Using Modern Learning Method to Teach Pharmacy Students Psychopharmacotherapy.

Background: Applying modern educational methods for digital native students seems necessary. Active learning strategies promote students' skills and knowledge. This study was conducted to design and evaluate active learning methods by teaching psychopharmacotherapy to pharmacy students. Methods: This was a quasi-experimental study with three randomized study groups (control, game, and multimedia), using a pre-and post-test design, conducted on 155 students of 5-year pharmacy in 2022 at the Faculty of Pharmacy of Tehran University of Medical Sciences, Iran. Overall, 18 clinical cases were designed for the basic structure of interventions. After teaching psychopharmacotherapy contents through lecturing, the pre-test was held. The next steps were playing the educational game, studying the multimedia case-based learning files, and then completing questionnaires, respectively. Then, a post-test was held. Results: 65.33% of participants were female and 34.66% were male. The pre-test and post-test scores comparison showed no difference in control group (P=0.409). However, in the serious game and multimedia groups, the average score of pre-test and post-test had a statistically significant difference (P<0.001, P=0.002 respectively), this difference was higher in the serious game group. Questionnaire evaluation showed substantial differences between game and multimedia groups. Conclusion: The educational interventions were able to improve student's knowledge and skills so they can better help patients and promote public health. In the sections of Confidence, Social Interactions, Fun, Focused attention, Learnability, Relevance, and Perceived Learning, the serious game far outweighed the multimedia case-based learning.

Gene polymorphisms of TACR1 serve as the potential pharmacogenetic predictors of response to the neurokinin-1 receptor antagonist-based antiemetic regimens: a candidate-gene association study in breast cancer patients.

PURPOSE: The current candidate gene association study aims to investigate tag SNPs from the TACR1 gene as pharmacogenetic predictors of response to the antiemetic guidelines-recommended, NK-1 receptor antagonist-based, triple antiemetic regimens. METHODS: A set of eighteen tag SNPs of TACR1 were genotyped in breast cancer patients receiving anthracycline and cyclophosphamide (with/without docetaxel) applying real-time PCR-HRMA. Data analysis for 121 ultimately enrolled patients was initiated by defining haplotype blocks using PHASE v.2.1. The association of each tag SNP and haplotype alleles with failure to achieve the defined antiemetic regimen efficacy endpoints was tested using PLINK (v.1.9 and v.1.07, respectively) based on the logistic regression, adjusting for the previously known chemotherapy-induced nausea and vomiting (CINV) prognostic factors. All reported p-values were corrected using the permutation test (n = 100,000). RESULTS: Four variants of rs881, rs17010730, rs727156, and rs3755462, as well as haplotypes containing the mentioned variants, were significantly associated with failure to achieve at least one of the defined efficacy endpoints. Variant annotation via in-silico studies revealed that the non-seed sequence variant, rs881, is located in the miRNA (hsa-miR-613) binding site. The other three variants or a variant in complete linkage disequilibrium with them overlap a region of high H3K9ac-promoter-like signature or regions of high enhancer-like signature in the brain or gastrointestinal tissue. CONCLUSION: Playing an essential role in regulating TACR1 expression, gene polymorphisms of TACR1 serve as the potential pharmacogenetic predictors of response to the NK-1 receptor antagonist-based, triple antiemetic regimens. If clinically approved, modifying the NK-1 receptor antagonist dose leads to better management of CINV in risk-allele carriers.

Immediate hypersensitivity reaction to levetiracetam: a case report study.

BACKGROUND: Anticonvulsant drugs are one of the most common causes of delayed hypersensitivity reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). These reactions are more prevalent with aromatic anticonvulsant drugs such as phenytoin and carbamazepine. However, immediate hypersensitivity reactions such as urticaria, angioedema, and anaphylaxis with anticonvulsant drugs are rare. We describe a 51-year-old woman who developed spreading skin rashes on her wrists with urticaria and pruritus 24 h after receiving intravenous levetiracetam. CONCLUSION: Clinicians should be aware of immediate hypersensitivity reactions with intravenous levetiracetam.

The hypoglycemic effects of Juglans regia L. internal septum in type 2 diabetic patients: A double-blind, randomized, placebo-controlled clinical trial.

