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
The ASHP news piece makes reference to an old 503A guidance that included large-scale operations as one of several criteria that would influence agency enforcement and discretion decision-making. However, compounding outside federal quality standards even on a small scale in thousands of hospitals/clinics/pharmacies across the nation can represent a public health threat even larger than a single, crisis-level event. A concerning posture from ASHP, regarding FDA's mere "ideas," with little if any deference to current evidence and regulatory-science. Recall Geddes on intrinsic contamination (1976 Microbial Hazards of Infusion Therapy--Clinical Syndromes):
"In stating that this kind of episode is rare, I would point out that in the average general hospital in the UK only about 30% of patients who die have post-mortem examinations, and it is therefore impossible to state categorically that we have only seen one in 10 years. We have only IDENTIFIED one in 10 years, and I suspect that patients die from microbiological hazards of infusion therapy which go unrecognized, death being attributed to pulmonary embolism or to myocardial infarction, which can easily mimic septic shock, particularly in the elderly." [emphasis in original, italics]
What is our current understanding of intrinsic contamination rates and associated morbidity and mortality today, 40 years after the Geddes publication? Will we know about (detect), and document (with sufficient details in health records for further "population evidence" studies) and importantly count the 650 gm neonate that dies in an NICU from complications of infection arising from an intrinsically-contaminated TPN solution? Are we made sufficiently uncomfortable knowing we probably won't detect it to actually do something to begin to understand this problem in in its full scope? NECC was the tip of an as yet ill-defined iceberg. Over the past 4 years, state Boards of Pharmacy and the FDA have exposed another level of the iceberg, including wide-spread (systemic?) compounding under insanitary conditions (systematic?) across the nation, with documentation of further outbreaks--while smaller in scale compared to NECC, they are no less serious for individuals affected.
In the world of pharmacovigilance, safety "signals" are continuously evaluated. With additional clarification, some signals may become identified, important risks which are further characterized in order to determine under what circumstances such risks may offset the established benefits of a drug or therapy. This evolving information is further relied on to develop and modify risk minimization strategies. For extemporaneously compounded drugs, a rational approach to risk management should ensure that health systems 1) do not assume compounded drug interchangeability with drugs falling under the full scope of the federal Food, Drug and Cosmetic Act, 2) do not assume a baseline positive benefit-risk balance and 3) gauge under what circumstances a drug's benefits and therapeutic urgency may outweigh the fact that compounded drugs are not required to meet certain federal safety and efficacy requirements. The strategy should further require disclosures sufficient to inform individuals responsible for making benefit-risk trade-off decisions, be they fiduciary or patient.
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The ASHP news piece makes reference to an old 503A guidance that included large-scale operations as one of several criteria that would influence agency enforcement and discretion decision-making. However, compounding outside federal quality standards even on a small scale in thousands of hospitals/clinics/pharmacies across the nation can represent a public health threat even larger than a single, crisis-level event. A concerning posture from ASHP, regarding FDA's mere "ideas," with little if any deference to current evidence and regulatory-science. Recall Geddes on intrinsic contamination (1976 Microbial Hazards of Infusion Therapy--Clinical Syndromes):
"In stating that this kind of episode is rare, I would point out that in the average general hospital in the UK only about 30% of patients who die have post-mortem examinations, and it is therefore impossible to state categorically that we have only seen one in 10 years. We have only IDENTIFIED one in 10 years, and I suspect that patients die from microbiological hazards of infusion therapy which go unrecognized, death being attributed to pulmonary embolism or to myocardial infarction, which can easily mimic septic shock, particularly in the elderly." [emphasis in original, italics]
What is our current understanding of intrinsic contamination rates and associated morbidity and mortality today, 40 years after the Geddes publication? Will we know about (detect), and document (with sufficient details in health records for further "population evidence" studies) and importantly count the 650 gm neonate that dies in an NICU from complications of infection arising from an intrinsically-contaminated TPN solution? Are we made sufficiently uncomfortable knowing we probably won't detect it to actually do something to begin to understand this problem in in its full scope? NECC was the tip of an as yet ill-defined iceberg. Over the past 4 years, state Boards of Pharmacy and the FDA have exposed another level of the iceberg, including wide-spread (systemic?) compounding under insanitary conditions (systematic?) across the nation, with documentation of further outbreaks--while smaller in scale compared to NECC, they are no less serious for individuals affected.
In the world of pharmacovigilance, safety "signals" are continuously evaluated. With additional clarification, some signals may become identified, important risks which are further characterized in order to determine under what circumstances such risks may offset the established benefits of a drug or therapy. This evolving information is further relied on to develop and modify risk minimization strategies. For extemporaneously compounded drugs, a rational approach to risk management should ensure that health systems 1) do not assume compounded drug interchangeability with drugs falling under the full scope of the federal Food, Drug and Cosmetic Act, 2) do not assume a baseline positive benefit-risk balance and 3) gauge under what circumstances a drug's benefits and therapeutic urgency may outweigh the fact that compounded drugs are not required to meet certain federal safety and efficacy requirements. The strategy should further require disclosures sufficient to inform individuals responsible for making benefit-risk trade-off decisions, be they fiduciary or patient.
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