TY - JOUR
T1 - Off-label prescriptions of drugs used for the treatment of Crohn's disease or ulcerative colitis
AU - Simsek, Melek
AU - Lissenberg-Witte, Birgit I.
AU - van Riswijk, Milou L. M.
AU - Verschuren, Sander
AU - Hoentjen, Frank
AU - Oldenburg, Bas
AU - Ponsioen, Cyriel Y.
AU - van der Woude, C. Janneke
AU - van der Meulen, Andrea E.
AU - Pierik, Marieke
AU - Dijkstra, Gerard
AU - de Boer, Nanne K. H.
AU - Parelsnoer Institute (PSI)
AU - Dutch Initiative on Crohn's and Colitis (ICC)
PY - 2019/5
Y1 - 2019/5
N2 - BackgroundOff-label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off-label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before.AimTo assess the proportion and characteristics of off-label prescribing for IBD in tertiary care centres in the Netherlands.MethodsA prospective database of IBD patients from all Dutch university hospitals was used to collect data on drug prescriptions for IBD and demographics. Drugs were classified as off-label if they were unlicensed for Crohn's disease and/or ulcerative colitis by the Medicines Evaluation Board. Uni- and multivariable analyses were used to identify patient-specific characteristics predictive of increased off-label use.ResultsFor the induction and/or maintenance treatment of 4583 IBD patients, 12651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off-label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off-label drugs. Commonly prescribed off-label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non-thiopurine/methotrexate off-label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off-label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, PConclusionAbout one-fifth of prescriptions for IBD were off-label and one-third of IBD patients, especially ulcerative colitis patients, were exposed to off-label drugs.
AB - BackgroundOff-label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off-label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before.AimTo assess the proportion and characteristics of off-label prescribing for IBD in tertiary care centres in the Netherlands.MethodsA prospective database of IBD patients from all Dutch university hospitals was used to collect data on drug prescriptions for IBD and demographics. Drugs were classified as off-label if they were unlicensed for Crohn's disease and/or ulcerative colitis by the Medicines Evaluation Board. Uni- and multivariable analyses were used to identify patient-specific characteristics predictive of increased off-label use.ResultsFor the induction and/or maintenance treatment of 4583 IBD patients, 12651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off-label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off-label drugs. Commonly prescribed off-label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non-thiopurine/methotrexate off-label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off-label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, PConclusionAbout one-fifth of prescriptions for IBD were off-label and one-third of IBD patients, especially ulcerative colitis patients, were exposed to off-label drugs.
KW - Crohn's disease
KW - drugs
KW - inflammatory bowel disease
KW - off-label
KW - prescriptions
KW - therapeutic care
KW - ulcerative colitis
U2 - 10.1111/apt.15229
DO - 10.1111/apt.15229
M3 - Article
C2 - 30908719
VL - 49
SP - 1293
EP - 1300
JO - Alimentary Pharmacology & Therapeutics
JF - Alimentary Pharmacology & Therapeutics
SN - 0269-2813
IS - 10
ER -