title: Contraceptive methods and informed consent among women receiving medications with potential for adverse fetal effects: a Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region study.
abstract: BACKGROUND
  Increasing diabetes, hypertension, and hypercholesterolemia rates expose some young women to medications with potential adverse fetal effects, such as angiotensin-converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), and statins. This study examined whether quality improvement (QI) interventions promote informed consent and contraception to minimize risks with use of ACE-I/ARB/statins.
  
  
  METHODS
  This longitudinal cohort study at 7 clinics abstracted medical records of 328 women aged 18 to 44 with ≥1 prescription for ACE-I/ARB/statins and ≥1 visit for hypertension, diabetes, or hypercholesterolemia during the previous year. We measured informed consent documentation and contraceptive methods before and after QI interventions in which providers contacted their patients to discuss medication risks and benefits.
  
  
  RESULTS
  Of 179 women who were not surgically sterilized, only 11.7% had documented informed consent related to the risks of ACE-I/ARB/statin use. One hundred fifty-eight women were eligible for the QI intervention (not surgically sterilized, no documented informed consent); only 76 (48.1%) received the intervention. Before the intervention, 23.7% of these 76 were "at risk" of an adverse fetal effect. After the intervention, only 7.9% (P ≤ .001) were "at risk" because some women started contraception, discontinued ACE-I/ARB/statins, or changed drug class.
  
  
  CONCLUSIONS
  Women prescribed ACE-I/ARB/statins were not consistently using contraception or were not consistently informed of the risks. Provider-implemented QI interventions improved care but were difficult to accomplish, suggesting that new interventions are needed.
authors.affiliation: Department of Family Medicine, Idaho State University, Pocatello, ID, USA.
authors.forename: Rex W
authors.initials: RW
authors.lastname: Force
authors.forename: Gina A
authors.initials: GA
authors.lastname: Keppel
authors.forename: Janelle
authors.initials: J
authors.lastname: Guirguis-Blake
authors.forename: Debra A
authors.initials: DA
authors.lastname: Gould
authors.forename: Chris
authors.initials: C
authors.lastname: Vincent
authors.forename: Kavitha
authors.initials: K
authors.lastname: Chunchu
authors.forename: Robert M
authors.initials: RM
authors.lastname: Monger
authors.forename: John T
authors.initials: JT
authors.lastname: Holmes
authors.forename: Jacintha
authors.initials: J
authors.lastname: Cauffield
authors.forename: Laura-Mae
authors.initials: LM
authors.lastname: Baldwin
mesh_terms: D000293:Adolescent; D000328:Adult; D000413:Alaska; D057911:Angiotensin Receptor Antagonists / Q000009:adverse effects; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects; D015331:Cohort Studies; D003267:Contraception / Q000379:methods*; D005260:Female; D005333:Fetus / Q000187:drug effects*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects; D007258:Informed Consent; D008485:Medical Audit; D016743:Mental Competency; D015205:Northwestern United States; D010353:Patient Education as Topic; D058996:Quality Improvement; D055815:Young Adult
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors