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Legal and economic identification and assessment of pharmacy substitution in narrow therapeutic index drugs, on the example of epileptic medications in Poland

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Zimmermann A., Gruchała K., Wąż P., Kawczak P.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 6
1447-1458
EN
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.
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Legitimacy and potential savings in automatic substitution of biological products in Poland, the example of insulin

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Wąż P., Gruchała K. A., Zimmermann A.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 5
1255-1263
EN
Currently in Poland there is no regulation aiming at framing the complexity of substitution process arising at pharmacy level. In practice such process exists in variety type of products, both generic and biological scope. Lack of integrity in terms of this process between authorised medical professions who held it, might lead to further costs both for the health care system and patients. The aim of the study is to explain, that the economic advantage, which very often is the result of performed substitution process, in some types of products such as bio-logical ones, should be preceded with the decision of the treating physi-cian. Only then, in the cooperation between persons prescribing and dispensing certain medicinal product the process of substitution may fully use its potential of money saving along with the control over a certain patient. The study brings the yet unknown classification of dif-ferences in costs between actually performed automatic substitution of products containing human insulin in the pharmacy setting in Poland in four year period in five Voivodeships.
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