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 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.

The Incidence and Nature of Adverse Reactions during Intravenous Acetylcysteine Therapy for Acetaminophen Overdose

2000 ◽  
Vol 16 (2) ◽  
pp. 47-49 ◽  
Author(s):  
Matitiahu Lifshitz ◽  
Perez Kornmehl ◽  
Haim Reuveni
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Medical Center ◽  
Clinical Manifestations ◽  
Cost Benefit ◽  
Maculopapular Rash ◽  
Oral Formulation ◽  
Drug Reactions ◽  
Acetaminophen Overdose ◽  
History Of

Objective: To determine the incidence of adverse drug reactions in patients with acetaminophen overdose following administration of intravenous acetylcysteine, and to evaluate the cost-benefit ratio of intravenous compared with oral acetylcysteine therapy. Methods: The incidence of adverse drug reactions to intravenous acetylcysteine therapy was studied retrospectively in all patients with acetaminophen overdose who were admitted to Soroka University Medical Center, Beer-Sheva, Israel, from 1994 to 1998. Data were obtained from hospital records. All patients were treated with a 20-hour intravenous regimen according to the Prescott protocol. Special attention was paid to the clinical manifestations of adverse reactions, time of onset, and history of patient allergy and asthma. Cost of therapy (drug prices, hospital per diems) for intravenous versus oral acetylcysteine administration was evaluated in accordance with average rates prevailing in Israel in December 1998. Results: Ninety-two patients, 32 adolescents aged 12–18 years (mean ± SD 14.2 ± 1.9) and 60 adults aged 18–52 years (28.2 ± 3.2), were treated with intravenous acetylcysteine for acetaminophen overdose during the study period. Three patients (3.2%) developed adverse reactions: one adult presented with a maculopapular rash and pruritus, and two adolescents developed mild urticaria; no other adverse reactions were reported. All adverse reactions occurred during administration of the loading dose, 15–20 minutes after initiation of therapy. The reactions subsided a few hours after the acetylcysteine infusion was stopped and did not require antiallergy therapy. None of the three patients had a history of allergy. The 20-hour intravenous acetylcysteine protocol is approximately three times less expensive than the recommended oral regimen in terms of drug cost and length of hospitalization. Conclusions: Intravenous acetylcysteine is a relatively safe antidote for acetaminophen poisoning. The incidence rate of adverse reactions is low, and they are mild and easily controlled by termination of the infusion. We recommend intravenous acetylcysteine therapy, particularly for patients with vomiting caused by the acetaminophen overdose or by oral acetylcysteine therapy. The 20-hour intravenous acetylcysteine therapy has a cost-benefit advantage over oral therapy; however, the oral formulation is not approved by the FDA.

Polypragmasy: A clinical pharmacologist’s view

2016 ◽  
Vol 88 (12) ◽  
pp. 94-102 ◽  
Author(s):  
D A Sychev ◽  
V A Otdelеnov ◽  
N M Krasnova ◽  
E S Ilyina
Keyword(s):  
Adverse Drug Reactions ◽  
Public Health Problem ◽  
Modern World ◽  
Drug Reactions ◽  
Treatment Standards ◽  
Level Of Evidence ◽  
Medical Associations ◽  
Start Criteria ◽  
High Level ◽  
Multiple Drugs

In the modern world, there is a rapid advance in the design and clinical introduction of a huge number of drugs that are able to cure a patient or to improve his/her health status on the one hand and to cause significant harm to his/her health on the other. Polypragmasy is the desire to enhance the efficiency of treatment and to help the patient recover from all developed diseases inevitably leads to the use of a large number of medications. At the present time, polypragmasy as a result of iatrogenia is a serious public health problem, as it is clinically manifested by a reduction in the effectiveness of pharmacotherapy, by the development of severe adverse drug reactions, and by a considerable increase in healthcare expenditures. The reason for the simultaneous prescription of multiple drugs may be comorbidity (multimorbidity), the availability of drugs, as well as clinical guidelines, manuals of professional medical associations, treatment standards that contain recommendations for using combination therapy with more than 5 drugs for only one disease in some cases, the efficiency of which corresponds to a high level of evidence. Currently, the fight against polypragmasy is one of the important tasks in rendering medical care to elderly and senile patients since it is a major risk factor of adverse drug reactions in this category of people. To minimize polypragmasy in elderly patients, it is necessary to use current methods for analyzing each prescription of a drug (the index of rational drug prescribing; an anticholinergic burden scale) and those for optimizing pharmacotherapy with the use of restrictive lists (Beers criteria, STOPP/START criteria) that will be able to reduce the number of errors in the administration of drugs and to maximize the efficiency and safety of pharmacotherapy.

