Abstract:

The group of people over 65 years old is growing not only in Bulgaria but in the whole EU. These patients experience changed physiological and biochemical characteristics. At the same time, they comprise a large part of the people who take painkillers.The contemporary pharmaceutical regulation is taking first steps in implementing adequate requirements and recommendations for the use of drugs among this specific group of patients, as well as towards the clinical research during the development of new products. Our goal was to examine to what level the medicinal products intended for management of neuropathic pain authorized in Bulgaria comply with the requirements for medicinal products among elderly and fatigued patients. The results show that all “old” products, including the reference listed drugs that have received marketing authorization after a national procedure before 2007 require harmonization.