Off-label medication use in adult critical care patients

Lat, Ishaq; Micek, Scott T.; Janzen, Jeffrey; Cohen, Henry; Olsen, Keith M.; Haas, Curtis E.

doi:10.1016/j.jcrc.2010.06.012

Cited by 57 publications

(72 citation statements)

References 17 publications

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“…OLDU is a common practice throughout the world with rates reported to be between 18% and 36% in adults (3)(4)(5)(6) and 3%-87% in pediatric patients (7)(8)(9)(10)(11)(12)(13)(14)(15). Moreover, the incidence of OLDU may vary depending on several factors such as the healthcare facility and the disease profile (11).…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

“…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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“…14 Majority of the patients were inappropriately prescribed ondansetron and pantoprazole without any approved indication, which was also reported by the earlier study. 15 Approximately, 234 (93.6%) of patients received antimicrobials. In an emergency setting, there is a dire need to give broad spectrum antibiotics as empirical therapy, which is essential is to narrow down the therapy as soon as we have a sensitivity report for the infecting organism.…”

Section: Discussionmentioning

confidence: 99%

Drug prescribing patterns in patients visiting the emergency medicine department at a tertiary care teaching hospital: a prospective study

Pandey

Khan

2016

Int J Basic Clin Pharmacol

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“…2 The off-label use of antidepressant, anticonvulsant, and antipsychotic medications is high and is more prevalent with increasing patient age. 12 In an intensive care unit, Lat et al 13 reported that 36.2% of medication orders were for an off-label use. In addition, ␤-adrenergic blocking agents are commonly prescribed for an off-label indication, and specialists may more commonly prescribe for off-label ␤-blocker use than primary care physicians.…”

Section: Question 2: Is Oldu Common?mentioning

confidence: 99%

“…In critical care patients, OLDU was without adequate evidence 48.3% of the time. 13 Because OLDU is typically less critically evaluated than is on-label drug use, OLDU may be associated with an increase in medication errors. 17 Rinke et al 17 studied pediatric antidepressant drug use in a national error-reporting database and found that 77% involved offlabel prescribing.…”

Section: Question 3: Can An Oldu For a Given Drug Become A Widely Accmentioning

confidence: 99%

Ten Common Questions (and Their Answers) About Off-label Drug Use

Wittich

Burkle

Lanier

2012

Mayo Clinic Proceedings

251

199

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The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have an underappreciation of its definition, prevalence, and implications. This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practice's meaning, breadth of application, acceptance, and liabilities. Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient. In addition, health care professionals should educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients.

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Off-label medication use in adult critical care patients

Cited by 57 publications

References 17 publications

A nationwide evaluation of off-label drug utilization in Turkey

A nationwide evaluation of off-label drug utilization in Turkey

Drug prescribing patterns in patients visiting the emergency medicine department at a tertiary care teaching hospital: a prospective study

Ten Common Questions (and Their Answers) About Off-label Drug Use

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