Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan

Lee, Shin Haeng; Shin, Ju Young; Park, Mi Ju; Park, Byung Joo

doi:10.1016/j.yrtph.2014.01.013

Cited by 7 publications

(9 citation statements)

References 18 publications

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“…Seven focused on the content of PIs [84][85][86][87][88][89][90], three of which compared aspects of Japanese PIs to those from the USA and UK [84,87,90]. One study also compared PIs from South Korea to those from Japan, the USA and UK [94]. Three further multi-country comparative studies were identified, which compared PI content from East Asian countries with that from Western countries [102][103][104].…”

Section: East Asiamentioning

confidence: 99%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

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Section: East Asiamentioning

confidence: 99%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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“…The drug interaction information in drug labeling among the US, the UK, China, Japan, and Korea has been systematically categorized for the first time. Although a few studies have compared the indication, precaution, and warning information in drug labeling among countries, [13][14][15][16]28 no study has evaluated the drug interaction information in drug labeling. In our study, drug interactions were divided into four categories depending on the clinical consequences, and the information of 38 recently approved drugs were analyzed using the kappa coefficient.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Consistency of Drug Interaction Information in Drug Labels Among the United States, the United Kingdom, China, Japan, and Korea

Jeong

Kam

et al. 2018

Clin Pharma and Therapeutics

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Information gap in drug labeling among countries create challenges in therapeutic use of drugs. We aimed to evaluate the consistency of drug interaction information in drug labels among five countries. The study drugs were chosen from the commonly approved drug list in the US, UK, China, Japan, and Korea. The degree of agreement of drug interaction data was evaluated by kappa coefficient. Thirty-eight drugs were evaluated, and moderate degree of agreement was observed among all countries' labeling (κ = 0.43, 95% confidence interval (CI) = 0.41-0.46). The degree of agreement was the highest for the UK and Korea (κ = 0.71, 95% CI = 0.67-0.75) and the lowest for the UK and Japan (κ = 0.02, 95% CI = 0.00-0.04). Information regarding drug interactions listed in the studied drug labels was not in high agreement. International standardization of drug labeling is required to ensure safe drug therapy.

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“…These findings align with previously demonstrated divergence in product monographs from North American, European, and Asian regulatory authorities. 7-12…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

“…These findings align with previously demonstrated divergence in product monographs from North American, European, and Asian regulatory authorities. [7][8][9][10][11][12] Recommendations for the treatment of the uncomplicated patient with atrial fibrillation or acute venous thromboembolism (VTE), with normal renal and hepatic function and few concomitant medications, were similar across the regulatory authorities. However, important differences emerged when the patient is no longer "uncomplicated"in situations when clinicians are likely to seek clarification for prescribing information.…”

Section: Relevance To Patient Care and Clinical Practicementioning

confidence: 99%

“…Comparison of product monographs from North America, Europe, and Asia have demonstrated that although there appear to be similarities in approved indications for medication use across jurisdictions, significant variation exists in the reporting of adverse drug reactions, precautions, contraindications, black box warning, drug interactions, and pregnancy prescribing information. [7][8][9][10][11][12] Most of the available comparisons have looked at alignment in 1 or 2 sections of product monographs, and none have specifically assessed alignment in DOAC product monographs.…”

Section: Introductionmentioning

confidence: 99%

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Jurisdictional Guidance on DOAC Use—Will It Affect Practice? A Comparison of European, American, and Canadian Product Monographs

et al. 2019

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Objective: To identify clinically relevant areas of concordance and discordance between product monographs for 4 direct oral anticoagulants (DOACs) approved by regulatory authorities in Europe, the United States, and Canada. Data Sources: For each DOAC (apixaban, dabigatran, edoxaban, rivaroxaban), manufacturer product monographs were retrieved from the European Medicines Database, US Food and Drug Administration, and Health Canada Drug Product Database. Data Extraction: Monographs for each DOAC were independently reviewed by 2 investigators to identify areas of concordance and discordance. Discordance existed if it was deemed that a potentially clinically relevant difference existed. A heat map summarizing the data was created to identify areas of complete concordance, partial concordance (concordance between 2 of 3 monographs), and complete discordance. Data Synthesis: The areas of concordance were indications for use, use in extremes of weight, and switching to/from the DOAC. Areas of discordance included the following: differing recommendations for use/dosing with renal dysfunction; contraindication or use with caution with drug interactions, pregnancy, and hepatic/renal dysfunction; and timing of DOAC with spinal/epidural anesthesia after a procedure or traumatic puncture. Relevance to Patient Care and Clinical Practice: Concordance was most evident for uncomplicated patients with atrial fibrillation or venous thromboembolism, whereas discordance emerged for those having characteristics/factors wherein clinicians may seek clarification within product monographs (eg, impaired renal/hepatic function, drug interactions). As such, clinicians must be familiar with product information within their country of practice. Conclusion: Variability between jurisdictions was evident, and variability of DOAC use is likely to increase with expanding worldwide uptake.

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Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan

Cited by 7 publications

References 18 publications

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Assessment of Consistency of Drug Interaction Information in Drug Labels Among the United States, the United Kingdom, China, Japan, and Korea

Jurisdictional Guidance on DOAC Use—Will It Affect Practice? A Comparison of European, American, and Canadian Product Monographs

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