scholarly journals Gender Differences in Adverse Drug Reactions Among Adult Patients Reported to the Iraqi Pharmacovigilance Center

2021 ◽  
Vol 30 (2) ◽  
pp. 249-260
Author(s):  
Areej Atheer Alsaedi ◽  
Dheyaa j. Kadhim ◽  
Manal M. Younus
Keyword(s):  
Gender Differences ◽  
Adverse Drug Reactions ◽  
Subcutaneous Tissue ◽  
Fatal Outcome ◽  
Age Groups ◽  
Reproductive Age ◽  
Adult Males ◽  
Drug Reactions ◽  
Significant Difference ◽  
Pharmacovigilance Center

For many years it was argued that there may be a gender differences in adverse drug reactions (ADRs). This assumption was based on many possible factors such as hormonal or behavior differences, and it was not clearly identified since the female gender was not preferred to be enrolled in many clinical trials. The primary aim of this study was to assess the extent of possibly relevant gender differences in drug–ADRs regarding causality, severity, preventability, seriousness, expectedness and outcome. While the secondary aim was to assess for which group of drugs and for which ADRs gender differences are identified most often. The study was a retrospective one that depends on processing a specially selected group of data obtained from the Iraqi Pharmacovigilance Center database. The data included consisted of 3833 individual case safety reports sent during the period from 1st January 2017 to 31st December 2019. It was found that the reported adverse drug reactions for females (60.84 %) were much more than males (39.16 %). In addition, significant differences in age group distribution of adverse drug reactions were found in which females in their reproductive age had more adverse drug reactions while the older adult males were more likely to suffer adverse drug reactions if compared with the same age groups from the opposite gender. The highest type of adverse drug reactions for both genders were those that fall in the skin and subcutaneous tissue disorders (26.4 % in females) and (22.6 % in males) with statically significant difference between the two genders. While the highest group to cause adverse drug reactions was the systemic anti-infective agents with a greater chance ‘statistically significant’ in females to suffer a side effect from this group of medications (40.8 %) compared to male gender (35.5 %). The frequency of serious adverse drug reactions was significantly more prevalent in females (45.4 %) than for males (41.3 %) while the fatal outcome was significantly more observed in males (0.8 %) as compared with females (0.2 %). The expectedness analysis gave the finding that for each gender the expectedness of adverse drug reactions was nearly equal.

scholarly journals Adverse Drug Reactions and Their Impact on the Treatment of Pulmonary Tuberculosis

2021 ◽  
pp. 1-4
Author(s):  
Takahiro Kaki ◽  
◽  
Yoshiaki Minakata ◽  
Yoichi Nakanishi ◽  
Seigo Sasaki ◽  
...  
Keyword(s):  
Liver Injury ◽  
Pulmonary Tuberculosis ◽  
Elderly Patients ◽  
Adverse Drug Reactions ◽  
Age Groups ◽  
Tuberculosis Treatment ◽  
Drug Reactions ◽  
Medication Discontinuation ◽  
Significant Difference ◽  
The Difference

Background: Although there have been some reports about adverse drug reactions (ADRs) in pulmonary tuberculosis treatment, there are few detailed data and the effect of age among elderly patients on ADRs and the period of medication discontinuation due to ADRs is unknown. Purpose: We evaluated the difference in the incidence of ADRs necessitating discontinuation or a change of medication (dADR) among the different age groups and the period of discontinuation in elderly patients undergoing pulmonary tuberculosis treatment. Subjects and Methods: We conducted a retrospective medical record survey of patients who started anti-tuberculosis medication at our hospital from April 1st, 2018 to March 31st, 2020. Results: A total of 120 patients were recruited. There was no significant difference in the incidence of dADR among the different age groups every 10 years in patients ≥50 years of age (p=0.78). The median period of discontinuation was approximately 4 weeks for fever (29.5 days), approximately 3 weeks for rash (18.5 days), approximately 2 weeks for gastrointestinal disorders (16 days), and hepatocellular liver injury (15.5 days), and approximately 1 week for cholestatic liver injury (8 days) and eosinophilia (7 days). Conclusion: The incidence of dADR was not different among the age groups when patients of ≥50 years of age were compared by age. The median times of onset were 1–3 weeks after the start of treatment. The median periods of discontinuation were 1–4 weeks, and the period of discontinuation due to allergic reactions tended to be the longest

scholarly journals Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

2020 ◽  
Vol 29 (2) ◽  
pp. 17-26
Author(s):  
Ahmed M. Hameed ◽  
Dheyaa J. Kadhim ◽  
Manal M. Younus
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Individual Case ◽  
Gastrointestinal Disorders ◽  
Drug Reactions ◽  
Individual Case Safety Report ◽  
Safety Report ◽  
Pharmacovigilance Center

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

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

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

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

Spontaneous reporting of adverse drug reactions at a department of Internal Medicine

Open Medicine ◽  
2010 ◽  
Vol 5 (3) ◽  
pp. 338-346 ◽  
Author(s):  
Zorica Jovic ◽  
Vidojko Djordjevic ◽  
Milovanovic Milena ◽  
Karin Vasic
Keyword(s):  
Adverse Drug Reactions ◽  
Age Groups ◽  
Additional Treatment ◽  
Predisposing Factors ◽  
University Teaching ◽  
Drug Reactions ◽  
Clinical Center ◽  
Significant Difference ◽  
Set Up ◽  
The Individual

AbstractThe aim of the present study was to characterize the pattern of adverse drug reactions (ADRs) reported in a university teaching hospital in south-east Serbia. The study was conducted based on ADRs reported during a six-month period to the ADR reporting unit of the university clinical center. Evaluation of data was done for various parameters, such as patient demographics, drug and reaction characteristics, and outcome of reactions. Assessment was also done for causality, severity and predisposing factors. During the 6-month study period, 44 ADRs were reported, with an overall incidence of 0.33%. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly (43.2%) and older (25%) adults was significantly higher than in other age groups. Type A reactions (66.7%) accounted for majority of the reports. The most commonly affected organ system was the renal system, (22.7%) with hyperkalemia as the only reported reaction. ACE inhibitors (48.6%) were the drug class most commonly involved, where fosinopril (25.7%) was the individual drug most frequently reported. Additional treatment was pursued for management of ADRs in majority (52.3%) of the reports. In 52.3 % of the reports, the patient had recovered from the reaction by the time of evaluation. Upon causality assessment, the majority of the reports were rated as probable (43.2%). Mild and moderate reactions accounted for 43.2% and 54.6%, respectively. In 36.3% of the reports, the reaction was considered to be preventable. The most common predisposing factors were polypharmacy and multiple disease state. The pattern of ADRs reported in our hospital is comparable to the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for intervention to ensure safer drug use.

Pharmacovigilence practice for safety of medication system in India

2018 ◽  
Vol 7 (2) ◽  
pp. 216-221
Author(s):  
Shobharam Sahu ◽  
◽  
Poonam Rishishwar ◽  
Chhaya Rathod ◽  
◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
India Institute ◽  
Family Welfare ◽  
New Delhi ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Ministry Of Health ◽  
Regulatory Authorities ◽  
Pharmacovigilance Center ◽  
Uppsala Monitoring

Pharmacovigilance is very essential tool to ensure the safety of drug. It provides safety to patients in case of medication. Activity of pharmacovigilance is coordinates by National pharmacovigilance center in collaboration with international regulatory authorities (WHO, The Uppsala Monitoring center). Under the aegis of Ministry of Health & Family Welfare, Government of India, the Central Drugs Standard Control Organisation (CDSCO), New Delhi, has initiated a nation-wide pharmacovigilance programme, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR)

scholarly journals Common Causes and Characteristics of Adverse Drug Reactions in Older Adults: A Retrospective Study

2020 ◽  
Author(s):  
Seong-Dae Woo ◽  
Jiwon Yoon ◽  
Go-Eun Doo ◽  
Youjin Park ◽  
Youngsoo Lee ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Younger Patients ◽  
Iodinated Contrast ◽  
Common Causes ◽  
Aging Populations ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs ◽  
Rate Ratios

Abstract Background: Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (<65 years). Methods: Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1,000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults. Results: In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21-1.44; P <0.001) and fentanyl (1.49, 1.16-1.92, P =0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30-0.40, P <0.001) and iodinated contrast media (ICM) (0.82, 0.76-0.89, P <0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48-3.15; P <0.001) and ICM (2.09, 1.36-3.21, P= 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P =0.019). Conclusion: For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

scholarly journals Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

2012 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Durga Bista ◽  
Bal Ram Shrestha ◽  
Prakash Rai ◽  
Akhilesh Chandra Jauhari ◽  
Vishnu Kant Kulshrestha
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Causality Assessment ◽  
Age Group ◽  
Drug Reactions ◽  
Preliminary Stage ◽  
Medical College ◽  
Probable Relationship ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

scholarly journals Incidence and Predictors of Adverse Drug Reactions Caused by Drug-Drug Interactions in Elderly Outpatients: A Prospective Cohort Study

2012 ◽  
Vol 15 (2) ◽  
pp. 332 ◽  
Author(s):  
Paulo Roque Obreli-Neto ◽  
Alessandro Nobili ◽  
Divaldo Pereira De Lyra Júnior ◽  
Diogo Pilger ◽  
Camilo Molino Guidoni ◽  
...  
Keyword(s):  
Cohort Study ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Primary Objective ◽  
Public Healthcare ◽  
Drug Reactions ◽  
Elderly Outpatients ◽  
Significant Difference

