About the Authors

Sharmeen Roy, PharmD, BCPS, is chief strategy and science officer at DoseMeRx.

Sara Rogers, PharmD, BCPS, is co-founder and president of the American Society of Pharmacovigilance.
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National Adverse Drug Event Awareness Day was established to promote awareness, drive policy changes, and encourage health care professionals and patients to prioritize medication safety.
Adverse drug events (ADEs) are a significant public health issue, ranking as the fourth leading cause of death in the United States. More than 1.5 million emergency department visits and approximately 500,000 hospitalizations occur each year due to ADEs, with older adults and those on multiple medications at the highest risk.1 Yet, many of these incidents are preventable. Pharmacists, as medication experts, play a critical role in mitigating these risks through comprehensive medication management, patient education, and advocacy for safer prescribing practices. Recognizing the urgency of this issue, National Adverse Drug Event Awareness Day was established to promote awareness, drive policy changes, and encourage health care professionals and patients to prioritize medication safety.2
Adverse drug events are a significant public health issue | Image credit: Joel bubble ben | stock.adobe.com
An ADE is any harm caused by a medication, including side effects, medication errors, allergic reactions, and drug interactions.3 Studies indicate that nearly 50% of ADEs are preventable, particularly those linked to high-risk medications such as anticoagulants, opioids, insulin, and certain cardiovascular drugs.4 Warfarin, for example, remains one of the most common culprits of ADE-related hospital admissions, often due to inadequate monitoring or drug interactions.5 Insulin mismanagement is another major concern, with dosing errors leading to severe hypoglycemia, which accounts for tens of thousands of emergency visits annually.6 While some ADEs result from known drug effects, others stem from avoidable issues such as inappropriate prescribing, lack of patient education, or pharmacogenomic variability. Addressing these factors requires a proactive approach that integrates technology, education, and interdisciplinary collaboration.
Polypharmacy is one of the most significant risk factors for ADEs, particularly in patients with chronic conditions. A study published in Annals of Emergency Medicine found that patients taking 5 or more medications had a 35% increased risk of experiencing an ADE, compared to those on fewer medications.7 Pharmacists can help by conducting thorough medication reviews, identifying unnecessary or high-risk drug combinations, and deprescribing when appropriate.
Inappropriate prescribing and dosing errors remain another major issue. Beta-blockers, for example, are frequently prescribed without proper dosage adjustments in patients with renal impairment, increasing the risk of adverse effects such as bradycardia and hypotension. Leveraging electronic prescribing systems with built-in clinical decision support can help flag potential errors before they reach the patient.
Advances in precision dosing technology have enabled health care providers to move beyond standardized dosing models and toward patient-specific medication management. Bayesian dosing algorithms, for instance, can optimize drug therapy by accounting for individual patient characteristics, real-time lab values, and pharmacokinetic variability. This approach is particularly valuable for narrow therapeutic index drugs like antibiotics, anticoagulants, and oncology medications, where suboptimal dosing increases the risk of both toxicity and therapeutic failure. By integrating model-informed precision dosing (MIPD) into clinical workflows, pharmacists can personalize therapy, reduce ADEs, and improve patient outcomes.
Another growing concern is the lack of pharmacogenomic considerations in medication management. Genetic variations in drug metabolism can significantly alter a patient's response to medications. For instance, CYP2C19 polymorphisms can affect the efficacy of clopidogrel, potentially leading to therapeutic failure in patients who are poor metabolizers.8 Despite strong evidence supporting pharmacogenomics-guided therapy, adoption remains inconsistent across health care settings. Pharmacists should advocate for increased pharmacogenomic testing and ensure that test results are incorporated into electronic health records to inform prescribing decisions.
Lack of patient education is another major contributor to ADEs. A study by the Agency for Healthcare Research and Quality found that nearly 20% of patients discharged from the hospital experienced an ADE within 3 weeks, often due to confusion over medication instructions.9 Pharmacists can play a crucial role in bridging this gap by using tools like the teach-back method, which ensures that patients understand how and when to take their medications. Providing easy-to-read medication lists and utilizing mobile apps that send medication reminders can also improve adherence and reduce errors.
Transitions of care present yet another high-risk period for ADEs. Patients moving from hospital to home often experience changes in their medication regimens, and miscommunication between providers can lead to dangerous duplications or omissions. A meta-analysis published in The Annals of Pharmacotherapy found that pharmacist-led medication reconciliation programs reduced hospital readmission rates by 30%.10 Implementing a structured handoff process and using shared electronic health records can further enhance medication safety during transitions of care.
