Abstract:
PURPOSE:Our study addresses how the information in the labels differed between United States (US) and Japan, what factors were associated with the decision to place the boxed warning on the label, and the relation of both countries in terms of drug label policy. METHODS:We investigated adverse drug reactions (ADRs) in boxed warnings for 44 oncological drug labels approved from 2004 to 2014 in both Japan and the US. We applied conditional logistic regression to examine how likely it was for each ADR to be included in a boxed warning. RESULTS:There were substantial differences in all sections of the labels. The concordance rate between US and Japanese labels was 44.1% for serious adverse reactions and 30.5% for boxed warnings. Our regression analysis indicated that deaths and/or terminations related to specific ADRs reported in clinical trials were significantly associated with inclusion of the ADR in boxed warnings in Japan, but not in the US. The boxed warnings of similar drugs seemed to affect those of follow-on drugs in both countries. US drug labels were likely to influence Japanese labels, but not vice versa. CONCLUSION:This study suggests that the observed differences are not solely due to differences in clinical outcomes between the two countries, but rather due to differences in regulatory considerations and historical factors in both local and global contexts. Further research is needed to examine the impact of these differences on public health and to determine how and to what extent we should intervene with this status quo. Copyright © 2016 John Wiley & Sons, Ltd.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Jayaputra K,Ono Sdoi
10.1002/pds.4111subject
Has Abstractpub_date
2017-02-01 00:00:00pages
143-151issue
2eissn
1053-8569issn
1099-1557journal_volume
26pub_type
杂志文章abstract:PURPOSE:Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS:ASA users...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4140
更新日期:2017-02-01 00:00:00
abstract:PURPOSE:Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. METHODS:A MEDLINE search of English language literature was performed to identify studies published between Janua...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1230
更新日期:2006-08-01 00:00:00
abstract:PURPOSE:To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand. SETTING:Tertiary teaching hospital, North-East Thailand. METHODS:Over a 6-month period doctors w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1708
更新日期:2009-03-01 00:00:00
abstract:PURPOSE:To develop a method for identifying the beginning and ending records of pregnancies in the automated medical records of the General Practice Research Database (GPRD). METHODS:Women's records from 1991 to 1999 were searched for codes from 17 pregnancy marker and 7 pregnancy outcome categories. Using the retriev...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.935
更新日期:2004-11-01 00:00:00
abstract::The article is devoted to the establishment and development of the National Pharmacovigilance system in Ukraine. A drug safety centre of Ukraine started to form a pharmacovigilance system in 1996. It has been operating on a regular basis since 2000 and now provides the regulatory services that include data collection ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.886
更新日期:2004-03-01 00:00:00
abstract:PURPOSE:To investigate the association between socioeconomic position and use of lipid-lowering drugs and ACE-inhibitors after an acute myocardial infarction (AMI) when simultaneously considering participation in the national quality register RIKS-HIA (Register of Information and Knowledge about Swedish Heart Intensive...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1917
更新日期:2010-04-01 00:00:00
abstract:PURPOSE:Determine the relative risk of cancer users of commonly prescribed antihypertensive drugs with a focus on documenting risk in long-term users (>7.5 years). METHODS:We conducted a nested case-control study using the Saskatchewan Health databases. Cancer risks in users of beta-blockers, calcium channel blockers ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1656
更新日期:2008-11-01 00:00:00
abstract:PURPOSE:To define periods of acceptable mortality reporting in primary care and to demonstrate through examples the implication for research using automated medical data. METHODS:Annual death counts were obtained for each primary care practice participating in The Health Improvement Network "THIN" (UK). Expected count...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1688
更新日期:2009-01-01 00:00:00
abstract:PURPOSE:Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States poison centers. METHODS:This retrospective database study utilized the National Poison Data System to compare the ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5136
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1788
更新日期:2009-09-01 00:00:00
abstract:BACKGROUND:Following approval in the EU in 2002 and the USA in 2003, an Intensive Safety Surveillance Scheme (IS(3) ) was initiated to educate prescribers on the appropriate use of miglustat for the treatment of type I Gaucher disease (GD1), and to actively solicit safety-relevant information. This report summarises da...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.3760
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:Risk assessment for natural health products (NHPs) may not be evaluated similarly to therapeutic products by Health Canada in terms of notification of harms to consumers and health professionals. In this descriptive study, we evaluated risk communications (RCs) issued by Health Canada for NHPs and for therapeut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2137
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVE:This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals. METHODS:A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199908/09)8:5<331::AID-PDS
更新日期:1999-08-01 00:00:00
