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

Silva, Joana; Flôr-de-Lima, Filipa; Soares, Henrique; Guimarães, Hercília

doi:10.20344/amp.5271

Cited by 30 publications

(27 citation statements)

References 30 publications

(78 reference statements)

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“…Similarly to previous studies we demonstrate a negative correlation between GA and number of drugs per patient [1,19,23,24]. We found that extremely preterms received drugs for alimentary tract and metabolism (e.g.…”

Section: Discussionsupporting

confidence: 89%

Drug prescription pattern in European neonatal units

Mesek

Nellis

Lass

et al. 2018

Preprint

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BackgroundHospitalized neonates receive the highest number of drugs compared to all other age groups, but consumption rates vary between studies depending on patient characteristics and local practices. There are no large scale international studies on drug use in neonatal units. We aimed to describe drug use in European neonatal units and characterize its associations with geographic region and gestational age (GA). MethodsA one-day point prevalence study (PPS) was performed as part of the European Study of Neonatal Exposure to Excipients (ESNEE) from January to June 2012. All neonatal prescriptions and demographic data were registered in a web-based database. The impact of GA and region on prescription rate were analyzed with logistic regression. ResultsIn total, 21 European countries with 89 neonatal units participated. Altogether 2173 prescriptions given to 726 neonates were registered. The 10 drugs with the highest prescription rate were multivitamins, vitamin D, caffeine, gentamicin, amino acids for parenteral nutrition, phytomenadione, ampicillin, benzylpenicillin, fat emulsion for parenteral nutrition and probiotics. The six most commonly prescribed ATC groups (alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous, respiratory and cardiovascular system) covered 98% of prescriptions. GA significantly affected the use of all commonly used drug groups. Geographic region influenced the use of alimentary tract and metabolism, blood and blood-forming organs, systemic anti-infectives, nervous and respiratory system drugs. ConclusionsWhile GA-dependent differences in neonatal drug use were expected, regional variations (except for systemic anti-infectives) indicate a need for cooperation in developing harmonized evidence-based guidelines and suggest priorities for collaborative work.

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Section: Discussionsupporting

confidence: 89%

Drug prescription pattern in European neonatal units

Mesek

Nellis

Lass

et al. 2018

Preprint

View full text Add to dashboard Cite

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“…However, a report published by Clark et al, showed that combination of ampicillin/gentamicin was more effective as compared to ampicillin/ cefotaxime in newborns infants for infectious diseases [ 24 ]. Ampicillin was more frequently prescribed drug in neonates and was also reported by a Portuguese research [ 25 ]. Many other studies conducted in different regions also reported ampicillin as most commonly prescribed drug [ 13 , 19 , 26 ].…”

Section: Discussionmentioning

confidence: 60%

Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing

et al. 2018

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BackgroundUnlicensed and off label drug use is an issue recognized worldwide in pediatric pharmacotherapy. The study was designed to assess the prevalence and predictors of unlicensed and off label drug use in neonatal population of Pakistan.MethodA prospective, observation study was conducted in nursery units at pediatric department of four tertiary care hospitals during the 1 year. Micromedex DRUGDEX was used to evaluate the case notes of 1300 patients. Logistic regression was employed to calculate the odds ratio for the predictors of unlicensed and off label drug use.ResultsA total of 1300 patients were included in this study who were treated with 52 different drugs. The prevalence of off label drug use was higher (52.14%) as compared to unlicensed drug use (33.35%). Dose (61.29%) and indication (13.68%) were the most frequent reasons for off label prescribing. In comparison to the corresponding reference categories, females and preterm infants were less likely to receive unlicensed prescriptions. While patients staying at hospital more than 5 days and infants receiving 3 or more medications were significantly more likely to receive unlicensed prescriptions. Moreover, in comparison to the corresponding reference categories, females were less likely to receive off label prescriptions while infants receiving 3 or more medications were 7 times more likely to receive off label prescriptions.ConclusionThe significant prevalence of unlicensed and off label drug prescriptions was found in neonatal population of Pakistan. The findings imply that more data on prevalence of unlicensed and off label prescriptions are required to provide a better picture of pediatric therapy in developing countries. Furthermore, advance formulations with new dosing in pediatrics is also necessary to minimize the risk of adverse drug events.Electronic supplementary materialThe online version of this article (10.1186/s12887-018-1211-y) contains supplementary material, which is available to authorized users.

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“…The authors found that in 42.9% of the cases, medicines were used according to the 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, and unlicensed prescriptions accounted for 4.4% of total. 17 Another study including patients aged from 4 days to 18 years assisted in a Portuguese pediatric emergency unit found that of the 724 medicines prescribed, 32.2% were offlabel. At least one drug was used off-label in 28.1% of the studied population, corresponding to 46.1% of the 427 children that received prescriptions.…”

Section: International Perspective: Regulations and Frequency Of Off-mentioning

confidence: 99%

Controversies in off‐label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies

França

Litewka

2018

Int J Dermatology

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The term "off-label drug use" involves the prescription of medications for unapproved indications or in unapproved dosage, dosage form, or route of administration. Off-label medications are common in the management of dermatologic diseases. In the recent years, new indications for botulinum toxin, biologics, spironolactone, topical calcineurin, and topical vitamin D analogues emerged, and these drugs are being used off-label to treat a variety of conditions. The high cost and long time required for the approval discourage pharmaceutical companies from developing studies and pursuing the approval by regulatory agencies. Patients and physicians may have a different perspective regarding the off-label use of medications. The ethical discussion is based on the different opinions concerning the need for informed consent by the patient and how this could be applicable in the clinical practice.

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

Cited by 30 publications

References 30 publications

Drug prescription pattern in European neonatal units

Drug prescription pattern in European neonatal units

Drug utilization in neonatal setting of Pakistan: focus on unlicensed and off label drug prescribing

Controversies in off‐label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies

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