The National Comprehensive Cancer Network (NCCN) has recommended Ado-trastuzumab emtansine (T-DM1) as a preferred agent for patients with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer and prior trastuzumab therapy. Overexpression of HER2 was reported in other cancer types such as bladder, gastric and urogenital carcinosarcomas similar to what is discovered in breast cancer. Some preclinical studies demonstrated the potential anti-tumor effects of T-DM1 in HER2-positive non-breast cancers. There is a paucity of data over the clinical evaluation of T-DM1 in human studies of non-breast cancer patients. We review some preclinical and ongoing clinical studies that assessed the efficacy of T-DM1 administration in the treatment of non-breast HER2 positive malignancies. Performing large and well-designed trials in this area is matter of interest and highly recommended.

Objective: Iran Food and Drug Administration (IFDA) has the mission to regulate all aspects of pharmaceutical market including registration of the new medicines. Iran Drug Selection Committee has the responsibility to maintain and revise Iran Medicine List (IML). The National law has banned production, importation, distribution, and prescription of medicines not included in IML. Although, IFDA policy makers have created a mechanism to provide medicines not included in the list but might be essential for the treatment of specific patients. Methods: A cross-sectional study was carried out on prescription of out of IML medicines during the year 2015. This study was conducted on a total of 1375 application forms received by Secretariat of Iran Drug Selection Committee for prescription of out of IML medicines. Findings: It has been shown that among 402 specialist physicians, the most out of IML medicine were prescribed by oncologist/hematologist. Antineoplastic and immunomodulating agents were the most frequently prescribed medicines both in terms of number and diversity. According to the collected data, more than 76% of all medicines were supplied by only 4 out of 25 pharmaceutical companies in 1 year. Conclusion: Results of this study show that despite its early intention this mechanism is easily abused by some pharmaceutical companies as an unethical way of induced demand and marketing of their products. Therefore, IFDA decision makers should revise this mechanism and decide based on its real benefits and harms both to the patients and Iran national health system.

Objective: The aim of the present study was to determine the pattern of antimicrobial resistance of Gram-positive bacteria during three consecutive years at the nephrology ward of Namazi Hospital in Shiraz, Southwest of Iran. Methods: During a 3-year period from 2013 to 2015, data of all biological samples of hospitalized patients at the adult nephrology ward of Namazi Hospital were sent to the central laboratory for identification of Gram-positive microorganisms and subsequently, their antimicrobial susceptibility testing by Kirby–Bauer disc diffusion method were analyzed in a retrospective manner. Findings: Coagulase-negative Staphylococci (CONS) (38.5%), Staphylococcus aureus(25.4%), and Enterococcus spp. (23.8%) were the most common isolated Gram-positive bacteria from all biological samples. All Enterococcus spp. isolates within the 3 years were resistant to oxacillin. The rate of vancomycin-resistant enterococci (VRE) increased from 40.63% in 2013 to 72.73% in 2015. Enterococcus spp. resistance rates to aminoglycosides during 3 years were above 85%. The frequencies of oxacillin-resistant S. aureus (ORSA) in 2013, 2014, and 2015 were 95.24%, 80.95%, and 36.36%, respectively. Two out of 11 (6.67%) S. aureus isolates were resistant to vancomycin. More than 90% of CONS were sensitive to vancomycin within the study period. The frequency of gentamicin-resistant CONS ranged from 40% to 57.14%. Conclusion: The rates of ORSA, VRE, and aminoglycoside-resistant CONS as well as Enterococcus spp. in our clinical setting were considerably high and concerning. These may be due to the failure or lack of infection control activities and antimicrobial selection pressure.

