MedWatch: Safety Information and Adverse Event Reporting

Introduction
How can a busy doctor, nurse, pharmacist, or other healthcare professional be sure that they are up to date with the current prescribing information for the medical products they prescribe, dispense, or administer each day?
With the complexity of healthcare delivery in the United States in 2009, it's becoming more difficult to practice the "safe" care we all aspire to achieve -- and we could use a little help. Consider these many challenges that have all increased in recent years. Our patients are older and sicker, often taking multiple medications, and sometimes, without our knowledge, self-medicating with over-the-counter (OTC) products and dietary supplements. Our armamentarium of drugs and devices is more complex. Care is often provided at multiple facilities with little ability to track patient records from multiple providers. The demand on all healthcare professionals to provide care more quickly, and often with more documentation, places extra time pressures on everyone.
These are big challenges. But I believe that the US Food and Drug Administration (FDA) has the resources to support you in your efforts and can serve as a trusted source of safety information as you provide the best care for your patients.
As the medical director of the FDA's MedWatch program, I can report that the FDA, as a public health agency, has an increased capacity and commitment to making timely, science-based and actionable new safety information available to busy practitioners across America. This necessary and important safety information is offered in a concise, electronic format that often can be received at the point of care and then used in the shared decision-making process between providers and their patients.
This column will provide you with some background on our FDA MedWatch drug safety efforts in the past 2 decades, describe current MedWatch and FDA safety resources, which I would encourage you to consider for your daily use, and look ahead to the next 5 years when current health information technology capabilities may allow for even more proactive monitoring of, and communication about, the risks inherent in medical product use for patient care.
MedWatch, the FDA's Safety Information and Adverse Event Reporting Program
The MedWatch program was launched in 1993[1] at the direction of then FDA Commissioner David Kessler, a physician who recognized that the identification and evaluation of serious adverse events and product quality issues related to the use of drugs and devices could not be done solely by the FDA without active support and collaboration with the nation's doctors, nurses, and pharmacists. Now that the voluntary reporting process is well established (see: www.fda.gov/medwatch/report.htm), the FDA receives over 40,000 adverse event reports directly from doctors, other clinicians, and their patients. Many hundreds of thousands of similar reports sent from clinicians to manufacturers are received indirectly by the FDA.
Reporting Adverse Events Often Leads to the Dissemination of New Safety Information
When MedWatch was launched, Dr. Kessler recognized that serious adverse event reports would often result in valuable new safety information that would need to be quickly disseminated to the busy practitioner. For example, adverse event reporting may demonstrate a new drug-drug interaction, requiring dose reductions in a certain patient subpopulation. Before the availability of the Internet, the FDA communicated new drug safety information by approving new text in the Prescribing Information (PI, or "the labeling") of the drug with the expectation that the end user would find that new information "in the labeling." Prior to the wide use of the Internet, the ability to locate current information on a drug during a busy work day was a formidable task -- it required locating the appropriate information in the Physicians' Desk Reference and then searching through the paper-thin pages of tiny font to locate the information of interest. Even then, the ability to identify newer information was not easily accomplished. Happily, this critical activity, the dissemination and retrieval of new safety information, has been facilitated with the arrival and growth of the Web in the late 1990s. Today, a decade later, the FDA uses the Web and other new information tools to inform busy clinicians of safety information beyond the label.
A New Focus on Managing the Risks of Medical Products
In May 1999, the FDA published "Managing the Risks from Medical Product Use: Creating a Risk Management Framework,"[2] which explicitly recognized that reducing unintended harm from using drugs and other medical products was a complex systems problem that involved many stakeholders, including the FDA, manufacturers, providers, and patients. In the past 10 years, particularly after attention was drawn to the FDA following the Vioxx® withdrawal in 2005[3] and the subsequent September 2006 Institute of Medicine evaluation,[4] the FDA responded[5] with an initiative to "improve communication and information flow among all stakeholders engaged in promoting the safe use of medical products." To implement this initiative, the FDA is now providing practitioners and the public with earlier communications, more scientific detail on safety issues for drugs and other medical products under surveillance and monitoring, and is using more communication channels to reach the widest audience possible. The FDA's goal is to deliver targeted, product-specific and actionable information to both providers and their patients, ideally at the point-of-care, so that this information can be considered in the shared decision-making about both therapeutic and diagnostic measures. Included below are some useful MedWatch information tools that may make your day-to-day practice a bit easier and reduce the risk for patient harm.
FDA MedWatch Information Tools
MedWatch Website
