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European Journal of Clinical Pharmacology

, Volume 74, Issue 11, pp 1471–1474 | Cite as

Towards preventive pharmacovigilance through medicine misuse identification: an example with recombinant human growth hormone for aesthetic purposes

  • Alfredo J. Rodrigues-Neto
  • Camila Biazoni-Albaricci
  • Adalton Ribeiro
  • Silvana Lima
  • Albert Figueras
Pharmacoepidemiology and Prescription

Abstract

Purpose

Historically, somatropin has been used for conditions related with ageing, but since the marketing of recombinant human growth hormone (rhGH), increasing promotional pressure has prompted aesthetic uses, despite lack of evidences about its efficacy and safety for those purposes.

Methods

A routine analysis of the Pharmacovigilance Center of São Paulo (Brazil) showed reports of suspected adverse reactions in young adults and mature patients receiving rhGH. After presuming an off-label use of this expensive product, a drug utilisation study within the pharmacovigilance database has been carried out.

Results

The analysis showed a bimodal age distribution of the rhGH reports. Up to 17.1% of the 1289 reports (n = 220) involved patients aged ≥ 20 years taking rhGH for off-label uses.

Conclusions

This information was the basis to design interventions in order to reduce inappropriate utilisation of this expensive product. Analyses of how medicines are being used through pharmacovigilance databases are a way to identify its irrational utilisation, thus facilitating preventive actions to improve how medicines are used and reducing avoidable adverse effects.

Keywords

Pharmacovigilance Medicines utilisation Off-label Somatropin 

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

228_2018_2510_MOESM1_ESM.docx (18 kb)
ESM 1 (DOCX 18 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Faculdade de Ciências FarmacêuticasUniversidade de São PauloSão PauloBrazil
  2. 2.Núcleo de Farmacovigilância, Centro de Vigilância Sanitária de São PauloSão PauloBrazil
  3. 3.Fundació Institut Català de Farmacologia, Departament de FarmacologiaUniversitat Autònoma de BarcelonaBarcelonaSpain
  4. 4.Fundació Institut Català de FarmacologiaHospital Vall d’HebronBarcelonaSpain

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