Analysis of spontaneous individual case safety reports reported at adverse drug reaction monitoring centre: tertiary care teaching hospital in South India

Background: Drugs are double edged weapons, they are used in treatment of the patients but in return can harm as well. The safety of drug prescribing has become a need of the hour topic in medicine. Safety monitoring of patients via Pharmacovigilance tool has become an integral part of pharmacotherapy. This study has been undertaken to analyze the various individual case safety reports including the Special situation cases of medicational error and over dose and to promote the reporting of adverse drug reactions (ADRs) among the healthcare professionals (HCPs).Methods: A retrospective non-interventional observational study was done for indexed period of six months at AMC-PvPI under Osmania Medical College and General Hospital. The reported individual case safety reports (ICSRs) are evaluated on basis of demographics of age and gender, seriousness criteria, outcome parameters and causality assessment of suspected drug (s) and suspected ADR/AE (s) as per the ICH guidelines and WHO causality assessment scale.Results: A total of 177 ICSRs are reported out of that 137 were ADRs, 36-medication error cases and 4-cases of over dose. The incidence of ADRs in females are high compared with males was identical. The occurrence of ADRs in adult patients (61%) was significantly higher than other age groups. Of total ADRs, most of them were with analgesics (26%) and highly reported system organ classification was CNS. Overall, 79% patients were recovered from ADRs.Conclusions: The results depicted an insight to the HCPs on the importance of monitoring and reporting of ICSRs. Our study results emphasized need to roll out a pharmacovigilance practice tool to ensure the safe use of drugs for better Pharmacotherapy and development of pharmacogenomic studies

Cross sectional study on different doses of acenocoumarol with INR in a tertiary care hospital

Background: It is of high value to be assess the relationship between doses of Acenocoumarol and the INR values to offer better patient care. Since Acenocoumarol is a commonly used drug with a narrow therapeutic range it is essential to monitor the variations encountered in response to it to avoid drastic complications and to provide better health care. Aim: The aim of this study is to compare the INR values with different doses of Acenocoumarol, to compare the association of dose of Acenocoumarol with their respective INR and to find out the occurrence of bleeding with different doses of Acenocoumarol.Methods: The study was conducted in a Tertiary care hospital. 40 patients taking Acenocoumarol were recruited in the study. Relevant details like age, weight, dose of Acenocoumarol, INR and other concomitant drugs were obtained in a prospective manner. Correlation of dose of Acenocoumarol with respective INR was done by simple linear regression.Results: The relationship between dose and INR was analyzed using Simple linear regression and the scatter plot revealed no significant correlation between the dose and INR values. There is a lot of inter-individual variability in the dose response and thereafter the INR values.Conclusions: The dose of Acenocoumarol cannot predict INR values. Patient can ideally be started treatment on a low dose of Acenocoumarol and based on the INR values, dose can be titrated. There is a need for consideration of other factors which influence the dose and INR values.

BIG DATA ANALYTICS IN PHARMACOVIGILANCE - A GLOBAL TREND

Big data analysis has enhanced its demand nowadays in various sectors of health-care including pharmacovigilance. The exact definition of big data is not known to many people though it is routinely used by them. Big data refer to immense and voluminous computerized medical information which are obtained from electronic health records, administrative data, registries related to disease, drug monitoring, etc. This data are usually collected from doctors and pharmacists in a health-care facility. Analysis of big data in pharmacovigilance is useful for early raising of safety alerts, line listing them for signal detection of drugs and vaccines, and also for their validation. The present paper is intended to discuss big data analytics in pharmacovigilance focusing on global prospect and domestic country-India

A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana

Background: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.ng

Microheater: material, design, fabrication, temperature control, and applications—a role in COVID‑19

Heating plays a vital role in science, engineering, mining, and space, where heating can be achieved via electrical, induction, infrared, or microwave radiation. For fast switching and continuous applications, hotplate or Peltier elements can be employed. However, due to bulkiness, they are inefective for portable applications or operation at remote locations. Miniaturization of heaters reduces power consumption and bulkiness, enhances the thermal response, and integrates with several sensors or microfuidic chips. The microheater has a thickness of~100 nm to~100 μm and ofers a temperature range up to 1900℃ with precise control. In recent years, due to the escalating demand for fexible electronics, thin-flm microheaters have emerged as an imperative research area. This review provides an overview of recent advancements in microheater as well as analyses diferent microheater designs, materials, fabrication, and temperature control. In addition, the applications of microheaters in gas sensing, biological, and electrical and mechanical sectors are emphasized. Moreover, the maximum temperature, voltage, power consumption, response time, and heating rate of each microheater are tabulated. Finally, we addressed the specifc key considerations for designing and fabricating a microheater as well as the importance of microheater integration in COVID-19 diagnostic kits. This review thereby provides general guidelines to researchers to integrate microheater in micro-electromechanical systems (MEMS), which may pave the way for developing rapid and large-scale SARS-CoV-2 diagnostic kits in resource-constrained clinical or home-based environments