Objective: Proton pump inhibitor-based triple therapy with two antibiotics for Helicobacter pylori eradication is widely accepted, but this combination fails in a considerable number of cases. Some studies have shown that cranberry inhibits the adhesion of a wide range of microbial pathogens, including H. pylori. The aim of this study was to assess the effect of cranberry on H. pylori eradication with a standard therapy including lansoprazole, clarithromycin, and amoxicillin (LCA) in patients with peptic ulcer disease (PUD). Methods: In this study, H. pylori-positive patients with PUD were randomized into two groups: Group A: A 14-day LCA triple therapy with 30 mg lansoprazole bid, 1000 mg amoxicillin bid, and 500 mg clarithromycin bid; Group B: A 14-day 500 mg cranberry capsules bid plus LCA triple therapy. A ¹³C-urea breath test was performed for eradication assessment 6 weeks after the completion of the treatment. Findings: Two hundred patients (53.5% males, between 23 and 77 years, mean age ± standard deviation: 50.29 ± 17.79 years) continued treatment protocols and underwent ¹³C-urea breath testing. H. pylori eradication was achieved in 74% in Group A (LCA without cranberry) and 89% in Group B (LCA with cranberry) (P = 0.042). Conclusion: The addition of cranberry to LCA triple therapy for H. pylori has a higher rate of eradication than the standard regimen alone (up to 89% and significant).

Objective: A randomized, double-blind, placebo-controlled clinical trial was performed to assess the effect of omega-3 supplementation (3 g/day) on atherosclerosis progression by measuring carotid intima-media thickness (cIMT) in hemodialysis (HD) patients. Methods: A total of 54 HD patients were randomized into two groups: Intervention group (n = 27), in which patients were given 3 g/day omega-3 for 6 months and placebo group (n = 27), in which patients received placebo using the same administration protocol. All patients underwent a carotid artery ultrasound scan to measure cIMT at baseline and at 6 months. Findings: cIMT decreased significantly in omega-3 group (0.79 ± 0.21 mm at baseline vs. 0.65 ± 0.18 mm at 6 months, P< 0.001). On the other hand, a nonsignificant increase in cIMT was seen in placebo group (0.75 ± 0.17 mm at baseline vs. 0.79 ± 0.17 mm at 6 months, P = 0.12). Moreover, cIMT was statistically significantly different between omega-3 and placebo groups at 6 months (P < 0.001). After 6 months, a statistically significant increase was observed in high-density lipoprotein level in omega-3 group compared to placebo group (P = 0.03). Urea reduction ratio was also statistically significantly higher in omega-3 than placebo group at 6 months (P = 0.03). No significant difference was observed in terms of other variables between the two groups. Conclusion: These data suggested that omega-3 supplementation plays a protective role in the progression of atherosclerosis in HD patients.

Objective: Drug–drug interactions (DDIs) can cause failure in treatment and adverse events. DDIs screening software is an important tool to aid clinicians in the detection and management of DDIs. However, clinicians should be aware of the advantages and limitations of these programs. We compared the ability of five common DDI programs to detect clinically important DDIs. Methods: Lexi-Interact, Micromedex Drug Interactions, iFacts, Medscape, and Epocrates were evaluated. The programs' sensitivity, specificity, and positive and negative predictive values were determined to assess their accuracy in detecting DDIs. The accuracy of each program was identified using 360 unknown pair interactions, taken randomly from prescriptions, and forty pairs of clinically important ones. The major reference was a clinical pharmacist alongside the Stockley's Drug Interaction and databases including PubMed, Scopus, and Google Scholar. Comprehensiveness of each program was determined by the number of components in the drug interaction monograph. The aggregate score for accuracy and comprehensiveness was calculated. Findings: Scoring 250 out of possible 400 points, Lexi-Interact and Epocrates, provided the most accurate software programs. Micromedex, Medscape, and iFacts ranked third, fourth, and fifth, scoring 236, 202, and 191, respectively. In comprehensiveness test, iFacts showed the highest score, 134 out of possible 134 points, whereas Lexi-Interact rated second, with a score of 120. Scoring 370 and 330 out of possible 534 points, Lexi-Interact and Micromedex, respectively, provided the most competent, complete, and user-friendly applications. Conclusion: Lexi-Interact and Micromedex showed the best performances. An increase in sensitivity is possible by the combination of more than one programs and expert pharmacist intervention.

