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FDA report: Drug quality tops OPQ's list of product defects

Posted 19 August 2021 | By Kari Oakes 

FDA report: Drug quality tops OPQ's list of product defects

A new report from the US Food and Drug Administration's (FDA's) Office of Pharmaceutical Quality (OPQ) details the top drug quality issues seen in from 2016-2020, with questions of product quality topping the list.
In all, just over a quarter (27%) of all Product Quality Defect (PQD) reports were related to product quality issues, while device and packaging issues together made up another third of the PDQ reports over the 5-year period.
The PQD reports came from 11,932 MedWatch reports, 4,308 field alert reports, 253 consumer complaints, 263 biological product deviation reports, and 2,623 tested samples, explained OPQ in its report on the state of pharmaceutical quality for FY 2020. The number of reports of all types except consumer complaints climbed annually over the 2016-2020 time period, according to the report.
Breaking down PQDs by product type, OPQ found that PQDs increased in FY 2020 for five different US Pharmacopeia therapeutic categories. “Most of these increases may be due, in part, to expanded use of drug products used to treat patients with COVID-19,” wrote OPQ. As in previous years, immunological agents continued to top other categories, accounting for 24% of PQDs in 2020. FDA is monitoring surveillance signals for this category, and “has formed an interdisciplinary group to address potential underlying issues with these products,” which are often sterile injectable products.
Other categories with increased PQDs included antibacterials, with the COVID-19-related spike in hand sanitizer demand contributing to the bump in this category; antineoplastics; respiratory tract agents including montelukast, fluticasone and fexofenadine; and blood products and modifiers, including the blood thinners heparin and enoxaparin, used in the treatment of hospitalized patients with COVID-19.
Drug recall statistics over the 5-year period studied in the OPQ report were driven by several large recall events. Povidone-iodine antiseptic pads and oral care solutions were recalled in early 2017, accounting for a spike in antibacterial recalls for that period. Antibacterials again saw a recall spike when a host of methanol-contaminated hand sanitizers, often produced by inexperienced small manufacturers during the early months of the pandemic, were recalled in 2020.
Cardiovascular and gastrointestinal agents saw separate recall spikes in 2018 and 2019, respectively, but for a common reason: nitrosamine contamination.
The OPQ report also examined 5 years of product sampling data that included 5,465 unique drug samples, according to the report. Hand sanitizers led the FY 2020 list of products that were classified as non-compliant following testing. Nitrosamine contamination was the culprit in increased non-compliant rates for the gastrointestinal agents ranitidine and nizatidine.
The OPQ report highlights ongoing FDA efforts to help reduce quality-related drug shortages and improve drug quality in general. One such initiative is the New Inspection Protocol Project, “aimed at using standardized electronic inspection protocols to collect data in a structured manner,” according to the report. FDA’s structured data collection should give the agency insight into how such variables as establishment and location type affect quality.
Also, FDA outsourced a project to Dun & Bradstreet and the University of St. Gallen to assess quality management maturity in over 200 pharmaceutical manufacturers. The findings from this project, wrote OPQ, “support the hypothesis that a high degree of quality management maturity has a positive impact across an organization, including on the fundamental ability to deliver supply.” FDA is using learnings from the investigation to develop a rating system that “incentivizes drug manufacturers to invest in quality and achieve higher levels of quality management maturity.”
Editor’s note: For more from OPQ’s 2020 pharmaceutical quality report, see FDA-registered sites declined in 2020: OPQ drug quality report, Regulatory Focus 17 August 2021.
OPQ Pharmaceutical Quality Report


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Tags: FDA, OPQ, quality, US

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