| Abstract | Cilj istraživanja: Cilj je ovog istraživanja utvrditi učestalost off-label propisivanja
antimikrobnih lijekova (AML-ova) u Klinici za infektivne bolesti “Dr. Fran Mihaljević” u
Zagrebu, odrediti vrste i usklađenost off-label primjene sa smjernicama Klinike i Europskog
društva kliničke mikrobiologije i infektologije (ESCMID, eng. European Society of Clinical
Microbiology and Infectious Diseases), kako bi se postavili temelji za daljnje analize.
Materijal i metode: Retrospektivnim presječnim istraživanjem obuhvaćena su djeca i odrasli
bolesnici hospitalizirani u Klinici na dan s najvećim brojem hospitalizacija, 17.1.2019.
godine. Off-label primjena AML-a bila je ona koja nije bila u skladu sa Sažetkom opisa
svojstava lijeka (SmPC).
Primjena AML-ova klasificirana je u pet skupina:
1. primjena u skladu sa SmPC-om
2. off-label primjena u skladu sa smjernicama Klinike
3. off-label primjena u skladu s ESCMID smjernicama
4. off-label primjena koja nije u skladu sa smjernicama Klinike
5. off-label primjena koja nije u skladu s ESCMID smjernicama
Rezultati: Istraživanje je obuhvatilo 63 odrasle osobe, od kojih 36 (57,1%) muškaraca, i 92
djece, od kojih 44 (47,8%) dječaka. Najmanje jednim AML-om liječen je 61 (96,8%) odrasli i
60 (65,2%) djece.
Ukupno je zabilježeno 134 preskripcije u odraslih, od toga 42 (31,3%) off-label u odnosu na
SmPC. AML-ovi su propisivani off-label u odnosu na dozu, režim doziranja i indikaciju,
nekad istovremeno prema dva kriterija, ukupno 52 off-label slučaja. Od navedenih off-label
slučajeva: u 22 (42,3%) nisu postojale smjernice Klinike, a 11 (36,7%) je bilo u skladu; u 20
(38,5%) slučajeva nisu postojale ESCMID smjernice, 5 (15,6%) je bilo u skladu, a u 22
(68,8%) usklađenost se nije mogla odrediti.
Najčešće su u odraslih off-label propisani: oseltamivir - 11 puta (8,2%), cefuroksim - 4 (3%)
te vankomicin, meropenem i piperacilin/tazobaktam - po 3 puta (2,2%).
Ukupno je zabilježeno 73 preskripcije u djece, od toga 31 (42,5%) off-label u odnosu na
SmPC. Lijekovi su propisivani off-label u odnosu na dozu, indikaciju i dob, nekad
istovremeno prema dva kriterija, ukupno 33 slučaja. Od navedenih off-label slučajeva za 10
(30,3%) nisu postojale smjernice Klinike, a 4 (17,4%) je bilo u skladu. ESCMID smjernice su
postojale za samo jedan klinički sindrom, s njim nije bilo usklađenosti.
Najčešće su u djece off-label propisani: ceftriakson - 8 (10,9%), oseltamivir - 7 (9,6%) i
azitromicin - 3 (4,1%) puta.
Zaključak: Rezultati ukazuju da je off-label primjena AML-ova u Klinici prisutna. Ovi
rezultati su u skladu s dosadašnjim istraživanjima. Na rezultate je utjecalo nepostojanje
smjernica za mnoge indikacije i heterogenost smjernica. Zabilježeno je i off-label propisivanje
koje nije u skladu sa smjernicama. |
| Abstract (english) | Objectives: The study aimed to determine the frequency of off-label prescribing of
antimicrobial drugs (AML) at the University Hospital for Infectious Diseases “Dr Fran
Mihaljević ”in Zagreb. Another aim was to determine the types of such prescribing and the
compliance of off-label applied AML with the Clinic guidelines and the European Society of
Clinical Microbiology and Infectious Diseases (ESCMID) guidelines to set foundations for
further analysis in the improvement of patient care.
Material and methods: A retrospective cross-sectional study included pediatric and adult
patients hospitalized at the Clinic on the day with the highest number of hospitalizations in
2019, January 17. Any use of AML that did not comply with the Summary of Product
Characteristics (SmPC) was considered off-label use.
The use of antimicrobial drugs was classified as one of the following:
1. use in accordance with the SmPC
2. the off-label use that follows Clinic guidelines
3. the off-label use that follows ESCMID guidelines
4. the off-label use that does not follow Clinic guidelines
5. the off-label use that does not follow ESCMID guidelines
Results: The study included 63 adults (36 men, 57.1%) and 92 pediatric patients (44 boys,
47.8%). 61 (96.8%) adult and 60 (65.2%) pediatric patients used at least one AML. We
recorded 134 prescriptions in adults, out of which 42 (31,3%) were off-label. Off-label was
prescribed concerning dose, dosing regimen and indication, sometimes simultaneously
concerning two criteria (dose and dosing regimen), so there were 52 off-label cases. Out of
those, in 22 (42,3%) off-label cases, there were no Clinic guidelines, and 11 (36,7%) cases
followed them, while in 20 (38,5%) cases, there were no ESCMID guidelines, 5 (15,6%)
followed them, and in 22 (68,8%) cases we could not establish compliance.
The most commonly off-label prescribed AMLs were: oseltamivir - 11 (8,2%) times,
cefuroxime - 4 (3%) and vancomycin, meropenem and piperacillin/tazobactam - 3 times each
(2,2%).
We recorded 73 prescriptions in children, out of which 31 (42,5%) were off-label. Offlabel
was prescribed concerning dose, indication and population, sometimes simultaneously
concerning two criteria, so there were 33 off-label cases. Out of those 33, in 10 (30,3%) offlabel
cases, there were no Clinic guidelines, and 4 (17,4%) followed them. There was only
one ESCMID guideline, and there was no compliance.
The most commonly off-label prescribed AMLs were: ceftriaxone - 8 (10,9%) times,
oseltamivir - 7 (9,6%) and azitromycin - 3 (4,1%) times.
Conclusion: The data obtained indicate that off-label use of AML in the Clinic is present,
which is consistent with previous research. The non-existence of guidelines for many
indications and the heterogeneity of available ones affected the results. There was also offlabel
prescribing not compliant with the guidelines. |
