Journal of Pharmacovigilance and Drug Research最新文献

{"title":"Prescription audit a tool to determine the effects of antibiotics in the pediatric inpatient department of a tertiary teaching care hospital in Punjab","authors":"Monika Kapoor, Jagminder Kaur Bajaj, Shalini Salwan","doi":"10.53411/jpadr.2021.2.1.5","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.5","url":null,"abstract":"Introduction: Health care professionals dealing with pediatric patients face a lot of challenges and pass through hurdles during their daily practice of medicines owing to the scarcity of suitable drugs and other facilities. A fundamental part of the antibiotic prescription is inappropriate due to errors in the selection of appropriate antibiotics, dose, duration, route of administration, and frequency for treatment. Medication use evaluation and audits are an integral part of evaluating whether the drugs are being utilized appropriately considering the social, economic, and medical points. \u0000Objectives: The main objective of this study was to do an antibiotic audit to analyze the prescribing pattern in the in-patient department of pediatrics of the hospital. \u0000Methods: A prospective observational study was conducted in the inpatient pediatrics department of Punjab Institute of Medical Science and Hospital, Jalandhar. The study was conducted on a total of 150 hospitalized children and infants for a period of two months from February 1, 2020, to March 30, 2020. \u0000Results: The analysis of 150 prescriptions was done using IBM SPSS software version 24 and statistical analysis was done. Antibiotic usage was expressed in percentile and the duration of treatment was expressed. Aminoglycosides (Amikacin) were the top most used class of antibiotics followed by cephalosporin. Among cephalosporins, the third generation ceftriaxone, and cefoperazone were found to be mostly used. \u0000Conclusions: Accordingly, health care professionals must keep a clear understanding of the need for microbiological diagnosis, antibiotics usage, and make good judgment in clinical situations. Regular antibiotic audits and staff education must be implemented.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"16 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":"129149374","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 rare case of accelerated gingival overgrowth with high dose amlodipine therapy","authors":"Rakesh B M, Sahithi Sharma, Chandana K H","doi":"10.53411/jpadr.2021.2.1.8","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.8","url":null,"abstract":"Introduction: Gingival overgrowth represents an over-exuberant response to a variety of local and systemic conditions. Certain anticonvulsants, immunosuppressive drugs, and a number of calcium channel blockers have been shown to produce similar gingival overgrowth in susceptible patients. \u0000Case report: We report a case of accelerated drug-induced gingival overgrowth in a 60-year-old hypertensive patient taking amlodipine at a dose of 10 mg. \u0000Conclusions: Among the calcium channel blockers, nifedipine is most frequently associated with gingival overgrowth.  Whereas, there is limited evidence of amlodipine-induced gingival hyperplasia.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"32 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":"123444480","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 two-year retrospective observational study of adverse drug reactions related to intravenous drug formulations","authors":"Ramani Gade, Neeraj Sadiq, Shivaraj B Patil, Venkata Rao Y, Raghuveer B, Yamini V, Sindhu P","doi":"10.53411/jpadr.2021.2.1.4","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.4","url":null,"abstract":"Introduction: Adverse drug reactions are the major obstacles to patient safety and drug therapy monitoring. \u0000Objectives: The present article provides information on intravenous products induced adverse drug reactions collected by spontaneous reporting method through an established pharmacovigilance wing working under NCC-PVPI in an Adverse Drug reaction monitoring center-Nalgonda, Telangana. \u0000Methods: A total number of 100 intravenous products induced ADRs were collected from different age groups by observational retrospective study for the year January 2018 to December 2019. \u0000Results: The results showed that the most affected age group was 20-29 yrs (28 %). The major contribution of the gender that exposed to ADRs was female- 73 % Most intravenous product induced ADRs were reported from the Department of OBG (46 %). Drug: Ceftriaxone-induced ADRs were (38 %). The most frequently reported ADR was fever and chills (56 %). Out of 100 ADRs, one was certain, 90 were probable/likely, and the remaining 9 were possible as per the WHO-causality scale. \u0000Conclusions: In the present work, most of the ADRs were because of intravenous antibiotics followed by anesthetic agents, antiepileptic drugs, ringer lactate, dextrose normal saline, and H2 blockers.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"314 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":"116284955","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":"Ecopharmacovigilance: Perspectives, concepts, applications, and relationships in modern context","authors":"Prachi Khamkar, Debarshi Kar Mahapatra, Atul Kadam","doi":"10.53411/jpadr.2021.2.1.2","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.2","url":null,"abstract":"Introduction: Environmental scientists have made great strides to regulate pharmaceutical waste. However, the monitoring of emerging environmental problems induced by drugs should attract the further interest of pharmacy and pharmacovigilance scientists. Ecopharmacovigilance (EPV) as a kind of pharmacovigilance for the atmosphere is widely recognized as essential to minimize the environmental impact of pharmaceutical toxins. \u0000Methods: In efforts to answer the environmental issues created by medications, the constructive involvement of the pharmaceutical sector is essential. On a prioritized basis, EPV