Coalition Urges FDA to Utilize Local Pharmacists in Drug Safety Programs

Alexandria, Va. - March 05, 2010

Seventeen health care organizations are asking the U.S. Food and Drug Administration (FDA) to consider the impact local pharmacists can have on ensuring patients use medicine safely and effectively as the agency evaluates Risk Evaluation and Mitigation Strategies (REMS). 

The American Pain Foundation, the American Pharmacists Association, the National Community Pharmacists Association and 14 regional pharmacy chains sent a letter to the FDA explaining how pharmacists can help head off potential adverse events and evaluate the patients' level of understanding through an in-person consultation. 

"Studies have shown that community pharmacists providing face-to-face patient interactions may have a greater impact on patient behavior compared to other methods of service delivery," the groups wrote. "Clearly, these services could be utilized to meet the goals of a REMS program." 

The text of the letter follows: 

March 3, 2010 

Douglas C. Throckmorton M.D.
Deputy Director
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993 

Subject: Role of Pharmacists in REMS Programs 

Dear Dr. Throckmorton: 

We are writing to reinforce our belief that the education and counseling services provided through the pharmacist with whom the patient has an established relationship are critical to assuring the appropriate and safe use of medications and to avoiding the potential risks of certain medications. We request that the agency take this into consideration as it considers the various components of effective risk evaluation and mitigation strategies (REMS) programs. 

As you know, pharmacists are medication experts on the health care team, and are highly trained and qualified to provide patient counseling and education. Many pharmacies have modified their practice settings to allow for more face-to-face interaction with the patient. The evolution of e-prescribing and pharmacist interconnectivity with other health care providers has further enhanced pharmacist access to patient information necessary to maximize the effective use of medications. 

The agency has itself recognized the role of the pharmacist as part of its recently-launched Safe Use Initiative. Pharmacists are prominently mentioned as part of the community of care providers necessary to help assure safe medication use. Our member experiences with patients suggest that safe medication use is greatly enhanced through personal face-to-face interaction with a pharmacist. 

Recent studies have shown that patients recognize the value of, and are willing to receive pharmacist delivered care. Ideally that care is delivered by a pharmacist with whom a patient has an established relationship. While other approaches to delivering these services exist, studies have shown that community pharmacists providing face-to-face patient interactions may have a greater impact on patient behavior compared to other methods of service delivery. Clearly, these services could be utilized to meet the goals of a REMS program. 

REMS solutions which leverage established technologies and existing workflows can provide the patient's pharmacist with the current medication list for review during the face-to-face counseling session. The pharmacist can review the medication list to help determine potential adverse event and drug interaction issues. Additionally, in a face-to-face dialogue, the patient's pharmacist can personally determine the patient's level of understanding. 

We urge you to leverage the value that community pharmacists bring to patient safety and risk management programs like REMS. We appreciate your consideration of these facts as various REMS programs are considered. 

Thank you, again, very much for your consideration. 

National Community Pharmacists Association
American Pain Foundation
American Pharmacists Association
Bartell Drugs
Discount Drug Mart
Hartig Drug Company
Hi-School Pharmacy
Kerr Drug, Inc.
Kinney Drugs, Inc.
Lewis Drug
Navarro Discount Pharmacy
Osborn Drugs
Thrifty-White Drug Stores, Inc.
USA Drug Stores 

cc: Margaret Hamburg, MD, FDA Commissioner
Joshua Sharfstein, MD, FDA Deputy Commissioner
Ilisa Bernstein, Pharm.D., JD, FDA Director of Pharmacy Affairs 

The National Community Pharmacists Association (NCPA®) represents America's community pharmacists, including the owners of more than 22,700 independent community pharmacies, pharmacy franchises, and chains. Together they represent an $88 billion health-care marketplace, employ over 65,000 pharmacists, and dispense over 40% of all retail prescriptions. To learn more go to or read NCPA's blog, The Dose, at

Ask Your Family Pharmacist TM