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Smith, Kelly M., Philip J. Trapskin, Philip E. Empey, Keith A. Hecht, and John A. Armitstead. "Internally-Developed Online Adverse Drug Reaction and Medication Error Reporting Systems." Hospital Pharmacy 41, no. 5 (May 2006): 428–36. http://dx.doi.org/10.1310/hpj4105-428.
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Online reporting systems for adverse drug reaction (ADR) and medication error (ME) reporting were developed at the University of Kentucky Chandler Medical Center. Collaboration between Pharmacy Services, Information Services, and the Drug Information Center resulted in the creation of two stand-alone systems that input data directly into centrally-stored databases. Web forms were designed using Web-authoring tools, as well as javascript and server-side scripting. Medication error reporting incorporated an E-mail notification process for hospital personnel based upon patient location, medical service, and severity of the error. Adverse drug reaction reporting increased initially following implementation, but leveled out soon thereafter. Conversely, ME reporting greatly increased, and also captured a greater number of type A MEs (eg, situations with a capacity for error). A number of system changes and patient safety initiatives have been implemented in response to data obtained from the reporting systems. Internally developed systems have supported customized forms that meet the institution's reporting needs and support a safer patient care environment.
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Robertson, Jane, and David A. Newby. "Low awareness of adverse drug reaction reporting systems: a consumer survey." Medical Journal of Australia 199, no. 10 (November 2013): 684–86. http://dx.doi.org/10.5694/mja13.10069.
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Rabbur, Reza S. M., and Lynne Emmerton. "An introduction to adverse drug reaction reporting systems in different countries." International Journal of Pharmacy Practice 13, no. 1 (March 1, 2005): 91–100. http://dx.doi.org/10.1211/0022357055821.
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Worakunphanich, Wiwan, Sitaporn Youngkong, Wimon Suwankesawong, Claire Anderson, and Montarat Thavorncharoensap. "Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries." International Journal of Environmental Research and Public Health 19, no. 8 (April 7, 2022): 4447. http://dx.doi.org/10.3390/ijerph19084447.
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Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country’s system should be adopted.
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Shang, Wei, Hsinchun Chen, and Christine Livoti. "Adverse drug reaction early warning using user search data." Online Information Review 41, no. 4 (August 14, 2017): 524–36. http://dx.doi.org/10.1108/oir-10-2015-0341.
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Purpose The purpose of this paper is to propose a framework to detect adverse drug reactions (ADRs) using internet user search data, so that ADR events can be identified early. Empirical investigation of Avandia, a type II diabetes treatment, is conducted to illustrate how to implement the proposed framework. Design/methodology/approach Typical ADR identification measures and time series processing techniques are used in the proposed framework. Google Trends Data are employed to represent user searches. The baseline model is a disproportionality analysis using official drug reaction reporting data from the US Food and Drug Administration’s Adverse Event Reporting System. Findings Results show that Google Trends series of Avandia side effects search reveal a significant early warning signal for the side effect emergence of Avandia. The proposed approach of using user search data to detect ADRs is proved to have a longer leading time than traditional drug reaction discovery methods. Three more drugs with known adverse reactions are investigated using the selected approach, and two are successfully identified. Research limitations/implications Validation of Google Trends data’s representativeness of user search is yet to be explored. In future research, user search in other search engines and in healthcare web forums can be incorporated to obtain a more comprehensive ADR early warning mechanism. Practical implications Using internet data in drug safety management with a proper early warning mechanism may serve as an earlier signal than traditional drug adverse reaction. This has great potential in public health emergency management. Originality/value The research work proposes a novel framework of using user search data in ADR identification. User search is a voluntary drug adverse reaction exploration behavior. Furthermore, user search data series are more concise and accurate than text mining in forums. The proposed methods as well as the empirical results will shed some light on incorporating user search data as a new source in pharmacovigilance.
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Sharma, Megha, Ruchi Baghel, Sunil Thakur, and Sandeep Adwal. "Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study." BMJ Open 11, no. 10 (October 2021): e052737. http://dx.doi.org/10.1136/bmjopen-2021-052737.
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ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was conducted between 2013 and 2019 at an ADR Monitoring Centre in Central India. ADRs were recorded using the standard ‘Suspected ADR Reporting form’.Outcome measuresThe causality of the ADRs were categorised using the WHO causality assessment scale to assess the relationship between a drug and the occurrence of an ADR.ResultsTotally 1980 spontaneous ADRs were reported involving 960 patients and 1316 drugs prescriptions. The occurrence of ADRs was common among male patients (64%) and patients of age between 19 and 65 years (81%). Antimicrobials caused 29% ADRs, followed by drugs of antiretroviral therapy (19%). Zidovudine caused most ADRs (88%) followed by ethambutol and ciprofloxacin. The ADRs of skin and subcutaneous tissue disorders (28%) were most common among all system organ classes followed by gastrointestinal systems (18%). Four per cent of all reported ADRs were severe. A peak of ADR reports was attained in 2016 with 224 reports, which decreased to 127 in 2019.ConclusionA high number of ADRs caused by antimicrobials is an alarming situation, which adds up to antimicrobial resistance. Judicious use of antimicrobials is yet again proven as need of the hour. Under-reporting of ADRs is evident in our study and is a major factor for the delay in the withdrawal of drugs responsible for causing ADRs. Interventions in terms of training and feedback are suggested to encourage and improve ADR reporting.
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Valinciute-Jankauskiene, Agne, and Loreta Kubiliene. "Adverse Drug Reaction Reporting by Patients in 12 European Countries." International Journal of Environmental Research and Public Health 18, no. 4 (February 5, 2021): 1507. http://dx.doi.org/10.3390/ijerph18041507.
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Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries that implemented this reporting type in 2012–2013. A web-based questionnaire was sent to the national competent authorities (NCAs) of the European countries. The received answers were systematized and compared using statistical analysis. The performed statistical analysis demonstrated that changes in the number of received ADR reports increased significantly in each country during the analyzed period. These changes were significantly different in Ireland and Finland from those in the other reviewed countries. The common source of information on direct patient reporting was the country’s NCA website. Other sources used were social media pages, leaflets, and posters. This is the first study on patient reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient reporting should organize comprehensive campaigns on ADR reporting.
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Zaheer, Sidra, Andaleeb Komal, and Ather Akhlaq. "ADVERSE DRUG REACTION REPORTING PRACTICES BY HEALTH CARE PROFESSIONALS OF KARACHI, PAKISTAN: A QUALITATIVE SURVEY." GJMS Vol 19, No.1, Jan-Mar 2021 19, no. 1 (March 31, 2021): 11–18. http://dx.doi.org/10.46903/gjms/19.01.943.
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Background: The safety of medications is of utmost concern for public health. In developed countries, adverse drug reaction reporting systems are well established, but in low-income and middle-income countries such as Pakistan, these are under-developed and ignored. The objective of this qualitative survey was to explore the adverse drug reaction reporting practices by health care professionals of Karachi, Pakistan. Materials & Methods: Fifteen health care professionals (HCPs), including physicians, nurses and pharmacists from public, semi-private and private tertiary care hospitals were selected using purposive and snowball sampling for semi-structured interviews. Interviews were digitally recorded, transcribed verbatim, and were analyzed using Thematic Analysis. Results: The results showed that almost all HCPs have a good understanding of ADR, but did not know the procedures of ADR reporting to the Drug Regulatory Authority of Pakistan (DRAP). Usually, the ADR was manually reported, with few hospitals having an electronic ADR reporting system. Barriers to the ADR reporting included a large influx of illiterate patients, over-burdened staff, lack of financial and technological resources, and ineffective administration. Facilitator to ADR reporting was electronic ADR system. Conclusion: These findings would help the policymakers and health administrators to revise existing policies and devise new ones for the adoption of adverse drugs reporting (ADR) systems in hospitals.
