Off-label drug use in palliative care in Poland

Introduction: Off-label drug use is when a drug is used in indications, doses, forms, routes of administration, and in groups of patients not mentioned in the summary of product characteristics, or despite contraindications. Aim of the study: Research in the population of palliative care patients, for ethical reasons, is significantly limited, and even impossible, so drug use is often based on the clinician's experience, predominant practice, or prevailing opinion. Off-label drug use may not bring the desired results, or may even harm the patient. Material and methods: In this study, 304 reports on possible off-label use of medicines in Poland were collected. After rejecting erroneous, repetitive, or unfounded cases, 86 cases of off-label drug use in adults in palliative care were finally obtained for which the literature was reviewed and which were evaluated by a team of experts. Experts admitted to off-label use in two-thirds of the presented cases, and 37.1% of them - often or very often. Results: Experts assessed nine of them as "necessary - no alternative" procedures. In this way, a list of off-label drug uses was created with the formulated recommendation, category of the necessity, level of evidence, and grade of recommendation. Frequent off-label drug use in palliative care results from the lack of alternative options, as well as the gap between clinical practice, the lack of clinical data, and the content of the summaries of product characteristics. Conclusions: Legal changes are needed for the use of medicines based on clinical recommendations, in particular for procedures that are necessary and have no alternatives.