title: Clinical pharmacology consultation: a better answer to safety issues of drug therapy during pregnancy?
abstract: OBJECTIVE
  drug safety classifications give a very basic estimation of risk and should only be used as general guideline when assessing risk of pregnancy-related drug exposure or planning treatment. We conducted a study to assess the strength of association between both the clinical pharmacologists' risk assessment and the FDA risk categorization, and adverse pregnancy outcomes.
  
  
  METHODS
  we retrospectively reviewed records of 1,076 patients consecutively referred to the clinical pharmacology outpatient clinic for pregnancy-related drug exposure (2000-2008). Clinical pharmacologists' risk assessments were reviewed in relation to FDA drug categorization and available pregnancy outcomes.
  
  
  RESULTS
  overall, clinical pharmacologists' risk estimation was in agreement with the FDA risk categorization system in only 28% of consulted women, and in only 9% of women with high-risk exposure (FDA DX). Clinical pharmacologists' risk assessment confirming high-risk drug exposure had a better positive predictive value for adverse pregnancy outcomes than the FDA DX categorization (25% vs 14% respectively), while the negative predictive values were similar (92% vs 94% respectively). Clinical pharmacologists' risk assessment was a better predictor of adverse pregnancy outcomes compared with FDA risk categorization (OR 2.11 [95%CI 1.5-3.1; p < 0.001] vs OR 1.52 [95%CI 1.1-2.1; p = 0.014] respectively).
  
  
  CONCLUSIONS
  additional evaluation beyond the FDA drug classification is essential for safer and more rational drug use in pregnancy. Clinical pharmacologists who have undergone rigorous medical training are ideally placed to consult on administration of medicines in pregnant women, thus making the prescribing of treatments in that patient category substantially safer and more rational.
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University Hospital Zagreb, Kispatićeva 12, 10000 Zagreb, Croatia. verdeljic@gmail.com
authors.forename: Viktorija
authors.initials: V
authors.lastname: Erdeljić
authors.forename: Igor
authors.initials: I
authors.lastname: Francetić
authors.forename: Ksenija
authors.initials: K
authors.lastname: Makar-Ausperger
authors.forename: Robert
authors.initials: R
authors.lastname: Likić
authors.forename: Matea
authors.initials: M
authors.lastname: Radacić-Aumiler
mesh_terms: D000293:Adolescent; D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008875:Middle Aged; D010601:Pharmacology, Clinical; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy; D011256:Pregnancy Outcome; D012017:Referral and Consultation; D012189:Retrospective Studies; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration