Enhancing Patient Safety: The Vital Role of the Care Team in Reporting Adverse Drug Events

In the realm of health care, patient safety stands as an uncompromisable cornerstone. The well-being of patients is the guiding principle that informs every decision, treatment, and prescription made by health care professionals. One essential component of ensuring patient safety, often underestimated, is the reporting of adverse drug events (ADEs). First, it is important to understand the definition of ADEs. The common technical definition of ADE is an injury resulting from the use of a drug, whereas the common lay definition is an undesirable patient outcome that occurs in conjunction with medication use. Additionally, these organizations define ADE as follows:

• US Food and Drug Administration (FDA): Any undesirable experience associated with the use of a medical product in a patient.
• Institute for Safe Medication Practices (ISMP): Any incident in which the use of a medication at normal doses causes harm to a patient or results in an adverse outcome.
• World Health Organization: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.

ADEs can have a profound impact on patients, particularly those in long-term care (LTC) settings given the prevalence of frailty and significant number of concomitant medications taken among this population. In this article, we delve into the significance of ADE reporting, the mechanisms involved, and the role of the LTC team in safeguarding patients through vigilant reporting.

Given that patient safety is paramount, it is the ethical and professional duty of health care providers to prioritize the well-being of patients above all else. Every medication, every treatment administered, and every decision made by health care professionals must be guided by the principle of "do no harm." In this context, the reporting of ADEs takes on a pivotal role.

ADEs encompass any harmful or unintended reactions to medications. They are events that compromise patient well-being and can range from mild side effects to severe and life-threatening complications. ADEs are not confined to any specific health care setting; they can occur in hospitals, outpatient clinics, and LTC facilities. However, the focus of this review is on the critical role of the care team in reporting ADEs, particularly in LTC settings.

Reporting is considered a vital component of pharmacovigilance and patient safety. However, underreporting of ADEs is a recognized issue in health care. Studies have shown that ADE reporting rates are often lower than expected, and many ADEs go unreported. Reasons for underreporting include lack of awareness about reporting requirements, time constraints in busy clinical settings, uncertainty about causality, or a perception that reporting is a complex process.  

To address underreporting and improve ADE reporting rates, health care organizations, regulatory agencies, and professional associations may conduct educational campaigns, provide training, and simplify the reporting process. The goal is that with increased awareness and improved reporting mechanisms, prescribers and other health care professionals will report ADEs more consistently, leading to improved patient safety.

To comprehend the significance of ADE reporting, we must first recognize the profound impact these events can have on patient care. ADEs are not mere statistics; they represent real patients who experience harm due to medications intended to help them. The consequences of ADEs can be devastating to every aspect of the quadruple aim from costly medical care, declining health of the LTC community, increasing caregiver burden, especially for individual patient experiences, and death.

In the context of LTC facilities, the vulnerability of the resident population cannot be overstated. Many LTC residents are older adults, with complex medical conditions and a high prevalence of polypharmacy. Polypharmacy, the concurrent use of multiple medications, significantly increases the risk of ADEs.^1,2 Moreover, age-related physiological changes, such as altered kidney function and decreased medication clearance, render older adults more susceptible to ADEs.

Studies estimate that 6.7% of hospitalized patients have a serious ADE, with a fatality rate of 0.32%. If these estimates are correct, then there are more than 2,216,000 serious ADEs in hospitalized patients, causing more than 106,000 deaths annually.³ Older adults in LTC facilities experience ADEs at a rate as high as 10.8 events per 100-patient months, often as a result of polypharmacy, multiple comorbid illness, and difficulty with monitoring prescribed medications. This translates into approximately 135 ADEs in an average-sized nursing home (bed size of 105) annually or approximately 2 million events among all US nursing home patients annually. A significant proportion of ADEs in LTC facilities are preventable, with research indicating that up to 40% of these events may be avoidable.⁴

ADEs represent the most clinically significant and costly medication-related problems in nursing homes; they are associated with 93,000 deaths each year and as much as $4 billion worth of excess health care expenditures.⁵

ADEs in LTC settings encompass a wide spectrum of adverse reactions, including, but not limited to, rashes, gastrointestinal disturbances, cognitive impairment, falls, and fractures. These events not only threaten the health and quality of life of LTC residents but also place a substantial burden on the health care system.