Purpose. The primary objective of this study was to investigate the incidence of drug-drug interactions (DDIs) related to adverse drug reactions (ADRs) in elderly outpatients who attended public primary healthcare units in a southeastern region of Brazil. The secondary objective was to investigate the possible predictors of DDI-related ADRs. Methods. A prospective cohort study was conducted between November 1, 2010, and November 31, 2011, in the primary public healthcare system in the Ourinhos micro-region in Brazil. Patients who were at least 60 years old, with at least one potential DDI, were eligible for inclusion in the study. Eligible patients were assessed by clinical pharmacists for DDI-related ADRs for 4 months. The causality of DDI-related ADRs was assessed independently by four clinicians using three decisional algorithms. The incidence of DDI-related ADRs during the study period was calculated. Logistic regression analysis was used to study DDI-related ADR predictors. Results. A total of 433 patients completed the study. The incidence of DDI-related ADRs was 6.5%. A multivariate analysis indicated that the adjusted odds ratios (ORs) rose from 0.91 (95% confidence interval [CI] = 0.75-1.12, p = 0.06) in patients aged 65-69 years to 4.40 (95% CI = 3.00-6.12, p < 0.01) in patients aged 80 years or older. Patients who presented two to three diagnosed diseases presented lower adjusted ORs (OR = 0.93 [95% CI = 0.68-1.18, p = 0.08]) than patients who presented six or more diseases (OR = 1.12 [95% CI = 1.02-2.01, p < 0.01]). Elderly patients who took five or more drugs had a significantly higher risk of DDI-related ADRs (OR = 2.72 [95% CI = 1.92-3.12, p < 0.01]) than patients who took three to four drugs (OR = 0.93 [95% CI = 0.74-1.11, p = 0.06]). No significant difference was found with regard to sex (OR = 1.08 [95% CI 0.48-2.02, p = 0.44]). Conclusion. The incidence of DDI-related ADRs in elderly outpatients was significant, and most of the events presented important clinical consequences. Because clinicians still have difficulty managing this problem, highlighting the factors that increase the risk of DDI-related ADRs is essential. Polypharmacy was found to be a significant predictor of DDI-related ADRs in our sample. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center

Therapies ◽  
2014 ◽  
Vol 69 (5) ◽  
pp. 395-400 ◽  
Author(s):  
Delphine Abadie ◽  
Leyla Chebane ◽  
Max Bert ◽  
Geneviève Durrieu ◽  
Jean-Louis Montastruc
Keyword(s):  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Pharmacovigilance Center

Incidence of adverse drug reactions induced by N-acetylcysteine in patients with acetaminophen overdose

2010 ◽  
Vol 29 (3) ◽  
pp. 153-160 ◽  
Author(s):  
Sa'ed H Zyoud ◽  
Rahmat Awang ◽  
Syed Azhar Syed Sulaiman ◽  
Waleed M Sweileh ◽  
Samah W Al-jabi
Keyword(s):  
Adverse Drug Reactions ◽  
Univariate Analysis ◽  
Drug Reactions ◽  
Chi Square ◽  
Exact Test ◽  
Acetaminophen Overdose ◽  
Significant Difference ◽  
Chi Square Test ◽  
Comparative Results ◽  
Student’S T

Background: Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay. Objective: the aim of this study was to investigate the type and incidence of ADR induced by IV-NAC in patients treated for acetaminophen overdose. Methods: This is a retrospective study of patients admitted to the hospital for acute acetaminophen overdose over a period of 4 years (1 January 2005 to 31 December 2008). The primary outcome of interest in this study was the occurrence of ADR during NAC administration. Pearson chi-square test or Fisher’s exact test, student’s t test, and Mann-Whitney U test were used in univariate analysis. SPSS 15 was used for data analysis. Results: Two hundred and fifty five patients were studied. Different types of ADR were observed in 119 (46.7%) cases. Of those patients, 83 (69.7%) had been treated with IV-NAC versus 36 (30.3%) who had not (p < .001). The following ADR were significantly associated with IV-NAC administration: vomiting (p = .001), flushing (p < .001), rash (p < .001), pruritus (p < .001), chest pain (p = .001), bronchospasm (p = .03), coughing (p = .01), headache (p = .001), dizziness (p < .001), convulsion (p = .03), and hypotension (p = .001). ADR were mild in 54 (43.2%), moderate in 17 (13.6%), and severe in 12 (9.6%) patients. There were no ADR in 42 (33.6%) patients. Comparative results of the characteristics of patients who reacted to IV-NAC and nonreactors showed that patients with ADR had no significant difference in age, gender, ethnicity, amount ingested, latency time, and acetaminophen level than nonreactors. Conclusion: ADR to IV-NAC were common among patients with acetaminophen overdose, but mostly minor and all reported adverse reactions were easily managed.

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