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.

scholarly journals No Evidence of Off-label Use of Olodaterol and Indacaterol in Denmark, France, and the Netherlands: A Drug Utilization Study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Cristina Rebordosa ◽  
Eline Houben ◽  
Kristina Laugesen ◽  
Ulrich Bothner ◽  
Jukka Montonen ◽  
...  
Keyword(s):  
The Netherlands ◽  
Drug Utilization ◽  
Off Label Use ◽  
Drug Utilization Study ◽  
Off Label ◽  
Label Use

scholarly journals Patterns of Off-Label Prescribing in the Pediatric Intensive Care Unit and Prioritizing Future Research

2015 ◽  
Vol 20 (3) ◽  
pp. 186-196 ◽  
Author(s):  
Angela S. Czaja ◽  
Pamela D. Reiter ◽  
M. Lynn Schultz ◽  
Robert J. Valuck
Keyword(s):  
Intensive Care ◽  
High Risk ◽  
Pediatric Intensive Care ◽  
Future Research ◽  
Off Label Use ◽  
Off Label ◽  
Lengths Of Stay ◽  
Uncertain Evidence ◽  
Organ Failures ◽  
Label Use

OBJECTIVES: To characterize off-label prescribing among US pediatric intensive care units (PICUs), determine characteristics associated with off-label use, and identify medications in highest need for additional study. METHODS: Medications prescribed for ≥1% PICU patients (age < 18 years) in 2010 were identified from 39 children's hospitals. Use in a patient younger than the Food and Drug Administration (FDA)-approved age for any indication was considered off-label. Hierarchical multivariable modeling was used to identify characteristics associated with off-label use, accounting for center effects. Highest-impact drugs were defined by: 1) high off-label use (off-label use in at least 5% of the PICU cohort), 2) high risk medication, and 3) high priority status by the FDA or Best Pharmaceuticals for Children Act (BPCA). RESULTS: A total of 66,896 patients received ≥1 medication of interest (n = 162) during their PICU stay. A median of 3 (interquartile range, 2–6) unique drugs per patient were used off-label. Those who received ≥1 drug off-label (85% of the cohort) had longer median PICU (2 days vs 1 day) and hospital (6 days vs 3 days) lengths of stay and higher mortality (3.6% vs 0.7%), p < 0.001. Factors independently associated with off-label drug use included: age 1 to 5 years, chronic conditions, acute organ failures, mechanical ventilation, arterial or venous catheters, dialysis, and blood products. Half of prescribed medications (n = 84) had been used off-label: 26 with significant off-label use, 30 high-risk medications, and 47 with high FDA/BPCA priority. The highest impact medications identified were: dexmedetomidine, dopamine, hydromorphone, ketamine, lorazepam, methadone, milrinone, and oxycodone. CONCLUSIONS: Most PICU patients are exposed to off-label medication use, with uncertain evidence. Future medication research in this population should focus on medications with high impact potential.

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.

Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands

2009 ◽  
Vol 11 (1,2) ◽  
pp. 51-59 ◽  
Author(s):  
M. Sturkenboom ◽  
M. Felisi ◽  
C. Manfredi ◽  
A. Neubert ◽  
L. Cantarutti ◽  
...  
Keyword(s):  
United Kingdom ◽  
The Netherlands ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Off-Label Use of Medicines in Children Attending a Secondary Healthcare Facility in Federal Capital Territory

2021 ◽  
pp. 1-4
Author(s):  
Godspower Onavbavba ◽  
Keyword(s):  
Social Sciences ◽  
Healthcare Facility ◽  
Off Label Use ◽  
Healthcare Facilities ◽  
Case File ◽  
Off Label ◽  
Inappropriate Use ◽  
Collection Form ◽  
Intended Use ◽  
Label Use

Before a new drug is approved for marketing in any country, it must have undergone three phases of clinical trials designed to assess its efficacy and safety when used according to an approved recommendation. After a drug has been tested and approved by the regulatory authorities, the drug is usually given a ‘label’ or ‘license’ which is a report describing the drug intended use and dosage. This study aimed at evaluating the use of medicines outside the terms stated in the label. The study was conducted using a data collection form to obtain information from patients’ case file. Data were analysed using Statistical Package for Social Sciences. The case notes of 449 patients were included in the study. The ages of the patients ranged from 4 days to 16 years. Females constituted 51.7% (232) and males 48.3% (217). A total of 1866 drugs were administered to patients, of which 469 (25.13%) were off-label prescriptions. The highest category of off-label drug was indication (45%). This study has revealed a considerable prevalence of off-label use of medicines, there is however need for proper pharmaceutical care to be emplaced in healthcare facilities so as to minimize off-label drug use and prevent adverse effect of drugs as a result of inappropriate use of medicines.

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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