Archives for 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.

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 think these would go a long way,” said Allen Vaida, executive vice president of the Institute for Safe Medication Practices, of the recommendations.

The HHS Office of Inspector General released a report Thursday showing significant gaps in oversight of hospitals’ use of compounded, sterile drugs and urged the CMS to step up its regulatory efforts. Specifically, the OIG recommends the CMS ensure hospital surveyors—who assess whether hospitals meet the safety requirements necessary to participate in Medicare—receive training on safe compounding practices. 

The CMS should also amend its guidelines for hospital surveys to ensure they address hospitals’ contracts with stand-alone compounding pharmacies, according to the OIG report. Also, the CMS could require surveyors to determine, when reviewing hospitals, whether the stand-alone pharmacies contracting with those hospitals have registered with the Food and Drug Administration, the OIG suggested.

Erin Fox, director of drug information services at University of Utah Health Care, said it would be advisable for surveyors to make sure hospitals are doing their due diligence in selecting compounding pharmacies. But she also appreciated that the recommendations don’t demand hospitals only contract with FDA-registered pharmacies. Compounding pharmacies that register with the FDA are subject to FDA inspection, but registration is voluntary.

Hospitals contract with specific compounding pharmacies for a variety of reasons, she said.

“I’m glad there’s room in this guidance, because I think it would be very difficult to take an all-or-nothing stance and still be able to meet patient needs,” Fox said.

The OIG’s new recommendations to prevent another tragedy are doable, though they might take some time to implement, Vaida said.

Mark Chalos, an attorney for families of victims of a deadly 2012 fungal meningitis outbreak linked to a Massachusetts compounding pharmacy in which 64 people died, also called the recommendations a positive development.

“At the end of the day it’s the providers’ responsibility to ensure patient safety, and any steps that encourage providers and hold providers accountable for their conduct, I think, is a step toward protecting patient safety,” Chalos said.

The accreditors examined in the report include the Joint Commission, the American Osteopathic Association, Det Norske Veritas Healthcare and the Center for Improvement in Healthcare Quality.

The Center for Improvement in Healthcare Quality is supportive of the study’s findings, said center CEO Richard Curtis in a statement.

“Sterile compounding and admixture carries risk, and patients have a right to expect that these activities are done in a safe manner,” Curtis said. He added that compounding and admixture practices vary widely across hospitals. “The key will be to enhance oversight in a manner that is meaningful and value-added to hospitals across the spectrum.”

Attempts to get comment from the other three accreditors were unsuccessful.

The CMS did, however, agree with the study’s recommendations in a written response to the report. The agency pledged to explore developing online training materials for surveyors with state survey agencies. 

The CMS also said it would look into revising guidelines to make surveyors aware that hospitals often contract with outside compounders for sterile compounded drugs. But the CMS stopped short of saying it would require surveyors to take into account whether stand-alone compounders contracting with hospitals were registered with the FDA.

“Since Medicare regulations do not require hospitals and [critical-access hospitals] to use only those compounding pharmacies that have voluntarily registered with the FDA, surveyors would limit their assessment of the contracts with stand-alone compounding pharmacies to how the facility assures that its contracted services comply with the regulations,” the CMS wrote in its response from Administrator Marilyn Tavenner.

The agency also noted in its response that it “relies on the Food and Drug Administration (FDA) oversight of manufacturers to ensure safety of commercially available prescription drugs.”

Gabrielle Cosel, manager of drug safety at the Pew Charitable Trusts, said it’s important that Congress and the FDA continue to work to improve safety.

“I think this study is about one piece of the pie,” Cosel said.

The OIG performed its study of the CMS and the four hospital accreditors following the deadly 2012 fungal meningitis outbreak. The FDA and state agencies typically handle oversight of stand-alone compounding pharmacies such as the one involved in that outbreak, but the CMS oversees the safety of sterile compounded drugs prepared and used in Medicare-participating hospitals. That federal oversight occurs through a hospital certification process in which state survey agencies or CMS-approved accreditors assess whether the hospitals meet the conditions necessary to participate in Medicare.

The OIG study found that the CMS and the accreditors follow most of the recommended practices for ensuring the safety of sterile compounded drugs, at least some of the time. But only one of the five entities the OIG examined always reviews contracts between hospitals and stand-alone compounding pharmacies.

The oversight entities also may not have enough properly trained staff to thoroughly review hospitals’ preparation and use of sterile compounded drugs, the study found. Additionally, pharmacists are not routinely involved in most hospital surveys, even though only a trained pharmacist would likely be able to perform a comprehensive review of recommended practices, according to the study.

“Surveyors need the appropriate knowledge of this highly technical aspect of hospital operations,” the study stated. “However, we found that oversight entities provide limited training specific to compounding to their surveyors.”

Additionally, three of the five oversight entities do not look at whether the stand-alone compounding pharmacies a hospital uses are registered with the FDA, according to the study. 

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.

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.

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 pathogens from one patient and spread them to others, even after cleaning. The panel will weigh whether the existing cleaning guidelines are adequate and, if not, how to improve them.

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 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 urged the public to avoid a compounder’s medicines or attempted to shutter an operation (see here and here).