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   Table of Contents - Current issue
Coverpage
April-June 2019
Volume 8 | Issue 2
Page Nos. 39-104

Online since Monday, July 1, 2019

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REVIEW ARTICLE  

The pharmacy profession in a developing country: Challenges and suggested governance solutions in Lebanon p. 39
Hala Sacre, Souheil Hallit, Aline Hajj, Rony M Zeenny, Georges Sili, Pascale Salameh
DOI:10.4103/jrpp.JRPP_19_5  
Throughout the years, changes occurred in pharmacists' roles on international levels. These changes are not being followed in Lebanon where community pharmacy is still practiced in a traditional way. Laws need to be updated to align with international standards to drive a change at the practice level. The Lebanese Order of Pharmacists' (OPL) mission is to raise the level of the profession. It also enforces the laws, defends the rights of pharmacists, and improves the level of practice and development of scientific competence. It is also aiming at providing the conditions for enhancing the patient's access to the appropriate medications and its safe use. Meanwhile, the OPL is facing several challenges, most importantly, the deteriorating financial situation of community pharmacists and the decrease in the retirement fund input. To find proper answers to all these issues, the OPL started working, since 2016, on solutions from a proper governance perspective, jointly with all the stakeholders such as the Ministry of Public Health, the Ministry of Education and Higher Education, the universities, and other professional associations. The suggested solutions include the application of the principles of good governance, provision of paid services, developing pharmacists' core and advanced competencies, accreditation standards generation, and new laws and decrees suggestions concerning clinical pharmacy application in hospitals and community settings, continuing education consolidation and professional development, and research- and assessment-based decisions. The suggested solutions are expected to overcome challenges and barriers while leveraging the profession and advancing it to reach international standards.
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ORIGINAL ARTICLES Top

