scholarly journals Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Josipa Bukic ◽  
Doris Rusic ◽  
Petar Mas ◽  
Deni Karabatic ◽  
Josko Bozic ◽  
...  

Abstract Background Adverse drug reaction (ADR) reporting practices by health care professionals remain poor. Over-the-counter (OTC) drugs are perceived as safe; however, they can also cause ADRs. The objective of this study was to analyze ADR reporting for OTC drugs in a 10-year period, in order to evaluate frequency of ADRs, population that ADRs most affect and reporters of ADRs of OTC drugs in Croatia. Methods Spontaneously reported ADRs of non-analgesic OTC drugs, collected from January 2008 to December 2017 were analyzed. Data was obtained from Agency for Medicinal Products and Medical Devices of Croatia (HALMED). Results There were 547 ADRs of OTC drugs reported in total and an increase in number of reports through the years was observed. Pharmacists reported 45.4% of all ADRs, and were most frequent reporters (p < 0.001). In 2017 majority of reports, 62 (49.2%), were obtained from consumers. ADRs were most frequently observed in patients aged 70 years and older (15% of ADRs). Five percent of all reports were accidental exposures among children. Conclusions Pharmacists most frequently reported ADRs of OTC drugs and consumers’ awareness of ADR reporting has risen. Other health care professionals (e.g., nurses and dentists) must be offered proper education in order to improve reporting practice of ADRs. Health care professionals should address concerns about OTC drug safety in elderly and children.

Author(s):  
Atul Jain ◽  
Arpita Singh ◽  
Ajay Kumar Verma ◽  
Manish Soni

Background: The success of PvPI depends upon spontaneous reporting of ADRs by health care professionals especially nurses as they are usually first contact persons for patients in case of ADRs after use of medicines. Underreporting of ADRs due to inadequate reporting culture among health care professionals is the main hindrance in the path of this programme. So, to assess the awareness, attitude and practices of nurses regarding PvPI and ADR reporting this study was undertaken.Methods: It was a cross-sectional, questionnaire-based study in which 130 nurses responded. The 12-items questionnaire feedback form provided by Indian Pharmacopoeia Commission (IPC) was used to assess the awareness of nurses towards pharmacovigilance programme and Adverse Drug Reaction (ADR) reporting practices.Results: After analysing the questionnaire, it was observed that, despite satisfactory level of awareness and interest of the nurses to participate in this programme, still there is meagre ADR reporting practices among the nurses.Conclusions: Lack of reporting culture and improper communication is the root of problem which should be overcome in future by proper training for patient safety.


Author(s):  
Kaksha J. Patel ◽  
Ashwin K. Panchasara ◽  
Manish J. Barvaliya ◽  
C. B. Tripathi

Background: The objective of the study was to study the clinical patterns, causality and severity of adverse drug reactions in a tertiary care hospital.Methods: Total 131 ADR forms were collected from January 2012 to December 2012 and evaluated. Patient’s characteristics, ADR and drug characteristics, causality, severity and preventability of collected ADR were analyzed.Results: Total 131 ADR forms were evaluated. Male patient experiencing ADR were more (73, 55.7%) than female (58, 44.2%). Adult patients (12-60 years) experienced 110 (84%) ADR followed by pediatric patients (< 12 years) 11 (8.4%) and geriatric patients (>60 years) 10 (7.63%). Antimicrobial were the most common group of drugs responsible for ADR followed by NSAIDs and antipsychotic group.Conclusions: Present study shows lack of awareness among health care professionals for reporting of an ADR. Training and collaboration of health care professionals are needed for improvement in ADR reporting. Appropriate feedback from ADR reporting will help in selection of drug and promotes safer use of drugs.


2012 ◽  
Vol 25 (6) ◽  
pp. 591-599 ◽  
Author(s):  
William P. Wynn ◽  
Ron T. Stroman ◽  
Michaela M. Almgren ◽  
Kelly J. Clark

Annually there are 500 000 preventable deaths in the United States caused by smoking; as health care professionals, pharmacists have a unique opportunity to advise, assess, and assist patients to quit smoking. This review article provides pharmacists with a “toolbox” containing an overview of pharmacologic and nonpharmacologic methods for smoking cessation. Currently approved over-the-counter (OTC) and prescription medications (nicotine replacement therapy, varenicline, and bupropion) are summarized, and nonpharmacologic therapies discussed include cognitive therapy and hypnosis. In addition to traditional therapies some potential approaches to smoking cessation are addressed, including nicotine immunizations and electronic cigarettes.