Introduction: The internal septum of J.regia is traditionally used to control diabetes, and its effectiveness has been shown in animal studies. Accordingly, human clinical trials are needed to confirm its effectiveness on hemoglobin A1c (HbA1c), fasting blood sugar (FBS), blood insulin level, and insulin resistance as a complementary for better control of type 2 diabetes. Methods: This study was a randomized, double-blinded, controlled trial. The lyophilized powder of extract of the internal septum of J.regia was used to fill the capsules. Sixty type 2 diabetic patients were randomly divided into two groups. 500 mg capsules three times daily before meal was added to their routine drug regimen, and HbA1c, FBS, and blood insulin level were checked at the baseline and after three months. Results: Sixty patients completed the study. The mean(±SD) age of patients was 49.1(10.2) and 50.9(12.7) years in the placebo and J.regia groups, respectively. We observed that J.regia internal septum increases the level of HbA1c by about 0.02 units, but this effect was not significant (MD=0.02,95%CI=-0.36 to 0.40, P=0.93). Regarding the impact of capsules on insulin level, it seems that J.regia-containing capsules can raise insulin level by one unit. However, it was not significant (MD=1.01,95%CI=-0.86 to 2.88, P=0.28). As for FBS, it can cause a decrease of four units, but this effect is also not significant (MD=-3.98,95%CI=-18.33 to 10.37, P=0.58). Conclusion: Based on our study, the internal septum of J.regia has no significant effect on HbA1c, FBS, and insulin resistance. Moreover, no specific adverse reaction was observed in any of the patients.

Iranian Consensus Guideline for Pharmacotherapy with Biologics and Small Molecules Drugs in Adults with Inflammatory Bowel Diseases.

Background: Pharmacotherapy with biologics and small molecules, as the more effective therapies for moderate to severe ulcerative colitis (UC) and Crohn's disease (CD), is complex. Choosing the best methods for their utilization in order to induce and maintain remission are critical for practicing gastroenterologists. We aimed to develop an Iranian consensus on the management of inflammatory bowel disease (IBD) patients with biologics and small molecules. Methods: A Delphi consensus was undertaken by experts who performed a literature summary and voting process. Quality of evidence was assessed using the Grading and Recommendations Assessment, Development, and Evaluation; and an additional risk of bias-protocol. Results: Following an extensive search of the literature, 219 studies were used to determine the quality of the evidence. After three rounds of voting, consensus (defined as≥80% agreement) was reached for 87 statements. Conclusion: We considered different aspects of pharmacotherapy in this consensus. This guideline, along with clinical judgment, can be used to optimize management of IBD patients.

The approach of Iranian clinical pharmacists in the treatment of dyslipidemia based on international guidelines.

Introduction: Optimal treatment of dyslipidemia is a top priority in the prevention of cardiovascular diseases. For this purpose, clinicians in Iran usually refer to four current international guidelines. The aim of this study was to assess the approach of Iranian clinical pharmacists in the treatment of dyslipidemia based on international guidelines. Methods: A structured questionnaire was prepared. Questions (n=24) included the demographics (n=7), dyslipidemia references (n=3), dyslipidemia general knowledge of respondents (n=10), and questions (n=4) designed based on the difference among the latest version of guidelines participants stated they use in their practice. After validity conformation, the questionnaire was distributed to 120 clinical pharmacists, electronically from May to August 2021. Results: Response rate was 77.5% (n=93). The majority of participants (80.6%, n=75) claimed to have used the 2018 ACC/AHA guideline. The Median (interquartile range [IQR]) score of the general knowledge questions was 5.0 (2.0) out of 10. The Median (IQR) score of questions designed based on the difference among guidelines was calculated 3(1) out of 4. There was no significant (P=0.25) difference in score among participants according to their guideline selection. Moreover, the gender and length of experience as a clinical pharmacist had no significant (P>0.05) effect on the score of participants. Conclusion: In this study, Iranian clinical pharmacists answered half of the dyslipidemia general knowledge questions correctly. Also, Participants were up-to-date on 75% of the questions designed based on the latest version of the guideline they had been using in their practice.

Design, Development and Evaluation of an Application based on Clinical Decision Support Systems (CDSS) for Over-The-Counter (OTC) Therapy: An Educational Interventions in Community Pharmacists.