Objective: This study aimed to compare two methods of controlled hypotension using labetalol and remifentanil in terms of capability to create controlled hypotension and to investigate the obtained complications, and satisfaction rate of surgeon and patient during functional endoscopic sinus surgery. Methods: In this prospective clinical trial, 62 patients underwent endoscopic sinus surgery in Al-Zahra and Ayatollah Kashani Hospitals of Isfahan were divided into two groups: in the first group, 20 mg bolus dose of labetalol and then infusion of it, at a rate of 0.5–2.0 mg/min and in the second group, remifentanil with dose of 0.5–1 μg/kg started and then 0.25–0.5 μg/kg/min were prescribed. Hemodynamic parameters during anesthesia and recovery time, surgeon and patient satisfaction, and recovery time were measured and recorded. Findings: Hemodynamics variable were comparable between two groups at different times of the study. The mean of bleeding and the frequency of side effects were higher in labetalol group (P = 0.033 and P < 0.0001, respectively). The median of surgeon satisfaction score in remifentanil group was statistically higher in labetalol group (P < 0.0001). Recovery time, fluid requirement, and pain score in labetalol group reported significantly more than remifentanil group. Richmond Agitation–Sedation Scale status at time points in the postanesthetic care unit showed differences between groups. Conclusion: With infusion of labetalol and remifentanil after a bolus dose we can induce effective controlled hypotension under general anesthesia. Remifentanil is a short-acting narcotic drug; then, patient satisfaction was better and recovery time was shorter. From the economic aspect, labetalol prefers to remifentanil.

Objective: The principal aim of this study was to explore the self-perception of clinical pharmacists of their impact on healthcare in Khartoum State, Sudan, how they think doctors perceive their impact, exploring the obstacles that clinical pharmacists are facing, and identifying what clinical pharmacists recommend for a better clinical pharmacy practice in Sudan. Methods: This was an exploratory cross-sectional study that employed a qualitative method. Individual, in-depth interviews were conducted with a convenient sample of 26 clinical pharmacists working in 14 governmental hospitals in Khartoum State, Sudan, in March 2016. Each interview was recorded, transcribed, and coded into themes. Thematic analysis was carried out. Findings: The study revealed different themes regarding clinical pharmacists' perception of their impact on healthcare. The majority believed that they made an improvement in healthcare but not to the level they aspire to. Participants expressed that junior doctors and nurses had a better acceptance of clinical pharmacists' interventions compared to senior doctors. The main obstacles that clinical pharmacists were facing were their limited number, lack of support from health authorities, lack of training and educational program, lack of job descriptions, lack of specific area in patient files for clinical pharmacist intervention, and low salaries. Most participants showed dissatisfaction with the syllabus of the master of clinical pharmacy they studied. Conclusion: The study revealed that clinical pharmacists were looking for a better contribution in healthcare in Sudan. This can be achieved by solving the problems identified in this study.

Objective: The risk of methicillin-resistant Staphylococcus aureus infections in Intensive Care Unit (ICU) is increasing in recent years with high rate of morbidity and mortality. Therefore, in this study, we aimed to evaluate the rationale use of vancomycin in ICU patients. Methods: A total of 200 patients who received at least 48 h intravenous vancomycin were randomly selected from ICU wards, during 9 months. Vancomycin administration and related clinical and laboratory data were gathered from patients' charts and health information system to evaluate the appropriateness of different aspects of vancomycin use during all days which vancomycin were ordered. Findings: During the study, 15,230 ± 1216 mg (mean ± standard error of the mean [SEM]) vancomycin was administered for 200 patients in the mean period of 9.79 ± 0.64 (SEM) days of ICU stay, for prophylaxis and empiric therapy. Results showed the appropriateness of vancomycin uses were 30.5%, 9%, and 5.5% in the first 24 h, after 72 h and during the whole time of treatment, respectively. In addition, infectious consultation was the only significantly different parameter between appropriate and inappropriate vancomycin administration groups (P < 0.001). Conclusion: Although vancomycin utilization evaluation were mentioned in previous studies, but data related to ICU patients and during all days of vancomycin therapy are limited. High prevalence of inappropriate use of vancomycin in ICU is alarming for health systems and necessitates implementation of antibiotic policies.

