Analysis and application of real-world evidence needs to transition to an essential part of pharmacist training. Never has this need been highlighted more than in the first few months of the COVID-19 pandemic, when I worked as a clinical pharmacist in a medical ICU.
We had many situations arise at the bedside in which we had to evaluate and apply suboptimal data, like case reports and case series, to determine optimal care for our critically ill patients with COVID-19. Questions came up every day in management: Is hydroxychloroquine providing a clinical benefit? What are the risks of hydroxychloroquine in this population? Should we use steroids in patients with COVID-19 and acute respiratory distress syndrome? Until prospective randomized data were available, use of RWE offered important insight to inform care.
Pharmacists are the drug information experts, proficient at finding, evaluating, and applying clinical evidence to patient care. Evaluating medical literature is a cornerstone of pharmacy education, typically focusing on learning critical analysis of prospective, randomized, placebo-controlled clinical trials. Students and residents alike, both in pharmacy and medicine, often select this trial design for journal clubs and to answer clinical questions based on the high level of evidence associated with a well-designed clinical trial. However, many will eventually specialize and work with more narrow populations than what is included in the standard clinical trial, so pharmacists need more tools at our disposal, including an understanding of the role of real-world evidence.
Real-world data, when evaluated with robust data analytics, generates real-world evidence that presents an additional, actionable tool in the clinician’s toolbox for decision making at the patient and health-system level. Real-world data can be gathered from many sources, including electronic health records, patient-generated metrics from wearables and applications, claims and billing information, and government data sources, and it can provide valuable clinical insights based on how drugs are actually being used at the bedside.
Real-world data can shed new light on gaps in patient care, including on small or uncommon populations not included in trials. It can also serve as a valuable post-marketing surveillance tool for safety, to assess novel indications for currently marketed drugs, and to help examine medication use patterns, informing decision making on drug procurement and shortages.1
The value of real-world evidence is recognized by the FDA, which created a framework for its use following the enactment of the 21st Century Cures Act in 2016, to evaluate post-market safety outcomes, support expanded label indications, and inform regulatory decisions.2 The recent approval of tacrolimus (Prograf), used to prevent organ rejection in adult and pediatric lung transplant recipients, was based on non-interventional real-world data study.3
Given the growing use of real-world evidence, and the pressing need to answer difficult clinical questions about treating diverse populations, real-world evidence should be incorporated into pharmacy training to prepare trainees on how to critically evaluate studies based on real-world data with an understanding of both the benefits and limitations. This charge aligns with the 2021-2024 American Association of Colleges of Pharmacy Strategic Plan objective to provide educational opportunities in digital health education and practice, including analytics and informatics.4 Opportunities to apply and evaluate real-world evidence could be implemented in both large and small classroom settings, on experiential rotations, and in postgraduate residency and fellowship training.
Infusing data analytics and the evaluation of real-world evidence into pharmacy education is also critical to prepare the workforce for expanding career opportunities, such as in the growing field of informatics. These skill sets are essential for the pharmacist involved in patient care, operations, formulary management, and drug procurement. For example, evaluating evidence-based literature is a key step in the formulary review and medical utilization evaluation processes. The pharmacist must be proficient at not only evaluation of literature, but also assessing and extrapolating it to their local population.
Pharmacists are constantly asked to answer questions about quality improvement and to assess performance measures for hospital-wide or national initiatives. Comparing local to nationwide real-world data is an essential step in this process. The 2021 ASHP Foundation Pharmacy Forecast on data analytics predicts that most health systems will routinely use population-level data to determine where to focus pharmacist care. Their recommendations include analyzing outcomes data to guide decisions on medication use to improve patient outcomes and to support recruitment and expansion of pharmacist roles with strong clinical decision-making. Pharmacists have a key role to play identifying opportunities and limitations with big data and using it to improve operational and clinical outcomes.5
The use of real-world evidence and data analytics is rapidly emerging as another tool to support safe and effective medication use and promote patient-centered care. While real-world evidence will never replace the traditional randomized trial, pharmacy trainees in this era need to know how to harness the information gained with real-world data to inform decision making at the patient and population levels.
Understanding real-world data and evidence can increase data literacy and enable pharmacists to make personalized, informed decisions for their patients to improve value-based care and resource utilization.
For further reading
1 Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence – what is it and what can it tell us? N Engl J Med. 2016;375:2293-7.
2 Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. U.S. Food and Drug Administration. Website: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed: September 28, 2021.
3 FDA approves new use of transplant drug based on real-world evidence. U.S. Food and Drug Administration. Website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence. Accessed: September 28, 2021.
4 2021-2024 Strategic Plan Priorities, Goals, and Objectives. Preparing Pharmacists and the Academy to Thrive in Challenging Times. American Association of Colleges of Pharmacy. Website: https://www.aacp.org/sites/default/files/2021-09/aacp-strategic-plan–2021-2024.pdf. Accessed: September 28, 2021.
5 DiPiro JT, et al. Pharmacy forecast 2021: Strategic planning advice for pharmacy departments in hospitals and health systems. Am J Health-Syst Pharm. 2021;78:472-97.