Evaluation of medication package inserts in Iran p. 45
Shahriyar Shahbazi Khamas, Atefeh Jafari, Morvarid Zarif-Yeganeh, Hamidreza Taghvaye-Masoumi
DOI:10.4103/jrpp.JRPP_18_32  
Objective: Package inserts (PIs) provide information for the safe and effective use of medication. There is no study on the evaluation of PIs in Iran. The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Methods: This cross-sectional observational study was conducted during 3 weeks in January 2017. One hundred medications were chosen from a list supplied by the Iran Food and Drug Administration (IFDA). The PIs were assessed for the presentation and completeness of quality criteria, which was consisted of two parts. The first part was the criteria required by the IFDA, mentioned in Chapter 16 of the Pharmaceutical Regulations and Instructions provided by the IFDA. The second part of the criteria was defined according to the critical comments of clinical and industrial pharmacists. Findings: Thirty-seven out of 100 medications included no PIs. None of the PIs met all the criteria required by the IFDA. The highest score for completeness was 18 out of 21 (85.7%). Medication name, description, and adverse reaction were mentioned in all PIs. Other items such as patient counseling information (98%), warnings (95.2%), precautions (95.2%), pregnancy/lactation (95%), and storage condition (90.5%) have been mentioned in a high percentage of PIs. Conclusion: PIs have improved in recent years in Iran, but there is an absolute need for more accurate and up-to-date information. The IFDA should supervise pharmaceutical companies more strictly in this regard and should revise its regulations requiring PIs to conform to the FDA regulations.
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Outcome evaluation of a subcutaneous immunoglobulin clinical management program p. 52
Julia Zhu, Gretchen Ayer, Heather S Kirkham, Chi-Chang Chen, Rolin L Wade, Swapna U Karkare, Chester H Robson, Jordan S Orange
DOI:10.4103/jrpp.JRPP_18_36  
Objective: The aim of this study is to compare clinical and cost outcomes of patients undergoing subcutaneous immunoglobulin (SCIG) therapy who were managed by a clinical management program to the matched controls in the United States. Methods: This was a retrospective cohort study using administrative claims data from the PharMetrics Plus™ (PMTX+) database. The patients from a high-touch SCIG clinical management program were matched to nonprogram patients in PMTX+ database using 1:4 propensity score matching without replacement. All patients were followed for 1 year during the study from September 1, 2011, to June 30, 2014, and both clinical and cost outcomes were compared between the two cohorts using the generalized estimating equation model. Findings: The clinical outcomes were measured by infection- and infusion-related adverse events (AEs). Most of them were not significantly different (P > 0.05) between the intervention group and matched controls. Although the proportion of patients who had a mild less common AE was higher (4.4% vs. 0.0%;P = 0.04), it could be due to increased reporting among the intervention group. The annual adjusted mean total health-care costs of patients in the program (n = 45) were $20,868 lower compared to matched controls (n = 180), representing a 24% lower costs ($66,450 vs. $87,318;P = 0.009). Conclusion: This study may demonstrate that clinical management programs for SCIG may be associated with lower health-care costs and comparable infection and severe AE rates. The limitations of this study included a small sample size and a reliance on administrative claim data.
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Frequency and predisposing factors for drug-induced hypoglycemia in patients with type-2 diabetes mellitus p. 64
Atiqulla Shariff, Sathvik Belagodu Sridhar, Hana Rami Bittar, Ahed Hamad, Reem Ahmed, Ghaidaa Kadour
DOI:10.4103/jrpp.JRPP_18_58  
Objective: Hypoglycemia is the most common complication of the treatment for diabetes mellitus. Various factors predispose an individual for drug-induced hypoglycemia. The aim of this study was to explore the relative frequency and likely predisposing factors for drug-induced hypoglycemia among type-2 diabetic patients in the United Arab Emirates (UAE). Methods: In this cross-sectional survey-based study which was conducted from February to April 2018 in two local community pharmacies in the UAE, diabetic patients underwent a structured interview on their diabetes mellitus status and management and specific open-ended questions related to hypoglycemic symptoms that they might have experienced and the occurrence of symptoms. Collected data were used to estimate the relative frequency of drug-induced hypoglycemia and to identify the probable predisposing factors and their contribution in causing hypoglycemia using relative risk, Chi-square test, and Fisher's exact test. Findings: The relative frequency of drug-induced hypoglycemia in our study was 46.25%. Patients' age of ≥65 years, duration of diabetes mellitus for more than 1 year, patients with more than one comorbid condition, and patients using more than one antidiabetic medication were predisposing for developing drug-induced hypoglycemia. Conclusion: The relative frequency of drug-induced hypoglycemia in a nontrial environment which lacks the special cares routinely provided in drug development clinical trials is high. We suggest that more attention should be paid to identify, prevent, and manage drug-induced hypoglycemia in type-2 diabetic patients who have more than 1 year of diabetes, more than one comorbidity, using more than one antidiabetic medication, and elderly.
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Antidepressant prescribing patterns in heart failure patients at residential aged care facilities in Australia: A cross-sectional study p. 69
Ruba A.M. Marashdeh, Richard Parsons, Tin Fei Sim
DOI:10.4103/jrpp.JRPP_18_63  
Objective: Depression is associated with poor outcomes following heart failure. Information regarding the use and effectiveness of antidepressants in heart failure patients is lacking. This study aims to evaluate the prescribing patterns of antidepressants in patients with heart failure residing in aged care facilities. Methods: This study was a cross-sectional analysis of de-identified Australian Residential Medication Management Reviews conducted between January 2016 and April 2017. SPSS version 24 software was used to analyze the data. Descriptive statistics were used to summarize age, gender, and antidepressants use. Wilcoxon signed-rank test was used to assess the differences in antidepressant prescribing between patients with and without heart failure. Findings: Of 4369 patients, 980 (22.4%) had heart failure. Of those with heart failure, 410 (41.8%) were using at least one antidepressant. Mirtazapine was the most commonly prescribed antidepressant in patients with heart failure (27.8%) and without heart failure (27.3%). When grouping antidepressants for class, selective serotonin reuptake inhibitors were the most commonly prescribed in both groups. There was no statistically significant difference in antidepressant prescribing patterns between patients with and without heart failure (P = 0.961). Conclusion: Mirtazapine was the most commonly used antidepressant in heart failure patients residing in aged care facilities. This study has highlighted a need for a randomized controlled trial to evaluate the efficacy and safety of mirtazapine in the management of depression in patients with heart failure.
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Potential role of Vitamin C intracoronary administration in preventing cardiac injury after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction p. 75
Negar Shafaei-Bajestani, Azita Hajhossein Talasaz, Mojtaba Salarifar, Hamidreza Pourhosseini, Farshad Sadri, Arash Jalali
DOI:10.4103/jrpp.JRPP_18_78  
Objective: The aim of the present study was to determine the effects of intravenous (IV) and intracoronary administration of Vitamin C on the incidence of periprocedural myocardial injury in patients undergoing primary percutaneous coronary intervention (PCI). Methods: In this prospective, double-blind, randomized clinical trial, that was conducted in Tehran Heart Center, Iran, between October 2016 and March 2017, 252 patients undergoing primary PCI were enrolled to receive either 3 g of IV Vitamin C before PCI and 100 mg of intracoronary Vitamin C during PCI in addition to the routine treatment (n = 126) or just the routine treatment (n = 126). Cardiac biomarkers were measured before and then 6 and 12 h postprocedurally. We determined the occurrence of contrast-induced acute kidney injury (CI-AKI), according to the levels of serum creatinine, neutrophil gelatinase-associated lipocalin, and platelet activation biomarker (P-selectin) in a subset of 119 patients before and 6 h after PCI. Findings: In the patients who received Vitamin C, the serum levels of troponin T after 12 h and creatine kinase-MB after 6 h were significantly lower than those in the placebo group (P = 0.003 andP = 0.00, respectively). CI-AKI occurred in 6 (4.7%) patients in the study group and 8 (6.3%) patients in the control group; there was no significant reduction in CI-AKI in the study group. In addition, the two groups were statically similar as regards the changes in the level of P-selectin. Conclusion: In primary PCI patients, the prophylactic use of IV and intracoronary Vitamin C can confer additional clinical benefits such as cardioprotection.
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The responsibility of clinical pharmacists for the safety of medication use in hospitalized children: A Middle Eastern experience p. 83
Khatereh Jafarian, Zahra Allameh, Mehrdad Memarzadeh, Ali Saffaei, Payam Peymani, Ali Mohammad Sabzghabaee
DOI:10.4103/jrpp.JRPP_19_66  
Objective: We aimed to detect and report the frequency of occurrence of drug-related problems (DRPs) in a Middle Eastern University Children's Hospital (Isfahan, Iran) and classify them in terms of their nature and cause to clarify the responsibility of clinical pharmacists for the safe utilization of medications in hospitalized children. Methods: In this cross-sectional study which was carried out in Imam Hossein Children's University Hospital affiliated with Isfahan University of Medical Sciences (Isfahan, Iran) from September 2017 to May 2018, DRPs during the hospitalization of pediatric patients in three medical wards, the pediatric intensive care unit, and two neonatal intensive care units were detected and identified concurrently with the treatment process using Pharmaceutical Care Network of Europe data gathering form for DRPs v. 8.01. All cases were verified and validated in a professional focus group before documentation. Findings: We detected 427 DRPs in 201 out of 250 randomly included hospitalized children in which 86% of them were directly reported by the hospital's clinical pharmacist. The highest frequency of DRPs (47.3%) was observed in the age range of 1 month–2 years. Safety of treatment was the most frequently reported as the nature of the problem (43.5%), followed by effectiveness issues (36.8%). The most frequent cause of DRPs was dose selection issues (34.2%), followed by drug-type selection (25.5%), and unavailability of appropriate dosage forms (13.6%). Ninety-eight interventions were proposed by the clinical pharmacist, in which 59.2% of them were accepted. Conclusion: This study confirms the necessity for the active role of clinical pharmacists before, during, and after drug therapy in hospitalized pediatric patients for the safety and proper utilization of drugs in this vulnerable population.
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Prescription pattern of antihypertensive drugs: An experience from a secondary care hospital in the United Arab Emirates p. 92
Maryam Salem Alkaabi, Syed Arman Rabbani, Padma G.M. Rao, Syed Rashid Ali
DOI:10.4103/jrpp.JRPP_18_85  
Objective: The aim of the study was to examine the prescription pattern of antihypertensive drugs used in a secondary care hospital in the United Arab Emirates (UAE). Methods: It was a prospective, observational study carried out in 588 adult hypertensive patients presenting to medicine outpatient and inpatient departments of Dibba Hospital, Fujairah, UAE. The study was conducted for a period of 6 months from December 2017 to May 2018. Demographic and clinical data were collected from electronic patient case records and documented. Prescriptions were studied overall for drug use details and for specific types of antihypertensive drugs. The World Health Organization Anatomical Therapeutic Chemical/Defined Daily Dose methodology was further used to calculate utilization. Statistical analysis of data was performed using Statistical Package for the Social Sciences 24.0. Findings: Of the 588 study participants, majority of the patients were on two-drug combination antihypertensive therapy (n = 210, 35.5%) followed by monotherapy (n = 188, 32.1%) and three-drug combination (n = 136, 23.1%). Calcium channel blockers were the most frequently (51%) prescribed class both in monotherapy and in combination therapy while angiotensin receptor blockers and angiotensin-converting enzyme inhibitors (55.9%) were the most preferred agents for monotherapy. Among individual antihypertensive drugs, amlodipine was prescribed the most (266 prescriptions), irrespective of monotherapy or combination therapy. Conclusion: Our study represents the current prescribing trends of antihypertensive drugs in a secondary care hospital in the UAE. The use of antihypertensive drugs largely conforms to international guidelines, but still, there is room for improvement in terms of rational drug utilization.
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BRIEF COMMUNICATION Top

Prescribing pattern of proton pump inhibitors in Qatar rehabilitation institute: A retrospective study p. 101
Lama Madi, Arwa Hassan Ahmed Elhada, Haneen Alrawashdeh, Afif Ahmed
DOI:10.4103/jrpp.JRPP_18_79  
Objective: Proton pump inhibitors (PPIs) are still widely used despite increasing reports of their adverse events. This drug use evaluation study was conducted to assess the prescribing pattern of PPIs for patients admitted to the Qatar Rehabilitation Institute (QRI). Methods: An observational, retrospective, patients' chart-based study included all patients who received a PPI in QRI between April 1, 2017, and October 1, 2017. A standardized tool was prepared and reviewed by the involved clinical pharmacists to collect appropriate data for the evaluation. Statistical analysis was performed using the 25th Version of the Statistical Package of the Social Sciences (SPSS®). Findings: A total of 119 patients received PPIs during the audit period, of which esomeprazole was the most frequently prescribed (34%). Majority of the patients (94%) were started on PPI without further investigations for confirming the indication, and the indication was not documented in 78% of the participants. Nonsteroidal anti-inflammatory drugs were the most commonly co-prescribed medications with PPIs (59%). Pantoprazole was co-prescribed with clopidogrel in 42% of the patients. Conclusion: This drug utilization study shows the need for a proper prescribing practice considering a clear indication and recommendations about the duration of therapy and the need for reassessment in QRI.
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