The FDA’s Office of Pharmaceutical Quality, or OPQ, covers product defects with drugs and medications. From 2016 to 2020, the OPQ found that 27% of the product complaints were quality issues. A third of the complaints were a combination of device and packaging issues.
The product quality defects reports from last year included 11,932 MedWatch reports, 4,308 field alert reports, 2,623 tested samples, 263 biological product deviations and 253 consumer complaints. The OPQ saw a rise in every category of pharmaceutical quality except customer complaints in 2020.
OPQ immunological agents
Defective products broke into five U.S. Pharmacopeia therapeutic categories during 2020. The increase in defective products was partly because of the increase of pharmaceuticals. Immunological agents were 24% of the product quality defects. The FDA has a group looking into the potential underlying issues with the products.
Other OPQ categories
During 2020, OPQ antibacterial products were high because hand sanitizer was in high demand. The rising OPQ Antineoplastics respiratory tract agents include fluticasone, fexofenadine and montelukast. The rising OPQ blood modifiers include blood thinners and treatments.
During the FDA’s five-year study, there were several notable events in the drug recall statistics. The recall of oral care solutions and povidone-iodine antiseptic pads were part of the antibacterial recalls in 2017. Antibacterial recalls during 2020 were from small, inexperienced manufacturers. The recall of cardiovascular agents in 2018 and gastrointestinal agents in 2019 was due to nitrosamine contamination.
The study includes 5,465 unique drug samples. The FDA classifies hand sanitizer recalls as non-compliant but are at the top of the recall list. The FDA is increasing its efforts to improve drug quality and reduce quality-related drug shortages. The new inspection protocol project uses standard electronic inspection protocols for structured data collection.
The FDA’s longer and tighter quality management could slow the number of defective products. The defective product reports allow the FDA to develop a new rating system and keep medicine users safer.