Objective: Nowadays, the role of clinical pharmacists has become more prominent by more clinical pharmacists joining the health-care teams. This study was aimed to assess the role of a clinical pharmacist specialist in detecting and managing drug-related problems (DRPs) in the neurology ward of a tertiary care teaching hospital in Iran. Methods: This is a prospective cross-sectional study conducted on 123 hospitalized patients admitted to the neurology ward of a teaching hospital. The clinical pharmacist visited the patients and filled out the designed pharmacotherapy sheet for each patient. Then, the general pharmacist checked the patients' files and pharmacotherapy sheets and categorized DRPs using modified method of “The Pharmaceutical Care Network Europe classification, Version 5.01.” Findings: A total of 168 errors were found and 346 interventions were done by the clinical pharmacist during the study period. The most common form of errors in our study was “drug choice problems” (57.76%). The acceptance rate of interventions was 41.91% among physicians. Conclusion: The large number of interventions reported in several studies, as well as this study, revealed that clinical pharmacy services could contribute to a rationalization of drug therapy and may eventually lead to more medication safety.

Objective: Methadone poisoning is common in our society, mainly in drug addicts. One of its lethal complications is pulmonary edema. Therefore, we evaluated the prevalence of pulmonary edema in the deceased cases with methadone poisoning and its possible relationship with some medical variables. Methods: In this cross-sectional study which was done in 2014, we have investigated the deceased patients with methadone toxicity who underwent autopsy at Isfahan Forensic Medicine Department (Iran). All variables including age, gender, and autopsy findings were recorded and analyzed. Demographic characteristics and medical complications of the patients were compared between the patients with or without pulmonary edema in the autopsy findings. Findings: There were 64 cases who died with methadone poisoning during the 1-year study period. The average age of cases (±standard deviation) was 32.1 ± 10.29 years, among which 92.2% were male. Based on the autopsy findings, 64.1% were diagnosed with pulmonary edema. There was no statistically significant relationship between pulmonary edema and age, gender, history of addiction, and hepatic or cardiovascular complications. Conclusion: Pulmonary edema is a common finding in deceased methadone poisoning cases and must be considered and ruled out in patients with acute methadone toxicity.

Third generation quinolones are extensively used to treat a variety of common bacterial infections. Due to their extensive use in clinical practice, an increase in neuropsychiatric events has been reported. We report the case of psychotic symptoms occurs after three doses of moxifloxacin in a healthy adult male with no underlying risk factors. After the discontinuation of moxifloxacin treatment, there was a complete resolution of patient's symptoms. The case draws attention to a rare side effect of a commonly use drug and alert the clinicians to be cautious in those patients that have a baseline risk factors which makes the patient more susceptible to such adverse drug effect.

Posterior reversible encephalopathy syndrome (PRES) is a recently described, scarcely documented clinical entity. PRES is caused by various factors, the most common being hypertension, followed by nonhypertensive causes such as renal diseases and immunosuppressive therapy. Recently, some cases have been reported about the association of increased use of cytotoxic and immunosuppressive agents in cancer patients, and relevant reports have increased with advances in radiological examinations. Here, we report a case of gallbladder cancer with liver metastasis undergoing gemcitabine- and cisplatin-based chemotherapy who presented with complaints of seizures, headache, and bilateral lower limb weakness. Thorough clinical examination, biochemical analysis, and radiological evaluation led to diagnosis of PRES. It is important to recognize this syndrome which will facilitate early diagnosis and prompt symptomatic management. Removal of causative agent is an important aspect of management. Studies are needed to identify factors of adverse prognostic significance and to develop neuroprotective strategies.