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Medication errors are the most frequent medical care adverse events in France. Their management process used in hospital remains poorly applied in primary ambulatory care.The main objective of our study was to assess medication error management in general ambulatory practice. The secondary objectives were the characterization of the errors and the analysis of their root causes in order to implement corrective measures.The study was performed in a pluriprofessionnal health care house, applying the stages and tools validated by the French high health authority, that we previously adapted to ambulatory medical cares.During the 3 months study 4712 medical consultations were performed and we collected 64 medication errors. Most of affected patients were at the extreme ages of life (9,4 % before 9 years and 64 % after 70 years). Medication errors occurred at home in 39,1 % of cases, at pluriprofessionnal health care house (25,0 %) or at drugstore (17,2 %). They led to serious clinical consequences (classified as major, critical or catastrophic) in 17,2 % of cases. Drug induced adverse effects occurred in 5 patients, 3 of them needing hospitalization (1 patient recovered, 1 displayed sequelae and 1 died). In more than half of cases, the errors occurred at prescribing stage. The most frequent type of errors was the use of a wrong drug, different from that indicated for the patient (37,5 %) and poor treatment adherence (18,75 %). The systemic reported causes were a care process dysfunction (in coordination or procedure), the health care action context (patient home, not planned act, professional overwork), human factors such as patient and professional condition. The professional team adherence to the study was excellent.Our study demonstrates, for the first time in France, that medication errors management in ambulatory general medical care can be implemented in a pluriprofessionnal health care house with two conditions: the presence of a trained team coordinator, and the use of validated adapted and simple processes and tools. This study also shows that medications errors in general practice are specific of the care process organization. We identified vulnerable points, as transferring and communication between home and care facilities or conversely, medical coordination and involvement of the patient himself in his care.

To analyse pristinamycin/vitamin K antagonists (VKA) drug interaction by using data recorded in the French pharmacovigilance database (FPVB).All cases with an increase effect of a VKA and an association with pristinamycin recorded in the FPVB between 1985 and 2013 were included. Data concerning patients, VKA treatments and side effects were recorded for a descriptive analysis.During this period, 31 reports with a VKA overdose after an association with pristinamycin were included. Fluindione is the most often involved VKA (77% of cases). In 20 cases (65.4%), VKA overdose caused bleeding and 24 cases (77.4%) were serious.Although mechanism is unknown, pristinamycine/AVK drug interaction is a reality that needs to be reported in the summary of product characteristics of these drugs and better known by practitioners to act in patients' interest.

Tramadol has been approved in France since 1994 for the treatment of moderate to severe pain. The most commonly reported adverse effects involve the central nervous system and gastrointestinal tract. To our knowledge, hypoglycemia has not previously been reported.We report 2 cases of hypoglycemia related to tramadol, one in a nondiabetic 88-year-old woman, and the other in a diabetic 8-year-old girl. Hypoglycemia resolved after tramadol discontinuation.The French Pharmacovigilance (Adverse Drug Reports) database includes several cases of hypoglycemia in patients receiving tramadol. Reports from the literature of dextropropoxyphene-induced hypoglycemia and a pharmacological study of tramadol in rats suggest that the micro opioid receptor is the principal target involved in this hypoglycemic mechanism.

Adverse drug reactions (ADRs) have been recognised as an important cause of hospital admission. Most of these drug-related admissions were expected ADRs and, thus, partly preventable. However, as far as we know, the assessment of the preventability of ADRs was addressed in only two studies performed in France. In contrast, several other studies have been performed, mainly in the USA, and using different methods of assessing preventability. None of these methods were clearly evaluated with regard to reproducibility, validity or relevance. The purpose of this study was to initiate the validation of a French preventability scale. Here, we propose the first two phases of validation: the content validity and reliability of the scale. A working group of pharmacovigilance experts has been specifically established for this purpose. The content validity was assessed by collecting items representative of preventability. The choice and the formulation of items and a proposal of a score (global and for each item) were adopted after the consensus of the experts. A definitive version of the ADR preventability scale was used for the assessment of reliability. During the second phase, experts independently tested the new scale from observations of ADRs (49 central nervous system haemorrhages with antivitamine K). The concordance of the experts' judgements was calculated using two statistical methods (Kappa statistic and correlation coefficient). The content validity phase was performed during several workshops where experts discussed the choice and formulation of the best items. We decided to construct a scale with a small number of items, allowing a rapid evaluation of the preventability of ADRs. On the basis of a global score, four categories of preventability of ADRs ("preventable", "potentially preventable", "unclassable", "not preventable" ADRs) were proposed. The agreement of experts regarding the global score was low, with a poor correlation coefficient value (coefficient interclass = 0.491). Classification of ADRs in the four categories by the experts showed discrepancies (Kappa = 0.1136). The preventability assessment using this scale was feasible, although poor concordance between the judges has raised some questions. Several experts found use of this scale difficult in terms of a clear understanding of the items, and found that two of them were redundant. We have oversimplified some items and revision of their formulation will be necessary. Moreover, most of ADR notifications were poorly documented, resulting in a frequent choice of an "unevaluable" item. This represented an important bias in the calculation of the global score. This experience suggests the need for further studies to improve this French ADR preventability scale and validate it in differing circumstances, in order to provide a useful tool to enhance the rational use of drugs.