An adverse drug event (ADE) is defined as an injury that is caused by a medicine, whether that’s through an allergic or otherwise unfavorable reaction, interaction with another drug being used, a medication error, or overdose. Remarkably, ADEs are estimated to be between the fourth and sixth most common cause of death globally [1]. Worldwide, hospitalizations related to ADEs range from 10 to 383 events per 100,000 people, costing $136 billion in health care costs each year in the U.S. and €4.5–21.8 billion in Europe [2, 3]. That makes them the costliest of all hospital-acquired conditions, while also being among the most preventable.
Groups Across the Globe Building Awareness about Adverse Drug Events
One of the first steps in preventing ADEs is to build awareness about their prevalence, causes, and potential mitigation strategies. That’s why groups across the globe are organizing campaigns to educate the public about ADEs and promote ADE reporting systems.
For example, in 2017, the Uppsala Monitoring Centre in Sweden launched #MedSafetyWeek, an international social media campaign to encourage the reporting of drug side effects. A few years later in 2021, the American Society of Pharmacovigilance (ASP) created National Adverse Drug Event Awareness Day, which is observed annually on March 24. As part of its mission, the ASP uses this day to encourage health care professionals and others to share any experiences they have had with ADEs. The goal is to improve understanding about the scope of this growing crisis, not just nationally, but globally, as well.
But building awareness is only part of the solution. What else can be done to prevent ADEs?
Using pharmacogenomic testing to prevent adverse drug events (ADEs)
In addition to building awareness, one of the best ways to prevent ADEs is for clinicians to thoroughly screen, evaluate, and monitor patients to minimize the risk of adverse events. This can be accomplished through traditional methods, such as accurate record-keeping and conventional blood testing, as well as through more advanced pharmacogenomic (PGx) testing.
PGx testing is a core element of precision medicine that assesses how a patient’s genes can affect the way their body responds to and reacts with certain medicines. Essentially, it takes advantage of each individual’s genomic information to identify which drugs are the most suitable and which ones could cause adverse reactions, as well as the most effective and safest dosage. These results are then used to customize each patient’s treatment plan.
The clinical utility of pharmacogenomic testing
Since the first PGx test was approved by the U.S. Food and Drug Administration in 2004, studies have repeatedly shown the benefits of this approach [4]. As the field has continued to evolve, clinical researchers have adopted several different technologies for PGx testing, including real-time PCR, microarrays, and next-generation sequencing. Each of these modalities is optimized for specific use cases, and researchers are continuing to demonstrate their unique benefits and utility in ongoing studies. For instance:
- In 2008, researchers found a strong correlation between a specific genotype and ADEs associated with the drug carbamazepine. This led the FDA to recommend genetic testing before prescribing carbamazepine for certain populations [5].
- More recently, a study found that pre-emptive genotype-guided treatment using a 12-gene PGx panel significantly reduced the incidence of clinically relevant adverse drug reactions and was feasible across a range of European health care systems and settings [6].
- A small-scale, pilot project in 2022 concluded that PCR could be used for the genetic screening of patients to minimize adverse drug reactions and enhance the efficacy of drug therapy [7].
Results like these point to the clinical utility of PGx testing and suggest that large-scale implementation could play a significant role in the reduction of ADEs. That’s because the results of a PGx test could help clinicians choose which drugs and dosages are optimal for each patient.
Click here to learn more about real-world examples of PGx and laboratory spotlights.
Thermo Fisher Scientific offers a comprehensive portfolio of PGx products for research use.
- Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action
- Hospitalizations and deaths related to adverse drug events worldwide: systematic review of studies with national coverage.
- Adverse drug events, Allergies, Side effects, and Adverse reactions. What are the differences?
- Overview of pharmacogenomic testing in clinical practice
- Carbamazepine, HLA-B*1502 and risk of Stevens–Johnson syndrome and toxic epidermal necrolysis: US FDA recommendations
- A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster randomised crossover implementation study
- Genetic screening to avoid adverse drug reactions from medication use and approach patients’ better outcomes: A lesson learn from the report of the Queen Savang Vadhana Memorial Hospital