Dataset Information

When the Safe Alternative Is Not That Safe: Tramadol Prescribing in Children.

ABSTRACT: Children represent a vulnerable population in which management of nociceptive pain is complex. Drug responses in children differ from adults due to age-related differences. Moreover, therapeutic choices are limited by the lack of indication for a number of analgesic drugs due to the challenge of conducting clinical trials in children. Furthermore the assessment of efficacy as well as tolerance may be complicated by children's inability to communicate properly. According to the World Health Organization, weak opioids such as tramadol and codeine, may be used in addition to paracetamol and ibuprofen for moderate nociceptive pain in both children and adults. However, codeine prescription has been restricted for the last 5 years in children because of the risk of fatal overdoses linked to the variable activity of cytochrome P450 (CYP) 2D6 which bioactivates codeine. Even though tramadol has been considered a safe alternative to codeine, it is well established that tramadol pharmacodynamic opioid effects, efficacy and safety, are also largely influenced by CYP2D6 activity. For this reason, the US Food and Drug Administration recently released a boxed warning regarding the use of tramadol in children. To provide safe and effective tramadol prescription in children, a personalized approach, with dose adaptation according to CYP2D6 activity, would certainly be the safest method. We therefore recommend this approach in children requiring chronic or recurrent nociceptive pain treatment with tramadol. In case of acute inpatients nociceptive pain management, prescribing tramadol at the minimal effective dose, in a child appropriate dosage form and after clear instructions are given to the parents, remains reasonable based on current data. In all other situations, morphine should be preferred for moderate to severe nociceptive pain conditions.

SUBMITTER: Rodieux F

PROVIDER: S-EPMC5844975 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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When the Safe Alternative Is Not That Safe: Tramadol Prescribing in Children.

Rodieux Frédérique F Vutskits Laszlo L Posfay-Barbe Klara M KM Habre Walid W Piguet Valérie V Desmeules Jules A JA Samer Caroline F CF

Frontiers in pharmacology 20180305

Children represent a vulnerable population in which management of nociceptive pain is complex. Drug responses in children differ from adults due to age-related differences. Moreover, therapeutic choices are limited by the lack of indication for a number of analgesic drugs due to the challenge of conducting clinical trials in children. Furthermore the assessment of efficacy as well as tolerance may be complicated by children's inability to communicate properly. According to the World Health Organ ...[more]

PMID: 29556194

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Project description:BackgroundPhysician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Methods and findingsCross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.ConclusionsFew physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.

Project description:Objectives(1) Systematically assemble, analyse and synthesise published evidence on causes of prescribing error in children. (2) Present results to a multidisciplinary group of paediatric prescribing stakeholders to validate findings and establish how causative factors lead to errors in practice.DesignScoping review using Arksey and O'Malley's framework, including stakeholder consultation; qualitative evidence synthesis.MethodsWe followed the six scoping review stages. (1) Research question-the research question was 'What is known about causes of prescribing error in children?' (2) Search strategy-we searched MEDLINE, EMBASE, CINAHL (from inception to February 2018), grey literature and reference lists of included studies. (3) Article selection-all published evidence contributing information on the causes of prescribing error in children was eligible for inclusion. We included review articles as secondary evidence to broaden understanding. (4) Charting data-results were collated in a custom data charting form. (5) Reporting results-we summarised article characteristics, extracted causal evidence and thematically synthesised findings. (6) Stakeholder consultation-results were presented to a multidisciplinary focus group of six prescribing stakeholders to establish validity, relevance and mechanisms by which causes lead to errors in practice.Results68 articles were included. We identified six main causes of prescribing errors: children's fundamental differences led to individualised dosing and calculations; off-licence prescribing; medication formulations; communication with children; and experience working with children. Primary evidence clarifying causes was lacking.ConclusionsSpecific factors complicate prescribing for children and increase risk of errors. Primary research is needed to confirm and elaborate these causes of error. In the meantime, this review uses existing evidence to make provisional paediatric-specific recommendations for policy, practice and education.

Dataset Information

When the Safe Alternative Is Not That Safe: Tramadol Prescribing in Children.

Publications

When the Safe Alternative Is Not That Safe: Tramadol Prescribing in Children.

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