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.

Impact of the 4th of August Beirut explosion mass casualty incident on a university hospital microbial Flora.

BACKGROUND: Following the Beirut explosion, our university hospital received at least 350 casualties. Subsequently, infection control standard practices were compromised. Concerns for Multi-Drug Resistant Organisms (MDROs) infections in injured patients and a resulting hospital outbreak were raised. The objectives of the study were to compare the rate of hospital growing MDROs 6 months before and 6 months after the Beirut explosion, to identify emerging microorganisms and to evaluate the change in surgical infection prevention practices. METHODS: This is a retrospective chart review of patients with hospital acquired infections (HAI) admitted to the hospital before and after the Beirut explosion. The study was conducted between February 4, 2020 and January 4, 2021. Excluded patients were those transferred from other hospitals and those with community acquired infections. The primary outcome was to identify the rate of growing MDROs post explosion. The secondary outcomes were identifying antibiotics used for surgical prophylaxis in patients requiring surgeries and patients diagnosed with a HAI. Therefore, patients were divided in three groups. Control group included patients admitted with explosion-related injuries on that same day. Patients admitted and between February 4 and August 4 and diagnosed with HAI were compared to those admitted post August 4 with explosion-related HAI and to patients diagnosed with non-explosion-related HAI between August 4 and January 4, 2021. An estimated rate of 18-22% MDRO was needed to achieve a statistical significance with 80% power and 0.05 α. Pearson Chi square test was used to analyze the primary outcome. RESULTS: A total of 82 patients with 150 cultures were included in this study. Data showed an increase in the rate of MDRO after the explosion with 37.1% of the cultures taken before the explosion and 53.1% after the explosion (p = 0.05). When comparing the types of HAI in both groups, culture sites were significantly different between pre- and post-explosion patients (p = 0.013). However, both groups had similar types of microbes (p = 0.996) with an increase in candida related infections. CONCLUSION: These findings confirmed that the Beirut explosion impact on antimicrobial resistance was similar to combat zone incidence, where an increase in MDROs rate such as Escherichia coli (E.Coli) and Stenotrophomonas maltophilia, in addition to the increase in candida related infections.

Emotional intelligence and professional identity formation in pharmacy education.

INTRODUCTION: Considering the various professional roles of pharmacists, pharmacy students and pharmacists have had difficulty identifying with a clear professional identity. Thereby there is a need for a professional identity formation (PIF) that conveys a consistent message about the role and value of pharmacists. Having a clear professional identity may also be a driver to advance the pharmacy profession. While achieving PIF is a challenging path, one element that conceivably contributes to PIF is emotional intelligence (EI). EI is acquired through life experiences and relates to personal and social awareness and the management of emotions and relationships. EI is critical for personal and professional success. PERSPECTIVE: Pharmacy students are exposed to different pharmacists' professional identities. This faces them with challenges as they try to incorporate their roles and expectations into practice. Integrating the core elements of EI into pharmacy education through a variety of teaching and learning methods is essential in the PIF of pharmacy students. PIF will enable pharmacy students to better associate with the profession by "thinking, acting, and feeling like a pharmacist." IMPLICATIONS: Both EI and PIF need to be integrated in pharmacy curricula. However, there is paucity of literature on how to best develop, integrate and assess EI and PIF. Therefore, a collaborative comprehensive approach by the pharmacy profession is necessary to that end.

Impact of social media education on antimicrobial stewardship awareness among pharmacy, medical and nursing students and residents.

