Month: May 2015

FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC), was re-created under a piece of 2013 legislation …

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Experts see value in stronger oversight of compounded drugs in hospitals

New recommendations on how to improve the safety of compounded, sterile drugs given in hospitals represent a step forward in the fight to prevent more patients from being sickened or killed by mishandled or improperly compounded drugs, experts say.“You could never be 100% [sure] that you’re not going to have an error occur, but I …

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Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil® (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL) Due to Particulate Matter

      Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. To date, Teva has not received any reports of adverse events related to this recall. Adrucil® Injection …

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Compounding Pharmacies Protected By Medical Liability Act

In a court decision holding that a compounding pharmacy is entitled to certain protections against medical malpractice claims, the Supreme Court of Texas established a precedent that may well prove valuable to pharmacists facing lawsuits stemming from compounded drugs. The court ruled that claims brought by a patient who allegedly suffered serious injuries as a result of …

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How One Hospital Stopped a Superbug Outbreak in Its Tracks

Specialized endoscopes that are used to perform a common medical procedure have contributed to at least 13 deaths and 121 injuries in recent years by spreading bacteria among patients. Next week a panel of medical experts will meet at the Food and Drug Administration to consider the safety of the devices. The instruments, known as duodenoscopes, have intricate channels that can harbor …

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TRICARE Revises Compound Drug Coverage

Starting May 1, 2015, Express Scripts, the TRICARE pharmacy contractor, will screen all ingredients in compound drug claims to ensure they are safe and effective, and covered by TRICARE. This screening process is like the one TRICARE already uses for other prescription drugs, but it will now apply to the ingredients in compound drugs. Compound …

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Compound Pharmacies Complain FDA is Compounding Their Problems

As far as compounding pharmacies are concerned, the FDA is compounding their problems. After a fungal meningitis outbreak that claimed 64 lives two years ago was traced to a compounding pharmacy, the agency has been cracking down. Dozens of compounders have been inspected, and some were issued warning letters for poor practices. In a few instances, the FDA …

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