The development of system of professional information about pharmaceuticals: Quo vadis?
Renad N. Alyautdin , B. K Romanov
Russian Medicine ›› 2016, Vol. 22 ›› Issue (3) : 162 -165.
The development of system of professional information about pharmaceuticals: Quo vadis?
The modern technologies provide broad possibilities for acquiring information about pharmaceuticals. However, reliability of this data has no guarantee. The document about pharmaceutical developed by manufacturer and regulatory authorities is taken very often for the source of official information. The quality of content of these documents is criticized by professional community. In the European Union it is taken for trusting the short characteristic of product (SmPC) that is an official source of information about pharmaceutical. The review presents sections of SmPC criticized more often.
review / short characteristic of product / interaction of medicinal substances / undesirable effect on fetus / interaction of medicinal substances with food / adjustment of dosage of pharmaceutical under renal impairment
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Директива 2001/83/ЕС Европейского Парламента и Совета ЕС. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. |
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Директива ЕС2010/84/EU5 Европейского Парламента и Совета EC. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf. |
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Arguello B., Salgado T. Assessing the information in the Summaries of Product Characteristics for the use of 1 medicines in pregnancy and lactation. Br. J. Clin. Pharmacol. 2015; 79(3): 537-44. |
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San Miguel M.T., Martínez J.A., Vargas E. Food-drug interactions in the summary of product characteristics of proprietary medicinal products. Eur. J. Clin. Pharmacol. 2005; 61(2): 77-83. |
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Salgado T.M., Arguello B., Martinez-Martinez F., Benrimoj S.I., Fernandez-Llimos F. Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment. Eur. J. Clin. Pharmacol. 2013; 69(11): 1973-9. |
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