scholarly journals The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

2021 ◽  
Vol 19 (1) ◽  
pp. 413
Author(s):  
Kamila Sienkiewicz ◽  
Monika Burzyńska ◽  
Izabela Rydlewska-Liszkowska ◽  
Jacek Sienkiewicz ◽  
Ewelina Gaszyńska
Keyword(s):  
Adverse Reaction ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Healthcare Professionals ◽  
Safety Information ◽  
Safety Monitoring ◽  
Pharmacovigilance System ◽  
Main Role ◽  
Patient Reporting ◽  
Drug Reactions

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

scholarly journals A comparative study of adverse drug reactions reported by healthcare professionals and patients in a tertiary care teaching hospital

2017 ◽  
Vol 6 (5) ◽  
pp. 1078 ◽  
Author(s):  
Harsha Ramakrishnaiah ◽  
Sushma Naidu ◽  
Jyothsnya S.
Keyword(s):  
Adverse Drug Reactions ◽  
Healthcare Professionals ◽  
Spontaneous Reporting ◽  
Health Concern ◽  
Selective Reporting ◽  
Patient Reporting ◽  
Drug Reactions ◽  
Patient Reports ◽  
The Impact

Background: Adverse drug reactions (ADRs) are one of major health concern affecting population of all ages causing significant morbidity mortality and hospitalization of the patients increasing the economic burden on the society. Monitoring of ADRs is of paramount importance for the continued effective and safe use of medicines. Though they are unavoidable accompaniments of pharmacotherapy, the reporting of ADR is poor and inadequate. Substantial under-reporting and selective reporting of ADRs are the major drawbacks of the commonly followed method of spontaneous reporting by healthcare professionals (HCP). Patient direct reporting of ADR has been incorporated into the pharmacivigilance (PV) system in several countries like USA, Canada, Australia, New Zealand, Denmark, Sweden and the Netherlands. Patient direct reporting of ADR was qualitatively similar to HCP ADR report. Patient reports often had richer narratives than those of HCPs. Patient reports often contained detailed information about the impact of the suspected ADR on the patient’s quality of life. The quality of ADR reported by the patients was similar to the reports by HCP in terms of description of ADRs and its severity. So, present study was taken to evaluate the process of spontaneous reporting of suspected ADR by the patient and compare the quality of ADR reported by Health care professional and Patients.Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine Comparison between spontaneous reporting by healthcare professionals and patient direct reporting of adverse drug reactions was assessed in terms of response rate, pattern of ADR reported, causality by Naranjo s scale, severity by modified Hartwig scale and preventability by using Schumock and Thornton scale. Social, emotional, occupational impact due to ADR and narrative elaboration scores were also compared.Results: Majority of the ADRs were from HCP as compared to patient reporting, indicating that better awareness among HCP about pharmacovigilance Majority of the reactions reported by patient were mild in severity, in contrast majority of ADR reported by HCP were moderate. Comparisons between HCP reporting and patient direct reporting also revealed that majority of ADR in both groups were probably preventable. Qualitative analysis reported ADR showed that majority of ADR reported by HCP had no narration or had scant narration, in contrast to patient direct reporting had very elaborate narration of ADR. Patient who did direct reporting of ADR highlighted more about emotional impact, occupational impact and social impact of ADR occurred to them, when compared to ADRs reported by HCP.Conclusions: Patients were clearly willing to report any adverse drug reactions occurring to them. The evidence indicates that patient reporting of suspected ADRs has more Potential benefits than drawbacks. The results indicate that patient perceptions of potential ADRs are relevant and should be an integral part of ADR reporting system.

scholarly journals Headache as an Adverse Reaction to the Use of Medication in the Elderly: A Pharmacovigilance Study

