Some of the medications you’ve been prescribed could put you at risk of experiencing an adverse drug event (ADE), or a situation where you might be harmed by a medication.1 As one example, one of your prescriptions could be interacting with another one (drug-drug interaction), or even your DNA could be interacting with one of your prescriptions (gene-drug interaction). Those interactions may be associated with adverse effects such as headaches, nausea, or even more serious medical emergencies.
Whatever the case may be, ADEs aren’t an isolated problem. They lead to about 1.3 million visits to emergency rooms and 350,000 hospitalizations for further treatment each year in the U.S., according to the Centers for Disease Control and Prevention.2
So what is being done about it? How is the healthcare industry making sure that fewer individuals may experience ADEs? That’s where the concept of pharmacovigilance comes into play.
Pharmacovigilance is a process centered on minimizing risk from certain medications. The science of pharmacovigilance aims to detect, assess, understand, and prevent adverse effects from any drugs, whether they’re a medication or vaccine.3
To help shed some light on the importance of pharmacovigilance, Genomind spoke with Kevin Lazaruk, RPh, who’s a board-certified geriatric pharmacist and an independent long-term care consultant based in Los Angeles.
Genomind: Why is pharmacovigilance so important for health care providers and their patients?
Lazaruk: Pharmacovigilance keeps healthcare professionals abreast of the most recent risk-versus-benefit data of a drug, including drug-related issues that come with use of a normal prescription dose, an incidental overdose, an abuse situation, or withdrawal.
What is the process of pharmacovigilance?
It’s ongoing, because safety data is collected and reviewed for the entire life cycle of a drug, as long as it’s on the market. There are limitations to clinical trials: The study population is limited, their duration is short, and they don’t reflect the real-life experience of chronic or ongoing use, Lazaruk explains.
Data regarding adverse drug events or reactions is retrieved from different groups once the drug is on the market. Each adverse event is evaluated for degree of seriousness, causality, and whether it’s been documented previously or if it’s a brand-new entity. Select data is submitted to the Food and Drug Administration (FDA) per specific guidelines. As a result, changes may be made to clinical guidelines or new ones may be developed.
How does pharmacovigilance help doctors flag drug-related safety problems?
Pharmacovigilance allows for the development of strategies and actions to minimize risk, which can help patients avoid ADEs and other safety concerns, Lazaruk states. These include:
- new dosing guidelines
- providing information about new adverse effects
- adding new warnings or precautions to take
- adding new information about contraindications for use of the drug (“Contraindication” refers to a situation in which a drug, procedure, or surgery should not be used because it may be harmful to the patient.4)
Furthermore, product quality complaints related to packaging, manufacturing, contamination, or discoloration could lead to a recall of a specific lot number or even discontinuation of the drug.
Ultimately, how does pharmacovigilance affect patient experiences and positive outcomes for their health?
Pharmacovigilance guides the healthcare experience toward positive clinical goals with minimal adverse drug reactions.
As the World Health Organization (WHO) notes, “Good pharmacovigilance practice can generate the evidence that will inspire public confidence and trust.”5 Many people have a role to play in pharmacovigilance, including researchers, physicians who are writing the prescriptions, pharmacists, patients, and their family members or caregivers.
- Definition of Adverse Drug Events (ADEs): What Are ADEs (2022)
- Adverse Drug Events stats: Adverse Drug Events in Adults (2017)
- Definition of pharmacovigilance: Regulation and Prequalification: What Is Pharmacovigilance? (2020)
- Definition of contraindication: Contraindication (2021)
- WHO quote from Lazaruk: The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool (2006)