Journal of Pharmacovigilance and Drug Research最新文献_第7页

An overview of the worldwide master key for pharmacovigilance and its role in India 概述全球药物警戒总钥匙及其在印度的作用

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.5

Janmejay Pant, Harneet Marwah, Ripudaman Singh, Subhajit Hazra

{"title":"An overview of the worldwide master key for pharmacovigilance and its role in India","authors":"Janmejay Pant, Harneet Marwah, Ripudaman Singh, Subhajit Hazra","doi":"10.53411/jpadr.2021.2.2.5","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.2.5","url":null,"abstract":"Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. \u0000Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. \u0000Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. \u0000Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"197 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133343699","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}

引用次数: 0

Story of the biggest vaccination drive in the world so far 这是迄今为止世界上最大的疫苗接种运动

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.1

Maya Sharma

引用次数: 2

Pharmacovigilance study in geriatric patients of a tertiary care hospital 某三级医院老年患者药物警戒研究

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.7

Rajalakshmi Rukmangathen, Vasundara Devi Brahmanapalli

{"title":"Pharmacovigilance study in geriatric patients of a tertiary care hospital","authors":"Rajalakshmi Rukmangathen, Vasundara Devi Brahmanapalli","doi":"10.53411/jpadr.2021.2.2.7","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.2.7","url":null,"abstract":"Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital. \u0000Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. \u0000Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). \u0000Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116422785","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}

引用次数: 0

Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment 印度非专利制药业的药物警戒——当下的需要

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.3

P. Rajpurohit, M. Suva, Hardik Rajpurohit, Yogesh Singh

{"title":"Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment","authors":"P. Rajpurohit, M. Suva, Hardik Rajpurohit, Yogesh Singh","doi":"10.53411/jpadr.2021.2.2.3","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.2.3","url":null,"abstract":"Introduction: The pharmacovigilance department is liable for monitoring the safety of medicines during clinical trials and normal clinical use. The necessity of the pharmacovigilance department is an utmost requirement for effective regulations of the drug approval process and conscious pre and post-approval vigilance of the undesired effects, especially in India. \u0000Methods: In the light of the regulatory notification GSR 287(E) dated on 8th march 2016 by CDCSO, it has become clear that it is necessary to take measures to set up and improve the operation of the pharmacovigilance of medicinal products for human use in pharmaceutical companies. \u0000Results: The regulators have also developed and posted Guidance document for marketing authorization holders (MAH) for Indian marketers and made clear that the MAH should be responsible for continuously monitoring the safety of its medicinal products for human use, for updating the health authorities of any changes related to the drug, and for ensuring that the product information is kept up-to-date. MAH should record all suspected adverse reactions occurring in the country, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of the post-authorization study. \u0000Conclusions: According to the Regulatory Guidance document, MAH is also responsible for the submission of the information on suspected adverse reactions of a newly approved drug or applicable product, in form of periodic safety update reports (PSURs), to the competent authorities.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"262 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121815154","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}

引用次数: 0

Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders 精神障碍患者精神药理学药物不良反应的评价

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.6

Ranita Kumari, Rachna Gupta, M. Bhatia, S. Gupta

{"title":"Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders","authors":"Ranita Kumari, Rachna Gupta, M. Bhatia, S. Gupta","doi":"10.53411/jpadr.2021.2.2.6","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.2.6","url":null,"abstract":"Introduction: Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity. \u0000Objectives: The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders. \u0000Methods: This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital, between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed. \u0000Results: Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable. \u0000Conclusions: Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125340043","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}

引用次数: 0

Stimulated adverse drug reaction reporting in pharmacovigilance: Indian perspectives 药物警戒中刺激药物不良反应报告:印度观点

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.4

Anusha Thota, S. Sarkar, Snehil Guptha, Prasad Thota

引用次数: 0

Global Pharmacovigilance, challenges, and future considerations: West globe and East globe 全球药物警戒，挑战和未来的考虑:西方世界和东方世界

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-06-01 DOI: 10.53411/jpadr.2021.2.2.2

