Jennifer Shepherd, a U.S. Public Health Service pharmacist, is one of the 25 pharmacists within FDA's Division of Drug Information who answer the calls, e-mails and letters that come into the agency every day. Get this photo on Flickr.
From their offices in Silver Spring, Md., Food and Drug Administration (FDA) pharmacists answer thousands of calls to 1-888-INFO-FDA each year.
On a recent morning, a mother wants help identifying a pill found in her son's bedroom.
Another woman asks if FDA investigators have issued a warrant for her arrest for buying a drug online, as she'd been told by a strange, threatening man who called her home.
A pharmacist in Britain wants to know where she can find a consent form to prescribe a strictly regulated drug, and she needs to know whether the rules also apply to the generic drug.
Twenty-five pharmacists and other experts who work in FDA's Division of Drug Information (DDI) assist the public by answering the calls, e-mails and letters that pour into FDA daily.
DDI is the public communications and information outreach arm of FDA's Center for Drug Evaluation and Research (CDER). The center is responsible for ensuring the safety and effectiveness of medicines— from aspirin to new cancer treatments—on the market. This gigantic task generates questions both simple and complex. Answering them, and reaching out to people affected by FDA's work, is the role of DDI.
That outreach takes many forms. DDI uses audio podcasts available on iTunes, webinars, YouTube videos, Facebook, Listserv email messages and Twitter to inform consumers, health care professionals and industry about the many issues that arise from the oversight of over-the-counter and prescription medications. DDI sponsors seminars and in-depth Webinars, and more than 83,000 people subscribe to DDI's Twitter feed for the fastest delivery of drug information.
Pharmacists on the Front Lines
Each weekday, from 8:00 a.m. to 4:30 p.m. ET, DDI pharmacists answer phone calls and personally respond to e-mails and letters. Hours are sometimes extended when an issue creates heightened public concern. News often drives calls. Calls from consumers concerned about adverse drug effects are a common occurrence. DDI is able to access and search the suspected drug’s approved labeling and give the caller important information about what has been documented about the drug's use. Additionally, DDI can provide a way to report serious, unexpected side effects via the MedWatch reporting system.
FDA's MedWatch keeps track of reports from consumers and health care professionals about side effects, product quality problems or medication errors involving drugs, biologics, medical devices and cosmetics. DDI also answers the MedWatch number, 1-800-332-1088, and helps the public report problems that involve drugs—either online, over the phone or in writing.
Sometimes, appeals are poignant. A woman e-mails that her psychiatrist has prescribed her the highest allowable dose of a particular drug, but it wasn't controlling her racing thoughts. Someone else had suggested to her that another drug might work.
The woman ends her email message: "Please help."
A DDI pharmacist offers the necessary balance of compassion and useful information about the suggested drug, and then urges the woman to speak with her psychiatrist.
As to the morning's first question, the answer provided may have prompted a further discussion between mother and son. The pill was identified as a painkiller.
The woman who'd been told the FDA planned to arrest her was reassured. It's a common scam, she was told, and was given information about how to report the incident.
The British pharmacist was linked to the proper form for a drug that is strictly regulated because it's dangerous for pregnant women. Women must register and take monthly pregnancy tests, and indeed the rules apply to the generic.
Additional Critical Outreach
In its outreach role, DDI oversees a number of programs, including internships and fellowships. As part of FDA's Pharmacy Student Experiential Program, which is run by DDI, 221 pharmacy interns will be exposed to FDA's multidisciplinary approach to public health involving drugs, biologics and medical devices in the 2012-2013 school year. Steadily growing, this program is up from 89 student interns in 2008.
The Regulatory Pharmaceutical Fellowship allows pharmacists to experience careers in academia, industry and the FDA. The two-year program has three tracks—drug information, drug marketing and advertising, and medication safety.
Online seminars are offered at DDI Webinars for pharmacists, nurse practitioners and medical students. DDI also hosts webinars and workshops as part of its CDER Small Business and Industry Assistance (CDER SBIA) Program, which focuses its efforts on businesses employing fewer than 500 employees. The small business program, in addition to answering individual requests for help, hosts workshops and recently started a newsletter.
Health care professionals and consumers tune into DDI's Drug Safety Podcasts for the latest drug safety information. Pharmacists can get information to help their patients make the best medical decisions through training videos produced by DDI at FDA Drug Info Rounds.
"We work to be both reactive and proactive," says DDI Director Mary Kremzner, Pharm.D. "FDA has information critical to consumers, and we're looking for every way possible to deliver."