Off-label use of drugs in Italy: a prospective, observational and multicentre study

Pandolfini, Chiara; Impicciatore, P.; Provasi, Davide; Rocchi, Francesca; Campi, Rita; Bonati, Maurizio

doi:10.1080/08035250252834030

Cited by 56 publications

(46 citation statements)

References 22 publications

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“…Observing the profile of oral solutions and suspensions compounded for newborns and children of the studied hospital, it was verified that solutions/suspensions of these active principles were identified in other studies: folic acid,9 , 19 folinic acid,9 , 20 ursodeoxycholic acid,11 , 14 captopril,8 , 9 , 14 , 15 , 18 , 21 caffeine,12 , 16 , 19 , 22 , 23 spironolactone,9 , 24 - 28 fluconazole,17 furosemide,8 , 9 , 26 hydrochlorothiazide,8 , 9 , 18 , 26 , 27 propranolol,10 ranitidine,9 pyrimethamine17 and sulfadiazine 17. Therefore, it is observed that the demand for oral solutions and suspensions administered to newborns and children in this study has also been observed in other studies and that the compounding of drugs is a national and international necessity due to the lack of oral liquid drugs from the pharmaceutical industry.…”

Section: Discussionsupporting

confidence: 66%

Magistral drugs in hospitalized newborns and children

Pereira

Miranda

Castilho

et al. 2016

Revista Paulista de Pediatria (English Edition)

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Objective:Study the use of magistral oral solutions and suspensions in infants and children at a university hospital.Methods:This is a descriptive study based on the analysis of the assessed hospital's magistral drug request forms regarding the patients in the neonatal ICU, Obstetrics, Pediatrics and Pediatric Emergency from January 2012 to December 2013. The frequency of drug requests and dispensation was evaluated and the consumption of each active ingredient of the preparations was expressed as number of “infant defined daily dose” (iDDD) and of iDDD/100 bed-days.Results:A total of 657 forms were analyzed - a monthly average of 27 pediatric preparations. The neonatal ICU accounted for 69.6% of these requests. Twenty-one drug items were used, of which the most common were folinic acid (88 requests), sulfadiazine (85) and captopril (73). The consumption of the active principle in these preparations varied in number of iDDD, from 7.5 (hydralazine) to 16,520.0 (folic acid), and in number of iDDD/100 bed-days in the neonatal ICU, from 0.1 (zinc sulfate) to 146.1 (folic acid).Conclusions:The constant consumption of magistral oral solutions and suspensions by newborns and children of the assessed hospital indicates the need for such preparations as a pediatric therapeutic alternative in this hospital.

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Section: Discussionsupporting

confidence: 66%

Magistral drugs in hospitalized newborns and children

Pereira

Miranda

Castilho

et al. 2016

Revista Paulista de Pediatria (English Edition)

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“…This finding reinforces the need for an adequate pharmaceutical form of medicinal products for the paediatric population since formulations suitable for the paediatric population are often unavailable, and therefore, licenced drugs have to be modified into extemporaneous preparations with unknown pharmacokinetic characteristics [2,56,57]. It was, however, possible to establish that the ATC groups which were most prescribed on an off-label and/or unlicenced basis were systemic hormonal preparations, excluding sex hormones and insulins (H), with some studies specifically identifying betamethasone and beclomethasone [21,23] and dexamethasone [36,42], i.e. the active substances in this group.…”

Section: 5mentioning

confidence: 99%

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Magalhães

Rodrigues

Roque

et al. 2014

Eur J Clin Pharmacol

103

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These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.

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“…Clinicians are therefore forced to extrapolate study data from adults. As a consequence, many drugs used in paediatric patients are prescribed without full knowledge on the optimal dosage and potential adverse drug reactions [1,2].…”

Section: Introductionmentioning

confidence: 99%

Drug utilization and off-label drug use among Spanish emergency room paediatric patients

Morales-Carpi

Estañ

Rubio

et al. 2009

Eur J Clin Pharmacol

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Objective To describe the use of medicines and to determine the frequency of off-label use in emergency room paediatric patients. Patients and methods A prospective, observational and descriptive study was carried out in the setting of the paediatric emergency room of a Spanish general hospital. Medicines used by children <14 years prior to their emergency room visit were analysed based on information collected from parents/guardians and relatives for each drug prescription. Off-label use was defined as the utilization of a drug at an indication, dosage, frequency or route of administration that differed from the specifications in the Summary of Product Characteristics or by children outside the authorized age group. Results The patient cohort comprised 462 children, among whom 336 children had been prescribed 667 prescriptions. Of the medicines prescribed, 90% fell into only five 5 Anatomical Therapeutic Chemical Classification System groups. The most frequent active principles were ibuprofen and paracetamol. Of a total of 152 different formulations recorded, no paediatric information was provided for 40 formulations, and one formulation was contraindicated in children. Based on the established criteria, 338 prescriptions were off-label: no paediatric information or contraindication in children were available (82 prescriptions); the drug was used for an indication different from the authorized one (111 prescriptions); drug use was inconsistent with age recommendations (16 prescriptions); drug use was inconsistent with dose/frequency (129 prescriptions). Of the 152 formulations, 107 were occasionally used in an off-label manner. Conclusions Although the mean number of drugs used in children is small, off-label use is frequent. Research efforts should target paediatric studies that allow a rational drug use in children.

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Off-label use of drugs in Italy: a prospective, observational and multicentre study

Abstract: Despite prescription profile differences among centres, off-label use was high everywhere. Immediate action for more rational drug use is necessary and requires not only regulatory intervention but also a more evidence-based, therapeutic approach.

Cited by 56 publications

References 22 publications

Magistral drugs in hospitalized newborns and children

Magistral drugs in hospitalized newborns and children

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

Drug utilization and off-label drug use among Spanish emergency room paediatric patients

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