Microheater: Material, design, fabrication, temperature control, and applications—a role in COVID-19

Heating plays a vital role in science, engineering, mining, and space, where heating can be achieved via electrical, induction, infrared, or microwave radiation. For fast switching and continuous applications, hotplate or Peltier elements can be employed. However, due to bulkiness, they are ineffective for portable applications or operation at remote locations. Miniaturization of heaters reduces power consumption and bulkiness, enhances the thermal response, and integrates with several sensors or microfluidic chips. The microheater has a thickness of ~ 100 nm to ~ 100 μm and offers a temperature range up to 1900℃ with precise control. In recent years, due to the escalating demand for flexible electronics, thin-film microheaters have emerged as an imperative research area. This review provides an overview of recent advancements in microheater as well as analyses different microheater designs, materials, fabrication, and temperature control. In addition, the applications of microheaters in gas sensing, biological, and electrical and mechanical sectors are emphasized. Moreover, the maximum temperature, voltage, power consumption, response time, and heating rate of each microheater are tabulated. Finally, we addressed the specific key considerations for designing and fabricating a microheater as well as the importance of microheater integration in COVID-19 diagnostic kits. This review thereby provides general guidelines to researchers to integrate microheater in micro-electromechanical systems (MEMS), which may pave the way for developing rapid and large-scale SARS-CoV-2 diagnostic kits in resource-constrained clinical or home-based environments. Graphical abstract: [Figure not available: see fulltext.

Tilt based passive optimizations for microfluidics and lab-on-chip devices - A simulation study

Microfluidics-based biochip applications have been increased abruptly in multiple fields because of the advantages in manifolds, which include decreased test sample utilization and reagent consumption with numerous purposes and highly listed benefits. In general, microfluidics involves two different techniques, namely active and passive methods, to enable the fluid flow within the channel that is mounted on the biochip. In this study, we focus on hydrostatic pressure-driven passive pumping methodology as it does not require any external actuators or power source to assist the flow. This technique solely depends on the gravitational pull to enhance fluid flow within the channel. The ultimate aim of this study is to design a microfluidic channel in which the geometrical parameters are optimized, and the respective velocity profile is obtained. The geometrical parameters such as the angle of contact between the channel and the ground (θ), channel dimension, and reservoir dimensions which decide the performance of the microfluidic device. These optimizations in the channels are performed as a theoretical simulation study in 3D modeling software COMSOL Multiphysics 5.0 to analyze the fluid velocity, where θ is varied between 0 degrees and 70 degrees and the channel width (wc) and channel height (hc) are varied between 1 mm to 10 mm and 0.05 mm to 0.5 mm, respectively. Also, the reservoir diameter (dr) and reservoir height (hr) are varied between 6 mm and 10 mm, and 0.5 mm and 3 mm, respectively for analyzing the velocity profiles. From the obtained results, it is observed that the overall flow velocity ranges between 7.27×10-5 – 3.77870×10-2 m/s. Hence an individual can select the best optimizations of the geometrical parameters and their respective velocity for designing a microfluidic chip with specific applications upon following this article

Hepatitis C virus (HCV) diagnosis via microfluidics

Humans are subjected to various diseases; hence, proper diagnosis helps avoid further disease consequences. One such severe issue that could cause significant damage to the human liver is the hepatitis C virus (HCV). Several techniques are available to detect HCV under various categories, such as detection through antibodies, antigens, and RNA. Although immunoassays play a significant role in discovering hepatitis viruses, there is a need for point-of-care tests (POCT). Some developing strategies are required to ensure the appropriate selection of POCT for HCV detection, initiate appropriate antiviral therapy, and define associated risks, which will be critical in achieving optimal outcomes. Though molecular assays are precise, reproducible, sensitive, and specific, alternative strategies are required to enhance HCV diagnosis among the infected population. Herein, we described and assessed the potential of various microfluidic detection techniques and confirmatory approaches used in present communities. In addition, current key market players in HCV chip-based diagnosis and the future perspectives on the basis of which the diagnosis can be made easier are presented in the present revie