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Bansal, Alka, Ashish Agrawal, Lokendra Sharma, and Smita Jain. "A comparative study of active and passive adverse drug reaction reporting systems in terms of false reporting rate." Scripta Medica 51, no. 4 (2020): 223–30. http://dx.doi.org/10.5937/scriptamed51-29065.
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Background: World Health Organisation Uppsala Monitoring Centre (WHO-UMC) was set up in 1968 to collect Adverse Drug Reactions (ADRs) periodically for all drugs across the globe. It identifies two main approaches to pharmacovigilance: active (intensive) and passive (spontaneous). However, very few studies are available to compare these two methods of adverse drug reaction reporting. Methods: A prospective observational study was done on 303 newly diagnosed patients with tuberculosis receiving directly observed therapy short-course (DOTS) in the Sawai Man Singh (SMS) Hospital, Jaipur between 1 January 2019 and 31 December 2019. They were randomly divided into groups A (150 patients) and B (153 patients). Group A patients were followed actively at fixed intervals of time for ADRs till next six months through electronic conversation or personal interview. Group B patients were required to report spontaneously for any ADRs to pharmacovigilance centre. After data collection causality assessment was done using the WHO-UMC scale to identify false reporting and finally results were analysed statistically by means of the t-test using Minitab 14 software Pennsylvania, USA. Results: 153 ADRs were reported in active and 39 in passive group. Hence the yield of ADR was four times more in active method. After causality assessment, 31 in group A and 12 in group B were found to be falsely related (unlikely) to antitubercular drugs. Two sample t-test revealed active method reported more false ADR (p = 0.005). Conclusion: Although active method of surveillance identifies more ADRs than passive method, it is also more prone to false reporting. Hence its benefits should be weighed against its cost before adopting it for countries with limited resources.
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Gupta, Rohini, Apoorva Malhotra, and Pavan Malhotra. "A study on determinants of underreporting of adverse drug reactions among resident doctors." International Journal of Research in Medical Sciences 6, no. 2 (January 24, 2018): 623. http://dx.doi.org/10.18203/2320-6012.ijrms20180310.
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Background: Adverse Drug Reactions (ADRs) are global problem with significant morbidity and mortality. Health care providers/professionals (HCPs) play a critical role in ADR surveillance. However, only 6% of all ADRs are reported and under-reporting acts as great impedance in exchange of drug information. Thus, spontaneous reporting of suspected adverse drug reactions requires greater commitment from healthcare professionals. The aim was to determine the reasons of underreporting of ADRs among resident doctors.Methods: This was a cross-sectional observational study with self-administered questionnaire assessing the reasons for underreporting of ADRs among resident doctors.Results: Very low level of awareness about ADR reporting was found among doctors. Eighty eight percent of doctors did not know the authority and the procedure for ADR reporting. About 32.8% were not sure with the reaction and the drug, while 46.3% doctors felt that there is no need of reporting the recognized reactions again. Other factors responsible for under reporting were lack of time in 73% and cumbersome procedure in 45% of the participants.Conclusions: A poor level of awareness of pharmacovigilance was seen among doctors. Measure to improve awareness, accessible systems for reporting and effective National Programme are required to improve reporting
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Kodam, Laxmipathi, Naveen Kumar Tamma, Janardhan Marupaka, and Srinivasu Karedla. "Adverse drug reactions observed in treatment of gastro intestinal and respiratory tract infections: a prospective analysis." International Journal of Basic & Clinical Pharmacology 9, no. 1 (December 24, 2019): 134. http://dx.doi.org/10.18203/2319-2003.ijbcp20195775.
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Background: The aim of the study was to observe common adverse drug reactions in treatment of gastro intestinal and respiratory tract infections in a tertiary care hospitals.Methods: A prospective observational study was conducted by Departments of Pharmacology for a period of one year from prescriptions and case sheets of medical record section. Adverse drug reaction reporting forms and alert cards were used for reporting.Results: The drugs most commonly used for gastrointestinal tract and respiratory diseases are tablets norflox 400 mg, norflox-tz, taxim 200 mg, IV amikacin and iv amoxicillin (500 mg) and clavulanic acid (125 mg) combination. Systems affected by use of above drugs were skin and gastrointestinal tract. Urticaria on skin, abdominal pain, itching in genital area, ulcer on oral mucosa are the common adverse drug reactions observed.Conclusions: Drugs used for common gastrointestinal tract and respiratory tract infections alert cards should be issued to patients when prescribing and adverse drug reactions should be reported to higher centres. Brand names causing adverse reactions should be monitored regularly and their further usage should be based on signals from other centres. All tertiary care hospitals should have antimicrobial guidelines policy to reduce adverse drug reactions.
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Yawson, Abena Ahwianfoa, Gordon Abekah-Nkrumah, Grace Adjei Okai, and Charles Gyamfi Ofori. "Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana." Therapeutic Advances in Drug Safety 13 (January 2022): 204209862211164. http://dx.doi.org/10.1177/20420986221116468.
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Background: Spontaneous reporting systems are the commonest means of reporting adverse drug reactions (ADRs) worldwide. Under-reporting remains a challenge particularly in developing countries among healthcare professionals (HCPs) who are considered the primary stakeholders in the reporting of ADRs. The challenge with studies in countries such as Ghana is that the focus has been on a single professional group or health facility. This study examines the rate of reporting as well as awareness, knowledge, and attitudes toward ADR reporting across professional groups (doctors, nurses, and pharmacist) and selected health facilities (ownership types: government, quasi-government, and private; hierarchy: district, regional, and teaching) in Ghana. Method: A cross-sectional survey was conducted to select and interview 424 healthcare professionals (HCPs) from 8 hospitals in the Greater Accra and Eastern regions of Ghana on issues of ADR reporting, awareness, knowledge, and attitudes toward ADR reporting. Valid responses from 378 HCPs were obtained and analyzed using frequencies and percentages. Findings: The results suggest that about 82.8% of the HCPs interviewed have come across an ADR incidence, but only 52.6% of them have reported such incidence, with pharmacist (66.7%) being the most likely to report. The results further suggest that about 85.8% of HCPs are aware of ADR reporting procedures and display positive attitudes toward same. In addition, the knowledge of HCPs on ADR reporting is low with training being a major area of need. Conclusion: There is the need for healthcare managers and the regulator to pay attention to existing gaps in awareness, attitudes, and most importantly knowledge of HCPs on structures and modalities for ADR reporting. Plain Language Summary Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana Reporting of unpleasant reactions related to the use of medicinal products has been very low in less developed countries. Studies conducted in Ghana to examine the reporting of unpleasant reactions associated with the use of medicinal products have focused mainly on one health facility or health care provider group. This article examines the level of awareness, knowledge, and attitudes toward the reporting of unpleasant reactions to the use of medicinal products. The authors used a quantitative method to examine the level of awareness, knowledge, and attitude toward reporting of unpleasant reactions to medicinal products. The study was conducted in eight hospitals in Greater Accra and Eastern regions of Ghana using a structured questionnaire. Only 378 out of 424 healthcare providers returned the completed questionnaire. The findings of the study show that 213 of the healthcare providers have encountered at least one patient with an unpleasant reaction to the use of medicinal products, although only 112 reported the unpleasant reactions. Pharmacists were found to be more likely to report unpleasant reactions as 12 out of 18 pharmacists who responded to the questionnaire indicated that they report the unpleasant reactions seen. In addition, 321 of the healthcare providers knew of the reporting procedures for unpleasant reactions to a medicinal product in Ghana. Only 219 healthcare providers knew of the reporting procedures in the facilities in which they worked, however. Furthermore, the knowledge of healthcare providers on the method of reporting is low.
