(62) Immediate Release Fentanyl: Real World Data on Abuse and Dependence in Spain

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1107

Presenting Author(s)

RAQUEL GUTIERREZ MACHIN
– Agencia Espanola de Medicamentos y Productos Sanitarios-AEMPS, MADRID, Madrid, Spain

Co-Author(s)

Diana González
– Spanish Agency of Medicines and Medical Devices, Spain
Alfonso Rodríguez
– Spanish Agency of Medicines and Medical Devices, Spain
Pilar Rayón
– Spanish Agency of Medicines and Medical Devices, Spain
Marta Monreal
– Agencia Espanola de Medicamentos y Productos Sanitarios-AEMPS, Madrid, Madrid, Spain
Dolores Montero
– Spanish Agency of Medicines and Medical Devices, Spain
Consuelo Huerta
– Assistant Professor Epidemiology and Public Health, Faculty of Medicine. Department of Public Health. Complutense University of Madrid, Spain

Background: A substantial increase in prescribing immediate relate fentanyl (IRF) has been observed over the last years, however the extent of IRFUD remains remains unknown

Objectives: To estimate the incidence, risk factors and effect of type of IRF use disorders (IRFUD), such us abuse and dependence, in Spain between 2012 and 2017.

Methods: Retrospective cohort study performed in a Spanish electronic healthcare record (BIFAP). The incidence rate (IR) of IRFUD was calculated by dividing the number of incident cases by the total patient-years (p-y) of exposure. Demographic data, lifestyle, cancer diagnosis, comorbidities and concomitant medication were described and analyzed overall and according to the development of IRFUD using Cox regression models. Effect of type of treatment and duration were also evaluated.

Results: IR of IRFUD in the 12,267 patients analyzed was 1.8 new cases per 100 p-y of exposure. Baseline analysis showed higher frequencies of IRFUD for smokers, substance abusers, non-oncology indications and diagnosis of depression and anxiety, respect to non-IRFUD patients (Table 1). Significant differences were only observed for patients aged ≥ 80, being this subgroup less likely to develop IRFUD. In patients IRFUD diagnosed in the follow up, significant differences were identified for concomitant treatments with benzodiazepines, opioids and gabapentine/pregabalin. The risk increased with duration of IRF treatment, being the highest for treatments during 180 days and longer.

Conclusions: Incidence of IRFUD is difficult to compare. It could be considered not too higher and potentially associated to longer periods of use and not necessarily in continuous treatment, which might reflect the presence of frequent episodes of BTCP, uncontrolled background pain, concomitant psychological distress and misunderstanding about the usage of the product.