{"title":"A Note on Medications, Devices and FDA","authors":"Preeti Gampala","doi":"10.35248/2329-6887.21.9.304","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.304","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"62 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86370155","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}
Sarbani Biswas, A. Chatterjee, S. Manna, Uddipan Kar
{"title":"An Observational Study Report on Adverse Drug Reactions of A Combination of Drugs in A Tertiary Care Hospital, Kolkata, West Bengal","authors":"Sarbani Biswas, A. Chatterjee, S. Manna, Uddipan Kar","doi":"10.35248/2329-6887.21.9.297","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.297","url":null,"abstract":"Background: Drugs or proper medications can be a preventive measure against several temporary or chronic human diseases and physiological conditions. But sometimes, drugs can turn out to be a bane to human life rather than becoming a boon. Administration of certain drugs may lead to several undesirable detrimental effects to human health that may even be fatal if gone unnoticed. These reactions are more commonly referred to as the Adverse drug Reactionsâ™. Aim: In the current study, our major aim is to probe the adverse drug reactions of two particular drugs Paracetamol and Cephalosporin, when administered in combination or separately in a tertiary care hospital, Kolkata, West Bengal. Material and methods: Our study involves a hospital-based observational study where the adverse drug reactions reported by medical practitioners over a period of six months were assessed in patients administered with paracetamol and cephalosporin group of drugs in combination or separately. Results: In this study, 100 patients were administered paracetamol and cephalosporin drug groups both separately or in combination. Out of them, 36 patients developed ADR like hepatotoxicity, hypotension, anemia, vomiting, skin rashes as well as Steven Johnson Syndrome. Adverse drug reaction is found to be more common in women than in men. Also, middle-aged adults (15-65 years) are more prone to adverse drug reactions on the administration of a combination of paracetamol and cephalosporin drugs. Further, when the patients were subjected to a dose of a combination of paracetamol and cephalosporin drug groups, they experienced mainly vomiting along with some minor cases of hypertension, hepatotoxicity, and skin rashes. Conclusion: Our study clearly indicates that when a patient is co-administered a combination of both paracetamol and cephalosporin drug groups, the majority of the observed adverse drug reaction symptom is vomiting which is a signature adverse drug reaction symptom of cephalosporin drug group alone, indicating a clear predominance in symptoms of adverse drug reaction exhibited by cephalosporin drug group over paracetamol.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"26 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78245307","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":"A Note on Medical Management of Uveitis","authors":"Apurupa Nedunuri","doi":"10.35248/2329-6887.21.9.303","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.303","url":null,"abstract":"Uveitis is a moving illness to treat. Corticosteroids have been utilized in the treatment of uveitis for a long time. Immunosuppressives are acquiring force lately in the treatment of uveitis. In this article we present an outline of current treatment of uveitis and the significant discoveries and advances in medications and visual medication conveyance frameworks in the treatment of uveitis.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"76 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73113311","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":"Study Designs in Medicine","authors":"Naresh Marlapudi","doi":"10.35248/2329-6887.21.9.318","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.318","url":null,"abstract":"Observational studies can be defined as non-interventional and non-experimental. They do not contain any experiment or intervention methods. Investigated factors aren’t controlled, repetitions of events aren’t generally possible and randomisation facilities are limited in these studies. However, their results are largely consistent with real life. They can be classified as descriptive or analytical [1].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"2005 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90386438","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 Beginning of Pharmacovigilance in Bosnia and Herzegovina","authors":"Kondza Martin, Tubic, Biljana, Muhovic, Dinka","doi":"10.35248/2329-6887.20.8.286","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.286","url":null,"abstract":"Aims: The aims of this article are to present the impact of the pharmacovigilance performance improvement in Bosnia and Herzegovina on the reporting results gathered at the national pharmacovigilance database. Subjects and methods: Bosnia and Herzegovina is a country in Europe with a complicated political structure, the highest rate of unemployment and a low Gross Domestic Product. Although the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina was established in 2009, with the Main Office for Pharmacovigilance as the national pharmacovigilance center, there were no activities and work in the field of pharmacovigilance. In 2017 several changes were made in the work of the Main Office such as: employment of an external expert for the work of pharmacovigilance, holding lectures and workshops, collecting and analyzing adverse drug reactions, signing various co-operations with professional chambers and health institutions forwarding reports to the World Health Organization and writing annual reports. Results: These changes showed an increase in the collected adverse drug reactions by 130% and 28% on an annual level for 2017 and 2018, respectively. Bosnia and Herzegovina became a full member of the Uppsala Monitoring Center, a global office for drug monitoring by the World Health Organization. Conclusion: Bosnia and Herzegovina can be used as an example for developing a sustainable pharmacovigilance system in countries with low economical standards.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"30 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87931459","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}