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Y. Osei, Johnson, Priscillia A. Nortey, Delia A. Bandoh, Ernest Kenu, and Adolphina A. Addo- Lartey. "Adverse drug reaction reporting by community pharmacists in the Greater Accra Region of Ghana, 2016." Ghana Medical Journal 55, no. 1 (March 31, 2021): 9–17. http://dx.doi.org/10.4314/gmj.v55i1.3.
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Objectives: To assess adverse drug reactions (ADRs) reporting and identify factors to improve ADR reporting among community pharmacists in the Greater Accra Region of Ghana.Design: A quantitative cross-sectional study.Setting: Community pharmacies in the Greater Accra Region of Ghana.Participants: We randomly selected 210 pharmacists from a list community of pharmacies in Accra, Ghana. All participants had been practicing in the past one year, with this study being conducted from June to July 2016.Main outcome measure: Prevalence of ADR reporting by community pharmacists in Accra, Ghana.Results: Of the 210 community pharmacists interviewed 54.0% were males. Mean age was 32±10 years. Majority (96.0%) had heard of ADR reporting in Ghana, yet 18% had never seen the ADR reporting form. Reasons given for failure to report suspected ADRs included unavailability of reporting forms (83.1%), uncertainty about a causal relationship between the drug and the suspected ADR and classification of the reaction as “normal” with the medication being taken (23.6%). Only 34.0% of pharmacists had the ADR reporting forms available in their facilities. Marital status was the only factor significantly associated with ADR reporting (OR 3.18, 95%CI 1.02 – 9.12).Conclusion: ADR reporting by community pharmacists in Ghana remains low. To improve the proportion of reporting, ADR forms should be made available in all pharmacies, pharmacists and the general public should be made aware of online reporting systems, with continuous professional development in Pharmacovigilance with the advice that all suspected ADRs should be reported irrespective of uncertainty about causality.
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KC, Bhuvan. "Do community pharmacists in Nepal have a role in adverse drug reaction reporting systems?" Australasian Medical Journal 6, no. 2 (March 1, 2013): 100–103. http://dx.doi.org/10.4066/amj.2013.1544.
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Fernandopulle, Rohini B. M., and Krisantha Weerasuriya. "What Can Consumer Adverse Drug Reaction Reporting Add to Existing Health Professional-Based Systems?" Drug Safety 26, no. 4 (2003): 219–25. http://dx.doi.org/10.2165/00002018-200326040-00002.
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Vaismoradi, Logan, Jordan, and Sletvold. "Adverse Drug Reactions in Norway: A Systematic Review." Pharmacy 7, no. 3 (July 25, 2019): 102. http://dx.doi.org/10.3390/pharmacy7030102.
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Prescription medicines aim to relieve patients’ suffering but they can be associated with adverse side effects or adverse drug reactions (ADRs). ADRs are an important cause of hospital admissions and a financial burden on healthcare systems across the globe. There is little integrative and collective knowledge on ADR reporting and monitoring in the Norwegian healthcare system. Accordingly, this systematic review aims to investigate the current trends in ADR reporting, monitoring, and handling in the Norwegian healthcare system and describe related interventions. Appropriate keywords, with regard to ADRs in both English and Norwegian languages, were used to retrieve articles published from 2010 to 2019. Six articles met the inclusion criteria. The findings offer a comprehensive picture of ADR reporting and monitoring in the Norwegian healthcare system. Psychotropic medicines were most commonly implicated by patients, while professionals most commonly reported ADRs associated with anticoagulants. The current ADR systems were compiled with the involvement of both patients and healthcare providers to record all types of drugs and ADRs of various severities, and aimed at improving ADR tracking. However, there is a need to improve current initiatives in terms of feedback and quality, and more studies are needed to explore how ADR profiles, and the associated vigilance, can improve the safety of medicines management in Norway.
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Bagbi, B. M., D. M. George, and M. B. Alagala. "Evaluation of Awareness and Knowledge of Pharmacovigilance amongst Final Year Students of Rivers State College of Health Science and Technology, Nigeria." Journal of Drug Delivery and Therapeutics 12, no. 3-S (June 15, 2022): 77–80. http://dx.doi.org/10.22270/jddt.v12i3-s.5371.
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Adverse drug reactions (ADRs) till date are still considered as one of the main problems of drug therapy. Pharmacovigilance is the monitoring of drug safety by means of spontaneous adverse-effect reporting systems, case control and cohort studies.
This study evaluated the levels of awareness and knowledge of pharmacovigilance (i.e., ADR reporting) amongst final year students of Rivers State College of Health Science and Technology, Port Harcourt, Nigeria. It was a cross sectional awareness and knowledge survey amongst 200 students from the eight Schools of the institution. Specially adapted and structured questionnaires were administered to the students to obtain information on their levels of awareness and knowledge on reporting of ADRs. Simple descriptive statistics was used to analyze the data that were obtained. The result showed that over 72% of the students from each of the Schools had good knowledge of ADR, about 62% were aware of ADR reporting system, while less than 50% had knowledge of the process of reporting ADRs.
Final year students of College of Health Science and Technology, Port Harcourt have good knowledge of ADR. However, their awareness of the reporting system and particularly the process of reporting (pharmacovigilance) is poor and needs improvement.
Keywords: Awareness, adverse drug reaction, pharmacovigilance
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Dhar, Kavita, Shalu Chauhan, Jyotsna Sharma, Preeti Gaur, V. S. Chopra, and Umakant Bajaj. "To monitor the adverse drug reactions and safety of medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital." Indian Journal of Pharmaceutical and Biological Research 2, no. 03 (September 30, 2014): 112–19. http://dx.doi.org/10.30750/ijpbr.2.3.17.
