Pub Date : 2018-06-09DOI: 10.4172/2329-6887.1000E174
Hiep X. Nguyen, M. Vu, L. Nguyen
In the United States, influenza epidemics cost approximately $87.1 billion annually in which $10.4 billion is attributed to direct medical cost [1]. Nearly 13 million influenza cases occur every year, costing $1.4 billion to third-party payers and $11.3 billion to the society [2]. Despite the recommendation for annual influenza vaccinations, a significant number of people fail to get vaccinated due to their concerns about vaccine effectiveness, adverse reactions, inconvenience, and needle phobia [3,4]. Thus, a novel, cost-effective, minimally invasive, and patient-compliant delivery technology-microneedles (an array of micron-sized solid-coated or polymeric dissolving needles) could address some of these issues [5-7]. The Centers for Disease Control and Prevention has named this technology the potential “game changer” of global vaccination. Preclinical studies have demonstrated that the use of microneedles could lead to long-lasting, robust antibody response, and improved efficacy of various vaccines against influenza, malaria, Alzheimer’s disease, and measles [8-10]. The usability and acceptability of microneedles were also assessed to reveal that 100% of the public and 74% of the healthcare providers surveyed were positive and showed a strong support for microneedle technology [11,12]. Furthermore, if patients could self-administer vaccines using microneedles, the vaccination intent would increase from 44% to 65% [13].
{"title":"Economic Evaluation of Microneedles for Vaccinations","authors":"Hiep X. Nguyen, M. Vu, L. Nguyen","doi":"10.4172/2329-6887.1000E174","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E174","url":null,"abstract":"In the United States, influenza epidemics cost approximately $87.1 billion annually in which $10.4 billion is attributed to direct medical cost [1]. Nearly 13 million influenza cases occur every year, costing $1.4 billion to third-party payers and $11.3 billion to the society [2]. Despite the recommendation for annual influenza vaccinations, a significant number of people fail to get vaccinated due to their concerns about vaccine effectiveness, adverse reactions, inconvenience, and needle phobia [3,4]. Thus, a novel, cost-effective, minimally invasive, and patient-compliant delivery technology-microneedles (an array of micron-sized solid-coated or polymeric dissolving needles) could address some of these issues [5-7]. The Centers for Disease Control and Prevention has named this technology the potential “game changer” of global vaccination. Preclinical studies have demonstrated that the use of microneedles could lead to long-lasting, robust antibody response, and improved efficacy of various vaccines against influenza, malaria, Alzheimer’s disease, and measles [8-10]. The usability and acceptability of microneedles were also assessed to reveal that 100% of the public and 74% of the healthcare providers surveyed were positive and showed a strong support for microneedle technology [11,12]. Furthermore, if patients could self-administer vaccines using microneedles, the vaccination intent would increase from 44% to 65% [13].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"26 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75886014","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}
Pub Date : 2018-03-05DOI: 10.4172/2329-6887.1000253
Wolde T, Kuma H, Trueha K, Yabeker A
In many developing countries a large proportion of the population relies on traditional practitioner of medicinal plants in order to meet health care need. Garlic is one of the herbs that used by traditional practitioners for preparation of herbals medicine. Emergence of drug resistance is obvious and global confront. Seeking for other antibiotics which are new, natural, plant based. Garlic is classified as member of family Alliaceae. Allicin is one of the active principal of freshly crushed garlic homogenates, have variety of antimicrobial activities. This study was conducted to evaluate the anti-bacterial effect of garlic against standard isolates of S. aureus and E. coli kindly obtained from EHNRI. Four different solvents having different polarity were used to extract the bioactive compound from garlic. The Antibacterial activity of the crude extracts of garlic was evaluated against Standard isolates of S. aureus and E. coli by an agar diffusion method. The trial was done in triplicates. A Factorial Design with three factors was used. The treatment means were compared by a Student’s t- test with least significant difference (LSD) at 5% (P=0.05) and the data analysis was performed using mini tab statistical software package. In this experiment the non-polar chloroform had higher inhibition zone. The highest yield potential was obtained from water followed by ethanol, chloroform and petroleum ether respectively. E. coli were so susceptible than S. aureus to the extracts. Garlic could be used as effective antibacterial agent for human pathogenic bacteria.