2021 ◽  
Vol 18 (5) ◽  
pp. 2674
Author(s):  
Cristina Monteiro ◽  
Beatriz Dias ◽  
Maria Vaz-Patto
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Adverse Reaction ◽  
Adverse Reactions ◽  
Healthcare Professionals ◽  
The Elderly ◽  
Pharmacovigilance System ◽  
Clinical Presentations ◽  
High Level Term ◽  
High Level

There is a consensus that elderly individuals are quite vulnerable to adverse drug reactions (ADRs), and headaches are one of the most frequent clinical presentations of central nervous system problems in the general population, which can be an ADR. The purpose of our work was to analyze reports of “headache” associated ADRs in the elderly sent to the Portuguese Pharmacovigilance System (PPS), and also which drugs were more frequently associated with this adverse reaction. A retrospective analysis of suspected ADR reports involving patients aged 65 years or older received by the PPS in the last 10 years was conducted. A search of all the terms associated with the High Level Term “headache” was performed. All duplicate reports were excluded from the analysis. A total of 155 ADRs reports were included, in which 15 reported isolated “headache” as suspected ADR, while the remaining 140 ADRs reports reported “headache” together with several other adverse reactions. Most reports of “headache” ADR occurred in women (74.8%; n = 116). About half (46.5%; n = 72) of the ADR reports were considered serious. Anti-viral medication, anti-depressants, anti-dyslipidemic agents and central nervous system-acting analgesics were the most frequent drugs associated with “headache” ADR reports in this population. In elderly patients, most ADR reports involving headaches occurred in women and a high percentage (46.5%) were considered serious. Thus, it is important that healthcare professionals pay more attention to headaches reported as ADRs in the elderly and drugs suspected to cause them, in order to increase knowledge about this type of reaction and contribute towards safely using drugs in this age group.

scholarly journals Factors that influence the intention to use mobile phone caller tunes for patient reporting of adverse drug reactions: a qualitative study

2019 ◽  
Vol 10 ◽  
pp. 204209861987119 ◽  
Author(s):  
Bernard Appiah ◽  
Anubhuti Poudyal ◽  
James N. Burdine ◽  
Lucy Asamoah-Akuoko ◽  
David Anidaso Anum ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Technology Acceptance ◽  
Adverse Drug Reactions ◽  
Drug Safety ◽  
Safety Information ◽  
Perceived Usefulness ◽  
Intention To Use ◽  
Patient Reporting ◽  
Drug Reactions ◽  
The Creation

Background: Patient reporting of adverse drug reactions (ADRs) is low in low- and middle-income countries, in part because of poor awareness to report. With the increase in mobile subscription, mobile phones can be used as a platform to disseminate information on ADRs. The aim of this study was to qualitatively assess the potential of using mobile phone caller tunes (the message or sound the caller hears before the receiver answers the call) to encourage patient reporting of ADRs. Methods: A total of 38 key informant interviews and 12 focus group discussions (57 participants in groups of 4–5) were conducted in Accra, Ghana. The transcripts were analysed using key constructs of the Technology Acceptance Model (TAM) including perceived usefulness, perceived ease of use, and behavioural intention to use caller tunes for patient reporting of ADRs. Results: Respondents mentioned lack of knowledge on reporting ADRs, and their willingness to use mobile phone caller tunes to promote patient reporting of ADRs. Many respondents pointed out how ADRs usually led to discontinuity in medication use, usually without consultation with health professionals. Caller tunes were regarded an innovative, accessible and convenient platform to disseminate information on ADRs. Most respondents intended to use caller tunes with drug safety information to promote ADR reporting, particularly to help their friends and family members. Simplicity of the message, use of songs or messages in local languages and price of downloading the caller tunes were important considerations. Conclusion: There is a need for the creation and testing of caller tunes on ADRs in Ghana to promote patient or consumer reporting of ADRs. Further studies are needed to assess factors that could influence the creation and use of caller tunes to disseminate information on drug safety.

