scholarly journals Analysis of adverse drug reactions reported to national pharmacovigilance center of Bhutan

2020 ◽  
Vol 6 (2) ◽  
pp. 1-5
Author(s):  
Pelden Chejor ◽  
Jigme Tenzin ◽  
Tsheten Tsheten ◽  
Jigme Dorji ◽  
Kinga Jamphel
Keyword(s):  
Adverse Drug Reactions ◽  
Monitoring Program ◽  
The Elderly ◽  
Drug Reactions ◽  
Permanent Disability ◽  
Safety Issues ◽  
Drug Regulatory Authority ◽  
Pharmacovigilance Center ◽  
Drug Safety Monitoring ◽  
System Disorder

Introduction: Medicines prescribed for diseases often causes adverse drug reactions in patients ranging from mere inconvenience to permanent disability and death. This is because, most of the adverse drug reactions especially the serious and latent ones may not have occurred during the clinical trials and vulnerable populations like children, pregnant women and the elderly are not all included in clinical trial studies considering the ethical and safety issues. Objectives: To study the demographic characteristics, types of adverse drug reactions and common drugs causing these reactions from the adverse drug reaction reports received by the national pharmacovigilance of Bhutan. Methods: A total of 222 adverse drug reactions were received at the national pharmacovigilance center from January 2016 to May 2018 were analyzed retrospectively. The Drug Regulatory Authority is the national pharmacovigilance center of Bhutan and is a member to the International Drug Monitoring Program since 2014. Results: 73% of adverse drug reactions occurred in adults while 13.5% occurred each in children and elderly. 48.7% of the total adverse drug reactions reports were caused by antibiotics out of which penicillin was the most common causal drug (32.4%). The most commonly reported adverse drug reactions was rashes (36.5%) followed by gastro-intestinal system disorder (14.9%). Conclusions: Antibiotics are common causal drugs for adverse drug reactions. All categories of health professional must be encouraged to report adverse drug reactions. Active surveillance for drug safety monitoring especially for those of patients who are on antibiotics is recommended.  

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.

Assessing risk of adverse drug reactions in the elderly: a feasibility study

2019 ◽  
Vol 41 (6) ◽  
pp. 1483-1490 ◽  
Author(s):  
Andrew Ridge ◽  
Kate Macintyre ◽  
Alex Kitsos ◽  
Linda Murray ◽  
Luke Bereznicki
Keyword(s):  
Adverse Drug Reactions ◽  
Feasibility Study ◽  
The Elderly ◽  
Drug Reactions

scholarly journals Study of adverse drug reactions and clinical profile of elderly in relation to polypharmacy

2019 ◽  
Vol 10 (6) ◽  
pp. 80-84
Author(s):  
Nagaraja BS ◽  
Keerthana Sharma
Keyword(s):  
Older Adults ◽  
Adverse Drug Reactions ◽  
The Elderly ◽  
Control Group ◽  
Case Group ◽  
Drug Reactions ◽  
Age Related ◽  
Improve Compliance ◽  
Clinical Conditions

Background: Polypharmacy is a becoming more prevalent in older adults and adverse risk increases with age-related change. Adverse drug reactions (ADRs) are common in older adults and worrisome aspect of treatment in elderly. Aims and Objective: The study aimed to identify the common clinical conditions leading to polypharmacy and to compare the adverse drug profiles of the 2 groups. Materials and Methods: This case-control study was conducted in Hospitals attached to BMCRI, where 200 patients aged 65 or more were interviewed. 100 elderly patients using 5 or more drugs were identified as cases and assessed against a control group of 100 patients. Results: Our study found that ADRs were found to be three times higher in individuals on polypharmacy compared to the control group (OR 3.4675 95% CI 1.6241 to 7.4035). The most commonly occurring ADRs were dyspepsia (OR 1.9259), drowsiness (OR 3.5926) and fatigue (OR 1.5319) with increased incidence in the case group. The most common conditions associated with polypharmacy were found to be hypertension (53%), diabetes mellitus(46%), COPD(14%) and IHD(14%). 66% of the study group had two or more of the above diseases, whereas in the control group only 32% had multiple illnesses. The most commonly prescribed medications were antihypertensives (61%), hypolipidemics (44%), antiplatelets (41%) and antibiotics(40%). Conclusion: Polypharmacy in the elderly comes with a significant increase in adverse effects. The reduced pill burden will not only decrease ADRs and improve compliance, but will also result in greater patient satisfaction and mental health, thereby improving the quality of geriatric care.

scholarly journals Potentially inappropriate prescribing and adverse drug reactions in the elderly: a population-based study

