A group of 17 health care organizations, including pharmacy chains and associations, have asked the Food and Drug Administration 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).


Food and Drug Administration, Risk Evaluation and Mitigation Strategies, REMS, National Community Pharmacists Association, American Pain Foundation, American Pharmacists Association, Douglas Throckmorton, FDA's Center for Drug Evaluation and Research, Bartell Drugs, Discount Drug Mart, Hartig Drug, Hi-School Pharmacy, Kerr Drug, Kinney Drugs, Lewis Drug, Navarro Discount Pharmacy, Osborn Drugs, Pamida, Shopko, Thrifty-White Drug Stores, USA Drug Stores, Lifechek


































































































































































































































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Coalition to FDA: Pharmacists can aid in drug safety

March 5th, 2010

ALEXANDRIA, Va. – A group of 17 health care organizations, including pharmacy chains and associations, have asked the Food and Drug Administration 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 National Community Pharmacists Association, the American Pain Foundation, the American Pharmacists Association and 14 regional pharmacy chains this week 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," stated the letter, which was directed to Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "Clearly, these services could be utilized to meet the goals of a REMS program."

The FDA Amendments Act of 2007 gave the agency the authority to require a Risk Evaluation and Mitigation Strategy from pharmaceutical manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

"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 group pointed out in the letter. "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."

Drug chains signing the letter included Bartell Drugs, Discount Drug Mart, Hartig Drug, Hi-School Pharmacy, Kerr Drug, Kinney Drugs, Lewis Drug, Navarro Discount Pharmacy, Osborn Drugs, Pamida, Shopko, Thrifty-White Drug Stores, USA Drug Stores and Lifechek.

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