Jyoti Sushma Gadhade, R. Hiray

{"title":"Global Pharmacovigilance, challenges, and future considerations: West globe and East globe","authors":"Jyoti Sushma Gadhade, R. Hiray","doi":"10.53411/jpadr.2021.2.2.2","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.2.2","url":null,"abstract":"Introduction: Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly evolving multifaceted field. In the process of carrying out its effective management, the PV system does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe (United States, United Kingdom, Germany) while the east globe (e.g.: India) is still in the evolving stage. \u0000Methods: Major discrepancies include different regulatory authorities for each nation with different forms for ADR reporting and also different timelines. \u0000Results: To mention a few; there is a regulatory gap because of the continuously evolving regulations and business processes, it is difficult to comply with the diverse regulations effectively; gross underreporting in the east as compared to the west; increased concern about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication; linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting; inclusion of PV in the curriculum etc. can be employed. \u0000Conclusions: While PV has witnessed substantial development over the years, areas of discrepancies need to be identified to build a seamless PV system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its harmonious functioning.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128870524","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}

引用次数: 0

Present era of drug safety in India: An overview 当前印度药品安全的时代:概述

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-03-01 DOI: 10.53411/jpadr.2021.2.1.1

Royal Patel, Anupam Kumar Sachan, Sanjana Chaohan, Aarti Tiwari, Taruna Giri, Nitish, Abdul Samad Ansari, Rajeshwar Kumar Yadav, Ehraz Mehmood Siddiqui, Shivam Kumar Pandey, Bindu Singh Yadav, Nandini Chaudhary

{"title":"Present era of drug safety in India: An overview","authors":"Royal Patel, Anupam Kumar Sachan, Sanjana Chaohan, Aarti Tiwari, Taruna Giri, Nitish, Abdul Samad Ansari, Rajeshwar Kumar Yadav, Ehraz Mehmood Siddiqui, Shivam Kumar Pandey, Bindu Singh Yadav, Nandini Chaudhary","doi":"10.53411/jpadr.2021.2.1.1","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.1","url":null,"abstract":"Introduction: Common Adverse Drug Reactions (ADR), evaluated by drug clinical trial studies, whereas an individual or specific population might suffer reactions after prolonged dormancy. Pharmacovigilance (PV) is a scientific investigation dealing with and keeping regular vigil on the drugs being used. \u0000Methods: The Indian Pharmacopoeia Commission (IPC) and other regulatory authorities like a National Coordination Committee (NCC) via the Central Drug Standard Control Organization (CDSCO) manage PV activity in synchronicity. Indian Pharmacovigilance (PV) system requires carving, therefore the Pharmacovigilance Program of India (PvPI) was enforced by the government in the year 2010, relying on exact ADR detection, evaluation, and reporting. \u0000Results: Thus, several regional, zonal and peripheral centers are developed for ADR reporting. Clinicians, Nurses, laypersons, pharmacists, and other healthcare professionals can fill ADR reporting forms online or offline at the nearest centers in suitable languages. Additionally, a toll-free number and mobile app could be used for reporting ADR. Every reported ADR gets collected and processed at the centers through Vigi-flow software, which detects and assesses the signal strength reported at CDSCO and World Health Organisation (WHO) for the required regulatory action. \u0000Conclusions: The final decision of CDSCO-WHO is passed by a suitable media source for the advancement of society's health.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"156 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123780215","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}

引用次数: 0

Ofloxacin/ tinidazole induced fixed drug eruption- a case report 氧氟沙星/替硝唑致固定药疹1例

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-03-01 DOI: 10.53411/jpadr.2021.2.1.7

Monika Kapoor

引用次数: 2

Cefpodoxime Proxetil associated bloody diarrhoea, itching and red rashes in child: A case report 头孢多肟伴发儿童带血腹泻、瘙痒和红疹1例报告

Journal of Pharmacovigilance and Drug Research Pub Date : 2021-03-01 DOI: 10.53411/jpadr.2021.2.1.6

Pushpraj Prafulla Gawai

引用次数: 0