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Association 'Women without Osteoporosis'

Bulgarian government overlooks requirements of European Union for measures against osteoporosis - before the first fracture. Response of non-governmental organizations causes some change, but insufficient.

With the approval of Regulations Nr.38 and Nr.39 from Ministry of Health, Bulgaria actually overlooked the requirements of EU outlined in the report of experts’ group to the European Commission titled “Osteoporosis in EU – call for action” /2000/. There is said that “…the measures against osteoporosis should be undertaken before the first fracture”.

According to the Regulations Nr. 38 and Nr.39 of Ministry of Health published on December 3, 2004, the partial and full payment of the medicines for osteoporosis as well the dispensarization of this disease since January 1, 2005, will be done only after “pathological osteoporosis fracture available”. From the regulations is fallen away the former existed disease “Osteoporosis” remaining only “Osteoporosis with pathological fractures” to the International Code Ì80.

Both the regulations contradict the diagnostic criteria of WHO as well, according to which availability of osteoporosis is estimated on the basis of data for the bone density. From the next year on, WHO foresees to introduce also the clinical analyses as additional criterion. By the approval of Regulations Nr.38 and Nr.39 Ñ, in Bulgaria will be cured not the reason for osteoporosis – the reduced bone density, but its consequence – the fracture.

It Europe, in 2003, the total direct costs for treatment of hip fractures in the first year after the fracture amounted to EUR 17,4 MLD, and taking into account all the fractures - EUR 25 MLD. One of each 3 women and one of each 5 men over 50 has an osteoporosis fracture. If this statistics refers only to Bulgarians born in 1955, it is obtained that from the next year on we have to treat about 30 000 people with medicines to value over BGL 33 mill. Taking into account also the population over 50, this amount jumps.

The evidence available shows that it is reasonable to be foreseen means for equipments for estimation of the fracture risk, instead the occurred fractures to be treated. The examination of the bone density is the best way to determine fracture risk and the double-energy X-ray absorption (DXA) is acknowledged as the gold standard for measurement of this parameter. The norm for the so-called “osteometers for whole body” is 8 pcs. per one million population, while the technics in our country numbers just about 7 apparatuses available only in Sofia and Plovdiv.

It is evaluated that the screening of women over 65 combined with examination of bone density and clinical analyses can prevent 23% of all fractures in women for a 10-year period of time in case 25% of the subjects to treatment embraced. Bulgaria declines this resource accepting the osteoporosis fracture as criterion for treatment of this heavy and disabling disease. The rise of a fracture alone leads to the so-called “cascade effect” – increase of the fractures, if no treatment before the fracture undertaken. The rise of vertebral fracture, for example, increases the risk for new fractures from 2 to 5 times during the next year.

The main problem, not taken into account by the approval of Regulations Nr.38 and Nr.39 with respect to the criteria for treatment and dispensarization of the osteoporosis patients, is that a great part of the vertebral fractures (which are especially painful, disabling and drastically worsening the quality of life) become non-diagnosticated. It is established, in clinical investigations, that about 2 of each 3 vertebral fractures remain unnoticed by the physicians. Bearing in mind the insufficient diagnostic resources in Bulgaria, this statistics is probably much more disturbing. About 20-25% of women over 50 have already one or more vertebral fractures. An adequate medical treatment could prevent 50 to 60% of the following vertebral fractures so that the early diagnostics and treatment are of exclusive importance. Once the woman has endured the first vertebral fracture, a fivefold risk increase for new vertebral fracture exists, only within the frames of one year.
The hip fractures as result of osteoporosis have the heaviest consequences. In a year after having hip fracture, every 1 of each 4 patients dies, one of each 4 is not able to walk and 2 of each 4 are moving but very limitedly.
Association “Women without Osteoporosis” as patient non-governmental society and full member of the International Osteoporosis Foundation, for its 5-year existence, has obtained the right of public auditor in the field of osteoporosis in our country. The Association has at disposal an active membership mass and high-qualified expert, and contributes not only to increase of the public susceptibility about the problem osteoporosis, but provides also data to the responsible institutions outlining the volume of the disease propagation in the country. From this position, Association “Women without Osteoporosis” invokes the Ministry of Health to reconsider the Regulations Nr. 38 and Nr. 39 in respect with the criteria for treatment and dispensarization of osteoporosis conforming them to the contemporary requirements for treatment of osteoporosis before the rise of fractures.

Dec. 6, 2004



In response of the protests on the part of the non-governmental sector, the Ministry of Health published on December 8, 2004, supplements to Regulation 38 referring to full or partial payment of the medicines for home treatment, as follows:


“After a certain age, the progress of osteoporosis is connected with natural processes of ageing of the organism. The prophylaxis of the disease and the delay of these processes is connected not only and not mainly with medicine treatment, but with reduction of the risk factors for the disease (limited consumption of milk and milk products, smoking, etc.). The medicine treatment is strictly manifested when heavy morbid changes are available, such as bone fractures. Namely for this reason, the Ministry of Health has foreseen in Regulation 38 the treatment of this patient contingent, for which the Health-Insurance Fund will pay partially or completely the foreseen medicinal products.”
Published: December 8, 2004 in: www.government.mh.bg


These changes are not conformed to the contemporary formulations for treatment of the disease and doom the patients to sufferings, worsened quality of life loading with an additional financial burden the health insurance and the budgets of the families having osteoporosis patients.
The Association “Women without Osteoporosis” insists that to the patients of osteoporosis must be applied the modern and acknowledged in Europe standards for treatment of the disease.

08.12.2004


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