Objective. To perform pharmacoepidemiological analysis of spontaneous reports adverse drug reactions (ADRs) occurred during macrolide group antibiotics prescription and registered in the “Pharmacovigilance 2.0” subsystem Federal Service for Surveillance Healthcare. Materials Methods. A retrospective ADRs arising from use all azalide Russia electronic database Healthcare period 01.04.2019 to 30....

A Systematic Review of Knowledge, Attitude and Practice on Adverse Drug Reactions Pharmacovigilance among DoctorsAbdullahi Rabiu Abubakar, Nordin Bin Simbak, Mainul Haque

EDITORIAL article Front. Drug Saf. Regul., 21 April 2023Sec. Advanced Methods in Pharmacovigilance and Pharmacoepidemiology Volume 3 - 2023 | https://doi.org/10.3389/fdsfr.2023.1188715

Confidence in vaccine safety is critical to national immunization strategies and to global public health. To meet the Millenium Development Goals, and buoyed by the success of new vaccines produced in developing countries, the World Health Organization has been developing a strategy to establish a global system for effective vaccine pharmacovigilance in all countries. This paper reports the fin...

Signal detection and its assessment is the most important aspect in pharmacovigilance which plays a key role in ensuring that patients receive safe drugs. For detection of adverse drug reactions, clinical trials usually provide limited information as they are conducted under strictly controlled conditions. Some of the adverse drug reactions can be detected only after long term use in larger pop...

The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or onlin...

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report m...

1 signalled a very important change. It amended Directive 2001/83/EC on the community code relating to human medicines, and said that Union rules on pharmacovigilance: '... should be based on the crucial role of healthcare professionals in monitoring the safety of medicines, and should take account of the fact that patients are also well placed to report suspected adverse reactions to medical p...