Drug Safety Surveillance

A New Approach at Conducting Post-Market Drug Safety Surveillance 
A New Approach at Conducting Post-Market Drug Safety Surveillance 

Production of Real-World Evidence at the hospital level to provide accurate and timely insight into the safety and efficacy of marketed drugs 

Stakeholders in the healthcare ecosystem need accurate, comprehensive and timely medical evidence. An integrated solution to provide this evidence through analysis of real-world data can be designed and developed. Utilizing master study protocols, such a service would employ data analysis and integration platforms that would process real-world data within each contributing hospital. By producing standardized and layered medical evidence, valuable insight into the safety and efficacy of marketed drugs can be obtained and shared.

Redesigning post-market safety surveillance
Redesigning post-market safety surveillance

Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies. Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications. While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications. 
Pharmacovigilance as integral part of hospital quality management systems 
Pharmacovigilance as integral part of hospital quality management systems 

Information on adverse drug effects is collected to monitor patterns of use, detect new safety signals that were not discovered in clinical trials, and update benefit:risk profile of marketed drugs. Accurate information on the safety profile and the limitations of use is in the best interest of patients and physicians as well as manufacturers and insurers. Denial of a useful drug to a patient who may benefit from it is as harmful as prescribing it to a patient who is likely to develop an adverse event. The main limitations are the lack of epidemiological indicators, variable quality of data, and lacking causality assessments. The system needs to improve to achieve higher accuracy and speed of detection of safety data to provide valid, reliable, and accurate information for benefit:risk assessment. 
Opioids: Adverse Drug Events & Adverse Drug Reactions
Opioids: Adverse Drug Events & Adverse Drug Reactions

What makes pain the fifth vital sign?
Where are those 14,600 deaths a year in FAERS?
Did the reporting systems accurately capture overdose trends?
How do FAERS data correspond with other sources?
Is overdose death subject to expedited reporting?
How do PV systems detect rates of occurrence?
How do PV reporting systems detect changes in trends?
How did the introduction of REMS for ER/LA affect the trends?
How the data from FAERS compare to data from DEA?
For what indications are Rx opioids typically prescribed?
How do labeled indications compare to actual prescriptions?
What changes can we expect with package-level identifiers imposed by DSCSA?
Big data in drug safety
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigilance more efficient 
Published April 2014, revised January 2020

The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
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