This is the second in a three-part blog series on National Pharmacovigilance systems and the role of technology in bridging the gaps in pharmacovigilance of regulatory authorities around the world. Read our first blog, “Pharmacovigilance with an ‘e’?” for background information on this discussion.
There is a differential incursion of technology into pharmacovigilance across countries globally. The countries with higher healthcare expenditure and high Human Development Index (HDI), composite statistic of life expectancy, education, and per capita income, see here) generally have advanced pharmacovigilance systems. These countries are incorporating state-of-the-art technologies into their pharmacovigilance systems and investing further in futuristic technologies.
The United States FDA uses FAERS (FDA Adverse Event Reporting System), an electronic database of spontaneously submitted adverse events (AEs) associated with drugs and biologic products. For the past 47 years, spontaneous reporting has been the cornerstone of CDER’s (Center for Drug Evaluation and Research) post-marketing drug safety monitoring. These are based on voluntary MedWatch reports from the public, healthcare professionals. It has 12 million reports since 1969, and in 2016 only, the FAERS database had logged nearly two million AE reports.
FAERS helps to bridge the gap between known AEs seen in pre-approval clinical trials and those seen once an approved drug is used in the general population. If a potential safety concern is identified in FAERS, further evaluation is conducted on a systematic basis. Monitoring of individual spontaneous reports and aggregate data from the FAERS database for all marketed products is conducted weekly. Reviews of AE reports and benefit-risk evaluation reports occur at quarterly, bi-annual and annual intervals, and full drug product safety reviews are conducted 18 months after approval. CDER employs data mining techniques to efficiently identify FAERS reports of greatest value and is continuously working to update these approaches.
In order to systematically detect and to rapidly evaluate the emerging risks associated with regulated medical products, an integrated electronic system called The US FDA Sentinel System is used. It connects the healthcare databases across many data sources. Sentinel enables FDA to proactively assess medical product safety under real-world conditions and complements existing FAERS post-marketing monitoring capabilities.
Similarly, the European Medicines Agency (EMA) continuously monitors the adverse drug reaction (ADR) data through EudraVigilance. It is used to determine whether there are new or changed risks and whether those risks have an impact on a medicine’s overall benefit-risk balance. It is a comprehensive multi-component system that facilitates data collection, data management, and the analysis in a secure manner. The post-authorization module of EudraVigilance has about one million ADR reports.
Modern technologies are being utilized by regulatory authorities with advanced pharmacovigilance systems, to collect, characterize and evaluate the adverse events associated with medicinal products. The countries with advanced pharmacovigilance systems have made major strides in technologies for spontaneous reporting systems, adverse event database management, and signal detection.
The countries with emerging and rudimentary pharmacovigilance systems mostly depend on the tools provided by WHO-UMC. The countries with emerging pharmacovigilance systems utilize tools such as VigiBase (the adverse event database), VigiFlow, (adverse event report exchange system) and VigiLyze, (the analytics tool), for data collection, management, and analysis of adverse drug reactions. The countries with a rudimentary pharmacovigilance system have access to systems supplied by WHO-UMC if they qualify for WHO Programme for International Drug Monitoring. However, these systems are not effectively utilized by these countries. The countries that require advanced systems like E2B (R3) compliance and IDMP are increasingly moving towards adopting advanced software solutions like LifeSphere® Safety provided by ArisGlobal. These newer systems aid in conducting more efficient pharmacovigilance processes aligned with the latest regulatory expectations.
Regulatory Authorities are increasingly moving up the value chain from being emerging to advanced regulatory authorities by opting for ArisGlobal’s Lifesphere safety solutions. Eight regulatory authorities with seven of them in Europe and North America are using ArisGlobal’s safety solution as their national pharmacovigilance systems.
Look for our third blog, “Advanced pharmacovigilance technologies – A solution for deficiencies in national pharmacovigilance systems?” to be published shortly.