cardiovascular-agents and Drug-Related-Side-Effects-and-Adverse-Reactions

This systemic review aims to provide a practical overview of the prevalence, clinical manifestation, and management of adverse photoinduced skin reactions caused by frequently used cardiovascular drugs and to assess their potential relevance for skin cancer development. Data search included PubMed, Web of Science, and the Cochrane Library. A systematic review of peer-reviewed studies reporting the photosensitizing and/or skin cancer-inducing properties of common cardiovascular drugs was performed and a guide to clinical management of photoinduced skin eruptions by cardiovascular drugs was provided. Study quality was assessed for major methodological biases. A total of 58 studies were identified (i.e. 23 case reports, 14 observational studies, 10 review articles, 10 experimental studies, and 1 meta-analysis). Most commonly, drug-associated adverse photoinduced cutaneous reactions were caused by phototoxic and photoallergic mechanisms. There is evidence suggesting that amiodarone and dronedarone, thiazide diuretics, thiazide-like diuretics, angiotensin receptor blockers, dihydropyridine-type calcium channel blockers, and certain angiotensin-converting enzyme inhibitors and statins may cause photoinduced adverse cutaneous reactions. Other drugs such as anticoagulants, antiplatelets, aldosterone antagonists, and fibrates have not been linked with photosensitizing reactions or adverse cutaneous reactions. Some drugs, i.e. thiazides and thiazide-like diuretics, were associated with an increased risk of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma). Certain commonly used cardiovascular drugs have been associated with adverse photoinduced cutaneous reactions. If they occur, further diagnosis and treatment might be needed, depending on the severity and progress. Whether photosensitizing drugs increase the risk of skin cancer remains elusive and further randomized controlled trials are required.

Topics: Antihypertensive Agents; Calcium Channel Blockers; Cardiovascular Agents; Diuretics; Drug-Related Side Effects and Adverse Reactions; Humans; Photosensitizing Agents; Skin Neoplasms; Thiazides

Older people are increasingly susceptible to adverse drug reactions (ADRs) or therapeutic failure. This could be mediated by considerable polypharmacy, which increases the possibility of drug-drug and drug-gene interactions. Precision medicine, based on individual genetic variations, enables the screening of patients at risk for ADRs and the implementation of personalized treatment regimens. It combines genetic and genomic data with environmental and clinical factors in order to tailor prevention and disease-management strategies, including pharmacotherapy. The identification of genetic factors that influence drug absorption, distribution, metabolism, excretion, and action at the drug target level allows individualized therapy. Positive pharmacogenomic findings have been reported for the majority of cardiovascular drugs (CVD), suggesting that pre-emptive testing can improve efficacy and minimize the toxicity risk. Gene variants related to drug metabolism and transport variability or pharmacodynamics of major CVD have been translated into dosing recommendations. Pharmacogenetics consortia have issued guidelines for oral anticoagulants, antiplatelet agents, statins, and some beta-blockers. Since the majority of pharmacogenetics recommendations are based on the assessment of single drug-gene interactions, it is imperative to develop tools for the prediction of multiple drug-drug-gene interactions, which are common in the elderly with comorbidity. The availability of genomic testing has grown, but its clinical application is still insufficient.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacogenetics; Precision Medicine

This study sought to summarize all available evidence on sex differences in adverse drug reactions (ADRs) to heart failure (HF) medication.. Women are more likely to experience ADRs than men, and these reactions may negatively affect women's immediate and long-term health. HF in particular is associated with increased ADR risk because of the high number of comorbidities and older age. However, little is known about ADRs in women with HF who are treated with guideline-recommended drugs.. A systematic search of PubMed and EMBASE was performed to collect all available information on ADRs to angiotensin-converting enzyme inhibitors, β-blockers, angiotensin II receptor blockers, mineralocorticoid receptor antagonists, ivabradine, and digoxin in both women and men with HF.. The search identified 155 eligible records, of which only 11 (7%) reported ADR data for women and men separately. Sex-stratified reporting of ADRs did not increase over the last decades. Six of the 11 studies did not report sex differences. Three studies reported a higher risk of angiotensin-converting enzyme inhibitor-related ADRs in women, 1 study showed higher digoxin-related mortality risk for women, and 1 study reported a higher risk of mineralocorticoid receptor antagonist-related ADRs in men. No sex differences in ADRs were reported for angiotensin II receptor blockers and β-blockers. Sex-stratified data were not available for ivabradine.. These results underline the scarcity of ADR data stratified by sex. The study investigators call for a change in standard scientific practice toward reporting of ADR data for women and men separately.

Topics: Adrenergic beta-Antagonists; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Cardiotonic Agents; Cardiovascular Agents; Digoxin; Drug-Related Side Effects and Adverse Reactions; Female; Heart Failure; Humans; Ivabradine; Male; Mineralocorticoid Receptor Antagonists; Mortality; Practice Guidelines as Topic; Research Design; Research Report; Sex Distribution; Sex Factors; Stroke Volume

This review will provide an overview of the principles of pharmacogenomics from basic discovery to implementation, encompassing application of tools of contemporary genome science to the field (including areas of apparent divergence from disease-based genomics), a summary of lessons learned from the extensively studied drugs clopidogrel and warfarin, the current status of implementing pharmacogenetic testing in practice, the role of genomics and related tools in the drug development process, and a summary of future opportunities and challenges.

Topics: Biological Variation, Individual; Biotransformation; Cardiovascular Agents; Drug Development; Drug-Related Side Effects and Adverse Reactions; Forecasting; Genetic Association Studies; Genetic Predisposition to Disease; Genetic Testing; Genetic Variation; Genomics; Genotyping Techniques; Human Genome Project; Humans; Pharmacogenetics; Precision Medicine; Randomized Controlled Trials as Topic; Risk Assessment; Sample Size

Polypharmacy is now a frequent aspect and reality of current medicine practice, driven by managing multiple comorbidities, especially in older adults. However and unfortunately, polypharmacy can expose patients to adverse drug reactions, and drug-drug or drug-disease interactions. On the other hand, clinicians are often hesitant to add new drugs to complex regimens even when recommended by evidence-based medicine and guidelines. In addition, there is frequently a failure to assess which medications might not be beneficial and may therefore be stopped.. Cardiovascular disease prevalence is increasing despite the efforts to prevent this with pandemics of obesity and diabetes as leading causes. The healthcare system is facing an increasing number of cardiovascular diseases in older patients with multiple comorbidities. New cardiovascular guidelines encourage multiple drug use to control these conditions and improve mortality and morbidity. However, use of multiple drugs can lead to inappropriate drug interactions and increased adverse outcomes. On the other hand, the so-called polypill has been proposed as a means to decrease the burden of multiple medications as well as increase cardiovascular disease prevention.. This review discusses multiple issues of polypharmacy and its challenges, with a focus on cardiovascular diseases.

Topics: Age Factors; Animals; Cardiovascular Agents; Cardiovascular Diseases; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Polypharmacy

Most pharmaceutical companies test their discovery-stage proprietary molecules in a battery of in vitro pharmacology assays to try to determine off-target interactions. During all phases of drug discovery and development, various questions arise regarding potential side effects associated with such off-target pharmacological activity. Here we present a scientific literature curation effort undertaken to determine and summarize the most likely functional and pathological outcomes associated with interactions at 70 receptors, enzymes, ion channels and transporters with established links to adverse effects. To that end, the scientific literature was reviewed using an on-line database, and the most commonly reported effects were summarized in tabular format. The resultant table should serve as a practical guide for research scientists and clinical investigators for the prediction and interpretation of adverse side effects associated with molecules interacting with components of this screening battery.

