Comparative Study of Medical Device Vigilance in Canada, USA, Australia

2019 ◽  
Vol 10 (03) ◽  
Author(s):  
S Sridhar ◽  
V Balamuralidhara ◽  
V Balamuralidara
Keyword(s):  
Health Professional ◽  
Information Sharing ◽  
Medical Device ◽  
Adverse Reactions ◽  
Surveillance Systems ◽  
Safety Issues ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Set Up

The medical device vigilance system was set up to minimize risks to the safety of patients, users and others by detecting the possible adverse reactions in patients, the medical device safety issues are identified and reported manufacture or health professional through identification and reporting of issues by members of the public or through information sharing with other competent authorities. Medical device reporting is important from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action, Manufacturers are obliged to maintain robust medical device vigilance and post-marketing surveillance systems for the maintenance of the marketing authorization in the country were the product is marketed.

Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance

2015 ◽  
Vol 14 (9) ◽  
pp. 1341-1351 ◽  
Author(s):  
Maurizio Sessa ◽  
Claudia Rossi ◽  
Annamaria Mascolo ◽  
Enrico Grassi ◽  
Sonia Fiorentino ◽  
...  
Keyword(s):  
Contrast Media ◽  
Adverse Reactions ◽  
Campania Region ◽  
Post Marketing Surveillance ◽  
Suspected Adverse Reactions ◽  
Post Marketing

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

scholarly journals Vaccines and Allergic reactions: the past, the current COVID-19 pandemic, and future perspectives

2021 ◽  
Author(s):  
Vanitha Sampath ◽  
Grace Rabinowitz ◽  
Mihir Shah ◽  
Surabhi Jain ◽  
Zuzana Diamant ◽  
...  
Keyword(s):  
Disease Burden ◽  
Adverse Reactions ◽  
Future Research ◽  
Allergic Reactions ◽  
The Past ◽  
Post Marketing Surveillance ◽  
Different Types ◽  
Post Marketing ◽  
Underlying Mechanisms ◽  
Favorable Safety

Vaccines are essential public health tools with a favorable safety profile and prophylactic effectiveness that have historically played significant roles in reducing infectious disease burden in populations, when the majority of individuals are vaccinated. The COVID-19 vaccines are expected to have similar positive impacts on health across the globe. While serious allergic reactions to vaccines are rare, their underlying mechanisms and implications for clinical management should be considered to provide individuals with the safest care possible. In this review, we provide an overview of different types of allergic adverse reactions that can potentially occur after vaccination and individual vaccine components capable of causing the allergic adverse reactions. We present the incidence of allergic adverse reactions during clinical studies and through post-authorization and post-marketing surveillance and provide plausible causes of these reactions based on potential allergenic components present in several common vaccines. Additionally, we review implications for individual diagnosis and management and vaccine manufacturing overall. Finally, we suggest areas for future research.

scholarly journals Adult GH deficiency throughout lifetime

2009 ◽  
Vol 161 (suppl_1) ◽  
pp. S97-S106 ◽  
Author(s):  
Julia D J Thomas ◽  
John P Monson
Keyword(s):  
Gh Deficiency ◽  
Safety Data ◽  
Well Being ◽  
Term Treatment ◽  
Post Marketing Surveillance ◽  
Long Term Treatment ◽  
Post Marketing ◽  
Added Benefit ◽  
Set Up ◽  
The Individual

It is now accepted that adults with severe GH deficiency (GHD) demonstrate impaired physical and psychological well-being and may benefit from replacement with recombinant human GH. Post-marketing surveillance surveys, such as the Pfizer International Metabolic Database (KIMS), were initially set-up to provide safety data on long-term treatment but have the added benefit of providing ongoing observational data on the effect of GH replacement on body composition, lipid and glucose status, hypertension, bone density and quality of life. These data demonstrate that although GHD has clinical impact at all ages, the individual consequences of this condition may take on greater significance at different stages in life. At all ages, accurate, safe diagnosis and appropriate GH dosing are necessary to provide the individual with the best possible outcome.

scholarly journals Global Perspective of Paediatric Pharmacovigilance and its Importance: Where Have We Reached?

