Background Spanish laws include the special availability situation of drugs that can be used for ‘off label’ indications. Off-label use is regulated by the RD 1015/2009 from 19th June law.
Purpose To study the drugs prescribed to be used for off-label indications.
Materials and methods Observational and retrospective study of the drugs prescribed for ‘off label’ indications to patients who were admitted to a second level university hospital from January 2013 to June 2013.
To evaluate the evidence level of each drug indication we reviewed the Micromedex online data base. Patients’ data were obtained from their medical records and were treated as anonymous. We evaluated the economic impact of the drugs, the average number of treatment doses given to patients and the possible adverse effects of the drugs, the effect of those drugs on each patient and the final outcomes.
Results The hospital pharmacy was asked for 29 drugs for off-label indications, for 36 pathologies. 63 reports were sent to the medical manager, and 100% were approved.
The most-prescribed drugs were Avastin (bevacizumab) (11 patients) and Abraxane (paclitaxel formulated as albumin-bound nanoparticles)(5 patients). The total cost of these drugs was 107,588 €. The wards that requested more off-label drugs were Oncology (14 patients) and Haematology (12 patients), with a spend of 27,276 € and 24,008 €. The pathologies that were most treated with off-label drugs were endometrial and pancreatic cancer. The most expensive drug per dose was plerixafor. Evidence about the majority of indications was low (11 indications were found on the Micromedex database). Finally 53 patients were treated with the off-label indications drugs. Currently there are 18 patients still getting treatment. 7 patients’ conditions clearly improved and 5 worsened after treatment. 12 patients had adverse effects due to these drugs.
Conclusions Off-label drugs are a very important element of oncohaematology treatments. These drugs can have an important effect on patient health and treatment cost, and therefore should be tightly controlled.
No conflict of interest.
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