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A tripartite group, entitled « CRI » (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., (Copyright © 2011 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.)

Introduction: Acetazolamide is a carbonic anhydrase inhibitor used topically for local secondary treatment of posttraumatic or postoperative edema., Cases: Two women had contact dermatitis, secondarily extensive, after local cutaneous use of acetazolamide under a compression panty after liposuction. The eruption disappeared after acetazolamide was stopped and local treatment administered. Cutaneous tests were positive for acetazolamide., Discussion: Local allergic reactions are mentioned in the monograph on topical acetazolamide. Cases of contact dermatitis from this drug have not so far been published, but French adverse drug reaction reporting data include 10 other cases of eczema or rash at the application site. In one of these, a positive reaction was observed on readministration, and in 2 cases allergy skin tests were positive. The application of the drug under occlusion, which is contraindicated, may have contributed to spreading the lesions. Cases have also been described with another carbonic anhydrase inhibitor, dorzolamide, used in ophthalmology.

Le vaccin est un médicament biologique (le plus souvent anti-infectieux) administré dans un but le plus souvent préventif, dont l'effet n'est pas pharmacologique mais immunologique. Il doit être évalué par les techniques habituelles de la pharmacologie clinique et de la pharmacovigilance, mais en tenant compte de ses particularités (mécanisme d'action, fabrication, administration le plus souvent à des sujets sains, modalités de prescription particulières avec des recommandations mises à jour régulièrement, protection à la fois individuelle et collective, etc.). Quelques expériences de campagnes vaccinales ont révélé des insuffisances dans l'obtention des données permettant d'évaluer l'intérêt de santé publique d'un vaccin, son adaptation à l'épidémiologie récente de la maladie et sa sécurité d'emploi à long terme. L'absence de données peut générer des craintes relayées par les ligues anti-vaccinales. Pour une meilleure pharmacovigilance des vaccins, il est nécessaire : (i) d'améliorer la cohérence entre les instances d'évaluation, même si des efforts ont été récemment faits ; (ii) de compléter les plans de gestion de risque par une surveillance microbiologique et épidémiologique active et par l'obtention des données nécessaires au suivi de pharmacovigilance des populations exposées ; (iii) d'assurer l'enseignement sur la vaccination au sein de la communauté médicale, ainsi que l'éducation à la santé pour les populations., (Copyright © 2007 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.)

In year 2000, two european regulations have been adopted in order to increase the availability of orphan drugs in the European Union. To describe the current orphan drug market in France, a cross sectional analysis was conducted, five years later, taking account of publicly available informations, including designation, registration, reimbursement. These informations are mostly available on the Internet. Eighteen orphan drugs were marketed in France in November 2005, with restricted prescription and dispensing conditions. Four of them were available before registration for compassional use. Eight will be reassessed soon, with complementary data requested by health authorities. Informations about orphan drugs are scattered on different French or European websites, which complicate access for health professionals. The opinions of "Commission de Transparence", which assess utility of drugs, give some precisions for each orphan drug (prevalence of the disease, therapeutic alternative, etc.).

Objective: To analyse the nature of adverse drug reactions, their frequency, the drugs incriminated, their outcome, the different ways to treat them and their cost., Methods: Descriptive, prospective and non-comparative study, based on spontaneous reporting. Each patient was followed-up over a 6-month period., Results: One hundred and fifteen adverse events were reported in 113 patients (58 men and 55 women), with a mean age of 59.5 years. Cutaneous and haematological reactions predominated, with a majority of cardiovascular and psychotropic agents incriminated. Sixty-three percent of adverse reactions were serious: 49% led to (or prolonged) hospitalisation, 6% led to death, 4% to after effects, 3% were life-threatening and 1% led to congenital malformation. The mean duration of an adverse reaction was of 37.4 days. The total cost of these 115 adverse reactions was an estimated 610.110 Euros, with a mean global cost of 5.305 Euros per event., Conclusion: This study shows the individual and collective extent of the impact of adverse individual and collective reactions.

The prescription of antidepressants in the elderly has changed since the marketing of new antidepressants such as selective serotonin reuptake inhibitors (SSRIs). We analysed the adverse effects associated with antidepressants in subjects aged > or =75 years reported to the pharmacovigilance centres in France. Among the 2381 cases recorded between 1985 and 2001, the distribution of adverse effects may reflect sales figures: 1040 for SSRIs (44%), 586 for tricyclic and related antidepressants (25%), 46 for monoamine oxidase inhibitors (2%) and 654 for other antidepressants (27%). Adverse effect patterns differed according to antidepressant class. For SSRIs, hyponatraemia was predominant (30%), followed by psychiatric (13%) and nervous system (10%) effects. For tricyclic antidepressants, psychiatric effects (confusion, agitation) [21%] were the most frequent followed by cardiovascular effects (15%). However, the consequences of adverse effects such as hyponatraemia are far from negligible in the elderly.

Our goal was to establish new pharmacological criteria for a drug to be used in the treatment of opioid dependence. We propose the following six pharmacodynamic and pharmacokinetic criteria: (i) the same pharmacodynamic properties as the drug being substituted; (ii) a long duration of action (minimum 24 hours, not requiring several daily doses) in order to prevent fluctuations in effect and especially withdrawal symptoms; (iii) few euphoric effects together with a minimal reinforcing effect for the drug itself and other drugs; (iv) oral or sublingual administration without any special affinity for other routes, especially the intravenous; (v) a New Drug Application (NDA) in this indication, after submission of a dossier including both clinical randomised comparative trials and security data; and (vi) compatibility with a socially satisfying quality of life. These criteria were applied to methadone, buprenorphine and other drugs that were proposed in the treatment of opioid dependence (such as morphine or codeine).

More than ten years after the statins became available in therapeutics, some questions remain unanswered. What would be the populational impact if the results of clinical trials were applied to a country such as France? Is the extrapolation licit? Does the benefit of the statins actually exceed the risk? What is the relevant target population? Are statins more effective than agents acting on other cardiovascular risk factors? How efficient are the statins really? Are the statins effective in non-hypercholesterolaemic patients? What is the overall cost of the statins? Despite the fact that the statins are the drug of choice in many situations, it is still important for these questions to be answered before we accept the widespread use of statins in the general population, such as the large numbers of patients that the drug may be prescribed for in France.