scholarly journals Adverse Drug Reaction Reports Containing AMR-Relevant MedDRA Terms in the Dutch Pharmacovigilance Database

2021 ◽  
Author(s):  
Jean Marie Vianney Habarugira ◽  
Linda Harmark ◽  
Albert Figueras
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Resistance ◽  
Drug Reaction ◽  
Descriptive Analysis ◽  
Pathogen Resistance ◽  
Pharmacovigilance Centre ◽  
Off Label Use ◽  
Off Label ◽  
Pv Systems ◽  
Pharmacovigilance Database

(1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and Pharmacovigilance (PV) has the potential to strengthen current antimicrobial stewardship (AMS) strategies. This study aimed to characterise AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre (Lareb); (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs).; (3) Results: Between 1998 and Jan 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n=89; 35%), colistin (n=30; 11,9%), ciprofloxacin (n=16; 6,35%), doxycycline (n=14; 5,5%) and aztreonam (n=12; 4,76%). The most frequently used PTs were drug ineffective (n=71; 28%), pathogen resistance (n=14; 5%) and drug resistance (n=13; 13%). A total of 119 reports (74%) suggested use-related issues. Watch antibiotics were in 54% of the reports and Reserve antibiotics were in 19%. In the Watch group, “Off label use” and “Product use in unapproved indication” were the most frequent PTs and majority of reports on Reserve antibiotics were coded as “Off label”. (4) Conclusions: Addressing AMR using the PV methods will provide an opportunity for PV expansion and could encourage further investment in both in AMS programs and PV systems.

scholarly journals Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre

Antibiotics ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. 1512
Author(s):  
Jean Marie Vianney Habarugira ◽  
Linda Härmark ◽  
Albert Figueras
Keyword(s):  
Antimicrobial Resistance ◽  
The Netherlands ◽  
Pathogen Resistance ◽  
Future Research ◽  
Pharmacovigilance Centre ◽  
Off Label Use ◽  
Off Label ◽  
Inappropriate Use ◽  
Product Use ◽  
Label Use

(1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n = 89; 35%), colistin (n = 30; 11.9%), cipro-floxacin (n = 16; 6.3%), doxycycline (n = 14; 5.5%), and aztreonam (n = 12; 4.8%). The PTs used included off label use (n = 91; 36.1%), drug ineffective (n = 71; 28.2%), product use in unapproved indication (n = 28; 11.1%), pathogen resistance (n = 14; 5.6%), and drug resistance (n = 13; 5.2%). 54% of the reports were on Watch antibiotics and 19% were involved in the Reserve group. In the Watch group, “off label use” and “product use in unapproved indication” were the most frequent PTs and the majority of reports on Reserve antibiotics were coded as “Off label”. A sharp increase in the number of reports was observed in the three consecutive years with 21 in 2013, 54 in 2014, and 83 in 2015; (4) Conclusions: In addition to existing AMR monitoring strategies, pharmacovigilance databases can serve as a source of data on suspected resistance and inappropriate use. Future research should explore how these AMR-relevant MedDRA Terms are used in resource-limited settings with less capacity to generate laboratory-confirmed resistance data.

Off-label use of nicardipine as tocolytic and acute pulmonary oedema: a post-marketing analysis of adverse drug reaction reports in EudraVigilance

2015 ◽  
Vol 24 (11) ◽  
pp. 1220-1224 ◽  
Author(s):  
Mauro Melis ◽  
Amelia Cupelli ◽  
Laura Sottosanti ◽  
Elena Buccellato ◽  
Chiara Biagi ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Pulmonary Oedema ◽  
Acute Pulmonary Oedema ◽  
Off Label Use ◽  
Off Label ◽  
Post Marketing ◽  
Marketing Analysis ◽  
Label Use

Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study

Drug Safety ◽  
2016 ◽  
Vol 39 (12) ◽  
pp. 1189-1195 ◽  
Author(s):  
Geneviève Durrieu ◽  
Julien Jacquot ◽  
Mathilde Mège ◽  
Emmanuelle Bondon-Guitton ◽  
Vanessa Rousseau ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
General Practitioners ◽  
Descriptive Study ◽  
Pharmacovigilance Centre ◽  
Spontaneous Adverse Drug Reaction

scholarly journals Promoting adverse drug reaction reporting: comparison of different approaches

