Background Off-label use of medication is common in hospital clinical practice and should be applied together with follow-up of a healthcare treatment protocol and in compliance with a procedure which ensures that the patient is informed and that he or she provides informed consent.
Purpose The study aims to assess the clinical practice of off-label use of medicines in the hospital setting.
Material and methods Cross-sectional study with retrospective data collection, which analysed prescriptions issued to 1890 patients from January 2007 to January 2017 in a 500-bed general hospital.
Results One thousand, eight hundred and ninety patients were treated with off-label drugs, 875 (46.3%) females and 1015 (53.7%) males, with an average age of 51.7 years (SD 36–65).
The off-label drugs were used in the following physician specialties: 5.2% neurology, 6.1% endocrinology, 6.3% nephrology, 5.8% rheumatology, 6.7% gastroenterology, 4.3% dermatology, 5% haematology, 10% gynaecology, 11% ophthalmology, 12% pain specialty, 18,4% oncology and 8.2% others.
In all these cases there is scientific and medical evidence to justify off-label use. In 80% of cases its use was due to the absence of other therapeutic alternatives.
When the use of drug out of indications approved will be frequent, there must be clinical protocols to use these off-label drugs in the hospital. During the period of study, 58 protocols were approved for the following indications: autoinmune thrombocytopaenia, haemolytic anaemia, lichen planus, hidradenitis suppurativa, atopic dermatitis, myelodysplastic syndrome, chronic idiopathic urticaria, carcinomas, ulcerative colitis, myofascial pain síndrome, antithrombolytic, allergic asthma, lupus nephritis, arthroplasties, anal fissure, refractory alopecia, gastroparesis, uveítis, spastic paraparesis, Sjögren’s syndrome, cluster headache, psoriasis, neuropathic pain and fibromyalgia.
100 per cent of patients (1,890) signed consent form prior to initiating treatment.
Conclusion In the hospital area the use of medicines is frequent out of indications approved in the specification sheet. These situations should be gathered in therapeutic protocols and welfare, and regulated by the Commission of Drugstore and Therapeutics. In all the cases it is necessary to inform the patient adequately and gain his assent.
Reference and/or Acknowledgements 1. Shah SS, Hall M, Goodman DM, et al. Off-label drug use in hospitalised children. Arch Pediatr Adolesc Med2007;161(3):282–290.
No conflict of interest
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