Inherent Limitations of the Yellow Card System for the Detection of Unsuspected Adverse Drug Reactions

1984 ◽  
Vol 3 (4) ◽  
pp. 261-269 ◽  
Author(s):  
I. Crombie
Keyword(s):  
Adverse Reaction ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Single Case ◽  
Drug Reactions ◽  
Yellow Card ◽  
Yellow Card Scheme ◽  
Card System ◽  
Hospital Doctors ◽  
Almost All

The number of cases of an adverse reaction which could be seen by individual doctors was investigated taking realistic values for the frequency of drug prescribing and a range of frequencies of adverse drug reactions. The results indicated that, for almost all drugs, general practitioners (GPs) will seldom see other than single cases of an adverse reaction. It is argued that doctors will be unlikely to recognize an adverse reaction from a single case (unless it presented with some striking clinical features) so that potential new adverse reactions will rarely be reported by GPs under the Yellow Card scheme. A similar analysis for hospital doctors indicated that clinicians working in some specialities, may have a greater chance of seeing more than one case of an adverse reaction. A review of the identification of several important adverse reactions revealed that all the reports from British doctors were submitted by clinicians with hospital appointments. This study suggests that the major part of the operation of the Yellow Card system will contribute little to the identification of adverse reactions and that its organization and activities need to be reassessed. A modified system designed to encourage reporting by hospital clinicians could be of greater value.

scholarly journals Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

2021 ◽  
Vol 319 ◽  
pp. 01048
Author(s):  
Donia Kharbouch ◽  
Houda Sefiani ◽  
Zineb Nabih ◽  
Sanou Khô Coulibaly ◽  
Tidiane Diallo ◽  
...  
Keyword(s):  
Sex Ratio ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Descriptive Study ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Spontaneous Reports ◽  
Pharmacovigilance Center ◽  
Research Period

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.

scholarly journals Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

2014 ◽  
Vol 4 (2) ◽  
pp. 120-125 ◽  
Author(s):  
Maša Amrain ◽  
Fahir Bečić
Keyword(s):  
Health Care ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Bosnia And Herzegovina ◽  
Health Care Professionals ◽  
Healthcare Professionals ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Adr Reporting

Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR) reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87%) completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH). Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4%) of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

Adverse Drug Reactions to Radiographic Contrast Media in a Teaching Hospital in North India: An Observational Study

2019 ◽  
Vol 14 (2) ◽  
pp. 122-126
Author(s):  
Deepti Chopra ◽  
Abhinav Jain ◽  
Richa Garg ◽  
Shreya Dhingra
Keyword(s):  
Observational Study ◽  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Adverse Reactions ◽  
North India ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Radiographic Contrast ◽  
Radiographic Contrast Media

Background: Radiocontrast media are used extensively nowadays to visualize internal organs. Currently, non-ionic iodinated contrast media are used which are generally considered to be safe but some adverse reactions have been reported. Thus, the present study was carried out to analyze the nature and incidence of adverse drug reactions (ADRs) to radiographic contrast media in a teaching hospital. Methods:An observational study carried out for a period of six months in a teaching hospital. Contrast media induced adverse reactions were analyzed in terms of affected organs, rate, causality assessment, severity and preventability. The treatment and outcomes of adverse events were also recorded. Naranjo Probability Scale was used to evaluate the relationship between the contrast agent used and the suspected ADR. The severity of the suspected ADRs was determined using Hartwig Scale and preventability was assessed using modified Schumock and Thornton criterion. Results:A total of 15 suspected ADRs occurred in 11 patients with an incidence of 1.4%. It included 5 (45.4%) males and 6 (54.5%) females (p < 05). The highest percentage (72.7 %) of ADRs was seen in adult patients, the mean age being 40.8 years. Vomiting (33.3%) was the most common ADR noted followed by severe nausea and rashes. 64.7 % of ADRs were categorized as probable and 35.3 % were possible. Adverse reactions required treatment in 46.6% patients. There was no fatality reported. Conclusion:The reactions observed were mild to moderate in severity and occurred within 30 minutes of the administration of the contrast.

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