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Medistat RX Voluntary Recall – Compounding Pharmacy Consulting

Medistat RX Voluntary Recall – Compounding Pharmacy Consulting

Medistat RX Voluntary Recall:

Compounding pharmacies are once again under scrutiny on a national level as Medistat RX voluntarily recalled all sterile drug products that it had produced last week. The sterile compounding pharmacy located in Foley, Alabama, recalled all manufactured and compounded medications which it distributed between November 1st, 2014 and September 3rd, 2015. It was a voluntary recall announced by the FDA pertaining to all unexpired compounded drugs produced by the pharmacy because of possible contamination.

It must be noted that although the recall is classified as “voluntary”, the FDA had previously performed a routine inspection last September 2014 and found “deficiencies in good manufacturing practices”. That inspection resulted in a notification to Medistat RX that the deficiencies were found in their manufacturing practices and that the FDA would be re-inspecting them (via FDA Form 483). The pharmacy chose to voluntarily cease all sterile compounding operations on September 1st, 2015. Additionally, the FDA announced that it has received several reports regarding harmful “events” that have been linked to medications compounded by Medistat RX. The FDA also stated that it would protect public health in the case by working jointly with the Alabama Board of Pharmacy in any subsequent actions it takes.

Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case which drew a substantial amount of national media attention, 48 patients actually died and up to 14,000 people may have received the contaminated injections.

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.


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Compounding Pharmacy Consulting – NIH Pharmacy Shuts Down

NIH Pharmacy Shuts Down:

Compounding pharmacies are once again under scrutiny on a national level as The National Institutes of Health (NIH) suspended all operations of its Clinical Center Pharmaceutical Development Section (PDS) last Thursday. The pharmacy, located at the NIH clinical center in Bethesda, Md., was shut down after the discovery of a fungus contamination in two vials of albumin being used in cancer treatments. Six cancer patients had already been administered treatments from the same batch and so far none have developed any signs of infection or become ill. Additionally, the NIH will be notifying almost 250 other patients involved in 46 studies that may be potentially affected. Patients travel from almost everywhere in the United States to participate in experimental therapies taking place at the NIH. The NIH facility acts partly as a compounding pharmacy, making special orders of medications that aren’t routinely available elsewhere.

Of greater concern is the fact that a complaint about the NIH pharmacy had already led the Food and Drug Administration to inspect the facility in May. Inspectors documented numerous problems, including flaws in air handling systems, insufficient employee training and lack of compliance with standard operating procedures. Concerns about the safety of compounding pharmacies were raised after a 2012 outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts. In that case which drew a substantial amount of national media attention, 48 patients actually died and up to 14,000 people may have received the contaminated injections.

The biggest questions facing the NIH are all based around the issues of compliance regarding adherence to established policies and procedures. Various studies to date have shown that many compounding pharmacies have been slow to react to the newest guidelines of US797 regarding compliance. The most often cited reasons include:
– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes

A quote from Leigh Briscoe-Dwyer, the chief pharmacy and medication safety officer at North Shore-Long Island Jewish Health System really gets to the heart of the matter. “Because this is the NIH, the expectation is that standards are higher than you would expect from other sites,” Briscoe-Dwyer said. “It shows that no one is immune to failing to adhere to standard operating procedures. All of us involved in pharmacy need to pay attention. If it can happen at NIH, it can happen anywhere.”

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

Bob Miller
6/18/2015


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