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 consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan. METHODS:This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. RESULTS:The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. CONCLUSIONS:The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Pane J,Francisca RDC,Verhamme KMC,Orozco M,Viroux H,Rebollo I,Sturkenboom MCJMdoi
10.1002/pds.4859subject
Has Abstractpub_date
2019-09-01 00:00:00pages
1155-1165issue
9eissn
1053-8569issn
1099-1557journal_volume
28pub_type
杂志文章,评审abstract:PURPOSE:To evaluate whether the risk of coronary heart disease (CHD) differs among adult diabetic patients treated with thiazolidinediones (TZDs) and similar patients treated with combined oral metformin and sulfonylurea (M + S) therapy. METHODS:We conducted a retrospective cohort study involving 25 140 diabetic patie...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1356
更新日期:2007-05-01 00:00:00
abstract:PURPOSE:To develop and validate an algorithm to identify preterm infants in the absence of birth certificates within Medicaid data. METHODS:Medicaid fee-for-service claims data from Florida (FL) and Texas (TX) were linked to vital statistics data for infants who were continuously eligible during the first 3 months fol...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3264
更新日期:2012-06-01 00:00:00
abstract:PURPOSE:UK primary care databases are frequently used in observational studies with cancer outcomes. We aimed to systematically review methods used by such studies to identify and validate incident cancers of the breast, colorectum, and prostate. METHODS:Medline and Embase (1980-2013) were searched for UK primary care...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3729
更新日期:2015-01-01 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:OBJECTIVE:To study the human teratogenic potential of two acetylsalicylic acid (ASA) drugs ASA-100 mg and ASA-500 mg. DESIGN:Pair analysis of cases with congenital abnormalities and matched healthy controls. SETTINGS:The large population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormali...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/1099-1557(200005/06)9:3<193::AID-PDS498>3.
更新日期:2000-05-01 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:The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS:The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during th...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2169
更新日期:2012-02-01 00:00:00
abstract::Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial inf...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199707)6:4<283::AID-PDS270
更新日期:1997-07-01 00:00:00
abstract:PURPOSE:Direct oral anticoagulants (DOACs) have been promoted in patients with nonvalvular atrial fibrillation (nv-AF) as a more convenient alternative to vitamin K antagonists. We estimated 1-year dabigatran and rivaroxaban adherence rates in nv-AF patients and assessed associations between baseline patient characteri...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4268
更新日期:2017-11-01 00:00:00
abstract:PURPOSE:Ejection fraction (EF) is crucial information when studying the use and effectiveness of therapies in patients with heart failure (HF) and myocardial infarction (MI). We aimed to assess the validity of claims data-based definitions of systolic dysfunction (SD). METHODS:We identified 1072 patients with EF recor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2146
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:Warfarin is commonly used among patients who receive influenza, pneumococcal, and tetanus and diphtheria toxoid vaccines, and persons on warfarin therapy may also receive Hepatitis A vaccine. There has been concern that vaccinations could potentially alter coagulation parameters in patients on warfarin therapy....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1386
更新日期:2007-07-01 00:00:00
abstract::When a biological hypothesis of causal effect can be inferred, the hypothesis can sometimes be tested in the selfsame database that gave rise to the study data from which the hypothesis grew. Valid testing happens when the inferred biological hypothesis has scientific implications that predict new relations between ob...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1929
更新日期:2010-05-01 00:00:00
abstract:PURPOSE:To determine healthcare claim patterns associated using nonsteroidal anti-inflammatory drugs (NSAIDs) for rheumatoid arthritis (RA). METHODS:The CADEUS study randomly identified NSAID users within the French health insurance database. One-year claims data were extracted, and NSAID indication was obtained from ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.3221
更新日期:2012-06-01 00:00:00
abstract:PURPOSE:The General Practice Research Database (GPRD) is a database of longitudinal patient records from general practices in the United Kingdom. It is an important data source for pharmacoepidemiology studies, but until now it has been tedious to calculate the daily dose and duration of exposure to drugs prescribed. T...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1151
更新日期:2006-03-01 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::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:Confounding, a concern in nonexperimental research using administrative claims, is nearly ubiquitous in claims-based pharmacoepidemiology studies. A fixed-length look-back window for assessing comorbidity from claims is common, but it may be advantageous to use all historical claims. We assessed how the strengt...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3922
更新日期:2016-03-01 00:00:00
abstract:PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4948
更新日期:2020-03-01 00:00:00
abstract::Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5005
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:Breast cancer is the most common cancer in women worldwide. We attempted to investigate the association between the risk of breast cancer and use of captopril and other antihypertensive medication. METHODS:We performed a cohort study with a nested case-control analysis using the General Practitioner Research D...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.910
更新日期:2004-08-01 00:00:00
abstract:INTRODUCTION:The analgesic metamizole (dipyrone) is not recommended during pregnancy due to limited experience. In several countries, metamizole has no market authorization because of agranulocytosis as a rare but severe adverse effect. However, in others, metamizole is available and widely used as a pain reliever, and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4277
更新日期:2017-10-01 00:00:00
abstract:PURPOSE:The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS:Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate an...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3928
更新日期:2016-03-01 00:00:00
abstract:PURPOSE:To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS:People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4330
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:Hydroxyzine is indicated for the management of anxiety, skin and sleep disorders. In 2015, the European Medicines Agency (EMA) concluded that hydroxyzine was pro-arrhythmogenic and changes to the product information were implemented in Europe. This study aimed to evaluate their impact in Denmark, Scotland, E...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5191
更新日期:2021-01-01 00:00:00
abstract:PURPOSE:The study aimed to evaluate the comparative risk of oral ulcerations among antipsychotic medications. METHODS:We analyzed the National Health Insurance Research Database of Taiwan and included patients newly initiated with a single antipsychotic agent including haloperidol, sulpiride, olanzapine, quetiapine, r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3903
更新日期:2016-02-01 00:00:00
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:OBJECTIVE:This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS:Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving AD...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1805
更新日期:2009-10-01 00:00:00
abstract:PURPOSE:Research using healthcare databases often includes patients frequently excluded from clinical trials; yet it is not known whether commonly used data represents the overall population or specific sub-populations of interest. We aimed to examine population representativeness from data sources in recent research s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5087
更新日期:2020-11-01 00:00:00
abstract:OBJECTIVE:We sought to describe the epidemiology of viral respiratory-tract infections and patterns in prescriptions of cough and cold medications among young children who were suffering from viral respiratory tract infections (vRTIs). METHODS:We conducted a cross-sectional study to examine vRTI-episode occurrence and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1002/pds.3460
更新日期:2014-01-01 00:00:00
abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4646
更新日期:2018-11-01 00:00:00