POLICY CURRENTS
GAO Report Focuses on Antipsychotic Use in the Community
T
he Government Accountability Office (GAO) has issued a report raising concern over the number of Medicare enrollees outside of nursing facilities with a diagnosis of dementia who have been prescribed an antipsychotic medication. The agency, the investigative arm of Congress, reports on the success of efforts to reduce the unnecessary use of antipsychotic drugs in nursing facilities and recommends that the Centers for Medicare & Medicaid apply similar efforts to reduce unnecessary antipsychotic drug use in the community. While GAO notes that proportionally fewer dementia patients in the community receive antipsychotic medicines than in nursing facilities, inappropriate drug use in longterm care has been trending down since the Health and Human Services (HHS) Inspector General reported on the high rates of antipsychotic prescribing in nursing facilities in 2011. Reading through the numbers can get a bit confusing, but GAO emphasizes that of all Medicare enrollees living in the community, 6% have a diagnosis of dementia. Of these individuals, 14% have been prescribed an antipsychotic drug. The report, Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use Among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings, provides an extensive summary of the current thinking on appropriate and inappropriate use of antipsychotic medications in patients with dementia, noting the temptation is to use these drugs to control behavior, even when their therapeutic efficacy in dementia is in doubt and when nonpharmacological alternatives may exist. The study was requested by Sen. Susan Collins (R-ME), chairman of the Senate Special Committee on Aging, and Sen. Tom Carper (D-DE), ranking minority member of the Senate Committee on Homeland Security and Governmental Affairs.
FDA Releases Draft Guidelines on Repackaging The Food and Drug Administration (FDA) has released a guideline document, Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
368
Guidance for Industry, in response to the 2013 passage of the Drug Quality and Security Act (DQSA), which intended to implement prescription drug-tracking systems as well as to regulate drug compounding. The draft guidelines would impose serious limitations on institutional pharmacies’ ability to maintain emergency supplies of drugs in nursing facilities, restrict or eliminate the ability of pharmacies to operate and maintain remote dispensing equipment, and limit the amount of medication pharmacies could prepackage in unit-of-use systems within the pharmacy. The guideline document was written without any apparent consideration of the needs of institutionalized patients and would impair long-term care pharmacy compliance with Medicare regulatory and subregulatory guidances. FDA also issued another draft guidance document, Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between States and the Food and Drug Administration. This document was required by DQSA and creates an obligation on states that enter into this agreement to monitor and enforce regulatory standards on instate pharmacies that distribute compounded drugs across state lines. States that sign this agreement would be required to take oversight and enforcement action when a pharmacy distributes 30% or more of its compounded volumes across state lines. They would also be required to file reports with FDA. Pharmacies located in states without the agreement would be limited to distribution of 5% of compounded drug products across state lines to avoid FDA enforcement action. An FDA long-term care working group, including the American Society of Consultant Pharmacists, is drafting comments to the proposed guidance document and will submit a comprehensive analysis of its shortcomings and recommend modifications to ensure that nursing facility residents continue to have access to medication in a safe and effective manner.
THE CONSULTANT PHARMACIST
Doi:10.4140/TCP.n.2015.368.
JUNE 2015
VOL. 30, NO. 6
GAO Report Focuses on Antipsychotic Use in the Community
T
he Government Accountability Office (GAO) has issued a report raising concern over the number of Medicare enrollees outside of nursing facilities with a diagnosis of dementia who have been prescribed an antipsychotic medication. The agency, the investigative arm of Congress, reports on the success of efforts to reduce the unnecessary use of antipsychotic drugs in nursing facilities and recommends that the Centers for Medicare & Medicaid apply similar efforts to reduce unnecessary antipsychotic drug use in the community. While GAO notes that proportionally fewer dementia patients in the community receive antipsychotic medicines than in nursing facilities, inappropriate drug use in longterm care has been trending down since the Health and Human Services (HHS) Inspector General reported on the high rates of antipsychotic prescribing in nursing facilities in 2011. Reading through the numbers can get a bit confusing, but GAO emphasizes that of all Medicare enrollees living in the community, 6% have a diagnosis of dementia. Of these individuals, 14% have been prescribed an antipsychotic drug. The report, Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use Among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings, provides an extensive summary of the current thinking on appropriate and inappropriate use of antipsychotic medications in patients with dementia, noting the temptation is to use these drugs to control behavior, even when their therapeutic efficacy in dementia is in doubt and when nonpharmacological alternatives may exist. The study was requested by Sen. Susan Collins (R-ME), chairman of the Senate Special Committee on Aging, and Sen. Tom Carper (D-DE), ranking minority member of the Senate Committee on Homeland Security and Governmental Affairs.
FDA Releases Draft Guidelines on Repackaging The Food and Drug Administration (FDA) has released a guideline document, Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
368
Guidance for Industry, in response to the 2013 passage of the Drug Quality and Security Act (DQSA), which intended to implement prescription drug-tracking systems as well as to regulate drug compounding. The draft guidelines would impose serious limitations on institutional pharmacies’ ability to maintain emergency supplies of drugs in nursing facilities, restrict or eliminate the ability of pharmacies to operate and maintain remote dispensing equipment, and limit the amount of medication pharmacies could prepackage in unit-of-use systems within the pharmacy. The guideline document was written without any apparent consideration of the needs of institutionalized patients and would impair long-term care pharmacy compliance with Medicare regulatory and subregulatory guidances. FDA also issued another draft guidance document, Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between States and the Food and Drug Administration. This document was required by DQSA and creates an obligation on states that enter into this agreement to monitor and enforce regulatory standards on instate pharmacies that distribute compounded drugs across state lines. States that sign this agreement would be required to take oversight and enforcement action when a pharmacy distributes 30% or more of its compounded volumes across state lines. They would also be required to file reports with FDA. Pharmacies located in states without the agreement would be limited to distribution of 5% of compounded drug products across state lines to avoid FDA enforcement action. An FDA long-term care working group, including the American Society of Consultant Pharmacists, is drafting comments to the proposed guidance document and will submit a comprehensive analysis of its shortcomings and recommend modifications to ensure that nursing facility residents continue to have access to medication in a safe and effective manner.
THE CONSULTANT PHARMACIST
Doi:10.4140/TCP.n.2015.368.
JUNE 2015
VOL. 30, NO. 6
