{"title":"Risk Communication in Pharmacovigilance","authors":"Sakshi Desai","doi":"10.53411/jpadr.2022.3.3.01","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.3.01","url":null,"abstract":"Risk communication is a critical aspect of pharmacovigilance that must be considered by organizations during their Risk Management planning phase. The main challenges that hinder effective risk communication is its dependence on the perception of stakeholders, underpinned by their opinions, experiences and emotional responses to risk. The way to address these challenges is two-fold. One is dealing with it at a strategic level which involves collaborative problem-solving providing an understanding of strengths and limitations of risk analysis along with tools for internal and external communication to ensure consistent messaging. And the second is dealing at an interpersonal level, which involves utilizing empathetic listening to understand needs of the stakeholders and then sharing expert insights, translating technical information into understandable language to ensure effective delivery of messages. Ultimately, integrating expert communication with computational methods creates a strong foundation and increases success of risk communication.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115828199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Life threatening gastrointestinal tract complications in a patient of rheumatoid arthritis. Is it drug or disease related?","authors":"Kanisha Shah, Sapna D. Gupta, S. Malhotra","doi":"10.53411/jpadr.2022.3.3.08","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.3.08","url":null,"abstract":"Introduction: Gastrointestinal (GI) complications are very frequent and sometimes fatal in patients with Rheumatoid Arthritis (RA). Gastrointestinal perforation is a rare but serious event, most frequently involving the lower GIT, which has been observed in patients with RA. \u0000Case Presentation: We present here an Adverse Drug Reaction (ADR) which is small bowel ischemia with perforation in a 61-year-old RA patient, who was taking a tablet of Prednisolone and tablet Hydroxychloroquine. \u0000Discussion: Several studies indicated that RA patients may be at a higher risk of GI perforation. This could be attributed to the disease pathophysiology or the use of drugs for treatment like Glucocorticoids and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Rheumatologists must be vigilant for GI complications while prescribing anti-rheumatoid drugs. \u0000Conclusion: GI perforations are rare events in RA patients, but cause significant morbidity and mortality. Increasing age and other comorbid conditions also increase the risk of adverse GI events.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"85 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131231432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Y. Al-Bairmany, Noor Kasib Hadi, Abdul Karim Nazar
{"title":"The efficacy of single dose palonosetron in highly emetogenic chemotherapy protocols compared to oral aprepitant and ondansetron","authors":"Y. Al-Bairmany, Noor Kasib Hadi, Abdul Karim Nazar","doi":"10.53411/jpadr.2022.3.3.06","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.3.06","url":null,"abstract":"Background: Chemotherapy-induced nausea and vomiting (CINV) is a common problem during cancer treatment and its proper management is essential. The primary objective of this study was to compare the efficacy of a single dose palonosetron in the control of chemotherapy-induced nausea and vomiting (CINV) to that of oral aprepitant and ondansetron. The secondary objective is to determine age, gender, morning sickness, motion sickness, as well as chemotherapy protocols as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV). \u0000Methods: This is a prospective cohort study carried out at Al-Andalus Private Hospital for Cancer Patients in Baghdad, Iraq. The study included 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol. Patients were divided into 3 arms according to the antiemetic received. Arm 1 received aprepitant and ondansetron, arm 2 received ondansetron, and arm 3 received palonosetron. The primary endpoint was the response rate defined as the percentage of patients without nausea or vomiting episodes during the chemotherapy treatment cycles. Other secondary endpoints such as age, gender, morning sickness, motion sickness, as well as chemotherapy protocols, were measured as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV). \u0000Results: A total of 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol were evaluated. There was no significant association between age or gender and CINV. The incidence of nausea and vomiting with ondansetron was more than the incidence of nausea and vomiting with aprepitant, and the incidence of nausea and vomiting with palonosetron was less than the incidence of nausea and vomiting with aprepitant. There was no significant association between morning sickness and nausea or vomiting. On the other hand, there was a significant association between motion sickness and nausea or vomiting. The most common cycle reported in nausea and vomiting was cycle 3. Regarding suffering from nausea and vomiting with some chemotherapy drugs, the most common drugs were adriamycin cyclophosphamide (AC) and carboplatin. \u0000Conclusion: The results of the present study confirm the previous reports on the superiority of palonosetron over ondansetron and its aprepitant in reducing the incidence of CINV. Regarding risk factors, motion sickness, chemotherapy cycle 3, as well as adriamycin cyclophosphamide (AC) and carboplatin were risk factors inducing CINV in high emetogenic chemotherapy protocols.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115800033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Knowledge, attitude and practice towards adverse drug events reporting among graduating health science students of college of health sciences, Addis Ababa University, Ethiopia","authors":"M. Senbeta, Hiluf Maldey, Melaku Gedamu","doi":"10.53411/jpadr.2022.3.2.6","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.6","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125118765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
H. Mishra, A. Goel, Sahil Kumar, Mihir Chauhan, M. Patnaik, I. Rehman
{"title":"Drug development hit by war","authors":"H. Mishra, A. Goel, Sahil Kumar, Mihir Chauhan, M. Patnaik, I. Rehman","doi":"10.53411/jpadr.2022.3.2.3","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.3","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"51 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130371805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The need for Quality","authors":"Erika Barbarosie","doi":"10.53411/jpadr.2022.3.2.1","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.1","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134144856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Safety and tolerability of antipsychotic drugs in pediatric patients","authors":"Nabih Lawand, Samaa Al Tabbah","doi":"10.53411/jpadr.2022.3.2.2","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.2","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116175210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Samajdar, S. Dutta, Aneek Ghosh, Shatavisa Mukherjee, Jayanta Sharma, Anwesha Behera, Oyendrilla Mitra, Ishanee Das Sharma, Mohojit Chakraborty, S. Tripathi
{"title":"Exploring position of colchicine in management of COVID 19 – A systematic review","authors":"S. Samajdar, S. Dutta, Aneek Ghosh, Shatavisa Mukherjee, Jayanta Sharma, Anwesha Behera, Oyendrilla Mitra, Ishanee Das Sharma, Mohojit Chakraborty, S. Tripathi","doi":"10.53411/jpadr.2022.3.2.4","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.4","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134046486","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Anti-viral activity of Withania somnifera phytoconstituents against corona virus (SARS-COV-2)","authors":"S. Parihar","doi":"10.53411/jpadr.2022.3.2.5","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.5","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128181852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
H. Atshemyan, N. Khachatryan, A. Manukyan, A. Khachatryan, Alvard Poghosyan
{"title":"Lymphoproliferative skin lesion as a previously unreported adverse event detected in a patient receiving mSTR TB treatment","authors":"H. Atshemyan, N. Khachatryan, A. Manukyan, A. Khachatryan, Alvard Poghosyan","doi":"10.53411/jpadr.2022.3.2.7","DOIUrl":"https://doi.org/10.53411/jpadr.2022.3.2.7","url":null,"abstract":"","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129116877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}