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

Abstract

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.

The challenge of HIV treatment in an era of polypharmacy

“…Information about DDIs are presented in the relevant sections of the product label, the purpose of which is to assist the prescriber in the use of a specific medicine. However, a recent assessment of the consistency of DDI information in drug labels in several countries (USA, UK, China, Japan, Korea) showed only a moderate level of agreement among the countries' labelling . The study concluded that there is a need for international harmonization of the drug labelling process and regulation to produce standardized information that can ensure safe drug therapy worldwide.…”

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

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

“…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.…”

“…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.…”

A Study on the Description of Anticancer Drug Combination Therapy in the Package Insert in Japan

“…14) A separate study compared the indications of reference labels among the US, Japan, and the European Union. 15) Another study compared package inserts among the US, the United Kingdom, China, South Korea, and Japan concerning information described in the drug-drug interaction section, 16) whereas one study compared pharmacokinetics information among China, Japan, and the US regarding anticancer drugs. 17) A study on the operational aspects of the Japanese package insert 18) and a proposal for improving the package insert based on previous studies 19) have also been reported.…”