BACKGROUND: Antimicrobial resistance has always been an important issue as antimicrobial therapies are becoming less effective due to incorrect use and overuse. Our objective was to evaluate the impact of social media education on spreading antimicrobial stewardship awareness among healthcare students and residents. METHODS: A prospective interventional study was conducted over 5 months, from November 2021 until March 2022. Weekly educational posts on infectious diseases were posted along with pre- and post- quizzes on a designated Facebook page. The primary endpoint of change in knowledge score was assessed using the independent t-test. Expected average pre-training is 2.5 over 5, and the expected average post-training is a minimum of 3.5 over 5 (common standard deviation of 1) for a minimum of 20% improvement that produces an effect size d = 1. Expecting a larger number of respondents on the pre-test than post-test, the ratio N1/N2 was set to 1.5. With the desired power set to 80% and alpha at 5%, sample size was determined as a minimum of 22 (N1) and 14 (N2). All analyses were carried at the 0.05 significance level. RESULTS: In the entry questionnaire, 85.6% (107/125) of participants believed that antibiotics are overused, 26.4% (33/125) confirmed that they overuse antibiotics, and 88.8% (111/125) confirmed the importance of having an antimicrobial stewardship program. 76.8% (96/125) of the participants regularly use social media for educational purposes and only 2.4% sometimes refer to social media as an educational tool. Improvement in knowledge was noted in all pre and post - quizzes except for two quizzes (prostatitis and acute cystitis - 18.4% and 13.2% improvement respectively). In total, there was a significant 36.2% improvement between all pre and post quizzes [min 13.2% and max 52.8% across all quizzes]. CONCLUSION: This intervention demonstrated the importance of social media as a valuable tool to enhance antimicrobial stewardship knowledge among pharmacy, medical and nursing students and residents. Future studies are needed to examine the impact of social media education on behaviors in practice.

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.

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.

Effects of statins on clinical outcomes in hospitalized patients with community-acquired pneumonia.

OBJECTIVE: We evaluated the effect of chronic use of statins based on C-reactive protein (CRP) levels and hospital length of stay (LOS) in patients admitted with community-acquired pneumonia (CAP). METHODS: We conducted a retrospective study over 12 months at a teaching hospital in Lebanon comparing patients with CAP taking chronic statins with patients not taking statins. Included patients with CAP were older than age 18 years and had two CRP level measures during hospitalization. CURB-65 criteria were used to assess the severity of pneumonia. A decrease in CRP levels on days 1 and 3, LOS, and normalization of fever were used to assess the response to antibiotics. RESULTS: Sixty-one patients were taking statins and 90 patients were not taking statins. Patients on statins had significantly more comorbid conditions; both groups had comparable CURB-65 scores. In both groups, no statistically significant difference was seen for the decrease in CRP level on days 1 and 3 and LOS. No difference in days to normalization of fever was detected in either group. CONCLUSION: No association was found between the chronic use of statins and CRP levels, LOS, or days to fever normalization in patients with CAP.

Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment.

BACKGROUND: Thromboprophylaxis dosing strategies using enoxaparin in elderly patients with renal disease are limited, while dose adjustments or monitoring of anti-Xa levels are recommended. We sought to evaluate the efficacy and safety of enoxaparin 20 mg versus 30 mg subcutaneously daily by comparing anti-Xa levels, thrombosis and bleeding. METHODS: We conducted a prospective, single-blinded, single-center randomized clinical trial including non-surgical patients, 70 years of age or older, with renal disease requiring thromboprophylaxis. Patients were randomized to receive either 20 mg or 30 mg of enoxaparin. The primary endpoint was peak anti-Xa levels on day 3. Secondary endpoints included trough anti-Xa levels on day 3, achievement of within range prophylactic target peak anti-Xa levels and the occurrence of hemorrhage, thrombosis, thrombocytopenia or hyperkalemia during hospitalization. RESULTS: Thirty-two patients were recruited and sixteen patients were randomized to each arm. Mean peak anti-Xa level was significantly higher in 30 mg arm (n = 13) compared to the 20 mg arm (n = 11) 0.26 ± 0.11, 95%CI (0.18-0.34), versus 0.14 ± 0.09, 95CI (0.08-0.19) UI/ml, respectively; p = 0.004. Mean trough anti-Xa level was higher in 30 mg arm (n = 10) compared to the 20 mg arm (n = 16), 0.06 ± 0.03, 95CI (0.04-0.08) versus 0.03 ± 0.03, 95CI (0.01-0.05) UI/ml, respectively; p = 0.044. Bleeding events reported in the 30 mg arm were one retroperitoneal bleed requiring multiple transfusions, and in the 20 mg arm one hematuria. No thrombotic events were reported. CONCLUSION: Peak anti-Xa levels provided by enoxaparin 20 mg were lower than the desired range for thromboprophylaxis in comparison to enoxaparin 30 mg. TRIAL REGISTRATION: The trial was retrospectively registered on ClinicalTrials.gov identifier: NCT03158792 . Registered: May 18, 2017.

