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Poste d’ingénieur.e de recherche en microbiologie environnementale – Rennes – concours CNRS

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Official websites use. Share sensitive information only on official, secure websites. Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author s and the source are credited. The aim of this study was to determine the frequency and severity of ADRs related to self-medication ADR-SM among emergency department ED patients and to describe their main characteristics. A prospective, cross-sectional, observational study was conducted over a period of 8 weeks 1 March to 20 April , in the ED of 11 French academic hospitals. Adult patients presenting to the ED during randomization periods were included, with the exception of cases of self-drug poisoning, inability to complete self-medication questionnaire, or refusal. Clinical outcomes were assessed as well as history of self-medication behaviours and all drugs taken. A total of 3, of 4, patients presenting to the ED met the inclusion criteria. Of these, A total of patients experienced an ADR 9. The online version of this article doi Drug-related problems are an important cause of morbidity and mortality and a significant burden on healthcare resources. A high rate of adverse drug reactions ADRs has been demonstrated in hospitalized patients \[ 1 — 4 \], potentially leading to death. The definition of self-medication is still debated. Furthermore, the WHO defines self-medication as the selection and use of medicines by individuals to treat self-recognized illnesses or symptoms \[ 7 \], and cites self-medication as a common problem leading to incorrect use of medicine \[ 8 \]. Therefore, a patient-based approach of self-medication should include all modalities of self-use of drugs, whether previously prescribed or not. This study was based on such a patient-based approach. As such, the risk related to current self-medication behaviours is under-investigated. In the ED-specific context, previously published studies \[ 5 , 6 \] have not focused on the link between self-medication and ADRs. No data on the rate and severity of ADRs related to self-medication in this setting are available. During the 8-week period from 1 March until 20 April , a prospective, cross-sectional, observational study was conducted in the ED of 11 French academic hospitals distributed throughout the country. To take drugs without relevant prescription sold without prescription, rest of an ancient prescription or prescribed for another person. The study protocol and patient informed consent procedures were approved by the Ethics Committee St. A high volume of visits in participating EDs precluded uninterrupted prospective screening for inclusion throughout the study period. Additionally, as rates of hourly ED visits varied markedly within each day and from one day to another, we defined 13 time slots a priori covering the h day as follows: 10 time slots of 1 h from am to pm and from pm to pm , one time slot of 8 hours from pm to am and two time slots of 3 h from am to am and from pm to pm. Subsequently, we randomly allocated these 13 predefined time slots throughout the 8 weeks of the study period for each participating ED. Randomization was done with computer-generated codes prior to the study enrolment period by our clinical research unit, which was not involved in data collection or patient care. Allocations were disclosed to research staff in every participating ED just prior to the study enrolment period. This method was designed to limit the potential for sampling bias. Additionally, patient demographics age, gender and acute severity triage score \[ 9 \] were collected from administrative data of each participating centre over the same 8-week enrolment period. These data were compared with the overall study population to verify the representativeness of the ED population studied. All adult patients presenting to participating EDs during one of the predefined time slots were eligible for study enrolment. On entry, they were informed with a specific form about the study and the opportunity to participate. Medical or pharmacy students hereafter designated as research staff in every participating ED were specifically trained to screen candidates for study enrolment, using standardized screening forms. Consenting patients were subsequently included in the absence of exclusion criteria. In each instance, the reason for exclusion was systematically recorded. Self-medication behaviours were explored by a standardized questionnaire that had been previously built, implemented and tested in one centre \[ 10 \] see electronic supplementary material. This questionnaire is divided into two parts. The first part consists of a set of 20 closed-ended questions exploring all indications and dimensions of self-medication. The second part collects the characteristics of each medication cited by the patient during the first part dosage, time between last dose and the ED visit, origin. Special attention was paid to all