scholarly journals Spontaneous Adverse Drug Reaction Reporting in China: An Analysis of Reports Made to the Spontaneous Reporting System of Henan Province From 2016 to 2020

2021 ◽  
Author(s):  
Ziqi Yan ◽  
Zhanchun Feng ◽  
Zhiming Jiao ◽  
Chaoyi Chen ◽  
Ganyi Wang ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Reactions ◽  
Adverse Drug Reaction Reporting ◽  
Public Health Problem ◽  
Factors Affecting ◽  
Medical Institutions ◽  
History Of ◽  
Multiple Drugs ◽  
Different Levels

Abstract Introduction: Adverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. Objective: This study has analyzed the factors leading to the occurrence of SADRs, determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. Methods: We used descriptive analysis and chi-square test analysis the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. Result: A total of 387 642 people’s 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. Conclusions: The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories , and use imported drugs and biological agents with caution to ensured the safety and health of patients.

scholarly journals The severity of adverse drug reactions and their influencing factors based on the ADR monitoring center of Henan Province

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ziqi Yan ◽  
Zhanchun Feng ◽  
Zhiming Jiao ◽  
Chaoyi Chen ◽  
Ganyi Wang ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Public Health Problem ◽  
Drug Reactions ◽  
Factors Affecting ◽  
Medical Institutions ◽  
History Of ◽  
Monitoring Center ◽  
Multiple Drugs ◽  
Different Levels

AbstractAdverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. This study has analyzed the factors leading to the occurrence of serious ADRs (SADRs), determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. We used descriptive analysis and chi-square test to analyze the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. A total of 387 642 people’s 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories, and use imported drugs and biological agents with caution to ensure the safety and health of patients.

scholarly journals COMPARISON OF PHARMACISTS PROFESSIONAL ACTIVITY OF UKRAINIAN PHARMACY ON PROVISION OF INFORMATION ON ADVERSE REACTIONS OF PHARMACEUTICAL PRODUCTS

2020 ◽  
Vol 5 ◽  
pp. 92-98
Author(s):  
Oksana Mishchenko ◽  
Vasiliy Ostashko ◽  
Iuliia Greshko
Keyword(s):  
Higher Education ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Reactions ◽  
Adverse Drug Reaction Reporting ◽  
Postgraduate Education ◽  
Pharmaceutical Products ◽  
Professional Activity ◽  
Ratio Test ◽  
Reaction Reporting

The aim of the research is the comparison of professional activity of pharmacists of pharmaceutical institution in Ukraine with different education level in relation to their responsibilities in detection and prevention of adverse reactions (AR) or lack of efficacy of pharmaceutical products (PP), set out in the regulatory documentation on this matter. Materials and methods. The questionnaire was developed and used for pharmacists of pharmaceutical institution, taken training on cycles of postgraduate education during 2016–2018. 70 higher education pharmacists (HEPs) and 80 specialized secondary education pharmacists (SSEP) were inquired. The integrity was evaluated by Fisher's ratio test (F). For convenience of calculation the corresponding functions of MS Excel were used. Results. The majority of SSEPs and HEPs of Ukrainian pharmaceutical institutions are aware of their duty to provide information on AR or lack of efficacy of pharmaceutical products to the Department of Post-authorization Supervision of the State Expert Center of the Ministry of Health of Ukraine and are aware of the regulatory legal documentation on this issue, however they are not active enough to take necessary action filling in the “Adverse drug reaction reporting form” and sending it to the national department. One of the reasons for the underactivity of pharmacy workers, irrespective of their level of education, is the low organization of this process in pharmacy institutions, in particular the absence of the “Adverse drug reaction reporting forms”. Conclusion. Higher education pharmacist are more self-acting in completing “Adverse drug reaction reporting forms” and are less likely to shift their responsibilities to the pharmacy manager. It is critical to resolve the issue on enhancement of efficiency of detecting AR and/or lack of efficacy of PP in pharmacy institutions of Ukraine is to improve the quality of organizational work of pharmacy managers.

scholarly journals ANALYSIS OF ADVERSE DRUG REACTION REPORT FORMS ON THE MEDICINES, USED FOR AIDS TREATMENT (REGISTERED IN THE REPUBLIC OF CRIMEA IN THE PERIOD FROM 2011 TO 2016)

2019 ◽  
Vol 6 (6) ◽  
pp. 568-583
Author(s):  
A. V. Matveev ◽  
A. Е. Krasheninnikov ◽  
E. A. Egorova ◽  
E. I. Konyaeva
Keyword(s):  
Quality Of Life ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Reactions ◽  
Clinical Manifestations ◽  
Public Health Problem ◽  
World Health ◽  
The Republic