Introduction: Mobile health (mHealth) technology-based applications provide strong medical health-care support. Applications have an important impact as tools to improve the knowledge and support the health-care team practice. In this study, an over-the-counter (OTC) therapy application was developed based on Clinical Decision Support Systems (CDSS). CDSS is a key to improve health-related decisions and healthcare delivery. Furthermore, the quality and effectiveness of this application were evaluated among community pharmacists. Methods: The application was designed and developed for 10 topics of OTC therapy. After the approval of the expert panel, 40 pharmacists affiliated with Tehran University of Medical Science (TUMS) participated in this before and after quasi-experimental study. The related scenarios and checklists were designed for the ten topics. The participants had to manage the scenarios first by their knowledge and then with the application. The knowledge and pharmaceutical skills in OTC therapy were evaluated based on the obtained scores and the time recorded. The quality of the application was evaluated by pharmacists using user version of mobile application rating scale (uMARS) questionnaire. To compare before/after measurements of parametric and non-parametric data, we used the paired t-test and Wilcoxon matched-pairs test, respectively. Besides, the variables was compared using Mann-Whitney test. The statistical significance was considered at P<0.05. The analyses were performed using the statistical software Stata (ver. 13). Results: All scores after using the application increased, and the P-value was not significant. Also, the recorded time was increased after the use of the application, and the P-value was not significant. The minimum mean scores of the six uMARS questionnaire sections were 3. It means that acceptable scores were obtained in all sections of the questionnaire. The "App quality score" section of the application was reported 3.45±0.94. No relationship was found between gender and the median score of each section of the uMARS questionnaire. Conclusion: The OTC therapy application developed in this study will help Persian-speaking pharmacists to increase their knowledge and pharmaceutical skills.

Trimethoprim/sulfamethoxazole desensitization in an HIV-positive patient with previous Stevens-Johnson syndrome; a failed study.

Drug-induced Stevens-Johnson syndrome (SJS) is a rare but life-threatening hypersensitivity reaction. Drug desensitization might be considered in drug-allergic patients with no therapeutic alternative. A 29-year-old man with a recent diagnosis of HIV and HBV (CD4 count: 4 cells/mm3) who has been receiving Trimethoprim/sulfamethoxazole (TMP/SMX) for Pneumocystis pneumonia (PCP) prophylaxis was admitted at Imam Khomeini hospital complex affiliated to Tehran University of Medical Sciences, with the diagnosis of SJS due to TMP/SMX. After 45 days of supportive care, the patient was a candidate for TMP/SMX desensitization due to our region's unavailability of alternative agents. A 9-day desensitization protocol was used, but the patient complained about diarrhea with severe pain in the rectal mucosa, and macules developed over his lips again on the third day. As a result, the desensitization process immediately stopped, and after the signs and symptoms were resolved, the patient was discharged with Clindamycin tablet 600 mg TDS. Unfortunately, two weeks after discharge, the patient experienced acute kidney injury (AKI) and expired after two dialysis sessions.

Evaluation of important human CYP450 isoforms and P-glycoprotein phenotype changes and genotype in type 2 diabetic patients, before and after intensifying treatment regimen using Geneva cocktail.

The present study evaluates the influence of type 2 diabetes (T2D) on important CYP450 (CYP) isoforms and P-glycoprotein (Pgp) transporter activities before and 3 months after an intensifying treatment regimen involving 40 patients. Results have been compared with 21 non-T2D healthy participants (the control group). CYPs and Pgp activities were assessed after administering the Geneva cocktail. The mean metabolic ratios (MR) for CYP2B6 (1.81 ± 0.93 versus 2.68 ± 0.87), CYP2C19 (0.420 ± 0.360 versus 0.687 ± 0.558) and CYP3A4/5 (0.487 ± 0.226 versus 0.633 ± 0.254) significantly decreased in T2D patients compared to the control group (p < 0.05). CYP2C9 (0.089 ± 0.037 versus 0.069 ± 0.017) activities slightly increased in diabetic patients, and no difference was observed regarding CYP1A2 (0.154 ± 0.085 versus 0.136 ± 0.065), CYP2D6 (1.17 ± 0.56 versus 1.24 ± 0.83), and Pgp activities in comparison to the control group. Three months after the intensifying treatment regimen, MRs of CYP2C9 (0.080 ± 0.030) and CYP3A4/5 (0.592 ± 0.268) improved significantly and were not statistically different compared to the control group (P > 0.05). Several covariables, such as inflammatory markers (IL-1ß and IL-6), genotypes, diabetes and demographic-related factors, were considered in the analyses. The results indicate that chronic inflammatory status associated with T2D modulates CYP450 activities in an isoform-specific manner.

