Two studies in
JAMA Internal Medicine yesterday illustrate the effects of contaminated drugs
from compounding pharmacies, even when no cases are reported.
The first study, described in a research letter, involved Hamigera insecticola fungal contamination in an intravenous (IV) magnesium sulfate solution detected after a nurse at the Yale-New Haven Hospital in Connecticut noticed a substance floating in an IV bag. Pharmacy personnel then recalled all 12,000 units of 44 products from the compounding pharmacy that were used in the hospital and two affiliated facilities.
Hospital personnel contacted 1,309 patients and 460 physicians who may have been exposed to the contaminated products, but no infections were detected. The hospital's response, however, involved an estimated 14,915 hours of personnel time and an estimated cost of $874,989.
The second study highlights a seven-patient outbreak of Burkholderia cepacia bacteria in fentanyl infusion administered at Duke University Hospital in Durham, N.C., and prepared by the on-site Duke Compounding Facility.
The patients ranged in age from 6 to 62 years, with a median age of 40. B cepacia matching the outbreak strain was detected in environmental samples from the compounding facility.
An accompanying commentary notes that 90% of US hospitals use compounded sterile preparations, which may pose a risk because they aren't required to meet FDA standards. In the commentary, Allan Coukell, BScPharm, of the Pew Charitable Trusts, recommends that physicians prefer products from FDA-approved compounding pharmacies that meet good manufacturing practice standards.
Feb 3 JAMA Intern Med research letter
Feb 3 JAMA Intern Med study abstract
Feb 3 JAMA Intern Med commentary
The first study, described in a research letter, involved Hamigera insecticola fungal contamination in an intravenous (IV) magnesium sulfate solution detected after a nurse at the Yale-New Haven Hospital in Connecticut noticed a substance floating in an IV bag. Pharmacy personnel then recalled all 12,000 units of 44 products from the compounding pharmacy that were used in the hospital and two affiliated facilities.
Hospital personnel contacted 1,309 patients and 460 physicians who may have been exposed to the contaminated products, but no infections were detected. The hospital's response, however, involved an estimated 14,915 hours of personnel time and an estimated cost of $874,989.
The second study highlights a seven-patient outbreak of Burkholderia cepacia bacteria in fentanyl infusion administered at Duke University Hospital in Durham, N.C., and prepared by the on-site Duke Compounding Facility.
The patients ranged in age from 6 to 62 years, with a median age of 40. B cepacia matching the outbreak strain was detected in environmental samples from the compounding facility.
An accompanying commentary notes that 90% of US hospitals use compounded sterile preparations, which may pose a risk because they aren't required to meet FDA standards. In the commentary, Allan Coukell, BScPharm, of the Pew Charitable Trusts, recommends that physicians prefer products from FDA-approved compounding pharmacies that meet good manufacturing practice standards.
Feb 3 JAMA Intern Med research letter
Feb 3 JAMA Intern Med study abstract
Feb 3 JAMA Intern Med commentary
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