Should doctors and patients be informed when high-risk pharmacy compounded products are used?

The fungal meningitis outbreak that's been gripping the country since last fall has now affected 678 patients and caused 44 deaths. Contaminated steroid injections tied to the outbreak have led to a wake-up call about a dangerous gap in regulatory oversight of compounding pharmacies that mix some injectable medications. In an earlier blog, I noted that such compounded preparations are not approved by the FDA and pharmacies also are generally not FDA-inspected.  So there is inherent risk when a compounding pharmacy acts as a manufacturer using non-sterile drug powder. In most states, including Pennsylvania, compounding pharmacy sterile processes do not undergo intensive state inspection.

Should these conditions warrant disclosure to those prescribing and administering the medication and to patients who receive the compounded medications? Do healthcare providers even consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products (injectables made from non-sterile ingredients) prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source. We decided to probe into pharmacy staff viewpoints about whether or not such transparency should be a part of the picture.

Results of a survey the Institute for Safe Medication Practices (ISMP) conducted in the fall were released this week and provide new insights into how hospitals have been managing the preparation and/or purchase of compounded high risk sterile products. Our survey was fielded in November and December and had 412 pharmacist and pharmacy technician respondents. Results were published in the January 24, 2013 issue of the ISMP Medication Safety Alert!^®.

Comments from respondents who did not believe disclosure to prescribers was necessary predominantly suggest that the pharmacy is responsible for the dispensed high-risk products and the prescriber should be able to trust the pharmacy and have confidence in the preparation. Some felt that required disclosure was akin to pharmacy "passing the buck" of responsibility on to the prescriber. I can't agree with either of these contentions. In my mind, doctors must be aware of the source. If something goes wrong after a patient receives one of these drugs, the doctor would need to have that information in order to consider whether the product was a factor when making a diagnosis.

I was also surprised to learn that only about half (54%) of respondents did not think prescribers need to disclose to patients the source of high-risk CSPs. More felt that disclosure to patients was warranted when high-risk products were prepared by an external compounding pharmacy (59%) than when prepared by the hospital pharmacy (48%). However, less than half (45%) felt that written, informed consent should be required before drug administration. Common reasons cited by this group for informing the patient included their right to be informed about the risks associated with their care, particularly the fact that a high-risk product is not approved by FDA. They felt the patient should have an opportunity to decline the treatment based on informed risk.

Respondents who do not believe disclosure to patients is necessary generally felt that patients would not have the knowledge to assess the safety of high-risk CSPs from either source, and would not have an objective way to decide whether to refuse or accept treatment. Some respondents suggested that the disclosure should be just one part of an overall informed consent for procedures or treatments where the high-risk CSP would be used. With that I must agree.

For another question we included in the survey, of major concern is that about 13% of respondents reported that contamination of high-risk products had happened in their facility during the past year. And only half (50%) of all staff pharmacists and 38% of pharmacy technicians were confident that contamination had not occurred in the past. Close to three-quarters (74%) of all respondents agreed that contamination could happen in their facility.

As noted, the meningitis incident has put this entire area of healthcare under the microscope. FDA Commissioner Margaret Hamburg has called for a new system under which compounding pharmacies that make high risk products would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. Earlier this month, Governor Deval Patrick of Massachusetts, location of the Framingham compounding pharmacy involved in the meningitis outbreak, announced proposed legislation that would require special licensing and oversight of compounding pharmacies in the state. And there is also proposed federal legislation by Congressman Markey of Massachusetts that would increase transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness. Doctors and 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.