Prevalence, Correlates and Management of Hyperglycemia in Diabetic Non-critically Ill Patients at a Tertiary Care Center in Lebanon.

BACKGROUND: Diabetes Mellitus is a chronic metabolic disease that affects 387 million people around the world. Episodes of hyperglycemia in hospitalized diabetic patients are associated with poor clinical outcomes and increased morbidity and mortality. Therefore, prevention of hyperglycemia is critical to decrease the length of hospital stay and to reduce complications and readmissions. OBJECTIVE: The study aims to examine the prevalence of hyperglycemia and assess the correlates and management of hyperglycemia in diabetic non-critically ill patients. METHODS: The study was conducted on the medical wards of a tertiary care teaching hospital in Lebanon. A retrospective chart review was conducted from January 2014 until September 2015. Diabetic patients admitted to Internal Medicine floors were identified. Descriptive analysis was first carried out, followed by a multivariable analysis to study the correlates of hyperglycemia occurrence. RESULTS: A total of 235 medical charts were reviewed. Seventy percent of participants suffered from hyperglycemia during their hospital stay. The identified significant positive correlates for inpatient hyperglycemia, were the use of insulin sliding scale alone (OR=16.438 ± 6.765-39.941, p=0.001) and the low frequency of glucose monitoring. Measuring glucose every 8 hours (OR= 3.583 ± 1.506-8.524, p=0.004) and/or every 12 hours (OR=7.647 ± 0.704-79.231, p=0.0095) was associated with hyperglycemia. The major factor perceived by nurses as a barrier to successful hyperglycemia management was the lack of knowledge about appropriate insulin use (87.5%). CONCLUSION: Considerable mismanagement of hyperglycemia in diabetic non-critically ill patients exists; indicating a compelling need for the development and implementation of protocol-driven insulin order forms a comprehensive education plan on the appropriate use of insulin.

Cost-effectiveness of novel treatment of hepatitis C virus in Lebanese patients.

Background Limited data is available on Hepatitis C disease prevalence, treatment initiation and its cost-effectiveness in Lebanon and the whole Middle East. Objective The aim of the study is to assess whether initiation of novel Direct Acting Antiviral agents (DAAs) at early stage of hepatitis C is cost-effective in Lebanese patients. Setting Lebanon. Methods This modeling study was conducted from the perspective of Lebanese third party payers, where existing practice is based on international guidelines for the diagnosis and treatment of diseases. The model assessed cost-effectiveness of early versus delayed DAAs treatment in a standard patient upon HCV diagnosis. Medical costs were valued using in-house database. Main outcome measures Incremental Cost-Effectiveness Ratio (ICER) per QALY and per life-year extended. Results Treatment at early HCV disease stage has led to an ICER of 587 euro per QALY gained throughout the course of the disease. Outcomes of early treatment with DAAs upon HCV diagnosis led to an incremental cost of 27,268 euro per QALY gained at first year of treatment, and of 1527 euro per additional life-year extended. Sensitivity analysis showed that a 25% decrease in the cost of dual drug option resulted in a decrease of incremental cost to 16,982 euro per QALY gained at first year of treatment with DAAs upon early HCV diagnosis. Conclusion Decision makers are encouraged to reinforce the need to screen for HCV and initiate novel treatment at early disease stage in the Lebanese healthcare system.

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.

Treatment outcomes of fixed-dose combination versus separate tablet regimens in pulmonary tuberculosis patients with or without diabetes in Qatar.

