scholarly journals Direct Cost Associated with Adverse Drug Reactions among Hospitalised Chronic Kidney Patients in a Public Healthcare Facility in Malaysia: A Retrospective 3-Year Study

2021 ◽  
Vol 19 (2) ◽  
pp. 1-21
Author(s):  
Monica Danial ◽  
◽  
Mohamed Azmi Hassali ◽  
Ong Loke Meng ◽  
Amer Hayat Khan ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Clinical Symptoms ◽  
Healthcare Facility ◽  
Medical Costs ◽  
Cost Of Care ◽  
Public Healthcare ◽  
Drug Reactions ◽  
Direct Medical Costs ◽  
True Value ◽  
Drug Classes

Adverse reactions which are clinically diverse increases the overall cost of care, as it often results in additional days of hospitalisation, clinical investigations and treatment drugs. Thus, the main objective of this study is to evaluate direct medical costs among chronic kidney disease (CKD) patients who experienced adverse drug reactions (ADRs) during hospitalisation and identification of associated drug classes and clinical symptoms. Individual direct medical costs from the perspective of Ministry of Health (MOH), Malaysia among stages 3–5 CKD patients who experienced ADRs during hospitalisation were evaluated from 2014 till 2016. A higher number of days of hospitalisation (11.5 [4.25–39.25] days), ward and laboratory costs (RM48.50 [0–195.75]) plus drug costs (RM2.05 [0–91.30]) were observed among patients who did not survive ADRs. The highest number of hospitalisations, monitoring and laboratory costs were attributed to anti-arrhythmic drug class (11.0 [4.00–] days; RM326.00 [0–]) and haematological reactions (11.0 [1.00–19.00] days; RM116.80 [±112.38]). Furthermore, the highest treatment drug cost was attributed to anti-platelet (RM104.60 [0–]) and psychiatric reactions (RM17.50 [±24.13]). Top five major treatment drug classes contributed to ADRs were anti-infectives (n = 63 [39.4%]), anti-hypertensive (n = 23 [14.4%]), analgesic (n = 12 [7.5%]), statin (n = 10 [6.3%]) and anti-diabetic (n = 8 [5.0%]). Antibacterial constitutes the majority of the anti-infectives reactions. Vancomycin (n = 7 [13.7%]) tops the most ADRs contributing antibacterial. ADRs experienced during hospitalisation caused prolongation of hospitalisation and its associated investigational and treatment charges. The true value of the cost estimate could be much higher than the calculated value as the indirect costs were not included in the final estimates of this study and as a result of the Malaysian government’s waiver policy.

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.

scholarly journals Improving Pharmacovigilliance Quality Management System in the Pharmacy and Poisions Board of Kenya

2021 ◽  
Author(s):  
Eric Apiyo ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Adverse Drug Reactions ◽  
Evaluation System ◽  
Impact Analysis ◽  
Quality Management System ◽  
Clinical Symptoms ◽  
Poor Performance ◽  
Poor Quality ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Media Reports

The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow and delayed system that captures the data much later after the fact and the agency will always be behind the curve in controlling the adverse incidents and events. This means that the incidences might continue to arise or go out of control. This project attempts to develop a system that would be more proactive in the collection of pharmacovigilance data and more predictive of pharmacovigilance incidences. The pharmacovigilance system should have the capacity to detect and analyze subtle changes in reporting frequencies and in patterns of clinical symptoms and signs that are reported as suspected adverse drug reactions. The method involved carrying out a thorough literature review of the latest trends in pharmacovigilance employed by different regulatory agencies across the world, especially the more stringent regulatory authorities. A review of the system employed by the Pharmacy and Poisons Board of Kenya was also done. Pharmacovigilance data, both primary and secondary, were collected and reviewed. Media reports on adverse drug reactions and poor-quality medicines over the period were also collected and reviewed. An appropriate predictive pharmacovigilance tool was also researched and identified. It was found that the Pharmacy and Poisons Board had a robust system of collecting historical pharmacovigilance data both from the healthcare workers and the general public. However, a more responsive data collection and evaluation system is proposed that will help the agency achieve its pharmacovigilance objectives. On analysis of the data it was found that just above half of all the product complaints, about 55%, involved poor quality medicines; 15% poor performance, 13% presentation, 8% adverse drug reactions, 7% market authorization, 2% expired drugs and 1% adulteration complaints. A regulatory pharmacovigilance prioritization tool was identified, employing a risk impact analysis was proposed for regulatory action.

