Publications by authors named "Shadi Baniasadi"

35 Publications

Antibiotic use evaluation in hospitalized pediatric patients with respiratory tract infections: A retrospective chart review study.

Curr Drug Saf 2021 Feb 17. Epub 2021 Feb 17.

Pediatric Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran. Iran.

Introduction: Respiratory tract infections (RTIs) are a common cause of antibiotic usage in hospitalized pediatric patients. Inappropriate use of antibiotics may lead to the emergence of multidrug-resistant microorganisms and increased treatment costs.

Objective: This study was designed to assess antibiotic usage in hospitalized pediatric patients with RTIs.

Methods: Medical charts of the patients admitted to the pediatric ward (PW) and pediatric intensive care unit (PICU) of a tertiary respiratory center were reviewed. Patients' demographic and clinical data including gender, age, weight, history of allergy, length of hospital stay, clinical diagnosis, prescribed antibiotics (indication, dose, and frequency of administration) were collected. The appropriateness of antibiotic usage was evaluated in each patient according to international guidelines.

Results: Two hundred seventy-nine hospitalized patients were included in the study. The most common reason for hospitalization was pneumonia (38%), followed by cystic fibrosis (20.1%) and bronchitis (5%). The most commonly used antimicrobial agents were ceftriaxone, azithromycin, and clindamycin which guideline adherence for their usage was 85.3%, 23.3%, and 47%; respectively. Inappropriate dose selection was the main reason for non-adherence to the guidelines. The adherence rate to RTIs' guidelines (considering all parameters for each patient) was 27.6%. Multivariate logistic regression analysis demonstrated CF and prescription of azithromycin are predictors of guideline non-adherence.

Conclusion: We found relatively low adherence to international guidelines in our center that could be related to restricted definitions of optimal antibiotic therapy. Despite most patients received logical antimicrobial therapy, actions should be taken into account to reach optimal antibiotic usage.
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http://dx.doi.org/10.2174/1574886316666210218104644DOI Listing
February 2021

Clinically important drug-drug interactions in patients admitted to hospital with COVID-19: drug pairs, risk factors, and management.

Drug Metab Pers Ther 2020 Dec 21. Epub 2020 Dec 21.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objectives: Coronavirus disease 2019 (COVID-19) is an emerging viral infection without any approved treatment. Investigational therapies for COVID-19 may cause clinically important drug-drug interactions (DDIs). We aimed to study potential DDIs (pDDIs) and their risk factors in COVID-19 patients admitted to the hospital.

Methods: We conducted a cross-sectional study in a tertiary respiratory hospital dedicated to COVID-19 patients. The Lexi-Interact database was used to investigate clinically important pDDIs. The database output including interacting drug pairs, risk rating, reliability rating, mechanism, and management was evaluated. Associations between the occurrence of pDDIs and probable risk factors were assessed by logistic regression analysis.

Results: Medical charts of 227 patients were reviewed. About 38% of the patients had at least one clinically important pDDI. More than half of the interactions were between protease inhibitors (lopinavir/ritonavir) and regularly prescribed medications for the management of comorbidities or COVID-19 symptoms (e.g., atorvastatin, alprazolam, salmeterol, and tamsulosin). Ischemic heart disease, chronic respiratory diseases, and ICU admission were significantly associated with the occurrence of pDDIs.

Conclusions: We recommend considering the risk factors for the emergence of clinically important DDIs in the pharmacotherapy of COVID-19 patients. Using an alternative medication or dose adjustments may be required in high-risk patients.
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http://dx.doi.org/10.1515/dmpt-2020-0145DOI Listing
December 2020

Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial.

Trials 2021 Jan 18;22(1):60. Epub 2021 Jan 18.

Tracheal Diseases Research Centre, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objectives: Basic and clinical studies have shown that magnesium sulphate ameliorates lung injury and controls asthma attacks by anti-inflammatory and bronchodilatory effects. Both intravenous and inhaled magnesium sulphate have a clinical impact on acute severe asthma by inhibition of airway smooth muscle contraction. Besides, magnesium sulphate can dilate constricted pulmonary arteries and reduce pulmonary artery resistance. However, it may affect systemic arteries when administered intravenously. A large number of patients with covid-19 admitted to the hospital suffer from pulmonary involvement. COVID-19 can cause hypoxia due to the involvement of the respiratory airways and parenchyma along with circulatory impairment, which induce ventilation-perfusion mismatch. This condition may result in hypoxemia and low arterial blood oxygen pressure and saturation presented with some degree of dyspnoea and shortness of breath. Inhaled magnesium sulphate as a smooth muscle relaxant (natural calcium antagonist) can cause both bronchodilator and consequently vasodilator effects (via a direct effect on alveolar arterioles in well-ventilated areas) in the respiratory tract. We aim to investigate if inhaled magnesium sulphate as adjuvant therapy to standard treatment can reduce ventilation-perfusion mismatch in the respiratory tract and subsequently improve arterial oxygen saturation in hospitalized patients with COVID-19.

Trial Design: A multi-centre, open-label, randomised controlled trial (RCT) with two parallel arms design (1:1 ratio) PARTICIPANTS: Patients aged 18-80 years hospitalized at Masih Daneshvari Hospital and Shahid Dr. Labbafinejad hospital in Tehran and Shahid Sadoughi Hospital in Yazd will be included if they meet the inclusion criteria of the study. Inclusion criteria are defined as 1. Confirmed diagnosis of SARS-CoV-2 infection based on polymerase chain reaction (PCR) of nasopharyngeal secretions or clinical manifestations along with chest computed tomography (chest CT) scan 2. Presenting with moderate or severe COVID-19 lung involvement confirmed with chest CT scan and arterial oxygen saturation below 93% 3. Length of hospital stay ≤48 hours. Patients with underlying cardiovascular diseases including congestive heart failure, bradyarrhythmia, heart block, the myocardial injury will be excluded from the study.

Intervention And Comparator: Participants will be randomly divided into two arms. Patients in the intervention arm will be given both standard treatment for COVID-19 (according to the national guideline) and magnesium sulphate (5 cc of a 20% injectable vial or 2 cc of a 50% injectable vial will be diluted by 50 cc distilled water and nebulized via a mask) every eight hours for five days. Patients in the control (comparator) arm will only receive standard treatment for COVID-19.

Main Outcomes: Improvement of respiratory function and symptoms including arterial blood oxygen saturation, dyspnoea (according to NYHA functional classification), and cough within the first five days of randomization.

