BACKGROUND: A randomized study published in 2003 by the National Institute of Child Health and Human Development Maternal Fetal Medicine Units network showed efficacy of 17-alpha hydroxyprogesterone caproate (17P) for the prevention of recurrent preterm delivery. Between 2003 and 2011 the drug was often provided by compounding pharmacies. In 2011, the US Food and Drug Administration (FDA) approved the drug for this indication. OBJECTIVE: The objective of this study was to evaluate the impact of FDA approval on physician attitudes and perceptions regarding use of 17P as a drug for preventing recurrent preterm delivery. METHODS: A 10-min online survey using a structure closed-ended questionnaire format was designed and administered from 17 June 2011 to 7 July 2011 among 401 obstetricians distributed evenly throughout the USA. RESULTS: There is nearly universal awareness of 17P for the prevention of preterm birth (93 %), with a large majority (80 %) of obstetricians having reported prescribing the medication. However, surveyed physicians reported that the average proportion of eligible patients seen in their practice but not prescribed 17P in 2009-2010 was 41 %. Financial and logistical barriers carried the most weight (approximately 75 %) in the decision not to prescribe 17P to an eligible patient. Forty-one percent of respondents cited lack of FDA approval of 17P as a deterrent to prescribing the medication. Thirty-nine percent of respondents had professional liability concerns regarding prescribing compounded 17P. Assuming the same out-of-pocket expense for patients, two-thirds of obstetricians would choose to prescribe Makena(®). CONCLUSION: Awareness of 17P for the prevention of preterm birth among obstetricians is high. FDA-approved medications seem to have physician preference due to enhanced assurance for product efficacy and safety.
BACKGROUND: A randomized study published in 2003 by the National Institute of Child Health and Human Development Maternal Fetal Medicine Units network showed efficacy of 17-alpha hydroxyprogesterone caproate (17P) for the prevention of recurrent preterm delivery. Between 2003 and 2011 the drug was often provided by compounding pharmacies. In 2011, the US Food and Drug Administration (FDA) approved the drug for this indication. OBJECTIVE: The objective of this study was to evaluate the impact of FDA approval on physician attitudes and perceptions regarding use of 17P as a drug for preventing recurrent preterm delivery. METHODS: A 10-min online survey using a structure closed-ended questionnaire format was designed and administered from 17 June 2011 to 7 July 2011 among 401 obstetricians distributed evenly throughout the USA. RESULTS: There is nearly universal awareness of 17P for the prevention of preterm birth (93 %), with a large majority (80 %) of obstetricians having reported prescribing the medication. However, surveyed physicians reported that the average proportion of eligible patients seen in their practice but not prescribed 17P in 2009-2010 was 41 %. Financial and logistical barriers carried the most weight (approximately 75 %) in the decision not to prescribe 17P to an eligible patient. Forty-one percent of respondents cited lack of FDA approval of 17P as a deterrent to prescribing the medication. Thirty-nine percent of respondents had professional liability concerns regarding prescribing compounded 17P. Assuming the same out-of-pocket expense for patients, two-thirds of obstetricians would choose to prescribe Makena(®). CONCLUSION: Awareness of 17P for the prevention of preterm birth among obstetricians is high. FDA-approved medications seem to have physician preference due to enhanced assurance for product efficacy and safety.
Authors: Andrei Rebarber; Nathan S Fox; Chad K Klauser; Niki B Istwan; Debbie J Rhea; Gary J Stanziano; Daniel H Saltzman Journal: J Matern Fetal Neonatal Med Date: 2010-10
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