| Title |
Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France
|
|---|---|
| Published in |
Drug Safety, December 2016
|
| DOI | 10.1007/s40264-016-0489-7 |
| Pubmed ID | |
| Authors |
Marine Auffret, Julien Labreuche, Alain Duhamel, Sylvie Deheul, Olivier Cottencin, Régis Bordet, Sophie Gautier, Benjamin Rolland |
| Abstract |
Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting. The 2012-2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among 'serious' and 'non-serious' reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences. A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in 'serious' reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space-time disorientation (5.1%). A standardized difference of <0.2 was identified for six out of the ten most frequent 'serious' ADRs, and eight of the ten 'non-serious' ADRs. A proactive regional pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system. |
X Demographics
The data shown below were collected from the profiles of 9 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| France | 4 | 44% |
| Belgium | 1 | 11% |
| Unknown | 4 | 44% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 7 | 78% |
| Science communicators (journalists, bloggers, editors) | 1 | 11% |
| Scientists | 1 | 11% |
Mendeley readers
The data shown below were compiled from readership statistics for 41 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 41 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 8 | 20% |
| Student > Master | 8 | 20% |
| Librarian | 4 | 10% |
| Student > Bachelor | 3 | 7% |
| Student > Doctoral Student | 3 | 7% |
| Other | 8 | 20% |
| Unknown | 7 | 17% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 9 | 22% |
| Medicine and Dentistry | 8 | 20% |
| Nursing and Health Professions | 2 | 5% |
| Agricultural and Biological Sciences | 2 | 5% |
| Psychology | 2 | 5% |
| Other | 5 | 12% |
| Unknown | 13 | 32% |
Attention Score in Context
This research output has an Altmetric Attention Score of 7. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 24 March 2017.
All research outputs
#5,429,287
of 25,374,917 outputs
Outputs from Drug Safety
#592
of 1,852 outputs
Outputs of similar age
#95,074
of 407,548 outputs
Outputs of similar age from Drug Safety
#13
of 26 outputs
Altmetric has tracked 25,374,917 research outputs across all sources so far. Compared to these this one has done well and is in the 78th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
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