- State governments have stepped up their oversight of drug compounding in recent years, yet resource limitations may be hamstringing regulators from even more thorough inspections of traditional pharmacies, according to a new report.
- In 2015, the District of Columbia and 26 states required routine inspections of compounding pharmacies at least once a year. But by 2017, the number had fallen to 22 states plus the nation's capital, The Pew Charitable Trust's report found. "This may be due to resource constraints. Representatives from all four state boards of pharmacy interviewed for this report described the need for more resources and inspection capacity," Pew wrote.
- Drug compounding refers to when a physician, local pharmacist or outsourcing facility makes patient-specific medicines. While the medicines offer a valuable source of treatment for many patients, they're also risky because they aren't usually made in accordance with the Food and Drug Administration's strict quality standards. In 2012, 76 people died and nearly 800 more got sick after steroid injections at the New England Compounding Center became contaminated.
Many states have taken significant steps to better regulate drug compounding since the disastrous meningitis outbreak that came as a result of the New England Compounding Center's adulterated steroids.
According to Pew, 32 state boards of pharmacy require traditional pharmacies that compound sterile drugs to be in complete alignment with quality standards set forth in the U.S. Pharmaceutical Convention (USP) General Chapter. Another 11 states have provisions in place that they've determined are as strong — if not stronger — as the General Chapter's guidance.
That guidance explains best practices for drug compounders, such as what protective clothing to wear, how to conduct quality tests and how to perform the necessary calculations for compounding and dispensing medications. Currently, four more states have pending legislation that could mandate traditional pharmacies be in full compliance with the chapter.
Issues have arisen despite that progress, however.
Pew's research identified more than 50 reported or potential compounding errors from 2001 to 2017. The errors were linked to 1,227 adverse events, including 99 deaths — and those figures are likely low estimates, according to the organization.
"Although the chapter is incorporated into or referenced by many states' laws and regulations, state boards of pharmacy have cited challenges in using it as an enforceable set of rules," Pew wrote. "For example, the standards' generally descriptive language and use of the words 'should' and 'shall' can lead to ambiguity as to what is required versus what is recommended."
What's more, "[e]nforcement challenges result not only from the way [the General Chapter] is written, but also because it is constantly updated to reflect new research and evidence-based best practices, respond to stakeholder input, and clarify aspects of the standards."
Amid these challenges, some states have developed methods to more clearly navigate drug compounding legislation. One example is Washington state, wherein regulators instituted a Sterile Compounding Self-Assessment Compliance Checklist so pharmacies and prescribers could know which provisions in the General Chapter are mandatory.
The USP is also looking to gather input from stakeholders as it works to revise sterile compounding guidelines. Its Compounding Expert Committee, which is responsible for any revisions to compounding-related chapters within the convention's standards, expects to open a second public comment period on its draft guidance in September. A new version of the General Chapter may come to fruition as soon as December 2019, according to Pew.
To conduct its report, Pew verified publicly available data with pharmacy boards from 43 states and D.C. and interviewed representatives from four randomly selected boards.