Randomisation: Block randomisation will be used to allocate eligible patients to the study arms (in a 1:1 ratio). Computer software will be applied to randomly select the blocks.

Blinding (masking): The study is an open-label RCT without blinding.

Numbers To Be Randomised (sample Size): The trial will be performed on 100 patients who will be randomly divided into two arms of control (50) and intervention (50).

Trial Status: The protocol is Version 5.0, January 05, 2021. Recruitment of the participants started on July 30, 2020, and it is anticipated to be completed by February 28, 2021.

Trial Registration: The trial was registered in the Iranian Registry of Clinical Trials (IRCT) on July 28, 2020. It is available on https://en.irct.ir/trial/49879 . The registration number is IRCT20191211045691N1.

Full Protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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http://dx.doi.org/10.1186/s13063-021-05032-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812339PMC
January 2021

Metabolism-based Drug-drug Interactions in Patients with Chronic Respiratory Diseases: A Review Focusing on Drugs Affecting the Respiratory System.

Authors:
Shadi Baniasadi

Curr Drug Metab 2020 ;21(9):704-713

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Chronic respiratory diseases (CRDs) are increasing in prevalence, as reported by the World Health Organization (WHO). Patients with CRDs usually require co-administration of multiple drugs due to the complex pathogenic mechanisms of CRDs and the existence of concomitant diseases. Polypharmacy (co-administration of more than four medications) is the main risk factor of the occurrence of drug-drug interactions (DDIs) that may lead to reducing treatment efficacy and/or increasing adverse effects.

Methods: This literature-based review focuses on metabolism-based DDIs, the most prevalent DDIs responsible for difficulties in therapeutic management in patients with CRDs.

Results: Clinically relevant metabolism-based DDIs occur between drugs used for the treatment of respiratory diseases (corticosteroids, orally inhaled bronchodilators, methylxanthines, anti-leukotrienes, antimicrobials, endothelin receptor antagonists, phosphodiesterase inhibitors, antitussives, and antineoplastic agents) and drugs affecting cytochrome P450 (CYP) (inducers and inhibitors). Considering alternative therapies, adjusting medication doses, or monitoring patients during treatment are recommended to prevent the harmful consequences of these interactions.

Conclusion: Providing information on clinically relevant interactions of drugs more likely prescribed in daily practices of physicians is essential to improve patient safety. A list of known metabolism-based interactions of drugs affecting the respiratory systems should be available for physicians engaged in the treatment of CRDs.
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http://dx.doi.org/10.2174/1389200221999200820164038DOI Listing
January 2020

An Observational Study of QTc Prolongation in Critically Ill Patients: Identification of Incidence and Predictors.

Indian J Crit Care Med 2020 Apr;24(4):270-275

Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.

Aims: Despite the importance of abnormal QTc interval values in intensive care unit (ICU) patients, there is a paucity of information on this topic. The current study was designed to identify the incidence and predictors of QTc prolongation in medical (M), surgical (S), and emergency (E) ICUs.

Materials And Methods: A prospective observational study was conducted for 6 months. Patients more than 18 years old who admitted to MICU, SICU, and EICU were included in the study. Electrocardiogram (ECG) was taken on day 1, 3, and 5 of ICU admission. The QTc intervals >460 ms in male and >470 ms in female and increased >60 ms above baseline were considered QTc prolongation. Comparative analysis was done between two groups of patients (normal vs prolonged QTc). Logistic regression models were carried out to determine the predictors of QTc prolongation.

Results: Incidence of QTc prolongation was 6.5, 9.8, and 15.7% on day 1, 3, and 5 of ICU admission, respectively. On day 1, the history of alcohol addiction and the reason of ICU admission were associated with a prolonged QTc. A significant association was demonstrated between administration of azithromycin and QTc prolongation on day 3. High serum creatinine and hospitalization in EICU were predictors of QTc prolongation on day 5 of ICU admission.

Conclusion: The QTc prolongation is relatively common among patients admitted to ICUs and its incidence increases with increasing length of hospital stay. Predictors of QTc prolongation may be affected by the duration of ICU admission. Physicians should consider these predictors particularly before prescribing QTc-prolonging drugs.

How To Cite This Article: Farzanegan B, Hosseinpoor Z, Baniasadi S, Seyyedi SR, Rajabi M. An Observational Study of QTc Prolongation in Critically Ill Patients: Identification of Incidence and Predictors. Indian J Crit Care Med 2020;24(4):270-275.
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http://dx.doi.org/10.5005/jp-journals-10071-23411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297246PMC
April 2020

Potential drug-drug interactions in hospitalized pediatric patients with respiratory disorders: a retrospective review of clinically important interactions.

Drug Metab Pers Ther 2020 01 31;35(1). Epub 2020 Jan 31.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background Hospitalized pediatric patients are at an increased risk of experiencing potential drug-drug interactions (pDDIs) due to polypharmacy and the unlicensed and off-label administration of drugs. The aim of this study is to characterize clinically significant pDDIs in pediatric patients hospitalized in a tertiary respiratory center. Methods A retrospective analysis of medications prescribed to pediatric patients admitted to the pediatric ward (PW) and pediatric intensive care unit (PICU) of a respiratory referral center was carried out over a six-month period. The pDDIs were identified using the Lexi-Interact database and considered as clinically relevant according to the severity rating as defined in the database. Frequency, drug classes, mechanisms, clinical managements, and risk factors were recorded for these potential interactions. Results Eight hundred and forty-five pDDIs were identified from the analysis of 176 prescriptions. Of the total pDDIs, 10.2% in PW and 14.6% in PICU were classified as clinically significant. Anti-infective agents and central nervous system drugs were the main drug classes involved in clinically significant pDDIs as object and/or precipitant drugs. A higher number of medications [odds ratio (OR): 4.8; 95% confidence interval (CI): 2.0-11.4; p < 0.001] and the existence of a nonrespiratory disease, which led to a respiratory disorder (OR: 3.8; 95% CI: 1.40-10.4; p < 0.05), were the main risk factors associated with an increased incidence of pDDIs. Conclusions A high and similar risk of pDDIs exists in pediatric patients with respiratory disorders hospitalized in PW and PICU. The patients prescribed a higher number of medications and presenting respiratory symptoms induced by a nonrespiratory disease require extra care and monitoring. Pediatricians should be educated about clinically significant DDIs for highly prescribed medications in their settings in order to take preventive measures and safeguard patient safety.
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http://dx.doi.org/10.1515/dmpt-2019-0012DOI Listing
January 2020

Drug interactions and creatinine levels are associated with QTc prolongation in intensive care units: a prospective, observational study.