Antidepressant-Induced Adverse Reactions in a Patient with Hemorrhagic Stroke

2005 ◽  
Vol 39 (10) ◽  
pp. 1755-1757 ◽  
Author(s):  
Zoran Bogdanovic ◽  
Jhansi R Nalamati ◽  
John K Kilcullen ◽  
Sunil Dhuper
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Hemorrhagic Stroke ◽  
Hormone Secretion ◽  
Drug Reactions ◽  
Inappropriate Antidiuretic Hormone Secretion ◽  
Number Of Patients ◽  
Close Supervision ◽  
Post Stroke Depression ◽  
History Of

Objective: To report a case of antidepressant-induced adverse drug reactions in a patient with hemorrhagic stroke. Case Summary: A 56-year-old man developed life-threatening adverse reactions after fluoxetine was added to his previously prescribed regimen of buspirone and olanzapine. One week after starting fluoxetine 60 mg/day, the patient developed syndrome of inappropriate antidiuretic hormone secretion and serotonin syndrome concurrently. The patient had experienced a hemorrhagic stroke before the adverse drug reactions occurred. DISCUSSION: A patient with a history of hemorrhagic stroke developed serious adverse drug reactions when fluoxetine was added to his drug therapy. When the combination therapy was stopped, all adverse effects gradually disappeared and laboratory abnormalities were corrected. The likelihood that the adverse reactions were caused by fluoxetine is probable according to the Naranjo probability scale. In addition, a history of stroke may be a risk factor for the development of such reactions. CONCLUSIONS: Today, patients with depression after experiencing a stroke are treated more effectively, but antidepressant-induced adverse drug reactions may be serious. A growing number of patients are treated for post-stroke depression; they require close supervision and careful dosing of antidepressants to prevent full-blown adverse reactions from occurring.

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

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

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

scholarly journals The Wonderful DMARD with Multiple Toxicities

2021 ◽  
Vol 5 (7) ◽  
pp. RV5-RV10
Author(s):  
Yashika Kaushal ◽  
Ratibha Kausal ◽  
Isha Sharma
Keyword(s):  
Immune System ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Close Monitoring ◽  
Drug Reactions ◽  
Therapy Discontinuation ◽  
Chemotherapy Agent ◽  
Reduce Activity ◽  
Potential Risk Factors ◽  
Rheumatic Drug

Methotrexate is a type of disease-modifying anti-rheumatic drug (DMARD). It is used to reduce activity of the immune system for people who have certain conditions. Methotrexate is a chemotherapy agent and immune system suppressant. Its use may be limited by concerns regarding its adverse reactions. The occurrence of adverse drug reactions in some cases leads to the therapy discontinuation. Although adverse drug reactions (ADR) of methotrexate generally do not pose a serious threat to the health of patients and a reduction in the dose of methotrexate leads to their elimination, in some cases severe toxicities of the drug occur unpredictably. These facts explain the need for close monitoring of the patient’s condition and the identification of potential risk factors for drug toxicity on the part of different organs and functional systems. The purpose of this review is to detail about safety and tolerability of methotrexate.

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

scholarly journals A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of MDR-TB at tertiary care hospital

2018 ◽  
Vol 7 (7) ◽  
pp. 1291
Author(s):  
Mirza Shiraz Baig ◽  
Monali Raghunath Kale ◽  
Avinash Lamb
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Public Health Problem ◽  
Treatment Withdrawal ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Mdr Tb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

Cutaneous reactions to drugs

2020 ◽  
pp. 5752-5760
Author(s):  
Sarah Walsh ◽  
Daniel Creamer ◽  
Haur Yueh Lee
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Normal Function ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Drug Induced ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Iatrogenic Illness ◽  
Systemic Symptoms

Adverse reactions to medications are common and important cause of iatrogenic illness. Severe cutaneous adverse drug reactions include toxic epidermal necrolysis, Stevens–Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, which together constitute 2% of all adverse drug reactions and may be life-threatening. Less severe drug-induced skin reactions such as exanthems, urticaria, lichenoid drug rashes, and fixed drug eruptions are more common, sometimes termed benign cutaneous adverse reactions, and generally resolve without sequelae. Drugs may also cause adverse events due to alteration of the normal function of the skin or its appendages. This may take the form of photosensitivity, abnormal pigmentation, or disrupted growth of hair or nails.

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