Consuming tainted medication can lead to deadly infections and other potentially life-threatening consequences. Pharmaceutical companies, physicians, and pharmacists have a duty of care to consumers to ensure that the medications patients consume won’t adversely affect their health. When deficient manufacturing, storage, or handling procedures negatively impact the safety of a medication, then those within the distribution chain are responsible for ensuring that consumers don’t consume tainted products.
Tainted Supplements and Drugs
There have been numerous incidents involving tainted medications and dietary supplements in the past few years. These include dietary supplements which the FDA found to have significant levels of pharmaceutical drugs. From 2007 to 2016, more than 750 dietary supplements were discovered to have banned or unapproved chemicals not listed on the labels. Nearly 20% of these had more than one unapproved ingredient. Of the 750 dietary supplements flagged by the FDA, only 360 were recalled.
In 2017, an outbreak of Burkholderia cepacia was traced to PharmaTech, LLC in Florida. Their stool softener, Rugby Diocoto, is taken orally to alleviate constipation. This product was tainted with the bacteria that infected 63 confirmed patients, and 45 suspected patients in 2016. It is believed that the product was contaminated via the water source used within PharmaTech’s manufacturing facilities. Other contaminants found within the product included other types of bacteria, yeast, and mold. Each of these can have serious health consequences when ingested by a patient.
Since 2013, nearly 8,000 medications sold by pharmaceutical companies have been recalled due to concerns about potential contamination. A significant number of the facilities manufacturing these pharmaceuticals had passed FDA inspections within the 12 months proceeding the recall. From the time of manufacture to the time the recall was issued, every patient who took these medications was at risk of suffering serious or fatal injuries.
Understanding “Good Manufacturing”
The risk of contamination during the manufacturing process is significant. Pharmaceutical manufacturers are required to adhere to strict regulations regarding “good manufacturing practices.” These guidelines address the sourcing of materials, the sterilization of machinery and tools, product testing, storage, and distribution procedures.
Facilities that fail to comply with FDA regulations can have their products listed as “adulterated.” However, in most cases, the FDA cannot order a recall on adulterated products and companies are allowed to use their discretion when determining when, how, and whether to recall a potentially contaminated product. In only very rare instances does the FDA order seizures of potentially contaminated drugs.