Analgesic switching in chronic users of dextropropoxyphene in France.

Background: The combination dextropropoxyphene/paracetamol (DXP/P) was the most prescribed opioid analgesic until its withdrawal in 2011.

Objectives: This study investigated dispensations of analgesics in chronic users of DXP/P during the 18 months following its withdrawal.

Methods: A cross-sectional study repeated yearly was conducted by using the French reimbursement database from 2006 to 2015.

A 13-Year National Monitoring Study to Assess Narcotic Prescriptions and Indications (2007-2019).

Introduction: Analgesics are among the most widely used drugs worldwide. This study describes the population treated with narcotic analgesics, their therapeutic indications and how the data have evolved over a decade.

Methods: A cross-sectional, national, multicentre survey study was conducted that included surveys taken every year from 2007 to 2019 in a national sample of 1500 randomly selected dispensing pharmacies.

Adverse drug reactions induced by cotrimoxazole: Still a lot of preventable harm.

Owing to a broad spectrum and low cost antimicrobial, cotrimoxazole is largely prescribed. However, its use is associated with various adverse drug reactions (ADRs) that warrant to ensure rational prescribing. This study aimed to describe spontaneous reports of cotrimoxazole ADRs and to evaluate the quality of prescription in patients who had ADRs.

[Use of synthetic substances in France and in Europe].

This paper aims to present the main information presented at the 9th Meeting about addictovigilance in 2016 by four healthcare professionals and addiction experts on the issue of new psychoactive substance use. A new psychoactive substance (NPS) is defined as a narcotic or psychotropic drug, in pure form or in preparation, that is not controlled by the United Nations drug conventions, but which may pose a public health threat comparable to that posed by substances listed in these conventions. The emergence of NPS consumption is a worldwide concern.

Ten-year trend of opioid and nonopioid analgesic use in the French adult population.

Aims: Analgesics are the most widely used medicines worldwide. In parallel, opioid abuse has increased and is of major concern. The accessibility of pharmacologically powerful medicines and the addictovigilance signals in France about the risk of opiates addiction call for an overview of analgesic use.

Identifying Drugs Inducing Prematurity by Mining Claims Data with High-Dimensional Confounder Score Strategies.

Background: Pregnant women are largely exposed to medications. However, knowledge is lacking about their effects on pregnancy and the fetus.

Objective: This study sought to evaluate the potential of high-dimensional propensity scores and high-dimensional disease risk scores for automated signal detection in pregnant women from medico-administrative databases in the context of drug-induced prematurity.

[From psychoactive medicines to addictovigilance in French Public Health Code (1990-2017)].

Addictovigilance in the French Public Health Code, in the section related to poisonous substances, refers to a monitoring system developed since 1990: control of psychoactive substances and products, with medicinal use or not, was completed by a specific system focused on evaluation and information on pharmacodependance in 1999. The French medicines agency (Agence du médicament) created in 1993 was involved in this monitoring system; pharmacodependance evaluation was added by law to the missions of the agencies that followed: the Agence française de sécurité sanitaire des produits de santé missions (AFSSAPS, 1998) and the Agence nationale de sécurité du médicament et des produits de santé (ANSM, 2011). "Addictovigilance" first appears in French Law in 2017 whereas it was used by pharmacodependance centers and AFSSAPS since 2007.

[Psychoactive substances use in Réunion Island and Mayotte, French departments in Indian Ocean].

Introduction: The government plan for the fight against drugs and addictive behaviors 2013-2017 includes several actions concerning French overseas territories, in particular to strengthen information on drug addiction. The Interministerial mission for combating drugs and addictive behaviors (MILD&CA) has commissioned the Bordeaux addictovigilance center to strengthen exchanges on addictovigilance with Réunion Island and Mayotte and to make an inventory of problematic drug use in these two French departments of Indian Ocean.

Method: Two pharmacologists went on an assignment 4.

Tamper-resistant prescription forms for narcotics in France: Should we generalize them?

In France, prescription of narcotics must be written on a tamper-resistant prescription form with specific technical particularities. Dosage and daily dose of medicines shall be written out entirely in letters. These prescription forms are also mandatory for buprenorphine, clorazepate, clonazepam, tianeptine, buccal midazolam and zolpidem owing to traffic, abuse or diversion.

Rhabdomyolysis after co-administration of a statin and fusidic acid: an analysis of the literature and of the WHO database of adverse drug reactions.

Following a severe case of rhabdomyolysis in our University Hospital after a co-administration of atorvastatin and fusidic acid, we describe this interaction as this combination is not clearly contraindicated in some countries, particularly for long-term treatment by fusidic acid. All cases of rhabdomyolysis during a co-administration of a statin and fusidic acid were identified in the literature and in the World and Health Organization database, VigiBase . In the literature, 29 cases of rhabdomyolysis were identified; mean age was 66 years, median duration of co-administration before rhabdomyolysis occurrence was 21 days, 28% of cases were fatal.

Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database.

The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.

Parachuting psychoactive substances: Pharmacokinetic clues for harm reduction.

Background: Parachuting, also called bombing, is a way to ingest psychoactive substances wrapped into cigarette paper, toilet paper, etc. There is little data describing parachuting in terms of substances use, context of use and, most importantly, the motivations for using such wrappers, although some authors hypothesized that parachute could be used for pharmacokinetic reason. However, inconsistently, some authors report that parachutes are used for sustained-release whereas others report that users are looking for an immediate effect.

Impact of Medicine Withdrawal on Reporting of Adverse Events Involving Therapeutic Alternatives: A Study from the French Spontaneous Reporting Database.

Introduction: The consequences of the withdrawal of marketing authorisation of drugs have mostly been studied considering drug prescription patterns for the therapeutic alternatives of the withdrawn drugs. The potential concomitant changes in the reporting of adverse reactions concerning these alternatives have been studied less often.

Objective: The objective of this study was to analyse the changes in the reporting of adverse events (AEs) for therapeutic alternatives after the withdrawal of three medicines (dextropropoxyphene, pioglitazone and tetrazepam) from the market for safety reasons.

Which psychoactive substances are used by patients seen in the healthcare system in French overseas territories? Results of the OPPIDUM survey.

Addiction to illicit substances or medicines is influenced by cultural, religious, ethnic factors as well as local availability. The purpose of this study was to evaluate the profile of drug users and characteristics of the psychoactive substances used in French overseas territories, using data from the OPPIDUM survey. OPPIDUM is an annual, nationwide, multicentric, cross-sectional study based on specialized care centres that included subjects presenting a drug addiction or under opiate maintenance treatment.

Acute Methiopropamine Intoxication After "Synthacaine" Consumption.

Use of methiopropamine (MPA), a synthetic metamfetamine analog, has been detected since 2011 in Europe, but there is limited information on its acute toxicity. A 30-year-old man was admitted to the emergency department in a confused state, with paranoid delusion, auditory and visual hallucinatory experiences, and incoherent speech following the use of "synthacaine" (a slang term derived from "synthetic" and "cocaine"). Toxicological screening for pharmaceuticals and drugs of abuse by liquid chromatography-diode-array detector, gas chromatography-mass spectrometry and liquid chromatography-tandem mass spectrometry (LC-MS-MS) detected MPA, which was subsequently quantified by a specific LC-MS-MS method.

Causality assessment in pharmacovigilance: The French method and its successive updates.

The methods for causality assessment of adverse drug reactions were developed in the 1970s and 1980s, alongside the development of pharmacovigilance. The French method is one of the earlier of these, following on from the pioneering works by Irey and Karch and Lasagna. Initially published in 1978, it was updated in 1985, and again in 2011.

Illicit drugs or medicines taken by parachuting.

Parachuting (also called bombing) is a method of drug delivery where illicit drugs or medicines are ingested after wrapping the substance. There are little data describing parachuting in the literature. To provide a description of this practice, all cases of parachuting reported to the national addictovigilance network up to 31 December 2014 were identified from spontaneous reports and specific surveillance programs.

Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

Objective: Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use.

Methods: A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method.

Signal identification in addictovigilance: the functioning of the French system.

The French addictovigilance network (addictovigilance: surveillance of addiction), composed of 13 Addictovigilance Centres, was set up in 1990 in order to achieve reliable surveillance and evaluation of abuse and dependence cases due to psychoactive substances (alcohol and tobacco excepted). The detection of safety signals is one of the roles of the addictovigilance centres. Signals from spontaneous reports need to be analyzed before further communication.

Preventability of adverse effects of analgesics: analysis of spontaneous reports.

Objectives: The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors.

Methods: This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012.

Results: The 141 cases selected for the analysis included 16 cases of medication errors (11.

Drugs and Sleep Apneas? A review of the French Pharmacovigilance database.

The present work reviews the case reports of drug-induced sleep apnea recorded in the French pharmacovigilance database. Notifications are very rare (around 1/100 000 notifications). This paper shows that sleep apnea can be aggravated or revealed by some drugs.

Probable interaction between an oral vitamin K antagonist and turmeric (Curcuma longa).

We report a probable interaction between a vitamin K antagonist, fluindione, and the herbal medicine turmeric that resulted in the elevation of the international normalized ratio (INR). The case presented here underlines the importance of considering potential exposure to herbal medications when assessing adverse effects.

Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study.

To assess the incidence of hospital admissions related to adverse drug reactions (ADRs) in France and the frequency of preventable ADRs in France, a prospective study was conducted among a representative randomly selected sample of medical wards in public hospitals between December 2006 and June 2007; all patients admitted during a 2-week period were included. An ADR-related hospitalization case was defined as a hospital admission because of an ADR, and an independent committee reviewed and validated all potential cases. Preventability was assessed using the French ADR preventability scale.