Drug Metab Pers Ther 2019 12;34(4)

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background Prolongation of the QTc interval may lead to life threatening arrhythmias. QTc prolongation is common in intensive care unit (ICU) patients. The objectives of this study were to identify the role of drug-drug interactions (DDIs) and other predictors (age, sex, cardiovascular diseases, and electrolyte abnormalities) in life threatening QTc prolongation in patients admitted to medical (M), surgical (S) and emergency (E) ICUs. Methods This prospective, observational study included patients above the age of 18 years who were admitted to SICU, EICU, and MICU at a tertiary respiratory referral center. Electrocardiogram (ECG) monitoring was performed during the first 5 days of ICU admission. Risk factors and DDIs which were anticipated to be associated with the prolongation of the QTc interval were assessed for all patients. Results Two hundred patients were included in the study. QTc prolongation occurred in 10.7% of patients and the majority of patients presenting with QTc prolongation had creatinine levels above 1.3 mg/dL during their 5 days of ICU admission. Incidence of pharmacodynamic (PD) DDIs was significantly higher in patients with QTc prolongation vs. other patients. Creatinine levels above 1.3 mg/dL and PD DDIs were associated with QTc prolongation during 5 days of ICU admission. Conclusions High serum creatinine and PD DDIs can increase the risk of QTc prolongation in patients admitted to the ICU. QTc interval measurements should be performed prior to initiation or after starting any drug that is associated with QT prolongation, specifically in patients with the known risk factors.
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http://dx.doi.org/10.1515/dmpt-2019-0022DOI Listing
December 2019

Effect of Nebulized Verapamil on Oxygenation in Chronic Obstructive Pulmonary Disease (COPD) Patients Admitted to the Intensive Care Unit.

Tanaffos 2019 Apr;18(4):329-337

Critical Care Quality Improvement Research Center, Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Many pharmacological and behavioral therapies have been investigated to improve oxygenation in the intensive care unit (ICU). In patients with chronic obstructive pulmonary disease (COPD), the purpose of therapy is to correct the ventilation perfusion (V/Q) mismatch. Agents, such as calcium blockers, can affect both ventilation and vasculature. The inhalation route allows a more rapid achievement of therapeutic effects with few systemic side effects. Therefore, the present study aimed to investigate the effect of nebulized verapamil on oxygenation in COPD patients.

Materials And Methods: In this double-blind, randomized clinical trial, twenty hypoxic COPD patients, admitted to ICU, were treated with 10 mg of verapamil twice daily for three days. Also, twenty patients with COPD, who were matched in terms of age, sex, and severity of the disease, were enrolled in the control group and received nebulized normal saline. The oxygenation parameters were compared using an arterial blood gas (ABG) test before and after the intervention.

Results: The mean oxygen saturation was 91.2%±12.15 before verapamil inhalation, which increased to 95.75%±14.57 after receiving nebulized verapamil (P<0.05). Also, correction of blood pH, blood oxygen pressure, and oxygen ratio (PaO/FIO) were higher in patients receiving verapamil, compared to the control group. The length of hospital stay was similar in the two groups. During the first three days, 30% of patients in the verapamil group and 20% of patients in the control group were intubated.

Conclusion: Our results indicated that verapamil inhalation increased oxygen saturation and accelerated extubation in patients with COPD.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7309890PMC
April 2019

Biological Monitoring of Healthcare Workers Exposed to Antineoplastic Drugs: Urinary Assessment of Cyclophosphamide and Ifosfamide.

Iran J Pharm Res 2018 ;17(4):1458-1464

Center for Air Pollution Research (CAPR), Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran.

Exposure of health care workers to antineoplastic drugs and subsequent adverse health effects is still an open issue. Very little has been studied on the extent of occupational exposure and handling conditions of antineoplastic drugs in Iran. We aimed to determine cyclophosphamide and ifosfamide concentrations in the urine samples of oncology healthcare workers. In addition, we assessed workplace safety controls that are important to decrease occupational exposure. Urinary samples of subject and control groups were collected to measure pre and post-shift cyclophosphamide and ifosfamide concentrations. Prior to sample collection, an occupational toxicologist observed and recorded working safety conditions for the healthcare workers during an eight-week period. Heath care workers were also asked about occurrence of acute adverse health effects. A total number of 425 chemotherapeutic drugs (389.83 g) were prepared during the study. Cyclophosphamide was detected in five pre-shift and nine post-shift urine samples. One pre-shift and four post-shift urine samples were positive for Ifosfamide. The urine samples of control group had no detectable concentrations of cyclophosphamide and ifosfamide. Personal protective equipment usage was not adequate for handling activities. Some adverse health effects reported by oncology personnel confirmed exposure to antineoplastic drugs. High percentage of oncology personnel was exposed to antineoplastic drugs that could be related to the large amount of drug preparations and inadequate safety controls. We recommend training of oncology personnel, implementation of safety controls, and periodic surveillance in order to minimize workplace contamination and occupational exposure to antineoplastic drugs.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6269561PMC
January 2018

Effect of Adding Magnesium Sulphate to Epidural Bupivacaine and Morphine on Post-Thoracotomy Pain Management: A Randomized, Double-Blind, Clinical Trial.

Basic Clin Pharmacol Toxicol 2018 Nov 9;123(5):602-606. Epub 2018 Jul 9.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Post-thoracotomy pain is very severe and may cause pulmonary complications. Thoracic epidural analgesia can greatly decrease the pain experience and its consequences. However, finding new methods to decrease the amount of administered opioids is an important issue of research. We aimed to evaluate the effect of adding epidural magnesium sulphate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral centre were enrolled in a randomized, double-blind trial. Patients were randomly allocated to two groups. Bupivacaine (12.5 mg) and morphine (2 mg) were administered epidurally to all patients at the end of operation. Patients in the magnesium (Mg) group received epidural magnesium sulphate (50 mg), and patients in the control (C) group received normal saline as an adjuvant. Visual analogue scale (VAS) score and the amount of morphine consumption were measured during 24 hr post-operation. Thirty-nine patients in the Mg group and 41 patients in the C group completed the study. Patients in the Mg group had significantly less VAS score at recovery time (p < 0.05), 2 hr (p < 0.01) and 4 hr (p < 0.05) after surgery. The patient-controlled analgesia pump was started earlier in the C group than in the Mg group (p < 0.05). The amount of morphine needed in the Mg group was significantly lower than in the C group (5.64 ± 1.69 mg/24 hr versus 8.44 ± 3.98 mg/24 hr; p < 0.001). Pruritus was seen in the C group (9.7%) and absent in the Mg group (p < 0.05). Co-administration of magnesium sulphate with bupivacaine and morphine for thoracic epidural analgesia after thoracotomy leads to a reduction in post-operative pain score and the need for opioid administration.
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http://dx.doi.org/10.1111/bcpt.13047DOI Listing
November 2018

Important exposure controls for protection against antineoplastic agents: Highlights for oncology health care workers.