2021 ◽  
pp. 276-288
Author(s):  
S. Narmada ◽  
M. P. Gowrav ◽  
Akhilesh Akki ◽  
Vishakharaju Motupalli ◽  
V. Balamuralidhara ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Providers ◽  
The United States ◽  
Reporting Rate ◽  
Global Perspective ◽  
Drug Reactions ◽  
Paediatric Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.

Adverse reactions: getting the best from the yellow card system

1980 ◽  
Vol 18 (19) ◽  
pp. 75-76
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Yellow Card ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Card System ◽  
The Many ◽  
Source Of Information

Yellow cards provide the Committees on Safety of Medicines (CSM) and Dental and Surgical Materials (CDSM) with their major source of information on the occurrence of adverse drug reactions. Of the many forms of post-marketing surveillance now in use, it is the most widely applied and probably the cheapest. Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. However, probably only 10% of serious adverse reactions are reported to the Committees.1 Why is reporting reactions important, and how can doctors help to make the system work better?

The method to detect the adverse drug events through the chronological relationship between the medication period and the presence of adverse reactions from electronic medical record systems. (Preprint)

2021 ◽  
Author(s):  
Kei Teramoto ◽  
Toshihiro Takeda ◽  
Naoki Mihara ◽  
Yoshie Shimai ◽  
Shirou Manabe ◽  
...  
Keyword(s):  
Medical Records ◽  
Adverse Reactions ◽  
Adverse Drug Events ◽  
Assessment Method ◽  
Medication History ◽  
Real World Data ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Post Marketing Surveillance ◽  
Post Marketing

BACKGROUND Taking medicine may cause a variety of adverse reactions. An enormous amount of money and effort are spent investigating adverse drug events (ADEs) in clinical trials and post-marketing surveillance. Real world data from multiple electronic medical records (EMRs) can make it easy to understand the ADEs that occur in actual patients. OBJECTIVE In this study, we generated a database of the patients’ medication history from the records of physician orders of EMR, which allowed the period of medication to be clearly identified. METHODS We developed the method to detect the ADE based on the chronological relationship between the presence of the adverse event and the medication period. To verify our method, we detected the ADE with alanine aminotransferase (ALT) elevation for aspirin, clopidogrel and ticlopidine. The accuracy of detecting ADE were examined by chart review and by the comparison with Roussel Uclaf Causality Assessment Method (RUCAM) which was known as standard method for detecting drug induced liver injury. RESULTS The calculated rates of ADE with ALT elevation for aspirin, clopidogrel and ticlopidine were 3.33%, 3.70% and 5.69%, respectively, which were in line with the rates of previous reports. We reviewed the medical records of the patients in whom ADE were detected. Our method accurately predicted ADE in 90%, 100% and 100%, of patients with ALT elevation from aspirin, clopidogrel, and ticlopidine, respectively. With the comparison of the RUCAM, only 3 patients were not detected as ADE by our method. CONCLUSIONS These findings demonstrate that the present method is effective for detecting ADE from EMR data.

scholarly journals Mécanismes d’action et toxicités potentielles des anticorps monoclonaux

2019 ◽  
Vol 35 (12) ◽  
pp. 1114-1120
Author(s):  
Theodora Bejan-Angoulvant ◽  
Joachim Alexandre
Keyword(s):  
Monoclonal Antibodies ◽  
Immune System ◽  
Mechanism Of Action ◽  
Adverse Reactions ◽  
Specific Binding ◽  
Target Antigen ◽  
Post Marketing Surveillance ◽  
Anticorps Monoclonaux ◽  
Post Marketing ◽  
Infusion Reactions

Monoclonal antibodies are therapeutic monoclonal Ig that act by highly specific binding to their target antigen and by interacting with the immune system. Their side effects are mainly related to their mechanism of action. The most frequent adverse effects are infusion reactions. Post-marketing surveillance is essential for identifying adverse reactions and improving knowledge of their mechanism of action.

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