FLOT (a chemotherapy regimen for gastric/esophagogastric junction cancer): to be treated as a highly emetogenic regimen or a moderately emetogenic one? Comparison of the emetogenic potential of FLOT versus FOLFOX and TAC regimens.

PURPOSE: The current study aimed at investigating the efficacy of aprepitant-containing triple antiemetic regimen in FLOT (fluorouracil + leucovorin + oxaliplatin + docetaxel) recipients as well as the emetogenic potential of FLOT regimen, through comparison of nausea and vomiting rates in a moderately emetogenic chemotherapy, FLOT, and a highly emetogenic chemotherapy recipients. STUDY: Patients planned to receive one of FLOT, FOLFOX (fluorouracil + leucovorin + oxaliplatin/moderate-emetic risk), or TAC (docetaxel + doxorubicin + cyclophosphamide/high-emetic risk) regimens were recruited. All patients were treated with the same triple antiemetic regimen containing aprepitant. RESULTS: A total of 165 chemotherapy-naïve patients (52 FLOT recipients) were eligible to enter the study. At the end of day 5, "complete response" (primary efficacy endpoint) was achieved by 84.6%, 63.5%, and 61.5% of the FLOT-receiving patients in acute, delayed, and overall phases, respectively. A significant difference was seen among the odds of FLOT recipients and FOLFOX recipients concerning "complete response" achievement in delayed (p = 0.014) and overall (p = 0.017) phases, "no emesis" in delayed (p = 0.018) and overall (p = 0.010) phases, and also "complete protection" in acute (p = 0.023), delayed (p = 0.009), and overall (p = 0.006) phases; however, the difference between the odds of FLOT recipients and TAC recipients, in relation to achieving these endpoints, was insignificant. FLOT group showed significantly faster time-to-antiemetic regimen failure and time-to-first emetic episode in comparison with the FOLFOX group, which was insignificant in comparison with the TAC group. CONCLUSION: According to the findings, FLOT has to be considered as a high-emetic-risk regimen; provided that, as recommended by the antiemetic guidelines towards better management of delayed nausea and vomiting induced by highly emetogenic regimens, executing clinical trials concerning the efficacy of continuing dexamethasone on days 2-4 in aprepitant-containing triple antiemetic regimen schedule is required.

Melatonin effect on platelet count in patients with liver disease.

AIM: A positive effect of melatonin on platelet count in patients with chronic liver disease is reported in the current study. BACKGROUND: Thrombocytopenia occurs when the severity of liver disease is exacerbated. Reduction in the secretion of thrombopoetin, as an intrinsic hormone produced mainly by the liver, plays an important role in this complication induced by liver disease. METHODS: This research was a double-blind, cross-over, placebo-controlled pilot study. Patients with liver disease were given two 5-mg pearls of melatonin or a placebo for two weeks, and after a 2-week washout period, their groups were switched. Liver function tests and platelet counts were assessed once at the beginning and once at the end of each phase of the study. RESULTS: In the current study, 40 patients meeting the eligibility criteria were included. The average platelet count was significantly increased by melatonin in comparison with the placebo (from 175.67±92.84 to 191.10±98.82 vs. from 185.22±98.39 to 176.45±91.45) (p-value <0.001). Melatonin also significantly reduced ALT, AST, total bilirubin, and direct and MELD scores in patients with liver disease (p-value <0.05). CONCLUSION: Melatonin may increase platelet count and inhibit thrombocytopenia in patients with liver disease; however, more investigations are needed to confirm the current results.

A Pilot Randomized, Clinical Trial of the Anti-pruritus Effect of Melatonin in Patients with Chronic Liver Disease.

Pruritus is one of the disturbing complications induced by chronic liver disease (CLD), bearing a negative impact on patient quality of life and potentially resulting in early liver transplants. Given the main role of the autotaxin enzyme in pruritus induced by CLD and the suppressive effects of melatonin on the expression of the autotaxin gene, this study was designed to evaluate the antipruritic effect of melatonin in patients with CLD. A double-blind, cross-over, randomized, placebo-controlled pilot trial was conducted on patients with CLD -induced pruritis. Patients were randomly assigned to two groups where they received melatonin 10-mg at night or placebo for 2 weeks. After a 2-week washout period, patients were then crossed over to the other group. The Visual Analog Scale (VAS) and the 12-Item Pruritus Severity Score (12-PSS) were used to assess patient response to therapy as the co-primary outcomes, while liver function tests were assayed too. Forty patients completed the study. The VAS score showed alleviation of 3.21 ± 2.24 (in pruritus) with melatonin (p-value <0.05). The study goal (a reduction of at least 20% in VAS) was achieved in 33 (82%) of study participants. In patients who received melatonin, the 12-PSS and Body Surface Area (BSA) affected by pruritus decreased on average 46.57% and 51.71%, respectively, with mood, sleep pattern and daily activity levels also demonstrating significant improvement (p-value < 0.05). Melatonin was found to be effective for managing pruritus in patients with CLD.

