FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

MedWatch: Improving on 20 Years of Excellence

By: Margaret A. Hamburg, M.D. 

This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA. 

Margaret Hamburg, M.D.Reports of problems with FDA-regulated products provide information we need to protect consumers.  In the 1950s, FDA was alerted to the fatal blood disorders associated with the antibiotic chloramphenicol as a result of a lone physician’s report. This dramatic illustration of the importance of voluntary reporting prompted our initial efforts to encourage physicians to systematically report adverse medical product reactions. 

MedWatch was launched in 1993 by then-FDA Commissioner David Kessler to expand the voluntary system beyond physicians to include other health professionals such as nurses and pharmacists. 

In a journal article announcing the launch, Dr. Kessler said he hoped the new MedWatch system would encourage health care professionals to regard reporting “as a fundamental professional and public health responsibility.” 

During the past 20 years, MedWatch has prevented serious illnesses and even deaths by alerting FDA to problems. Actions range from removing products from the market to adding warnings of risks on product labels.

During that time, FDA has systematically expanded MedWatch to: 

    • make it easier for providers to report serious events;
    • make it clear to physicians and others what types of reports FDA wants to receive;
    • more widely disseminate information on FDA’s actions that have resulted from adverse event and product problem reporting; and,
    • increase physician understanding and awareness of drug-and device-induced disease.

To continue that tradition, this week FDA’s MedWatch is launching a new, consumer-friendly reporting form with less technical language. Additionally, MedWatch is working with consumer groups to promote more participation in MedWatch. 

Consumers have been encouraged to report side effects, product quality problems and other issues to MedWatch since the program was founded in 1993. However, previous efforts to increase participation have been aimed predominately at health care professionals. But the fact that more consumers are turning to the Internet to research health information created an opportunity that MedWatch is seizing. 

FDA is also launching MedWatchLearn, a web-based learning tool designed to educate students, health professionals and consumers on reporting in a way that provides the best information for reviewers to further investigate a problem. 

I urge consumers and health care professionals to submit reports, and encourage the use of the MedWatchLearn to gain a better understanding of preparing a report that is useful to FDA. Your help is invaluable, and enables us to continue ensuring that the products we regulate are safe and effective. 

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration

Students Bring Energy and Good Ideas to the Table

By: Jesse Goodman, M.D., M.P.H.

Graduate students who won a faculty-judged “America’s Got Regulatory Science Talent” competition at the University of Maryland recently filled my office with some of their ideas and energy.

Their winning ideas, and their commitment and excitement, bode well for the future of the sciences involved in ensuring that medical products are safe and effective. Perhaps above all, the problems that inspired their ideas provided powerful reminders that consumers should be engaged by health professionals and involved in their own care, including understanding the names and purposes of any medicines they are taking.

Jane Kalinina and Neha Patel, who are both pursuing degrees in law and pharmacy, saw the need for better patient awareness and understanding while working in pharmacies.

“Patients regularly called and asked, ‘What am I taking this for?’” said Kalinina. Citing a typical example, she described a patient who had been confusing her hypertension and diabetes medicines, and thus had been taking the wrong amount of each.

Such problems, they noted, are particularly problematic among the elderly, who often take multiple medicines and may see multiple doctors who may not always be aware what their colleagues have already prescribed.

Kalinina and Patel’s idea to help potentially better inform patients include the name of the condition a prescription medicine treats right on the bottle. In researching this idea, they learned that the State of California recently implemented just such an approach, with plans to evaluate potential benefits due in 2014. Kalinina and Patel plan to track this program and its evaluation and, if benefits are confirmed, hope to see the approach adopted nationally. Their idea won third place in the competition sponsored by the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Second place was awarded to five doctoral students in Pharmaceutical Health Services Research: Patience Moyo, Mehmet Burcu, Sarah Dutcher, Xinyi Ng and Dinci Pennap. Their proposal was aimed at reducing the risk of harmful drug interactions through enhancing links among doctors, health systems and pharmacists, so that pharmacists have access to complete records of medicines being prescribed.

First place went to Curtis Gallagher, a doctoral student in molecular medicine at the University of Maryland, Baltimore, who researched “untapped opportunities” to facilitate reporting and monitoring of potential drug side effects and other unanticipated problems.

He noted that about 150 million Americans take at least one prescription. Based on personal experience and a 100-person survey, he found most people did not know about MedWatch, the FDA program where negative events can be reported and are tracked for trends, or found reporting too time consuming. His suggestion was for FDA to develop easier-to-use pull down menus of potential side effects, based on a drug’s FDA labeling, and allow consumers to file through FDA or through other websites consumers typically find when doing a computer search for information on a drug or condition. His ideas are being discussed at FDA.

As our health care system works to develop and refine many new approaches to enhancing the safe use of medications, this advice to consumers remains critical: know what you are taking, and why.

Jesse L. Goodman, M.D., M.P.H., is FDA’s chief scientist. In addition to being responsible for FDA’s cross-cutting scientific and public health efforts, he also provides strategic leadership for FDA’s regulatory science and innovation initiatives.

Report Adverse Events and Sign Up to Get Medical Product Information with MedWatch

By: Jay Wattenberg

Have you ever wondered how FDA hears about side effects of drugs and other medical products once they are on the market? Or how product problems are discovered? FDA gets important reports of problems from the nation’s doctors, nurses, pharmacists, and their patients, through the MedWatch program.

MedWatch logoMedWatch, the FDA Safety Information and Adverse Event Reporting Program, has two parts. The first is a process that seeks and accepts the voluntary reporting of serious adverse events and product quality problems into the FDA. The second part is FDA’s timely release of clinically important, product-specific safety information. MedWatch gives healthcare providers and patients access to relevant safety information to share in their decision-making about therapeutic and diagnostic choices.

MedWatch Reporting:

MedWatch is a voluntary system, active after the product is introduced into healthcare system, and adverse event reports supplement what is known about the product beyond what was evaluated during clinical trials.

In 2011, FDA received 34,000 adverse event reports directly from doctors, other clinicians, and their patients. In addition, hundreds of thousands of reports are sent to manufacturers from these same groups of reporters and are received indirectly by the FDA each year.

Even just a few adverse event reports can be the source of a signal that may result in new information on how the product should be used or how a patient receiving the drug should be monitored. For example, a drug used to treat a serious illness was reported through MedWatch to have an effect on a patient’s heart function. This effect became evident after the patient had been receiving the drug for over two years. This patient’s case resulted in new recommendations on the doses of the product to be given to patients, and on monitoring patients taking it.

MedWatch Information:

The MedWatch web page, with over one million visitors each month, is your gateway into the FDA network of information for all human medical products, including drugs, biologic products, medical devices, or dietary supplements. It is a useful reference resource for the busy clinician, providing both individual product safety alerts, and a monthly compilation of safety labeling changes for drugs and relevant biologic products in a table format, allowing for quick review.

Sign Up Today!

MedWatch offers several ways to help you stay informed about the medical products you prescribe, use, or dispense every day, by sending safety alerts directly to you, as soon as they appear on the web site.

You can sign up here for free MedWatch safety alerts and you can follow MedWatch on Twitter. And, you can also receive safety alerts by text messaging directly to your cell phone – just look for the “Wireless Alerts” option in the MedWatch E-list signup!

Jay Wattenberg is a Technical Information Specialist in FDA’s Office of Special Health Issues