2015 ◽  
Vol 71 (12) ◽  
pp. 1525-1533 ◽  
Author(s):  
Khedidja Hedna ◽  
Katja M. Hakkarainen ◽  
Hanna Gyllensten ◽  
Anna K. Jönsson ◽  
Max Petzold ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Inappropriate Prescribing ◽  
The Elderly ◽  
Population Based ◽  
Potentially Inappropriate Prescribing ◽  
Drug Reactions ◽  
Population Based Study

scholarly journals Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Milo Gatti ◽  
Emanuel Raschi ◽  
Fabrizio De Ponti
Keyword(s):  
Klebsiella Pneumoniae ◽  
Adverse Drug Reactions ◽  
Resistance Rate ◽  
System Organ Class ◽  
Drug Reactions ◽  
Safety Issues ◽  
Klebsiella Pneumoniae Carbapenemase ◽  
Outbreak Period ◽  
Close Relationship ◽  
Safety Signals

Abstract Background The management of Klebsiella pneumoniae carbapenemase producing (KPC) infections represents a major challenge. Several safety and efficacy concerns are shared by available antibiotics used in KPC infections, leading to the occurrence of serious adverse drug reactions (ADRs), with ceftazidime-avibactam possibly showing a more favourable risk-benefit profile. We investigated the potential impact of resistance on ADR reports in countries with different prevalence of KPC isolates (Italy vs. United Kingdom [UK]), and described safety profile of newer and older antibiotics used in KPC infections. Methods Three spontaneous reporting systems (SRSs) with different features (Italy, UK and worldwide FAERS) were used to describe safety profiles of colistin, meropenem, tigecycline, gentamicin and ceftazidime-avibactam in terms of System Organ Class and Preferred Term level. ADRs were plotted with prevalence of KPC isolates in Italy and UK. A comparison between before-after the KPC outbreak period (1999–2008 vs. 2009–2018) of overall and serious ADRs for selected antibiotics in each SRS was performed. Relationship between total and serious number of ADR reports per year and KPC isolates per year after KPC outbreak (2009–2017) was investigated for both Italy and UK. Results A total of 16,329 ADR reports were collected in the three SRSs, with meropenem (42.6%) and gentamicin (36.9%) having the highest number of reports. Significant increase in total and serious ADR reports after the KPC outbreak compared to previous 10 years was found for colistin, meropenem and gentamicin (p < 0.01). No significant increase in tigecycline ADRs was reported in FAERS and UK database. Unexpected safety signals involving selected antibiotics were not detected. Significant positive relationship between overall and serious ADR reports and KPC isolates per year for both Italy (p < 0.01; p = 0.005) and UK (p = 0.032; p = 0.013) was found. Conclusion KPC outbreak led to significant increase in ADRs to selected antibiotics, and a close relationship with antimicrobial resistance was found, both in countries with high and low resistance rate. New safety signals were not detected for selected agents. Active surveillance should be maintained to promptly identify unexpected safety issues.

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 PREDICTORS ASSOCIATED WITH ADVERSE DRUG REACTIONS AMONG GERIATRIC PATIENTS IN AN OUTPATIENT CLINIC

2019 ◽  
pp. 106-110
Author(s):  
GAYATRI SUJIVE ◽  
BENSAM T MATHEW ◽  
MAMATHA K ◽  
ANURADHA HV
Keyword(s):  
Adverse Drug Reactions ◽  
Outpatient Clinic ◽  
The Elderly ◽  
Drug Reactions ◽  
Organ Systems ◽  
Centered Care ◽  
Health Quality ◽  
Health Quality Of Life ◽  
Pedal Edema

Objective: The process of aging involves an individual’s structural and functional depravity of their organ systems often results in compromised pharmacological principles of the prescribed drugs. Multimorbidity and polypharmacy along with change in pharmacokinetic and pharmacodynamic responses of drugs predispose the elderly to adverse drug reactions (ADRs). The present study was aimed to identify and report the characteristics and incidence of ADRs among geriatrics in an outpatient clinic. Methods: This was a 6-month prospective hospital-based observational study among patients of either sex aged 60 years and above visiting an outpatient clinic at the study site. The suspected ADRs were categorized according to the Will’s and Brown classification system. Causality of these ADRs was verified by applying the WHO-UMC criteria and the Naranjo’s scale. Severity and preventability of the ADRs were classified using the modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. Multivariate logistic regression was used to determine the risk factors for developing ADRs. Results: Among the 365 patients monitored, 57 (15%) patients experienced 60 ADRs. Therapeutic classes of drugs frequently associated with ADRs were the drugs used in hypertension (27 [45%]). Patients presenting with amlodipine (9 [15%]) induced pedal edema were observed with the highest frequency of ADRs. Polypharmacy (OR: 1.619, 95% confidence interval: 0.957−2.741, p=0.021) was observed as the influential risk factor for ADRs. Conclusion: Pharmacist’s services and involvement in geriatric patient’s centered care can be associated with their improved health, quality of life and economic outcomes, a reduction in medicine-related adverse events, and limiting the morbidity and mortality in this age band.

Sign in / Sign up

Export Citation Format

Share Document