Journal of Pharmacovigilance and Drug Research

Counterfeiting Medical Devices: A Global Threat

Manvi Aggarwal — 2023-09-01

The safety of patients is constantly and seriously threatened by counterfeit medical devices. Counterfeit medical supplies violates patients' rights, diminishes the value of the brand, and costs original equipment manufacturers revenue. The objective and purpose of medical treatment can be completely defeated by fake or inferior equipment. When a counterfeit product is used in the life sciences sector, particularly medical devices, it puts the patient at risk and has an impact on the manufacturer through potential brand damage, the expense of removing these counterfeit products from the supply chain, and additional work to prevent future problems. Therefore, it is imperative that producers of medical devices make sure their supply chain, packing, and labeling are tight and carefully traced until the point of use. Both the manufacturer and the consumer are safeguarded by anti-counterfeiting techniques. Manufacturers can include deterrents to each of components of packaging to prevent counterfeiting like hologram, UV identifying code, a 2D barcode with special numbering or serialization, or concealed text written with magnetic or security ink. To make sure the functional quality and effectiveness of these medical devices, proper adaptive and regulatory measures are needed to be in place.

Machine learning in drug safety: exploring applications and addressing challenges for improved patient safety

Riya Jose — 2023-09-01

Artificial intelligence (AI) has emerged as a powerful tool in the pharmaceutical industry, utilizing machine learning and natural language processing to access and analyze vast amounts of research and information. AI has a wide range of applications in the field of pharmacovigilance (PV) and drug safety, including the improvement of information retrieval, the identification of medical concepts, text translation, automated illness image classification, and the gathering of adverse drug response (ADR) data. This review article explores the potential of AI in drug safety and its challenges, highlighting its applications along with examples. By embracing AI advancements, the industry can enhance drug safety monitoring, improve data analysis, and contribute to better healthcare outcomes.

COVID pandemic: its impact on human health, environment, and potential strategies for sustanibility

Kamini Kashyap — 2023-08-30

Despite the advised measures, worries concerning the pathways of transmission for this pandemic disease have been raised because to the fast increase of COVID-19 symptoms and fatalities over the world. Inhaling tiny airborne droplets, in addition to the more generally documented transmission routes of larger respiratory droplets and direct contact with sick persons or contaminated surfaces, is a likely third route of infection. While there are still some questions about the proportional contributions of the various transmission channels, we believe the data is robust enough to justify developing interventions that target airborne transmission as part of a larger effort to reduce infection risk inside. Sufficient and adequate ventilation, potentially augmented by particle filtering and air disinfection, avoidance of air recirculation, and avoidance of overcrowding are all examples of appropriate building engineering controls. Such procedures are often simple to adopt and low in cost, but only if they are recognized as important in achieving infection control objectives. We believe that, in addition to effective application of other controls (such as isolation and quarantine, social distancing, and hand hygiene), the use of engineering controls in public buildings, such as hospitals, shops, offices, schools, kindergartens, libraries, restaurants, cruise ships, elevators, conference rooms, or public transportation, would be an additional important measure globally.

Assessment of educational intervention impact on improving pharmacovigilance knowledge among health care providers: A study from different hospitals in tanzania.

Eva Muro — 2023-09-01

Introduction: Under-reporting of adverse drug reactions is a major challenge in Tanzania. It is important to educate the health care providers about pharmacovigilance in order to improve the reporting rate.

Objectives: We conducted a study with the objective of evaluating the impact of an educational intervention based on the knowledge on pharmacovigilance among healthcare providers in Tanzania.

Methods: A pharmacovigilance e-blended learning method was used. Pre and post-test, courses were the basic concepts in Pharmacovigilance and the safety of Anti-Tuberculosis Drugs. Descriptive analyses were run to determine the proportions of the correct and wrong answers for pre and post training.

Results A total of 118 (72%) completed the pre-and post-test for both the first and the second courses. There was an increase in the correct answers in the post-test to every question. The median score of pre-intervention for knowledge about basic pharmacovigilance increased from 5 (range 4-7) in pre-test to 8 (range 7-9) in post-test. The median score for anti-TB drug safety issues monitoring and management increased from 4 (range 4-6) in pre-test to 7 (range 7-9) in post-test.

Conclusion: The findings of this study showed that knowledge scores and correct answers were increased following an educational intervention among HCP.

Teratogenicity: analysis of European risk management plan summaries.

Kalindi Hapani — 2023-09-01

Background: A judicious decision is significant in clinical practice when a known teratogenic medicine is prescribed for women considering her ailment or avoiding its exposure due to foetal harm. For this careful balance, European medicine agency (EMA) and marketing authorization holder provides complete pharmacological information regarding each medicinal product for clinicians to take informed decision. Proactively, EMA publishes the safety concerns included in the risk management plan (RMP) and subsequent risk minimisation measures.

Objectives: The objective of present study is to review safety information published in RMP summaries for teratogenic medicines and to explore the proactive approaches considered to improve its benefit-risk balance.

