To analyse the off-label use of drugs on a paediatric ward in Germany, and to identify domains of pharmacotherapy with the highest need for research concerning off-label use in children.
A prospective observational study was conducted on a paediatric ward in Duesseldorf in Germany between January and June 2006.
Data about patients, diagnoses and prescribed drugs were collected from the prescription records and the discharge letters. Diagnoses were classified in groups by means of the International Classification of Diseases. Drugs were grouped according to the Anatomical Therapeutic Chemical Classification system. We compared the off-label prescriptions with those on the list of paediatric needs and priority list established by the European Medicines Agency (EMEA).
Off-label use was defined due to age, indication, route of application and dose.
The study included 417 patients. We analysed 1,812 prescriptions representing 211 different drugs. In total, 253 patients (61%) received at least one off-label prescription. Of all analysed prescriptions, 553 (31%) were off-label. The percentage of off-label prescriptions among the five most frequently prescribed drug groups were as follows: 60% cardiovascular drugs (CV: 129/216), 42% anti-infectives (AI: 190/449), 30% drugs for respiratory system (RS: 100/335), 25% drugs for alimentary tract and metabolism (AM: 67/269) and 3% analgesics and antipyretics (AA: 8/264); with 17 drugs, the cardiovascular drugs also showed the highest number of different off-label prescribed drugs due to age: AI: 14; AM: 11; RS: 5; AA: 1. In addition, there was a nearly complete overlap between the identified off-label prescriptions in cardiovascular drugs and those listed by the EMEA to be prioritized for urgent research in Europe.
Cardiovascular drugs are a domain of pharmacotherapy, with a large need for research in paediatrics. The results of our study can guide the researcher to future trials on off-label prescriptions such as cardiovascular drugs, especially due to the fact that the identified off-label prescribed drugs in this group are also mentioned by the EMEA to be prioritized for paediatric research.
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"The five drug groups most frequently prescribed off-label were: cardiovascular drugs (60% of prescriptions), anti-infectives (42%), drugs of the respiratory system (30%), drugs of the alimentary tract and metabolism (25%) and analgesics and antipyretics (3%). The cardiovascular drugs also exhibited the highest number of drugs prescribed off-label due to the patient’s age
[Show abstract][Hide abstract] ABSTRACT: Many common drugs have not been licensed for use in children.
This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.
Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.
This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.
Full-text · Article · Feb 2014 · Italian Journal of Pediatrics
"It may, however, lead to changes in pharmacokinetic parameters, and is thus considered unlicensed use. 19
In our facility, oseltamivir was modified, even though an oral suspension is commercially available for use in children aged 1 year or over. An oral preparation was extemporaneously prepared from oseltamivir capsules, as recommended by the Brazilian Ministry of Health, due to temporary unavailability of the oral suspension during an influenza epidemic. "
[Show abstract][Hide abstract] ABSTRACT: To characterise the prescription of non-formulary drugs to children and neonates at a Brazilian teaching hospital and identify adverse drug reactions (ADRs), drug interactions, and prescription of potentially hazardous medicines.
A prospective exploratory study was carried out between January and May 2011 at the general paediatric wards and paediatric oncology, paediatric intensive care, and neonatal care units of the study hospital. Non-formulary drugs were categorised as approved, off-label, or not approved for use in children according to Brazilian compendia. Electronic health records were actively searched for ADRs and the possibility of moderate to severe interactions between non-formulary drugs and other medicines was determined with the Micromedex® database.
Overall, 109 children or neonates received non-formulary drugs. Of these drugs, 54% were approved for use in children, 12.2% were used off-label, and 33.8% were not approved for use in children. Non-formulary drugs accounted for 13.4% of total prescriptions; 5.3% of drugs had a potential for interactions and five were possibly associated with ADRs.
Prescription of non-formulary drugs not approved for use in children was common at the study hospital. Studies such as this provide information on the use of medicines for special indications and permit assessment of the relevance of hospital formularies for the paediatric population.