medications taken within 2 weeks prior to patient enrolment, including prescribed and non-prescribed drugs. All data were entered using online electronic case report forms e-CRF , which allowed for real-time assessment of data completeness and patient follow-up. Data collection was performed by the local research staff, which was monitored by a clinical research pharmacist and supervised by the investigators. The primary outcome was the diagnosis of ADR-SM and the identification of clinical and biological findings related to the effect of the drug s. The investigators reviewed all cases to identify ADRs in each study centre, based on VIDAL dictionary French book summarizing the characteristics of all medications, including pharmacology, adverse effects and drug-drug interactions. The local investigators were helped by the Naranjo scale \[ 11 \] for drug causality assessment. Nevertheless, whatever could be the result of this score, they were asked to transmit all clinically relevant cases. If necessary, notification of cases of drug toxicity was provided to the pharmacovigilance regional centre at the discretion of the local investigator. All contentious issues transmitted by local investigators, every ADR-SM case whether contentious or not , and some randomly assigned files were reviewed by an expert committee comprised of therapeutics professors, clinical pharmacists and emergency physicians, whose meetings and minutes were managed by the clinical research pharmacist. Furthermore, the entire database was scrutinized by the clinical research pharmacist in order to detect each case potentially related to an ADR; the expert committee was asked to assess such cases and to confirm drug causality in order to validate the main outcome. Every local investigator was also asked to verify each subject file and to transmit all useful information regarding the possibility of an ADR to the expert committee. This committee was finally able to resolve each contentious case, and to validate the entire database. Last, the expert committee determined, for each ADR-SM case, the type of self-medication leading to the adverse event: self-modification of a prescribed treatment, discontinuation of treatment, non-prescribed drugs, or a drug interaction with non-prescribed drugs i. All drugs cited by patients, whether prescribed or not, were encoded to the Anatomical Therapeutic Chemical ATC classification system \[ 14 \]. Chi-square tests for qualitative variables or Student t tests for quantitative variables were computed to determine if an association exists between patients admitted with ADRs and self-medication. A p -value of less than 0. In a second step, a multivariate logistic regression analysis was used to predict whether or not a patient had an ADR-SM based on significant characteristics of the patients as determined by univariate analysis. Analyses were carried out with SAS version 9. During the randomization periods, 4, patients were admitted to the ED. Among these, Table 1 shows the comparison of the study population with the total ED population during the study period. The demographic data appeared relatively equivalent. Nevertheless, there was a significant difference in terms of gender between the groups. Likewise, the acute severity triage score was also different, whereby level 1 was underrepresented and level 5 was overrepresented among the study patients. The 3, study patients were The chief complaint was trauma in about one-third of the patients, with the other most frequent complaints being abdominal pain, weakness and cardiovascular diseases Table 2. Of the patients included, Additionally, Of the 11, drugs taken by the study population, Among the 3, drugs used in self-medication, origin was most frequently a non-prescribed medication purchased over the counter OTC at the pharmacy Less frequent sources of self-medication were drugs supplied by relatives 5. Of the entire cohort, 9. Depending on the population considered for the denominator, the rate of ADR-SM could be expressed as ADR-SM related to prescribed drugs self-medication behaviour : The type of self-medication leading to an ADR was most frequently associated with prescribed drugs, as a self-modification of a prescribed treatment in 21 cases or discontinuation of treatment in 14 cases. The rate of ADRs related to non-prescribed drugs was Bleeding was the most frequent ADR diagnosed, but for ADRs related to self-medication the diagnoses were most frequently neurologic and psychiatric. The drugs most frequently causative of ADRs were antithrombotics class B. The frequency and severity of ADRs seem to be weaker when related to self-medication. Nevertheless, these results should be carefully interpreted. The importance of the risk demonstrated here in the ED population should be weighed against the potential benefit, which has to be important enough to make the risk acceptable. Several studies have confirmed that antithrombotic agents, especially vitamin K inhibitors, are a common cause of ADRs \[ 2 — 4 \]. These data are confirmed in our results; however, we have not observed ADR-SM related to this class in the study population. We have observed that the most common class associated with ADR-SM was psycholeptic and analgesic drugs. The increasing consumption of analgesic self-medication highlights the need for information and prevention regarding the risks of OTC medications \[ 15 \], particularly as patients commonly underrate the risks of ADR-SM \[ 16 \]. Moreover, the high frequency of ADR-SM associated with self-modification or self-discontinuation of treatment advocates strongly for patient education, especially for the use of psycholeptic and antiepileptic drugs. Tracks for the analysis of ADR-SM were proposed 2 decades ago to understand how they arise \[ 17 \], whereby the most commonly explored are factors dependent on doctors, healthcare professionals and institutions. On the other hand, factors that appear linked to the patient and to the doctor-patient relationship are lesser studied. This sociopsychological approach considers the patient as greater in importance than the drug or the professional. Therefore, the definition of self-medication should not be restricted to OTC drugs. In a national French report \[ 19 \], self-medication was recognized as a behaviour rather than as a class of medications specifically OTC, as it is recognized in the UK. This approach allows for the inclusion of all therapeutic choices decided by the patient in the definition of self-medication and self-medicating behaviour. However, scientific data regarding self-medication are, to date, rare in the medical literature, and they mostly concern OTC drugs and focus on pharmaceutical aspects of self-medication \[ 20 , 21 \]. Several risks are related to self-medication, of which ADRs are a part. Self-medication is also associated with diagnostic risks, because the treatment of symptoms could be delayed before visiting a physician or the clinical setting could be modified enough to lead the physician to a medical error. Other risks should also be considered in the overall management of self-medication, such as exacerbation of psychiatric diseases \[ 23 , 24 \] and addiction to drugs \[ 25 \]. Strategies to control and to minimize the risk of self-medication should involve monitoring systems, the promotion of education and information, and a partnership between patients, physicians and pharmacists \[ 26 , 27 \]. The context and objectives of this study have generated some bias that requires discussion. Because of the focus of this study, the self-medication behaviours are explored by self-report, restricting those enrolled to patients able to answer the standardized questionnaire. Therefore, the sample of included patients could not exactly represent the entire ED population, particularly along the lines of the severity of illness. Moreover, the collection of declarative data could lead to recall and reporting bias. The known discrepancies in self-medication access, depending on local rules and on the financial ability of patients to pay for their drugs, could also have influenced our results. Despite these recognized limits, the overall quality of this survey renders our results strong enough to be considered as quantitative of the frequency of ADR-SM in patients admitted to the ED. This first result of frequency and severity of ADRs related to self-medication should lead to further studies beyond the ED population. The misuse of self-medication in the general population and its potential impact on the occurrence of ADRs has to be further explored. Before considering self-medication as a safe and economic method of care, the reality of the risk related to self-medication should be taken into account by healthcare professionals and institutions. In addition, prevention strategies should include all aspects of self-medication including self-use of prescribed drugs , which must be re-configured to make self-medication a valuable way of care involving all concerned, including patients and healthcare professionals. The supplement was guest edited by Stephen J. It was peer reviewed by Olaf H. Klungel who received a small honorarium to cover out-of-pocket expenses. None of these funding sources have intervened in the collection, management, analysis and interpretation of the data; and preparation, review, or approval of the manuscript. Written permission has been obtained from all persons named here. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Drug Saf. Find articles by Nathalie Asseray. Find articles by Jacques Bouget. Find articles by Nadine Foucher. Find articles by Bertrand Renaud. Find articles by Lucien Roulet. Find articles by Gerald Kierzek. Find articles by Aurore Armand-Perroux. Find articles by Gilles Potel. Find articles by Jeannot Schmidt. Find articles by Patrice Queneau. Issue date Open in a new tab. Characteristics explicating adverse drug reactions related to self-medication. Supplementary material 1 DOC kb Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. B, Blood drugs—antithrombotics and platelet aggregation inhibitors.

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