2019 ◽  
Vol 2019 ◽  
pp. 1-11 ◽  
Author(s):  
Belete Kassa Alemu ◽  
Tessema Tsehay Biru

Background. The role of health care professionals among other stakeholders in early detection, assessment, documentation, and reporting as well as preventing suspected adverse reactions is very crucial to mitigate drug-related problems in health facilities. Previous reports from literatures have indicated that adverse drug reaction reporting is highly linked to the knowledge and attitude of the health care professionals. Objective. To assess knowledge, attitude, and practice of health care professionals about adverse drug reactions and the associated factors at selected public hospitals in Northeast Ethiopia. Methods. A hospital-based quantitative cross-sectional study design was employed. A structured self-administered questionnaire was used to collect data on KAP of selected health care providers by the convenience sampling method. Data were entered into Epi info version 3.5.3 and analyzed using SPSS Version 20. Association between dependent and independent variables was found by using bivariate and multivariate logistic regression analysis where p<0.05 was considered to be statistically significant. Results. Out of 120 questionnaires distributed, 114 respondents filled and returned, giving a 95% response rate. From total, 49 (43%) were nurses, 26 (22.8%) physicians, 17 (14.9%) pharmacy professionals, 12 (10.5%) health officers, and 10 (8.8%) midwives. About 86 (75.44%) study participants had an inadequate knowledge towards ADR reporting, and half of participants failed to report the adverse drug reactions they encountered. But the majority of participants (84, 73.68%) had a favorable attitude towards ADR reporting. Nurses [AOR = 0.069, 95% CI (0.018–0.275)], health officers [AOR = 0.10, 95% CI (0.015–0.647)], and physicians [AOR = 0.14, 95% CI (0.03–0.64)] were found to be less likely to have adequate knowledge on ADR reporting compared to pharmacy professionals. Conclusion. Even though the majority of health care professionals had a positive attitude, they had inadequate knowledge and poor practice towards ADR reporting.


2018 ◽  
Vol 54 (2) ◽  
pp. 93-99 ◽  
Author(s):  
Masami Tsuchiya ◽  
Akihisa Esashi ◽  
Taku Obara ◽  
Kyoko Inooka ◽  
Nariyasu Mano ◽  
...  

Background: Limited data regarding knowledge and factors related to understanding the adverse drug reaction (ADR) reporting system of health care professionals are available in Japan. Objective: The objective of this study was to identify factors related to understanding the ADR reporting system in Miyagi Cancer Center and to find ways to increase the number and quality of ADR reports. Methods: Self-administered questionnaire surveys were administered before and after the educational meeting among health care professionals who were working in our hospital during the study period. Subanalyses restricted to nurses were also performed. Main Outcome Measure: Understanding ADR reporting system among healthcare professionals. Results: The percentage of respondents who understood the ADR reporting system in the questionnaire after the educational meeting was significantly higher than that in the questionnaire before the educational meeting. In the questionnaire after the educational meeting, multivariate logistic regression analysis found that having over 30 years of practical experience (odds ratio [OR], 3.852; 95% confidence interval [CI], 1.228-12.081 for 20-29 years, 7.695; 1.650-35.881 for over 30 years), being a physician (8.071; 1.923-33.878), being a pharmacist (18.357; 3.847-87.585), and participating in the educational meeting (5.111; 1.700-15.365) were factors associated with understanding the ADR reporting system. Multivariate logistic regression analysis of the questionnaire results before the educational meeting among nurses showed that working at outpatient departments (8.330; 3.008-23.069) was significantly and independently associated with understanding the ADR reporting system. Conclusions: The present study demonstrated that many years of practical experience, profession (physicians, pharmacists), and educational interventions were associated with good understanding of the ADR reporting system among health care professionals.


2000 ◽  
Vol 13 (1) ◽  
pp. 37-81
Author(s):  
David L. Laven ◽  
Lisa Oller

Exposure to over-the-counter and prescription medications can pose significant therapeutic and health hazards to patients, and present health care professionals with scenarios that require proper assessment and treatment. Knowing when an exposure to or overdose of a drug requires emergency medical attention is equally as important as to knowing when such assistance is not necessary—that simple treatment measures performed at home will suffice. This current discussion is intended to highlight select principles and clinical information pertaining to common drug exposures and overdoses, but not replace the full spectrum of information that would be available to health care professionals (and the lay public) by contacting their nearest poison control center. Many of the basic principles and concerns that are encountered with exposures to chemicals (i.e., route of exposure, patient medical history, quantity of the substance involved, elapsed time since the initial exposure, etc.) apply equally well to drug exposures. Likewise, evaluating each of these variables will determine which type of treatment approaches are, and are not, considered in situations of drug (or chemical) exposure and overdose.


