Abstract:
PURPOSES:The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activities of the national PV centers in Arab countries. METHODS:A cross sectional study was conducted between March and May in 2018. The current survey was adopted and modified from a study that used the questionnaire designed by the World Health Organization Collaborating Centre for International Drug Monitoring. The national PV centers of 22 Arab countries were invited to participate in this study. Descriptive analyses were conducted utilizing the analysis services provided by SurveyMonkey. RESULTS:In total of, 15 countries responded to our invitation (response rate: 68%). Most Arab countries started their PV program in the last decade, with Palestine implementing its program in 2017. Among the respondents, nine (60%) were members of the WHO International Drug Monitoring Program and were all users of the software provided by the WHO Uppsala Monitoring Center (VigiFlow or VigiBase), except Sudan. In 2017, a total of 27 502 reports were received by the centers in the studied countries, ranging from three reports received in Lebanon to a total of 7362 reports received by the national program of Algeria. CONCLUSIONS:An improvement was noticed among the national PV programs in the Arab countries. However, a considerable difference still exists among the countries in terms of the implementation and practice of PV.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Alshammari TM,Alenzi KA,Ata SIdoi
10.1002/pds.4991subject
Has Abstractpub_date
2020-09-01 00:00:00pages
1001-1010issue
9eissn
1053-8569issn
1099-1557journal_volume
29pub_type
杂志文章abstract:PURPOSE:To explore associations between preterm birth and use of medications in young adulthood as a proxy for different diseases. METHODS:We linked data on birth characteristics from the Medical Birth Registry of Norway (1967-1999) and the Norwegian Prescription Database (2004-2015). Individuals born as singletons du...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4174
更新日期:2017-07-01 00:00:00
abstract:PURPOSE:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequen...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4859
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:Gut microbiota has been postulated to serve as a significant promoter of CRC formation, and colonic dysbiosis was previously reported in CRC tissue. Our aim was to evaluate the association between the type and cumulative duration of antibiotic exposure and CRC risk. METHODS:We conducted a nested case-control s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3765
更新日期:2015-05-01 00:00:00
abstract:PURPOSE:There is an increasing number of children with in utero exposure to opioids. Knowledge about opioid safety in pregnancy, particularly for outcomes later in childhood is scarce. It has been suggested that opioids can modulate immune system and increase the risk of infections. Our goal was to study the impact of ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5088
更新日期:2020-12-01 00:00:00
abstract:PURPOSE:vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggeste...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4247
更新日期:2017-08-01 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: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:BACKGROUND:Various strategies have been studied in the literature to address the significant underreporting of adverse drug reactions (ADRs) in healthcare systems worldwide. OBJECTIVES:We conducted a systematic review of the literature that assessed the impact of various strategies to improve ADR reporting published i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4906
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:(1) To identify factors associated with the choice among the three atypical antipsychotics available in France (amisulpride, olanzapine, risperidone) and the typical antipsychotic of reference: (haloperidol), (2) to compare psychotropic co-prescription rates according to antipsychotic. METHODS:All antipsychoti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1122
更新日期:2005-11-01 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:Administrative claim databases are increasingly being used to study the safety of medication exposures during pregnancy. These studies are restricted to live births due to a reliance on algorithms for estimating gestational age that are based on codes associated with live delivery. Conditioning on live birth ma...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4387
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Despite numerous clinical guidelines on asthma management, patients often receive suboptimal drug therapy. This study identified patients who received suboptimal regimens according to the National Heart, Lung and Blood Institute (NHLBI) Guidelines for the Diagnosis and Management of Asthma in a complete popu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3444
更新日期:2013-07-01 00:00:00
abstract:PURPOSE:A recent regulatory warning and case reports have described the development of muscle complications with the use of 5-α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. METHODS:We used a matched cohort design and linked administrative data from the...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4383
更新日期:2018-03-01 00:00:00
abstract:INTRODUCTION:Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined. OBJECTIVE:This paper aimed to conduct...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3596
更新日期:2014-06-01 00:00:00
abstract:PURPOSE:Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3902
更新日期:2016-05-01 00:00:00
abstract:PURPOSE:The objective of this study was to determine the fraction of variance in patient-level medication adherence accounted for by prescribers and pharmacies. METHODS:We used prescription drug claims paid between January 2010 and July 2011 to a national pharmacy benefits manager to define implementation during persi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4025
更新日期:2016-07-01 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:Because health insurance claims lack clinical information, comparative effectiveness research studies that rely on these data may be challenging to interpret and may result in biased inference. We conducted an exploratory study to determine if medical information contained in patient charts could offer clinical...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1988
更新日期:2010-08-01 00:00:00
abstract:PURPOSE:Few studies have reported an association between proton pump inhibitor (PPI) use and tuberculosis. Tuberculosis incidence is relatively high in Asian people, and an increase in PPI prescriptions has been reported in South Korea. Thus, we investigated the association between PPI use and tuberculosis development....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4773
更新日期:2019-06-01 00:00:00
abstract:PURPOSE:To study the association between antibiotic use in early pregnancy and the risk of isolated orofacial clefts. METHODS:We conducted a cohort study of 806,011 live births in Denmark from 1996 through September 2008. Individual-level information on prescribed antibiotics during pregnancy, orofacial cleft diagnosi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2179
更新日期:2012-03-01 00:00:00
abstract:PURPOSE:The purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. METHODS:Using a large integrated healthcare system innovative infrastructure in...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3228
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4614
更新日期:2018-09-01 00:00:00
abstract:PURPOSE:To examine the association between maternal use of beta-2-adrenergic agonists (β2AAs) and the risk of epilepsy in offspring. METHODS:A nationwide retrospective cohort study was performed based on Danish registries. Children of mothers who used β2AAs during pregnancy were allocated to the exposed group and othe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4648
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example. METHODS:We compared self-reported triptan use durin...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5089
更新日期:2020-09-01 00:00:00
abstract:PURPOSE:The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality. METHODS:A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings,...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3906
更新日期:2016-05-01 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: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:Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear u...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4394
更新日期:2018-04-01 00:00:00
abstract::The current medical care environment has created expectations that exceed its capabilities, one effect of which has been an increasing awareness of lapses in the quality of healthcare, including medical errors. As more new therapies reach clinical application, the expectations on the part of the public are unlikely to...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.699
更新日期:2002-06-01 00:00:00
abstract:PURPOSE:To display a ranked presentation of the data given in the Drug Analysis Prints (DAPs) provided by the MHRA/CSM so that the monitoring clinician may be readily alerted to the most important findings. The practolol DAP is taken as an example of the presentation. METHOD:The data for the ranked system organ classe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1144
更新日期:2005-10-01 00:00:00