Presence of metallic components in transdermal drug delivery systems and risk of skin burns

Abstract

Objective: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion, or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain.

Method: For each pharmaceutical form, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted.

Results: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%) A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields, and references.

Conclusion: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

Keywords: Cultura de seguridad; Medication safety; Mejora de la calidad; Parches transdérmicos de medicamentos; Patient safety; Quality improvement; Safety culture; Seguridad del medicamento; Seguridad del paciente; Transdermal drug delivery systems.