scholarly journals Off-label antipsychotics prescription to adolescents with acute psychotic episodes does not cause adverse drug reactions

2021 ◽  
Vol 13 (3) ◽  
pp. 19-26
Author(s):  
D. V. Ivashchenko ◽  
N. I. Buromskaya ◽  
A. D. Malakhova ◽  
N. A. Tsarkova ◽  
L. M. Savchenko ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Psychotic Episode ◽  
Age Group ◽  
Off Label Use ◽  
Drug Reactions ◽  
Off Label ◽  
Drug Classes ◽  
Increased Risk ◽  
Label Use

Antipsychotics are often used to treat children and adolescents. Because of their age, there are a lot of off-label prescribed antipsychotics in that population. However, the off-label use of medications is considered to be potentially unsafe.Objective: to evaluate whether the off-label prescription of antipsychotics outside of the approved age group increased the risk of adverse drug reactions in adolescents experiencing an acute psychotic episode.Patients and methods. We analyzed 450 charts of adolescents hospitalized due to an acute psychotic episode (only completed cases). In addition, we evaluated adverse drug reactions adjusted by off-label antipsychotics prescription outside the approved age group using the Global Trigger Tool (GTT). We also registered prescriptions with duplicates drug classes and potentially dangerous drug interactions.Results and discussion. Off-label antipsychotics prescription outside the approved age group was less frequently associated with adverse drug reactions (3.2% vs. 10.5%; p=0.013). The logistic regression analysis did not show any significant associations between the off-label antipsychotic use and increased risk of adverse drug reactions (Odds ratio=0.994 (95% confidence interval 0.572-1.726), p=0.982). Although, patients with off-label use of antipsychotics were more likely to have potentially dangerous drug interactions (35.2% vs. 16.15%; p=0.0001) and prescriptions with duplicates drug classes (39.6% vs. 15.43%; p=0.0001).Conclusion. Off-label antipsychotic prescription outside the approved age group in adolescents with acute psychotic episode does not increase the risk of adverse drug reactions. However, an increase in potentially dangerous drug interactions and prescriptions with duplicates drug classes frequency could be considered red flags. Therefore, we have concluded that the concerns about off-label antipsychotics prescription outside of approved age groups in adolescents with acute psychotic episodes were overrated.

Adverse drug reactions in older people

2010 ◽  
Vol 20 (3) ◽  
pp. 246-259 ◽  
Author(s):  
B Tangiisuran ◽  
MP Gozzoli ◽  
JG Davies ◽  
C Rajkumar
Keyword(s):  
Older People ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Drug Reactions ◽  
Drug Classes ◽  
Significant Incidence ◽  
Drug Pharmacokinetic ◽  
Common Causes ◽  
Health Related ◽  
Cognitive Problems

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.

scholarly journals In-hospital adverse drug reactions in older adults; prevalence, presentation and associated drugs—a systematic review and meta-analysis

2020 ◽  
Vol 49 (6) ◽  
pp. 948-958 ◽  
Author(s):  
Emma L M Jennings ◽  
Kevin D Murphy ◽  
Paul Gallagher ◽  
Denis O’Mahony
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Adverse Drug Reactions ◽  
Older Patients ◽  
Final Analysis ◽  
Cochrane Library ◽  
Drug Reactions ◽  
Drug Classes ◽  
Clinical Presentations ◽  
Hospitalised Patients

