Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Aagaard, Lise; Hansen, Ebba Holme

doi:10.1186/2050-6511-14-30

Cited by 28 publications

(19 citation statements)

References 13 publications

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“…All of the 14 observational studies were retrospective, and most commonly (8 out of 14 studies) had the aim of comparing patient and HCP ADR reports . There were five studies from Denmark , five from the Netherlands , two from the UK , one from France and one from China . Two of the Danish studies focused on analysing the Danish experience with patient ADR reporting , and three studies performed an analysis of the ADRs presented in the European ADR database EudraVigilance .…”

Section: Resultsmentioning

confidence: 99%

“…There were five studies from Denmark , five from the Netherlands , two from the UK , one from France and one from China . Two of the Danish studies focused on analysing the Danish experience with patient ADR reporting , and three studies performed an analysis of the ADRs presented in the European ADR database EudraVigilance . The majority of the studies coming from the Netherlands and the UK compared the differences between ADR reports from patients and HCPs.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

The value of patient reporting to the pharmacovigilance system: a systematic review

Inácio

Cavaco

Airaksinen

2016

Brit J Clinical Pharma

169

162

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The value of patient reporting to the pharmacovigilance system: a systematic review

Inácio

Cavaco

Airaksinen

2016

Brit J Clinical Pharma

169

162

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“…Daily doses exceeding the clinical recommendation measured by means of prescription fills, further suggest misuse in a proportion of patients (112,114,211). Notably, sub-therapeutic effects of pregabalin are among the most commonly reported ADRs (212), potentially an important cause of treatment discontinuations (195).…”

Section: Pregabalinmentioning

confidence: 99%

Psychoactive prescription drug use disorders, misuse and abuse : Pharmacoepidemiological aspects

Tjäderborn

2016

Linköping University Medical Dissertations

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Background: There is a widespread and increasing use of psychoactive prescription drugs, such as opioid analgesics, anxiolytics, hypnotics and anti-epileptics, but their use is associated with a risk of drug use disorder, misuse and abuse. Today, these are globally recognised and emerging public health concerns. Aim:The aim of this thesis is to estimate the occurrence and prevalence of psychoactive prescription drug use disorders, misuse and abuse, and to investigate the association with some potential risk factors. Methods:A study using register data from forensic cause of death investigations analysed and described cases of fatal unintentional intoxications with tramadol (Study I). Based on register data on spontaneously reported adverse drug reactions (ADRs) reported cases of tramadol dependence were scrutinized and summarised (Study II). In a study in suspected drug-impaired drivers with a toxicology analysis confirming intake of tramadol, diazepam, flunitrazepam, zolpidem and zopiclone, the prevalence of non-prescribed use was assessed and associated factors were investigated (Study III). From a national cohort of patients initiating prescribed treatment with pregabalin, identified using data on prescription fills, a study investigated longitudinal utilisation patterns during five years with regards to use above the maximum approved daily dose (MAD) of the drug, and factors associated with the utilisation patterns (Study IV).Results: In the first study, 17 cases of unintentional intoxications were identified, in which tramadol was judged to have caused or contributed to the death. Of the deceased, more were men, the median age was 44 years and the majority used multiple psychoactive substances (prescription drugs, alcohol and/or illicit drugs). In the second study, 104 spontaneously vi reported cases of possible or probable tramadol dependence were identified, of which more concerned women. The median age in these cases was 45 years and in about a third of cases the person had a history of substance abuse and in 40% of cases there was documented history of psychoactive medication use. Severe addiction was reported. In the third study, more than half of the individuals suspected of drug-impaired driving used the drug without a recent prescription.Non prescribed use was most frequent in users of benzodiazepines and of tramadol compared to users of zolpidem or zopiclone, and was more likely in younger individuals and in multiplesubstance users and less likely in individuals with a recent prescription for another psychoactive medication. In the last paper, five longitudinal utilisation patterns were found in pregabalin users, with two patterns associated with a particularly high risk of use of doses above the maximum approved daily dose. The highest risk of use of daily doses above the MAD over time was associated with male sex, younger age, non-urban residency, and a recent prescribed treatment with an antiepileptic or opioid analgesic drug. Conclusions

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“…A study in the EudraVigilance database, investigating the characteristics of adverse drug reactions reported by patients from 2007 to 2011, has found that pregabalin was the most frequently involved in adverse reactions related to central nervous system drugs (1 510 reports out of a total of 4 766 reports related to central nervous systems drugs). [40] The most frequently reported reaction was a lack of efficacy, and 14 reports concerned withdrawal syndrome. However, it is likely that patients who misuse or abuse pregabalin do not report this event as an adverse drug reaction, if they are not suffering of the morbid consequences of this abuse.…”

Section: Why a Pharmacoepidemiological Approach Is Needed? Pregabalinmentioning

confidence: 99%

Drug Abuse Monitoring: Which Pharmacoepidemiological Resources at the European Level?

Lapeyre‐Mestre

Dupui

2015

Therapies

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-Monitoring the potential for abuse and dependence of psychoactive substances falls within the scope of international conventions on narcotic drugs. At the European level, this monitoring is based on activities controlled by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) for substance abuse in general and by the European Medicines Agency (EMA) for marketed drugs, in the context of pharmacovigilance. If France has set up in the early 1990s an original system to assess potential for abuse of psychoactive substances, with specific tools combining both the evaluation of the use of these substances (illicit substances or diverted drugs), and the consequences of that use in terms of morbidity and mortality, there is no equivalent in other European countries. Indeed, unlike the USA, who, for several decades, organized this type of surveillance, with a multisource approach (sentinel systems, databases, medical and administrative data, databases for seeking care in relation abuse), we have not found in other European countries integrated system for identifying a signal of drug abuse, or to assess the impact of measures for minimizing the risk of abuse. However, some recent examples show a growing concern about drug addiction, based on a pharmacoepidemiological approach using pharmacovigilance databases or medical administrative data. These examples illustrate the interest of these approaches in the field of drug of abuse.Abbreviations: see end of article.

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Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

Cited by 28 publications

References 13 publications

The value of patient reporting to the pharmacovigilance system: a systematic review

The value of patient reporting to the pharmacovigilance system: a systematic review

Psychoactive prescription drug use disorders, misuse and abuse : Pharmacoepidemiological aspects

Drug Abuse Monitoring: Which Pharmacoepidemiological Resources at the European Level?

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