abstract:BACKGROUND:High-grade cervical dysplasia or cervical intraepithelial neoplasia grade 2 or worse has been widely used as a surrogate endpoint in cervical cancer screening or prevention trials. METHODS:To identify high-grade cervical dysplasia and cervical cancer, we developed claims-based algorithms that incorporated a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3520
更新日期:2013-11-01 00:00:00
abstract::Not everything is known about a medicine when it receives its licence for marketing. The merits of a new drug, balancing its beneficial and its untoward effects, become only established after sufficient experience has been gained from its use in real practice. Part of the reason for this is that our extensive phase II...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199901/02)8:1<61::AID-PDS3
更新日期:1999-01-01 00:00:00
abstract:PURPOSE:An increasing consumption of opioids in the general population has been reported in several countries also among pregnant women. Limited information is available regarding the effect of prenatal exposure to analgesic opioids on long-term neurocognitive function in children. The primary aim of the study was to d...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4170
更新日期:2017-06-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the prevalence of potential drug-drug interactions (DDIs) in hospitalised patients in correlation with patient's age and number of drugs prescribed and to determine the prevalence of inappropriate drugs prescribed to elderly patients. METHODS:Drugs prescribed during ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1531
更新日期:2008-07-01 00:00:00
abstract:PURPOSE:In Spain, a human papillomavirus (HPV) vaccine was firstly marketed in 2006 and mainly administered in primary care (PC) practices for girls/women or schools. As for all vaccines, a valid data source is required for research on observational effectiveness or safety. The objective of this study is to identify an...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4674
更新日期:2019-02-01 00:00:00
abstract:PURPOSE:Stimulant medications used for treating attention deficit hyperactivity disorder (ADHD) can be associated with an increased risk of seizures. Atomoxetine is a non-stimulant medication approved for treating ADHD. This retrospective cohort analysis evaluated risk of seizures among pediatric patients naïve to ADHD...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3390
更新日期:2013-04-01 00:00:00
abstract:PURPOSE:We aimed to investigate the association between psychotropic treatment and risk of burn injury in individuals with mental illness. METHODS:A nested case-control study was conducted by using the National Health Insurance Research Database in Taiwan. A total of 3187 cases with burn injury under International Cla...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3995
更新日期:2016-08-01 00:00:00
abstract:PURPOSE:Multimorbidity (MM) (presence of more than one chronic condition within a same patient) imposes a heavy burden on patients and health care systems. In contrast to high-income countries, the epidemiology of this phenomenon is unclear in low- and middle-income countries, particularly among Iranian population. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4925
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:Early detection of risky behaviors involving prescription opioids can assist prescribers in implementing safer prescribing. Patient-to-prescriber travel patterns may indicate potential opioid misuse. We introduce doctor hopping, patients bypassing nearby prescribers in favor of more distant ones, as a new spati...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4838
更新日期:2019-08-01 00:00:00
abstract:PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2030
更新日期:2010-11-01 00:00:00
abstract:PURPOSE:We discuss the practical advantages and challenges of sharing controls among two or more concurrently conducted case-control studies. METHODS:We conducted two case-control studies, one of breast cancer and the other of endometrial cancer, with overlapping, shared control groups. The studies had overlapping geo...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1130
更新日期:2005-08-01 00:00:00
abstract:PURPOSE:We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD). METHODS:Using a retrospective, observational cohort s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3585
更新日期:2014-05-01 00:00:00
abstract:PURPOSE:To assess the effect of moderate alcohol consumption on Adverse Drug Reactions (ADRs) among older adults admitted to acute care hospitals and to examine the consistency of this effect across gender and age groups. METHODS:We used the GIFA (Italian Group of Pharmacoepidemiology in the Elderly) database, which i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.721
更新日期:2002-07-01 00:00:00
abstract:AIM:The aim of the present study was to investigate to what extent patients using prescription antiobesity drugs (orlistat, sibutramine and rimonabant) concomitantly or concurrently used psychotropic drugs and analgesics and the association between this drug use and the patients' gender and age. An additional aim was t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1896
更新日期:2010-03-01 00:00:00
abstract:PURPOSE:We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS:A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3896
更新日期:2016-01-01 00:00:00
abstract:PURPOSE:Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1509
更新日期:2007-12-01 00:00:00
abstract:PURPOSE:This study aims to examine the associations between proton pump inhibitors (PPIs), traditional nonsteroidal anti-inflammatory drugs (tNSAIDs), PPI + tNSAID co-exposure, and the development of the following: (i) acute interstitial nephritis (AIN), a specific kidney injury often attributed to these drugs, and (ii...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3329
更新日期:2012-11-01 00:00:00