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Limitation of patients’ rights during the COVID-19 pandemic in Poland

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Piątkowska K., Zimmermann A., Pilarska A.
European Journal of Translational and Clinical Medicine
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2021
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vol. 4
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issue 1
79-85
EN
Background: The COVID-19 pandemic has had an impact on the observance and limitation of patients’ rights all over the world, including Poland. Material and methods: We analysed in detail the Polish legal acts relevant to healthcare in terms of their impact on the patients’ rights. Our analysis is based on the Bill of Patients’ Rights that was in force in Poland before the announcement of the state of epidemic (March 20th 2020). The legal acts were analysed by use of the exegesis of legal texts and comparative legal literature rules. Results: The patients’ right to family life and presence of relatives during the performance of healthcare services and to additional nursing care has been directly limited. Rights that have been limited indirectly include the right to healthcare services (limited by the use of telemedicine) and the right to dignified death and pastoral care (patients often die alone). The limitations also have an indirect impact on the right to confidentiality and respect for privacy and dignity. Conclusions: Our analysis identified limited patients’ rights in Poland without entitlement to pursue claims thereunder.
2
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EVALUATION OF PHARMACEUTICAL EMERGENCY CONTRACEPTIVE SERVICES IN POLAND

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Zimmermann A., Susłowska N., Gaworska-Krzemińska A.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 6
1431-1438
EN
Pharmacies are acknowledged to have a key role in the provision of health services, including emergency contraceptive services and under the right circumstances could meet the growing expectations for reproductive health education and consultations. Pharmaceutical emergency contraceptive service provided by pharmacists include ensuring the availability of required medicines, correct dispensing, providing comprehensive information, all of which requires not only consultations that are health-oriented and educational, but also providing the patient with an adequately private situation to talk with the pharmacist. Objectives: The aim of the paper is to evaluate pharmaceutical emergency contraceptive services provided in polish pharmacies. Material and methods: The observational study included 60 community pharmacies of different profiles located in Gdansk (Poland). Our method was to use “standardized (simulated) patients”. Results: The study revealed the low availability of emergency contraception in Gdańsk pharmacies. Pharmacy employees provided drug-related information in 51.6% of study’s visits. None of the pharmacies provided patients with educational information on reproductive health. Regarding the respecting of patients’ rights privacy and intimacy, overall, the pharmacies scored 4.41 on a five-point scale. Conclusions: Our study sought to identify both the developed and underdeveloped aspects of a comprehensive emergency contraceptive service. Pharmacy employees in the study provided patients with a narrow range of information on hormonal medications and they failed to include sexual health education in their work. The patient’s right to expect that intimacy and privacy will be respected during their consultation was met to a satisfactory degree.
3
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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.
4
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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.
5
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A policy view: gaps and weaknesses of substitution between biological products in law and economics dimension: the example of insulin

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Gruchała K. A., Waz P., Kawczak P., Zimmermann A., Wolnik B., Baczek T.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 4
1003-1015
EN
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.
6
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OFF-LABEL USE OF MEDICINAL PRODUCTS - LEGAL RULES AND PRACTICES

64%
Jaroszyński J., Mela A., Furtak-Niczyporuk M., Staniszewska A., Poniatowski Ł. A., Dąbrowski J., Czajka-Bełz A., Zimmermann A., Dreher P., Drop B.
Acta Poloniae Pharmaceutica - Drug Research
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2019
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vol. 76
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issue 4
621-628
EN
The off-label use of medicinal products raises many interpretation-related issues, not only among physicians, but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated by Polish law. The authors’ goal is to discuss the topic mainly from the practical perspective, while also considering its theoretical aspects, and to identify systemic solutions to several problems, that are extremely important for the proper functioning of the entire healthcare system. The paper highlights that there is a fine line between experimental medicinal practices and those that are in keeping with current medical knowledge.
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