BACKGROUND: Tuberculosis is considered the second most common cause of death due to infectious agent. The currently preferred regimen for treatment of pulmonary tuberculosis (PTB) is isoniazid, rifampin, pyrazinamide, and ethambutol, which has been used either as separate tablets (ST) or as fixed-dose combination (FDC). To date, no studies have compared both regimens in Qatar. We aim to evaluate the safety and effectiveness of FDC and ST regimen for treating PTB, in addition to comparing safety and efficacy of FDC and ST regimens in patients with diabetes treated for TB. METHODS: A retrospective observational study was conducted in two general hospitals in Qatar. Patients diagnosed with PTB received anti-tuberculosis medications (either as FDC or ST) administered by the nurse. Sputum smears were tested weekly. We assessed the time to negative sputum smear and incidence of adverse events among FDC and ST groups. RESULTS: The study included 148 patients. FDC was used in 90 patients (61%). Effectiveness was not different between FDC and ST regimens as shown by mean time to sputum conversion (29.9 ± 18.3 vs. 35.6 ± 23 days, p = 0.12). Similarly, there was no difference in the incidence of adverse events, except for visual one that was higher in ST group. Among the 33 diabetic patients, 19 received the FDC and had faster sputum conversion compared to those who received ST (31 ± 12 vs. 49.4 ± 30.9 days, p = 0.05). Overall, diabetic patients needed longer time for sputum conversion and had more hepatotoxic and gastric adverse events compared to non-diabetics. CONCLUSION: ST group had higher visual side effects compared to FDC. FDC may be more effective in diabetic patients; however, further studies are required to confirm such finding.

Antibiotic knowledge and self-medication practices in a developing country: A cross-sectional study.

BACKGROUND: Self-medication is identified by the World Health Organization as a major factor leading to antibiotics overuse, misuse and resistance. This study's objectives were to evaluate the knowledge and self-medication with antibiotics in a sample of the population of Lebanon. METHODS: This study surveyed a sample of adults (over 18 years of age) residing in 2 major cities in Lebanon about their knowledge and self-medication with antibiotics. Health care professionals were excluded from the study. RESULTS: Four hundred questionnaires were completed. Of the responders, 72% were between 18 and 45 years of age with an overall 86% having completed at least high school. For their knowledge about antibiotics, 61% thought that antibiotics should be taken for common cold and 83% knew that misuse of antibiotics could result in microbial resistance. Self-medication significantly correlated with a lower educational level (P = .036). Those with lower knowledge about antibiotics stopped antibiotics at the inappropriate time (P = .002). Socioeconomic status, gender and age did not correlate with self-medication. CONCLUSION: Self-medication was associated with a person's educational level and knowledge of antibiotics. Awareness campaigns and enforcing medication dispensing laws are needed in to avoid self-medication with antibiotics.

Impact of clinical pharmacy interventions on medication error nodes.

Background Pharmacists' involvement in patient care has improved the quality of care and reduced medication errors. However, this has required a lot of work that could not have been accomplished without documentation of interventions. Several means of documenting errors have been proposed in the literature but without a consistent comprehensive process. Recently, the American College of Clinical Pharmacy (ACCP) recognized that pharmacy practice lacks a consistent process for direct patient care and discussed several options for a pharmaceutical care plan, essentially encompassing medication therapy assessment, development and implementation of a pharmaceutical care plan and finally evaluation of the outcome. Therefore, as per the recommendations of ACCP, we sought to retrospectively analyze interventions by grouping them according to medication related problems (MRP) and their nodes such as prescribing; administering; monitoring; documenting and dispensing. Objective The aim of this study is to report interventions according to medication error (ME) nodes and show the impact of pharmacy interventions in reducing MRPs. Setting The study was conducted at the cardiology and infectious diseases services at a teaching hospital located in Beirut, Lebanon. Methods Intervention documentation was completed by pharmacy students on infectious diseases and cardiology rotations then reviewed by clinical pharmacists with respective specialties. Before data analysis, a new pharmacy reporting sheet was developed in order to link interventions according to MRP. Then, MRPs were grouped in the five ME nodes. During the documentation process, whether MRP had reached the patient or not may have not been reported which prevented the classification to the corresponding medication error nodes as ME. Main outcome Reduction in medication related problems across all ME nodes. Results A total of n = 1174 interventions were documented. N = 1091 interventions were classified as MRPs. Interventions were analyzed per 1000 patient days and resulted in 340 medication related problem/1000 patient days. A 72 % reduction in MRP across all ME nodes was seen. The majority of interventions were in the field of cardiology followed by infectious disease related. When interventions per ME nodes were analyzed, a high percentage of intervention acceptance was noted across all nodes especially prescribing (68.30 %) monitoring (77.7 %) and in documenting errors (79.36 %). Conclusion The role of pharmacists in reducing preventable MRPs can be shown when pharmacy interventions are analyzed according to corresponding MRP and ME nodes.

