A CDER conversation with Sheilyn Huang, PharmD, Safety and Risk Communication Team analyst, Division of Health Communications, Office of Communications, Center for Drug Evaluation and Research, FDA
When a drug gains FDA approval, it says that the known benefits of the drug outweigh any known risks. After drug products are approved and on the market, CDER continues to review safety information from various sources. Once a problem bubbles to the surface, CDER’s drug review experts and staff determine when and how to notify the public about the issue through a Drug Safety Communication.
Drug Safety Communications outline information for patients, consumers, and health care professionals on new drug warnings, drug label changes and other safety information. Let’s look at how these drug safety messages are researched, developed, and communicated.
How do you define a Drug Safety Communication?
A Drug Safety Communication, or DSC, is CDER’s primary tool for communicating important new and emerging safety information to the public. Although safety is carefully evaluated before a drug is approved, sometimes safety issues emerge only after approval when the drug’s use is expanded from the clinical trial setting to the general population. DSCs represent CDER’s independent scientific analyses of a drug safety issue and our communication of that information to the public.
What does a DSC communicate?
DSCs highlight new safety issues that pose potentially serious or life-threatening risks or adverse events, about which CDER thinks patients and health care professionals should be informed. DSCs often communicate information about a previously unknown drug interaction, a potential medication error like drug name confusion that may result in a serious or life-threatening adverse reaction, or even updated information about a known adverse event.
When did the program start?
The current DSC program started in January 2010. Prior to that, we often issued separate safety notifications containing the same information to health care professionals, patients, and the general public. In 2010, we consolidated these separate communication pieces into a single communication tool known as the DSC. The DSC is organized into sections so that each of our audiences can access the information that is relevant to them.
In those nearly 5 years, how many DSCs have been issued?
Since 2010, a total of 203 DSCs have been issued through August 2015.
What information is monitored to determine if a DSC is needed?
We monitor as many drug information sources as possible to see how drugs are performing once they are approved and being used by patients. We look at safety concerns or adverse events submitted by patients, health care professionals, and drug companies to MedWatch -- our adverse event reporting tool. We also monitor research reports, and data obtained from health insurance and drug companies.
What types of events warrant the development of a DSC?
There are various factors that determine whether a DSC or some other form of risk communication is needed. We carefully review the data around a new adverse event and analyze if this information could significantly alter the risk-benefit balance of a drug. So when developing a DSC, we ask if the information can aid prescribing decisions, affect a patient’s decision to use the drug, and whether actions can be taken to avoid, prevent, or minimize harm. We also take into consideration the strength of the evidence, the magnitude of the risk, and the severity of the adverse event.
Then the DSC decision is made?
Well, once we have the new safety information we often investigate the issue further and decide whether label changes are needed and if we need to communicate this information to the public. Once staff members from the drug safety and surveillance teams identify an issue to report to the public, pharmacists on our Safety and Risk Communication Team work with them to develop the DSC. We all work to make sure that the most recent science is included in a DSC so patients and health care professionals can make informed decisions.
Are DSCs approved by or agreed to by industry?
Neither. As I mentioned, DSCs are FDA’s independent scientific analysis of a drug safety issue and our communication of that information to the public. We try our best to notify drug manufacturers 24 hours before a DSC is posted on the FDA website. We do this so the companies are aware and will be able to answer questions from health care professionals or patients about the drug.
What do you want your stakeholders to learn from a DSC?
DSCs are primarily intended for patients and health care professionals. We want them to be informed about the safety issue being communicated and of any recommended actions they can take. We want to provide information that will help patients and prescribers make the best health care decisions possible.
Beyond the FDA website how is DSC information disseminated to the public?
In this digital age we must bring our messages to people when and where they want to get them. After the DSC is posted to our website, it is disseminated through a variety of channels such as listservs, health professional newsletters, podcasts, Twitter, Facebook, and MedWatch. Our DSCs are often picked up by the media, professional associations, and patient organizations. Each DSC is distributed to more than a million listserv subscribers and social media followers, and is viewed many thousands of times on our website alone.
We also work closely with the Veterans Administration, Department of Defense, Indian Health Service, and Bureau of Prisons, in addition to our foreign regulatory counterparts.
Can you track whether the information in a DSC is being used?
We currently do not have a way to reliably track whether or how the information in a DSC is being used. We do have anecdotal data gathered from safety reports and public inquires that indicate DSCs are well-received. We are conducting a research study to assess the impact DSCs have on prescribing, patient use and other health measures. It’s likely that the impact varies greatly for each drug and safety issue.
Ideally, what do you want health care professionals to do with the information provided in a DSC?
Most importantly, we want to make health care professionals aware of the safety issue. Once aware, we want them to weigh the information and the recommendations we make as they consider whether to prescribe the drug. We also want them to counsel patients who may be affected by the safety issue discussed in the DSC. Patients and health care professionals who have questions about the information in the DSC can call CDER’s Division of Drug Information at 855-543-3784.
Sometimes a DSC indicates there may be a potential risk with a drug but recommends patients continue taking it until they speak with their health care professional. How should a patient respond to this information?
DSCs often communicate emerging safety information. In these cases, information is still being analyzed or has not yet been confirmed, usually because there isn’t enough scientific evidence, the available studies are unreliable or the results from several studies do not agree. While we investigate further, we issue the DSC to let patients know about the potential risk. With this information, they can discuss it further with their health care professionals. Our research shows that the majority of patients want to know about potential problems with their medications as soon as possible.
What about not taking the medicine?
In most DSCs we recommend that patients should not stop taking a medication on their own because that can cause serious negative consequences as well. Balancing the benefits of a drug against potential risks is something that patients should always do in consultation with health care professionals.
What type of feedback have you gotten from stakeholders related to DCS?
We are conducting research with consumers and health care professionals to get feedback from them on how DSCs can be enhanced to better communicate the risks and benefits of drugs. This work will also help us to learn more about how they obtain and use information on new safety issues.
Have you made any tweaks based on feedback?
Based on our earlier research results, we have already made changes to DSCs. We now separate content into shorter, more manageable sections that are targeted to patients and health care professionals with specific recommendations for each of these two groups. We aim to explain technical and complicated scientific words and concepts using easy-to-understand language. We want to minimize any potential fear when we report these issues by providing the benefits of the drug along with the risks. As part of our continuing research we plan to test some DSC content, update formatting and make other modifications to see if they improve patients’ understanding of our messages.
How do you think the program is working?
It’s working well. Research has told us that there are some potential safety issues that consumers want to know about early. I think we are meeting their needs by alerting consumers and health care professionals about potential safety issues as soon as possible. And our messages seem to be reaching our intended audiences. We are also taking feedback from stakeholders very seriously and are making changes in order to improve the effectiveness of DSCs.
What changes would you like to see in future?
Future changes will depend on the feedback we receive from consumers and health care professionals through our research projects. We want to make sure that we continue to respond to the needs of our stakeholders, and we have already started making some modifications based on preliminary feedback. We try to make each one a little bit better than the last one, but it’s still very much a work in progress.