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April 13, 2016

Contamination Control News: When Honey is Not So Sweet.

pharmaceutical compounding soultions

In Lithuanian, the noun ‘Medaus’ translates as ‘honey,’ at once a description of nature’s superlative food and a term that’s come to describe something of excellent quality. ‘That’s one honey of a car!’ we might exclaim in admiration of our neighbor’s Jaguar, for example. But excellence is not what immediately springs to mind when reviewing the case of Medaus Pharmacy, whose slick website touts their ‘Absolute Service. Absolute Professionalism. Absolute Value’ and an ‘A+’ rating from the Better Business Bureau.

To the uninformed eye, this might seem like a company to do business with.

But Medaus Pharmacy, based in Birmingham, AL, hit the news last week for a litany of infringements that raised flags with the Federal Drug Administration (FDA) and has resulted in a nationwide alert to healthcare professionals. Medaus Pharmacy is a compounding pharmacy founded in 1997 that specializes in injectables, bio-identical hormone replacement, pain management, chelating agents, and nutritional/longevity support. Doing business in all 50 US states, it also has some overseas clients who may, or may not, be aware of the developing situation.

During a recent inspection of Medaus’ facilities, FDA inspectors were shocked to discover ‘sterile’ preparations being made in conditions that were patently unsanitary and could result in ‘potentially life-threatening infections or death.’(1) In a FDA Form 483 issued last month, the agency made no fewer than nine (9) official ‘inspectional observations.’(2) These were assessed as follows:

  1. some aseptic processing areas were deficient in their monitoring of environmental conditions
  2. the validation of the sterilization process was inadequate
  3. the company had no testing program to assess product stability
  4. building infrastructure was inadequate and precluded proper cleaning and maintenance
  5. testing for sterility, endotoxins, and potency was not conducted on some sterile product lots
  6. SOPs for personnel clothing were not followed
  7. some time limits for production phases were exceeded
  8. non-sterile cleaning agents were seen being used in an ISO 7 cleanroom
  9. industry-standard amber vials were not in use to protect light-sensitive drug products from light degradation.

With such a damning report, the FDA immediately recommended the recall of all unexpired drugs that were marked as sterile to prevent them from use in unsuspecting patients. To date, Medaus Pharmacy has not voluntarily recalled these items.

A History of Failure to Comply

In itself, this is a shocking situation. But Medaus’ failures are rendered even more egregious by the fact that this is not the first time the pharmacy has found itself in the FDA’s crosshairs. Way back in January of 2014, it received an official warning latter – ‘No. 2014-NOL-09’ – which referenced a disastrous inspection in 2013. A complete report of that investigation is available here and runs to twelve (12) inspectional observations – including the fact that technicians were observed ‘wearing non-sterile laboratory coats, hairnets, beard covers, and facemasks while performing aseptic processing. In addition, investigators observed technicians performing aseptic processing with exposed skin.’ (3) In a section of the warning letter detailing the specific ‘Adulteration Charges,’ the complaint also highlighted building conditions that were highly unsuited to aseptic processing. In addition to unsealed panels in the ceiling of the ‘ISO 5’ cleanroom, the lack of a HEPA filtration system combined with a unidirectional airflow created a situation of low quality air flow. FDA representatives also noted that Medaus was labeling some products with expiration dates that had ‘not been established by appropriate stability testing.’ In other words: even their expiration dates were incorrect.

In the 2013 report, the corrective actions recommended by the FDA were numerous and essentially called for a comprehensive assessment of the entire operation – from facility design to SOPs and personnel selection – in order for Medaus to be in compliance with what the regulators termed ‘basic quality standards that ensure safety, identity, strength, quality, and purity.’ The second, more recent report – dated 3/11/16 – reiterates many of the same complaints. And this means that despite the grievous concerns raised in 2013/2014, for the last 3 years Medaus Pharmacy has continued to produce compounded products in conditions that do not conform to FDA guidelines. In other words, those early compliance demands appear to have been roundly ignored.

A Need for Change?

The situation with Medaus Pharmacy represents a terrible indictment of the compounding pharmacy industry and speaks to a need for greater official oversight and enforcement. Although it is incumbent upon healthcare professionals to be aware of FDA recalls, the greater responsibility for patient safety lies with the manufacturer of these types of drugs. In this case, although a recall has been recommended by the FDA, it is voluntary and, since Medaus Pharmacy appears to have willfully ignored it, it does not seem to be enforceable. Perhaps it is indeed time for change?

And on a final linguistic note, it is wryly interesting to observe that the word ‘Medaus’ is also an anagram of the term ‘amused.’ In reviewing the case of this history of flagrant violations as outlined by the FDA, we very much doubt that the agency, healthcare professionals, or their unsuspecting patients are much amused by this appalling situation.

We’d love to learn your thoughts on this article. Please leave us your comments below!

References:

(1) Sterile Drug Products by Medaus Pharmacy: FDA Alert – Lack of Sterility Assurance
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493871.htm

(2)
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM491595.pdf

(3)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm399786.htm

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Comments

  1. Ron J.

    Great Insight!

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