- Against the backdrop of a multi-state bacterial infection caused by a batch of contaminated stool softener, the Food and Drug Administration is underscoring to pharmaceutical developers the importance of keeping their equipment clean and their quality control standards up to par.
- The agency on Monday released a warning about Burkholderia cepacia, a type of bacteria that can cause respiratory infections and pneumonia, particularly for people with weaker immune systems such as the elderly and children. Last year, the pathogen made headlines when more than 60 people across eight states became infected due to a contaminated batches of PharmaTech LLC's oral, liquid docusate sodium.
- In its warning, the FDA encouraged makers of non-sterile, water-based drug to create and maintain protocols that would preventing microorganisms from ruining their products. Examples included making sure manufacturing facilities were sanitary and establishing materials inspections at various stages throughout the production cycle.
B. cepacia has been on the regulators' radars for years because of its ability to sneak into drugs, which are then widely distributed, in turn helping the pathogen spread.
That's what happened with PharmaTech's stool softener, docusate sodium. An FDA investigation discovered the water used for the medicine's production was infested with the microbe, and then shipped out to multiple states by six companies. Before that investigation concluded, PharmaTech enacted a nationwide recall of the product.
Other pharmaceutical developers have also had to recall their treatments because of B. cepacia contamination. Sage Products, for instance, reeled back in its Comfort Shield Barrier Cream Cloths last August. More recently, Nurse Assist took back all unexpired lots of its I.V. Flush Syringes after patients receiving intravenous saline flush reported demonstrated bloodstream infections.
In response to the growing number of cases where B. cepacia has posed problems for pharmaceutical companies, the agency has made concerted efforts to remind developers to keep a watchful eye over bacterial contamination.
"To prevent the risk of this opportunistic and adaptable pathogen, manufacturing control measures must include not only effective cleaning, disinfecting, and drying of equipment but also must consider almost any source of water as a potential reservoir," the FDA wrote in a 2011 journal article. "Water is the most common raw material in pharmaceutical manufacturing, and potable water is a common source of [a species of B. cepacia]. Water for pharmaceutical purposes is processed and held in a manner that minimizes microbial numbers, endotoxins, and organic and inorganic compounds."
The FDA in general has also been cracking down on current good manufacturing practices violators. In the last year alone, the agency cited drugmakers such as Sun Pharma, Jazz and GlaxoSmithKline for contamination-related issues at their respective production sites and contract manufacturing service providers.