First French Experience of ADR Reporting by Patients After a Mass Immunization Campaign with Influenza A (H1N1) Pandemic Vaccines
Geneviève DurrieuAurore PalmaroLaure PourcelCéline CailletAngeline FaucherAlexis JacquetShéhérazade OuaretMarie Christine Pérault‐PochatC. Kreft-JaïsA CastotMaryse Lapeyre‐MestreJean‐Louis Montastruc
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Adverse drug reaction (ADR) is one of the most life threatening problems, and the economic burden of ADR is considerable. The main objective of this study was to assess the attitude of the Kerman health system staff, to evaluate their knowledge of the spontaneous reporting system and to identify the reasons for low reporting rate. In this descriptive study, a Persian translated questioner was used based on standard European pharmacovigilance research group. Among 800 distributed questionnaires, 78% were filled and returned. Returned questioner (82%) indicated to have already suspected an ADR but only 4% reported it to Iranian ADR centre. The 4 major reasons for not reporting were: a) reporting process was unknown (65%), b) Iranian pharmacovigilance centre was unknown for the staff (45%), c) the yellow cards for reporting ADR were not available (30%), and d) ADR were not important (22%). We concluded that our medical staff's knowledge about ADR is little. Appropriate teaching and acceptable effort is needed to strengthen the current system and to prevent other serious ADRs.
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This review explain process what is used for medical coding in Pharmacovigilance and, in brief, most commonly used medical dictionary MedDRA. The purpose of this paper is a modest contribution to easier and more successful understanding of the encoding process in clinical data management in the field of Pharmacovigilance. There may be severe result if there is miscategorise of adverse events in clinical trials. For the purpose of decreasing the scope for interpretation several steps are involved such as from subject adverse event experience to presentation in tablets should be possibly standardised. MedDRA is a predefined dictionary where adverse events, signs, symptoms, diseases and diagnosis and statistical analysis are categorized. Coding is a process in which the universal dictionary is which is required for translating the event which is reported by the investigator into a standard term. For the hunt for safety signal frequencies and incidences of adverse events can be scrutinized once the adverse events have been accurately coded5.
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Abstract Purpose The main aim of this study was to determine the most frequently reported drugs to the Serbian Pharmacovigilance Database (SPD) with suspected induced hepatotoxicity. Additionally, reasons for the low reporting rate of adverse drug reactions (ADRs) in Serbia were identified. Methods Retrospective observational study of spontaneously reported ADRs recorded in the SPD from January 1995 to December 2008 was performed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hepatobiliary disorders (HD). Drugs were classified using the Anatomical Therapeutic Chemical (ATC) classification. Medline and WHO‐UMC databases were used to address specific queries suggested by our results. The questionnaire was used to investigate the health care professionals' knowledge and practice related to spontaneous reporting. Results Among the 1804 reports of ADRs recorded in the SPD between 1995 and 2008, 70 (3.9%) cases of HD were identified. Drugs most frequently associated with hepatotoxicity were anti‐infectives for systemic use, drugs affecting the nervous system, herbal products, hypolipemics, and anticoagulant drugs (26.83, 24.39, 12.20, 9.76, and 8.54% cases, respectively). Four cases (5.71%) of liver injury resulted in death, which accounted for 10.26% of all ADR fatalities reported to the SPD. The main reasons for not reporting ADRs were lack of reporting knowledge (30.26%), well‐known ADRs (29.89%), and insecurity about causality relationship (15.50%). Conclusions Anti‐infectives, nervous system drugs, and herbal products were the most common drug classes reported for hepatotoxicity in Serbia. There is a need for additional education about ADRs, and enhanced reporting by health care professionals. Copyright © 2011 John Wiley & Sons, Ltd.
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Objective To promote the pharmaovigilance in China. Methods Compare the concept ofpharmacovigilance and adverse drug reaction monitoring , and analysis their differences and relations.Conclusions Pharmacovigilance is related closely with adverse drug reaction monitoring. It is thetendency to launch pharmacovigilance. Our government should pay attention to the pharmacovigilance.
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Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs. Beside other methods, statistical methods are used to detect new ADRs in the framework of signal detection. Groupings of terms containing similar ADRs allow to increase the signal intensity and to improve the detection of new ADRs. SMQs have become reference groupings in the field of pharmacovigilance. They are built on the MedDRA terminology and thanks to the study of scientific literature. Even if SMQs are built manually by experts, they still show some shortcomings: they tend to be over-inclusive and thus become too sensitive, although they can also miss several relevant terms. Moreover, the spectrum of available SMQs is limited. The objective of this work is to propose an automated method for a flexible creation of groupings of terms. This method is based on exploitation of the semantic distance between MedDRA terms. In a first experience, we used ARD terms alone and obtained results with a high precision (mean 74% within the interval [49; 91]). In a second experience, we used ADR terms and their formal definitions and this worsened the results because the semantic information within definitions may be missing. We assume that more exhaustive definitions will have a positive effect on results.