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Adverse drug reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. Adverse Drug Reactions result in increased healthcare cost due to the need of some interventions and increased hospital stay. The study was undertaken to monitor the adverse drug reactions to medicines commonly prescribed at obstetrics and gynaecology unit in a tertiary care hospital, to establish ten most commonly prescribed medicines in this unit that gave maximum adverse drug reactions and to determine the list of commonly affected organ systems and assess their causality. In this Retrospective, non-interventional study a total of 63 adverse drug reaction reports were collected from 249 patients. The most common medicine that caused maximum ADRs was Oxytocin 10 (15.87%). Other frequently used drugs were Amikacin, Methylergometrine, Mifepristone+Misoprostol,Levonorgestrel+Ethinylestradiol, Cefotaxim+sulbactam, Cefixime+Ofloxacin, Mifepristone alone,Clomifene citrate, Tramadol. The most commonly affected organ system was cardio-vascular system 12 (19.04%).The assessment by Naranjo’s scale showed that out of 63 ADRs, 41 (65.07%) ADRs were probably related to drugs, 21 (33.33%) ADRs were possibly related to drugs and 1 (1.58%) ADR was doubtful. WHO causality assessment scale revealed that out of 63 ADRs, 51(80.95%) ADRs were probable or likely, 12(19.04%) ADRs were possible. It was observed that safe medicines were prescribed in obstetrics and gynaecology department as per FDA category A with no banned drugs .However, there is a need to sensitize the doctors to prescribe rationally and emphasize this aspect in under and post graduate medical teaching as well. The health system needs to promote spontaneous reporting of Adverse Drug Reactions from all health care professionals and the public at large in a well structured programme to build synergies for monitoring ADR in the country. Also proper documentation and periodic reporting to regional pharmacovigilance centres should be encouraged to arrive at meaningful conclusion on safety issue of medicines and thereby reduce considerably social and economic consequences of ADRs.
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Brabete, Andreea C., Lorraine Greaves, Mira Maximos, Ella Huber, Alice Li, and Mê-Linh Lê. "A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases." Pharmaceuticals 15, no. 3 (February 28, 2022): 298. http://dx.doi.org/10.3390/ph15030298.
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Drug-related adverse events or adverse drug reactions (ADRs) are currently partially or substantially under-reported. ADR reporting systems need to expand their focus to include sex- and gender-related factors in order to understand, prevent, or reduce the occurrence of ADRs in all people, particularly women. This scoping review describes adverse drug reactions reported to international pharmacovigilance databases. It identifies the drug classes most commonly associated with ADRs and synthesizes the evidence on ADRs utilizing a sex- and gender-based analysis plus (SGBA+) to assess the differential outcomes reported in the individual studies. We developed a systematic search strategy and applied it to six electronic databases, ultimately including 35 papers. Overall, the evidence shows that women are involved in more ADR reports than men across different countries, although in some cases, men experience more serious ADRs. Most studies were conducted in higher-income countries; the terms adverse drug reactions and adverse drug events are used interchangeably, and there is a lack of standardization between systems. Additional research is needed to identify the relationships between sex- and gender-related factors in the occurrence and reporting of ADRs to adequately detect and prevent ADRs, as well as to tailor and prepare effective reporting for the lifecycle management of drugs.
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K., Kabilan, Sathyanarayanan V., and R. Jammuna Rani. "Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study." International Journal of Basic & Clinical Pharmacology 7, no. 7 (June 22, 2018): 1345. http://dx.doi.org/10.18203/2319-2003.ijbcp20182680.
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Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.
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Shin, Hyunah, Jaehun Cha, Youngho Lee, Jong-Yeup Kim, and Suehyun Lee. "Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm." Health Informatics Journal 27, no. 3 (July 2021): 146045822110330. http://dx.doi.org/10.1177/14604582211033014.
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Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.
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Kurma, Veereswara Rao, Triveni Manchu, Meena Kumari Amancharla, Kalyani Manchu, and Pavan Kumar Kandula. "Pattern of adverse drug reactions in paediatric patients reported to adverse drug reaction monitoring centre in a tertiary care hospital." International Journal of Contemporary Pediatrics 6, no. 4 (June 27, 2019): 1557. http://dx.doi.org/10.18203/2349-3291.ijcp20192754.
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Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.
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Zachary, Rebecca. "Formulary Management from a Health Maintenance Organization (HMO) Perspective." Journal of Pharmacy Practice 7, no. 2 (April 1994): 68–73. http://dx.doi.org/10.1177/089719009400700204.
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With the rise of managed care, formularies are being increasingly employed in the outpatient setting to manage use and control costs of prescription drugs. The formulary management policies of various managed care organizations are widely diverse and are largely dependent on the organizational structure of the managed care program. Although reasons for choosing certain types of formulary systems will be briefly explored, this article primarily focuses on formulary management tools used in the group model HMO setting. Various aspects of the formulary process that require ongoing management are described, including non-formulary drug usage, drug restrictions, drug use review, adverse drug reaction reporting, education of the professional staff, reporting of drug use data to physicians, and visitation by pharmaceutical sales representatives.
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Misra, Debasish, Manika Bose, Sansita Parida, Smita Das, Swati Mishra, and Sudhansu Sekhar Mishra. "Adverse drug reaction reporting in a tertiary care teaching hospital in eastern India: a retrospective study." International Journal of Basic & Clinical Pharmacology 8, no. 10 (September 25, 2019): 2322. http://dx.doi.org/10.18203/2319-2003.ijbcp20194280.
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Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum reactions is dermatological (51.1%). Drug class most commonly affected is anti-microbials (36.1%). Paracetamol (8.9%) is the most common drug with reactions. Causality assessment stated that 41.7% ADRs are probable and 58.3% were possible. Severity assessment showed 86.7% as mild and 13.3% as moderate. Preventability assessment stated that 93.3% ADRs not preventable, 5.6% probably preventable and 1.1% definitely preventable.Conclusions: The study provides a valuable insight with regards to the pattern of ADRs in our hospital. This will be useful in initiating a reporting culture, increase awareness, reducing under-reporting of ADR in our set up.
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Wei, Jianxiang, Jimin Dai, Yingya Zhao, Pu Han, Yunxia Zhu, and Weidong Huang. "Application of Association Rules Analysis in Mining Adverse Drug Reaction Signals." Applied Sciences 11, no. 22 (November 16, 2021): 10828. http://dx.doi.org/10.3390/app112210828.
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Adverse drug reactions (ADRs) are increasingly becoming a serious public health problem. Spontaneous reporting systems (SRSs) are an important way for many countries to monitor ADRs produced in the clinical use of drugs, and they are the main data source for ADR signal detection. The traditional signal detection methods are based on disproportionality analysis (DPA) and lack the application of data mining technology. In this paper, we selected the spontaneous reports from 2011 to 2018 in Jiangsu Province of China as the research data and used association rules analysis (ARA) to mine signals. We defined some important metrics of the ARA according to the two-dimensional contingency table of ADRs, such as Confidence and Lift, and constructed performance evaluation indicators such as Precision, Recall, and F1 as objective standards. We used experimental methods based on data to objectively determine the optimal thresholds of the corresponding metrics, which, in the best case, are Confidence = 0.007 and Lift = 1. We obtained the average performance of the method through 10-fold cross-validation. The experimental results showed that F1 increased from 31.43% in the MHRA method to 40.38% in the ARA method; this was a significant improvement. To reduce drug risk and provide decision making for drug safety, more data mining methods need to be introduced and applied to ADR signal detection.
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Sen, Manodeep, Arpita Singh, and Mukul Misra. "Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 7, no. 2 (January 23, 2018): 303. http://dx.doi.org/10.18203/2319-2003.ijbcp20180103.
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Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.
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Gahr, M., J. Eller, B. J. Connemann, and C. Schönfeldt-Lecuona. "Underreporting of adverse drug reactions: Results from a survey among physicians." European Psychiatry 41, S1 (April 2017): S369. http://dx.doi.org/10.1016/j.eurpsy.2017.02.377.
