Development and Application of an Active Pharmacovigilance Framework Based on Electronic Healthcare Records from Multiple Centers in Korea
ConclusionThese results are similar to those from previous studies and are conducive for new research, thereby demonstrating the feasibility of K-CDM for pharmacovigilance. However, the low quality of original EMR data, incomplete mapping, and heterogeneity between institutions reduced the validity of the analysis, thus necessitating continuous calibration among researchers, clinicians, and the government. (Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Authors ’ Reply to Juergen O Kirchner’s Comment on “Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
Comment on “Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project”
(Source: Drug Safety)
Source: Drug Safety - May 27, 2023 Category: Drugs & Pharmacology Source Type: research
The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed
(Source: Drug Safety)
Source: Drug Safety - May 25, 2023 Category: Drugs & Pharmacology Source Type: research
Expert Consensus on the Nephrotoxic Potential of 195 Medications in the Non-intensive Care Setting: A Modified Delphi Method
ConclusionsNxP index rating provides clinical consensus on perceived nephrotoxic medications in the non-intensive care setting and homogeneity for future clinical evaluations and research. (Source: Drug Safety)
Source: Drug Safety - May 24, 2023 Category: Drugs & Pharmacology Source Type: research
Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - May 23, 2023 Category: Drugs & Pharmacology Source Type: research
Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson ’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study
ConclusionsSafety data in this study indicated no extra safety concerns. Rasagiline is generally safe and well tolerated in Chinese PD patients. The safety profile and tolerability were in line with the established safety profile. Moreover, rasagiline reduced the severity of PD motor symptoms, confirming findings by previous clinical trials. (Source: Drug Safety)
Source: Drug Safety - May 17, 2023 Category: Drugs & Pharmacology Source Type: research
Correction to: Comment on: “Should Antidepressants be Avoided in Pregnancy?”
(Source: Drug Safety)
Source: Drug Safety - May 16, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India
ConclusionNearly half of the ChAdOx1-nCoV-19 vaccine recipients developed COVID-19 over one year. Vigilance is warranted for AESIs such as musculoskeletal disorders. Females, individuals with hypothyroidism, diabetes, and pre-vaccination history of COVID-19 are at higher risk of adverse events. Vaccines received after natural SARS-CoV-2 infection may increase the risk of persistence of adverse events. Sex and endocrinal differences and timing of the COVID-19 vaccine with respect to natural infection should be explored as determinants of AESIs in the future. Pathogenetic mechanisms of vaccine-related adverse events should b...
Source: Drug Safety - May 3, 2023 Category: Drugs & Pharmacology Source Type: research