Another important consideration that underscores the need for the ADE reporting in LTC facilities is the historical limitations of clinical study populations during medication research and development. Clinical trials during the medication approval process generally include younger, healthier patient populations and often exclude patients of advanced age with multiple comorbidities and concomitant therapies, such as nursing home residents. Although clinical trial study population diversity is expanding and improving, many studies continue to be limited in the diversity of patients by sex, race, and ethnicity. Once a medication is approved and available to the general population, real-world data and ADE experiences are crucial for strengthening utilization recommendations for these products, as they often identify critical situations that were not recognized during preliminary studies.

The collection and analysis of ADE reports play a pivotal role in enhancing medication safety and protecting patient well-being. The FDA uses information from ADE reports to improve various aspects of medication management, including the following⁶:

• Signal detection and identification: ADE reports serve as a critical source of data for detecting potential safety concerns associated with specific medications. Patterns and trends in ADE reports can alert regulatory agencies and pharmaceutical manufacturers to previously unrecognized risks.
• Evaluation of drug labeling and packaging: ADE reports can prompt the FDA to reevaluate and update medication labeling and packaging information. This ensures that health care professionals and patients receive accurate, current information about a medication’s potential risks and benefits.
• Regulatory actions: In cases where ADE reports indicate significant safety concerns, the FDA can take regulatory actions to mitigate risks. These actions may include issuing warnings, contraindications, safety communications, or, in extreme cases, recalls of specific drug products.⁷

The impact of ADE reporting on medication management is not limited to theoretical considerations; it has tangible and far-reaching consequences. The collaborative efforts of health care professionals, including prescribers, in reporting ADEs have resulted in numerous successes in improving drug safety.

Public safety organizations, such as the ISMP, serve as vital partners in the effort to enhance patient safety and reduce ADEs. The ISMP conducts independent analyses of ADE reports, identifies patterns, trends, and systemic issues contributing to medication errors, and recommends targeted actions to improve medication use systems. As previously mentioned, a key use of ADE reports is to evaluate issues related to drug labeling, packaging, nomenclature, and administration that may contribute to medication errors. The ISMP’s expertise in medication error analysis and human factors engineering makes them ideally positioned to provide critical insights and recommend evidence-based solutions that can prevent errors and enhance safety across health care settings, including LTC facilities. Thus, public safety organizations reinforce and complement the FDA’s review of ADE reports by conducting multifaceted safety evaluations and spearheading collaborative initiatives on safe medication practices vital to the shared goal of patient protection.

To emphasize the real-world significance of ADE reporting, let us delve into a compelling case where diligent reporting resulted in a tangible improvement in patient safety. In the early 2000s, the medication Vioxx (rofecoxib) was widely prescribed to manage pain and inflammation, particularly for patients with arthritis. However, concerns began to surface regarding the medication’s safety profile. Reports of cardiovascular events, including myocardial infarction and stroke, among patients taking Vioxx raised alarm within the medical community.⁸

Prescribers across various health care settings, including primary care physicians, rheumatologists, and specialists, started observing a concerning pattern: patients who had been prescribed Vioxx were experiencing severe cardiovascular complications that could not be ignored.

Recognizing the potential link between Vioxx and these ADEs, health care professionals took action. They diligently documented each case, including patient details, medical history, the timing of events, and any additional factors that might have contributed. These reports were not isolated incidents; they represented a growing body of evidence suggesting a significant safety concern associated with Vioxx. Prescribers collaborated with other health care professionals, sharing their findings and concerns, culminating in a substantial volume of ADE reports related to Vioxx.

The FDA, responsible for monitoring the safety of medications on the market, received these reports and initiated a thorough investigation. The data collected from prescribers and other health care providers painted a compelling picture of the risks associated with Vioxx. The FDA’s investigation revealed a clear and concerning pattern: patients taking Vioxx had a heightened risk of experiencing cardiovascular events. In light of this substantial evidence, the FDA took decisive action to protect patient safety, and in September 2004, made a landmark decision to request the voluntary withdrawal of Vioxx from the market. This decision was based on the overwhelming data provided by prescribers and health care professionals across the country. It was a pivotal moment in medication safety regulation, demonstrating the power of collaborative ADE reporting in safeguarding patients.