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IntroductionDrug safety surveillance strongly depends on the spontaneous and voluntary reporting of adverse drug reactions (ADR). A major limiting factor of spontaneous reporting systems is underreporting (UR) which describes incorrectly low reporting rates of ADR. Factors contributing to UR are numerous and feature country-dependent differences.Objectives/aimsUnderstanding causes of UR is necessary to facilitate targeted interventions to improve ADR reporting and pharmacovigilance.MethodsA cross-sectional questionnaire-based telephone survey was performed among physicians in outpatient care in a federal state of Germany.ResultsFrom n = 316 eligible physicians n = 176 completed the questionnaire (response rate = 55.7%). Most of the physicians (n = 137/77.8%) stated that they report ADR, which they have observed to the competent authority rarely (n = 59/33.5%), very rarely (n = 59/33.5%) or never (n = 19/10.8%); the majority (n = 123/69.9%) had not reported any ADR in 2014. Frequent subjective reasons for ADR non-reporting were (specified response options): lack of time (n = 52/29.5%), the subjective evaluation that the required process of reporting is complicated (n = 47/26.7%) or requires too much time (n = 25/14.2%) or the assessment that reporting of an ADR is needless (n = 22/12.5%); within free answers the participants frequently stated that they do not report ADR that are already known (n = 72/40.9%) and they only report severe ADR (n = 46/26.1%).ConclusionsOur results suggest a need of interventions to inform physicians about pharmacovigilance and to modify the required procedure of ADR reporting or to offer other reporting options.Disclosure of interestThe authors have not supplied their declaration of competing interest.
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Akalu, Suchitra D., and Niveditha G. Belavadi. "Pattern of adverse drug reaction to antiepileptic drugs in a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 6, no. 9 (August 22, 2017): 2219. http://dx.doi.org/10.18203/2319-2003.ijbcp20173748.
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Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality, and are the leading cause of hospital admission. The overall rate of ADRs is estimated to be 6.5% and 28% of these ADRs are preventable. Antiepileptic drugs (AEDs) are authorized for several therapeutic indications and are highly prescribed. ADRs due to AEDs range from minor maculopapular exanthem (MPE) to severe life-threatening reactions like Drug reaction eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS). Objective of the study was to evaluate the pattern of ADRs reported with AEDs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital.Methods: Retrospective analysis of the records was done for a period 48 months from January 2013 to December 2016. During this period, all the ADRs caused by AEDs reported to the AMC were included in the study. The study evaluated the pattern of ADRs due to AEDs. The study also assessed the gender-wise distribution, predilection for various systems, causality, severity, and preventability of ADRs. Data was analysed using descriptive statistics.Results: A total of 319 ADRs were reported by spontaneous reporting during the entire study period. Out of the total 319 ADR reports received, antiepileptic drugs related ADRs were 35 (11%). Antiepileptic drugs which caused the ADRs included phenytoin, carbamazepine, clobazam and lorazepam. The most common system affected was dermatological (60%), followed by gastrointestinal system (17.14%), vascular system (11.42%), blood (5.8%), respiratory system (5.8%) and central nervous system (2.9%). Among the dermatological ADRs, SJS accounted for 11 cases of which 10 cases were due to phenytoin and one case was due to carbamazepine. DRESS syndrome due to phenytoin was documented in one case.Conclusions: AEDs are the most commonly prescribed drugs for various indications. Uses of AEDs are accompanied by ADRs which vary from mild rashes and itching to SJS and DRESS/TEN. Post-marketing surveillance of the AEDs is important for compliance, therapeutic efficacy and ultimately safety of the patient.
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Pop, Gabriela, Andreea Farcaș, Anca Butucă, Claudiu Morgovan, Anca Maria Arseniu, Manuela Pumnea, Minodora Teodoru, and Felicia Gabriela Gligor. "Post-Marketing Surveillance of Statins—A Descriptive Analysis of Psychiatric Adverse Reactions in EudraVigilance." Pharmaceuticals 15, no. 12 (December 10, 2022): 1536. http://dx.doi.org/10.3390/ph15121536.
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Statins are included in the category of high-frequency prescription drugs, and their use is on an upward trend worldwide. In 2012, the FDA issued a warning about possible cognitive adverse drug reactions (ADRs) related to statins, some of which are listed in the Summary of Product Characteristics, but there are still concerns about their potential risk of psychiatric events. The aim of this research was to investigate spontaneous reports containing psychiatric ADRs associated with statins by analyzing the EudraVigilance (EV) database. From January 2004 to July 2021, a total of 8965 ADRs were reported for the Systems Organ Class (SOC) “psychiatric disorders”, of which 88.64% were registered for atorvastatin (3659), simvastatin (2326) and rosuvastatin (1962). Out of a total of 7947 individual case safety reports (ICSRs) of the 3 statins mentioned above, in 36.3% (2885) of them, statins were considered the only suspected drug, and in 42% (3338), no other co-administered drugs were mentioned. Moreover, insomnia has been reported in 19.3% (1536) of cases, being the most frequent adverse reaction. A disproportionality analysis of psychiatric ADRs was performed. The Reporting Odds Ratio (ROR) and 95% confidence interval (95% CI) were calculated for simvastatin, atorvastatin and rosuvastatin compared with antiplatelets and antihypertensive drugs. The reporting probability for most ADRs of these statins compared to antiplatelets was higher. The reporting probability for insomnia, nightmares and depression produced by statins compared to antihypertensive drugs was also higher. The results of this analysis augment the existing data about a possible correlation between the administration of statins and the occurrence of psychiatric side effects.
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Alomar, Muaed, Ali M. Tawfiq, Nageeb Hassan, and Subish Palaian. "Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future." Therapeutic Advances in Drug Safety 11 (January 2020): 204209862093859. http://dx.doi.org/10.1177/2042098620938595.
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Background: To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance. Plain language summary Monitoring adverse effects of marketed medicines through reporting by healthcare professionals and its challenges and way forward Introduction: This article highlights the importance of safety monitoring of medicines after they are launched in the market, mainly through reporting by healthcare professionals. We also highlight the strengths and weaknesses, and provide an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to the topic were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. Health professionals’ awareness regarding existing programs on reporting safety of medicines is highlighted. Results: Though beneficial, reporting of adverse effects by healthcare professionals who deal with patient lacks clarity in diagnosing the adverse effects. Under-reporting and bias are the major challenges. Online software is needed to strengthen reporting by healthcare professionals. We list the various issues to be considered while depending on healthcare professionals’ reporting of adverse effects as a method of post marketing surveillance. Conclusion: To strengthen medicine safety monitoring and reporting by healthcare professionals, more awareness among health professionals and innovative strategies are needed. Integrating the genetic data of patients can be beneficial in predicting adverse effects, therefore avoiding them and enhancing safe prescribing and dispensing by healthcare professionals.
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Hohl, Corinne, Joel R. Lexchin, and Ellen Balka. "Can reporting of adverse drug reactions create safer systems while improving health data?" Canadian Medical Association Journal 187, no. 11 (May 4, 2015): 789–90. http://dx.doi.org/10.1503/cmaj.150057.