The MedWatch Website, www.fda.gov/medwatch, is your gateway into the vast FDA Web, bringing you directly to product-specific safety information for all human medical products, whether drugs (prescription or OTC), biologics and other vaccines, medical devices (including laboratory diagnostics and imaging devices), or dietary supplements. The MedWatch homepage, with over 1 million visitors each month, can be a useful reference resource for you, the busy clinician, or for your organization's informaticians, especially when bookmarked and accessed directly either through your organization's Intranet resources, your smartphone, or other handheld device.
MedWatch e-List Notification
MedWatch recognized the advantages of offering busy clinicians new safety information (ie, sending information toclinicians), rather than expecting the clinician to interrupt work to seek information from the FDA. With email now a ubiquitous form of work communication, the MedWatch e-list, with more than 130,000 current subscribers, is an easy and automatic method for pharmacists, nurses, doctors, and other health professionals to learn immediately about new safety information. This information is sent out the moment the FDA identifies a new safety issue and announces it to the public. This information could, for example, alert a physician about adverse events associated with a new drug and the need to monitor the patient closely and make any necessary dosage adjustments. This timely information can avert unnecessary patient harm, allow the medication to continue to be used safely, and lead to better health outcomes. I encourage you, or perhaps a "designated subscriber" in your work unit, to subscribe to our safety alerts at http://www.fda.gov/Safety/MedWatch/ucm168422.htm.
MedWatch RSS Feeds and Text Messaging
In addition to e-list notification, MedWatch is now distributing timely safety alerts by RSS feed and as short text messages directly to cell phones. This is convenient for those who want immediate safety alerts and wish to avoid one more email message. RSS feeds are also an effective way for organizations to "grab" the safety content and automatically populate their Web pages, as an Internet or an intranet information resource. The MedWatch feed can be viewed at www.fda.gov/medwatch/rssMedWatch.xml; you can learn more and subscribe at:http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm.
MedWatch Monthly Safety Labeling Changes
Each month the FDA's Center for Drug Evaluation and Research (CDER) approves clinically important safety labeling changes for about 50 drug products. This new information, of particular interest to our pharmacist colleagues, is posted on the MedWatch Website in a table format. This allows for quick review of the drug name, sections changed, details on the most critical changes, and a link to the revised label. For example, see:http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm121083.htm for recent safety information about the combination of promethazine hydrochloride and codeine phosphate. This combination is now contraindicated in pediatric patients younger than 6 years of age due to the risk for fatal respiratory depression in this population.
Other FDA Safety Information Resources
The following FDA safety resources are not intended to serve as alerts but may supplement the MedWatch Safety Alert process, provide information in a different format, or provide more detail and depth. For example, the Patient Safety News video broadcast may include previous MedWatch alerts but present the information in an appealing video format suitable for viewing in a staff meeting setting. It could also be added to the medical center's Intranet as a safety resource.
• Drug Safety Newsletter , http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/default.htm: a quarterly, Web-based, newsletter for healthcare professionals that provides findings of selected postmarketing drug safety reviews from the CDER;
• FDA Drug Safety Podcasts , http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/UCM2007003: provide 2- to 5-minute audio recordings that discuss emerging safety information about drugs in conjunction with the release of Public Health Advisories;
• FDA Patient Safety News , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm: a monthly video presentation for healthcare professionals that features information on new drugs, biologics and medical devices, FDA safety notifications and product recalls, and ways to protect patients when using medical products; and
• DailyMed : an FDA/National Library of Medicine online collaboration providing clinicians with current prescribing information for drug products in a format that is easy to view and search. Not all approved drugs are currently listed; however, with over 4300 drugs in the database, you're likely to find what you're looking for. Take a look at this example of the current Cipro® label,http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10062, and see if you agree that it would be worth bookmarking this Website.

What Can Busy Clinicians Expect in the Coming Years?

We have heard clearly from our current e-list subscribers that they are interested in safety information messages that are targeted. These are messages that provide information on exactly what clinicians need to know, when they need to know it, and in a format that they can use or apply directly at the point of care. While this remains an elusive goal in 2009, certain capabilities in existing health information technology, trends in the organization of care delivery and payment, and recent actions by the federal government, suggest that this patient safety goal may be achievable in the next 5 years. The electronic data captured in clinical healthcare transactions using electronic health records may allow drug- and device-specific safety information to be delivered in the form of tailored reminders or alerts, or as education specific to a given provider, patient, and product. This would be a win-win outcome for all. The provider's care decisions would be assisted without interruption of normal work flow, the patient's health outcomes would be maximized, unnecessary harm could be averted, and the FDA's goal of providing the best evidence-based information to benefit the public's health would be served.

source:FDA

by

Akshaya Srikanth

Pharm.D Internee

akshaypharmd@gmail.com