Abstract Background the prevalence of adverse drug reactions (ADRs) in hospitalised older patients, their clinical presentations, causative drugs, severity, preventability and measurable outcomes are unclear, ADRs being an increasing challenge to older patient safety. Methods we systematically searched PubMed, Embase, EBSCO-CINAHL, the Cochrane Library, ‘rey’ literature and relevant systematic review bibliographies, published from database inception to March 2020. We included any study reporting occurrence of in-hospital ADRs as primary or secondary outcomes in hospitalised older adults (mean age ≥ 65 years). Two authors independently extracted relevant information and appraised studies for bias. Study characteristics, ADR clinical presentations, causative drugs, severity, preventability and clinical outcomes were analysed. Study estimates were pooled using random-effects meta-analytic models. Results from 2,399 abstracts, we undertook full-text screening in 286, identifying 27 studies (29 papers). Final analysis yielded a pooled ADR prevalence of 16% (95%CI 12–22%, I2 98%,τ2 0.8585), in a population of 20,153 hospitalised patients aged ≥65 years of whom 2,479 patients experienced ≥ one ADR. ADR ascertainment was highly heterogeneous. Almost 48.3% of all ADRs involved five presentations: fluid/electrolyte disturbances (17.3%), gastrointestinal motility/defaecation disorders (13.3%), renal disorders (8.2%), hypotension/blood pressure dysregulation disorders/shock (5.5%) and delirium (4.1%). Four drug classes accounted for 57.8% of causative medications i.e. diuretics (19.8%), anti-bacterials (14.8%), antithrombotic agents (12.2%) and analgesics (10.9%). Pooled analysis of severity was not feasible. Four studies reported the majority of ADRs as preventable (55–95%). Conclusions on average, 16% of hospitalised older patients experience significant ADRs, varying in severity and mostly preventable, with commonly prescribed drug classes accounting for most ADRs.

Recognizing Hospital Adverse Drug Reactions

1989 ◽  
Vol 2 (4) ◽  
pp. 203-208 ◽  
Author(s):  
Maureen E. Savitsky
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Prescribing Patterns ◽  
Accurate Information ◽  
Drug Reactions ◽  
Drug Classes ◽  
Diagnostic Agents ◽  
Life Threatening ◽  
Nonsteroidal Antiinflammatory Agents ◽  
Chemical Mediators

Adverse drug reactions (ADRs) are a frequently overlooked complication of drug therapy. The categories of drugs most commonly implicated include anticoagulants, antimicrobials, cardiac agents, CNS agents, diagnostic agents, nonsteroidal antiinflammatory agents, and hormones. In addition to knowing what drug classes most commonly produce ADRs, the clinician should also recognize what drugs are most frequently associated with specific ADRs. Anaphylaxis is one of the most serious, and potentially life-threatening, ADRs. Treatment of an anaphylactic reaction involves correcting the physiologic effects of released chemical mediators and also inhibiting the release of additional mediators. The mainstay of therapy is aqueous epinephrine. Severe reactions may require administration of aminophylline, inotropic agents, antihistamines, corticosteroids, and intravenous fluids. The best treatment for any ADR is prevention. Pharmacists can actively participate in the monitoring of risk factors, especially the number of drugs in a regimen, potential drug interactions, and drug allergies, which may predispose patients to ADR development. Pharmacists can also assist in the detection of ADRs by monitoring alerting orders. Other potential activities for pharmacists include providing timely and accurate information about ADRs ; educating patients, physicians, and other health care professionals; and influencing prescribing patterns to minimize the trend towards polypharmacy.

scholarly journals Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review

2016 ◽  
Vol 24 (0) ◽  
Author(s):  
Maria Cristina Soares Rodrigues ◽  
Cesar de Oliveira
Keyword(s):  
Older Adults ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Inappropriate Prescribing ◽  
Integrative Review ◽  
Geriatric Nursing ◽  
Drug Reactions ◽  
Exclusion Criteria ◽  
Drug Classes ◽  
Negative Health Outcomes

ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps.