P. Dar, Nahida Rashid, S. A. Rather, Farooq A Dar, Shabir A Parray d, I. Hussain, S. F. Iqbal
{"title":"Proactive Pharmacovigilance of Unani drugs; Prospects and Challenges","authors":"P. Dar, Nahida Rashid, S. A. Rather, Farooq A Dar, Shabir A Parray d, I. Hussain, S. F. Iqbal","doi":"10.35248/2329-6887.20.8.285","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.285","url":null,"abstract":"Ethnopharmacological relevance: Traditionally herbal (Unani) medicines are considered to be safe for therapeutic usage without any major harmful effects. However, besides beneficial therapeutic effects several suspected adverse effects have been reported in the literature as well asclinical practice that inter alia include hepatotoxicity, renal failure and allergic reactions. Since the safety of patients remains central to any kind of therapy, it becomes imperative for the relevant regulatory authorities to take appropriate measures required to safeguard the public health by ensuring that all herbal medicines are safe, effective and of standard quality. Therefore, the role of pharmacovigilance in Unani medicine is essential to determine which adverse effects cross the line of a drug�??s efficacy and safe therapeutic use. For safe and effective use of Unani drugs, constant vigil and monitoring is required for each medicine throughout its life cycle. This review aims to provide a systematic summary on the importance, gaps, challenges and prospects of pharmacovigilance in the Unani system of medicine. Materials and methods: Relevant literature regarding pharmacovigilance of traditional system of medicine including Unani drugs was retrieved from databases like Web of Science, Google Scholar, Baidu Scholar, Springer, PubMed, SciFinder and ScienceDirect. Information was also collected from classic books of Unani medicine and conference papers on pharmacovigilance of herbal drugs. Results: In order to achieve operational competence in the development of pharmacovigilance for Unani drugs and for the best practice model for Unani medicine, a systematic analysis of the areas to be focussed upon and the challenges ahead, starting from proper nomenclature of Unani drugs, cultivation, procurement, drying, transportation, processing, labelling and dispensing was undertaken. All the crucial areas were identified and an understanding for the recognition and management of adverse reactions due to Unani drugs was developed. Conclusions: Pharmacovigilance is a process of identification, documentation and monitoring of adverse drug reaction of selected medicine and reporting to the regulatory body, so that appropriate decisions can be made for the protection of public health. Herbal (Unani) medicines are generally considered as safe medicine, however several case reports of adverse drug reactions have been reported, so they need consistent monitoring for adverse effects. In this regard, this review will provide an insight for the need of the pharmacovigilance and regulation of Unani drugs including their procurement, processing, manufacturing, dispensing and formulation of a comprehensive policy for effective pharmacovigilance of these drugs.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"64 2 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77423837","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":"Medication Errors during Pregnancy","authors":"V. Vardhan","doi":"10.35248/2329-6887.20.8.293","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.293","url":null,"abstract":"The concern almost medicine utilize during pregnancy was prompted by verifiable occasions such as the thalidomide tragedy which had come about in birth defects and fetal passing’s in thousands of babies. Medicines utilized during this period may cross the placenta and reach the foetus, depending on their lipophilicity, molecular estimate, concentration and metabolic pathway.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"172 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86221379","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 and Attitude about Pharmacovigilance: A Cross-sectionalStudy Involving Pharmacy Students of Selected Universities inBangladesh","authors":"S. Neelotpol, Marzia Alam, S. Mimmi, Hamza Albee","doi":"10.35248/2329-6887.20.8.289","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.289","url":null,"abstract":"Purpose: Now-a-days, the role of Pharmacists has become more patient-centric that includes drug safety by preventing, identifying, documenting, and reporting of adverse drug reactions (ADRs). The objective of this study was to evaluate the knowledge of pharmacy undergraduate and graduate students of Bangladesh towards pharmacovigilance (PV) and their attitude on reporting of ADRs. Methods: A cross-sectional study was conducted by distributing a pretested questionnaire. The randomly selected participants of undergraduate and graduate pharmacy students from both public and private universities of Dhaka city, Bangladesh took part in the study. The data were analyzed by using Statistical Package for Social Science (SPSS) for calculating descriptive statistics; the Pearson's Chi-square (χ2) test was performed to observe any significant difference between the public and private university students’ response. Results: Among the participants (n=504), 36% and 52% students gave the correct definition of PV and ADRs, respectively. Among the correct answer givers, most of the students were from public universities (p=0.01). The results to assess the attitude of the students suggested that about three quarters of participants thought that reporting of ADRs is a professional obligation. However, surprisingly 65% students believed they were not well prepared to report any ADRs with their present knowledge. Conclusion: From the study we concluded that the pharmacy students had a positive attitude towards PV, however, their knowledge was inadequate for PV implementation in professional life. Thus to improve the overall ADR reporting in Bangladesh it is imperative for the future graduates to be well equipped with PV knowledge.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"4 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78749136","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}
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