Trainees’ Attitudes and Preferences towards the Use of Over the Counter Analgesics in Patients with Chronic Liver Disease

D, Nguyen

doi:10.4172/2167-1052.1000167

Cited by 3 publications

(1 citation statement)

References 34 publications

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“…Another important finding was that the type of hepatic disease of patients included in PK studies was not specified in the SmPC text, even though specifically requested by the EMA guideline (European Medicines Agency, 2005). As shown in literature, prescribers other than gastroenterologists often do not know which patients with a liver disease need dose adjustments or avoidance of certain medicines (Rossi et al, 2008; Nguyen et al, 2014) that is possibly caused by the use of the undefined term “hepatic impairment.” In the one medicine where the type of hepatic disease studied was available in the SmPC, the recommendations were ambiguous because different wordings were used interchangeably to define the “at-risk population.” The study from 2001 already concluded that this “at-risk population” was often vaguely described (Anonymous, 2001), so it seems little to no progress has been made in this area. We could find the information on the hepatic disease that caused the impairment for most medicines in the study reports.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment

et al. 2019

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Background: In 2005, the European Medicines Agency (EMA) released guidance on pharmacokinetic studies in patients with hepatic impairment. This guidance describes the design of these studies and what information should be presented in the Summary of Product Characteristics (SmPC). We aim to evaluate the availability and clinical applicability of information on medicine use in patients with hepatic impairment in SmPCs and registrational dossiers of recently approved medicines. Methods: We reviewed SmPC information on use in patients with hepatic impairment of 51 new medicines authorized between 2015 and 2017. Per medicine, we assessed the availability of nine information items derived from the EMA guidance, i.e. type of hepatic disease studied; stratification by severity of hepatic impairment; influence of hepatic impairment on the pharmacokinetics; safety advice in mild, moderate, and severe hepatic impairments; and dosing recommendation in mild, moderate, and severe hepatic impairments. If unavailable, the European Public Assessment Report (EPAR) and study report were consulted consecutively. Of available items, clinical applicability was assessed by labeling information as “clear” or “ambiguous”. Results: Of 51 medicines, 15 had no pharmacokinetic study in patients with hepatic impairment described in their SmPC. The other 36 SmPCs contained on average seven of the nine information items (range 4–9). One SmPC contained all 9 items, and after consulting, the study reports, 11 SmPCs were complete. The item “type of hepatic disease studied” was available in one SmPC, though it could be retrieved in 21 study reports. Regarding clinical applicability, there was no medicine with all information items available and clearly formulated in the SmPC. A total of 12 medicines (33%) contained only clearly formulated information, while 24 (67%) contained at least one ambiguously formulated information item (range 0–4). Items often ambiguously formulated were: “definition of mild, moderate, and severe hepatic impairment” (15 ambiguous SmPCs) and “safety advice in severe hepatic impairment” (17 ambiguous SmPCs). Conclusion: While SmPCs contain a large part of information requested by the EMA, clinical applicability seems low, as it is often unclear to which specific type of hepatic disease patient the advice applies. This can negatively influence the practical use by healthcare professionals.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment

et al. 2019

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Current and future directions in the treatment and prevention of drug-induced liver injury: a systematic review

Stine¹,

Lewis²

2015

Expert Review of Gastroenterology & Hepatology

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While the pace of discovery of new agents, mechanisms and risk factors involved in drug-induced liver injury (DILI) remains brisk, advances in the treatment of acute DILI seems slow by comparison. In general, the key to treating suspected DILI is to stop using the drug prior to developing irreversible liver failure. However, predicting when to stop is an inexact science, and commonly used ALT monitoring is an ineffective strategy outside of clinical trials. The only specific antidote for acute DILI remains N-acetylcysteine (NAC) for acetaminophen poisoning, although NAC is proving to be beneficial in some cases of non-acetaminophen DILI in adults. Corticosteroids can be effective for DILI associated with autoimmune or systemic hypersensitivity features. Ursodeoxycholic acid, silymarin and glycyrrhizin have been used to treat DILI for decades, but success remains anecdotal. Bile acid washout regimens using cholestyramine appear to be more evidenced based, in particular for lefluonomide toxicity. For drug-induced acute liver failure, the use of liver support systems is still investigational in the United States and emergency liver transplant remains limited by its availability. Primary prevention appears to be the key to avoiding DILI and the need for acute treatment. Pharmacogenomics, including HLA genotyping and the discovery of specific DILI biomarkers offers significant promise for the future. This article describes and summarizes the numerous and diverse treatment and prevention modalities that are currently available to manage DILI.

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Epidemiology Concepts for Clinical Trials

Kamarapu¹

2016

Epidemiology (Sunnyvale)

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Trainees’ Attitudes and Preferences towards the Use of Over the Counter Analgesics in Patients with Chronic Liver Disease

Cited by 3 publications

References 34 publications

Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment

Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment

Current and future directions in the treatment and prevention of drug-induced liver injury: a systematic review

Epidemiology Concepts for Clinical Trials

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