{"title":"Anti-Bacterial Activity of Garlic Extract against Human Pathogenic Bacteria","authors":"Wolde T, Kuma H, Trueha K, Yabeker A","doi":"10.4172/2329-6887.1000253","DOIUrl":"https://doi.org/10.4172/2329-6887.1000253","url":null,"abstract":"In many developing countries a large proportion of the population relies on traditional practitioner of medicinal plants in order to meet health care need. Garlic is one of the herbs that used by traditional practitioners for preparation of herbals medicine. Emergence of drug resistance is obvious and global confront. Seeking for other antibiotics which are new, natural, plant based. Garlic is classified as member of family Alliaceae. Allicin is one of the active principal of freshly crushed garlic homogenates, have variety of antimicrobial activities. This study was conducted to evaluate the anti-bacterial effect of garlic against standard isolates of S. aureus and E. coli kindly obtained from EHNRI. Four different solvents having different polarity were used to extract the bioactive compound from garlic. The Antibacterial activity of the crude extracts of garlic was evaluated against Standard isolates of S. aureus and E. coli by an agar diffusion method. The trial was done in triplicates. A Factorial Design with three factors was used. The treatment means were compared by a Student’s t- test with least significant difference (LSD) at 5% (P=0.05) and the data analysis was performed using mini tab statistical software package. In this experiment the non-polar chloroform had higher inhibition zone. The highest yield potential was obtained from water followed by ethanol, chloroform and petroleum ether respectively. E. coli were so susceptible than S. aureus to the extracts. Garlic could be used as effective antibacterial agent for human pathogenic bacteria.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"383 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2018-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76640435","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}
Pub Date : 2018-01-13DOI: 10.4172/2329-6887.1000250
T. Bashir, M. Z. Zafar, Muhammad Ahsan, M. Asim, M. Abu-Huzaifa
Introduction: Rational prescribing is the prescribing of drug by physician in the right way, right drug, right dose and right time to the right person through the right route of administration. On the other hand irrational prescribing is blanket term which is a combination of no drug need, drug abuse and misuse, use of polypharmacy and use of unsafe drugs. Methodology: This was cross sectional study and was conducted at District Head Quarters of Gujranwala, Hafiz Abad, Wazirabad and Okara from July-August 2017. The case histories of 400 patients were scrutinized thoroughly on the basis of questionnaire filling related to rational and irrational guidelines and compare our results with international standards. We used a Microsoft Excel 2013 for to evaluate our results. Results: A total of 400 patients were studied. Pharmacoeconomics analysis shows that in 177 patients’ drug therapy is rational while in 223 patients’ medications prescribed were irrational. Conclusion: It is the need of the hour that the mutual relationship among the medical health care professionals is necessary like doctors, pharmacists, nurses, nutritionist, physiotherapist and other technicians to provide optimum and rational drug therapy to the patients.
{"title":"Study of Rational and Irrational Prescribing in Different Government and Private Health Care Centres of Punjab","authors":"T. Bashir, M. Z. Zafar, Muhammad Ahsan, M. Asim, M. Abu-Huzaifa","doi":"10.4172/2329-6887.1000250","DOIUrl":"https://doi.org/10.4172/2329-6887.1000250","url":null,"abstract":"Introduction: Rational prescribing is the prescribing of drug by physician in the right way, right drug, right dose and right time to the right person through the right route of administration. On the other hand irrational prescribing is blanket term which is a combination of no drug need, drug abuse and misuse, use of polypharmacy and use of unsafe drugs. \u0000Methodology: This was cross sectional study and was conducted at District Head Quarters of Gujranwala, Hafiz Abad, Wazirabad and Okara from July-August 2017. The case histories of 400 patients were scrutinized thoroughly on the basis of questionnaire filling related to rational and irrational guidelines and compare our results with international standards. We used a Microsoft Excel 2013 for to evaluate our results. \u0000Results: A total of 400 patients were studied. Pharmacoeconomics analysis shows that in 177 patients’ drug therapy is rational while in 223 patients’ medications prescribed were irrational. \u0000Conclusion: It is the need of the hour that the mutual relationship among the medical health care professionals is necessary like doctors, pharmacists, nurses, nutritionist, physiotherapist and other technicians to provide optimum and rational drug therapy to the patients.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"10 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84853578","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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000255
P. Mura, S. Fakir, S. Mura, P. Onida, G. Finco
Locally applied hemostatic agents, are used in various surgical procedures. In our case a thrombin based hemostatic matrix (FloSealTM) was used in the hepatic bed to facilitate haemostasis in a 63 year old-male undergoing video-laparoscopic cholecystectomy. Immediately after the surgery the patient developed severe anxiety, acute shortness of breath with associated hypoxia. An angiographic computerized tomography chest scan demonstrated multiple bilateral sub segmental pulmonary emboli that resolved in the following 12 h. A bilateral lower extremity duplex ultrasound showed no evidence of deep venous thrombosis.