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Sandberg, Andreas, Veera Salminen, Susanna Heinonen, and Mia Sivén. "Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals’ Perspectives on How to Improve Reporting." Healthcare 10, no. 6 (May 31, 2022): 1015. http://dx.doi.org/10.3390/healthcare10061015.
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Background: Adverse drug reaction (ADR) reporting has been studied relatively extensively in all the Nordic countries besides Finland, but no definitive solution to decrease under-reporting has been found. Despite many similarities in reporting, the most notable difference compared to other Nordic countries is that ADR reporting is completely voluntary in Finland. Purpose: The purpose was to examine if voluntary reporting influences healthcare professional (HCP) ADR reporting, why HCPs do not report all suspected ADRs, how could reporting be enhanced, and do we need to develop the process for collecting ADR follow-up (F/U) information from HCPs. Methods: An open and anonymous questionnaire was developed and made available online at the e-form portal of the University of Helsinki. Trade and area unions distributed the questionnaire to their respective member physicians, nurses, and pharmacists. Two independent coders performed the content analysis of answers to open-ended questions. Results: A total of 149 responses was received. Two fifths (38%) of the HCPs confirmed that they had not always reported suspected ADRs. The main reason for not reporting was that the ADR was already known. HCPs who had no previous ADR reporting experience did not report ADRs mainly because it was not clear how to report them. Seriousness (chosen by 76%) and unexpectedness of the reaction (chosen by 64%) were the most actuating factors in reporting an ADR. Only 52% of the HCPs had received ADR reporting training and only 16% of the HCPs felt that they had enough information about reporting. Most HCPs felt that ADR F/U requests are justified, and these requests did not affect their ADR reporting willingness. Conclusions: As in other Nordic countries, ADR under-reporting occurs also in Finland despite differences in reporting guidance. ADR reporting rate could be enhanced by organizing recurring training, information campaigns, and including reporting reminders to the patient information systems that HCPs use. Training should primarily aid in recognizing ADRs, educate in how to report, and promote a reporting culture among HCPs.
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Hartzema, Abraham G., Miquel S. Porta, Hugh H. Tilson, Carlos R. Herrera, Jeffrey T. Moss, Randall R. Reves, and Patricia A. Buffler. "Feasibility Study of Surveying the Adverse Drug Reaction Surveillance Systems in a Large Community of Hospitals." Annals of Pharmacotherapy 26, no. 3 (March 1992): 384–91. http://dx.doi.org/10.1177/106002809202600314.
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OBJECTIVE: To determine the feasibility of accurately assessing the types of hospital adverse drug reaction (ADR) surveillance systems. DESIGN: Cross-sectional survey by mailed, self-administered questionnaire followed by selected verification interviews. SETTING: Harris County, Texas. PARTICIPANTS: All hospitals in the county with different pharmacy directors. MAIN OUTCOME MEASURE: Self description of surveillance system and number of ADRs reported. RESULTS: Forty-nine of 61 hospitals (80 percent) responded to a questionnaire. Forty-seven (96 percent) of the responding hospitals collected information on ADRs with 11 (22 percent) describing their surveillance system as active. Those individuals most often cited as responsible for ADR surveillance included pharmacists, quality assurance personnel, and nurses. Data were verified by personal interviews for 10 hospitals. The number of ADRs reported during the interviews was significantly lower than that reported in the questionnaires. Overall, the reporting of fatal and severe ADRs were more reliable than the reporting of moderate ADRs. These differences were the result of inadequate documentation and the lack of a uniform definition of ADRs. CONCLUSIONS: These data suggest that a large-scale ongoing survey of surveillance systems and reported adverse event rates has limitations and the reliability of data derived from a questionnaire should be verified. To improve the accuracy of surveys used to monitor hospital ADR surveillance systems, it is essential to develop reliable definitions for classifying ADRs and surveillance methods, as well as accurate measures of ADR documentation procedures.
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Hussain, Rabia, Mohamed Azmi Hassali, Anees ur Rehman, Jaya Muneswarao, and Furqan Hashmi. "Physicians’ Understanding and Practices of Pharmacovigilance: Qualitative Experience from a Lower Middle-Income Country." International Journal of Environmental Research and Public Health 17, no. 7 (March 25, 2020): 2209. http://dx.doi.org/10.3390/ijerph17072209.
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Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist’s role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians’ and other healthcare professionals’ communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.
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Kassem, Lamyaa M., Bushra Alhabib, Khaledah Alzunaydi, and Maryam Farooqui. "Understanding Patient Needs Regarding Adverse Drug Reaction Reporting Smartphone Applications: A Qualitative Insight from Saudi Arabia." International Journal of Environmental Research and Public Health 18, no. 8 (April 7, 2021): 3862. http://dx.doi.org/10.3390/ijerph18083862.
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Background: A pragmatic shift in the healthcare sector characterized by moving from curative to preventive approaches highlights the role of pharmacovigilance in patient safety. There have been few published studies on patient reporting of adverse drug reactions (ADRs) in Saudi Arabia. This qualitative study aims to explore the community opinions and the need for patient-friendly smartphone applications (SPAs) to enhance their participation in ADR reporting. Methods: Purposeful sampling was followed to recruit study participants, a semi-structured interview guide was used to conduct interviews, and the saturation was reached after the 13th interviewer; no new information was obtained after two subsequent interviews. All the interviews were audio-recorded, transcribed verbatim, and analyzed by means of a standard content analysis framework. Results: As per the WHO guidelines, eleven participants were aware of the term “ADR”. All the participants denied receiving any prior education and attending events about ADRs and were unaware of the Saudi FDA-ADR reporting systems. The use of technologies such as SPAs has been widely accepted with a high level of concern for data confidentiality and privacy. Conclusions: These findings point out the need to build patient-oriented educational programs to increase their awareness of ADR reporting and to prioritize the use of artificial intelligence (AI) to be integrated in the Saudi healthcare system to develop future SPAs for improving both patient safety and signal detection of ADRs.
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Dijkstra, Louis, Marco Garling, Ronja Foraita, and Iris Pigeot. "Adverse drug reaction or innocent bystander? A systematic comparison of statistical discovery methods for spontaneous reporting systems." Pharmacoepidemiology and Drug Safety 29, no. 4 (February 24, 2020): 396–403. http://dx.doi.org/10.1002/pds.4970.
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Tangiisuran, B., MP Gozzoli, JG Davies, and C. Rajkumar. "Adverse drug reactions in older people." Reviews in Clinical Gerontology 20, no. 3 (June 14, 2010): 246–59. http://dx.doi.org/10.1017/s0959259810000171.
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SummaryAdverse drug reactions (ADR) pose significant health-related problems for the older person. Many studies from around the world report a significant incidence of ADR in general and in elderly people in particular, resulting in an increase in drug-related morbidity and mortality. Older people appear to be particularly at risk of experiencing an ADR due to a range of factors, which include polypharmacy, altered drug pharmacokinetic profiles and pharmacodynamic responses, drug interactions and cognitive problems that increase the risk in this patient group. Certain drug classes, such as hypoglycaemic agents and cardiovascular active medicines, have been identified as common causes of ADR. Many studies suggest that the majority of ADR are preventable, so that several different approaches have been tried in an attempt to limit this problem, such as the use of computerized systems to communicate routine issues of patient care, interventions made by pharmacists, spontaneous reporting and continuous education of health care professionals. Whilst all have been shown to reduce drug-related events, identifying individuals at high risk of developing ADR at the point of prescribing by using a risk stratification model could improve the identification and prevention of ADR. This article discusses the clinical impact of ADR in older people and the relative merits of the various approaches tested to date before suggesting areas that require further research.