According to the data of the World Health Organization (WHO), human immunodeficiency virus (HIV) remains a major global public health problem.The mainmethod of treating HIV is using highly active antiretroviral therapy (HAART), which is the use of multiple medicines acting on different viral targets. The timely onset of HAART can suppress the replication of the virus in the human body and helps to strengthen its immune system and restore its ability to fight infections. At the same time, the choice of medicines to improve the quality of life and patients’ compliance during antiretroviral therapy should be based on their effectiveness and safety. The aim of this research was to analyze and study the adverse reactions that occur in patients with HIV living in the territory of the Republic of Crimea, when using HAART.Materials and methods.The objects of research were 274 report cards about the adverse reactions, registered in the regional base (registry) of spontaneous messages called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2011 to 2016.Results.The results of the study showed that the most often adverse reactions were observed when using medicines of the group of Nucleoside Reverse Transcriptase Inhibitors (NRTI). This is explained by the inclusion of NRTI medicines as the main medicine in the method of HAART. Efavirenz (EFV) and Nevirapine (NVP) were absolute leaders among these groups of antiretroviral medicines. Among the combined antiviral medicines active against HIV, the most frequently adverse reactions were associated with the use of a combination of Lamivudine (3TC) and Zidovudine (ZDV). The main clinical manifestations of adverse reactions in the use of combination medicines for treating HIV were a decrease in the level of hemoglobin and the development of anemia. At the same time, in 85% of cases, the patients needed medication in order to correct the resulting adverse drug reaction (ADR). The combination of antiretroviral therapy has often been associated with the development of serious ADR. In case of monotherapy, the main clinical manifestations of adverse reactions were disorders of the central nervous system (dizziness, hallucinations, sleep disorders) and allergic reactions of varying severity (including 1 case of angioedema to “Eferven” (Efavirenz (EFV)),600 mg). Hereby, in almost half of the cases, the usage of antiretroviral medicines of the NRTI group and protease inhibitors caused the development of serious side effects. This confirms the necessity to study and analyze adverse reactions in order to increase the safety of patients’ pharmacotherapy and improve their quality of life.Conclusion.The study of adverse reactions to the medicines used for treatment of HIV is of a paramount importance in improving the safety and compliance of HIV patients to lifelong pharmacotherapy.

Reliability Factors in Adverse Drug Reaction Reporting

1981 ◽  
Vol 20 (03) ◽  
pp. 157-162 ◽  
Author(s):  
R. L. Marlin
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Reactions ◽  
Adverse Drug Reaction Reporting ◽  
Pharmaceutical Preparations ◽  
Primary Concern ◽  
Orientation Programs ◽  
Valid Data ◽  
Uniform Manner ◽  
Collection Program

In the process of utilizing marketed pharmaceutical preparations, a primary concern of researchers, physicians, industry and government agencies is the occurrence of adverse reactions.The purpose of this research was to devise and test a method of evaluating the FDA’s voluntary system for collection of adverse reactions that occur during hospitalization, as a form of communicating valid data. The Federal Government generates data and as such becomes an originator of instructions, specifications/ directives for job and/or projects within its bureaucratic structure. These descriptions (»Guidelines«) of responsibilities regulate the activities of all systems.The objectives of this study were to determine whether the guidelines established by the issuing agency (FDA) were interpreted in a uniform manner with those individuals who generate the data (hospital coordinators) and to determine if factors external to the system affect the reporting.Three phases were employed:1. Review of data in a baseline year,2. A survey questionnaire to all hospital coordinators and FDA personnel involved in the system,3. Interviews with a conveniently selected sample of coordinators.The findings showed that the guidelines were interpreted differently by the coordinators and the FDA personnel. The study also demonstrated that the external factors such as legality, »defensive medicine«, various definitions of the term »adverse drug reaction«, individual bias and FDA feedback all affect participation in the program. It is also affected by the poorly coordinated education and orientation programs of the FDA and attitudes affecting patient care.Detailed instructions to participants on the procedures, purposes and goals of a collection program, with communication feedback to and from the agency and the generators, are important facts in maintaining voluntary participation.

Impact of Preexisting Health Conditions on the Outcome of an Adverse Drug Reaction Alerting Program: Gastrointestinal Disorders Before Piroxicam and Sulindac Therapy

1995 ◽  
Vol 29 (7-8) ◽  
pp. 676-680 ◽  
Author(s):  
Nigel SB Rawson
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Reactions ◽  
Peptic Ulceration ◽  
Health Conditions ◽  
Recent History ◽  
Physician Services ◽  
History Of ◽  
Healthcare Insurance ◽  
The Impact