Topics: Animals; Cardiovascular Agents; Databases, Factual; Drug Discovery; Drug Evaluation, Preclinical; Drug-Related Side Effects and Adverse Reactions; Humans

Current clinical cardiovascular practice requires a clinician to have a strong foundation in multiple aspects of pharmacology. Modern cardiovascular regimens are complex, and optimal management, application of evolving guidelines, and adoption of new therapies build off a more basic understanding of pharmacokinetics and pharmacodynamics. In addition, it is likely time to add a third pillar into this discussion, the expanding field of pharmacogenomics referring to the genetic influences on drug response. This field has increasing applications in medicine and clearly holds significant promise for cardiovascular disease management. Awareness of pharmacogenomic advances and the fundamentals of pharmacokinetics and pharmacodynamics can help the clinician more easily deliver great care. Here we attempt to briefly summarize and simplify key concepts of pharmacokinetics, pharmacodynamics, and pharmacogenomics relevant to the cardiovascular disease practitioner.

Topics: Biotransformation; Cardiovascular Agents; Cardiovascular Diseases; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Genotype; Humans; Pharmacogenetics; Phenotype; Risk Factors

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Heart Diseases; Humans; Hypertension; Male; Needs Assessment; Sex Factors; Treatment Outcome

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Drugs, Generic; Humans; Randomized Controlled Trials as Topic; Therapeutic Equivalency

Elderly subjects with cognitive disorders are at particularly high risk of adverse drug reactions (ADRs). The objectives of our systematic review were to describe the prevalence of ADRs in elderly patients with cognitive disorders, the different types of ADRs and the medications suspected of involvement; to describe whether the ADRs were preventable or not, and to identify risk factors for occurrence of ADRs in this population. A bibliographic search was performed in the following databases: PubMed, Embase, Google Scholar, Opengrey and Scopus. The search included all publications up to and including 4th February 2015, with no specific start date specified. Studies concerning ADRs in elderly patients with cognitive disorders or dementia were included. Two senior authors identified eligible studies and extracted data independently. In total, 113 studies were identified by the bibliographic search, of which six full-text articles were retained and analyzed. Prevalence of ADRs ranged from 4.8 to 37%. The main ADRs reported were neurological and psychological disorders, gastro-intestinal disorders, dermatological and allergic disorders, falls, renal and urinary disorders, cardiovascular disorders, metabolic disorders and electrolyte imbalance, and hemorrhagic events. The medications most commonly suspected of involvement in the ADRs were drugs affecting the nervous system, cardiovascular drugs, anticoagulants, and painkillers. Medical prescriptions should take into account the presence of Alzheimer's disease and related syndromes. Compliance should systematically be evaluated, and cognitive disorders need to be better recognized. Therapeutic education of patients and/or their caregiver is key to management of elderly patients with cognitive disorders.

Topics: Aged; Analgesics; Anticoagulants; Cardiovascular Agents; Cognition Disorders; Dementia; Drug-Related Side Effects and Adverse Reactions; Humans; Prevalence; Risk Factors

Antimalarial drugs (e.g. chloroquine and its close structural analogues) were developed primarily to treat malaria; however, they are beneficial for many dermatological, immunological, rheumatological and severe infectious diseases, for which they are used mostly today. Chloroquine and hydroxychloroquine, two of the most fascinating drugs developed in the last 50 years, are increasingly recognized for their effectiveness in myriad non-malarial diseases. In advanced research, chloroquine and hydroxychloroquine have been shown to have various immunomodulatory and immunosuppressive effects, and currently have established roles in the management of rheumatic diseases, lupus erythematosus (different forms) and skin diseases, and in the treatment of different forms of cancer. Recently, chloroquine analogues have also been found to have metabolic, cardiovascular, antithrombotic and antineoplastic effects. This review is concerned with the lysosomotropic, anti-inflammatory and immunomodulatory mechanisms of chloroquine, hydroxychloroquine, quinacrine and related analogues, and the current evidence for both their beneficial effects and potential adverse manifestations in various diseases.

