Physicians and other providers are the gatekeepers for prescription medicines; they decide who, under what circumstances, and for how long someone takes one – or several – medicines. But how do physicians stay abreast of the latest research about the safety and efficacy of the medicines they prescribe? We set out to understand how they keep updated about the risks and benefits of the medicines they prescribe and also to gather suggestions from them about how to improve communications about new and emerging drug safety risks.
In addition to knowing a newly approved medication’s indication(s) and its benefits and risks, physicians must also be kept up-to-date on emerging information about side effects and adverse drug reactions (ADRs) when it becomes available. Before a medication can be approved by the U.S. Food and Drug Administration (FDA) and used by the public, the pharmaceutical company must conduct well-designed clinical trials to show that the medication is safe and effective to treat a particular condition or disease. The FDA then reviews the data submitted by these companies to decide whether the medication’s benefits outweigh its risks and decides whether to approve the medication for use among patients more broadly. After FDA approves a medication and it is on the market, the Agency continues to monitor its safety and will issue a variety of communications if issues arise, such as the Drug Safety Communications (DSCs) and/or Drug-Safety related Labeling Changes.
Busy physicians are inundated with information, so they need easily accessible, up-to-date safety information to ensure they can provide scientifically based care to their patients. Despite FDA’s broad efforts to reach providers with medication safety information, little research is available on how physicians receive and use this information. As a result, RTI and FDA partnered to learn more.
We held small round-table discussions with 21 neurologists about DSCs for two medications used to prevent seizures (clobazam and ezogabine), and we conducted in-depth interviews with family practice physicians about safety announcements for testosterone and methylphenidate, a medication for attention deficit hyperactivity disorder.
During these discussions, we found that:
- While physicians value keeping up-to-date on new medication safety information, many find the task daunting and time-consuming.
- Many physicians were familiar with the medication safety issues discussed in these DSCs but were unsure from what source(s) they received the information, and few remembered receiving the information directly from FDA, which they said they would value.
- Because they received the safety information through indirect sources, most were unaware that all DSCs are posted on the FDA’s website or of the other ways FDA disseminates the DSC information, (e.g., through MedWatch or Medication Information listservs; podcasts; social media, including LinkedIn, and through targeted outreach to patient and healthcare professional organizations), nor were they aware of FDA’s searchable medication database.
If physicians are not receiving the information directly from the FDA, it’s important to understand where they are getting their medication safety information. In our discussions, physicians said that when there is an emerging safety concern for medications they frequently prescribe, they look to trusted scientific sources to learn more. The most common sources for neurologists included journal articles, direct mail from drug companies, and pharmaceutical representatives, whereas family practice physicians most often reviewed email summaries provided by professional society listservs or subscription services.
Journal articles and information from the FDA were considered the most credible sources by both groups of physicians, and they were suspicious of information that did not include citations to these sources. When we asked physicians for their thoughts on electronic health record alerts, most said that the alerts were helpful; however, a few said they were “alerted out” and wanted to be able to disable them.
So, what does all this mean for medication safety communication efforts geared toward prescribers? The illustration shows the key features of what these physicians thought would be effective for keeping them up-to-date on medication safety.
When considering the visual design of communications, best practices in public health and risk communication suggest key takeaways should be highlighted at the top of a document. Some physicians also suggested including a visual rating system, indicating how frequently the adverse event occurs, its severity, and the magnitude of the risk. Some physicians suggested a readily available and searchable database that would allow them to quickly check updated medication safety information, especially for medications they do not prescribe often. Another suggestion was for mobile app developers to allow physicians to tailor information search and retrieval according to their practice specialty, prescribing patterns and patient populations.
Additionally, as EHRs increasingly become a mainstay in physician practice, finding ways to effectively use them without undue burden, disruptions in clinical workflow, or alert fatigue are important to raise awareness of emerging medication safety information. Future research could explore whether EHRs and mobile apps are providing the safety information the physicians desire and how this information can be better presented to them when and where they need it.
RTI International acknowledges the assistance of Marc Bolick and David Phillips from the Design Thinkers Group, who worked with RTI on the design and execution of the study.
The U.S. Food and Medication Administration (FDA) Center for Medication Evaluation and Research (CDER) Office of Communications funded and participated in all phases of this project through a cooperative agreement with RTI International, U18 FD004608-02. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of FDA, CDER, or the U.S. Department of Health and Human Services.
The RTI International authors have no conflicts of interest. Dr. Paula Rausch works for FDA.
Lauren McCormack
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