Work 2018 ;59(1):165-172

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: A great number of antineoplastic drugs (ANPDs) are used globally in cancer treatment. Due to their adverse health effects, occupational exposure to ANPDs is considered a potential health risk to health care workers.

Objective: The current study aimed to evaluate safe-handling practices of ANPDs, exposure controls, and adverse health implications for health care providers exposed to ANDPs.

Methods: Prevention measures, including engineering, administrative, and work practice controls, as well as personal protective equipment (PPE), were recorded daily through a questionnaire for six weeks. Acute adverse health effects experienced by health care workers were also documented.

Results: The implemented exposure controls for preparation, administration, cleaning, and waste disposal were not in accordance with the safe handling guidelines. Central nervous system disorders (26.33%) were the most frequent acute adverse effects reported by health care workers. A significant correlation was found between the number of experienced adverse effects and handling characteristics, including the number of preparations (r = 0.38, p < 0.05), dose, and the number of prepared drugs (r = 0.46, p < 0.01 and 0.39, p < 0.05), and working hours in different locations of oncology setting for six weeks (preparation room: r = 0.38, P < 0.05, treatment room: r = 0.46, P < 0.01, patient room: r = 0.63, P < 0.01, and station: r = 0.68, P < 0.01).

Conclusions: Due to inadequate control measures, oncology health care workers were in danger of exposure to ANPDs and experienced acute adverse health effects. Implementation of appropriate exposure controls is required to prevent occupational exposure to ANPDs.
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http://dx.doi.org/10.3233/WOR-172656DOI Listing
September 2018

Potential Drug-Drug Interactions Among Critically Ill Pediatric Patients in a Tertiary Pulmonary Center.

J Clin Pharmacol 2018 02 23;58(2):221-227. Epub 2017 Aug 23.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Patients in the pediatric intensive care unit (PICU) are at increased risk of potential drug-drug interactions (pDDIs) because of the complexity of pharmacotherapy. The current study aimed to assess the rate, pattern, risk factors, and management of pDDIs in the PICU of an academic pulmonary hospital. A prospective observational study was conducted for 6 months. Pharmacotherapy data of PICU-admitted patients were evaluated by a clinical pharmacologist. Interacting drugs, reliability, mechanism, potential outcome, and clinical management of pDDIs were identified using the Lexi-Interact database. Logistic regression was applied to analyze the risk factors that could be associated with the interactions. One hundred and twenty-three medication profiles were evaluated during the study period. Diseases of the respiratory system were the main diagnoses among intensive care unit (ICU)-admitted patients (56.1%). A total of 38.6% of the patients exposed to at least 1 major and/or contraindicated interaction during ICU admission. Most pDDIs occurred through metabolic (35.4%) and additive (34.8%) mechanisms. The existence of pDDIs was significantly associated with the number of prescribed medications. Exposure to pDDIs is frequent in critically ill pediatric patients and related to the number of medications. Daily and close cooperation between clinicians and clinical pharmacologists is recommended to prevent harmful outcomes of DDIs.
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http://dx.doi.org/10.1002/jcph.996DOI Listing
February 2018

Surgical Antibiotic Prophylaxis: A Descriptive Study among Thoracic Surgeons.

Tanaffos 2016 ;15(3):154-159

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Surgical site infections (SSIs) are common complications following surgeries and increase mortality, morbidity and healthcare costs. The use of antimicrobial prophylaxis is an effective measure to prevent development of SSIs. This study aimed to evaluate the current use of prophylactic antibiotics in thoracic surgeries in Iran.

Materials And Methods: A descriptive study was conducted among thoracic surgeons in order to assess their knowledge, attitude and practice (KAP) about surgical antibiotic prophylaxis (SAP). A four-section multiple-choice questionnaire was designed and hand-delivered to registered thoracic surgeons. The surgeons' answers were considered correct when they were in accordance to the American Society of Health-System Pharmacist (ASHP) guidelines.

Results: Seventy thoracic surgeons were requested to participate in this study and their response rate was 71.4%. Thirty-five (70%) surgeons had good knowledge about appropriate SAP. However, less than half of the respondents were aware of appropriate SAP in case of Ig E-mediated reaction to penicillin and risk of Gram-negative infections. The surgeon's attitude score about the need for local and national guidelines for SAP was 78% and 90%, respectively. Accordance of the physician's practice with ASHP guidelines regarding timing of the first dosage of SAP was acceptable while correct administration of an intraoperative dose was 40% in agreement with the guideline.

Conclusion: Although thoracic surgeons had a good attitude towards antibiotic prophylaxis guidelines, their knowledge and practice should be improved for proper administration of SAP.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5304959PMC
January 2016

Prevalence of HLA-B*5701 and Its Relationship with Abacavir Hypersensitivity Reaction in Iranian HIV-Infected Patients.

Tanaffos 2016 ;15(1):48-52

Virology Research Center, NRITLD, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Hypersensitivity reaction (HSR) is a major adverse effect of abacavir (ABC), which occurs in 5-8% of Caucasians. The relationship between Human Leukocyte Antigen (HLA) and ABC HSR has been reported in various populations. It has been proposed to administer ABC only to HLA-B*5701 negative patients to avoid this reaction. The purpose of this study was to assess the prevalence of HLA-B*5701 in Iranian HIV positive patients. We also sought to find the relationship between this allele with ABC HSR in patients who received the medication.

Materials And Methods: We screened patients for HLA-B*5701 allele using SybrGreen real time PCR-melting method on blood samples from HIV positive patients who were referred to our hospital. The quality of the extracted genome was evaluated by B-globin housekeeping gene as internal control prior to HLA-B*5701 allele screening.

