Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance
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Keywords:
MedDRA
Adverse drug reaction
Pharmacoepidemiology
Drug reaction
Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice.This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan.A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study.The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them.The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.
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Background : Pharmacovigilance systems are crucial for monitoring, ensuring the safe use of medications, and reducing the frequency of adverse drug reactions (ADRs). They also raise awareness of the importance of reporting ADRs to healthcare systems. Aim : Explore the hampered and perspective held by Duhok pharmacists, particularly those employed in hospitals and private pharmacy sectors, about pharmacovigilance and ADR reporting. Methods : A cross-sectional study was carried out from 20 February to 20 March 2019 using a self-administered questionnaire that had been previously created and modified. The data were examined using SPSS version 20, a statistical application for social software. Results : The majority of respondents, pharmacists, stated that it is their responsibility to report adverse drug reactions (ADRs), and that drug safety monitoring is crucial (91%). More than 85% of pharmacists agreed that ADRs that result in life-threatening situations and those that result in congenital abnormalities should be reported immediately. The majority of them, however, were unaware of the Iraqi pharmacovigilance system, had never reported any adverse drug reactions, were unable to get reporting forms, and lacked the clinical knowledge required to recognize ADRs. Conclusion : Underreporting was the main issue identified by the study because the majority of respondents were unable to define the term “pharmacovigilance” correctly, but they were aware of ADRs and displayed a positive attitude toward ADR reporting despite the fact that the majority of them had never reported any ADRs. To raise pharmacists’ knowledge and awareness of the ADR reporting procedure, however, required steps should be made to establish interventional programs.
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Adverse drug reaction
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Health Professionals
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Adverse drug event
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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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Background: Adverse drug reactions (ADR) are more commonly observed during treatment course in a substantial number of patients. Though we have a functioning pharmacovigilance programme in India, we have only fewer number of adverse drug reactions being reported indicating lack of awareness, the unsure attitude and reluctance in reporting adverse drug reactions.Methods: We conducted a cross sectional pretested questionnaire based study for a period of six months. 600 questionnaires were distributed. 521 responded back to the questionnaire of which 29.6% were interns, 56.8% were junior residents, 5.2% doctors were senior residents, and 8.4% were Assistant professors. Awareness on ADR reporting, ADRs encountered in practice, common causative drugs for ADR, and awareness on the functions of Pharmacovigilance programme of India were assessed.Results: 44.9% were not aware of the pharmacovigilance programme; 59.5% of the study population were not aware of the voluntary reporting of ADRs. 100% of the doctors who participated actively in the study responded that have not reported any ADR so far under pharmacovigilance programme of India. 88.1% of the doctors who participated in the study were willing to undergo a training on ADR reporting and pharmacovigilance.Conclusions: This study concludes that serious measures have to be taken to educate the doctors on ADR reporting and pharmacovigilance. By means of involving pharmacovigilance as a part of the undergraduate programme and by organising regular workshops, group discussion and continuous medical education, we can improve the awareness among doctors regarding ADR reporting and pharmacovigilance.
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Abstract: Background: The Pharmacovigilance Program of India recently initiated a process for direct patient reporting of Adverse Drug Reactions (ADRs) with a designated form. Keywords: Adverse Drug Reactions, consumer reporting, direct consumers’ ADR reporting form, direct patient ADR reporting form, patient reporting, pharmacovigilance.
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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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Under-reporting
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Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health care costs. To study the adverse drug reactions reported in a tertiary care hospital and study of causality assessment and severity of adverse drug reaction (ADR) cases reported.Methods: A prospective observational study was conducted as part of pharmacovigilance program over 12months between September 2015 and August 2016. Adverse drug reactions reported from hospital were filled into Suspected ADR - CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo’s algorithm and WHO - UMC causality scale. The severity of each ADR was assessed using Modified Hartwig and Siegel scale.Results: Total 120 cases were reported over 12 months. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by haematinics (12%) and anti-epileptics (10%). Maximum number of patients (30.25%) reported with dermatological manifestations. Highest number of ADRs was reported from the department of medicine (45%). As per Naranjo’s scale, 54% reports were assessed as probable and 46% classified as possible. Majority of cases were mild to moderate in severity.Conclusions: The pattern of ADRs reported in our hospital is similar with the pattern of studies conducted in other hospitals elsewhere. This study provides a database of ADRs due to commonly used drugs in our hospital, which will help clinicians for their optimum and safe use. Hence effective pharmacovigilance is required for the use of these drugs and their safety assessment.
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