Database analysis of the risk factors of bisphosphonate-related osteonecrosis of the jaw in Hungarian patients.

OBJECTIVE: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is a rare but serious side effect of bisphosphonates (BPs). Since this disease has no independent code in either of the diseases' or in the medical procedures' classifications, it is hard to estimate how many BP patients are affected. DESIGN: A retrospective observational epidemiological registry-based study was carried out, using the data of the national service of Hungary on the incidence of BRONJ and related factors. SETTING: A data analysis was performed, which is relevant for the whole Hungarian population from 2010 to 2014. The socioeconomic and medication data of 236 207 BP patients were analysed, and a method was worked out to define BRONJ patients from the Hungarian BP population. PRIMARY AND SECONDARY OUTCOME MEASURES: The incidences of BRONJ were analysed according to genders and the types of the BP drugs administered. The marginal interdependence between the types of BP drugs, modes of administration and main indication was calculated. RESULTS: 340 BP patients (0.1%) developed BRONJ. The incidence of BRONJ in Hungary in the malignant indication of BPs is 0.9%, and 0.1% in the non-malignant indication, and the OR to develop BRONJ was OR=9.7 (95% CI 7.8 to 12.1) between them. Although more women developed BRONJ, the proportion of men was significantly higher than that of women. Steroids increase the risk of jaw osteonecrosis, and differences were also found between the BP drugs. CONCLUSIONS: Oncology indicated, intravenously administered and steroid comedicated BP therapies pose a high risk of developing BRONJ in the Hungarian population.

[Therapeutic practice of bisphosphonate use and related pharmaceutical issues I]. / A biszfoszfonátok alkalmazásának gyakorlata és aktuális gyógyszerészeti vonatkozásai I.

The therapeutic use of Bisphosphonates was common in Hungary for the past two and a half decades. The main clinical application of Bisphosphonates is the therapy of osteoporosis and bone manifestations of malignant diseases. Patients' quality of life depends on the prevalence of the typical fragility fractures and their complications. Bisphosphonates are the basis of the therapy in both therapeutic areas, since they are able to decrease progression of the disease. In patients with good compliance adequate therapy is proven to minimize the number of bone fractures. In the present paper we summarize the pharmacological knowledge of the therapeutic use of Bisphosphonates in the two main therapeutic areas: osteoporosis and osseal manifestations of malignancies. In the second part of our paper we present analysis of the prescribed bisphosphonate drug use, reimbursed by the National Health Insurance Fund. Our results provide data on the changes of druguse and reimbursement strategy of Bisphosphonates in Hungary. Our data highlights the fact that pharmacists have to pay a special attention to the growing aging population affected by osteoporosis, moreover there should be a special focus on osteoporotic patients, since there is a decreasing rate of treated patients. To help lowering this therapeutic gap in osteoporosis, pharmacists should take an active role in the therapy management.

[Bisphosphonate use and related pharmaceutical issues II]. / A biszfoszfonátok alkalmazásának gyakorlata és aktuális gyógyszerészeti vonatkozásai II.

UNLABELLED: Bisphosphonates have basic role in decreasing progression of malignant bone processes as well as in the prevention and therapy of osteoporosis. Use of bisphosphonates is common in Hungary since 20 years. In the past decade their reimbursement has been changed several times, the use of generics decreased the price of bisphosphonates. In this paper we analyze the consumption of prescribed bisphosphonates in Hungary. DATA: Prescription data of the National Health Insurance Fund of Hungary. METHOD: We analysed the prescribed bisphosphonates between 2006-2014. We examined the type and amount of bisphosphonates used by years. After identifying therapy areas of use, we calculated the years of therapy from the DOT data. From this data we estimated the mean bisphosphonate therapy costs and costs falling for the patients. Changes in the reimbursement system regarding these medications was analysed. RESULTS: Bisphosphonate years of therapy was decreasing in osteoporosis over the 9 years examined. In oncology bisphosphonate use shows stability in drug consumption. In both therapeutic areas the proportion in therapy choice of specific bisphosphonates has changed. Bisphosphonate reimbursement costs paid by the Hungarian reimbursement system was approx. 8 billion HUF in osteoporosis and 4,7 billion HUF in oncology in 2006. Changes of the reimbursement strategy, the compulsory generic use and decreasing consumption in osteoporosis has significantly reduced the overall costs by 2014. CONCLUSION: According to our results bisphpsphonate use in oncology is moderate in Hungary, a decreasing consumption can be detected in osteoporosis, that is still expected to decrease. The use of generics reduced bisphosphonate therapy costs and also overall health care costs. In osteoporosis patients cost have substantially lowered.