Amoxicillin/Clavulanic Acid-induced thrombocytopenia.

INTRODUCTION AND OBJECTIVE: Drug-induced thrombocytopenia is a common adverse effect reported in the literature. Typically patients present with a low platelet count with signs and symptoms ranging from bruising to bleeding, and major organ damage. Penicillin-induced thrombocytopenia previously reported in the literature is explained primarily through the hapten-dependent antibody process. The goal of this report is to present a case of an amoxicillin/clavulanic acid-induced thrombocytopenia. CASE PRESENTATION: A 23-year-old male presented to the emergency department with bruises on his arms and legs after completing a full course of amoxicillin/clavulanic acid of 625 mg twice a day for 5 days for tonsillitis. After several tests, the patient was diagnosed with thrombocytopenia induced by amoxicillin/clavulanic acid. The patient was treated with a corticosteroids taper regimen for 3 weeks. He was discharged after 3 days of inpatient treatment with instructions to avoid physical activity for 2 weeks. Two weeks post discharge, the follow-up showed that the platelet count had increased. DISCUSSION: Penicillin-induced thrombocytopenia has been previously reported in the inpatient setting where bleeding was observed. However, the patient in this case report presented with bruises on his arms and legs. The diagnosis was made by the process of elimination; not all possible tests were conducted. The patient was prescribed corticosteroids that are not indicated for drug-induced thrombocytopenia. The Naranjo scale showed that this is a probable adverse event of amoxicillin/clavulanic acid. CONCLUSION: This is a unique case where amoxicillin/clavulanic acid was reported to be a probable cause of thrombocytopenia in an outpatient setting without signs of bleeding and without concomitant medications.

Tedizolid: a new oxazolidinone antimicrobial.

PURPOSE: The mechanism of action, pharmacokinetics, pharmacodynamics, and clinical efficacy and safety of an investigational second-generation oxazolidinone are reviewed. SUMMARY: Tedizolid is a protein synthesis inhibitor in clinical development for the treatment of gram-positive infections. Similar to linezolid, tedizolid works by binding to the 23S ribosomal RNA of the 50S subunit, thereby preventing the formation of the 70S initiation complex and inhibiting protein synthesis. Tedizolid has demonstrated potent in vitro activity against multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pneumoniae, and vancomycin-resistant enterococci (VRE), including some linezolid-resistant strains. Tedizolid has a favorable pharmacokinetic profile that allows for once-daily dosing and easy i.v.-to-oral conversion. Unlike linezolid, tedizolid has not been shown to interact with serotonergic agents in clinical studies. Two Phase III studies in patients with acute bacterial skin and skin structure infections have demonstrated the noninferiority of 6 days of tedizolid therapy (200 mg i.v. or orally once daily) relative to 10 days of linezolid therapy. In clinical trials to date, overall rates of treatment-related adverse effects with linezolid and tedizolid were comparable (40.8% versus 43.3%), with nausea being the most commonly reported adverse effect associated with tedizolid use (16% of patients). Planned studies will investigate tedizolid's potential role in the treatment of community-acquired bacterial pneumonia, hospital-acquired/ventilator-associated bacterial pneumonia, and bacteremia. CONCLUSION: Tedizolid is an investigational oxazolidinone antibiotic for the treatment of multidrug-resistant gram-positive pathogens such as MRSA, Streptococcus pneumoniae, and VRE, including some linezolid-resistant strains.

