An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them.
Enforcing this linkage expectation speaks to the agency’s commitment not to wait for a clearer legislative mandate to begin to fill in the deep gap in regulatory oversight that was placed in prominent relief by the nationwide meningitis outbreak caused by deficient quality controls in the large-scale injectable operations at the New England Compounding Center (NECC).
“The recent fungal meningitis outbreak that has been associated with over 40 deaths and 650 illnesses is the most recent and most serious in a series of adverse events associated with compounded drugs that have occurred in the last ten years,” Woodcock stressed in the letter. The agency is particularly concerned, she said, “about the large-scale distribution of compounded sterile drugs to health care facilities nationwide when compliance with appropriate standards for large-scale sterile production may not have been met, putting patients at risk” (see IPQ’s Special Report on “The Current Crisis in Pharmacy Compounding and its Implications” and follow-up coverage cited below).
The CDER director explained that “these events have caused the agency to reexamine its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions.”
The letter represents a response to a request from PharMEDium that FDA reaffirm the more flexible position the CDER compliance office had expressed to the company in 2005.
At that time, the office had informed the hospital supplier that its proposed approach to link patients to the firm’s compounded drugs after shipment would be an acceptable alternative. The February 2012 letter essentially denies the firm’s request and provides an explanation why.
Regulatory Focus Shifts Downstream
The inability to establish the linkage to the production lot when adverse events occur in hospitals involving compounded products is among the more dangerous of the current regulatory soft spots.
It prevents drawing connections between adverse events, tracking them to quality control breakdowns, and taking corrective and preventive action both at the compounding production and distribution levels.
Adding to the problem is that the intravenous preparations are often given to relatively sick patients, making the association of health issues with quality problems that much more difficult to draw. Raising the stakes is the high-risk nature of the sterile operations and of the delivery form in which health threats are magnified and speed of detection critical to prevent tragedy (IPQ November Special Report).
See related IPQ stories: