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   Table of Contents - Current issue
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July-September 2021
Volume 10 | Issue 3
Page Nos. 107-148

Online since Saturday, December 25, 2021

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REVIEW ARTICLES  

Summary of COVID-19 vaccine-related reports in the vaccine adverse event reporting system p. 107
Alice C Ceacareanu, Zachary A. P. Wintrob
DOI:10.4103/jrpp.jrpp_49_21  
Identification of the severe acute respiratory syndrome coronavirus 2 in humans toward the end of 2019 triggered a rapid, intensive effort to develop a vaccine. Among the first three COVID-19 vaccines granted emergency use authorization by the U. S. Food and Drug Administration (FDA) were two mRNA vaccines, never used on a large scale in humans, and one replication-incompetent human adenovirus vector vaccine. Since the beginning of the vaccination efforts in December 2020, almost 220,000 adverse events (AEs) have been reported through the Vaccine Adverse Event Reporting System, a reporting platform administered jointly by the FDA and the Centers for Disease Control to monitor vaccine-related AEs. We queried this database twice (04/23/21 and 05/14/21) and identified the AE reports with valid manufacturer-specific lot numbers (n = 76,336), a subset representing 33.54% of the total reported AEs. Using vaccine and demographic characteristics at the time of each query date, a model was generated to predict significant AEs, such as death. Our regression analysis revealed that the average age (IRR 1.08) and the number of doses administered in an assisted living facility (IRR 1.01) were significantly associated with the number of deaths observed in each lot, whereas the proportion of remaining vaccine shelf-life (IRR 1.30) and the vaccine manufacturer (IRR 1.09) were not. Studies such as this one are vital, as one of the best answers to vaccine hesitancy is reliable data confirming that the available COVID-19 vaccines are safe and not associated with a significantly higher risk of AEs than vaccines for other conditions.
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Homocysteine-lowering interventions in chronic kidney disease p. 114
Shirinsadat Badri, Sahar Vahdat, Shiva Seirafian, Morteza Pourfarzam, Tahereh Gholipur-Shahraki, Sara Ataei
DOI:10.4103/jrpp.jrpp_75_21  
The incidence of cardiovascular events and mortality is higher in patients with chronic kidney disease (CKD) compared to the general population. Homocysteine (Hcy) appears to be an independent risk factor for cardiovascular diseases in general populations and patients with CKD. Further, hyperhomocysteinemia can cause endothelial damage and increase the activity and production of coagulation factors, and its prevalence among patients with end-stage renal disease is approximately 85%–100%. Most treatments, which lower Hcy levels and have been considered in previous studies, include folic acid, B vitamins, omega-3 fatty acids, and N-acetylcysteine. However, the effect of therapies that can decrease Hcy levels and thus cardiovascular events in these patients is still unclear. The results are conflicting and require further investigation. To guide treatment decisions and improve patient outcomes, multiple databases were searched, including Web of Science, PubMed, and Medline to summarize the available evidence (i.e., clinical trial and meta-analyses) on Hcy-lowering interventions and cardiovascular events.
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ORIGINAL ARTICLES Top

