Pharmacovigilance 2.0

New medicine clinical trials are primarily designed to assess efficacy (not safety)
- PROBLEM: Serious and life-threatening adverse drug events may not be detected or adequately quantified in small scale clinical trials and may only be revealed after many thousand or millions of patients are treated
New medicine clinical trials often exclude the sickest patients
- PROBLEM: Pre-approval medication safety is often not established for high-risk, vulnerable patients with the greatest therapeutic need. Thus, medication safety must be evaluated and established following regulatory approval

Reliance on voluntary or “passive” adverse drug event reporting
- PROBLEM: Post-approval safety surveillance of voluntarily reported adverse drug events leads to substantial underrepresentation, as most (>90%) remain unreported. This impedes the ability to detect true safety signals. Additionally, voluntary or passive reporting is substantially biased due to lack of systematic adverse drug event ascertainment.
Inadequate adverse drug event report quality
- PROBLEM: Substantial variability of adverse drug event report content obstructs the precise quantification and contextualization of potential medication-related harm.
Voluntary or “passive” safety surveillance systems lack critical data to assess risk and causality
- PROBLEM: Absent the true number of adverse drug event in the population and the number of patients treated with a medication in the same population, causal ambiguity results. Thereby making it impossible to estimate the risk of medication-related harm and to assess the causal relationship.

Purpose: To prevent medication-related harm, cultivate safer medication practices, and ensure equitable access to safe pharmacotherapy and optimal outcomes
Primary research question: What serious adverse drug events are associated with commonly used medications among Medicare beneficiaries?

Innovative methodology:
- Real World Data Integration: Transitioning from the inherent biases of voluntary or “spontaneous” adverse drug event (ADE) reporting systems, Pharmacovigilance 2.0’s integration of comprehensive real world data (RWD) captures critical details pertaining to medication exposure, reveals unreported ADEs, and includes detailed patient narratives. This novel utilization of RWD signifies a sea change in safeguarding public health.
- Surveillance Amplified: A departure from passive safety signal surveillance, Pharmacovigilance 2.0 actively detects medication-linked safety signals exposing otherwise concealed patient harm using systematic and innovative methods.
- Contextual Understanding: Elevating from isolated safety signals devoid of context, Pharmacovigilance 2.0 employs rigorous methodology to identify, contextualize, and confirm adverse drug events thereby generating robust inferences regarding medication related harm.

Pharmacovigilance 2.0 employs systematic and comprehensive methodology to:

Aim 1: Identify commonly used medications (target medications) among Medicare beneficiaries
Aim 2: Describe “known” and “unknown” suspected adverse drug events (S-ADEs) for each target medication
Aim 3: Estimate the crude association of S-ADEs with target medication exposure
- When a significant crude association is observed, the S-ADE will be reclassified as a probable adverse drug event (P-ADE)
Aim 4: Confirm the causal association between P-ADEs with target medication exposure
- When a significant casual association is observed, the P-ADE will be reclassified as a confirmed adverse drug event (C-ADE).

Click the link above to view and download the full study protocol