By Michael R. Cohen, R.Ph.
In response to the national outbreak of fungal meningitis, it makes sense for healthcare providers to seriously consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source.
While some physicians order compounded preparations directly from external compounding pharmacies, others simply prescribe the compounded medication and leave it up to the pharmacy or office staff to secure it from a reputable source. Thus, they may not know that a drug has been compounded from non-sterile ingredients or by an external pharmacy.
Yesterday, Congressman Edward J. Markey (D-Mass) took a step in this direction. Markey is proposing legislation to strengthen federal regulations for compounding pharmacies. Among the features in the bill is a requirement that compounded drugs be labeled to ensure that recipients are aware that FDA has not tested the drug for safety or effectiveness. The New England Compounding Center (NECC), a compounding pharmacy located in Rep. Markey’s Congressional District, has been found to be the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states.
Compounded preparations are unapproved by FDA. Thus inherent risk enters the picture when a compounding pharmacy acts as a manufacturer using non-sterile drug powder. The pharmacy’s exact clinical properties have not undergone rigorous testing nor has the compounding process undergone intensive state or federal inspection. These conditions warrant disclosure to those prescribing and administering the medication and to patients who receive the compounded medications.
Recent discussions I had with a bioethicist and an attorney representing victims of the meningitis outbreak provided some insight. According to Gerald Schatz at the Center for Clinical Bioethics at Georgetown University Medical Center, disclosure is required when providing care beyond what one would typically consider “ordinary care” and/or when conditions are such that the provider has reason to believe there could be an adverse outcome. The recent public health disaster involving compounded injectable steroid indicates that it would be prudent to advise patients regarding the source of externally compounded preparations, to disclose that these are not FDA-approved, and to discuss the benefits and risks, including possible adverse effects.
Michael Barrett of Saltz Mongeluzzi Barrett & Bendesky, the attorney handling the meningitis cases, believes each prescriber and facility where the contaminated injections occurred is equally culpable along with the compounding source if patients experience a related adverse event. Thus, the New England Compounding Center, the healthcare facilities where the patients received the injections, and the prescribers who injected the drugs are all defendants in the meningitis cases. Mr. Barrett believes that informed consent was required in these cases because the compounding pharmacy had a “checkered past” that could have been identified by the defendants had they used due diligence to investigate the source of the preparations.
The labeling requirement in Markey’s bill will improve recognition of the source of the drug. But disclosure is also dependent on information that should be obtained during a due diligence investigation of the compounding source prior to administering the drug. This should be conducted by the hospital pharmacy that purchases the drug or by a pharmacy and therapeutics committee or other body. The results of such an investigation and the issue of disclosure need to be brought to the medical staff for a decision regarding whether to use the product and whether disclosure is required.
Bottom line: Patients should be informed when sterile products are compounded from non-sterile ingredients or are otherwise modified or prepared in a way that providers have reason to believe there might be increased risk of an adverse outcome vs. an FDA-approved product.