title: Can We Rely on Pharmacy Claims Databases to Ascertain Maternal Use of Medications during Pregnancy?
abstract: BACKGROUND
  Administrative databases are increasingly used to measure drug exposure in perinatal pharmacoepidemiology. We aimed to estimate the concordance between records of prescriptions filled in pharmacies and self-reported drug use during pregnancy.
  
  
  METHODS
  Data on self-reported medication use were collected at each trimester of pregnancy among a sub-sample from the Organization of Teratology Information Specialists Antidepressants in Pregnancy Cohort. Women were eligible if they were Quebec resident and provided their pharmacist's contact information. Maternal self-reports were compared with prescriptions filled in pharmacies, which are transferred to pharmaceutical services files of Quebec provincial health plan database (Régie de l'asssurance maladie du Québec). Positive and negative predictive values (PPV and NPV) for medications taken chronically (antidepressants, thyroid hormones), acutely (antibiotics), and as needed (antiemetics, asthma medications) were calculated.
  
  
  RESULTS
  Among the 93 participants (mean age = 30.2 ± 3.8 years), 41.9% (n = 39) took at least one antidepressant during pregnancy according to self-reports, and 39.8% (n = 37) according to pharmacy records. Other commonly used drugs were antiemetics (self-reported 22.6%, pharmacy record 24.7%), antibiotics (20.4%, 16.1%), asthma medications (15.1%, 15.1%), and thyroid hormones (10.8%, 8.6%). PPVs and NPVs were: (1) chronic medication: antidepressants PPV = 100% (95% confidence interval [CI], 100-100%), NPV = 96% (95% CI, 92-100%); thyroid hormones PPV = 100% (95% CI, 100-100%), NPV = 98% (95% CI, 95-100%); (2) Acute medication: antibiotics PPV = 87% (95% CI, 70-100%), NPV = 92% (95% CI, 86-98%); (3) as needed medications: antiemetics: PPV = 78% (95% CI, 62-95%), NPV = 96% (95% CI, 91-100%); asthma: PPV = 33% (95% CI, 3-64%), NPV = 99% (95% CI, 97-100%).
  
  
  CONCLUSIONS
  The high PPV and NPV validate the use of filled prescription data in large databases as a measure of medication exposure. Birth Defects Research 109:423-431, 2017. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Research Center, CHU Sainte-Justine, Montreal, Canada.
authors.forename: Jin-Ping
authors.initials: JP
authors.lastname: Zhao
authors.affiliation: Research Center, CHU Sainte-Justine, Montreal, Canada.
authors.forename: Odile
authors.initials: O
authors.lastname: Sheehy
authors.affiliation: Research Center, CHU Sainte-Justine, Montreal, Canada.|Faculty of Pharmacy, University of Montreal, Montreal, Canada.
authors.forename: Jessica
authors.initials: J
authors.lastname: Gorgui
authors.affiliation: Research Center, CHU Sainte-Justine, Montreal, Canada.|Faculty of Pharmacy, University of Montreal, Montreal, Canada.
authors.forename: Anick
authors.initials: A
authors.lastname: Bérard
mesh_terms: D015331:Cohort Studies; D016208:Databases, Factual / Q000706:statistics & numerical data; D062313:Databases, Pharmaceutical / Q000706:statistics & numerical data; D011307:Drug Prescriptions; D005260:Female; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000706:statistics & numerical data; D010593:Pharmaceutical Services; D017891:Pharmacoepidemiology / Q000379:methods*; D010604:Pharmacy; D011237:Predictive Value of Tests; D011247:Pregnancy; D011264:Pregnancy Trimesters; D011792:Quebec; D015203:Reproducibility of Results; D057566:Self Report
keywords: RAMQ; exposure; pharmacy claims; pregnancy; self-report drug use; validation