Medical device-related counseling practice and barriers among Sudanese pharmacists: A questionnaire-based study p. 125
Ahmed Ibrahim Fathelrahman
DOI:10.4103/jrpp.JRPP_21_32  
Objective: The aim of the present study was to assess medical devices-related counseling practice and barriers among pharmacists. Methods: This was a cross-sectional study conducted using a convenient sample of Sudanese pharmacists. An online-version survey was used to collect data. Findings: One hundred and thirty pharmacists responded to the online survey. Most pharmacists in this sample were master or Ph.D. degree holders (62.3% and 12.3%, respectively), having a clinical training experience (70%) and substantial proportion are board-certified (30%). Medical devices reported to be commonly inquired by patients were blood glucose monitors, nebulizers, blood pressure monitors, dry powder inhalers, and insulin pens. Devices most frequently requiring counselling were blood glucose monitors, blood pressure monitors, syringes, thermometers, nebulizers, dry powder inhalers, insulin, and weighing scales. The most frequently supplied devices reported were syringes, blood glucose monitors, insulin pens, blood pressure monitors, thermometers, nebulizers, and dry powder inhalers. Devices least frequently requiring counselling were implanted devices, respirometers, and stethoscopes. The least frequently supplied devices were respirometers, implanted devices, and heart rate monitors. Conclusion: Medical devices reported to be commonly inquired by patients were most frequently requiring counseling, and most frequently supplied. Findings reflect the availability of devices in the market and pharmacists' response to the needs of their patients. Pharmacists should maintain adequate knowledge about the proper use of medical devices because this is a common patient inquiry.
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Patients' satisfaction with the community pharmacy services in Iran p. 133
Ali Saffaei, Azadeh Moghaddas, Ali Mohammad Sabzghabaee
DOI:10.4103/jrpp.JRPP_21_21  
Objective: This study aimed to measure patient satisfaction with community pharmacy in Isfahan, Iran, in 2019. Methods: In this cross-sectional study (2019), we selected 104 pharmacies located in the second largest city of Iran (Isfahan) based on systematic random sampling and at least five clients at different times of a day who finished the process of obtaining medications from the pharmacies were randomly selected for a short and structured interview using the Persian version of the MacKeigan and Larson questionnaire for measuring patients' satisfaction with pharmacy services. Findings: The reliability of the questionnaire was confirmed after distributing 520 among the patients (r = 0.958). No significant difference was observed between sex, marital status, housing status, and total satisfaction score based on the results. In addition, there was a significant difference between educational levels, location, job status, insurance status, real income, and total score of satisfaction (P < 0.05). Our results revealed acceptable satisfaction in some aspects, such as paying attention to pharmacists, the general condition of the pharmacy, and their technical competence. On the other hand, the patients were not satisfied enough in different aspects, for example, counseling, accessibility to their needed drugs, and expenses. Conclusion: Patient satisfaction needs to be improved and enhanced in the case of counseling the patients on their medications, and drug accessibility and expenses remain the primary source of dissatisfaction in the studied population, which should be noted by the Iranian Food and Drug Organization and other related authorities.
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Effectiveness of megestrol for the treatment of patients with atypical endometrial hyperplasia or endometrial endometrioid adenocarcinoma (Stage IA, well differentiated) p. 138
Setareh Akhavan, Fahimeh Sabet, Azam-Sadat Mousavi, Mitra Modarres Gilani, Shahrzad Sheikh Hasani
DOI:10.4103/jrpp.JRPP_20_128  
Objective: We aimed to evaluate treatment responses and recurrence rate of atypical endometrial hyperplasia (AEH) and endometrial endometrioid adenocarcinoma (EA) with Stage IA Grade 1 to megestrol in Iranian patients who are candidates for medical treatments. Methods: In a retrospective cohort study that was conducted on 50 patients with AEH and 22 patients with EA who were referred to the oncology clinic of Imam Khomeini Hospital, Tehran, Iran, during 2006–2016, we recruited all patients with AEH or EA of Stage IA Grade 1 and their disease was diagnosed during endometrial curettage with or without hysteroscopy. Patients were initially treated with 160 mg of megestrol daily, along with aspirin up to 3 months, and then after 3–4 weeks of discharge of the drugs, patients underwent curettage with hysteroscopy. Findings: The patients with AEH had 31 complete responses and five progressive diseases, and the patients with EA had seven complete responses and seven progressive diseases. After treatment, 25 cases with AEH and 5 cases with EA had an intention to get pregnant, whereas eight patients with AEH and 1 case with endometrial cancer became pregnant. Recurrence occurred in the 2 cases with AEH and 2 cases with endometrial cancer which the time of recurrence in the patients with AEH was longer than in patients with endometrial cancer (P = 0.011). Conclusion: Megestrol is an effective therapeutic agent in endometrial hyperplasia or low-grade endometrial cancer patients who are willing to conserve their childbearing.
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A safety evaluation of midazolam use for nasogastric tube placement p. 144
Jenna B Wells, David H Murman, Alison L Sullivan
DOI:10.4103/jrpp.jrpp_78_21  
Objective: Nasogastric tube (NGT) insertion is one of the most painful procedures in the emergency department (ED). A recent study determined that giving intravenous (IV) midazolam before NGT insertion decreased patients' pain; however, the sample size was insufficient to draw the conclusions on safety. We conducted a retrospective chart review of patients who received IV midazolam for NGT insertion to determine the frequency of adverse events. Methods: All patients treated at a Level 1 trauma center ED from June 2016 to June 2019 who received IV midazolam for NGT insertion were included. The medical records were screened for the following serious adverse events: hypoxia, respiratory suppression, excessive somnolence/sedation, hemodynamic instability, epistaxis, vomiting, and choking. Adverse events, patient demographics, chief complaint, diagnosis, disposition, number of midazolam administrations, dose per administration, and total dose were recorded for the analysis. Findings: Three out of 159 participants (2%) were identified as having an adverse event. In two cases, the adverse event was hypoxia, which was corrected with the administration of supplemental oxygen through nasal cannula. The third adverse event was somnolence noted in a patient who was also hypotensive and in atrial fibrillation around the time of midazolam administration. Conclusion: It is safe to premedicate patients with midazolam before NGT insertions. Patients with borderline oxygen saturation and those receiving opioid analgesics may warrant dose titration with close vital sign monitoring.
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