2016 ◽  
Vol 50 (0) ◽  
Author(s):  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Ricardo Cruz-Correia
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Cost Effectiveness ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Adverse Drug Reaction Reporting ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Educational Approach ◽  
Reaction Reporting

ABSTRACT OBJECTIVE To describe different approaches to promote adverse drug reaction reporting among health care professionals, determining their cost-effectiveness. METHODS We analyzed and compared several approaches taken by the Northern Pharmacovigilance Centre (Portugal) to promote adverse drug reaction reporting. Approaches were compared regarding the number and relevance of adverse drug reaction reports obtained and costs involved. Costs by report were estimated by adding the initial costs and the running costs of each intervention. These costs were divided by the number of reports obtained with each intervention, to assess its cost-effectiveness. RESULTS All the approaches seem to have increased the number of adverse drug reaction reports. We noted the biggest increase with protocols (321 reports, costing 1.96 € each), followed by first educational approach (265 reports, 20.31 €/report) and by the hyperlink approach (136 reports, 15.59 €/report). Regarding the severity of adverse drug reactions, protocols were the most efficient approach, costing 2.29 €/report, followed by hyperlinks (30.28 €/report, having no running costs). Concerning unexpected adverse drug reactions, the best result was obtained with protocols (5.12 €/report), followed by first educational approach (38.79 €/report). CONCLUSIONS We recommend implementing protocols in other pharmacovigilance centers. They seem to be the most efficient intervention, allowing receiving adverse drug reactions reports at lower costs. The increase applied not only to the total number of reports, but also to the severity, unexpectedness and high degree of causality attributed to the adverse drug reactions. Still, hyperlinks have the advantage of not involving running costs, showing the second best performance in cost per adverse drug reactions report.

Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database

2012 ◽  
Vol 21 (6) ◽  
pp. 597-602 ◽  
Author(s):  
Anita Conforti ◽  
Sibilla Opri ◽  
Paola D'Incau ◽  
Laura Sottosanti ◽  
Ugo Moretti ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reaction Reporting ◽  
Reaction Reporting ◽  
Pharmacovigilance Database

scholarly journals A RETROSPECTIVE STUDY: THE OFF-LABEL USE OF ANTICONVULSANTS AT A PRIVATE HOSPITAL IN INDONESIA

2018 ◽  
Vol 10 (5) ◽  
pp. 119
Author(s):  
Bangunawati Rahajeng ◽  
Zullies Ikawati ◽  
Tri Murti Andayani ◽  
Iwan Dwiprahasto
Keyword(s):  
Medical Records ◽  
Private Hospital ◽  
Descriptive Analysis ◽  
Food Control ◽  
Off Label Use ◽  
National Agency ◽  
Off Label ◽  
Retrospective Data Collection ◽  
One Year ◽  
Label Use

Objective: Anticonvulsant is one class of drugs often used off-label. This study was conducted to investigate the prevalence and the indication of the off-label use of anticonvulsants in a private hospital in Java, Indonesia.Methods: This was an observational study with a retrospective data collection in a private hospital in Java. Data were obtained on the prescription of anticonvulsants. Indications of the use of anticonvulsants were obtained from the medical records of patients who were prescribed anticonvulsants. The off-label use of anticonvulsants was defined a prescribing of medication outside the indication approved by The National Agency of Drug and Food Control Indonesia (NA-DFC). The use off-label of anticonvulsants was calculated by descriptive analysis and presented as a percentage.Results: It showed that in one year there were 5,310 for 1,316 patients: of this 462 patients (35.11%) were for an off-label use. The anticonvulsants used off-label were oxcarbazepine 67.27% (37/55), carbamazepine 46.15% (54/117), pregabalin45.45% (60/132), phenytoin37.62% (225/598), valproate 25.34% (37/109), and gabapentin 18.28% (49/219). The highest off-label use of anticonvulsants was found in neurological and psychiatric disorders 67.32% (n=311), and on 97.19% of them were not supported by strong clinical evidence.Conclusion: The off-label use of anticonvulsants occurred in one-third of patients receiving prescriptions of anticonvulsants, even though for most of them there was a lack of evidence. More attention must be paid to the efficacy and risk of side effects of the drug used.

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