Characterization of Guideline Evidence for Off-label Medication Use in the Intensive Care Unit

Shoulders, Bethany; Smithburger, Pamela L.; Tchen, Stephanie; Buckley, Mitchell S.; Lat, Ishaq; Kane‐Gill, Sandra L.

doi:10.1177/1060028017699635

Cited by 7 publications

(8 citation statements)

References 115 publications

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“…The most prescribed therapeutic class in the off-label use of drugs was systemic antimicrobials (14.44%), which corroborates studies performed in ICUs of American hospitals (17%) (Shoulders et al, 2017). Lat et al (2011) indicated that the low number of drugs approved by the FDA for treatment of sepsis is a major reason for the off-label use of antimicrobial drugs.…”

Section: Discussionsupporting

confidence: 79%

“…The term "off-label" refers to the prescribing and administration of drugs in a different manner to that described in package inserts with regard to factors such as the age of the patient, therapeutic indication, dosage, and frequency (Aronson, Ferner, 2017;Shoulders et al, 2017). In some hospital units, such as oncology, pediatrics, and intensive care, the use of drugs for unapproved indications and/or dosages is common, probably due to the lack of comprehensive clinical studies in these fields (Smithburger et al, 2015;Casañ et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

“…The substantial concerns about off-label drug use are related to the potential adverse effects and/or ineffective therapeutic outcomes of the practice, as well as the lack of strong scientific evidence to support it. (Shoulders et al, 2017;Gonçalves et al, 2018;European Medicines Agency, 2004;Eguale et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

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Off-label drug use in an adult intensive care unit of a Brazilian hospital

Chaves

Neto

Moreira

et al. 2022

Braz. J. Pharm. Sci.

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The objective of this study was to determine the prevalence and describe the factors associated with off-label drug use in an adult intensive care unit (ICU) of a Brazilian hospital. An analytical, crosssectional, prospective study was conducted in the adult ICU population from March 2018 to May 2018. Off-label use of medication was classified by indication, dosage, route of administration, type and volume of diluent, and duration of administration. Most patients were female (57.89%), nonelderly (56.14%), and had a mean age of 54.44 ± 17.15 years. The prevalence of off-label drug use was 70.31%, but was not associated with the clinical severity of the patients. A statistically significant association was observed between label use of drugs and prescribing potentially inappropriate medicines (PIM). The most common reasons for off-label drug use were therapeutic indication (19.58%) and volume of diluent (23.30%). Drug administration by enteral tubes accounted for the largest number of off-label uses due to route of administration (90.85%). There was a higher prevalence of off-label use of systemic antimicrobials (14.44%) and norepinephrine (9.28%). Our study provided a broad characterization of off-label drug use in an adult ICU and showed why it is important for health professionals to evaluate the specific risks and benefits of this practice.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

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Off-label drug use in an adult intensive care unit of a Brazilian hospital

Chaves

Neto

Moreira

et al. 2022

Braz. J. Pharm. Sci.

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“…Interestingly, the situation for adult off‐label prescribing appears more favorable. In the intensive care setting, off‐label drug use was supported by high to moderate quality evidence, defined as level A1, A2 or B, in 64% of the cases, 25 compared with only 34% in our study. In adult oncology patients, 61% of off‐label prescriptions were supported by at least well designed non‐RCTs 26 …”

Section: Discussionmentioning

confidence: 50%

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Zanden

Smeets

Hoop-Sommen

et al. 2022

Clin Pharma and Therapeutics

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This study shows that the level of evidence for off-label pediatric pharmacotherapy is low: for only 14% of off-label records, high quality studies are available. Thirty-seven percent of offlabel records are not supported by any clinical studies at all. HOW MIGHT THIS CHANGE CLINICAL PHARMA COLOGY OR TRANSLATIONAL SCIENCE? Performing high quality randomized controlled trials for the > 2,000 off-label record is a very long pathway to close this information gap. Alternatively, modeling and simulation may be valuable approaches to strengthen the evidence base for offlabel use of drugs, especially in younger age groups.

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“…7 Não há estudos na literatura evidenciando efetividade e segurança do uso prolongado da solução injetável de tartarato de metoprolol. 8 A literatura consultada recomenda a administração por sonda desde que seja realizada preparação de forma adequada (uso de cabine de segurança biológica e de equipamentos de proteção individual) para reduzir risco ao manipulador. 9 Água destilada (AD).…”

Section: Figuraunclassified

Off-label use of drugs administered by enteral feeding tubes in an Intensive Care Unit in Fortaleza, Brazil

Abreu¹,

Chaves²,

Neto³

et al. 2021

Rev Bras Farm Hosp Serv Saude

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Objective: To analyze the prescription profile of drugs administered through enteral feeding tubes in an adult intensive care unit and gather recommendations for their safe administration. Methods: This is a descriptive and retrospective study conducted with adult critical clinical patients of a university hospital in Fortaleza-Ceará from March to May 2018. We performed analyses of patients’ medical records and prescriptions regarding drugs, pharmaceutical presentations and the possibility of administration through enteral tubes. Results: 489 prescriptions containing 1914 items were evaluated, from which 16.6% (n = 318) through tubes. Medicines for the cardiovascular system (34.6%), nervous system (27.4%) and digestive system and metabolism (15.1%) were the most predominant, with an average of 5.8 (DP: 4.2) different per patient. Regarding the pharmaceutical presentation, oral solids were frequently prescribed via enteral tube (67.9%), especially risperidone (8.8%), carvedilol (8.3%) and amiodarone (7.9%). There were contraindications for administration through tubes in 21.6% of solid oral formulations, while there were alternative standardized pharmaceutical forms in the hospital for 43.1%. In addition, substitution for liquid preparations from the market were possible in 43.1%. Among those to which there were no alternative formulations, drugs targeting the cardiovascular system prevailed (52.2%). A table with guidelines for the proper administration of the prescribed solid medications was elaborated then. Conclusion: Solid oral medications were frequently prescribed through enteral tubes, especially those for the cardiovascular system without alternative formulations, which shows the need for guidelines to promote the safety of this process.

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Characterization of Guideline Evidence for Off-label Medication Use in the Intensive Care Unit

Cited by 7 publications

References 115 publications

Off-label drug use in an adult intensive care unit of a Brazilian hospital

Off-label drug use in an adult intensive care unit of a Brazilian hospital

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Off-label use of drugs administered by enteral feeding tubes in an Intensive Care Unit in Fortaleza, Brazil

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