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   Table of Contents - Current issue
October-December 2022
Volume 13 | Issue 4
Page Nos. 177-214

Online since Tuesday, September 27, 2022

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Pharmacovigilance and spontaneous adverse drug reaction reporting: Challenges and opportunities p. 177
Mira Desai
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Awareness and willingness to participate in clinical trials in togo p. 180
A Amadou, S Dziri, W Foma, A Gbadamassi
Context: Clinical Trials (CTs) are the key when it comes to informing clinical decision-making processes. There is a very low number of CTs conducted in Togo, and there is no study that assessed the willingness of Togolese to participate in CTs. Aims: The aim of this study was to assess public awareness and willingness to participate in CTs in Togo. Subjects and Methods: We designed a cross-sectional study, using an online survey with Google Form in the general population, carried out from December 2019 to March 2020. Statistical Analysis Used: An Excel sheet was generated from the Google Form, and we performed a descriptive analysis using IBM SPSS Statistics 21. All variables were presented as frequencies and percentages. Results: This study involved 210 participants. The findings of this study are showing that Togolese are reasonably aware about CTs, and they have a positive intention to participate, but they are ignorant of national CTs regulations. Although unawareness and unwillingness may be universally common, one challenge in Togo is the lack of communication. Conclusions: The findings of this study are encouraging. The National Bioethics Committee for Health needs to be better communicative, and providing training in clinical research is essential.
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A cross-sectional study of pre- and posttraining evaluation of inhaler use technique among outpatients with bronchial asthma or chronic obstructive pulmonary disease at a tertiary care hospital in India p. 184
Selvaraj Nitya, Sivagourounadin Kiruthika, R Meenakshi, H Suriya, S Yuvarajan
Context: Management of asthma and chronic obstructive pulmonary disease (COPD) includes use of inhalers as an integral component of drug delivery. Awareness about inhaler devices along with demonstration of the usage of inhaler technique aids in the optimization of therapeutic outcome. Aim: This study aimed to assess the correct use of inhaler technique following pre- and posttraining sessions for the management of COPD and asthma among pulmonary outpatients at a tertiary care hospital. Settings: This prospective cross-sectional study was carried out among patients diagnosed with asthma or COPD and prescribed with inhaler medication in the form of pressurized metered-dose inhaler (pMDI), MDI with spacer, or dry powder inhaler (DPI). Subjects and Methods: The inhaler device use by the patients was assessed initially, followed by a demonstration on inhaler device technique, and reassessed post training using a checklist. Statistical Analysis: Comparison of the median total score of pretraining and posttraining inhaler technique was analyzed by Wilcoxon signed rank test. P < 0.05 was considered statistically significant. Results: Out of 144 patients, 55.6%, 27.7%, and 16.7% of them were prescribed pMDI, MDI with spacer, and DPI, respectively. Post inhaler technique training, about 79.2% of the patients were able to demonstrate the inhaler technique correctly compared to 52.1% prior to training. A statistically significant difference in the median score of inhaler technique has been observed before and after training. Conclusions: This study reports a significant improvement in the correct use of inhaler technique post training. In addition, the most frequent error among inhaler users was revealed to be in the breath actuation.
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Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital p. 189
Ganesh Nathuji Dakhale, Mrunalini Vinay Kalikar, Akhil B Giradkar, Vishakha V Sinha
Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders. Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed. Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation. Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.
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Adverse drug reaction profile of daily regimen antituberculosis treatment p. 194
KN Hari Sankar, Kevin Roch, Doyce Jom, Dhanya S Palappallil, Prabitha Panattil, Rajani K Sankaranarayanan
Objectives: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern. Materials and Methods: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017–June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA). Results: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1–180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs. Conclusions: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable.
