Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review

Oshikoya, Kazeem Adeola; Wharton, Gerold T.; Avant, Debbie; Driest, Sara L. Van; Fenn, Norman E.; Lardieri, Allison; Doe, Edwin; Sood, Beena G.; Taketomo, Carol; Lieu, Phuong; Yen, Lilly; McMahon, Ann

doi:10.1007/s40272-018-0318-9

Cited by 18 publications

(15 citation statements)

References 19 publications

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“…Evaluation of experimental therapies can be conducted in terms of SeConts, for instance, by sharing data from single off-label (or compassionate) use from different hospitals. The secondary use of data from these therapies can help inform other physicians with similar patients about the course and outcome of different experimental therapeutic approaches [40]. Other studies that reuse clinical data in the sense of SeConts are drug safety and efficacy studies [41].…”

Section: Overview Of Different Types Of Secondary Use Of Clinical Data In Data-gathering Non-interventional Research or Learning Activitimentioning

confidence: 99%

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment

Jungkunz¹,

Köngeter²,

Mehlis³

et al. 2021

J Med Internet Res

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Background The secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used. Objective Since the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap. Methods In this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts. Results We offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example. Conclusions In the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.

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Section: Overview Of Different Types Of Secondary Use Of Clinical Data In Data-gathering Non-interventional Research or Learning Activitimentioning

confidence: 99%

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment

Jungkunz¹,

Köngeter²,

Mehlis³

et al. 2021

J Med Internet Res

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“…Nonetheless, caution should be exercised when administering pentazocine to neonates for anesthetic induction and when dose increases or repeated dosing is required. Considering the high rates of lifethreatening respiratory problems associated with opioids analgesics in neonates, which is of global concern [8, 45], it is important to intensely monitor for respiratory depression among neonates using pentazocine.…”

Section: Discussionmentioning

confidence: 99%

Off-label use of pentazocine and the associated adverse events among pediatric surgical patients in a tertiary hospital in Northern Nigeria: a retrospective chart review

Oshikoya

Ogunyinka

Godman

2019

Current Medical Research and Opinion

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Background and aims: Pentazocine remains a widely used opioid pre-anesthetic medication and postoperative analgesic in low-and middle-income countries (LMICs) despite concerns. We assessed the adverse events (AEs) associated with off-label use of pentazocine in pediatric surgical patients and determined the possible risk factors associated with slow respiratory AEs. Method: Children ≤ 18 years old for surgery administered pentazocine IM/IV as a pre-anesthetic medication or post-operative analgesic. Pertinent data including total daily dose and duration of use of pentazocine and its associated AEs were obtained from patients' case files. Risk factors associated with slow respiratory AEs were determined using logistic regression analyses. Results: 159 patients were included with median age of 2 years and mainly males (52.8%). Pentazocine was administered off-label to all patients for post-operative pain management (96.2%) or pre-anesthetic medication (3.8%). All patients experienced at least one AE with most experiencing 2-7 AEs. Rapid breathing (116; 18.4%), followed by sleepiness/sedation/drowsiness (90; 14.3%) and fast pulse (79; 12.5%) was the most frequently reported AEs. None of the demographics and clinical variables significantly predicted the risk of slow respiratory AEs. Conclusion: Off-label use of pentazocine is common and associated with multiple AEs. Care is needed as no predictors of slow respiratory AEs were observed.

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“…Since the onset of the pandemic, reports of cardiovascular adverse effects including QTc prolongation and ventricular arrhythmias have increased, even in indications other than COVID-19 12 leading to a revoke of FDA emergency authorization for the use of drugs such as hydroxychloroquine and azithromycin in COVID-19 treatment. 68 Studies show that there is a significant increased risk for QTc prolongation in combination with hydroxychloroquine within the first 4 days of treatment, in comparison with monotherapy, with substantial decrease in QTc after stopping the medication. 42 , 67 Furthermore, the risk of fatal cardiac outcomes (TdP, ventricular tachycardia, ventricular fibrillation, or cardiac arrest) is associated with azithromycin plus hydroxychloroquine with up to 12.27% increase in average risk of severe arrhythmia; however, the population with coronary artery disease and congestive heart failure are at higher risk.…”

Section: Drug Used For Self-medication In Covid-19mentioning

confidence: 99%

Drug safety of frequently used drugs and substances for self-medication in COVID-19

Baracaldo-Santamaría

Pabón-Londoño

Rojas-Rodriguez

2022

Therapeutic Advances in Drug Safety

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During the COVID-19 pandemic, the behavior of self-medication has increased. The dissemination of misleading information regarding the efficacy of certain drugs or substances for the prevention and treatment of COVID-19 has been the major contributing factor for this phenomenon. Alongside with the increase in self-medication behavior, the inherent risks to this act such as drug–drug interactions, adverse events, drug toxicity, and masking of symptoms have also increased. Self-medication in the context of COVID-19 has led to drug misuse leading in some cases to the development of fatal adverse drug reactions. It is important that during this ongoing pandemic drugs with potential clinical efficacy against COVID-19 are adequately analyzed regarding their efficacy, safety, and monitoring. The aim of this review is to describe the available evidence regarding the efficacy, safety, and monitoring of the drugs and substances that have been shown to be frequently used for self-medication in patients with COVID-19 (hydroxychloroquine, non-steroidal anti-inflammatory drugs, ivermectin, azithromycin, vitamins, aspirin, and chlorine dioxide) to adequately characterize their risks, safe use, monitoring strategies, and to reinforce the concept that these substances should not be used for self-medication and require a medical prescription. Plain Language Summary Drug safety of frequently used drugs and substances for self-medication in COVID-19 Dissemination of information about potential COVID-19 treatments has led individuals to self-medicate and expose themselves to risks such as drug–drug interactions, side effects, antibiotic resistance, and misdiagnosis. There is a need to review the medical literature to evaluate the safety and efficacy of the drugs and substances commonly used by the population for the treatment and prevention of SARS CoV-2 infection. In this review, we included drugs that are frequently used for self-medication and commonly advertised such as ivermectin, hydroxychloroquine, chlorine dioxide, azithromycin, and non-steroidal anti-inflammatory drugs, among others. A brief introduction of the drug and its mechanism of action, followed by a summary of the efficacy in COVID-19 and safety, will be described for each drug in order to promote their responsible use.

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Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review

Cited by 18 publications

References 19 publications

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment

Off-label use of pentazocine and the associated adverse events among pediatric surgical patients in a tertiary hospital in Northern Nigeria: a retrospective chart review

Drug safety of frequently used drugs and substances for self-medication in COVID-19

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