To combat ADEs effectively, a multi-faceted approach is needed, encompassing public education, professional training, and policy initiatives. Public awareness campaigns like the #FourthCause movement have been successful in highlighting ADE-related harms, using real-world patient stories to personalize the issue.11 Professional training programs must emphasize ADE prevention strategies, particularly in pharmacy and medical schools, to ensure that future health care providers are well-versed in medication safety.
Policy advocacy is essential to drive systemic change. Efforts should focus on improving medication labeling, requiring stronger safety alerts for high-risk drugs, and expanding insurance coverage for pharmacist-led medication reviews. One example is the successful push for naloxone co-prescribing with opioids, which has reduced overdose-related deaths in multiple states.12 Pharmacogenomics education must also be expanded, as incorporating genetic testing into prescribing decisions can prevent serious ADEs, particularly for drugs like thiopurines, where thiopurine methyltransferase testing can help avoid life-threatening myelosuppression.
Pharmacists are uniquely positioned to lead ADE prevention efforts. Conducting medication therapy management (MTM) services can identify and mitigate risks before they cause harm. Utilizing MIPD tools helps pharmacists individualize drug regimens, particularly for high-risk medications, ensuring optimal therapeutic exposure while minimizing adverse effects. Leveraging electronic health records and decision support tools allows for real-time detection of potential ADEs. Incorporating MIPD into these systems provides an additional layer of safety by refining drug dosages based on real-time patient-specific data, such as renal biomarkers, weight, and drug levels. Championing pharmacogenomic testing can personalize drug therapy, ensuring that patients receive medications suited to their genetic profiles. Enhancing patient education through 1-on-1 counseling sessions improves medication adherence and reduces the likelihood of errors.13 Collaboration with other health care providers during transitions of care ensures continuity in medication management, further reducing the risk of ADEs. Encouraging deprescribing when appropriate is another crucial intervention, as studies show that reducing unnecessary medications leads to lower rates of ADEs and improved patient outcomes.14
Several initiatives are actively working to reduce ADEs on a national level. At Texas A&M Health, we have developed a comprehensive medication management service that includes a real-time clinical decision support dashboard. This system integrates patient-specific factors, including pharmacogenomic data, to provide precise medication recommendations and identify potential risks before they translate into harm.15 Additionally, the STRIPE Initiative, which theFDA participates in, is focused on standardizing pharmacogenomics practices to ensure safe and effective integration of genetic testing into routine care.16
Artificial intelligence applications are also being used to analyze electronic health record data to predict ADE risks, enabling early intervention and improved patient safety. Building on these advancements, MIPD is emerging as a critical tool for optimizing medication regimens. By incorporating real-time patient data—such as renal function, weight, and genetic markers—precision dosing platforms refine drug dosing to balance efficacy and safety. Clinical experience and emerging data suggest that individualized dosing strategies for high-risk medications, including aminoglycosides, vancomycin, and chemotherapy agents, can reduce ADEs while maintaining therapeutic effectiveness. Expanding access to these technologies within hospital and outpatient settings represents a key step in advancing medication safety efforts.
Sharmeen Roy, PharmD, BCPS, is chief strategy and science officer at DoseMeRx.
Sara Rogers, PharmD, BCPS, is co-founder and president of the American Society of Pharmacovigilance.
Looking ahead, we envision National ADE Awareness Day as a catalyst for broader health care transformation. Our goal is to see more health care institutions formally recognizing the day and implementing ADE prevention programs. Increased funding for research into clinical decision support tools and medication safety innovations will be essential in reducing ADEs at a systemic level. Policy advancements, including enhanced safety labeling and expanded pharmacist-led medication reviews, will help drive these efforts forward. A public-facing campaign will encourage patients to take an active role in their medication safety, empowering them to ask informed questions and recognize early warning signs of ADEs.
Preventing ADEs requires a collective effort from health care providers, policymakers, and patients. Pharmacists, as the frontline defense against medication-related harm, have a unique opportunity to drive meaningful change. By staying vigilant, leveraging technology, and advocating for patient safety, we can reduce preventable ADEs and create a safer health care system for all. As we continue to push for awareness and action, let’s remember: medication safety isn’t just about preventing errors—it’s about protecting lives.