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“With funding from AHRQ, I’ve helped ensure that warnings for drug-drug interactions are appropriate and useful to clinicians and pharmacists, reducing harm to patients.”

Taking certain medicines together can cause adverse effects in patients. While these drug-drug interactions (DDIs) are preventable, millions of Americans receive potentially harmful drug combinations each year. 

Daniel C. Malone, Ph.D., a professor of pharmacotherapy at the University of Utah’s Skaggs College of Pharmacy, is helping to make care safer by increasing our understanding of DDIs and developing tools that alert physicians and patients to potentially risky drug combinations. With funding from AHRQ, Dr. Malone established a framework for collecting and disseminating information on DDIs. He also worked to optimize digital tools, such as DDI alerts and shared decision-making resources, to help protect patients from preventable medication errors.

His initial work in this area started in 2002 during his time with the University of Arizona. The University had received a grant from the ������ƵCenters for Education and Research on Therapeutics (CERTs) Program focused on drug-drug medication errors, and Dr. Malone served as a co-investigator for the project. Since then, Dr. Malone received a 1-year ������Ƶgrant in 2009 to host a conference about DDI issues to build consensus among attendees with varying backgrounds and expertise. Based on input from attendees, Dr. Malone outlined a series of issues associated with DDIs, including the design of clinical decision support (CDS) systems. This knowledge served as a foundation for his research projects.

In 2010, Dr. Malone received a 3-year ������Ƶgrant focused on the adoption of AHRQ’s Comparative Effectiveness Research (CER) methods to improve prescribing decisions. Specifically, he held focus groups with hospital pharmacy and therapeutic (P&T) committee members—whose primary purpose is to encourage safe and effective prescribing of medications—to identify ways to increase awareness and use of AHRQ’s CER methods and guides. His indicated that, while most participants were aware of ������ƵCER reviews, few had used them in the P&T process. Session feedback was used to develop content for two workshops on AHRQ’s CER held in 2012. A follow-up assessment 1 year after the workshops found that the had incorporated AHRQ’s CER materials into their P&T committee decision-making process.

Building on the findings from his 2009 DDI conference, Dr. Malone received another ������Ƶconference grant in 2012 that partially funded four annual meetings to discuss designing better systems to prevent DDIs. The conference series helped Dr. Malone develop strategies to evaluate improvements to the DDI evidence base and electronic clinical decision aids, and he also published three working papers. According to Dr. Malone, the papers, including , were well-received and have been widely cited, and “the conference created some momentum among other investigators to research the topic.”

In 2015, Dr. Malone received a 2-year ������Ƶ to improve the underlying framework for DDI alerts. He felt that the existing software was poorly designed, because it relied on simple drug combination rules and ignored drug attributes and patient-specific information available in the electronic health record. This resulted in excessive alerts and alert fatigue. Dr. Malone studied the most commonly overridden DDI warnings and identified specific patient and drug attributes that influence the risk of an adverse drug reaction. He developed a knowledgebase with alerting rules that were tailored to these factors to increase the precision of warnings concerning dangerous drug combinations. This clinical decision support (CDS) software is being used by healthcare providers and is helping to reduce the occurrence of irrelevant alerts while simultaneously improving patient safety.

With a continued focus on improving medication safety, Dr. Malone received a 4-year ������Ƶgrant in 2018 to further improve the accuracy of the DDI alert algorithm in the CDS system and to implement these systems in healthcare facilities across the United States. While the COVID-19 pandemic made it more challenging to implement the system in healthcare facilities, his team was able to work with several organizations as part of the study.

In 2019, Dr. Malone received a 2-year ������Ƶ to adapt and implement a CDS algorithm to reduce at-risk patients’ exposure to medicines that may cause potentially fatal irregular heartbeats. The algorithm was implemented in 28 hospitals that have a high proportion of underserved American Indian, Latino, and economically disadvantaged populations, including rural critical access facilities. The CDS was incorporated as an advisory into an existing medication alert system, and the research showed that decision support tools placed appropriately within a provider’s workflow are accepted and used by clinicians.

Also in 2019, Dr. Malone received another 2-year ������Ƶ to develop and disseminate that enable patients and clinicians to engage in shared decision making about DDI risks. “While patients can play a critical role in preventing potentially catastrophic harm due to DDIs, there are very few tools that help them engage in shared decision making about DDI risks,” said Dr. Malone. After developing a shared decision-making , called , his team conducted a randomized study in which clinicians and patients compared the tool with other DDI resources. Clinicians found the tool easy to use and time-saving. Dr. Malone has recently received another ������Ƶgrant to implement the tool in the electronic health records at three university health systems—University of Utah, University of Colorado, and Vanderbilt University.

Dr. Malone is a member of the Academy of Managed Care Pharmacy and ISPOR–The Professional Society for Health Economics and Outcomes Research.

Principal Investigator: Daniel C. Malone, Ph.D.
Institution: University of Utah
Grantee Since: 2009
Type of Grant: Various

Related ������ƵResources

• Medication Safety

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