Topics: Antimalarials; Antineoplastic Agents; Cardiovascular Agents; Chloroquine; Drug Repositioning; Drug-Related Side Effects and Adverse Reactions; Humans; Hydroxychloroquine; Immunologic Factors

Dyslipidaemia is an important cardiovascular disease risk factor. Many drugs affect lipid profile and lipoprotein metabolism. We reviewed unintended effects of nonlipid modifying, commonly used medications on lipid profile and lipoprotein metabolism.. Several detrimental effects of many drug classes such as diuretics, antidepressant, anticonvulsant and antiretroviral drugs have been reported, whereas other drug classes such as antiobesity, alpha 1-blockers, oestrogens and thyroid replacement therapy were associated with positive effects.. Dyslipidaemia is a common side-effect of many medications. This should be taken into consideration, especially in patients at high risk of cardiovascular disease. Other drugs demonstrated positive effects on circulating lipids and lipoproteins. The impact of these unintended effects on atherosclerotic disease risk and progression is unclear.

Topics: Animals; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Endocrine System; Humans; Lipoproteins

Oral health is an imperative part of overall human health. Oral disorders are often unreported, but are highly troublesome to human health in a long-standing situation. A strong association exists between cardiovascular drugs and oral adverse effects. Indeed, several cardiovascular drugs employed clinically have been reported to cause oral adverse effects such as xerostomia, oral lichen planus, angioedema, aphthae, dysgeusia, gingival enlargement, scalded mouth syndrome, cheilitis, glossitis and so forth. Oral complications might in turn worsen the cardiovascular disease condition as some reports suggest an adverse correlation between periodontal oral disease pathogenesis and cardiovascular disease. These are certainly important to be understood for a better use of cardiovascular medicines and control of associated oral adverse effects. This review sheds lights on the oral adverse effects pertaining to the clinical use of cardiovascular drugs. Above and beyond, an adverse correlation between oral disease and cardiovascular disease has been discussed.

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Mouth Diseases

Due to the high prevalence of cardiovascular diseases and the corresponding prescription of cardiac drugs, side effects and interactions may occur in a substantial number of patients. They can be explained by either pharmacokinetic or pharmaco-dynamic drug interactions which may be desired, but may also be life-threatening. Despite the fact that the novel oral anticoagulants are well tolerated, several factors restricting the use of these drugs, such as renal failure, have to be considered. The use of antihypertensive drugs may be limited by concomitant use of drugs that either induce of inhibit enzymatic metabolism, respectively inhibit renal drug, electrolyte, and/or water excretion. In this respect, the interaction between beta-blockers, ACE inhibitors, angiotensin receptor blockers and thiazide diuretics with non-steroidal antiinflammatory drugs is especially important. Muscle disorders are frequent side effects in patients undergoing statin therapy and affect up to 5% of patients. They may manifest as mild myalgia, but also as life-threatening rhabdomyolysis.

Topics: Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Germany; Hemorrhage; Humans; Kidney Diseases; Muscular Diseases

medication problems are thought to cause between 10 and 30% of all hospital admissions in older people. This systematic review aimed to evaluate the effectiveness of interventions led by hospital or community pharmacists in reducing unplanned hospital admissions for older people.. eighteen databases were searched with a customised search strategy. Relevant websites and reference lists of included trials were checked. Randomised controlled trials were included that evaluated pharmacist-led interventions compared with usual care, with unplanned admissions or readmissions as an outcome. Two authors independently extracted data and assessed methodological quality.. twenty-seven randomised controlled trials (RCTs) were identified; seven trials were excluded. The 20 included trials comprised 16 for older people and 4 for older people with heart failure. Interventions led by hospital pharmacists (seven trials) or community pharmacists (nine trials) did not reduce unplanned admissions in the older population (risk ratios 0.97 95% CI: 0.88, 1.07; 1.07 95% CI: 0.96, 1.20). Three trials in older people with heart failure showed that interventions delivered by a hospital pharmacist reduced the relative risk of admissions. However, these trials were heterogeneous in intensity and duration of follow-up. One trial had a high risk of bias.. evidence from three randomised controlled trials suggests that interventions led by hospital pharmacists reduce unplanned hospital admissions in older patients with heart failure, although these trials were heterogeneous. Data from 16 trials do not support the concept that interventions led by hospital or community pharmacists for the general older population reduces unplanned admissions.

