Month: June 2015

Pharmacy Response to King v. Burwell Decision

For many pharmacy organizations, the Supreme Court King v. Burwell decision upholding the Affordable Care Act’s (ACA) tax subsidies fended off potential confusion for patients concerning health insurance. National Community Pharmacists Association CEO B. Douglas Hoey, RPh, MBA, remarked that community pharmacists are often the first providers that Americans—especially those who are in underserved rural and inner-city areas—turn to for …

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Tricare: Compounded medication orders fall sharply

A change to Tricare’s compounded medication coverage policy May 1 slashed costs for these medications by more than 74 percent in less than a month. But for some patients, the switch has been anything but easy. The Defense Health Agency saw reimbursements for approved compounds drop from nearly $1 billion in the first four months …

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Three More Compounders Hit With Sterility Issue Warnings

The FDA has warned three more drug compounding pharmacies over sterility issues and other GMP shortcomings, bringing to 12 the number cited since October. Florida-based Premier Pharmacy Labs and HHCS Pharmacy and Noblesville, Ind.-based Pharmakon Pharmaceuticals were cited for failing to maintain sterile rooms for manufacturing and failing to establish and follow procedures for preventing …

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Clinical Perspectives in Compounding

Human Factors in Sterile Compounding Involving a Hospital Pharmacy In the April issue of JAMA Internal Medicine published last year¹, an outbreak of bacteremia due to Burholderia contaminans (BCC) was linked to intravenous fentanyl produced by the compounding pharmacy at Duke University Hospital. The blood cultures of 7 patients during a 7 day period were …

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Docs Fight for Right to Compound Drugs

Following the 2012 scandal involving 64 patients who died and another 750 who became ill with fungal meningitis traced to unsterile conditions in a New England compounding pharmacy, the US Food and Drug Administration has been given new powers to enforce safety issues related to that practice.But at the American Medical Association’s annual House of …

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FDA Committee to Continue Considering Drug Compounding Issues

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics. The FDA’s Pharmacy Compounding Advisory Committee …

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Automated Compounding Enhances Safety and Regulatory Compliance

Several recent events point to glaring problems in ensuring the safety of compounded sterile preparations (CSPs)—problems that technology might be able to solve. In January, the Department of Health and Human Services’ Office of Inspector General (OIG) issued a report about hospitals’ use of stand-alone compounding pharmacies for CSPs. The study was spurred by concerns …

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