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Lege Artis Medicinae

DECEMBER 18, 2012

[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.]

Lege Artis Medicinae

JULY 20, 2005

[THE USE OF GENERIC DRUGS IN THE MEDICAL THERAPY OF EPILEPSY]

RAJNA Péter

[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

JULY 27, 2009

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

NOSZÁL Béla

[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.]