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General and Risk Management, Patient Safety (including: medication errors, quality control)
Risk management for biological agents I in rheumatoid arthritis
  1. M. Sánchez de Castro,
  2. E. Díaz Gomez,
  3. A. Lázaro López,
  4. M. Fernández de Prada,
  5. S. Cuerda Coronel,
  6. M. Gasanz Goricoechea,
  7. M. Blanco Cresco,
  8. G. Sevilla Santos,
  9. E. Luque López,
  10. A. Horta Hernández
  1. 1Hospital Universitario De Guadalajara, Pharmacy, Guadalajara, Spain
  2. 2Hospital Universitario De Guadalajara, Rheumatology, Guadalajara, Spain


Background TNF antagonists have been successfully used for the treatment of rheumatoid arthritis (RA). However, data from clinical trials and databases have shown that patients treated with these biological agents have an increased risk of reactivation of latent tuberculosis (TB), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections. The Spanish Society of Rheumatology (SSR) has made some recommendations. According to these guidelines it is mandatory to exclude tuberculosis infection with an evidence level (EL) 2b, Grade of evidence (GR) B. Serology for HBV (EL4, GRC) and HCV (EL4, GRC) are recommended as complementary tests.

Purpose To establish the percentage of patients who underwent the recommended tests prior to treatment in a tertiary hospital. Latent infections are ruled out by a tuberculin test and chest x-rays (tuberculosis), HBV markers and HCV antibodies.

Materials and methods Retrospective observational study of patients with RA who started treatment with biological agents between January 2010 and August 2011. Data were extracted from Farmatools and Sinapsis care databases. The variables collected were: age, sex, biological agent, BCG skin tests, chest x-rays, anti HCV antibodies and HBV markers.

Results A total of 36 patients (78% female, 22% male), started a biological treatment for RA. The average age was 55 years. The drugs used were: etanercept 28%, adalimumab 69% and certolizumab 3%. Tuberculosis was evaluated in all patients, HCV in 58% and HBV in 56%. HCV and HBV tests were positive in 3% and 11% of the patients respectively.

Conclusions Screening for tuberculosis infections is a common practice in this hospital. Serology for HCV and HBV were tested in a noteworthy percentage of patients although these complementary tests had recently been recommended by SSR. The pharmacy department may improve this goal by making a double check before the first dose is dispensed.

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