Results: Of 198 HIV-infected patients, 6 (3.0%) had the HLA-B*5701 allele (95% CI, 1%-5%). Among the 28 patients who were given ABC, one individual had the HLA-B*5701 allele and experienced ABC HSR.

Conclusion: Prevalence of HLA-B*5701 in Iranian patients was lower than that in Caucasians but was comparable with that of other Middle Eastern populations. Screening for HLA-B*5701 before ABC administration as part of antiretroviral therapy may reduce the risk of HSR.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4937762PMC
July 2016

Important drug classes associated with potential drug-drug interactions in critically ill patients: highlights for cardiothoracic intensivists.

Ann Intensive Care 2015 Dec 24;5(1):44. Epub 2015 Nov 24.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Patients in the intensive care unit (ICU) are more prone to drug-drug interactions (DDIs). The software and charts that indicate all interactions may not be proper for clinical usage. This study aimed to identify the main drug classes associated with clinically significant DDIs in cardiothoracic ICU and categorize DDIs to make cardiothoracic intensivists aware of safe medication usage.

Methods: This prospective study was conducted over 6 months in a cardiothoracic ICU of a university-affiliated teaching hospital. The presence of potential drug-drug interactions (pDDIs) was assessed by a clinical pharmacologist using Lexi-Interact database. Clinically significant pDDIs were defined according to severity and reliability rating. Interacting drug classes, mechanisms, and recommendations were identified for each interaction.

Results: From 1780 administered drugs, 496 lead to major (D) and contraindicated (X) interactions. Nine drug classes were responsible for D and/or X interactions with excellent (E) and/or good (G) reliability. Anti-infective agents (45.87 %) were the main drug classes that caused clinically significant pDDIs followed by central nervous system drugs (14.67 %). Azole antifungals as the most interacting antimicrobial agents precipitated metabolism inhibition of CYP3A substrates.

Conclusions: Clinically significant pDDIs as potential patient safety risks were prevalent in critically ill patients. The findings from current study help to improve knowledge and awareness of clinicians in this area and minimize adverse events due to pDDIs.
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http://dx.doi.org/10.1186/s13613-015-0086-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4658340PMC
December 2015

Efficacy and Safety of Orally Administered Intravenous Midazolam Versus a Commercially Prepared Syrup.

Iran J Pediatr 2015 Jun 27;25(3):e494. Epub 2015 Jun 27.

Deparment of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran.

Background: Among different categories of sedative agents, benzodiazepines have been prescribed for more than three decades to patients of all ages. The effective and predictable sedative and amnestic effects of benzodiazepines support their use in pediatric patients. Midazolam is one of the most extensively used benzodiazepines in this age group. Oral form of drug is the best accepted route of administration in children.

Objectives: The purpose of this study was to compare the efficacy and safety of a commercially midazolam syrup versus orally administered IV midazolam in uncooperative dental patients. Second objective was to determine whether differences concerning sedation success can be explained by child's behavioral problems and dental fear.

Patients And Methods: Eighty eight uncooperative dental patients (Frankl Scales 1,2) aged 3 to 6 years, and ASA I participated in this double blind, parallel randomized, controlled clinical trial. Midazolam was administered in a dose of 0.5 mg/kg for children under the age 5 and 0.2 mg/kg in patients over 5 years of age. Physiologic parameters including heart rate, respiratory rate, oxygen saturation and blood pressure were recorded. Behavior assessment was conducted throughout the course of treatment using Houpt Sedation Rating Scale and at critical moments of treatment (injection and cavity preparation) by North Carolina Scale. Dental fear and behavioral problems were evaluated using Child Fear Schedule Survey-Dental Subscale (CFSS-DS), and Strength and Difficulties Questionnaire (SDQ). Independent t-test, Chi-Square, and Pearson correlation were used for statistical analysis.

Results: Acceptable overall sedation ratings were observed in 90% and 86% of syrup and IV/Oral group respectively; Chi-Square P = 0.5. Other domains of Houpt Scale including: sleep, crying and movement were also not significantly different between groups. Physiological parameters remained in normal limits during study without significant difference between groups.

Conclusions: "Orally administered IV midazolam" preparation can be used as an alternative for commercially midazolam syrup.
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http://dx.doi.org/10.5812/ijp.25(3)2015.494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4505992PMC
June 2015

Potential drug-drug interactions in cardiothoracic intensive care unit of a pulmonary teaching hospital.

J Clin Pharmacol 2015 Feb 5;55(2):132-6. Epub 2014 Dec 5.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Little is known about clinically significant drug-drug interactions (DDIs) in respiratory settings. DDIs are more likely to occur in critically ill patients due to complex pharmacotherapy regimens and organ dysfunctions. The aim of this study was to identify the pattern of potential DDIs (pDDIs) occurring in cardiothoracic intensive care unit (ICU) of a pulmonary hospital. A prospective observational study was conducted for 6 months. All pDDIs for admitted patients in cardiothoracic ICU were identified with Lexi-Interact program and assessed by a clinical pharmacologist. The interacting drugs, reliability, mechanisms, potential outcomes, and clinical management were evaluated for severe and contraindicated interactions. The study included 195 patients. Lung cancer (14.9%) was the most common diagnosis followed by tracheal stenosis (14.3%). The rate of pDDIs was 720.5/100 patients. Interactions were more commonly observed in transplant patients. 17.7% of pDDIs were considered as severe and contraindicated interactions. Metabolism (54.8%) and additive (24.2%) interactions were the most frequent mechanisms leading to pDDIs, and azole antifungals and fluoroquinolones were the main drug classes involved. The pattern of pDDIs in cardiothoracic ICU differs from other ICU settings. Specialized epidemiological knowledge of drug interactions may help clinical practitioners to reduce the risk of adverse drug events.
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http://dx.doi.org/10.1002/jcph.421DOI Listing
February 2015

Increasing the number of adverse drug reactions reporting: the role of clinical pharmacy residents.

Iran J Pharm Res 2014 ;13(1):291-7

Chronic Respiratory Disease Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ; Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Detection of adverse drug reactions (ADRs) in hospitals provides an important measure of the burden of drug related morbidity on the healthcare system. Spontaneous reporting of ADRs is scare and several obstacles to such reporting have been identified formerly. This study aimed to determine the role of clinical pharmacy residents in ADR reporting within a hospital setting. Clinical pharmacy residents were trained to report all suspected ADRs through ADR-reporting yellow cards. The incidence, pattern, seriousness, and preventability of the reported ADRs were analyzed. During the period of 12 months, for 8559 patients, 202 ADR reports were received. The most frequently reported reactions were due to anti-infective agents (38.38%). Rifampin accounted for the highest number of the reported ADRs among anti-infective agents. The gastro-intestinal system was the most frequently affected system (21.56%) of all reactions. Fifty four of the ADRs were reported as serious reactions. Eighteen of the ADRs were classified as preventable. Clinical pharmacy residents' involvement in the ADR reporting program could improve the ADR reporting system.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985255PMC
April 2014

Vincristine-induced seizure potentiated by itraconazole following RCHOP chemotherapy for diffuse large B-cell lymphoma.

Curr Drug Saf 2012 Nov;7(5):372-4

Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, Iran.

Objectives: To report the case of a patient with diffuse large B-cell lymphoma (DLBCL) who developed vincristine (VCR)-induced seizure after R-CHOP chemotherapy.

Case Summary: A 22-year-old boy with DLBCL developed generalized tonic clonic seizures following R-CHOP chemotherapy. After receiving the third cycle of chemotherapy, he developed Aspergillus pneumonia; therefore, itraconazole was started 18 days before the administration of cycle 4 of chemotherapy. Seven days after the administration of the fifth doses of vincristine, the patient reported symptoms of gastrointestinal toxicity (abdominal cramps and constipation). Subsequently, he developed three episodes of generalized tonic-clonic seizure which lasted for 2-3 minutes during one day and became unconsciousness. His serum electrolytes were normal with the exception of low serum sodium (128mEq/L). Blood glucose, blood urea nitrogen, the complete blood count, and a cerebrospinal fluid study were also normal. A computed tomography scan of the brain did not show any abnormalities. He had no previous history of convulsion. Occurrence of seizure due to central nervous system invasion of DLBCL was ruled out with a normal cerebrospinal fluid examination, computed tomography scan, and magnetic resonance imaging of the head. Therefore, the patient's neurotoxicity has been attributed to vincristine, the effects of which were likely potentiated by itraconazole therapy.

Discussion: Vincristine is a naturally occurring vinca alkaloid used in various chemotherapy regimens. Neurotoxicity is a known and commonly encountered side effect of vincristine. Peripheral neuropathy is the most common form of vincristine neuropathy whereas central effects are rarer. Enhanced VCR neurotoxicities from drug interactions with several azole antifungals such as itraconazole and voriconazole have been reported. Our case represents a drug possible adverse drug effect based on the Naranjo ADR Probability Scale.

Conclusion: Administration of vincristine in conjunction with azole antifungals should be with caution and after carefully considering the risks and benefits. Also, it is important to rule out other causes of seizure in these patients.
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http://dx.doi.org/10.2174/157488612805076633DOI Listing
November 2012

Microbial contamination of single- and multiple-dose vials after opening in a pulmonary teaching hospital.

Braz J Infect Dis 2013 Jan-Feb;17(1):69-73. Epub 2013 Jan 5.

Virology Research Center, National Research Institute of Tuberculosis and Lung Diseases NRITLD, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objectives: Intravenous therapy is a complex procedure usually requiring the preparation of the medication in the clinical area before administration to the patient. Breaches in aseptic technique may result in microbial contaminations of vials which is a potential cause of different avoidable infections. We aimed to investigate the prevalence and pattern of microbial contamination of single- and multiple-dose vials in the largest pulmonary teaching hospital in Iran.

Methods: In a period of 2 months, opened single- and multiple-dose vials from different wards were sampled by a pharmacist. The name of the medication, ward, labeling of the vials, the date of opening, and storing temperature were recorded for each vial. Remained contents of each vial were cultured using appropriate bacterial and fungal growth media.

Results: Microbial contamination was identified in 11 of 205 (5.36%) of vials. The highest contamination rate was 14.28% for vials used in interventional bronchoscopy unit. The most frequent contaminated medication was insulin. Gram-positive bacteria (81.82%) were more significantly involved than gram-negative ones (9.09%) and fungi (9.09%), with the highest frequency for Staphylococcus epidermidis.

Conclusions: Our data demonstrate that repeated use of vials especially if basic sterility measures are disobeyed can cause microbial contamination of administered products to the patients. Infection preventionists are responsible to train health care workers regarding aseptic techniques and apply guidelines for aseptic handling of intravenous solutions.
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http://dx.doi.org/10.1016/j.bjid.2012.09.005DOI Listing
July 2013

Clinical pharmacy services in an Iranian teaching hospital: Type, severity, resolution, and accuracy.

J Res Pharm Pract 2013 Jan;2(1):10-7

Department of Clinical Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran ; Department of Pharmaceutical Care, Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Objective: Clinical pharmacy services are improving in hospitals. For assessing the impact of these services, first it is important to exactly describe them by categorizing into types, severity, resolution, and accuracy. The objective of this study is to provide a detailed analysis of the clinical pharmacists' services performed on in-patients in a teaching hospital during 28 months.

Setting: Masih Daneshvari hospital, Tehran, Iran.

Methods: This is a descriptive study. The authors retrospectively reviewed the notes of all services and entered them in a designed SPSS sheet. Documentation was carried out based on the "findings, assessment, resolution, and monitoring" method. The data were descriptively analyzed.

Main Outcome Measure: Types, subtypes, severities, resolutions, and accuracies of services were defined, documented, and analyzed.

Findings: In total 3152 records (2227 interventions and 925 visits with no intervention) were classified and analyzed in this study. Among all types of interventions, "improper medication use" (36.2%) was the most frequent intervention and among categories (subgroups) of "improper medication use," "untreated indication" was the most frequent (23.7%). From the aspect of severity, 75.4% of interventions were estimated as of minor potential inconvenience to the patient (severity degree 1). Most interventions (78%) were finally recommended to the prescriber and 97.6% of interventions were considered accurate on further evaluation.

Conclusion: Clinical pharmacists' interventions are highly demanded in the hospitals. Based on the results of this study, conditions needing medication to prevent later complications in the course of therapy are sometimes ignored, which emphasizes the positive role of the clinical pharmacists' involvements in clinical teams to improve outcome.
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http://dx.doi.org/10.4103/2279-042X.114083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4076891PMC
January 2013

The Bioavailability of Salbutamol in Urine via Volumatic and Nonvolumatic Valved Holding Chambers.

World Allergy Organ J 2011 Nov 18;4(11):179-83. Epub 2011 Nov 18.

Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran ; Department of Pharmaceutical Care, Chronic Respiratory Disease Research Center, TB and Lung Disease Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Purpose: Pressurized metered dose inhalers are commonly used in patients with asthma. However, the need to coordinate inhalation with inhaler actuation means that they are not suitable for use per se. Valved holding chamber devices were developed to overcome some of the problems of pressurized metered dose inhalers. Several types of holding chambers of different sizes are available in Iran. This study was designed to compare the effects of 2 commonly used valved holding chambers (Asthm Yar and Dam Yar) in Iran on bioavailability of salbutamol spray and also spirometric parameters in asthmatic patients.

Methods: This was a comparative experimental crossover study. Patients with mild to moderate asthma were entered in this study. Lung function was assessed using a portable spirometer (Spirolab, Progetti, Italy). Spirometric parameters of forced expiratory flow (FEF)(50%), FEF(25-75%), peak expiratory flow (PEF), forced expiratory volume in the first second of expiration (FEV(1)), forced vital capacity (FVC), and FEV(1)/FVC were measured. Urinary concentration of salbutamol as an index of pulmonary bioavailability was assayed with high-performance liquid chromatography.

Results: Forty patients (25 women and 15 men) with the mean age of 43.10 ± 12.99 years were studied. Mean ± SD changes of spirometric parameters before and after using Asthm Yar were not significantly different from those of Dam Yar. The relative bioavailability after inhalation with Asthm Yar was significantly higher than after inhalation with Dam Yar (P = 0.002).

Conclusions: Although the results indicate that relative bioavailability to the lung after inhalation with Asthm Yar was significantly higher than after inhalation with Dam Yar, its clinical importance should be tested.
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http://dx.doi.org/10.1097/WOX.0b013e31823890f6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3488906PMC
November 2011

Continuous versus intermittent administration of piperacillin-tazobactam in intensive care unit patients with ventilator-associated pneumonia.

Indian J Crit Care Med 2012 Jul;16(3):141-7

Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease, Masih Daneshvari Hospital, Tehran, Iran.

Background And Aims: Ventilator-associated pneumonia (VAP) is one of the most common Intensive Care Unit (ICU)-acquired infection. The aim of this study was to compare the clinical outcome of continuous and intermittent administration of piperacillin-tazobactam by serial measurements of the Clinical Pulmonary Infection Score (CPIS).

Subjects And Methods: Groups were designed as parallel and the study was designed as quasi-experimental and conducted at a semi-closed ICU between September 2008 and May 2010. Patients received 3.375 g (piperacillin 3 g/tazobactam 0.375 g) either through intermittent infusion every 6 h for 30 min [Intermittent Infusion (II) group; n = 30] or through continuous infusion every 8 h for 4 h [Continuous Infusion (CI) group; n = 31]. CPIS was used to assess the clinical diagnosis and outcome of VAP patients.

Results: Sex, age, Acute Physiology and Chronic Health Evaluation II II score on ICU admission, diagnosis and underlying disease of VAP patients were not significantly different in the CI (n = 31) and II (n = 30) groups. Duration of mechanical ventilation, length of stay, total number of antibiotics used per patient and duration of piperacillin/tazobactam treatment were similar in both groups. Mortality rates of VAP patients were similar between both groups during hospitalization.

Conclusion: There was no significant difference in clinical outcomes of patients receiving piperacillin-tazobactam via CI or II when measured by serial CPIS score.
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http://dx.doi.org/10.4103/0972-5229.102083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3506071PMC
July 2012

Physical and Chemical Stability of Mycophenolate Mofetil (MMF) Suspension Prepared at the Hospital.

Iran J Pharm Res 2012 ;11(1):171-5

Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences ; Chronic Respiratory Disease Research Center (CRDRC), NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences.

To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules and tablets. Extemporaneous pharmacy was used as a feasible method in this experimental study to prepare suspension form of MMF. Suspension formulations were prepared from both tablets and capsules forms of MMF. Thereafter the stability parameters such as pH, microbial control, thermal and physical stability and particle sizes were evaluated. The amount of MMF, in the suspension was measured at various time points by HPLC. The HPLC method showed that concentration of suspensions prepared from tablets and capsules were 49 mg/mL and 50 mg/mL at time 0, respectively. The effective amount of suspensions prepared from capsules was 101% at time 0, 100% after 7 days, 98% after 14 days, and less than 70% after 28 days. According to the obtained results in this study, capsule-based suspension was stable for as long as 14 days at 5°C. This formulation appears to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative period.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3813101PMC
November 2013

Adverse drug reactions in a pulmonary teaching hospital: incidence, pattern, seriousness, and preventability.

Curr Drug Saf 2011 Sep;6(4):230-6

Pharmaceutical Care Department, Virology Research Center, NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Introduction: Monitoring and reporting of adverse drug reactions (ADRs) in specialized hospitals provide an important measure to identify and quantify the risks associated with the use of specific drugs.

Aims: This study aimed to determine the incidence, pattern, seriousness, and preventability of hospital-acquired ADRs, in medical wards of a pulmonary teaching hospital in Iran.

Methods: The study was conducted based on the ADRs reported by clinicians, nurses, and clinical pharmacists between March 2009 and February 2011 to the ADR reporting unit of the hospital. The incidence, pattern, seriousness, and preventability of the reported ADRs were analyzed.

Results: During the period of 24 months, for 11975 patients, 306 ADR reports were received. The most frequently reported reactions were due to anti-infective agents (34.08%). Rifampin accounted for the highest number of the reported ADRs among anti-infective agents. The gastro-intestinal system was the most frequently affected system (21.90% of all reactions). Seventy two (23.53%) of the ADRs were reported as serious reactions and twenty-five (8.17%) of the ADRs were classified as preventable.

Conclusions: Our study shows that ADRs pattern in our hospital is different from the other studies. Preventive measures have decreased the preventable ADRs and ensured safer drug use. Education and clinical pharmacist interventions have increased the quality and quantity of reported ADRs.
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http://dx.doi.org/10.2174/157488611798280942DOI Listing
September 2011

Evaluating the effect of zingiber officinalis on nausea and vomiting in patients receiving Cisplatin based regimens.

