{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T08:08:10Z","timestamp":1782202090343,"version":"3.54.5"},"reference-count":26,"publisher":"Index Copernicus","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Otolaryngol Pol"],"published-print":{"date-parts":[[2024,2,29]]},"abstract":"<jats:p>&lt;b&gt;&lt;br&gt;Introduction:&lt;\/b&gt; \u2018Off-label drug use\u2019 refers to the administration of drugs for unapproved indications or age groups, a different dosage or other form of administration. Considering the legal issues, there clearly exists a need to implement rules that would regulate the use of pharmaceuticals outside the scope of a marketing authorisation. The brevity and diversity of Polish laws in the field of health care leads to many interpretative doubts associated with particular legal acts.&lt;\/br&gt;  &lt;b&gt;&lt;br&gt;Aim:&lt;\/b&gt; We aimed to present clinical examples from everyday practice of off-label drug use from the medical and legal perspectives, and to support it with relevant legal acts.&lt;\/br&gt;  &lt;b&gt;&lt;br&gt;Material and method:&lt;\/b&gt; Off-label drug use in various otolaryngology subspecialties \u2013 otology (mesna), laryngology (bevacizumab, cidofovir and botulinum toxin) and head and neck surgery (botulinum toxin) \u2013 are presented and discussed in detail.&lt;\/br&gt;  &lt;b&gt;&lt;br&gt;Results:&lt;\/b&gt; Fourteen Polish legal acts regarding off-label drug use and 4 from EU legislation are commented on. The algorithm of cascade of decision-making processes in off-label drug use is shown.&lt;\/br&gt; &lt;b&gt;&lt;br&gt;Conclusions:&lt;\/b&gt; Off-label use of medicinal products is not prohibited in Poland or the EU; nevertheless, it is undeniable that the unclear legal situation regarding the use of medicinal products for nonregistered indications creates difficulties. To minimise a doctor\u2019s liability risk, obtaining the informed consent from the patient for such treatment is advisable.&lt;\/br&gt;<\/jats:p>","DOI":"10.5604\/01.3001.0054.1185","type":"journal-article","created":{"date-parts":[[2024,2,9]],"date-time":"2024-02-09T07:53:11Z","timestamp":1707465191000},"page":"36-43","source":"Crossref","is-referenced-by-count":1,"title":["Off-label drugs in otolaryngological practice against the background of legal conditions of Polish legislation"],"prefix":"10.5604","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5626-0512","authenticated-orcid":false,"given":"Renata","family":"Kopczyk","sequence":"first","affiliation":[{"name":"Wroclaw University of Science and Technology, Wroclaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3729-2679","authenticated-orcid":false,"given":"Dariusz","family":"Jurkiewicz","sequence":"additional","affiliation":[{"name":"Clinic of Otolaryngology and Oncological Otolaryngology with the Clinical Department of Cranio-Maxillofacial Surgery, Military Institute of Medicine \u2013 National Research Institute, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0545-551X","authenticated-orcid":false,"given":"Marek","family":"Rogowski","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Medical University of Bialystok, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Szyd\u0142owski","sequence":"additional","affiliation":[{"name":"Wroclaw Regional Specialist Hospital, Research & Development Centre, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ma\u0142gorzata","family":"Wierzbicka","sequence":"additional","affiliation":[{"name":"Wroclaw University of Science and Technology, Wroclaw, Poland, Wroclaw Regional Specialist Hospital, Research & Development Centre, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3689","reference":[{"key":"615603r1","unstructured":"Kircik L., Siegel D.M.: Clinical and Legal Considerations in PharmaceuticalCompounding. 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