{"title":"在医生责任的背景下允许在标签外使用药品——试图根据波兰法律澄清这一问题","authors":"Krzysztof Kozłowski, W. Wierzba, B. Machaliński","doi":"10.32383/appdr/153591","DOIUrl":null,"url":null,"abstract":"Practising the profession of a doctor involves high social recognition but also entails responsibility for the health and life of a patient. In this context, pharmacological treatment applied in compliance with the formal registration of a medicinal product does not raise any serious concerns. However, it is not always possible to administer a medicine in a way that corresponds to its official characteristics. Clinical practice shows that it is often necessary to administer a medicine outside the requirements specified in the summary of product characteristics. In such cases, a legal, ethical and typically medical problem arises. The aim of the study is to analyse the entire legal environment of the doctors’ use of medicines outside the summary of product characteristics. The discussion leads to the conclusion that medical personnel are fully authorised to administer a medicinal product outside its official characteristics. However, this may only take place if such a decision is based on current knowledge, the doctor’s individual experience and acting in the best interest of the patient, as well as proper diagnosis of his/her current therapeutic needs. The legal regulations in force in Poland are sufficient in that sphere to ensure the well-being of the patient and protect the interests of the doctor, although – it should be admitted – their wording is not unambiguous enough to prevent more or less serious doubts as to their interpretation. Hence the proposal for legal clarification of the situation related to the administration of a medicine off-label.","PeriodicalId":7147,"journal":{"name":"Acta poloniae pharmaceutica","volume":null,"pages":null},"PeriodicalIF":0.4000,"publicationDate":"2022-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Permissibility of the off-label use of a medicinal product in the context of a doctor’s liability – an attempt at clarification of the issue under the Polish law\",\"authors\":\"Krzysztof Kozłowski, W. Wierzba, B. Machaliński\",\"doi\":\"10.32383/appdr/153591\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Practising the profession of a doctor involves high social recognition but also entails responsibility for the health and life of a patient. In this context, pharmacological treatment applied in compliance with the formal registration of a medicinal product does not raise any serious concerns. However, it is not always possible to administer a medicine in a way that corresponds to its official characteristics. Clinical practice shows that it is often necessary to administer a medicine outside the requirements specified in the summary of product characteristics. In such cases, a legal, ethical and typically medical problem arises. The aim of the study is to analyse the entire legal environment of the doctors’ use of medicines outside the summary of product characteristics. The discussion leads to the conclusion that medical personnel are fully authorised to administer a medicinal product outside its official characteristics. However, this may only take place if such a decision is based on current knowledge, the doctor’s individual experience and acting in the best interest of the patient, as well as proper diagnosis of his/her current therapeutic needs. The legal regulations in force in Poland are sufficient in that sphere to ensure the well-being of the patient and protect the interests of the doctor, although – it should be admitted – their wording is not unambiguous enough to prevent more or less serious doubts as to their interpretation. Hence the proposal for legal clarification of the situation related to the administration of a medicine off-label.\",\"PeriodicalId\":7147,\"journal\":{\"name\":\"Acta poloniae pharmaceutica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.4000,\"publicationDate\":\"2022-11-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta poloniae pharmaceutica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.32383/appdr/153591\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta poloniae pharmaceutica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.32383/appdr/153591","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Permissibility of the off-label use of a medicinal product in the context of a doctor’s liability – an attempt at clarification of the issue under the Polish law
Practising the profession of a doctor involves high social recognition but also entails responsibility for the health and life of a patient. In this context, pharmacological treatment applied in compliance with the formal registration of a medicinal product does not raise any serious concerns. However, it is not always possible to administer a medicine in a way that corresponds to its official characteristics. Clinical practice shows that it is often necessary to administer a medicine outside the requirements specified in the summary of product characteristics. In such cases, a legal, ethical and typically medical problem arises. The aim of the study is to analyse the entire legal environment of the doctors’ use of medicines outside the summary of product characteristics. The discussion leads to the conclusion that medical personnel are fully authorised to administer a medicinal product outside its official characteristics. However, this may only take place if such a decision is based on current knowledge, the doctor’s individual experience and acting in the best interest of the patient, as well as proper diagnosis of his/her current therapeutic needs. The legal regulations in force in Poland are sufficient in that sphere to ensure the well-being of the patient and protect the interests of the doctor, although – it should be admitted – their wording is not unambiguous enough to prevent more or less serious doubts as to their interpretation. Hence the proposal for legal clarification of the situation related to the administration of a medicine off-label.
期刊介绍:
The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General.
A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.