Prevention of risks associated with inappropriate use/unnecessary consumption of medicines.

In the code of public health, misuse is defined as intentional and inappropriate use of a medicine or product, which is not in accordance with the terms of the marketing authorisation or the registration as well as with good practice recommendations. Very often this involves an individual or the interaction of several individuals including the patient, his/her carers, prescriber(s) and/or dispensers. Misuse is common; it is the source of medicinal adverse effects for which a significant part is avoidable. Medicines initially prescribed or dispensed in the context of their marketing authorization (MA) can also be the subject of primary dependency and misappropriation. Companies which develop medicines nationally make declarations to the ANSM (French National Agency for the Safety of Medicines and Health Products) and implement measures to limit non-compliant use of their products. Recently, the coronavirus disease-2019 (COVID-19) pandemic has highlighted the influence and societal impact of drug misuse. The finding of the existence of systemic misuse, the impossibility of proposing simple solutions leads us to propose two main areas for improved information and the training of users and health professionals in medicines in the context of multi-faceted interventions: prevention of misuse on the one hand and its identification and treatment on the other hand.

Assessing Patient Perceptions and Experiences of Paracetamol in France: Infodemiology Study Using Social Media Data Mining.

BACKGROUND: Individuals frequently turning to social media to discuss medical conditions and medication, sharing their experiences and information and asking questions among themselves. These online discussions can provide valuable insights into individual perceptions of medical treatment, and increasingly, studies are focusing on the potential use of this information to improve health care management. OBJECTIVE: The objective of this infodemiology study was to identify social media posts mentioning paracetamol-containing products to develop a better understanding of patients' opinions and perceptions of the drug. METHODS: Posts between January 2003 and March 2019 containing at least one mention of paracetamol were extracted from 18 French forums in May 2019 with the use of the Detec't (Kap Code) web crawler. Posts were then analyzed using the automated Detec't tool, which uses machine learning and text mining methods to inspect social media posts and extract relevant content. Posts were classified into groups: Paracetamol Only, Paracetamol and Opioids, Paracetamol and Others, and the Aggregate group. RESULTS: Overall, 44,283 posts were analyzed from 20,883 different users. Post volume over the study period showed a peak in activity between 2009 and 2012, as well as a spike in 2017 in the Aggregate group. The number of posts tended to be higher during winter each year. Posts were made predominantly by women (14,897/20,883, 71.34%), with 12.00% (2507/20,883) made by men and 16.67% (3479/20,883) by individuals of unknown gender. The mean age of web users was 39 (SD 19) years. In the Aggregate group, pain was the most common medical concept discussed (22,257/37,863, 58.78%), and paracetamol risk was the most common discussion topic, addressed in 20.36% (8902/43,725) of posts. Doliprane was the most common medication mentioned (14,058/44,283, 31.74%) within the Aggregate group, and tramadol was the most commonly mentioned drug in combination with paracetamol in the Aggregate group (1038/19,587, 5.30%). The most common unapproved indication mentioned within the Paracetamol Only group was fatigue (190/616, with 16.32% positive for an unapproved indication), with reference to dependence made by 1.61% (136/8470) of the web users, accounting for 1.33% (171/12,843) of the posts in the Paracetamol Only group. Dependence mentions in the Paracetamol and Opioids group were provided by 6.94% (248/3576) of web users, accounting for 5.44% (342/6281) of total posts. Reference to overdose was made by 245 web users across 291 posts within the Paracetamol Only group. The most common potential adverse event detected was nausea (306/12843, 2.38%) within the Paracetamol Only group. CONCLUSIONS: The use of social media mining with the Detec't tool provided valuable information on the perceptions and understanding of the web users, highlighting areas where providing more information for the general public on paracetamol, as well as other medications, may be of benefit.

Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS.

INTRODUCTION: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions. METHODS: Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data. In this study, we compare the performance of two other algorithms, the proportional query ratio (PQR) and the proportional query rate ratio (Q-PRR) against that of two reference signal-detection algorithms (SDAs) commonly used with the FDA AE Reporting System (FAERS) database. RESULTS: In summary, the web query methods have moderate sensitivity (80%) in detecting signals in web query data compared with reference SDAs in FAERS when the web query data are filtered, but the query metrics generate many false-positives and have low specificity compared with reference SDAs in FAERS. CONCLUSION: Future research is needed to find better refinements of query data and/or the metrics to improve the specificity of these web query log algorithms.

Updating the French method for the causality assessment of adverse drug reactions.

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.

[Update of the French drug reaction assessment method]. / Réactualisation de la méthode française d'imputabilité des effets indésirables des médicaments.

A tripartite group, entitled « CRI ¼ (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed: a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.

[Not Available]. / Réactualisation de la méthode française d'imputabilité des effets indésirables des médicaments.

A tripartite group, entitled « CRI ¼ (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed : a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.