Bosentan-induced immune hemolytic anemia in 17 years old man. A case report.

Hemolytic anemia is a very important immune-mediated reaction, which its late diagnosis can be fatal. Medications along with other causes can induce hemolytic anemia. Drug induced immune hemolytic anemia (DIIHA) is caused by the development of autoantibodies. Accordingly, DIIHA is rare and there is not enough data for its prevalence. Number of drugs that can cause DIIHA have increased in recent decades. A 17-year-old man who had congenital single ventricle heart (CHB) and pulmonary artery hypertension (PAH) was admitted at Imam Khomeini hospital complex affiliated to Tehran University of Medical Sciences, with chief complaint of jaundice and icter. Bosentan and Tadalafil were in the list of the drugs used by this patient. Although both drugs were recommended to be discontinued in the patient, in the course of hospitalization, the patient accidentally continued to take his Tadalafil. However, the patient's recovery continued. Given that the patient's Coombs test was positive, his hemolytic anemia mechanism was drug-induced immune-mediated hemolytic anemia. As a result, according to Naranjo score = 6, Bosentan was considered as the main possible culprit to induce DIIHA in this patient. Following the discontinuation of Bosentan and receiving Prednisolone, the patient's clinical symptoms and laboratory parameters resolved and the patient was then discharged.

Evaluation of Antipruritic Effect of Melatonin on Hemodialysis Patients with Uremic Pruritus, A Double-Blind, Randomized, Crossover Trial.

INTRODUCTION: Uremic pruritus (UP) is one of the major complaints in hemodialysis patients without specific treatment. Considering the antipruritic effect of melatonin in atopic dermatitis (AD) and similarities in mechanism between pruritus in AD and UP, this randomized clinical trial designed to evaluate the antipruritic effect of melatonin on hemodialysis patients with UP. METHODS: This multicenter double-blind randomized clinical trial was conducted among the hemodialysis patients with UP. Adult patients were randomly assigned to receive two capsules of melatonin 5 mg /d for a 2 weeks period, undergoing a 1 week washout period, and then two capsules of placebo for another 2 weeks period, or the reverse sequence. Visual Analogue Scale (VAS), % affected Body Surface Area (%BSA) and 12-Pruritus Severity Scale questionnaire (12-PSS) were measured before and after each of the three periods. A crossover analysis of variance adjusted by treatment, period and carryover effect was performed by STATA 14. RESULTS: Thirty-nine patients under hemodialysis (mean age of 55.08 ± 12.34 years) completed the study. Mean changes in VAS, 12-PSS, and %BSA after the interventions (melatonin vs. placebo, mean ± SD) were as follows, respectively: -3.21 ± 3.33 vs. -1.38 ± 2.23, -4.59 ± 5.22 vs. -2.08 ± 4.35, and -19.10 ± 30.31 vs. 4.64 ± 29.11 (P < .05). However, the statistical significance of the treatment effect from melatonin was observed, carryover and period effects were not significant (P > .05) for any of the main variables. CONCLUSION: Based on to the preliminary results of this study, melatonin can be introduced as an effective drug for management of pruritus in uremic patients.

Effect of Vitamin D Supplementation on the Regulation of Blood Pressure in Iranian Patients with Essential Hypertension: A Clinical Trial.

