Prescripción hospitalaria de medicamentos fuera de ficha técnica

Abstract

OBJECTIVES Describe off-label drugs clinical practice in Virgen de la Arrixaca University Hospital. Specific objectives: 1. Characterize patients, treatments, diagnostics and clinical units more prevalent related to off-label prescription drug use. 2. Determine the variables affecting off-label drugs treatments authorization. 3. Estimate the economic impact derived both authorized off label drugs treatments prescriptions as the theoretical saving of treatments not approved. 4. Compare the results of effectiveness and real cost, to those provided in the treatments most frequently requested. METHODS Descriptive and retrospective observational study conducted at the Virgen de la Arrixaca University Hospital. All off-label drug applications received in Pharmacy Department between October 2009 and September 2014 were analyzed. RESULTS A total of 834 applications were received, of which 88.1% were finally authorized. Rates for the approval of Pediatric Services were higher (95.7% vs. 86.6%; p <0.05). 73.4% of applications were off-label drugs antineoplastic prescriptions, and the most frequently prescribed drugs were rituximab (120) and bevacizumab (103). The reasons why prescriptions were considered off-label were: different indication (73.2%), different drugs combination (10.2%), different line therapy (8.6%) and different patient age (8%). The quality of the evidence warranted prescriptions showed no direct relation to the likelihood of approval (p = 0.413). Decreases the percentage of approved drugs with increasing economic cost and this was statistically significantly (p <0.05, Student&apos;s T test). The average cost of approved treatments was ¿11,656, significantly lower than those denied (¿ 22,916; p <0.0001). The cost of approved drugs was ¿ 8,567,537 and the theoretical savings of not authorized drugs were ¿ 2,268,642. The mean age of patients with authorized treatments (43 ± 23 years) was also significantly lower than the patients with denied treatment (p = 0.001). The most often treatment-diagnostic requested was bevacizumab to treat relapsed glioma. Median progression-free survival of these patients was 5.23 ± 0.85 months, and overall survival 8.60 ± 1.28 months, similar to those obtained previously in several phase II trials. The most often treatment-diagnostic requested in pediatrics was levosimendan for congenital heart disease, administered in 23 children. Registered mortality was 17.4%, also similar to that reported previously in other case series. CONCLUSIONS 1. The authorization rate of off-label drugs is high. Pediatric authorized treatments were proportionately higher that adult treatments, being bevacizumab and rituximab the most prescribed drugs, the oncohematologic units the departments that made most requests and the treatment of high-grade gliomas the most repeated indication. 2. Both the cost of treatment as the age of patients had shown significantly influence the decision to authorize the off-label drug treatments. Other variables, such as evidence level, have not been shown to significantly influence the decision. 3. The theoretical economic impact of approved drugs has led to more than 3.4% of the pharmacy budget in the period studied. Denied drugs have avoided an additional cost of 0.9% of the budget. 4. The effectiveness achieved in our center using bevacizumab to treat high grade gliomas has been similar to the phase II studies published, and the real cost very similar to the estimated cost. In Pediatrics, levosimendan treatment for children with congenital heart disease showed no significant benefit in analytical parameters, although mortality rates were not much different from those previously case series published.