However, the withdrawal of Vioxx was not the end of the story. The FDA also strengthened warnings and precautions related to similar medications in the therapeutic class, emphasizing the importance of vigilant monitoring and reporting of ADEs.

This case study illustrates how diligent ADE reporting by health care professionals can lead to significant regulatory actions, including the removal of a medication from the market. It underscores the critical role of health care professionals in monitoring and safeguarding patient well-being. The case of Vioxx serves as a powerful reminder of the impact that health care professionals can have on patient safety through diligent ADE reporting. It highlights the need for continuous vigilance and collaboration within the health care community to identify and address medication-related risks.⁹

ADE reporting is not the responsibility of prescribers alone. It is a collaborative effort that involves multiple stakeholders within the health care system. Effective collaboration among prescribers, pharmacists, nurses, and patients is essential for enhancing ADE identification and reporting. Each of these roles is described below.

Prescribers: As the primary decision-makers in medication management, prescribers are at the forefront of recognizing and documenting ADEs. Their clinical expertise and close patient interactions position them as key contributors to ADE reporting.

Pharmacists: Pharmacists play a crucial role in medication safety. They often have access to comprehensive medication profiles and can conduct medication regimen reviews to identify potential ADEs. Collaborating with prescribers, pharmacists can report ADEs and contribute to a holistic understanding of medication safety.

Nurses: Nurses, who frequently interact with patients in LTC settings, are well-positioned to observe and document ADEs. Their frontline role in patient care allows them to detect early signs of ADEs and communicate these observations to prescribers and other health care professionals.

Patients: Patient engagement and empowerment are increasingly recognized as valuable components of health care safety. Patients can actively participate in ADE reporting by promptly communicating any unusual symptoms or concerns related to their medications to their health care providers.

The identification and reporting of ADEs requires vigilant monitoring and collaboration among an interdisciplinary care team. In the LTC setting, this team encompasses the facility's medical director, attending physicians, pharmacists, nurses, and other health care professionals involved in the resident's care. The consultant pharmacist plays an integral role through comprehensive medication regimen reviews, assisting in causality assessments, and providing clinical insights into potential ADEs. Nurses contribute through frontline observation and documentation of the patients’ signs and symptoms. Effective communication within the care team ensures that observations indicative of possible ADEs are promptly highlighted and addressed through appropriate reporting mechanisms. With all members actively participating, the care team can leverage their collective expertise in service of patient safety and improved medication use outcomes. Open channels for collaborative discussion, information sharing, and reporting provide a framework for robust pharmacovigilance across the full continuum of LTC.

Effective collaboration among these stakeholders enhances the early detection, documentation, and reporting of ADEs, ultimately leading to improved patient safety and better medication management.

The process of identifying and reporting ADEs is a multifaceted and collaborative endeavor. Prescribers, as primary decision-makers in medication management, play a central role in this process. To effectively contribute to ADE reporting, health care professionals can follow a step-by-step guide¹⁰:

Recognition

The first step in ADE reporting is recognizing ADEs. Prescribers must be vigilant when monitoring patients for common signs of ADEs, which may include the following  :

• Skin rashes or eruptions
• Cognitive impairment or confusion
• Gastrointestinal disturbances
• Unexplained bleeding or bruising
• Dizziness, falls, or fractures
• Electrolyte imbalances
• Altered mental status

Prescribers should consider whether observed symptoms align with the known side effects or contraindications of medications.

Documentation

Upon identifying a potential ADE, prescribers must document the event comprehensively. This documentation should encompass the following key aspects:

• A detailed patient history, including existing medical conditions, past medical procedures, and known allergies.
•  A comprehensive list of all prescription medications, over-the-counter drugs, vitamins, and supplements being taken by the patient.
• Precise and thorough details about the ADEs, including its onset, duration, severity, and any treatments administered.
• An assessment of the causality between the medication(s) and the ADE, considering other potential contributing factors.

