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    Wyświetlanie 1-5 z 5
    Tytuł:
    Legal and economic identification and assessment of pharmacy substitution in narrow therapeutic index drugs, on the example of epileptic medications in Poland
    Autorzy:
    Zimmermann, Agnieszka
    Gruchała, Katarzyna
    Wąż, Piotr
    Kawczak, Piotr
    Powiązania:
    https://bibliotekanauki.pl/articles/895513.pdf
    Data publikacji:
    2018-12-31
    Wydawca:
    Polskie Towarzystwo Farmaceutyczne
    Tematy:
    pharmacy substitution
    carbamazepine
    pharmacy law
    Opis:
    Currently in Poland there is neither regulation aiming at framing the complexity of substitution process arising at pharmacy level, nor further guidelines depending on drug category. FDA describes a narrow therapeutic index drug (NTI) in the 21 Code of Federal Regulations 320.33(c) and highlights that safe and effective use of such drug products require careful titration and patient monitoring. In major therapeutic areas disadvantages of the generic substitution are irrelevant or minor in comparison to the economic benefit. In epilepsy, a number of experts and professional bodies have recommended caution with generic substitution of drugs used in this condition. Aim of the study is to legally and economically identify and assess drug sub-stitution occurrence in Polish background among selected narrow therapeutic index drugs used in epilepsy. Paper is divided into two sections: first is retrospective based and tackles the data received from the National Health Fund; whereas second section takes under consideration questionnaire based results gained during medical history being collect-ed with the patients. Basing on most commonly substituted substance in epilepsy: carbamazepine, the maximum single difference in cost in substitution at the pharmacy was identified around the level of 1.7 PLN, and maximum extra pay at the same level. Ob-served/reported changes, ADRs, discomfort were provided based on the question-naire. The study highlights the necessity of planning process and evaluation of cur-rent market regulations.
    Źródło:
    Acta Poloniae Pharmaceutica - Drug Research; 2018, 75, 6; 1447-1458
    0001-6837
    2353-5288
    Pojawia się w:
    Acta Poloniae Pharmaceutica - Drug Research
    Dostawca treści:
    Biblioteka Nauki
    Artykuł
    Tytuł:
    A policy view: gaps and weaknesses of substitution between biological products in law and economics dimension: the example of insulin
    Autorzy:
    Gruchała, Katarzyna A.
    Waz, Piotr
    Kawczak, Piotr
    Zimmermann, Agnieszka
    Wolnik, Bogumił
    Baczek, Tomasz
    Powiązania:
    https://bibliotekanauki.pl/articles/895366.pdf
    Data publikacji:
    2018-08-31
    Wydawca:
    Polskie Towarzystwo Farmaceutyczne
    Tematy:
    insulin
    biosimilars
    substitution
    drug policy
    legilation
    Opis:
    The purpose of the study is to analyze the act of substitution between biological products. Diabetes mellitus notes the greatest increase in the projected causes of deaths globally till 2030. The proper drug substitution process may help to increase the control over the disease management. In this paper authors try to identify and explain the challenges for the health policies and legislations in emerging markets and low- and middle-income countries. Analysis of retrospective data covering prescribed-dispensed insulin products was performed. The study is based on the law and economics approach with the application of the planning theory and modeling. The study shows the scope of substitution process of insulin and highlights the necessity of univocal legal approach profiled for this therapy area. Prognosis of created base model indicates at constant presence of substitution process of insulin. Substitution is to bring financial savings for patients, it is yet however unknown whether savings arising from the act of purchase will still have positive impact on undertaken therapy process in long-term period. These findings may inform about important factors and how emerging markets and low- and middle-income countries can increase progress of the substitution process.
    Źródło:
    Acta Poloniae Pharmaceutica - Drug Research; 2018, 75, 4; 1003-1015
    0001-6837
    2353-5288
    Pojawia się w:
    Acta Poloniae Pharmaceutica - Drug Research
    Dostawca treści:
    Biblioteka Nauki
    Artykuł
      Wyświetlanie 1-5 z 5

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