Challenges on off label medicine use

Carvalho, Márcia Lazaro de

doi:10.1016/j.rppede.2015.12.007

Cited by 4 publications

(6 citation statements)

References 7 publications

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“…Over the past two decades, changes in drug regulation generated by the FDA and EMA resulted in substantial changes in how new drugs with potential use in children are studied and labeled [ 75 , 76 ]. To achieve child’s health protection and to ensure that medications are used ethically, in 2007, the European Union (EU) issued legislation for the development and authorization of pediatric drugs [ 77 , 78 ]. In addition, pharmaceutical companies are required to submit a pediatric investigation plan (PIP) to the EMA’s Pediatric Committee (PDCO) for every new medicine unless an exemption (waiver) is granted [ 79 ].…”

Section: Legislative and Ethical Measures For Off-label Restrictionmentioning

confidence: 99%

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Petkova,

Georgieva,

Dimitrov

et al. 2023

Pharmaceutics

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Off-label prescribing is widespread among pediatricians, and it is unlikely that this trend will soon be bound by a uniform legal framework. This is necessitated by the fact that there are four variables: the patient’s health condition, the physician’s experience and knowledge, the legislative measures (laws, directives, guidelines, and recommendations), and finally, the pharmaceutical industry. There is considerable concern worldwide about the use of off-label medicines in children. We may call it an enormous global problem that is much talked about and written about; however, we should not forget that the goal around which everyone should unite is the patient’s life. For healthcare providers, the most important thing will always be the health and preservation of the patient’s life, particularly when it comes to children with life-threatening conditions in neonatal and pediatric intensive care units (NICU and PICU). The study aimed to examine the prevalence of off-label drug use in pediatrics. Literature research was conducted, and we included studies from 2012 to 2022 that evaluated off-label drug prevalence in various pediatric patient populations.

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Section: Legislative and Ethical Measures For Off-label Restrictionmentioning

confidence: 99%

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Petkova,

Georgieva,

Dimitrov

et al. 2023

Pharmaceutics

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“…The goal is to alert following adverse reactions from the off‐label use of drugs. These public measures to restrict off‐label prescriptions are more common in the control of the incentives and the dissemination of information to the medical community . Just like in the US, the regulatory agencies cannot restrict off‐label prescriptions beyond educational campaigns and have no jurisdiction on the practice of medicine.…”

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

confidence: 99%

“…These are named phase I, II, and III studies. They investigate aspects of the pharmacokinetics, toxicity, safety, and efficacy in humans . All clinical trials should follow ethical guidelines, requiring the approval of the institutional ethics committee and written informed consent from the participants of the study .…”

Section: Off‐label Prescriptions: Clinical Research Vs Medical Treatmentioning

confidence: 99%

“…They investigate aspects of the pharmacokinetics, toxicity, safety, and efficacy in humans. 8 All clinical trials should follow ethical guidelines, requiring the approval of the institutional ethics committee and written informed consent from the participants of the study. 9 Drawing a clear line of demarcation between drugs used in research vs. medical treatment can be challenging.…”

Section: Introductionmentioning

confidence: 99%

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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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“…These are termed phase I, II, and III studies, which investigate aspects of the pharmacokinetics, toxicity, and efficacy in humans. In clinical trials, several factors may meddle with the outcomes, such as inclusion and exclusion criteria, sample sizes, and ethical, completely defended at the beginning of the assessment of a new drug, preclude scientific study in specific populaces [3]. Children and pregnant women are well on the way to be prescribed off-label drugs because most trials are never acted in this subset of the population for ethical reasons.…”

Section: Introductionmentioning

confidence: 99%

Common Drugs with Effective Off-Label Uses

Alshehri

Mudawi

2020

JPRI

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The term off-label drug use (OLDU) is utilized broadly in the medical literature. It is a polarizing term since it may be related to incredible advantage or harm to patients. OLDU is defined as drug uses that not included in the indications or dosage regimens listed in the drug labeling. The main issue with off-label use is that there is insufficient information supports the use of the drug so this review aims to give brief information about some common drugs with effective and useful off-label uses based on scientific study and to encourage the researcher to provide sufficient information for the physician and health care providers about off-label uses to decrease the risk of harm to the patients. There are many drugs with various off-label uses that play an important role clinically such as using atorvastatin in chronic heart failure (CHF) due to its pleiotropic action also it can show a significant reduction in the frequency of hospitalization due to CHF exacerbation. However, that make off-label uses an important is several diseases do not have approved drugs, partly because the diseases are rare or conducting clinical trials and marketing the drug for such diseases may not be gainful.

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Challenges on off label medicine use

Cited by 4 publications

References 7 publications

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022

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

Common Drugs with Effective Off-Label Uses

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