Lege Artis Medicinae

[Original and generic drugs: Research, efficacy, utilization, and financing ]


JULY 27, 2009

Lege Artis Medicinae - 2009;19(06-07)

[Starting from the definition of medicinal drugs, this paper covers the terms of original, active principles, original and generic drugs, and their distinctive and identical properties. It also surveys the fundamentals of drug-marketing authorization, criteria of therapeutic and bioequivalence, pharmaceutical and pharmacokinetic equivalence, and development possibilities of generic drugs.]



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[Prevalence and potential predictors of morbidity among hungarian female physicians]

GYŐRFFY Zsuzsa, ÁDÁM Szilvia, KOPP Mária

[BACKGROUND - We explored the general health status of physicians in Hungary using a nationwide sample. Based on international and Hungarian literature, we hypothesised that the prevalence of psychiatric and somatic morbidity is higher among female physicians in Hungary compared to the normative population. SUBJECTS AND METHODS - The objective of our cross-sectional research was to study the morbidity of Hungarian female physicians as well as to analyse background factors. Data for this national study were collected from 408 female physicians. 818 white collar workers from a representative survey (Hungarostudy 2002) served as controls. RESULTS - The prevalence of chronic somatic morbidity and reproduction disorders among female physicians was significantly higher than that in the control group. The female physicians have more chronic diseases, and the somatic morbidity have been appeared earlier. Correlation analyses confirmed a significant relationship: the chronic morbidity associated with injurious to health, sleep disorders and higher levels of work-family conflict. We found that the prevalence of chronic somatic morbidity among female physicians was significantly higher than that in the respective control groups. CONCLUSION - The higher prevalence of somatic and mental morbidity of Hungarian female physicians has important consequences. This may influence health care systems and thus might lead increased morbidity and mortality of Hungarian population.]

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[Female Physicians in the Early History of European Medicine]


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Lege Artis Medicinae

[Melatonin, sleep and the circadian rhythm: theoretical considerations and their chronopharmacological applications ]


[The predictive homeostasis of living organisms is an anticipatory adaptation to rhythmical environmental changes. A good example for this is the circadian rhythm preparing the organism for the alternation of day and night. The circadian rhythm of melatonin production anticipates the timing and duration of nocturnal sleep of human subjects. It also induces a sleep-like stimulusprocessing mode of the brain and - in case of adequate environmental circumstances - a soporific and in part, a sleep-inducing effect. Specificities of melatonin effects on sleep are the reduction of slow-wave EEG activity, as well as the increase in seep EEG spindling and REM sleep time. Like other substances with hypnotic properties, melatonin decreases core body temperature, but has also a strong chronobiotic effect that is expressed as rapid and strong phase shifts of the circadian rhythm, depending on the time of day of melatonin administration. Because light acutely suppresses melatonin production, adequately timed light exposition, containing also low wavelength components, together with exogenous melatonin, could be useful in treating jet-lag syndrome and other circadian rhythm disorders.]

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[The Role of Playing in the Maintenance of Mental Fitness]


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[The author demonstrates the relationship between the innovative and generic antiepileptic drugs regarding the clinical aspects. Among the requirements for the registration of generics one can find small differences in the prescribed and the practical levels of bioequivalence. An important but not widely known fact is that these differences can lead to clinically important alterations if the effects of different generics or the effects on high risk patients are compared. While the increasing market of generics is due to economical factors (and rarely due to medical decisions), the safety of the drugs becomes extremely important. From this aspect, special patient populations eg. children, elderly people or patients with multiple illnesses under multidrug treatment are necessarily of greater medical importance. The characteristics of the antiepileptic drugs on the elderly patients, their increased sensitivity to particular adverse events and the possible somatic side effects are discussed in details. The type of epilepsy also has its special characteristics and is important in the choice of the most successful medicine. The development of the antiepileptic drugs shows a positive direction for their efficacy. In the discussion the author points out three main ways for using generic drugs: prescription of generic drug in monotherapy or as an additive in newly diagnosed patients, the exchange of the innovative agent to a generic and the exchange of one generic to another. The author also mentions the legal points and criticizies the regulations available in some countries allowing a free exchange of the bioequivalent drugs without the agreement of the physician or the patient. The final part of the paper reviews the results of the comparative studies on the effects of the generic antiepileptic drugs and the experiences of the physicians of their application based on surveys performed with questionnaires. The data of the literature is compared to the Hungarian methods of application and to his own experience. Recommendations for the application of generic antiepileptic drugs are summarized in „twelve points“.]

Lege Artis Medicinae

[The significance of generic valsartan in the treatment of patients]


[The renin-angiotensin-aldosterone system (RAAS) is involved in the regulation of electrolyte and water balance primarily; however, it also influences vascular function and increases blood pressure - especially under pathological conditions. Hypertension, post-myocardial infarction state, and heart failure are, for example, associated with excessive systemic and/or local activation of the RAAS. Angiotensin II (AT-II) generated by the latter contributes - along with additional factors and through its deleterious effects (vasoconstriction, endothelial dysfunction, atherosclerosis, prothrombotic state, fibrosis, etc.) - to damage to the target organs involved in the sequence of cardiovascular events. Inhibiting the RAAS at different levels is of therapeutic importance - its purpose is to delay disease progression, to prevent end organ damage, and to achieve a better outcome. As AT-II acts on several (AT1 and AT2) receptors, using angiotensin receptor blocking (ARB) agents with a high selectivity for the AT1 receptor is the rational choice. In view of its favourable therapeutic properties and efficacy demonstrated by morbidity and mortality studies, a generic formulation of appropriate quality, containing valsartan as active substance could prove to be the ideal treatment for patients with hypertension and other cardiovascular disorders.]

Lege Artis Medicinae

[Substitution of drugs with narrow therapeutic window in transplant immunology]

LANGER Róbert, TÖRÖK Szilárd

[Because of the economic crisis affecting the health care system, the Hungarian government have envisaged a number of measures. In Hungary, the system of reference support or fixing is an excellent cost-saving tool in the financing of drugs that have a similar mechanism of effect or contain the same molecule. However, in case of certain patient groups and of “critical drugs”, it is to be feared that an inadequate agent might actually bring loss rather than benefit. In this paper, we would like to draw attention to the fact that switching the original microemulsion cyclosporin to generic, no-microemulsion preparations might pose a direct risk for the safety of the transplanted organ and the transplanted patient.]