant Acinetobacter baumannii. Two phase 3 clinical trials of imipenem/cilastatin/relebactam were conducted. In the RESTORE-IMI 1 trial, the efficacy and safety of imipenem/cilastatin/relebactam was found to be comparable to that of imipenem/cilastatin plus colistin for the treatment of infections caused by imipenem-nonsusceptible gram-negative bacteria in patients with HABP/VABP, cUTIs, and cIAIs, with a significantly lower incidence of nephrotoxicity reported with the new antibiotic. The RESTORE-IMI 2 trial demonstrated the noninferiority of imipenem/cilastatin/relebactam to piperacillin/tazobactam for the treatment of HABP/VABP. Commonly reported adverse events in clinical trials included anemia, elevated liver enzymes, electrolyte imbalances, nausea, vomiting, diarrhea, headache, fever, phlebitis and/or infusion-site reactions, and hypertension. CONCLUSION: Imipenem/cilastatin/relebactam is a new ß-lactam/ß-lactamase inhibitor combination with activity against MDR gram-negative bacteria, including many CRE but excluding MBL-producing Enterobacterales and carbapenem-resistant Acinetobacter baumannii. It is approved for the treatment of cUTIs, cIAIs, and HABP/VABP.

Infertility Management and Pharmacotherapy: What Every Pharmacist Should Know.

Infertility is a significant public health concern in the United States. As such, utilization of infertility services, including pharmacotherapeutic treatments, is prevalent, and the role of the pharmacist as part of the health care team is essential. Pharmacists can assist patients by providing education on infertility causes, risk factor mitigation, referrals, nonpharmacologic and pharmacologic management options, navigation of the prescription process, and resource availability for the significant financial burden accompanying infertility treatment. In-depth pharmacotherapeutic information may not be readily available to pharmacists dispensing and counseling on these medications, and infertility management regimens are often varied and complicated requiring more in-depth counseling on use and administration. Given the complexity of infertility management, pharmacists are a valuable patient support and education resource. This article provides an in-depth review of infertility management strategies, both nonpharmacologic and pharmacologic.

COVID-19 and Academic Pharmacy: Navigating Uncharted Territory.

The current COVID-19 pandemic with the associated social distancing measures has imposed unprecedented challenges on educational institutions around the globe. Schools and colleges of pharmacy across the United States have responded by offering distance learning options and are designing contingency plans to maintain operations. The pandemic has impacted all aspects of pharmacy education including didactic instruction, experiential education, interprofessional education, cocurricular activities, community service, scholarship, professional service, well-being, resilience, recruitment, admissions, and celebrating student success. Pharmacy faculty, staff, and students are subsequently trying to navigate a rapidly changing environment by taking advantage of opportunities as they arise while mitigating many threats that are affecting their professional and personal lives. Pharmacy faculty will need to remain flexible, embrace change, and create innovative solutions to help students progress through the curriculum while maintaining their contributions to society. Students will need to find creative ways to remain engaged with their courses and cocurricular activities.

Current Trends in Hospital Pharmacy Practice in Lebanon.

Objectives: For decades, the role of hospital pharmacists has been instrumental in elevating pharmacy practice worldwide. Recently, the Hospital Pharmacy Section of the International Pharmaceutical Federation (FIP), the European Association of Hospital Pharmacists (EAHP), and the American Society of Health-System Pharmacists (ASHP) updated their statements about the future role and responsibilities of the pharmacy executive in hospitals and health systems. A series of surveys were conducted around the globe to better understand the current state of hospital pharmacy practice. The purpose of these surveys was to identify challenges in hospital pharmacy practice and to develop improvement strategies. The objective of this national survey is to evaluate hospital pharmacy practice in Lebanon. Methods: A cross-sectional observational study was performed among pharmacists working in hospital settings in Lebanon, from January through June 2016. Based on a literature review, a questionnaire to elicit Lebanese hospital pharmacists' practice was developed. Results: The results showed a nonsignificant difference between university teaching and nonuniversity teaching hospitals in the processes of drug procurement, preparation, dispensing, and drug administration. However, statistically significant differences were observed between university teaching and nonuniversity teaching hospitals with respect to having clinical pharmacists (P < .001) and highly qualified personnel (P < .005). Pharmacy services in teaching hospitals seemed to be more advanced cooperating with affiliated medical schools. Furthermore, teaching hospitals were more likely to have pharmacists providing information about the safety of the medications used (P = .029). Although not statistically significant, there was a higher trend toward having a designated champion for medication safety (P = .052). Conclusion: The results of our survey showed that teaching hospitals were more compliant with the International Statements of Hospital Pharmacy Practice compared with nonteaching hospitals. There is room for improvement especially if the application of the accreditation standards for safe hospital pharmacy practice becomes mandatory for all hospitals, which is expected to standardize pharmacy practice and secure both medication and patient safety.

Impact of pharmacy-led medication reconciliation on admission to internal medicine service: experience in two tertiary care teaching hospitals.

BACKGROUND: The Institute for Healthcare Improvement identifies medication reconciliation as the shared responsibility of nurses, pharmacists, and physicians, where each has a defined role. The study aims to assess the clinical impact of pharmacy-led medication reconciliation performed on day one of hospital admission to the internal medicine service. METHODS: This is a pilot prospective study conducted at two tertiary care teaching hospitals in Lebanon. Student pharmacists who were properly trained and closely supervised, collected the medication history, and pharmacists at the corresponding sites performed the reconciliation process. Interventions related to the unintended discrepancies were relayed to the medical team. The main outcome was the number of unintended discrepancies identified. The time needed for medication history, and the information sources used to complete the Best Possible Medication History were also assessed. The unintended discrepancies were classified by medication class and route of medication administration, by potential severity, and by proximal cause leading to the discrepancy. For the bivariate and multivariable analysis, the dependent variable was the incidence of unintended discrepancies. The "total number of unintended discrepancies" was dichotomized into yes (≥ 1 unintended discrepancy) or no (0 unintended discrepancies). Independent variables tested for their association with the dependent variable consisted of the following: gender, age, creatinine clearance, number of home medications, allergies, previous adverse drug reactions, and number of information sources used to obtain the BPMH. Results were assumed to be significant when p was < 0.05. RESULTS: During the study period, 204 patients were included, and 195 unintended discrepancies were identified. The most common discrepancies consisted of medication omission (71.8%), and the most common agents involved were dietary supplements (27.7%). Around 36% of the unintended discrepancies were judged as clinically significant, and only 1% were judged as serious. The most common interventions included the addition of a medication (71.8%) and the adjustment of a dose (12.8%). The number of home medications was significantly associated with the occurrence of unintended discrepancies (ORa = 1.11 (1.03-1.19) p = 0.007). CONCLUSIONS: Pharmacy-led medication reconciliation upon admission, along with student pharmacist involvement and physician communication can reduce unintended discrepancies and improve medication safety and patient outcomes.

Enoxaparin 20 mg for thromboprophylaxis in severe renal impairment.

OBJECTIVE: This study was performed to evaluate the efficacy of daily subcutaneous enoxaparin 20 mg in patients with renal failure. METHODS: This retrospective cohort study included nonsurgical patients aged ≥18 years with a creatinine clearance rate of <30 mL/minute who were prescribed enoxaparin 20 mg subcutaneously (SC) daily for ≥3 days. The main outcome measures were the occurrence of a venous thromboembolic event (VTE) and bleeding events. RESULTS: One hundred sixty patients were identified. VTE occurred in 9 patients (5.6%), and bleeding events occurred in 37 (23.1%). Multivariable analysis showed that an age of >75 years was significantly associated with an increased risk of bleeding, while a creatinine clearance rate of 15 to 29 mL/minute was significantly associated with a lower risk of bleeding. CONCLUSION: In patients with renal failure, enoxaparin 20 mg SC daily resulted in a 5.6% incidence of VTE, which is similar to the previously published acceptable incidence of VTE in patients with normal renal function receiving enoxaparin 40 mg SC daily. The incidence of major bleeding events was 10%, which is lower than that previously published in the literature.

Assessing the perceptions of pharmacists working in Lebanese hospitals on the continuing education preferences.

BACKGROUND: Continuing education (CE) is an international tool that requires lifelong active participation in learning activities allowing the pharmacist to stay a major player among others. In 2014 the CE program was introduced to the pharmacists licensed in Lebanon as a mandatory requirement for re-licensure. In the absence of guidelines regarding the quality and quantity of CE programs, behavioral resistance to precipitate in the CE programs might be encountered among the pharmacists. OBJECTIVE: The objective of this study is to assess the perceptions of pharmacists working in Lebanese hospitals on the continuing education preferences. The advantage of this program is to collect information that would help the Order of Pharmacy in Lebanon to upgrade the CE program in a way that is more acceptable and convenient for the pharmacists. METHODS: A cross-sectional study was carried out in 2016, using a proportionate random sample of Lebanese hospital pharmacies from all governorates in Lebanon. A structured questionnaire was distributed to all hospital pharmacies in Lebanon. Descriptive statistics were calculated for all study variables. This includes the mean and standard deviation for continuous measures, counts and percentages for categorical variables. RESULTS: A total of 107 (53.5%) participants completed the questionnaires. The majority of participants were from Beirut and Mount Lebanon. The percentage of participants working at private hospitals was (68.2%).The majority of participants who completed the questionnaire (86.2%) agreed that continuing education programs affects their way of practice and increases their knowledge. Their preferred CE types to be used in the future were the computer based ones (60.6%), interactive workshops (45.5%) and printed materials (44.9%). Their considerations for selecting the CE type is based on their interest in the topic (80.6%), the ease of access to print or online material (77.2%), or the convenience of being offered during an event (67.1%). Participants noted that barriers to attend live CEs were mainly work responsibilities (76%), travel distance (65.6%), family commitments (48.4%) and scheduling (40.6%). CONCLUSIONS: Lebanese hospital pharmacists are highly committed to CE. They consider it a practical tool for career development and advancement.

Assessing the perceptions of pharmacists working in Lebanese hospitals on the continuing education preferences

Background: Continuing education (CE) is an international tool that requires lifelong active participation in learning activities allowing the pharmacist to stay a major player among others. In 2014 the CE program was introduced to the pharmacists licensed in Lebanon as a mandatory requirement for re-licensure. In the absence of guidelines regarding the quality and quantity of CE programs, behavioral resistance to precipitate in the CE programs might be encountered among the pharmacists. Objective: The objective of this study is to assess the perceptions of pharmacists working in Lebanese hospitals on the continuing education preferences. The advantage of this program is to collect information that would help the Order of Pharmacy in Lebanon to upgrade the CE program in a way that is more acceptable and convenient for the pharmacists. Methods: A cross-sectional study was carried out in 2016, using a proportionate random sample of Lebanese hospital pharmacies from all governorates in Lebanon. A structured questionnaire was distributed to all hospital pharmacies in Lebanon. Descriptive statistics were calculated for all study variables. This includes the mean and standard deviation for continuous measures, counts and percentages for categorical variables Results: A total of 107 (53.5%) participants completed the questionnaires. The majority of participants were from Beirut and Mount Lebanon. The percentage of participants working at private hospitals was (68.2%).The majority of participants who completed the questionnaire (86.2%) agreed that continuing education programs affects their way of practice and increases their knowledge. Their preferred CE types to be used in the future were the computer based ones (60.6%), interactive workshops (45.5%) and printed materials (44.9%). Their considerations for selecting the CE type is based on their interest in the topic (80.6%), the ease of access to print or online material (77.2%), or the convenience of being offered during an event (67.1%). Participants noted that barriers to attend live CEs were mainly work responsibilities (76%), travel distance (65.6%), family commitments (48.4%) and scheduling (40.6%). Conclusions: Lebanese hospital pharmacists are highly committed to CE. They consider it a practical tool for career development and advancement

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Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study.

BACKGROUND: The objective of this study was to assess the knowledge and practice of Lebanese patients living with diabetes mellitus in regards to their diabetes self- management. METHODS: A cross-sectional study, conducted between January and June 2015, enrolled 207 urban adult patients with diabetes mellitus from community pharmacies while purchasing their diabetes medications. Their knowledge and self-management practices were assessed using a structured anonymous interview survey questionnaire. RESULTS: The mean age of the participants was 60.2 ± 15.5 years, and the Male/Female ratio was 1.38. The mean knowledge score was 2.34 ± 0.88 points (out of 6). Very few participants (17.4%) knew their current medication side effects. The mean practice score was 5.86 ± 1.77 points (out of 8). Only 15.9% of patients reported current physical activity. A multiple linear analysis showed that those with a university degree had a significantly higher knowledge (Beta = 0.448, p = 0.001) and practice score (Beta = 0.523 p = 0.047) than those with intermediate or primary schooling. Those who reported following a special diabetes diet had a higher knowledge score (Beta = 0.482, p < 0.001) than those who did not. Knowledge score and practice score were highly correlated (Beta = 0.844, p < 0.001). There was no significant differential by gender and age for knowledge and practice scores. CONCLUSIONS: The knowledge and practice scores of patients with diabetes mellitus were not satisfactory. Well-targeted interventions are needed, such as improving the communication between the pharmacist and people living with diabetes. The observed low adherence to physical exercise among patients with diabetes should also be addressed.

Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice.

OBJECTIVE: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. DATA SOURCES: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. STUDY SELECTION AND DATA EXTRACTION: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. DATA SYNTHESIS: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. CONCLUSIONS: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.

Elbasvir-grazoprevir: A new direct-acting antiviral combination for hepatitis C.

PURPOSE: The chemistry, pharmacology, pharmacodynamics, pharmacokinetics, efficacy, safety, dosage, administration, and role of elbasvir-grazoprevir in the treatment of hepatitis C virus (HCV) infection are reviewed. SUMMARY: Elbasvir-grazoprevir was recently approved by the Food and Drug Administration for the treatment of chronic HCV genotype 1 or 4 infections with or without ribavirin in patients with or without compensated cirrhosis. Elbasvir exhibits antiviral activity against HCV genotypes 1a, 1b, 2a, 3a, and 4a. Elbasvir-grazoprevir undergoes fecal excretion, does not require dosage adjustment in patients with renal impairment, and is contraindicated in moderate and severe hepatic impairment. In Phase II and III clinical trials, elbasvir-grazoprevir administered orally for 12 weeks was shown to achieve a high sustained virological response 12 weeks after the end of treatment. Elbasvir-grazoprevir is a once-daily, fixed-dose combination tablet that can be taken without regard to food. The adverse drug reactions most commonly reported include fatigue, headache, and nausea. Elbasvir-grazoprevir is indicated with ribavirin for treatment-naive and treatment-experienced patients with genotype 1a with baseline NS5A polymorphisms, for treatment-experienced patients with genotype 1b, and for treatment-experienced patients with genotype 4. CONCLUSION: Elbasvir-grazoprevir achieves a high cure rate in the treatment of patients with chronic HCV with a once-daily oral regimen and without serious adverse effects; however, it requires close monitoring of liver function values. It is an effective option for patients with HCV genotype 1a, 1b, or 4 with or without compensated cirrhosis and is a particularly attractive option in patients with chronic kidney disease receiving hemodialysis and in patients with HIV coinfection.

Mapping of the biomedical literature evaluation competencies based on pharmacy students' feedback.

BACKGROUND: This study aims to map the learned curriculum based on students' feedback regarding the biomedical literature evaluation competencies in a pharmacy curriculum, to evaluate teaching methods and to report students' longitudinal self-assessment of their achievement of related learning outcomes as they progress from didactic to experiential courses. METHODS: The biomedical literature evaluation competencies were mapped in three courses delivered during different pharmacy professional years (PPY): Drug Information and Literature Evaluation (PHA421) offered in the second PPY, Pharmacoeconomics (PHA557) and Professional Pharmacy Practice Experience-Hospital/Drug Information Services (PHA570) offered in the third PPY. A unified survey was developed to collect information from students at the beginning and completion of these courses. Survey results were then compared to school assessment data of identified courses for triangulation of findings. RESULTS: Listed student learning outcomes are consistently achieved through all three courses with more assertion from the students at the completion of the applied experiential course PHA 570 (>90 % agree or strongly agree). In terms of delivery methods, 84 % of students perceived the benefits of active learning methods in reinforcing acquired skills and increasing confidence in knowledge and critical thinking in a less stressful learning environment. Results shown at the end of each course indicate a favorable student response from one course to the next where almost all students replied with 'agree to strongly agree' to survey questions assessing their readiness to critically evaluating trials (72 %, 96 % and 92 %) in PHA421, PHA557 and PHA570, respectively. Study findings are in congruence with school assessment database of the selected courses. CONCLUSION: Formative assessment results demonstrated acquisition of required analytical skills, and completion of course learning outcomes as students progressed from introductory to advanced courses covering the biomedical literature component.