{"title":"Non-Fatal Thrombin Based Hemostatic Matrix Pulmonary Embolism in Laparoscopic Surgery. A Case Report","authors":"P. Mura, S. Fakir, S. Mura, P. Onida, G. Finco","doi":"10.4172/2329-6887.1000255","DOIUrl":"https://doi.org/10.4172/2329-6887.1000255","url":null,"abstract":"Locally applied hemostatic agents, are used in various surgical procedures. In our case a thrombin based hemostatic matrix (FloSealTM) was used in the hepatic bed to facilitate haemostasis in a 63 year old-male undergoing video-laparoscopic cholecystectomy. Immediately after the surgery the patient developed severe anxiety, acute shortness of breath with associated hypoxia. An angiographic computerized tomography chest scan demonstrated multiple bilateral sub segmental pulmonary emboli that resolved in the following 12 h. A bilateral lower extremity duplex ultrasound showed no evidence of deep venous thrombosis.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"308 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75670335","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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000264
Anna Soltitskaya
Some important things you should know about drug products localization regulations in Russia. Brief overview of the main local regulations and factual law-enforcement practices that have an impact on your drug products localization projects. According to the Russian Government Decree, № 1289 dated by Nov. 30, 2015 “On limitations of drug products manufactured by foreign manufacturers as participants of Government Procurement” (so called rule “The third wheel”): if two applications at least for the Russian products are submitted, so any third application from some foreign manufacturer (not the Russian product) cannot be accepted. The Russian Federal Law 61 FZ “On drugs circulation” is the basic general legislation Act that regulates Drugs (DP & API) circulation (research & developing, clinical trials, manufacturing, expertise and registration, supply, sale, marketing etc.)
{"title":"Some Specific Regulatory Aspects and Nuances of Drug Products Localization in the Russian Federation","authors":"Anna Soltitskaya","doi":"10.4172/2329-6887.1000264","DOIUrl":"https://doi.org/10.4172/2329-6887.1000264","url":null,"abstract":"Some important things you should know about drug products localization regulations in Russia. Brief overview of the main local regulations and factual law-enforcement practices that have an impact on your drug products localization projects. According to the Russian Government Decree, № 1289 dated by Nov. 30, 2015 “On limitations of drug products manufactured by foreign manufacturers as participants of Government Procurement” (so called rule “The third wheel”): if two applications at least for the Russian products are submitted, so any third application from some foreign manufacturer (not the Russian product) cannot be accepted. The Russian Federal Law 61 FZ “On drugs circulation” is the basic general legislation Act that regulates Drugs (DP & API) circulation (research & developing, clinical trials, manufacturing, expertise and registration, supply, sale, marketing etc.)","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"15 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88841170","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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000261
Bernadette D’Souza, Prathap Nagaraja Shastri, Gabrielle M. Hammons, Ellie Kim, L. Kolluru, G. Carlone, G. Rajam, M. D'souza
Microparticles (MPs) offer several advantages as unique vaccine delivery system, including the ease to manufacture, targeted delivery of antigen payload, sustained antigen release and possible role as an immuneadjuvant. In this study, we evaluated albumin matrix for pneumococcal (Pnc) serotype specific capsular polysaccharide (PS) antigen MPs. Microencapsulation of Pnc PS was successful with a product yield of >72%. The MP size, 1-5 μm, and negative zeta potential (-26.5 mV) were optimized to ensure effective -uptake and presentation of Pnc PS antigens to immune cells. In mice, ST 19F and 23F MPs exhibited >10-fold increase (P<0.01) in ST specific IgG response over PS in solution given with or without alum. Relatively higher immune response was observed for ST 6B MPs when compared to PS solution; however, ST6B PS solution along with alum resulted in an overall higher response when compared to ST6B MPs. Microencapsulation may offer a simple and effective mechanism for the immune-enhancement of poorly immunogenic antigens such as Pnc PS.