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Gohil, Jayendra R., Aniket B. Sarwade, Hardik R. Chauhan, Jay R. Jasani, and Hinal R. Gujrati. "Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar." International Journal of Basic & Clinical Pharmacology 9, no. 12 (November 25, 2020): 1883. http://dx.doi.org/10.18203/2319-2003.ijbcp20205127.
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Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.
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Masurkar, Prajakta Pradeep. "A NEED OF BETTER PHARMACOVIGILANCE SYSTEM IN INDIA." Asian Journal of Pharmaceutical and Clinical Research 10, no. 1 (January 1, 2016): 22. http://dx.doi.org/10.22159/ajpcr.2017.v10i1.14797.
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ABSTRACTIndia is one of the top producers of generics globally and is currently being recognized as the “pharmacy of the world” for the generic drug products.Thus, there is a need that it has best health-care systems in place to regulate and provide better quality drugs by monitoring the possible riskassociated with the use of drugs. Being the generic hub, physicians, pharmacists, etc., should be erudite to provide an alternative cost-effective genericmedicine, which is one of the education-related aspects of pharmacovigilance. We need a more systematic approach to surveillance of drug-relatedproblems, which is at the heart of pharmacovigilance. The health-care system requires new processes to understand the risk-benefit ratio of drugs.The challenges in implementation of better pharmacovigilance in country due to nonavailability of trained staff in pharmacovigilance, lack of trainingof health-care professionals on drug safety, and adverse drug reaction reporting which comprises adverse interactions of medicines with chemicals,other medicines, and food are often neglected leading to under-reporting by health-care professionals as well as patients, lack of expertise, etc., shouldbe overcome by Indian regulatory body via practical oriented knowledge-based system. The web market monitoring, global electronic database,education, association of stakeholders and regulation of herbal medicines standards and allied medicinal systems are vital restructurings needed tobe introduced for a better pharmacovigilance system in India.Keywords: Pharmacovigilance, India.
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Shajahan, Jihana, Abdul Aslam Parathoduvil, and Sangeetha Purushothaman. "An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study." International Journal of Basic & Clinical Pharmacology 7, no. 12 (November 24, 2018): 2433. http://dx.doi.org/10.18203/2319-2003.ijbcp20184861.
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Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.
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Alshakka, Mohammed, Nisha Jha, Saleh Algefri, Mohamed Izham M. Ibrahim, Mohamed Azmi Hassali, Ahmed Abdorabbo, and P. Ravi Shankar. "Problems and challenges faced in consumer reporting of adverse drug reactions in developing countries – A case study of Yemen, Nepal and Malaysia." Indian Journal of Pharmaceutical and Biological Research 2, no. 03 (September 30, 2014): 37–43. http://dx.doi.org/10.30750/ijpbr.2.3.7.
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Background: Pharmacovigilance is the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems”. The most commonly used adverse drug reaction (ADR) reporting system worldwide is spontaneous and voluntary reporting, which forms the backbone of reporting systems. Aims: To explore the current status of consumer involvement in the pharmacovigilance program in three developing countries, Yemen, Nepal and Malaysia. Method: An analysis was carried out for these three countries based on the current status of pharmacovigilance and involvement of consumers in their pharmacovigilance programs. Results: Malaysia has a good system for involving consumers in their national pharmacovigilance system, whereas Yemen still lacks the well-formed national drug policy. Lack of legislation and regulation which govern the import and distribution of drugs in Yemen is a limiting factor for development of consumer pharmacovigilance. Despite establishment of a pharmacovigilance centre, no reports have been released by the centre. The status of pharmacovigilance in Nepal is still in infancy. The regulatory body is assigned to be a national pharmacovigilance center, and coordinates with seven regional centers for pharmacovigilance activities. Nepal also lacks the involvement of consumers in the national pharmacovigilance program. Conclusion: Consumer reporting may be important for developing countries to implement a proper and effective pharmacovigilance program that can reduce morbidity and mortality rates, as well as reducing the economic burden of ADRs.
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Daulat, More Pankaj, Ambika Abhishake V. J., Prabhakar Singh, and Bhupendra Raj. "A prospective study of adverse drug reactions in a tertiary care teaching hospital." International Journal of Basic & Clinical Pharmacology 7, no. 10 (September 24, 2018): 1965. http://dx.doi.org/10.18203/2319-2003.ijbcp20183931.
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Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management.Methods: This was an observational and prospective study. ADR reports of 130 patients were collected of the inpatient department of various clinical departments of Sanjay Gandhi Memorial Hospital, Rewa, Madhya Pradesh (M.P.) The ADRs were collected during October 2014-September 2015, with ADR reporting form of Central Drugs Standard Control Organization (CDSCO), New Delhi. ADRs were assessed for their causality, severity, and preventability as per the standard scales. Data was analysed using descriptive statistics and expresses in percentages.Results: Overall occurrence of ADRs was slightly more in males (55%). Maximum (26%) suspected ADR reported during study period was skin rash. Skin (44%) was the most commonly affected organ system. Antimicrobials (68%) were the drug group most commonly involved in ADRs. Most of the suspected ADRs were probable in causality assessment, moderate in severity and probably preventable.Conclusions: The study results revealed opportunities for interventions in ADR management to ensure safer drug use.
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Bennett, C. L., C. Angelotta, A. J. Lurie, E. A. Lyons, P. R. Yarnold, and D. W. Raisch. "Complementary systems: Quality and timeliness of passive vs. active adverse event reporting and regulatory vs. peer-reviewed adverse drug reaction (ADR) dissemination." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 6062. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.6062.
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6062 Background: RADAR, a NIH funded R01 project, obtains reports of serious ADRs by conducting hypothesis-driven active surveillance efforts in hematology/oncology. The FDA and pharmaceutical sponsors conduct passive surveillance efforts based on review of reports voluntarily submitted by health care workers. Methods: Completeness and timeliness of ADR reports and dissemination efforts by RADAR versus the FDA/pharmaceutical sponsors were compared. Results: Individual reports were more complete in RADAR databases with fewer total reports (341 versus 1,341). Pharmaceutical sponsors disseminated ADR data 1 year (median) earlier as revised package inserts (PIs), but RADAR publications were more complete. Conclusion: Compared to pharmacovigilance efforts by the FDA/pharmaceutical suppliers, RADAR is more complete but less timely. [Table: see text] No significant financial relationships to disclose.
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Allela, Omer. "Explore Adverse Drug Reactions (ADRs) reporting by clinical and community pharmacists in Duhok, Kurdistan region- Iraq: hampered and perspective." Pharmacia 69, no. 4 (December 14, 2022): 1057–62. http://dx.doi.org/10.3897/pharmacia.69.e95691.
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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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F., Syed Hussain, Sathyanarayanan V., and Jamuna Rani R. "Analysis of adverse drug reactions encountered in a tertiary care hospital: a cross sectional study." International Journal of Basic & Clinical Pharmacology 7, no. 6 (May 22, 2018): 1164. http://dx.doi.org/10.18203/2319-2003.ijbcp20182100.
