RESUMEN

17α-hydroxyprogesterone caproate (17-OHPC; MAKENA and generic equivalents) is the only FDA-approved medicine available to reduce the risk of preterm birth (PTB) in pregnant women with a singleton pregnancy who have a history of singleton spontaneous PTB. The FDA held an Advisory Committee meeting in October 2019 to review conflicting data between one positive U.S.-based study and one international study that failed to confirm the benefit. At this meeting, the key vote as to whether the FDA should pursue withdrawal of Makena resulted in a split; 9 members voted that the FDA pursue withdrawal and 7 members voted to leave Makena on the market and require that additional effectiveness data be generated. Removal of FDA-approved formulations of 17-OHPC-both brand name Makena and the generic equivalents-would foreseeably result in clinicians administering compounded 17-OHPC to prevent PTB in their patients. Unlike FDA-approved products, compounded drugs are not approved by the FDA and, thus, have not undergone any FDA scrutiny with regard to safety, effectiveness, or quality (as designated by good manufacturing practices; GMP) before they are marketed. Compounded drugs may be associated with significant safety risks, as poor compounding practices have resulted in serious problems with drug quality (lack of sterility or stability) and potency. Given the markedly higher rates of PTB in the U.S. compared with other industrialized nations, it is imperative that FDA-approved, GMP-produced 17-OHPC (FDA-approved brand and generic formulations) is available while additional research on its optimal use is conducted, without providers and patients resorting to pharmacist-compounded formulations for their high-risk pregnant patients.

Asunto(s)

Caproato de 17 alfa-Hidroxiprogesterona/uso terapéutico , Aprobación de Drogas , Composición de Medicamentos , Nacimiento Prematuro/prevención & control , Etiquetado de Medicamentos , Femenino , Humanos , Recién Nacido , Servicios Farmacéuticos , Embarazo , Recurrencia , Estados Unidos , United States Food and Drug Administration

RESUMEN

PURPOSE: A market research study was conducted to characterize perceptions of intramuscular (IM) and subcutaneous (SC) routes of injection, including use of autoinjectors, and how these perceptions affect adherence to injection regimens. The perspectives were from women of childbearing age (18-45 years old; consumers) and health care providers (HCPs) involved in women's health care. METHODS: Two telephone surveys, one of HCPs and the other of consumers, were conducted by KRC Research (New York, NY, USA) between May and July 2017. HCPs were recruited across the US; the consumer survey was administered to a nationally representative sample. Survey questions identified potential challenges of IM and SC administration, their impact on treatment adherence, and perceptions of autoinjectors. Results are reported using descriptive statistics and reflect an unweighted sample; margin of error is ±3% for the consumer survey. RESULTS: HCP respondents included 100 generalist OB/GYNs, 101 maternal-fetal medicine specialists, and 519 nurses; there were 1,012 female consumer respondents. Nurses reported more experience than physicians in administering injections, including with autoinjectors. Consumers reported having received treatments via both IM and SC injections; 26% had received treatment with injections at regular intervals. Most HCPs (58%) said they preferred to administer SC injections, which was also the preference for receiving injections among consumers, who reported needle size as a concern regardless of administration mode. Other major concerns were perceptions of pain and fear/anxiety, and seeing the needle, all of which were greater for IM than for SC injections. HCPs and consumers both reported greater likelihood of adherence to therapy administered SC using an autoinjector because they believe that this method provides substantial HCP and patient benefits. CONCLUSION: HCPs and consumers identified similar challenges with adherence to injections. However, there was consistently higher preference for SC relative to IM. HCPs and consumers believe that autoinjectors may increase adherence.