I continue to ask readers to submit their positive stories relating to compounded medications. If you have such a story or know of one on the Internet that I have not already posted, please feel free to either comment or email it to me. I would love to hear from doctors, pharmacists, veterinarians, consumers or anyone else who has a positive story to tell.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Wednesday, January 30, 2013
Should doctors and patients be informed when high-risk pharmacy compounded products are used?
Filed Under: Michael Cohen
POSTED: Friday, January 25, 2013, 9:34 AM
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!®.
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