Last year, dozens of people in the Dallas, Texas, area reported symptoms such as vision impairment, poor night vision, and loss of color perception after they received eye injections of compounded antibiotics during cataract surgery. The Food and Drug Administration (FDA) later issued a safety alert that said the drug was made with a large amount of an inactive ingredient that apparently degraded as the drug was prepared.
Now, a series of lawsuits linked to the incidents has refocused attention on the potential risks of compounding, or the creation of medications for patients with a clinical need that cannot be met by an FDA-approved drug. But incidents like these, and the harm they cause, can be prevented. To protect patient safety, regulators must hold compounders to appropriate quality standards that mitigate the risks associated with compounded products.
Manufacturers, medical providers, and others in the supply chain must follow guidelines for how these drugs are made and stored to prevent dangerous contamination or other safety issues. The specifics of these guidelines can vary for different types of compounders.
Businesses that produce supplies of ready-made compounded drugs, known as office stock, are called outsourcing facilities, and must meet current Good Manufacturing Practices (cGMP) established by the FDA. These standards are comparable to those for pharmaceutical manufacturers making FDA-approved drugs and are designed to ensure safety for compounded products made in batches and stored for relatively lengthy periods of time.
Pharmacies that compound drugs to fill prescriptions for individual patients do not have to comply with cGMP; most states instead require them to follow standards developed by a scientific nonprofit organization called the United States Pharmacopeia. Both sets of standards set guidelines for practices—such as ingredient selection and stability testing—that are intended to ensure that patients are not harmed by improperly compounded drugs.
Enforcement is another critical component to protecting patients. FDA inspects outsourcing facilities for compliance with cGMP, while states are primarily responsible for inspecting compounding pharmacies. In states with strong policies, effective oversight should include annual inspections of each sterile compounder—those that produce drugs injected or infused into the body, or administered to areas highly susceptible to infection, such as the eye, bladder, or lungs. Other compounders should be inspected every two years.
The patients in Texas who experienced vision losses after the drug was injected into their eye during cataract surgery may be among those most recently harmed by substandard compounded drugs, but the problem is not new.
Last year, Pew collected incident information from FDA and the Centers for Disease Control and Prevention, as well as journal and news articles, to identify more than 71 reported compounding errors or potential errors. In total, those were linked with adverse events involving 1,416 patients from 2001 through 2017, including 115 deaths. To protect patients, both FDA and state pharmacy regulators must ensure effective enforcement of strong quality standards for all drug compounders.
Elizabeth Jungman directs The Pew Charitable Trusts’ work on public health.