BACKGROUND: Low serum vitamin D level is associated with both high blood pressure and incidence of primary hypertension. Experimental studies suggest that vitamin D supplements may reduce blood pressure. OBJECTIVE: The aim of this study was to investigate whether vitamin D supplementation reduces systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in Iranian patients with essential hypertension. METHOD: A total of 173 patients with essential hypertension participated in this open-label clinical trial. SBP, DBP, and serum vitamin D levels were measured at baseline and at the end of the study. Vitamin D was administered at a dose of 50,000 IU/week, and 1000 IU/day in patients with serum vitamin D levels <20 ng/mL and 20-30 ng/mL, respectively, for 8 weeks. RESULTS: Based on serum vitamin D levels, 45.1%, 17.3%, and 29.5% of patients were deficient, insufficient, and sufficient for vitamin D intake, respectively. Baseline serum levels of vitamin D were not correlated with SBP, DBP, and MAP at the beginning of the study (p = ns). Multiple logistic regression analysis revealed that the risk of vitamin D deficiency was 2.5-fold times higher in women than in men (p = 0.03). After 8 weeks of supplementation with vitamin D, mean SBP and MAP were significantly reduced by 5.5 ± 16.16 (p = 0.01) and 3.7 ± 9.24 (p = 0.004) mmHg, respectively. Neither sex nor age could significantly predict BP response to vitamin D supplementation. CONCLUSION: Vitamin D supplementation may significantly reduce SBP and MAP but not DBP in patients with essential hypertension.

Association of ABCB1 Gene Polymorphisms and Clopidogrel Responsiveness in Iranian Patients undergoing Percutaneous Coronary Intervention.

Clopidogrel is an antiplatelet agent currently used for preventing stent thrombosis. Despite certain clinical benefits of clopidogrel in patients undergoing percutaneous coronary intervention (PCI), adequate antiplatelet effect has not been obtained in some patients. The present study was designed to investigate the potential association of ABCB1 (ATP-Binding Cassette, Subfamily B, member1) gene polymorphism, and clopidogrel responsiveness in Iranian patients after PCI. Sixty-seven patients were included in the study. Blood samples were taken from patients at baseline, 2 h after administration of 600-mg loading dose of clopidogrel, 24 h and 30 days after PCI. Platelet aggregation was measured by light transmittance aggregometry (LTA) with two levels of adenosine diphosphate (ADP) concentrations (5 and 20 µM). ABCB1 genotyping was performed by restriction fragment length polymorphism-polymerase chain reaction (RFLP-PCR). The allelic frequencies of wild type, heterozygote, and homozygote genotypes of ABCB1 were 20.9%, 74.6%, and 4.5%, respectively. There was no significant association between polymorphism of ABCB1 and clopidogrel non-responsiveness (P > 0.05) in various situations. No significant difference was observed for demographic characteristics. Genetic and demographic factors had no significant effect on the platelet activity of clopidogrel in an Iranian population.

Evaluating the effect of type 2 diabetes mellitus on CYP450 enzymes and P-gp activities, before and after glycemic control: A protocol for a case-control pharmacokinetic study.

Cytochrome P450s (CYP450) family is one of the most critical factors in the metabolism process. Hence, the present study aims to characterize the activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4/5, and P-glycoprotein (P-gp) pump in patients with type 2 diabetes (T2DM). This characterization was performed before and after good glycemic control versus non-diabetic subjects following the administration of a substrate probe drug cocktail. This single-center clinical study proposes the characterization of T2DM impacts on major CYP450 drug-metabolizing enzyme and P-glycoprotein (P-gp) activities. The main propose of the present study is evaluating any alternation in major CYP450 enzymes and P-gp activities in patients with T2DM, before (A1C>7%) and after (A1C≤7%) good glycemic control along with comparing the activities versus non-diabetic subjects. The phenotypes will be assessed following the oral administration of a drug cocktail containing caffeine (CYP1A2), bupropion (CYP2B6), flurbiprofen (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5), and fexofenadine (P-gp) as probe substrates. Furthermore, the influence of variables such as glycemia, genetic polymorphisms, and inflammation on the metabolism process will be evaluated. The first patient has entered the study in Dec 2018.

Validity and Reliability of Persian Version of 12-Item Pruritus Severity Score Questionnaire in Patients with Chronic Liver Disease and Pruritus.

