FDA: Correct Draft Guidance on Drug Packaging

In 2013, Congress passed the Drug Quality and Security Act to strengthen the Food and Drug Administration’s supervision of compounded drugs. This legislation, passed in response to a nationwide outbreak of fungal meningitis, is well intentioned and designed to protect patient safety. Unfortunately, a draft guidance document the FDA issued last year, which outlines the agency’s interpretation of just one small provision of the law, may end up inadvertently putting hundreds of thousands of older and disabled Americans residing in long-term care (LTC) facilities at risk.

The FDA’s draft guidelines — developed without the LTC pharmacy community’s input — would prohibit essential patient safety care practices.

To explain, an LTC pharmacy is a specialized type of pharmacy that serves nursing home residents and other facilities that have residents with unique medication needs — requiring an average of 11 to 13 prescriptions per patient per day. Under Medicare and Medicaid rules, LTC pharmacies must dispense medications in specialized packaging designed to ensure safe and appropriate dispensing. Medications often are pre-positioned on the premises of LTC pharmacies to allow safe, efficient, and timely dispensing. In addition to patient-prescribed drugs, Medicare and Medicaid Requirements of Participation require LTC pharmacies to assure that nursing facilities have emergency medications on-site. Similarly, to qualify as a LTC pharmacy under Medicare Part D, the pharmacy must provide the same assurance regarding emergency medications.  Today, the FDA permits repackaging practices as long as they comply with state pharmacy law.

The FDA’s draft guidance would change that — if finalized as drafted — by preventing LTC pharmacies from providing emergency medications to nursing facilities.  It also would prevent LTC pharmacies from using remote dispensing technology – contrary to the federal government’s overarching goal of encouraging the entire health care sector to use technology to improve patient outcomes and reduce costs.  Finally, the guidance would significantly impair LTC pharmacies’ ability to pre-position commonly used medications at the pharmacies, discouraging the use of efficient pharmacy operations and delaying delivery of needed medications to patients. Extending this guidance to LTC pharmacies — which clearly was not the intent of DQSA — would put patients at risk and undermine the traditional practice of pharmacy to the detriment of patients and reducing the cost of health care. It also would subject both nursing facilities and LTC pharmacies to sanctions under the Medicare and Medicaid programs. Ironically, while DQSA targeted compounding pharmacies and compounded medications, fewer than 3 percent of prescriptions that LTC pharmacies dispense are compounded, and they only compound medications after receipt of a patient-specific prescription.

Fortunately, the FDA can take steps to fix this problem by excluding LTC pharmacies from the final guidance. Earlier this year, the Senior Care Pharmacy Coalition sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell asking that she intervene to avoid regulatory conflict between the FDA and Medicare requirements by exempting LTC pharmacies from the repackaging requirements under any final guidance. This would protect the traditional practice of pharmacy — an area that the FDA historically has left to state Boards of Pharmacy to oversee — and would assure that patients in LTC facilities receive timely medications without exposing both LTC facilities and pharmacies to unjustifiable sanctions.

Furthermore, the myriad of LTC pharmacy definitions coming from state governments, CMS, the FDA, and the Environmental Protection Agency creates an opportunity for regulatory conflict. To address this challenge, senior care pharmacies are urging Congress to create a standard, single definition of LTC pharmacies to eliminate these differing interpretations of what constitutes a LTC pharmacy, which add confusion to the provision of pharmacy services. LTC pharmacies provide a critical service to America’s seniors, which should not be compromised because of conflicting and poorly written regulations.

FDA must exclude LTC pharmacies from its final guidance, or new, needless, and conflicting regulations will threaten the care of hundreds of thousands of people and will drive up health care costs that the government can ill afford. To allow America’s LTC pharmacies to continue meeting the needs of nursing home residents, the draft guidance should be corrected before it becomes final. By doing so, safe, efficient, and appropriate dispensing of needed medications consistent with the historic practice of pharmacy will continue, benefitting patients, LTC pharmacies, and nursing homes alike.


Alan Rosenbloom is president and CEO of Senior Care Pharmacy Coalition in Washington, D.C.

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