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Better Prevention Strategies Rely on the Monitoring of Outpatient Adverse Drug Events
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Currently, limited data show the effect of adverse drug events in the outpatient setting.
In a study published in BMJ Quality and Safety, investigators identified the most frequent classes of drugs that resulted in adverse drug events (ADEs) in the outpatient setting. Currently, limited data show the effect of ADEs in the outpatient setting; therefore, investigators aimed to determine the incidence, severity, and preventability of ADEs for outpatients as well as potential strategies to mitigate these effects.1
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At recent scientific conferences, such as the American Diabetes Association 84th Scientific Sessions and the American Academy of Neurology Annual Meeting, presenters focused on the need for better monitoring and information surrounding ADEs, including with glucagon-like peptide-1 (GLP-1) and immune checkpoint inhibitors. GLP-1 medications have been associated with gastrointestinal ADEs, but it is unclear what the long-term effects of these medications can be. Some potential concerns include pancreatitis, pancreatic cancer, colorectal cancer, gallbladder emptying, aspiration, suicidal thoughts and other psychological effects, and thyroid cancer.2,3
Additionally, investigators have called for a better framework for diagnosing and classifying neurological immune-related ADEs from immune checkpoint inhibitors, especially because the effects will not likely occur immediately after administration due to the long half-life. In the current study, the authors acknowledge the lack of information around outpatient ADEs.1,3
“This study is the largest recent study regarding outpatient ADEs. Patients included a large population treated at multiple sites including primary care, specialty care and emergency departments, over a 1-year period,” investigators said in a press release.4
Investigators conducted an analysis using retrospective electronic health records in the outpatient setting in 2018, including 13 sites in Massachusetts. There were 13,416 encounters among 3323 patients, and triggers included medication, consultations, laboratory results, and other information that was available. If a trigger was detected, the investigators analyzed the records further to determine the relevant information for the study. Patients were aged 18 years and older who had at least 1 outpatient encounter with a physician, nurse practitioner, or physician’s assistant and were excluded if the encounter happened in outpatient surgery, psychiatric, rehabilitation, or pediatrics.1
Overall, 5% of individuals experienced ADEs in the 1-year period, with 198 events identified among 170 patients. Of the 170 patients, 87% experienced at least 1 ADE, 10% experienced 2, and 3% experienced 3 or more, according to the study authors. For drug classes, the most frequent included cardiovascular at 25%, central nervous system at 15%, and anti-infective agents at 14%. There were no fatal ADEs identified, but 1% were life-threatening, 14% were serious, and 85% were significant.1
Additionally, investigators found that approximately 22% of the ADEs were classified as preventable.1
“We assessed the preventability of ADEs and found that about 22% were preventable given what is known today. For both these and the remainder, we identified potential prevention strategies. The most desirable appeared to be [artificial intelligence]-related future prevention possibilities. Additional studies are needed to develop new prevention approaches and then assess their impact,” the investigators concluded.4
References
1. Wasserman RL, Edrees HH, Amato MG, et al. Frequency and preventability of adverse drug events in the outpatient setting. BMJ Qual Saf. Published online July 9, 2024. doi:10.1136/bmjqs-2024-017098
2. Gallagher A. Experts Discuss Serious Adverse Events for GLP-1 Medications. Pharmacy Times. June 23, 2024. July 11, 2024. https://www.pharmacytimes.com/view/experts-discuss-serious-adverse-events-for-glp-1-medications
3. McGovern G. Experts Report Need for Framework to Address CNS Immune-Related AEs Resulting From ICI Treatment. Pharmacy Times. April 30, 2024. Accessed July 11, 2024. https://www.pharmacytimes.com/view/experts-report-need-for-framework-to-address-cns-immune-related-aes-resulting-from-ici-treatment
4. Research spotlight: researchers find that adverse drug events are frequent and many are preventable in the outpatient setting. News release. EurekAlert. July 9, 2024. Accessed July 11, 2024. https://www.eurekalert.org/news-releases/1050699