[Show abstract][Hide abstract] ABSTRACT: Väitekirja elektroonilisest versioonist puuduvad publikatsioonide täistekstid. In industrial countries infection is the third common and in the developing world the most frequent cause of neonatal mortality. Antibacterial therapy is the cornerstone of treatment. Only a few studies have compared the clinical efficacy of different antibiotic regimens in this setting. Most of them date from time 15 to 20 years ago and study drugs or their combinations that are not even used in neonates today. Optimal drug dosing relies on the understanding of its pharmacokinetic and pharmacodynamic properties. In different age groups these may vary significantly due to differences in body composition and organ function. The thesis focuses on identification of optimal dosage of penicillin G in very low birth weight neonates and comparison of the clinical efficacy of two antibiotic regimens most widely used in the treatment of neonates at risk of sepsis. The half-life of penicillin G in very low birth weight neonates is significantly longer that in adults and the predominant renal mechanism of elimination is glomerular filtration in contrast to tubular secretion in adults. The dose of 25000 IU/kg q12h provides adequate serum concentrations of the drug in most cases. The clinical efficacy of ampicillin plus gentamicin and penicillin G plus gentamicin combinations is similar. Still, ampicillin containing regimen may be associated with lower mortality of extremely preterm (born before 26th week of gestation) neonates; with lower incidence rate of late onset sepsis due to coagulase negative staphylococci and lower use of late antibacterial therapy. Neonates who develop thrombocytopenia with concomitant need for vasoactive treatment or leucopenia or leucocytosis with hypoglycaemia within the first 72 h of life have high risk of treatment failure on ampicillin or penicillin G and gentamicin therapy. Further studies have to show, whether early change to broader spectrum agents would improve the outcomes for these babies. Infektsioon on arenenud riikides esinemissageduselt kolmas ning arengumaades kõige sagedasem vastsündinu surma põhjus. Antibakteriaalne ravi on üheks infektsiooni ravi nurgakiviks. Vastsündinu sepsise antibakteriaalse ravi režiimide efektiivsust võrdlevaid uuringuid on vähe ning enamik neist läbi viidud 15-20 aastat tagasi, käsitledes sageli ravimeid, mida vastsündinutel täna enam ei kasutata. Ravimi õige annustamise aluseks on tema farmakokineetiliste ja –dünaamiliste omaduste tundmine. Erinevates vanusegruppides võivad need erinevast keha koostisest ja organite talitluse iseärasustest tulenevalt oluliselt erineda. Käesolev doktoritöö keskendub bensüülpenitsilliini optimaalse annuse väljatöötamisele sügavalt enneaegsetel vastsündinutel ja vastsündinu sepsise ravis täna kasutatavate antibakteriaalse ravi režiimide kliinilise efektiivsuse võrdlemisele. Bensüülpenitsilliini poolväärtusaeg sügavalt enneaegsetel vastsündinutel on oluliselt pikem kui täiskasvanutel ja ajalistel vastsündinutel ning tema peamiseks renaalseks eliminatsioonimehhanismiks on glomerulaarfiltratsioon, mitte tubulaarne sekretsioon. Enamikul juhtudel on piisavaks intravenoosseks bensüülpenitsilliini annuseks 25000 TÜ/kg 12 tunni järel. Ampitsilliini-gentamütsiini ja penitsilliini-gentamütsiini kombinatsioonide kliiniline efektiivsus varase sepsise riskiga vastsündinutel on sarnane. Ampitsilliini sisaldav režiim võib olla seotud madalama väga sügavalt enneaegsete, s.o. enne 26-ndat gestatsiooninädalat sündinud vastsündinute surevuse ja väiksema koagulaas-negatiivsetest stafülokokkidest põhjustatud hiliste infektsioonide esinemissageduse ning väiksema huilise antibiootikumravi vajadusega. Varase sepsise riskiga vastsündinutel, kellel esimese 72 elutunni jooksul kujuneb trombotsütopeenia koos vasoaktiivse ravi vajadusega või leukopeenia või leukotsütoos koos hüpoglükeemiaga, osutub ampitsilliin-gentamütsiin- või penitsilliin-gentamütsiinravi suure tõenäosusega ebaefektiivseks. Järgnevad uuringud peaksid näitama, kas varane antibakteriaalse ravi vahetus laiema toimespektriga režiimi vastu võimaldab parandada ravitulemusi selles haigete grupis.