INNOVATIVE APPROACHES TO DRUG SAFETY
The current practice of pharmacovigilance is fraught with challenges and limitations, but new technologies, perspectives and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance, which offers you an opportunity to participate in a robust, informative and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
Virtual Workshop 2019
You are cordially invited to join our workshop on the future of pharmacovigilance. We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment into automation and AI tools, the monetary value of safety information, patient privacy issues and innovative approaches toward generating evidence.
- Stakeholders’ information requirements
- Benefit:risk profile assessment
- Nature of evidence in pharmacovigilance
- Real-world data / real-world evidence
- AI, machine learning, automation
- Financial impact of Adverse drug events
- Monetary value of safety information
- Incentives and barriers to investment
- Protecting patient privacy
RULES OF ENGAGEMENT
- The presentations will be live and prerecorded
- Recorded sessions and discussion will be archived on this site and made available under login to speakers and attendees
- Attendees will challenge, presenters will defend.
- Networking time allotted.
- Early registration is encouraged as the number of places is limited to ensure meaningful engagement.
- Factual statements should be accompanied by a source citation.
- We encourage vigorous, yet respectful debate.
THE COST OF ADVERSE EVENTS
The cost of Adverse Drug Reactions and Adverse Drug Events is estimated at $3.5 billion a year, but suspected to be $25 billion a year if unreported ADRs are considered. Consequences include an increased costs for treatment, increased length of hospital stay, higher readmission rates and higher in-hospital mortality.
THE COST OF DRUG SAFETY
By 2025, the outsourced pharmacovigilance market will be worth about $10.27 billion with an expected growth of 13.1% CAGR. Main drivers to this growth are regulatory requirements and increasing incidence of Adverse drug events due to an aging population and increasing demand for treatment for chronic diseases.
VISION FOR THE FUTURE
Pharmacovigilance needs reform to evolve beyond compliance in order to produce better quality, actionable intelligence that is responsive to the needs of stakeholders within the healthcare ecosystem, including healthcare providers and patients.
The unbearable cost of drug safety activities
Despite significant investment, drug safety surveillance systems produce minimum actionable information
Adverse Drug Events are the largest single category of adverse events in hospitalized patients responsible for 19% of all injuries. An estimated 380,000 to 450,000 preventable Adverse Drug Events occur annually in U.S. hospitals. The incremental cost of an Adverse Drug Events was estimated to be $5857 22 years ago (Bates, 1997) and is undoubtedly higher today. This places the estimated cost of Adverse Drug Events at $3.5 billion a year and $25 billion a year if unreported Adverse Drug Events are considered. In inpatient settings, Adverse Drug Events account for 1 in 3 of all hospital Adverse Events, affect about 2 million hospital stays a year and prolong hospital stays by 1.7 to 4.6 days.
In outpatient settings, Adverse Drug Events account for over 3.5 million physician office visits and 1 million emergency department visits a year and approximately 125,000 hospital admissions a year. High-priority targets of the National Adverse Drug Event Action Plan include bleeding linked to anticoagulants, hypoglycemia associated with diabetes agents and opioid overdose. The financial burden of pharmacovigilance activities has been steadily increasing over the last decade. The main drivers include more stringent regulatory requirements, increasing incidence and prevalence of adverse drug reactions due to demographic changes and liability resulting from high-profile product failures. Yet, other stakeholders in the healthcare ecosystem such as physicians, pharmacists, hospital administrators and patients remain underappreciated and underserved by current pharmacovigilance practice.
Veronika Valdova, DVM spent most of her career in various roles in exploring the safety and efficacy of drugs and medical devices. She is passionate about the operational costs of drug safety surveillance and the quality of intelligence drug safety monitoring activities can provide. She is the co-founder of ARETE-ZOE, LLC and Veracuity, LLC.