can target individual pharmaceuticals. For EPV deployment targeting pharmaceutical contamination, certain advice and management practice solutions are recommended. On administration certain drugs are metabolized throughout the bloodstream, being inert or becoming converted to metabolites, whereas others are excreted in the urine or liver and excreted in the sewage. The substances that are released into drainage can be processed into a number of chemicals by a sewage treatment process. \u0000Results: The involvement of different drugs and their components have been found in the marine world, with the aquatic environment being the most researched to date. Nanostructure materials have been around for a long time, and their interactions with biological processes have been discussed in various applications to enhance the understanding and importance of environmental and health effects. \u0000Conclusions: In order to regulate pharmaceutical residues in effluents, Technologies for sewage water management should be applied.  In particular, the presence of pharmacy including pharmacovigilance professionals is also important for enhancing multidisciplinary collaboration.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"18 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":"131756732","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 study on prospective monitoring of adverse drug reactions associated with hematinics at a tertiary care teaching hospital","authors":"P. Vinay, P. Venkata Ramana, B. Jaya Kiran, K. Meghana, N. Vineetha","doi":"10.53411/jpadr.2021.2.1.3","DOIUrl":"https://doi.org/10.53411/jpadr.2021.2.1.3","url":null,"abstract":"Introduction: Adverse reactions are the documented hazards of drug treatment and they can happen with any class of drugs and several studies exposed that the incidence is increasing with blood and blood products. \u0000Objectives: The main aim of this study is to identify and analyze Adverse Drug Reactions with Hematinics in a tertiary care hospital. \u0000Methods: This prospective observational study was conducted for a period of 6 months. \u0000Results: A total of 29 ADRs were reported during the study period with a female high proportion (79.31%), more amounts of ADRs were from Obstetrics & Gynecology and General Medicine in which the mainly affected organ systems were the skin (86.20%) and the GIT (13.79%). The hematinics mostly accounted were Iron sucrose (44.82%) followed by ferric carboxy maltose (37.93%) and Iron dextran (17.24%) in which type B reactions were more compared to type A and 72.41% of them were unpredictable. The severity assessment revealed that the majority of them were moderate reactions (62.06%). Out of the reported reactions, 58.62% were definitely preventable and a causality assessment was done which showed that 68.96% of the reactions were probable, possible (20.68%) and conditional (10.34%). Most of the patients (65.51%) were treated with Antihistamines & corticosteroids, with only anti-histamines (24.13%) and no treatment (10.34%). \u0000Conclusions: The study concludes that Adverse Drug Reactions with Hematinics are increasing in recent days. Better vigilance is necessary for the implementation of safe and effective treatment with hematinics for each and individual patient.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"8 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":"124657143","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 review on potential drug delivery system as a treatment of intercellular bacterial infection","authors":"M. Manna, A. Shil","doi":"10.53411/jpadr.2020.1.2.3","DOIUrl":"https://doi.org/10.53411/jpadr.2020.1.2.3","url":null,"abstract":"Introduction: Intracellular bacterial pathogens are hard to treat because of the inability of conventional antimicrobial agents belonging to widely used classes, like aminoglycosides and β-lactams, fluoroquinolones, or macrolides to penetrate, accumulate, or be retained in the mammalian cells. The increasing problem of antibiotic resistance complicates more the treatment of the diseases caused by these agents. \u0000Objectives: The purpose of this chapter is to present the limitations of each class of antibiotics in targeting intracellular pathogens and the main research directions for the development of drug delivery systems for the intracellular release of antibiotics. \u0000Methods: Different improved drug carriers have been developed for treating intracellular pathogens, including antibiotics loaded into liposomes, microspheres, polymeric carriers, and nanoplexes. \u0000Results: In many cases, the increase in therapeutic doses and treatment duration is accompanied by the occurrence of severe side effects. Taking into account the huge financial investment associated with bringing a new antibiotic to the market and the limited lifetime of antibiotics, the design of drug delivery systems to enable the targeting of antibiotics inside the cells, to improve their activity in different intracellular niches at different pH and oxygen concentrations, and to achieve a reduced dosage and frequency of administration could represent a prudent choice. An ideal drug delivery system should possess several properties, such as antimicrobial activity, biodegradability, and biocompatibility, making it suitable for use in biomedical and pharmaceutical formulations. Conclusions: This approach allow reviving old antibiotics rendered useless by resistance or toxicity, rescuing the last line therapy antibiotics by increasing the therapeutic index, widening the antimicrobial spectrum of antibiotics scaffolds that failed due to membrane permeability problems, and thus reducing the gap between increasingly drug-resistant pathogens and the development of new antibiotics.