Patient Safety is defined as “the prevention of errors and adverse effects to patients associated with healthcare” and is the phenomenon that forms the basis of healthcare activities around the world.
World Patient Safety Day aims to raise public awareness, encourage global engagement and improve the overall understanding in reducing patient harm and enhancing patient safety. Key stakeholders around the world participate in global campaigns to help raise awareness about patient safety.
Early identification of adverse events and adverse drug reactions is important in monitoring drug safety and subsequently enhancing patient safety. Patients, healthcare professionals, and manufacturers are equally responsible for submitting safety reports to databases so that regulatory authorities can monitor drug and patient safety. However, loopholes in efficient adverse event reporting mechanisms and lack of robust pharmacovigilance systems lead to underreporting of adverse events which can affect patient safety.
Pharmacovigilance processes help to capture Adverse Events (AEs) that occur once a drug product is marketed. These processes help in capturing the risks associated with a drug product and flag them as a risk update to already available product information (e.g CCDS, SPC, PIL etc) . PV processes like ICSR case processing, risk management plans, aggregate reporting, signal detection & management, safety literature search etc are ways by which adverse events are captured, processed, evaluated, and submitted to determine the safety profile of a drug for patient safety.
DDReg joins millions across the globe to participate in WHOs initiative and raise awareness of patient safety that is a growing concern worldwide.
Pharmacovigilance services and activities are an integral part of drug and patient safety particularly in post-marketing surveillance settings. DDReg is committed to patient safety by way of providing compliant pharmacovigilance solutions such ICSR case processing, risk management solutions, pharmacovigilance aggregate reporting and audit and compliance, to our customers.
An individual case study report (ICSR) is a crucial component of an adverse event reporting system that helps in detecting adverse events during the clinical phase, through literature as well as during post marketing phase, for patient safety. These reports also contain information on medication error and off-label use that are useful in monitoring drug safety.