A Review of the Economic Burden of Pleural and Pericardial Effusions in Cancer Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5514-5514
Author(s):  
Sarah Y. Liou ◽  
Jennifer M. Stephens ◽  
Kimbach T. Tran ◽  
Marc F. Botteman
Keyword(s):  
Pleural Effusion ◽  
Cancer Patients ◽  
Operating Room ◽  
Economic Burden ◽  
Medical Costs ◽  
Cost Of Care ◽  
Pleural Effusions ◽  
Cost Drivers ◽  
Direct Medical Costs ◽  
Pericardial Effusions

Abstract OBJECTIVES: Pleural and pericardial effusions can lead to severe outcomes. Cancer accounts for an estimated 40% of all pleural effusions. About half of the effusions diagnosed in cancer patients are malignant, while the rest are nonmalignant and may occur as complications of the cancer treatments themselves. Pleural and pericardial effusions are associated with increased morbidity and mortality as well as high healthcare costs. The objective of this study was to review the economic burden of pleural and pericardial effusions in cancer patients. METHODS: A systematic search of the English-language medical literature published between 1990 and 2006 was conducted. Additional publications and conference proceedings were retrieved from the article bibliographies and included in the review. Articles selected include prospective or retrospective studies specifically designed to examine burden of illness, direct medical costs, indirect costs, or cost drivers associated with pleural or pericardial effusions in cancer patients. All original costs were reported, with adjusted figures (to 2006 US dollars) presented in parentheses using the medical care component of the consumer price index from the US Bureau of Labor Statistics. RESULTS: Of 15 studies identified, 11 met selection criteria and were reviewed in detail. Seven references reported data on costs associated with pleural or pericardial effusions in cancer patients. The cost per episode of pleural effusion ranged from $3,391 (2006 US $4,387) for outpatient treatment with pleural catheter to $20,996 ($37,341) for talc pleurodesis. The most common treatment for malignant pleural effusion is chest tube insertion and drainage with instillation of a sclerosing agent. Key cost drivers for significant pleural effusions included operating room costs, surgeon fees, and drugs such as sclerosing agents. Resources used for management of low grade pleural effusions include chest x-rays, physician outpatient visits, diuretics, and corticosteroids. For the treatment of pericardial effusion, the costs of performing pericardiocentesis and a pericardial window procedure were estimated to be $4,446 and $14,641 (2006 US$), respectively. Cost components for pericardial effusions, depending on treatment modality selected, included echocardiogram (3–10%), intensive care unit (17–56%), sclerosant (1–4%), surgeon fees (28–29%), anesthesia fees (20%), and operating room costs (31%). CONCLUSIONS: Pleural and pericardial effusions lead to significant direct medical costs, contributing to the total cost of care among patients treated for cancer. These costs should be included in the economic evaluation of therapies that increase the risk of pleural and pericardial effusions. Given the scarcity of published analyses in this area, additional research is warranted to better understand the burden of pleural and pericardial effusions.

Drug safety warnings in psychiatry: Adverse drug reactions’ signaling from 2002 to 2014

2017 ◽  
Vol 41 (S1) ◽  
pp. S758-S758
Author(s):  
V. Prisco ◽  
T. Iannaccone ◽  
A. Capuano ◽  
M. Fabrazzo ◽  
F. Catapano
Keyword(s):  
Adverse Drug Reactions ◽  
Psychiatric Patients ◽  
Experimental Studies ◽  
Classical System ◽  
Antidepressant Drugs ◽  
Drug Reactions ◽  
Continuous Increase ◽  
Drug Classes ◽  
Co Morbidity ◽  
Competing Interest

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and co-morbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in ADRs (adverse drug reactions). This study performs an analysis of the Italian medicine agency (AIFA) data, in the section “signal analysis”, to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (anti-epileptics), N05 (anti-psychotics), N06 (psycho-analectic drugs). Then we analyzed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to anti-psychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical anti-spychotics. Other correlations (6 above all) were found among anti-epileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs’ signaling is a classical system to provide the required attention in relation to a potential risk.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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