2017 ◽  
Vol 69 (1) ◽  
pp. 57 ◽  
Author(s):  
Prabhat Chand ◽  
Naveen Jayaram ◽  
Pratima Murthy

<p>Tramadol, either alone or in combination with paracetamol, is a commonly prescribed opioid analgesic in routine clinical practice. It has reportedly low abuse potential. There are, however, a few reports of tramadol misuse among health care professionals and persons with a family history of addiction. We describe the clinical profile of three women developing addiction to tramadol. In all these cases tramadol was initially prescribed for pain by the physician. Physicians should not only prescribe tramadol cautiously and for a limited time period but also be trained in identifying misuse (self‑use, over the counter procuring, using for mind altering<br />properties) and dependence (craving, withdrawal symptoms etc.).</p>


Author(s):  
S. Sre Akshaya Kalyani ◽  
Pendota Srihitha ◽  
Katnapally Abhinay Sharma ◽  
Porandla Dharanija ◽  
Sandeep Kumar Bheemreddy

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.


2020 ◽  
Vol 2 (3) ◽  
pp. 01-03
Author(s):  
Gosaye Zewde

Background: Adverse drug reaction is any noxious, unintended and undesired effect of a drug which resulted from inadequate monitoring of therapy or inappropriate dosing. It may be unexpected, unknown and/or rare. Adverse drug reactions (ADRs) are an important cause of mortality and morbidity worldwide. In some case it is life- threatening, and can be major determinants of treatment outcomes. All healthcare professionals are encouraged to report ADR But under-reporting remains a major draw-back of spontaneous reporting. Therefore this study aims to investigate the knowledge, attitudes and practices of healthcare professionals towards ADR reporting and try to fill the information gap in the study area. Objective: To assess knowledge, attitude and practice of ADR reporting among health care professionals working at Public Hospitals in Harar Town Eastern Ethiopia 2020. Methodology: Health facility based cross sectional study was conducted on 238 Health professional who are working in Public Hospitals of Harar Town Eastern Ethiopia. Sample allocates proportionately and study participant was selected by systematic random sampling method. Collected and checked data were entered in to Epi Data software version 3.1 and analysis was done by SPSS version 21. Mean value were used to classify as good or poor knowledge, altitude and practice on ADR reporting. Finding was summarized and presented in forms of tables and statement. Result: The overall prevalence of good knowledge, altitude and practice of ADR reporting was 42.9 %, 34.5 % and 39.9 % respectively. Majority 158 (66.4%) of study participant does not feel that there are adequately trained on ADR reporting. While 206 (86.6 %) and 208 (87.4%) of health professional agree that reporting drug safety is important for the public and health care system. One third of health professionals 74 (31.4%, P = 0.002) significantly reported that there had encountered ADR. Conclusion and Recommendation: On this study majority respondent had poor knowledge, altitude and ADR Reporting practices. Therefore Training provision, awareness creation, Strong and collaborative ADR reporting mechanisms, continuous monitoring and evaluation need to be established on each health institution.


2015 ◽  
Vol 101 (1) ◽  
pp. e1.58-e1
Author(s):  
Pauline De Bruyne ◽  
Koen Boussery ◽  
Thierry Christiaens ◽  
Els Mehuys ◽  
Myriam Van Winckel

BackgroundFor obvious reasons, much attention has recently been paid to off-label prescriptions in paediatrics. However, on-label prescribing can cause health issues too: we discuss the case of first generation H1-antihistamines (FGAs). These have been in use for over 70 years, for a variety of indications such as relief of allergic conditions, cough and insomnia.Materials and methodsThe FGAs were listed using their International Nonproprietary Names (INN). For each formulation, the information of the Summary of Product Characteristics issued in five selected European countries (Belgium, France, Germany, the Netherlands and United Kingdom) was collected. This was plotted against the published evidence on efficacy and safety of each FGA.Results16 different FGAs are currently marketed in single-drug oral preparations in the evaluated countries. When investigating each drug separately, a huge variability in labelled indications, licensing age for paediatric use, and availability characteristics in the different countries is observed. Most of the indications are not supported by evidence from published clinical trials.ConclusionBoth health care professionals and consumers generally assume that all approved H1-antihistamines have been shown to be efficacious and safe, but many in this class – in particular those introduced before 1985 – have not been optimally studied. This might explain the inconsistencies in indications and licensing ages of the evaluated drugs in different countries. Moreover, many of the antihistamines are sold over the counter, which may contribute to overuse. Such overuse can be a serious problem, as sedation is a known side effect of all FGAs.


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