Article Text

STATE OF THE ART OF NON-APPROVED PAEDIATRIC ANTIPARASITIC DRUGS IN A TROPICAL DISEASE UNIT IN SPAIN
  1. R Pineiro1,2,
  2. A F Medina1,2,
  3. M Garcia-Ascaso1,2,
  4. M J Mellado1,2,
  5. M Garcia-Hortelano1,2,
  6. M J Cilleruelo1,2,
  7. J Villota1,2,
  8. P Martin-Fontelos1,2
  1. 1Paediatric Department, Carlos III Hospital, Madrid, Spain
  2. 2TEDDY Spanish Network: Task-Force in Europe for Drug Development for The Young, EU. FP06 Proyect Number: LSHB-CT-2005-005216

Abstract

Introduction Pharmacokinetic, efficacy, or safety data are either unavailable or non-existent for many paediatric drugs currently prescribed in Spain; major differences also exist in drug availability, their administrative status, and authorized use.

Aim To study the use of antiparasitics in a paediatric tropical care unit treating immigrants, internationally adopted, and children travelling internationally.

Materials and Methods We reviewed antiparasitics to identify their administrative and legal status in Spain: 1) National labelled drugs with paediatric indications. 2) Medicines not available in Spain and only authorized by the “Foreign Drug Department”; 3) Off-patent drugs, prescribed for “compassionate use”; 4) Off-label drugs; 5) Unlicensed drugs; 6) Magistral formulae; 7) Orphan drugs for rare diseases.

Results Our unit prescribes 24 antiparasitic drugs. Only four of them (16%) are labelled drugs. Requesting authorization from the “Foreign Drug Department” was the only way to get 13 drugs (54%). Ten drugs (41%) required “Compassionate use” authorization. Nine medicines (37%) were off-label and 17 (71%) were unlicensed. A magistral formulae is required for adult compounds for nine medicines (37.5%). Seven (29%) could be considered orphan drugs.

Conclusions Because most antiparasitic drugs are now improperly labelled or prescribed outside normal regulatory channels, the official regulatory status for prescribing these drugs should be urgently addressed in the new European Paediatric Regulation, with the active involvement of the TEDDY Network.

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