Bedaquiline: a novel diarylquinoline for multidrug-resistant tuberculosis.

OBJECTIVE: To review the chemistry, pharmacology, microbiology, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, dosage, and administration of bedaquiline, a novel oral diarylquinoline antimycobacterial agent approved by the Food and Drug Administration for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB). DATA SOURCES: A search of PubMed (January 2004-May 2013) and International Pharmaceutical Abstracts (January 2004-May 2013) using the search terms bedaquiline, diarylquinoline, R207910, and TMC207 was performed. Supplementary sources included proceedings of the Union World Conference on Lung Health. STUDY SELECTION AND DATA EXTRACTION: Preclinical data as well as Phase 1 and 2 studies published in English were evaluated. DATA SYNTHESIS: Bedaquiline possesses a unique mechanism of action that disrupts the activity of the mycobacterial adenosine triphosphate synthase. Clinical trials have been conducted evaluating the use of bedaquiline in combination with a background regimen for the treatment of adults with pulmonary MDR-TB. Bedaquiline has an excellent in vitro activity against Mycobacterium tuberculosis, including multidrug resistant M tuberculosis; however, its side effect profile limits its use against MDR-TB when no other effective regimen can be provided. Bedaquiline carries Black Box warnings for increased risk of unexplained mortality and QT prolongation. Bedaquiline is metabolized via the CYP3A4 isoenzyme and thus interacts with rifamycins and several antiretrovirals. CONCLUSIONS: In an era of emerging resistance and given the suboptimal efficacy and toxicity of currently available regimens for MDR-TB, bedaquiline represents a great addition to the existing armamentarium of anti-TB agents particularly in areas of the world where the disease is endemic.

Cethromycin: a new ketolide antibiotic.

OBJECTIVE: To review the pharmacology, chemistry, microbiology, in vitro susceptibility, mechanism of resistance, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, drug interactions, dosage, and administration of cethromycin, a new ketolide antibiotic. DATA SOURCES: Literature was obtained through searching PubMed (1950-October 2012), International Pharmaceutical Abstracts (1970-October 2012), and a bibliographic review of published articles. Search terms included cethromycin, ABT-773, ketolide antibiotic, and community-acquired pneumonia. STUDY SELECTION AND DATA EXTRACTION: All available in vitro and preclinical studies, as well as Phase 1, 2, and 3 clinical studies published in English were evaluated to summarize the pharmacology, chemistry, microbiology, efficacy, and safety of cethromycin in the treatment of respiratory tract infections. DATA SYNTHESIS: Cethromycin, a new ketolide, has a similar mechanism of action to telithromycin with an apparently better safety profile. Cethromycin displays in vitro activity against selected gram-positive, gram-negative, and atypical bacteria. The proposed indication of cethromycin is treatment of mild to moderate community-acquired bacterial pneumonia in patients aged 18 years or older. Based on clinical studies, the recommended dose is 300 mg orally once a day without regard to meals. Cethromycin has an orphan drug designation for tularemia, plague, and anthrax prophylaxis. The Food and Drug Administration denied approval for the treatment of community-acquired pneumonia in 2009; a recent noninferiority trial showed comparable efficacy between cethromycin and clarithromycin. Preliminary data on adverse effects suggest that cethromycin is safe and gastrointestinal adverse effects appear to be dose-related. CONCLUSIONS: Cethromycin appears to be a promising ketolide for the treatment of mild to moderate community-acquired pneumonia. It was denied approval by the FDA in 2009 pending more evidence to show its efficacy, with more recent studies showing its noninferiority to antibiotics for the same indication.