Risk control strategy in the sphere of circulation of pharmaceuticals
Aladysheva, Z.I.; Vorob'ev, A.A.
Vestnik Rossiiskoi Akademii Meditsinskikh Nauk 11: 37-41
2005
ISSN/ISBN: 0869-6047 PMID: 16408652 Document Number: 590382
The article deals with classification of pharmaceutical risks and methodical approaches to their control in the system of governmental regulation of pharmaceuticals. According to the origin of risks and possibilities of their control, the authors distinguish "outer risks", not controlled by a consumer, and "inner risks", whose probability can be lowered by a consumer. Among the "outer risks" there are systematic risks, expressed by probability of adverse effects, and diversified risks, associated with pharmaceutical quality, practice of their administration and application, and partly--with insufficient knowledge of them. As an example the authors analyze risks associated with pharmaceutical quality of medicaments withdrawn from drug-stores by Ministry of Health of Russian Federation. In order to control such risks, the authors offer classification of pharmaceuticals according to the degree of controllability of manufacturing process, the ways of administration of a pharmaceutical (pharmaceutical dosage form), the severity of harm that can be caused to a consumer due to a defect not revealed by the manufacturer, and the degree of risk for population health. The authors reckon that the methodical approaches to pharmaceutical risk control may be used in evaluation of existent mechanism of providing safety for a pharmaceutical consumer, as well as in development of State strategy of increasing pharmaceutical safety.