Pharmacovigilance: What It Is, Why It Matters, What Lies Ahead
Written by: Auren Weinberg M.D., M.B.A. and Cheryl Reifsnyder, PhD
The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.” This discipline has grown significantly over the past 10 to 15 years. In general, it focuses on drug safety; but more specifically, it refers to activities relating to adverse effects that might be caused by medications, with the goals of:
- Assessing the benefits of the medications compared to their potential risks
- Encouraging the medications’ safe and rational use in light of these potential risks
Pharmacovigilance is intended to protect patients from unnecessary harm by identifying drug hazards that may not have been previously recognized; figuring out factors that might predispose a patient to harm; refuting false safety signals; and quantifying the risks vs. benefits of potentially harmful medications—and thereby fulfilling the ultimate objectives of:
- Improving patient care and safety related to the use of medicines and medical interventions
- Improving public health and safety related to use of medicines
- Detecting problems related to medicine use and communicating these findings in a timely manner
- Contributing to assessment of the medicine’s effectiveness and risk-benefit ratio to aid in preventing harm and maximizing benefits for patients
- Encouraging safe, rational, and more effective use of medicines
In this article, we examine the value of pharmacovigilance, what we can expect from it in the future, and how Veradigm can help.
Why it matters
Medicines and vaccines provide numerous benefits for patients in preventing and treating disease, but they can also have side effects, which may be undesirable and/or unexpected. The discipline of pharmacovigilance seeks to ensure that the risk-benefit ratio of medications, vaccines, and medical interventions remain favorable throughout their life cycles. For this reason, pharmacovigilance includes activities related to managing and analyzing public health risks to help ensure the rational use of medicines, such as identifying, quantifying, and assessing risks associated with the medicine(s). This information can help to minimize or avoid harm to patients. It could also lead to the adoption of necessary safety measures and/or regulatory actions.
Pharmacovigilance frequently involves using surveillance tools such as the U.S. Food & Drug Administration (FDA) Adverse Event Reporting System (FAERS) to aid in identifying new safety concerns for medical products on the market. FAERS is an FDA database that collects reports of adverse events, medication errors, and product quality complaints that resulted in adverse events. FAERS collects these reports from healthcare professionals, consumers, and manufacturers.
FAERS was designed to support the FDA’s post-marketing surveillance program for drug and therapeutic biologic products. It provides a valuable way for the FDA to watch for new safety concerns that might be related to currently marketed medical products; however, FAERS data does have certain limitations:
- It’s uncertain that a reported event was actually due to the product; the FDA does not require proof of a causal relationship between a product and a reported event, and the reports don’t always include sufficient detail to permit proper evaluation of the event
- Information submitted in reports is unverified
- The FDA does not receive reports of every adverse event or medication error associated with a product
- Reports may also be duplicated because they are submitted by both consumers and sponsors
As a result, FAERS data cannot be used in isolation to calculate the incidence of adverse events or medication errors. If FAERS data are used to identify a potential safety concern, the FDA must perform further evaluation. This would include studies using other large databases, such as those in the Sentinel System.
Even so, FAERS data have been used for pharmacovigilance studies. For instance, one study explored adverse events caused by osimertinib. This irreversible epidermal growth factor receptor tyrosine kinase inhibitor was FDA-approved in 2015 for treatment of non-small cell lung cancer. Researchers were able to use FAERS data to identify significant new adverse event signals as well as new and unexpected adverse events occurring with this medication.
What lies ahead
The FDA’s Sentinel System was launched in 2016 to assist with pharmacovigilance. Sentinel is the FDA’s medical product safety surveillance system, created in response to a Congressional mandate to create an active post-market drug safety surveillance system. It is led by the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research (CDER). It is used to proactively assess the safety of FDA-sponsored drugs in real-world conditions.
Sentinel data is generated via numerous types of patient interactions with the U.S. healthcare system, primarily via electronic healthcare and administrative claims data. These data are collected for:
- Payment/billing
- Documentation of clinical care
- Physician decision support
- Record keeping
- Registries
Typical real-world safety surveillance, such as FAERS, is passive in nature, relying on individual reports of adverse events from healthcare providers, patients, caregivers, manufacturers, etc. (If a pharmaceutical manufacturer receives a report of an adverse event associated with one of their medications, they are required to report that event to FAERS.) However, Sentinel leverages real-world data (RWD) sourced primarily from administrative claims and electronic health records (EHRs), data that provide a rich source of information for patient safety evaluations. Sentinel uses these data to monitor the occurrence of adverse events in large numbers of patients over longer timeframes, going beyond the traditional clinical research setting.
Sentinel captures billions of patient encounters within the U.S. healthcare system, using them to generate real-world evidence to:
- Support risk management strategies and regulatory actions aimed at protecting the public’s health
- Provide evidence to alleviate drug safety concerns
- Contribute supporting evidence for FDA Drug Safety Communications or Label Changes
- Help inform healthcare providers’ clinical decision-making
The Active Risk Identification and Analysis (ARIA) system is the most significant and most developed Sentinel component. ARIA uses state-of-the-art analysis tools to monitor medication safety with Sentinel’s distributed database of standardized claims and claims linked with EHR data, enabling safety analyses to be conducted more quickly and efficiently, often taking months rather than years to complete.
For a few medications—those for which the FDA wishes to ensure that their benefits outweigh their risks because the medication has serious safety concerns—the FDA requires use of the Risk Evaluation and Mitigation Strategy (REMS) program. REMS is designed to reinforce behaviors supporting a medication’s safe use. This strategy is not designed to mitigate all a medication’s adverse effects, which are communicated to healthcare providers in the medication’s product information. Instead, REMS focuses on preventing, monitoring, and managing specific serious risks by means of informing, educating, and, in some cases, reinforcing actions to reduce the frequency and severity of an adverse event.
How Veradigm can help
Veradigm contributes to pharmacovigilance as a contributing partner with the FDA’s Sentinel System, helping manage the Sentinel Operations Center and helping develop a new Sentinel Innovation Center. Veradigm also supports biopharmaceutical sponsors in conducting post-marketing product surveillance to assist in detecting, understanding, and mitigating adverse events.
Veradigm’s Real World Evidence team specializes in supporting life science organizations with the analysis of RWD, either with you or on your behalf. Our team of industry experts can help you to identify, clarify, and address research questions.
Veradigm’s Real World Evidence team can support your pharmacovigilance needs by leading Prospective Studies, whether that means low-intervention observational studies or collaboration with Contract Research Organizations. Our team has experience with:
- Safety/Pharmacovigilance Analyses: Here we leverage EHR infrastructure to bring pharmacovigilance to the point of care with key safety event notifications and healthcare provider interactions to facilitate event reporting.
- Building Custom Clinical Registries: Our team can utilize EHR and registry data to provide you with the means to meet regulatory requirements for safety monitoring and RWD collection.
- Clinical Measure Enhancement: We can help you leverage existing clinical workflows to capture deeper clinical detail in our EHR data assets, such as patient surveys and patient reported outcomes.
Our library of Real World Evidence Publications illustrates some of the ways our Real World Evidence team is helping clients navigate even the most complex research questions.
Contact us today to learn how Veradigm can help you achieve your research goals.