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Impact of educational intervention on the knowledge, attitude, and practice of pharmacovigilance among postgraduates of a tertiary care center, Kanchipuram, Tamil Nadu, India p. 199
Nithya Panneerselvam, Parimala Kathirvelu, Rajesh Manoharan
Introduction: Prescription of drugs should always be done in a judicious manner and with a satisfactory risk/benefit ratio. Pharmacotherapeutic agents are one of the important causes of adverse effects starting from mere inconvenience to permanent disability and death. Studies suggest that about 0.2%–24% of patients with adverse drug reactions (ADRs) are subjected to hospital admission in India as well as in several highly developed industrialized countries. India contributes below 1% in terms of ADR reporting against the world rate of 5%. To enhance the reporting rate, it is important to improve the knowledge, attitude, and practice (KAP) of all the health-care professionals with regard to the ADR reporting and the pharmacovigilance (PV). Aim: The aim of the study was to evaluate the basic KAP of the postgraduate (PG) students at Meenakshi Medical College and Hospital, Enathur, Kanchipuram, Tamilnadu, India, regarding ADR monitoring and PV. Materials and Methods: This was a before and after comparison study with an educational intervention. A knowledge-, attitude-, and practice-based questionnaire on ADR reporting and PV program was prepared and administrated. Results: Participants had good theoretical knowledge regarding PV, but their attitudes and practical knowledge increased significantly after an educational intervention. The overall scores observed between pretest and posttest were found to be statistically significant. Conclusion: Educational intervention had proven to be an effective tool in improving the KAP of PV in the present study. Lack of motivation and training toward ADR reporting discourages PGs from reporting. Revisions are needed to include the clinical application of PV in the present academic curriculum. Ensuring a better safety profile for drugs can be done only through PV.
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An observational study to monitor and report radiation-related adverse events by a clinical pharmacist to achieve a better therapeutic outcome and suggest preventive measures in a tertiary care teaching hospital p. 205
Rajesh Hadia, Dhaval Joshi, Trupal Rathod
Objectives: This study was conducted to investigate the potential role of clinical pharmacists in monitoring and developing a reporting system of radiation-related adverse events (RRAEs) in cancer patients and provided suggestive measures to prevent RRAEs to achieve a better therapeutic outcome for improving patient health-related quality of life. Methodology: This study was a prospective observational study conducted for a period of 2 years at a private academic oncology teaching care hospital. Patients on radiation therapy or chemoradiation therapy were enrolled and followed by clinical pharmacists on daily basis to identify adverse event(s) if any. Upon identification, adverse events were discussed with concerned radiation oncologists for authentication and graded as defined by the radiation therapy oncology group. Enrolled patients were also followed to ensure if they were provided adequate supportive care for RRAEs. Results: A total of 715 patients were followed during the study period. A total of 422 RRAEs were identified in patients who were on radiation therapy or chemoradiation therapy. The most common reported events were fatigue (n = 64, 15.16%), followed by mucositis (n = 55, 13.03%), diarrhea (n = 37, 8.76%), vomiting (n = 31, 7.34%), gastritis (n = 29, 6.87%), and dryness of the mouth (n = 22, 5.21%). Among the study patients who developed RRAEs, majority (n = 253, 60%) of them received a combination of chemotherapy and radiation therapy and 169 (40%) of 442 patients received radiotherapy alone. Cisplatin weekly monotherapy or cisplatin-based chemotherapy was commonly used pharmacological treatment in patients on chemoradiation therapy. Clinical pharmacists intervened to initiate adequate supportive care for nearly 20% (n = 84) patients. Conclusions: Clinical pharmacists may be contributing to monitoring and development of reporting systems for radiation-related toxicities/RRAEs in cancer patients. Teamwork of clinical pharmacists with radiation oncologists can improve the safety reporting of radiation and can ensure required medical and supportive care to manage RRAEs.
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Training on anti-plagiarism and referencing: A step toward sensitizing and improving scientific authenticity in medical literature writing among academicians p. 211
Manisha Naithani, Rajesh Kathrotia, Tarun Goyal, Ashi Chug, Manisha Bisht, Sandeep Kumar Singh, Shalinee Rao
Background: Growing misconduct in the academic field is a worldwide concern. Among health professionals, this may be attributed to lack of awareness either due to no or inadequate formal training in anti-plagiarism and referencing. Objectives: The present study aimed to document the outcome and use of focused workshops on anti-plagiarism and referencing in improving awareness to academic misconduct. Method: Data of half-day workshop on anti-plagiarism and referencing conducted in a series of programs in the year 2018- 2019 were retrieved and reviewed. To evaluate the effectiveness of the training program knowledge of participants was analyzed based on their pre-test and post-test performance scores. Results: A total of 134 participants participated in 5 sessions over 2 years. Analysis of mean pre-test score (12.23 ± 4.5) and post-test scores (17.28 ±3.56) exhibited statistically significant improvement in knowledge with training provided. Conclusions: A low pre-test score with the improvement of scores after training points toward the necessity to address this lacuna in knowledge through structured training on anti-plagiarism and referencing to eliminate scientific misconduct. This study would provide a reference for other institutions to develop similar efforts to overcome hurdles towards better and more authentic medical literature writing.
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Compliance with International Committee of Medical Journal Editors policy on individual participant data sharing in clinical trial registries: An audit p. 213
Ronak Borana, Soumyadeep Bhaumik
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