{"title":"Immune-potentiation of Pneumococcal Capsular Polysaccharide Antigen using Albumin Microparticles","authors":"Bernadette D’Souza, Prathap Nagaraja Shastri, Gabrielle M. Hammons, Ellie Kim, L. Kolluru, G. Carlone, G. Rajam, M. D'souza","doi":"10.4172/2329-6887.1000261","DOIUrl":"https://doi.org/10.4172/2329-6887.1000261","url":null,"abstract":"Microparticles (MPs) offer several advantages as unique vaccine delivery system, including the ease to manufacture, targeted delivery of antigen payload, sustained antigen release and possible role as an immuneadjuvant. In this study, we evaluated albumin matrix for pneumococcal (Pnc) serotype specific capsular polysaccharide (PS) antigen MPs. Microencapsulation of Pnc PS was successful with a product yield of >72%. The MP size, 1-5 μm, and negative zeta potential (-26.5 mV) were optimized to ensure effective -uptake and presentation of Pnc PS antigens to immune cells. In mice, ST 19F and 23F MPs exhibited >10-fold increase (P<0.01) in ST specific IgG response over PS in solution given with or without alum. Relatively higher immune response was observed for ST 6B MPs when compared to PS solution; however, ST6B PS solution along with alum resulted in an overall higher response when compared to ST6B MPs. Microencapsulation may offer a simple and effective mechanism for the immune-enhancement of poorly immunogenic antigens such as Pnc PS.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"1 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75365841","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}
Toxic epidermal necrolysis (TEN) is a rare but potentially life threatening severe cutaneous adverse reaction with widespread epidermal detachment and mucosal erosions usually induced by medications. Tetracycline eye ointment is not known to cause TEN and recent literature search found no published articles that associate tetracycline (TTC) eye ointment and TEN. However, the Eritrean National Pharmacovigilance Centre has received one serious cutaneous reaction immediately following application of TTC eye ointment. The aim of this case report is therefore to describe this unusual and interesting adverse drug reaction, it’s possible explanations and treatment outcomes of the event. This is a case of 15 years old female patient admitted to hospital with a presentation of body skin desquamation, fever and malaise, eye and mouth pain with redness. Notably, this case study is designed for the peculiarity of its occurrence with a single dose instillation of tetracycline eye ointment purchased as an over the counter drug. As a result, patient developed generalized skin lesion with about 80% skin involvement. Though TEN is usually drug induced, it can also be explained with some etiological factors which can induce similar reaction such as infections as well as malignancy. Clinical and laboratory investigation report however show that the patient had no prior history of infection, history of allergy and other drugs intake. Taking into account the above facts complemented with the low disease background incidence, possible biological mechanism and the plausible time to reaction onset (4 days), this case is possibly associated with TTC eye ointment. The availability of tetracycline eye ointment without prescription in Eritrea makes this association alarming as it can amplify the occurrence of TEN. Hence, further studies are required to substantiate the association.
{"title":"Toxic Epidermal Necrolysis Associated with Tetracycline Eye Ointment: A Case Report","authors":"Selamawit Gebrehiwet, Abrahalei Kessete, Mulugeta Russom, Gelila Abrham","doi":"10.4172/2329-6887.1000251","DOIUrl":"https://doi.org/10.4172/2329-6887.1000251","url":null,"abstract":"Toxic epidermal necrolysis (TEN) is a rare but potentially life threatening severe cutaneous adverse reaction with widespread epidermal detachment and mucosal erosions usually induced by medications. Tetracycline eye ointment is not known to cause TEN and recent literature search found no published articles that associate tetracycline (TTC) eye ointment and TEN. However, the Eritrean National Pharmacovigilance Centre has received one serious cutaneous reaction immediately following application of TTC eye ointment. The aim of this case report is therefore to describe this unusual and interesting adverse drug reaction, it’s possible explanations and treatment outcomes of the event. This is a case of 15 years old female patient admitted to hospital with a presentation of body skin desquamation, fever and malaise, eye and mouth pain with redness. Notably, this case study is designed for the peculiarity of its occurrence with a single dose instillation of tetracycline eye ointment purchased as an over the counter drug. As a result, patient developed generalized skin lesion with about 80% skin involvement. Though TEN is usually drug induced, it can also be explained with some etiological factors which can induce similar reaction such as infections as well as malignancy. Clinical and laboratory investigation report however show that the patient had no prior history of infection, history of allergy and other drugs intake. Taking into account the above facts complemented with the low disease background incidence, possible biological mechanism and the plausible time to reaction onset (4 days), this case is possibly associated with TTC eye ointment. The availability of tetracycline eye ointment without prescription in Eritrea makes this association alarming as it can amplify the occurrence of TEN. Hence, further studies are required to substantiate the association.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"2 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87501054","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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000E173
Prashansa Agrawal
Artificial Intelligence (AI) has recently been developed into a sizzling topic in the area of medical care industry. The biopharmaceutical industries are making efforts to approach AI to enhance drug discovery process, reduce research and development expenses, diminish failure rates in clinical trials and ultimately generate superior medicines. The accessibility of immense statistics in life sciences and a speedy development in machine learning algorithms led to an evolution of AI-based start-up companies focused on drug discovery over the recent years [1]. Numerous remarkable AIbiopharmaceutical alliance were declared in 2016-2017 that include Pfizer and IBM Watson, Sanofi Genzyme and Recursion Pharmaceuticals, AstraZeneca, Abbvie, Merck, Novartis, GSK and Exscientia, etc.
