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The definition of pharmacovigilance was first proposed in the 1970s to safeguard public health and the safety of drug use, and to improve the quality of life of patients. China's traditional medicine has also always contained the idea of vigilance for the safe use of medicines in the process of development. In this article, we will discuss the origin and development of the idea of pharmacovigilance in China, the establishment of a realistic system, and the current status of pharmacovigilance construction, and look forward to the development of pharmacovigilance in the future.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12286246 | PMC |
http://dx.doi.org/10.3390/pharmacy13040090 | DOI Listing |
Vaccine
September 2025
Brighton Collaboration, The Task Force for Global Health, Atlanta, GA, United States of America.
Vaccine safety surveillance systems are vital for the post-market safety monitoring of novel and well-established vaccines, given the sample size, representativeness and follow-up time in clinical trials. The introduction of COVID-19 vaccines during the SARS-CoV-2 pandemic presented unprecedented challenges for safety surveillance. Here, we discuss methodologic considerations for epidemiologic study design and real world data for passive and active surveillance systems for COVID-19 vaccines in the United States (U.
View Article and Find Full Text PDFJ Pharm Pract
September 2025
ICPS, Pharmacovigilance & Clinical Research, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università Degli Studi di Milano, Milan, Italy.
Olmesartan, an angiotensin II receptor blocker (ARB) approved in 2002, is used to treat hypertension, either alone or with other antihypertensive drugs. It has been frequently associated with sprue-like enteropathy, while few cases of colitis have been reported. Differentiating between sprue-like enteropathy and colitis is of clinical concern, since just the first condition is a well-documented adverse event of olmesartan.
View Article and Find Full Text PDFEndocrinol Diabetes Metab Case Rep
July 2025
Department of Internal Medicine, Medical City Arlington, Arlington, Texas, USA.
Summary: Hypercalcemia is a prevalent electrolyte disturbance commonly associated with primary hyperparathyroidism, cancer, or medication adverse effects. Thiazide diuretics reduce urinary calcium excretion, increasing calcium reabsorption and hypercalcemia. Tirzepatide, a dual GIP and GLP-1 receptor agonist, is increasingly used for type 2 diabetes and obesity.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
September 2025
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
Purpose: The Food and Drug Administration Adverse Event Reporting System (FAERS) is an important source of information on suspected adverse drug reactions, but does not standardise drugs. The Adverse Event Open Learning Through Universal Standardization (AEOLUS) System Provides Standardisation of drugs in FAERS to RxNorm, but its coverage leaves room for improvement and mapping accuracy has not been established. Furthermore, drugs are not mapped to the Anatomical Therapeutic Chemical (ATC) Classification System, which is frequently used in pharmacovigilance studies.
View Article and Find Full Text PDFThorax
September 2025
Clinical Trials Accelerator Platform, London, UK
A common eligibility criterion in respiratory clinical trials is a per cent-predicted forced expiratory volume in 1 second (ppFEV) between 40% and 90%, using the ethnicity-dependent Global Lung Function Initiative (GLI)-2012 spirometry reference equations. International societies now endorse the newer 'race-neutral' GLI-Global equations. We quantify the impact on trial eligibility of switching from GLI-2012 to GLI-Global for the UK Cystic Fibrosis Registry (n=8182).
View Article and Find Full Text PDF