Source: Kordus K, Plichta D, Spiewak R. Farmakoterapia alergicznego wyprysku kontaktowego w czasach hegemonii Charakterystyki Produktu Leczniczego. Pol Merkur Lekarski 2013; 34 (199): 18-23. (In Polish)
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The treatment of allergic contact dermatitis (ACD) constitutes not only pharmacological, but also a moral and legal challenge. Only a half of the drugs recommended by expert bodies for the therapy of ACD is officially registered in Poland for treating this condition. Using medications whose effectiveness has been proven by scientific studies, yet not licensed for a given indication, can be interpreted by law as a 'therapeutic experiment', which leads to a range of consequences for the treating physician. The aim of this study was to analyze the concordance between up-to-date recommendations for ACD treatment and the scope of licensed use according to the Summary of Product Characteristics (SPC) of the recommended drugs. Materials and methods: The analysis based on the recent Polish and international recommendations regarding ACD treatment. A list of recommended drugs was compiled and confronted with the Official List of Medicinal Products that is in force in Poland. Medicinal products both recommended by expert bodies and allowed for ACD treatment in terms of SPC were indentified. Results: Among drugs recommended by experts for ACD treatment (topical and systemic glucocorticosteroids, topical and systemic immunosuppressants, barrier drugs and psoralens), only some topical and systemic glucocorticosteroids, as well as topical barrier drugs were registered for the treatment of this condition in Poland. On the other hand, SPC of some old antihistamines (cyproheptadine, hydroxizine, clemastine) contained the indication for ACD treatment, despite that they are not recommended by experts and no scientific evidence supports their efficiency in this disease. Conclusion: There are considerable discrepancies between current expert recommendations for the treatment of allergic contact dermatitis and the acceptable use of medicines as determined by official product characteristics. Keywords: allergic contact dermatitis, pharmacotherapy, therapeutic recommendations, expert guidelines, Summary of Product Characteristics, off-label use. Related articles:
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Document created: 4 February 2014, last updated: 5 February 2014.