We take this classic aphorism about the law in general to introduce a series of brief reflections on health policy and pharmaceutical expenses. Picking up a number of recycling containers of expired drugs at home, the other day I pointed all this fuss Aloysius which is assembled with generic drugs may be fix with a new national law on the subject.
As I know its effort reader I have sent to the Official State Bulletin, and more specifically to the Law 29/2006 of 26 July, on guarantees and rational use of medicines and medical devices text in the first 20 lines and its preamble makes clear what the role of physicians in all these questions: " is a central figure in the strategies for promotion of quality pharmaceutical services, given the role attributed to him in care of the patient's health, and therefore, prevention and diagnosis of disease and in prescribing, where necessary, drug treatment. "
The same law stated in Article 8, the generic definition of " Anyone who has the same qualitative and quantitative principles assets and the same pharmaceutical form and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an asset is considered the same active substance, unless they differ significantly in properties with regard to safety and / or efficacy. The different forms of immediate release oral dosage is considered a single dosage form. The applicant may be exempted from filing bioavailability studies can demonstrate that the generic drug meets the relevant criteria defined in the appropriate detailed guidelines . "
most heated discussions among experts focus precisely on the definition of bioavailability, pharmacokinetic term that refers to the dose of a drug that reaches the tissue on which it conducts its business, is ie on its therapeutic target. As this calculation is virtually impossible in humans, then in practice the bioavailability is considered the percentage of drug that appears on the patient's plasma.
Therefore, some medicines, whether branded or generic, depending also on the excipients that are vehicularizing, despite being present in the patient's blood at the same rate, may take longer or less time to reach the target organ and make its effect. If all of these add the individual variability in response to the same drug, continuous extremely tangled skein. Who will unravel? Difficult to answer. While the catalog Galician drug in the refrigerator cools the Constitutional Court by the action of the Ministry of Health in Castilla-La Mancha and Extremadura, both governed by the PSOE, copy the model of Galicia. I explain.
Therefore, some medicines, whether branded or generic, depending also on the excipients that are vehicularizing, despite being present in the patient's blood at the same rate, may take longer or less time to reach the target organ and make its effect. If all of these add the individual variability in response to the same drug, continuous extremely tangled skein. Who will unravel? Difficult to answer. While the catalog Galician drug in the refrigerator cools the Constitutional Court by the action of the Ministry of Health in Castilla-La Mancha and Extremadura, both governed by the PSOE, copy the model of Galicia. I explain.
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