Method: All safety concerns (SC) included in the RMPs of originator centrally authorised products (CAPs), authorised between 1 August 2012 and 31 December 2022, were collected from the European Public Assessment Report. Teratogenicity SCs were categorized by Anatomical Therapeutic Classification code, year of authorisation, category of safety concern and type of risk minimisation measures. Further, Summary of Product Characteristics (SmPC) were reviewed for safety information.

Results: During the study period, 324 CAPs were found to be associated with teratogenicity SC. Antineoplastic and immunomodulating agents had teratogenicity SCs most often. Out of 324 CAPs, 221 product SCs were categorized as missing information. Twenty-nine products had additional risk minimisation measures (aRMMs) which addressed teratogenicity SC. These aRMMs consisted of educational program, controlled distribution system and pregnancy prevention program targeted towards healthcare professionals and/or patients. Further, 155 additional pharmacovigilance activities were identified in these product RMP summaries for teratogenicity risk. Content analysis of SmPC revealed that important information on the use of medicines during pregnancy is missing.

Conclusion: More than half of the RMP summaries described teratogenicity as SC for the medicines approved during the study period. Post-authorization data on teratogenic medication should be actively collected and ensured to reach the clinicians via SmPC and/or aRMMs to keep them updated and enhance evidence-based decision making.

Evaluation of anticonvulsant activity of Bixa Orellana Linn. seed

Ramdas Bhat — 2023-09-01

Introduction: Epilepsy is a neurological disorder with recurrent seizures, often inadequately controlled by existing medications. Despite the availability of antiepileptic drugs, many patients experience inadequate seizure control and adverse effects, prompting the exploration of alternative treatments. Bixa orellana Linn., known as Annatto or Achiote, has traditional use for seizures. Objective: This study explored the anticonvulsant properties of Bixa orellana Linn. seed extract using animal models.

Method: The extract was then tested in animal models, including the maximal electroshock seizure (MES) and Pentylenetetrazole (PTZ) models.

Results and Discussion: The extract exhibited significant anticonvulsant activity in both the maximal electroshock seizure (MES) and Pentylenetetrazole (PTZ) models. It delayed clonus onset, reduced the duration of the tonic extensor phase, and provided 100% protection against convulsions at medium and high doses in the MES model. In the PTZ model, it increased convulsion latency and offered high protection. Bixa orellana Linn. seeds show promise as a natural antiepileptic agent, warranting further research for mechanistic understanding and identification of bioactive compounds.

Conclusion: Developing new antiepileptic drugs from natural sources like Bixa orellana Linn. could offer alternative treatment options for epilepsy.

Teprotumumab-Associated Deafness: A Pharmacovigilance Analysis

Mohini Bindal — 2023-09-01

Introduction: Teprotumumab was approved in 2020 for the treatment of thyroid eye disease after the Food and Drug Administration (FDA) fast-tracked its review. Though the initial trial showed 10% hearing loss, the results of the Phase 3b/4 safety study will not be completed until 2025.

Objective/Methods: The objective of this analysis was to investigate whether a statistically significant signal exists between deafness and teprotumumab in the real-world phase four post-marketing safety data. Adverse event reports in FDA Adverse Event Reporting System (FAERS) and literature review were also analyzed to determine the severity of the hearing loss and whether the deafness is irreversible.

Results: Of the 53 adverse event reports containing teprotumumab as the medicinal product in FAERS, nine reports had an adverse event of deafness. Teprotumumab was listed as the suspect drug in all such adverse events reports. Disproportionality analysis showed a statistically significant signal between teprotumumab and deafness (PRR 95, chi-squared 744, ROR₀₂₅ 56 and IC₀₂₅ 2.9). Eight of the nine teprotumumab-associated deafness adverse event reports described the deafness as resulting in a serious or disabling condition. Literature review revealed 24 patient case reports of teprotumumab-induced hearing loss. 67% (4/6) of adverse events reports in FAERS and 57% (12/21) of patient case reports in literature for teprotumumab associated deafness specified that the deafness did not resolve after withdrawal of teprotumumab.

Conclusion: FDA should evaluate whether severe hearing loss should be listed under “warning and precautions” of teprotumumab.

E-BOOK ON CLINICAL TRIAL MANAGEMENT

Shiva Murthy Nanjundappa — 2023-09-01

Book Title: "E-BOOK ON CLINICAL TRIAL MANAGEMENT"

Published by Medical Pharmacologists Society,

Bangalore, Karnataka and Authors of respective arti

cles (speakers of MPS NCTS 2023 Conference)

Managing Editor: Dr Shiva Murthy N

Other editorial board members: Dr Basavanna PL, Dr Chinmaya Mahapatra, and Dr Sanjeev Gupta.

Address for communication/Office address:

Dr Shiva Murthy N, SowmyaShiva Sadana, No 57, 1st cross, 4th main,

Kothanur Dinne, JP Nagar 8th Phase, Bangalore – 560078, Karnataka, India

Phone: +91 8884328275

Email: mps.mdpharmacologists@gmail.com