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"101 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114274097","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":"Overview of important methods used for causality assessment of adverse drug events in pharmacovigilance","authors":"Pushpraj Prafulla Gawai ","doi":"10.53411/jpadr.2020.1.2.2","DOIUrl":"https://doi.org/10.53411/jpadr.2020.1.2.2","url":null,"abstract":"Introduction: The method of assessing causality between adverse events and suspect drugs is the most challenging task in pharmacovigilance. It requires attentive consideration of both the adverse events and suspect drugs, patient-related factors, and co-suspect drugs and other medical conditions of the patient. \u0000Objectives: This review aimed to look for different methods available or reported for causality assessment and give a brief comparison between the methods. \u0000Methods: Many pieces of literature were reviewed to present a summary of commonly used important methods for causality assessment. \u0000Results: Though different methods were developed to assess causality, no single method has been proved to produce an accurate or authentic ascertainable evaluation of the causal relationship. \u0000Conclusions: Hence, causality assessment has become an important step in evaluating drug safety. Due to a lack of uniformity, reliability, and rationality, no single method can be accepted as a standard one across the world.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129954959","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":"Materiovigilance: Current status in India analogous to its global status","authors":"N. Pandey, M. Imran","doi":"10.53411/jpadr.2020.1.2.4","DOIUrl":"https://doi.org/10.53411/jpadr.2020.1.2.4","url":null,"abstract":"Introduction: Medical devices are boon to the healthcare system and are available in the market since long ago. More than 500,000 different types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and safety of these medical devices is essential. \u0000Objectives: This review article discusses the classification and regulation of medical devices in India and the world with framework of adverse event reporting system for medical devices in India. \u0000Methods: To address the aforesaid issue International Medical Device Regulators Forum (IMDF) was established in 2011 was established at international Level. In India, 4 years later in 2015, Materiovoigilance Program of india (MvPI) was introduced with the prime aim of improving the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood of reoccurrence of an adverse event associated with the use of medical devices. \u0000Results: At present, there are 50 Medical Device Adverse Event Monitoring Centres (MDMCs) in India. Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices eg: USFDA in USA, TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc. \u0000Conclusions: In India, the provisions of regulation of safety, quality and performance of medical devices are laid down in the Drugs and Cosmetics Act, 1940 and rules 1945.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122979129","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":"Nevirapine induced Stevens Johnson syndrome","authors":"H. Prajapati, Neetu Bala, D. Kansal","doi":"10.53411/jpadr.2020.1.2.6","DOIUrl":"https://doi.org/10.53411/jpadr.2020.1.2.6","url":null,"abstract":"Introduction: Severe and life-threatening SJS is more common with nevirapine than with other NNRTIs \u0000Case presentation: A 56-year-old male patient presented with a complaint of lesions all over the body with a burning sensation for 4 days. He was on an ART regimen, containing zidovudine, lamivudine, and efavirenz combination for 4 years. But patient accidentally started nevirapine and after 10 days he developed maculopapular lesions which were diagnosed as SJS syndrome. There was a history of rash with nevirapine when ART was started initially in 2012. This incident of an adverse event could be assigned a term \"probable\" according to the WHO-UMC scale for causality assessment as the re-challenge was found positive. \u0000Conclusion: Physicians and patients must be aware of this adverse effect on early diagnosis and treatment.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"148 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121250214","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":"Metformin related adverse events: A prospective observational study in health care centers of western Odisha","authors":"S. Kar, S. Khuntia, S. Nayak","doi":"10.53411/jpadr.2020.1.2.5","DOIUrl":"https://doi.org/10.53411/jpadr.2020.1.2.5","url":null,"abstract":"Introduction: The most common adverse drug reactions were lactic acidosis followed by hypoglycemia, hypersensitivity reactions, nausea, decreased appetite, vomiting, weakness, and diarrhea. \u0000Objectives: The study was done to explore the management of the patients having diabetes by primary care physicians, and the adverse reactions associated with the dose regimens. This study provided information regarding the adverse drug reactions that could be developed in any patient and increases the risk to the patient. \u0000Methods: A qualitative In-Depth Interview study was conducted among the primary care physicians at ten primary health care centers at Sambalpur city of Odisha, India. The data were analyzed using content analysis. This was a prospective observational study (March 2019 - September 2019) among diabetes patients receiving metformin. Data were collected and analyzed to find out the demographic characteristics, causality, and severity of adverse events with metformin regimens. \u0000Results: It was seen that 8 % of cases could be assessed as certain and 24 % could be assessed as probable. Most (60 %) cases were assessed as possible. Severity assessment of ADRs by modified Hart wig and Siegel's severity Scale (n=143) indicates 64% of the case were mild and 34% of cases are moderately severe. \u0000Conclusions: Hence with an aim of patient safety quality of the drug formulations has to be improved that could ultimately improve drug safety.","PeriodicalId":388338,"journal":{"name":"Journal of Pharmacovigilance and Drug Research","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122265835","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}