{"title":"Artificial Intelligence in Drug Discovery and Development","authors":"Prashansa Agrawal","doi":"10.4172/2329-6887.1000E173","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E173","url":null,"abstract":"Artificial Intelligence (AI) has recently been developed into a sizzling topic in the area of medical care industry. The biopharmaceutical industries are making efforts to approach AI to enhance drug discovery process, reduce research and development expenses, diminish failure rates in clinical trials and ultimately generate superior medicines. The accessibility of immense statistics in life sciences and a speedy development in machine learning algorithms led to an evolution of AI-based start-up companies focused on drug discovery over the recent years [1]. Numerous remarkable AIbiopharmaceutical alliance were declared in 2016-2017 that include Pfizer and IBM Watson, Sanofi Genzyme and Recursion Pharmaceuticals, AstraZeneca, Abbvie, Merck, Novartis, GSK and Exscientia, etc.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"14 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87020472","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}
Pub Date : 2018-01-01DOI: 10.4172/2329-6887.1000260
Karine Balero Marante
Prevention of adverse drug reactions (ADRs) is the essence of Pharmacovigilance and its precise diagnosis is crucially a primary step, which still remains a challenge among specialists. The objective here is to investigate and offer a notion of commonly used and the developed methods of causality assessment tools for the diagnosis of ADRs and discuss their pros and cons. There are several recognized ways for assessment methods with decisive factors of causality evaluation, all the information regarding reasons allocating causality, the advantages and limitations of the appraisal methods were extracted and evaluated. Expert judgment is typically based on the decisive factor on which algorithms are based, nevertheless in imprecise manner. The probabilistic methods use the similar principle; however, connect probabilities to each measure. Such approaches are quite skeptical and liable to generate cloudy causation results. The final evaluation is quite intricate due to numerous inherent shortcomings in causality assessment tools. Thus we are still looking for developing a high quality assessment tool (very specific, but at the same time, sensitive enough) which can meticulously establish suitable diagnostic criteria for ADRs with universal acceptance to improvise the fundamental aspect of drug safety.
{"title":"The Challenges of Adverse Drug Reaction Evaluation","authors":"Karine Balero Marante","doi":"10.4172/2329-6887.1000260","DOIUrl":"https://doi.org/10.4172/2329-6887.1000260","url":null,"abstract":"Prevention of adverse drug reactions (ADRs) is the essence of Pharmacovigilance and its precise diagnosis is crucially a primary step, which still remains a challenge among specialists. The objective here is to investigate and offer a notion of commonly used and the developed methods of causality assessment tools for the diagnosis of ADRs and discuss their pros and cons. There are several recognized ways for assessment methods with decisive factors of causality evaluation, all the information regarding reasons allocating causality, the advantages and limitations of the appraisal methods were extracted and evaluated. Expert judgment is typically based on the decisive factor on which algorithms are based, nevertheless in imprecise manner. The probabilistic methods use the similar principle; however, connect probabilities to each measure. Such approaches are quite skeptical and liable to generate cloudy causation results. The final evaluation is quite intricate due to numerous inherent shortcomings in causality assessment tools. Thus we are still looking for developing a high quality assessment tool (very specific, but at the same time, sensitive enough) which can meticulously establish suitable diagnostic criteria for ADRs with universal acceptance to improvise the fundamental aspect of drug safety.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"60 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74104831","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：