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Background: Adverse drug reactions are due to hazards of drug therapy and can occur with any class of drugs. The aim of this study was to evaluate and record adverse drug reactions reported from various departments of a tertiary care hospital.Methods: A Cross Sectional study conducted in a tertiary care hospital for a period of 4 months from March to June 2017 after Institutional Ethics Committee approval. ADRs reports collected and analyzed for causality, severity and preventability by international standardized scales.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%). Most commonly affected organ systems were skin (45%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). According to Naranjo’s causality assessment scale 74% of reactions were probable, 26% were possible, Modified Hartwig and Seigel severity assessment scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe, Modified Schumock and Thorton Preventability assessment scale which revealed 61% ADRs were not preventable, 32% were probably preventable,7% were definitively preventable.Conclusions: Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADR’s. The proper documentation and periodic reporting to Pharmacovigilance Centres is required to ensure drug safety.
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Koryanova, Ksenia N., Alexander V. Matveev, Elena A. Egorova, and Elvira Yu Bekirova. "Features of International and Regional Pharmacovigilance Systems." REGIONOLOGY 28, no. 3 (September 30, 2020): 571–97. http://dx.doi.org/10.15507/2413-1407.112.028.202003.571-597.
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Introduction. Ensuring the safety of medicines is the basis for the existence and functioning of any pharmacovigilance system as a type of activity aimed at obtaining and processing information about the undesirable consequences of the use of medicines. The objective of the paper is to identify the features of functioning of international and regional pharmacovigilance systems on the basis of the study conducted. Materials and Methods. To achieve the objective set, the authors have conducted a literature search and performed systemic analysis of the available publications and information presented on the websites of regulatory authorities in different countries. Comparative methods of analysis of the existing pharmacovigilance systems by the types of their organization and functioning in individual countries have been used with further analysis of the indicators of adverse drug reactions reporting. Results. The performed analysis of the peculiarities of functioning of pharmacovigilance systems has made it possible to identify several types of collecting information on adverse drug reactions (the centralized, decentralized, and mixed types), as well as to determine their strengths and weaknesses. It has been revealed that the maximum indicator of the average number of received spontaneous reports of adverse drug reactions per 1 million people a year was registered in countries practicing the centralized type of pharmacovigilance organization. Lower rates have been observed in countries using the decentralized or mixed pharmacovigilance systems. Discussion and Conclusion. The revealed features of the described approaches seem to be important for further improvement of the organization of work of the state system for monitoring the safety of medicines in the Russian Federation and the CIS countries. The use of the centralized type of organization of the pharmacovigilance system promotes active involvement of all actors involved in circulation of medicines, as well as helps to achieve a higher level of expert skills in assessing adverse drug reactions reporting, which contributes to the qualitative analysis of the information received and the timely adoption of regulatory decisions in order to improve safety of patients.
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Machado-Alba, Jorge Enrique, Anyi Liliana Jiménez-Morales, Yulieth Carolina Moran-Yela, Ilsa Yadira Parrado-Fajardo, and Luis Fernando Valladales-Restrepo. "Adverse drug reactions associated with the use of biological agents." PLOS ONE 15, no. 12 (December 18, 2020): e0240276. http://dx.doi.org/10.1371/journal.pone.0240276.
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Introduction Biological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs). Objective To identify the ADRs associated with the use of biological drugs in Colombia. Methods This was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified. Results In total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%). Conclusions The reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.
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van der Heijden, Peter G. M., Eug�ne P. van Puijenbroek, Stef van Buuren, and Jacques W. van der Hofstede. "On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios." Statistics in Medicine 21, no. 14 (2002): 2027–44. http://dx.doi.org/10.1002/sim.1157.
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Sharma, Vivekanand, Luiz Fernando Fracassi Gelin, and Indra Neil Sarkar. "Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach." Bioinformatics and Biology Insights 14 (January 2020): 117793222092135. http://dx.doi.org/10.1177/1177932220921350.
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The efficacy and safety of herbal supplements suffer from challenges due to non-uniform representation of ingredient terms within biomedical and observational health data sources. The nature of how supplement data are reported within Spontaneous Reporting Systems (SRS) can limit analyses of supplement-associated adverse events due to the use of incorrect nomenclature or failing to identify herbs. This study aimed to extract, standardize, and summarize supplement-relevant reports from two SRSs: (1) Food and Drug Administration Adverse Event Reporting System (FAERS) and (2) Canada Vigilance Adverse Reaction (CVAR) database. A thesaurus of plant names was developed and integrated with a mapping and normalization approach that accommodated misspellings and variants. The reports gathered from FAERS between the years 2004 and 2016 show 185,915 herbal and 7,235,330 non-herbal accounting for 2.51%. The data from CVAR found 36,940 reports of herbal and 503,580 non-herbal reports between the years 1965 and 2017 for a total of 6.83%. Although not all cases were actual adverse events due to numerous variables and incomplete reporting, it is interesting to note that the herbs most frequently reported and significantly associated with adverse events were as follows: Avena sativa (Oats), Cannabis sativa (marijuana), Digitalis purpurea (foxglove), Humulus lupulus (hops), Hypericum perforatum (St John’s Wort), Paullinia cupana (guarana), Phleum pretense (timothy-grass), Silybum marianum (milk thistle), Taraxacum officinale (Dandelion), and Valeriana officinalis (valerian). Using a scalable approach for mapping and resolution of herb names allowed data-driven exploration of potential adverse events from sources that have remained isolated in this specific area of research. The results from this study highlight several herb-associated safety issues providing motivation for subsequent in-depth analyses, including those that focus on the scope and severity of potential safety issues with supplement use.
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Shan, Wenya, Dongsheng Hong, Jieqiang Zhu, and Qingwei Zhao. "Assessment of the Potential Adverse Events Related to Ribavirin-Interferon Combination for Novel Coronavirus Therapy." Computational and Mathematical Methods in Medicine 2020 (September 24, 2020): 1–7. http://dx.doi.org/10.1155/2020/1391583.
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Purpose. We aimed to analyze and evaluate the safety signals of ribavirin-interferon combination through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS), so as to provide reference for the rationale use of these agents in the management of relevant toxicities emerging in patients with novel coronavirus pneumonia (COVID-19). Methods. Reports to the FAERS from 1 January 2004 to 8 March 2020 were analyzed. The proportion of report ratio (PRR), reporting odds ratio (ROR), and Bayesian confidence interval progressive neural network (BCPNN) method were used to detect the safety signals. Results. A total of 55 safety signals were detected from the top 250 adverse event reactions in 2200 reports, but 19 signals were not included in the drug labels. All the detected adverse event reactions were associated with 13 System Organ Classes (SOC), such as gastrointestinal, blood and lymph, hepatobiliary, endocrine, and various nervous systems. The most frequent adverse events were analyzed, and the results showed that females were more likely to suffer from anemia, vomiting, neutropenia, diarrhea, and insomnia. Conclusion. The ADE (adverse drug event) signal detection based on FAERS is helpful to clarify the potential adverse events related to ribavirin-interferon combination for novel coronavirus therapy; clinicians should pay attention to the adverse reactions of gastrointestinal and blood systems, closely monitor the fluctuations of the platelet count, and carry out necessary mental health interventions to avoid serious adverse events.