Accurate and detailed documentation is essential for building a comprehensive ADE report and ensuring that health care authorities can conduct a thorough safety evaluation.

Reporting

The next step involves the actual submission of the ADE report. Prescribers should use the FDA’s designated reporting tools, such as the electronic reporting portal or the MedWatch form 3500, to submit the report. The report should contain all the information gathered during the recognition and documentation phases. Prescribers must emphasize the impact of the ADE on the patient's well-being and quality of life. This information provides essential context for evaluating the severity and significance of the ADE.

Follow-up

Following the initial ADE report, prescribers should maintain a proactive approach by monitoring the patient's response to any interventions, such as discontinuation of the suspected medication or the administration of treatments. If new and relevant details emerge, prescribers should be prepared to update the ADE report accordingly. Adequate follow-up ensures that the patient’s progress and response to interventions are documented, contributing to a more comprehensive understanding of the event's course.

The FDA’s ADE reporting form serves as a critical tool in the process of identifying and addressing medication-related safety concerns. Prescribers are at the forefront of this process, as they are uniquely positioned to recognize and document ADEs. Understanding the essential components of the ADE reporting form is vital for prescribers in LTC settings.

The ADE reporting form requires detailed information about the patient, the medication(s) involved, and the ADE. Key components are as follows:

• Demographic information: This includes the patient’s age, sex, and weight, which are crucial factors in assessing the potential impact of the ADE.
• Medical history: The patient’s medical history, including existing medical conditions, prior medical procedures, and known allergies, provides critical context for understanding the event.
• Medication details: Prescribers must list all prescription medications, over-the-counter products, vitamins, and supplements that the patient is taking. Comprehensive information about the patient’s medication regimen is essential for identifying potential interactions or contraindications.
• ADE description: Prescribers are required to provide a precise and detailed description of the ADE, including its severity and any treatment administered. Clarity in describing the event is essential for effective assessment.
• Causality assessment: An essential aspect of ADE reporting is determining the likelihood that the medication(s) caused the ADE. Prescribers must consider other possible contributing factors and provide an informed assessment of causality.
• Additional documentation: In many cases, supporting documentation, such as photographs of physical manifestations, relevant laboratory reports, and hospital records, can strengthen the ADE report and facilitate a more comprehensive evaluation.

The process of completing the ADE reporting form is meticulous and requires attention to detail. The accuracy and completeness of the information provided are crucial, as they directly impact the FDA's ability to conduct a thorough safety assessment.

The reporting of ADEs is a fundamental component of patient safety, and prescribers play a pivotal role in this process. ADEs can have profound consequences for patients, particularly those in LTC settings, where vulnerability to medication-related harm is heightened.

Understanding the significance of ADE reporting, navigating the FDA's reporting form, and actively engaging in the reporting process are essential responsibilities of prescribers. By following a stepwise approach, prescribers can contribute invaluable data that inform drug safety evaluations, regulatory actions, and improvements in medication management.

The impact of ADE reporting is not theoretical; it has tangible and far-reaching consequences. The collaboration of health care professionals, including prescribers, pharmacists, nurses, and engaged patients, is vital for enhancing ADE identification and reporting.

In the pursuit of patient safety, prescribers are not mere observers; they are catalysts of change. Their commitment to vigilant ADE reporting ensures that patient care remains at the forefront of health care practice, safeguarding the well-being of those they serve, and contributing to the broader goal of improving medication safety.

As we reflect on the critical role of prescribers in ADE reporting, let us embrace the shared responsibility of patient safety and commit to a health care system where every ADE is an opportunity for improvement, and every report is a step toward safer and more effective medication management. In this collective effort, we can protect patients, enhance medication safety, and continually strive for the highest standard of care.

Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD¹1 • Jen Devinney-Lavsa, BPharm, PharmD, FASCP²

Affiliations:

¹Jefferson College of Population Health, Thomas Jefferson University, Philadelphia, PA

²GraneRx, Pittsburgh, PA

Disclosure:

The authors report employment with GraneRx.

Address correspondence to:

Richard G. Stefanacci, DO, MGHm MBA, AGSF, CMD

Email: Richard.Stefanacci@Jefferson.edu

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