Iran J Pharm Res 2011 ;10(2):379-84

Pharmaceutical Care Department, Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. ; Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ginger, the rhizome of Zingiber officinalis, has long been used as herbal medicine for its antiemetic effect. For evaluating the effect of zingiber officinalis on nausea and vomiting (N and V) in patients receiving cisplatin based regimens, a randomized double-blind placebo-controlled cross-over clinical trial was carried out in patients receiving cisplatin in combination with other chemotherapeutic agents. The patients were randomly assigned to receive ginger capsules (rhizome of zingiber officinalis) or placebo in their first cycle of the study. All patients received standard antiemetics for chemotherapy induced nausea and vomiting (CINV). The patients were crossed-over to receive ginger or placebo in their next cycle of chemotherapy. Among 36 eligible patients who received both cycles of treatment, there were no difference in prevalence, severity, and duration of both acute and delayed N and V. Addition of ginger to the standard antiemetic regimen has shown no advantage in reducing acute and delayed N and V in patients with cisplatin-based regimen in this study.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828901PMC
November 2013

Isoniazid blood levels in patients with pulmonary tuberculosis at a tuberculosis referral center.

Chemotherapy 2011 3;57(1):7-11. Epub 2010 Dec 3.

Department of Pharmaceutical Care, Masih Daneshvari Hospital, Tehran, Iran.

Background: Serum concentrations of isoniazid (INH) were evaluated in Iranian patients admitted to the Tuberculosis Ward of Masih Daneshvari Hospital, Tehran, Iran. Factors correlated to plasma INH levels were determined.

Methods: Blood samples were obtained 2 h after ingestion of 5 mg/kg INH in 82 patients (1 sample/patient) on days 3-15 of treatment. The following variables were investigated: INH plasma level, duration of therapy, age, sex, weight, dose of INH administered and smoking status.

Results: The average (±SD) age and weight of patients were 60.68 ± 18.53 years and 74.96 ± 7.15 kg, respectively. INH concentrations were low in 14.63% and high in 23.17% of the patients (INH reference range: 3-5 μg/ml). Plasma INH was statistically correlated with duration of INH administration (Kendall's rank correlation, r = 0.66, p < 0.001) but not with other variables.

Conclusion: Based on the result of this study, plasma INH concentrations were not within the therapeutic range for 37.80% of the patients on conventional therapy. Therefore therapeutic drug monitoring may be needed to optimize INH dosage, especially in patients with inadequate clinical response or toxicity to INH.
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http://dx.doi.org/10.1159/000321045DOI Listing
July 2011

Novel VKORC1 mutations associated with warfarin sensitivity.

Cardiovasc Ther 2011 Aug 24;29(4):e1-5. Epub 2010 Jun 24.

Pharmaceutical Care Department, TB and Lung Disease Research Center, Shahid Beheshti University, M.C., Tehran, Iran.

Unlabelled: Warfarin is widely used anticoagulant drug for the prophylaxis and treatment of venous and arterial thromboembolic disorders and exerts its anticoagulant effect by inhibiting the vitamin K epoxide reductase. To determine the impact of genetic variants of the vitamin K epoxide reductase complex subunit 1 gene (VKORC1) on the anticoagulant response to warfarin, polymorphisms in exon 1, exon 3, and 3'-untranslated region (3' UTR) were assessed.

Results: Sixty patients (34 males and 26 females) with stable INR (2-3) were selected from cardiology and anticoagulant clinic. Three VKORC1 frameshift mutations were detected. The first frameshift mutation was nucleotide deletion (91delCC) in exon 3 (1 patient). The second variation was nucleotide addition (51addCT) in exon 3 (2 patients). All the 3 patients reported bleeding during warfarin use, while no other bleeding was reported during the study period. Warfarin maintenance dose was significantly different between 3 patients with mutations and patients without mutations. The use of a fixed-dose warfarin for all patients and in range INR may not be sufficient for warfarin monitoring. Many factors including unknown ones may also play an important role in highly variable response among patients. Our data for the first time, suggested a new possible call for screening to reduce the risk of bleeding and guide for dosing.
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http://dx.doi.org/10.1111/j.1755-5922.2009.00107.xDOI Listing
August 2011

Protective effect of N-acetylcysteine on antituberculosis drug-induced hepatotoxicity.

Eur J Gastroenterol Hepatol 2010 Oct;22(10):1235-8

Pharmaceutical Care Department, Virology Research Center, School of Medical Sciences, Tarbiat Modares University, Tehran, Iran.

Introduction: Isoniazid, rifampicin, and pyrazinamide, the first-line antituberculosis (anti-TB) drugs, are associated with hepatotoxicity.

Aims And Objectives: To study the hepatoprotective effect of N-acetylcysteine (NAC) on liver injury induced by anti-TB drugs.

Methods: A randomized clinical trial was conducted on 60 new TB patients who were aged 60 years or more. Patients were randomized into two groups. In group I (n=32), drug regimen included daily doses of isoniazid, rifampicin, pyrazinamide, and ethambutol. Patients in group II (n=28) were treated with the same regimen and NAC. The patients were followed up for 2 weeks. Liver enzymes and bilirubins were measured at baseline, after 1 and 2 weeks of treatment, and whenever the patients presented with clinical symptoms of hepatotoxicity.

Results: The mean+/-SD values of aspartate aminotransferase and alanine aminotransferase were significantly higher in group I than in group II after 1 and 2 weeks of treatment. Hepatotoxicity occurred in 12 patients with (37.5%) group I and none in group II. The mean duration of treatment before the onset of hepatotoxicity was 4.67+/-4.58 days.

Conclusion: NAC protects against anti-TB drug-induced hepatotoxicity.
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http://dx.doi.org/10.1097/MEG.0b013e32833aa11bDOI Listing
October 2010

Dose switch to another dosage form of Neoral increase the risk of medication error?

Ann Transplant 2009 Oct-Dec;14(4):58-60

Clinical Pharmacy Department, Pharmacy School, Shahid Beheshti University, M.C., Tehran, Iran.

Background: One of the most significant ways to avoid medication errors is to study the errors that have occurred in other institutions and to use the information to prevent similar accidents at other practice sites.

Case Report: We report a cyclosporine overdose that was caused, in part, by misinterpretation of the medication order of a transplanted patient. In transplantation regimen, a 15 mg BID dose of cyclosporine was supposed to be given as part of the immunosuppressive therapy. Unfortunately the patient received a total of 1500 mg but survived the overdose.

Conclusions: This case should be considered in the development of strategies to prevent unfavorable outcomes resulting from such errors.
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February 2010