How Registries Can Help Optimize Patient Care and Safety
Written By: Tom Pasquariello, PharmD; Geoff Caplea, MD, FAAFP; and John Farah, PhD
Have you ever had a patient who could have benefited from participating in a clinical study, but weren’t sure where to begin? Or perhaps you are looking for ways to optimize care delivery and outcomes for your patients with rare or chronic conditions. If so, you and your patient might consider enrolling in a clinical registry. A registry is “an organized system that uses observational study methods to collect uniform data to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical, or policy purpose(s).”1 Below we discuss some important aspects of registries that can benefit clinicians and the patients under their care.
Registries can play a vital role in clinical research. For example, by continuing evaluation of a new medical product’s effectiveness, registries “serve as a bridge” between clinical trials and clinical practice.2 Such real-world studies have great value, as they can reveal new insights into patient care that inform treatment and improve individual as well as population outcomes.
Clinicians and other healthcare stakeholders may support patient safety by documenting and reporting real-world safety data not fully captured in clinical trials. The science and activities relating to the detection, assessment, monitoring, and prevention of adverse effects or any other drug-related problem are included under the umbrella of pharmacovigilance.3 Given the large numbers of medical product approvals—between 2012 and 2017, for example, there were 29 FDA-approved therapies with a cardiovascular disease indication4—having formalized pharmacovigilance processes or programs for conducting post-marketing surveillance is essential.5
Registries provide opportunities to identify and capture post-marketing information on adverse events for approved drugs and therapeutic biologics. Many registries utilize structured questionnaires or adverse event case report forms to identify and capture information, including serious adverse events that require patient safety narratives, from providers and patients or their caregivers.6
Registries have been used to monitor the safety of certain FDA-approved medications through clinician participation in Risk Minimization Action Plans (RiskMAPs) or Risk Management Programs (RMPs), now known as Risk Evaluation and Mitigation Strategy (REMS). REMS programs are required as contingencies for FDA approval for medications that may have serious safety concerns but are also highly effective for treatment of certain diseases.7 Clinicians and pharmacists may be required to undergo training to become registered to handle, prescribe, and dispense these products. Patient enrollment registries, often for rare disease and orphan products (that may, for example, lead to cardiotoxicity) may be required for some REMS programs due to the limited data obtainable from clinical trials.7
Veradigm is pleased to offer two clinical data registries operated in association with the American College of Cardiology (ACC): The PINNACLE Registry® and The Diabetes Collaborative Registry®. The PINNACLE Registry is cardiology’s largest outpatient quality improvement registry, capturing data on coronary artery disease, hypertension, heart failure, and atrial fibrillation. The Diabetes Collaborative Registry is the first clinical ambulatory registry aimed at tracking and improving the quality of diabetes and cardiometabolic care across the primary and specialty care continuum.8
Clinician participation in the registries has many advantages including the ability to collect data on patients with cardiovascular complications, easy-to-interpret online benchmark reports to help validate quality of care, and seamless participation in federal quality reporting programs such as the Quality Payment Program. Other benefits to clinicians through Veradigm’s collaboration with the ACC includes access to the ACC’s National Cardiovascular Data Registry (NCDR) clinical toolkits, opportunity to submit hypothesis-driven research requests, and participation in continuing education programs. To learn more about how you can support your patients through registry participation, please click here.
References:
- Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User’s Guide (Internet). 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. 1, Patient Registries. Accessed 2021 July 30. https://www.ncbi.nlm.nih.gov/books/NBK208643/
- Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for evaluating patient outcomes: a user’s guide (internet): Health information Technology (IT) and Patient Registries. 3rd edition, addendum 2. Rockville, MD: Agency for healthcare research and Quality (US); 2019 October. Accessed 2021 July 25. https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/ehc-registries-users-guide-third-edition-second-addendum.pdf.
- World Health Organization. What is Pharmacovigilance? 2021 August. Accessed 2021 August 1. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance.
- Patel N, Stottlemyer B, Gray M, et al. A pharmacovigilance study of adverse drug reactions reported for cardiovascular disease medications approved between 2012 and 2017 in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Cardiovascular Drugs Ther. 2021 Feb 18. https://pubmed.ncbi.nlm.nih.gov/33599896/
- U.S. Food & Drug Administration. Postmarketing surveillance programs. 2021 August. Accessed 2021 August 3. https://www.fda.gov/drugs/surveillance/postmarketing-surveillance-programs.
- Gliklich RE, Leavy MB, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User’s Guide (Internet). 4th edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Sep. Chapter 12, Adverse Event Detection, Processing, and Reporting. Accessed 2021 July 25. https://www.ncbi.nlm.nih.gov/books/NBK562574/
- Gannon V. The history, benefits of pharmaceutical REMS programs. Pharmacy Times. 2020 January. Accessed 2021 July 28. https://www.pharmacytimes.com/view/the-history-benefits-of-pharmaceutical-rems-programs.
- Quality improvement for institutions. Outpatient registries. 2021 August. Accessed 2021 August 2. https://cvquality.acc.org/NCDR-Home/registries/outpatient-registries.