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General and Risk Management, Patient Safety (including: medication errors, quality control)
Teratogenicity pharmacotherapeutic report as a new standard of care for pregnant women
  1. J. Crespo Bernabeu,
  2. P. Mas Morey,
  3. B. Calderón Hernanz,
  4. M. Sanz Muñoz,
  5. J.C. Pérez Pons,
  6. M. Vilanova Boltó
  1. 1Hospital Son Llatzer, Pharmacy, Palma de Mallorca, Spain


Background Pregnant women are usually excluded from clinical drug trials. However, many women take medicines while they are fertile. Because of this, the pharmacy department agreed with the Department of Obstetrics and Gynaecology (DOG) to write drug teratogenicity reports (TDR) for pregnant women (or women who desired a child).

Purpose To evaluate drug teratogenicity and write reports as requested by the DOG. Furthermore, to assess the suitability of prescriptions in the light of recommendations drawn up by the clinical pharmacist.

Materials and methods Drug teratogenicity was reviewed from September 2009 to October 2011. Drugs were classified according to drug class and the FDA teratogenicity category (A, B, C, D, X). Category recommendations were as follow: categories A and B: continue treatment; Category C: consider the risk-benefit balance; Categories D and X: stop treatment. The suitability of prescriptions in the light of TDR recommendations was assessed by reviewing the electronic medical records and the electronic ambulatory prescription records.

Results 32 TDRs were written, with 59 drugs reviewed. The FDA classification categories were: A (n=2), B (n=6), C (n=31), D (n=18), X (n=2). 49% of drugs taken belonged to the classes antidepressant, benzodiazepines or antiepileptics. During the study period seven of the 32 women were lost to follow-up. In three cases, pregnancy was legally interrupted, and the last 22 women were monitored to the end. Of all the drugs of each of the 22 women monitored, 21 drugs were discontinued (B=1; C=10; D=10; X=1), 12 drugs were continued (A=2; B=1; C=6; D=3) and it was not possible to figure it out in two drugs (B=1; C=1). The prescriptions were appropriate in the light of the TDR recommendations in 88% of the cases.

Conclusions The contribution of clinical pharmacists to the multidisciplinary team is increasingly valuable. The TDR and the subsequent monitoring of these special patients improved the knowledge of drugs during pregnancy.

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