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The need for systematic follow up of medicines for adverse drug reactions once they are introduced into general use has been widely recognised today. Even in developing countries like India, national pharmacovigilance programme has been started for monitoring adverse drug reactions. In its first year this program mainly aimed to foster the culture of ADR notification among health care professionals. As a part of health care team every pharmacist must have knowledge about adverse drug reaction monitoring systems and pharmacovigilance.
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INTRODUCTION:
WHO characterizes adverse drug reaction (ADR) as any reaction to a medication which is harmful and unintended, and which happens at measurements typically utilized as a part of man for prophylaxis, analysis or treatment of illness or for the alteration of physiological capacity. Antagonistic medication responses are negative outcomes of medication treatment. They are one of the main sources of grimness and mortality. It has been assessed that around 2.9-5.6% of all clinic affirmations are because of ADRs and upwards of 35% of hospitalized patients encounter an ADR amid their hospitalization. An unconstrained revealing of ADRs has remained the foundation of pharmacovigilance and is imperative in keeping up tolerant wellbeing. In India, all social insurance experts including specialists, medical caretakers, and drug specialists can report an ADR by filling an ADR type of the Central Drugs Standard Control Organization. The dynamic interest of social insurance experts in the pharmacovigilance program can enhance the ADR revealing.
AIM OF THE STUDY:
To assess the knowledge, attitude and practice of pharmacovigilance and adverse drug reaction reporting among nursing staffs.
OBJECTIVES:
1. To assess the knowledge of pharmacovigilance towards adverse drug reaction reporting.
2. To assess the attitude and practice towards adverse drug reaction reporting.
3. To determine the factors that encourages the study subjects to report adverse drug reaction.
4. To evaluate the factors that discourages the study subjects not to report adverse drug reaction.
NEED OF THE STUDY:
The most serious ADRs lead to hospitalization, and hospital stays can lead to further ADRs. Hence, HCPs and hospitals can play a significant role in minimizing ADR-related morbidity and mortality. HCPs can play multiple roles by carefully reviewing the full patient history, particularly the drug allergy and drug-drug interaction history, to avoid any unwanted ADRs. In addition, reporting ADRs to the
responsible office at their hospital or the regulatory authority is a pharmacovigilance approach that can be used to minimize ADRs because reporting ADRs can increase HCPs’ awareness of reactions, which could result in the avoidance of particular drugs, thus reducing the harm associated with reactions to particular drugs.
Several drugs have been withdrawn from the market as a result of HCPs reporting ADRs. However, understanding the knowledge and practice of health care professionals regarding ADR reporting is very important for enhancing the reporting of ADRs.
Therefore, the present study is undertaken to determine the current status of ADR reporting and also to investigate knowledge and attitude of particularly nursing
staffs towards pharmacovigilance and ADR reporting.
METHODOLOGY:
The study was conducted in 3 different multi-speciality hospitals, at Chennai.
Study design: Cross sectional, questionnaire based study
Study setting:
This study was conducted from December 2017 to August 2018 for a period of 10 months.
Study sample:
The study sample size was 300.
Inclusion criteria:
Nurses,
Any age group.
Exclusion criteria:
Other health care professionals,
Study participants with unwillingness are excluded.
CONCLUSION:
The study discloses that nursing staffs have poor knowledge and poor practice but good in attitude towards ADR reporting. Even though they have reported more number of severe ADRs, they didn’t perform any further interventions to prevent it. The major factor which discourages them from reporting ADR is a patient confidentiality issue and managing patient was more important. Seriousness of reaction, unusualness of reaction, involvement of new drug, confidence in diagnosis of ADR was the factors that encourage nursing staffs to report ADR.
Based on the outcomes of the present study following recommendations are concluded. ADR reporting forms should be freely available in all hospitals as it can improve the reporting rates of ADR in the country. ADR reporting should be mandatory for all healthcare professionals. Each hospital should have a database on ADR which should be considered by healthcare professionals. The nursing syllabus curriculum needs to be revised to include ADR and pharmacovigilance. Continuous education programme and workshop want to be conducted regularly relate to how and where to report ADR.
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Background: Pharmacovigilance experts detect new adverse drug reactions (ADR) by manually reviewing spontaneous reporting systems. Automated signal generation aims to focus the attention of experts on drug – adverse event associations which are disproportionally present in the database. Although adverse events are coded by means of controlled vocabularies such as the MedDRA dictionary, this semantic information is not taken into account for signal generation.
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