TOP-MEDS: Developing Tools to Promote Medication Safety
By On Mar 19, 2012Center for Education and Research on Therapeutics at University of Illinois-Chicago Aims to Deliver Tools, Training, and Technology
A hospitalized patient receiving opioids for pain may have little in common with a patient in a primary care clinic who is struggling to control diabetes mellitus. Yet these vastly different clinical scenarios are similar in one significant way: In both cases, there is a strong risk that medication is not being optimally prescribed or taken, with the result being less-than-optimal outcomes and, perhaps, gaps in patient safety.
These problems are also part of the focus of a $4.25 million, five-year contract awarded last fall by the Agency for Healthcare Research and Quality as part of the Centers for Education and Research on Therapeutics (CERTs) program. Led by Bruce Lambert, PhD, professor of pharmacy administration and director of the CERT at the University of Illinois at Chicago, the Tools for Optimizing Medication Safety (TOP-MEDS) project has broad goals for improving the prescribing of opioids; reducing drug name confusion; enhancing post-marketing surveillance of adverse drug events; and improving patients’ understanding of and compliance with drug regimens.
Bruce Lambert, PhD
“We set out to address unambiguously big, important problems,” Lambert said recently during a discussion of the project’s start-up and progress to date. “We wanted to work on projects that had a very high likelihood of success in five years.”
The CERTs program was started as part of the Food and Drug Administration Modernization Act of 1997. Its mission is to “increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics.” That includes medications, medical devices, and biological products. The TOP-MEDS CERT is one of six research centers in the country to receive funding in the latest round and the only one focused exclusively upon patient safety. The others are at Duke University Medical Center (cardiovascular therapeutics), Rutgers University (mental health therapeutics), Brigham and Women’s Hospital (health information technology), University of Alabama at Birmingham (musculoskeletal disorders), and Cincinnati Hospital Children’s Medical Center (pediatric therapeutics). There is also a coordinating center, the CERTs Scientific Forum, to lead scientific collaborations of all six CERTs Research Centers; it is based at the Kaiser Foundation Center for Health Research in Portland, OR.
Lambert said that the current projects grew from prior research in these areas. For example, Lambert himself first began researching drug-name confusion in 1998 with a grant from the National Patient Safety Foundation. “This current project is a direct continuation of that line of research,” he said. “If you look at data on medication errors, wrong drug errors account for about 8 percent. Even when we know which names are likely to be confused, the errors just keep happening.”
Yet, beyond adding to the pool of knowledge, the TOP-MEDS program also plans to deliver tools that can be applied in practice. For example, Robert Gibbons, PhD, statistical director for the program, whom Lambert calls “one of the foremost biostatisticians in the world,” is involved in a project to develop a new statistical model for analyzing large observational databases of adverse drug events. “We aim to have a statistics program that we can give away for free,” Lambert said. “We’ll produce good research papers, but we will embody the methods in tools that others can put to use.”
TOP-MEDS has four main areas of research:
- Developing a model for large-scale adverse drug event screening that will surpass spontaneous reporting and detect ADEs not noted in pre-approval clinical trials.
- Developing a web-based simulation program to train clinicians in the proper selection and dosing of opioids to improve the safety and effectiveness of acute pain control in inpatients.
- Developing and testing methods of preventing and detecting drug-name confusion both pre-approval and post-approval.
- Evaluating low-literacy materials and the use of electronic health records to promote safe and effective use of medications among English and Spanish-speaking patients in an urban primary care practice.
“We hope to make a meaningful, incremental contribution in these areas,” Lambert said. “We’re modest about the impact we can have, but we hold ourselves accountable to make a contribution. We owe the public a substantial return on their investment.”
Also collaborating on the project are Dr. Bill Galanter, clinical director, and a number of co-investigators from Rush University Medical Center; Northwestern University; University of Chicago; and Brigham and Women’s Hospital, Boston. The Institute for Safe Medication Practices, Horsham, Penn.; and the National Patient Safety Foundation, Boston, are subcontractors and partners in dissemination of results and findings.
“We are proud to be a partner in such a rigorous program that is also characterized by innovative uses of technology and a focus on patient-centeredness,” said Diane C. Pinakiewicz, MBA, president of NPSF.
Lambert will be among the faculty at the NPSF Patient Safety Congress this coming May, presenting a breakout session that will focus on the CERTs patient safety work. As the TOP-MEDS project progresses, he and his team plan subsequent presentations at the annual Congress.
This is the first in a series of articles about the TOP-MEDS projects and the patient safety work being done by the other Centers for Education and Research on Therapeutics. NPSF will report on the progress of these projects periodically.
—Patricia McTiernan
