Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

Khdour, Maher; Hallak, Hussein; Alayasa, Kawther S.; Al-Shahed, Qusai N; Hawwa, Ahmed F.; McElnay, James

doi:10.1007/s11096-011-9520-3

Cited by 34 publications

(40 citation statements)

References 31 publications

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“…This frequency is similar to those described in recent studies (46.5%-65%), [21][22][23][24] but is superior to some researches that report rates of 15.5% 7 , 27.7% 14 and 29.5%.…”

Section: Discussion Prescription In Neonatal Settingsupporting

confidence: 91%

“…10,12,14,19,20,[23][24][25] Comparing to our results, if we add the use of unlicensed to off-label drugs, a rate of 57.1% offlabel/unlicensed prescriptions is obtained, according to SPCs information.…”

supporting

confidence: 63%

“…10,20 In others, off-label use was assigned to different doses and dosing frequencies from those recommended in product licenses. 3,11,23 The latter is the main reason that led us to classify an approved drug as off-label too, which occurred in 33.5% of the cases in fullterm and 20.3% in preterm neonates (p < 0.001).…”

Section: Approved Drugs In Neonatal Periodmentioning

confidence: 99%

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Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

et al. 2015

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Results:We analyzed 1011 prescriptions of 84 active substances, made in 218 admissions. In 42.9% of the cases, medicines were used according to Summary of Product Characteristics information; 27.9% of drugs were approved for neonatal period but used in an off-label manner; off-label drugs for neonates were used in 10.1%, whereas those with undetermined approval state and contraindicated were used 6.0% and 8.7% of the cases, respectively. Unlicensed prescriptions accounted for 4.4% of total. Preterm received a higher rate of drugs used according to Summary of Product Characteristics (p < 0.0001), whereas full-term received more off-label drugs for dose/frequency (p < 0.0001) and contra-indicated for neonates (p < 0.012). Discussion: Preterm neonates received a higher median number of drugs, since they stayed longer in the unit. The main reason for off-label prescribing was the use of doses/frequencies of administration different from those stated in the Summary of Product Characteristics, suggesting that updating these documents is necessary. Manipulation of medicines is one of the causes for unlicensed drugs use, emphasizing the lack of appropriate formulations for neonatal age. Conclusion:Progresses have been made to reduce the risks of off-label/unlicensed prescriptions, but competent authorities must continue their efforts to develop safer and more effective drugs for neonatal period.

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“…This frequency is similar to those described in recent studies (46.5%-65%), [21][22][23][24] but is superior to some researches that report rates of 15.5% 7 , 27.7% 14 and 29.5%.…”

Section: Discussion Prescription In Neonatal Settingsupporting

confidence: 91%

supporting

confidence: 63%

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Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

et al. 2015

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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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“…Most of the studies investigating OLDU in the literature are specific to particular age groups, healthcare facilities, and indication (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17). Therefore, there is a need for pharmacoepidemiological studies assessing OLDU more thoroughly from a nationwide perspective.…”

Section: Introductionmentioning

confidence: 99%

A nationwide evaluation of off-label drug utilization in Turkey

Özdamar¹,

Akıcı²,

Alkan³

et al. 2017

Turk J Med Sci

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Background/aim: Off-label drug use (OLDU) is under the control of the Turkish Medicines and Medical Devices Agency (TMMDA) in Turkey. It was aimed to investigate demographic and medical features of patients with OLDU applications in Turkey. Materials and methods:A total of 4426 electronic OLDU application records of the TMMDA were evaluated retrospectively. Information regarding patients' demographic characteristics, diagnoses, requested drugs, institutions, and specialties of the physicians were evaluated.Results: OLDU applications were mostly made by rheumatologists (21.5%) and 95.2% of them were approved by the TMMDA. The mean age of the patients was 35 years and 54.4% of them were female. Off-label drugs were mostly prescribed for patients aged 18-64 years (62.1%) and were most frequently prescribed by physicians from university medical centers (81.0%). Systemic lupus erythematosus (10.1%) was the most common diagnosis. Mycophenolate (16.1%) and rituximab (10.1%) were the most frequently prescribed off-label drugs. There were differences regarding some characteristics of patients and their physicians among most frequently prescribed off-label drugs (P < 0.05). Conclusion:It is noteworthy that OLDU applications showed demographical and institutional differences. It is expected that this study will provide important contributions to physicians working in the relevant area with respect to treatment alternatives of diseases with treatment challenges.

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Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

Abstract: The present findings confirmed the elevated prevalence of unlicensed and off-label paediatric drugs use in Palestine and strongly support the need to perform well designed clinical studies in children.

Cited by 34 publications

References 31 publications

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

Magistral drugs in hospitalized newborns and children

A nationwide evaluation of off-label drug utilization in Turkey

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