Objective: To assess the impact of data concerning preexisting serious gastrointestinal (GI) disorders before piroxicam and sulindac therapy in an acute adverse drug reaction alerting program. Design: Cohort study. Setting: Saskatchewan province's prescription drug and healthcare insurance system covering a population of approximately 1 million. Participants: The first 20 000 new patients who were dispensed piroxicam in 1982 and the first 20 000 patients who were dispensed sulindac in 1979-1981 through the Saskatchewan drug plan. Main Outcome Measures: Physician services and hospitalizations with a diagnosis of peptic ulceration or GI hemorrhage within 30 days of the first piroxicam or sulindac prescription. Results: Rates of physician services for peptic ulceration or GI hemorrhage in the 30 days after starting piroxicam or sulindac therapy for patients who had services or hospitalizations for serious stomach or duodenum disorders in the 90 days before their prescriptions were significantly greater than the corresponding rates for patients without a recent history of these conditions (piroxicam: odds ratio [OR] = 7.89; 95% confidence interval [CI] =5.71 to 10.91; p> 0.001; sulindac: OR = 24.08; 95% CI = 18.99 to 30.54; p < 0.001). Also, the rate of hospitalizations for peptic ulceration or GI hemorrhage in the 30 days after starting sulindac therapy for patients who had services for the conditions in the previous 90 days was significantly greater than the rate for patients who did not (OR = 10.91; 95% CI = 5.70 to 20.87; p> 0.001). Conclusions: Rates of serious GI disorders in patients taking piroxicam and sulindac with a recent history of such disorders were larger than those in the other patients. However, because the proportion of individuals with recent serious GI disorders is small, these differences are lost in an overall assessment of patients taking these drugs. Data regarding preexisting health conditions are essential in adverse drug reaction alerting programs and, indeed, in all evaluations of adverse reactions.

Knowledge, Attitudes, and Practice of Hospital Pharmacists Regarding Pharmacovigilance and Adverse Drug Reaction Reporting in Japan

2019 ◽  
pp. 001857871985145
Author(s):  
Tomonori Kobayashi ◽  
Aoi Noda ◽  
Taku Obara ◽  
Masami Tsuchiya ◽  
Kazutoshi Akasaka ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Reporting System ◽  
Outcome Measure ◽  
Response Rate ◽  
Adverse Drug Reaction Reporting ◽  
Personal History ◽  
Hospital Pharmacists ◽  
Adr Reporting ◽  
History Of

Background: The importance of pharmacovigilance in Japan is gradually being recognized. However, Japanese pharmacists’ knowledge of and perspectives on pharmacovigilance have been examined only in some areas of Japan. Objective: The objective of this study was to clarify the knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting among hospital pharmacists in Japan. Setting: A questionnaire survey among Japanese hospital pharmacists. Method: The questionnaire was distributed to 48 028 pharmacists during a 3-month period between January and March 2017. Main Outcome Measure: The prevalence of hospital pharmacists who understood pharmacovigilance and the ADR reporting system. Results: Of the respondents (response rate; 9.9% = 4760/48 028), 21.9% were <30 years of age, 27.3% were ≥50 years of age, and 46.7% were women. In response to the question “Have you ever heard of the term ‘pharmacovigilance’?,” 12.4%, 33.8%, and 47.4% answered “I understand what it is,” “I have heard of it, but I do not understand what it is,” and “I do not know what it is,” respectively. Pharmacists who understood the term “pharmacovigilance” were also more frequently acquainted with its associated terms and actions. And, 69.7% of respondents wished to acquire more information on pharmacovigilance and 50.9% did not have a personal history of ADR reporting. The most common reason for ADR nonreporting was “It was a well-known adverse drug reaction” (44.5%). Conclusions: Our results suggest that more aggressive promotion of pharmacovigilance and of the ADR reporting system among Japanese pharmacists is needed.

scholarly journals Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Zuzaan Zulzaga ◽  
Erdenetuya Myagmarsuren ◽  
Herman J. Woerdenbag ◽  
Eugene P. van Puijenbroek
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Safety ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Safety Data ◽  
Regulatory System ◽  
Basic Structure ◽  
Reaction Reporting ◽  
Adr Reporting

AbstractMonitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.

scholarly journals A Qualitative Evaluation of Adverse Drug Reaction Reporting System in Pakistan: Findings from the Nurses’ Perspective

2020 ◽  
Vol 17 (9) ◽  
pp. 3039
Author(s):  
Rabia Hussain ◽  
Mohamed Azmi Hassali ◽  
Anees ur Rehman ◽  
Jaya Muneswarao ◽  
Muhammad Atif ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Healthcare Professionals ◽  
Reporting System ◽  
Adverse Drug Reaction Reporting ◽  
Qualitative Interviews ◽  
Qualitative Evaluation ◽  
Adr Reporting ◽  
Willingness To Report ◽  
And Training

The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient’s response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.

NATIONAL ADVERSE DRUG REACTION REPORTING???A SILVER JUBILEE

1989 ◽  
Vol 138 (1) ◽  
pp. 516-519 ◽  
Author(s):  
Michael D Rawlins ◽  
Alasdair M Breckenridge ◽  
Susan M Wood
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reaction Reporting ◽  
Reaction Reporting
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