BACKGROUND Currently, there is no published questionnaire translated in the Persian language for pruritus evaluation in patients with chronic liver disease. Therefore, it would be well worth having a valid and reliable Persian questionnaire for assessing pruritus with its different aspects. This study was designed to evaluate the validity and reliability of the translated version of the 12-Item Pruritus Severity Score (12-PSS) METHODS The patients with pruritus due to chronic liver disease, who referred to the liver clinic affiliated to Tehran University of Medical Sciences, were enrolled in this cross-sectional study. Following the forward-backward translation of 12-PSS into Persian, the content validity index (CVI) and its reliability were assessed. The patients were asked to respond to the visual analog scale (VAS) along with 12-PSS on their visits to evaluate the correlation between them. RESULTS 160 eligible patients were entered in the present study. The mean age was 46.03 (±13.05) years. The Cronbach's alpha for all domains of 12-PSS was 0.81-0.92 (average 0.89), which showed a strong consistency. The mean VAS and 12-PSS were 5.47±2.55 and 11.71 ± 5.25, respectively, and the correlation of VAS and 12-PSS was strong (p < 0.05, r = 0.89). CONCLUSION The Persian version of 12-PSS is a valid questionnaire for assessing pruritus and follow up response to treatment for patients with chronic liver disease.

Economic Burden Of Inappropriate Empiric Antibiotic Therapy: A Report From Southern Iran.

INTRODUCTION: Widespread inappropriate antibiotic prescribing by healthcare professionals in the hospital setting is a great concern that may cause many undesirable consequences. Adherences to antibiotic guidelines have proven to be a simple and effective intervention to guide the choice of appropriate empiric antibiotic regimens and reduce the unnecessary variations in the practice among practitioners. The objective of this study was to evaluate the prescription patterns of empiric antibiotic therapy in relation to treatment guidelines and the economic burden of discordance with guidelines in a major referral Iranian university hospital. METHOD: Hospital records of hospitalized patients with empiric antibiotic prescription, from September 2016 to February 2017 were reviewed. The process consisted of comparing empiric antimicrobial administration with institutional guidelines for each patient by a clinical pharmacist and an infectious disease specialist to evaluate the appropriate utilization of antibiotics. Adherence to guideline, the cost of antibiotics usage for each patient and the excess cost consequent from discordance with guideline was calculated. RESULTS: The most inappropriate prescribed antibiotics were carbapenems and aminoglycosides. Overall guideline adherence was 27.8%. Frequency of antibiotic usage incompatibility with the guidelines on the basis of dosing interval, duration of therapy and drug indication were 31.46%, 29.44% and 19.36%, respectively. General surgery and internal medicine wards had the least and the most inappropriate antibiotic administration, respectively. Totally antibiotic usage cost was 578,959.39 USD (24,316,294,800 Iranian Rials, IRR) for 6 months, which the excess costs of inappropriate antibiotic prescribing, was 471,319.69 USD (19,795,427,225 IRR). The estimated annual excess cost is 942,639.38 USD (39,590,854,450 IRR). CONCLUSION: In this research, physicians' adherence with guidelines for empiric antibiotic therapy was low which was led to 471,319.69 USD excess costs. These results urge institution policy makers to develop guidelines to ensure active dissemination and implementation of them to decrease inappropriate antibiotic usage.

Impact of Clinical Pharmacist's Interventions on Potential Drug-Drug Interactions in the Cardiac Care Units of Two University Hospitals in Shiraz, South of Iran.

OBJECTIVE: The main objective of this study aimed to assess drug-drug interactions (DDIs) in the cardiac care unit (CCU) and cardiac surgery units and the role of a clinical pharmacist in detecting and preventing the expected DDIs. METHODS: This cross-sectional study was conducted in the CCU Units of Nemazee and Shahid Faghihi Hospitals, two referral hospitals in Shiraz, South of Iran, from August to February 2016. Patients older than 18 years, who were admitted and had received >24 h of inpatient services in these wards with two or more medication orders, were included in this study. All medication orders were evaluated by a pharmacist and DDIs were examined based on the Lexi-Interact™ software. In cases with serious DDIs (D or X), the physicians and nurses were informed, and intervention was conducted by a clinical pharmacist. FINDINGS: A total of 3706 medical orders were evaluated. 6478 DDIs were detected, of which, 446 (6.88%) belonged to Classes D and X, and a total of 43.43% of all hospitalizations had at least one DDI. Factors with the most considerable influence on DDIs included an increased number of prescribed medications and patients underlying disease. The physicians accepted 62% of the interventions. The most frequent drugs responsible for interactions of Classes C, D, and X were aspirin, warfarin, and clopidogrel, respectively. CONCLUSION: This study shows that a significant number of clinical DDIs exist in hospitalized patients, especially among consumers of warfarin and aspirin. The role of a clinical pharmacist in preventing such interactions and safer pharmacotherapy management for hospitalized patients is essential.