Topics: Age Factors; Aged; Aged, 80 and over; Aging; Cardiovascular Agents; Chi-Square Distribution; Community Pharmacy Services; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Heart Failure; Humans; Medication Adherence; Medication Errors; Middle Aged; Odds Ratio; Patient Admission; Patient Safety; Pharmacists; Pharmacy Service, Hospital; Polypharmacy; Professional Role; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome

Heart transplantation remains the treatment of choice in selected patients with severe heart failure (HF) despite optimal medical therapy. Since long-term survival after HTX is improving, there is a growing need for evidence-based strategies that reduce long-term mortality resulting from both immunological and non-immunological risk. This manuscript summarizes recommendations for treatment of transplant vasculopathy, malignancy after transplantation, and prevention of corticosteroid induced bone disease. Based on actual understanding of cardiovascular risk factors in the population, preservation of renal function, prevention and treatment of hyperlipidemia and diabetes, as well as blood pressure control play an important role in the long-term follow-up after heart transplantation.

Topics: Cardiovascular Agents; Contraindications; Drug-Related Side Effects and Adverse Reactions; Graft Survival; Heart Failure; Heart Transplantation; Humans; Immunosuppressive Agents; Practice Guidelines as Topic

Adverse drug effects often complicate the care of critically ill patients. Therefore, each patient's medical history, maintenance medication, and new therapies administered in the intensive care unit must be evaluated to prevent unwanted neurologic adverse effects. Optimization of pharmacotherapy in critically ill patients can be achieved by considering the need to reinitiate home medications, and avoiding drugs that can decrease the seizure threshold, increase sedation and cognitive deficits, induce delirium, increase intracranial pressure, or induce fever. Avoiding medication-induced neurologic adverse effects is essential in critically ill patients, especially those with neurologic injury.

Topics: Adult; Aged; Aged, 80 and over; Analgesics; Cardiovascular Agents; Critical Care; Critical Illness; Drug-Related Side Effects and Adverse Reactions; Humans; Hypnotics and Sedatives; Middle Aged; Practice Guidelines as Topic; Young Adult

Authors analyze actual situation in treatment of cardiovascular diseases in older patients. Different groups of recommended drugs are discussed separately; possible risks for elderly patients are stressed. Angiotensin converting enzyme inhibitors-this group is widely used in older patients because of their hypotensive effect, positive influence on cardiac failure, and positive modulation of endothelial dysfunction. The risk of hyperkalemia must be considered. Antiaggregants and anticoagulants are proved as potent prophylactic treatment, but the associated risk of gastrointestinal bleeding must be weighed very carefully. Bradycardia related to β-blockers, especially in combination with other medications lowering the heart rate must be taken into account. Otherwise, this group brings the highest profit in cardiovascular diseases as for morbidity and mortality. Attention is paid to calcium channel blockers, statins, diuretics, nitrates, and digoxin. A table listing the possible side effects and clinical symptoms of overdose by medications most frequently used in the elderly concludes the article.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Drug-Related Side Effects and Adverse Reactions; Evidence-Based Medicine; Female; Humans; Incidence; Male; Middle Aged; Risk Factors

Meta-analyses showed that psychotropic drugs (antidepressants, neuroleptics, benzodiazepines, antiepileptic drugs) and some cardiac drugs (digoxin, type IA anti-arrhythmics, diuretics) are associated with increased fall risk. Because balance and gait disorders are the most consistent predictors of future falls, falls due to use of these so-called fall-risk-increasing drugs (FRIDs) might be partly caused by impairments of postural control that these drugs can induce. Therefore, the effects of FRIDs on postural control were examined by reviewing literature. Electronic databases and reference lists of identified papers were searched until June 2013. Only controlled research papers examining the effects of FRIDs on postural control were included. FRIDs were defined according to meta-analyses as antidepressants, neuroleptics, benzodiazepines, antiepileptic drugs, digoxin, type IA anti-arrhythmics, and diuretics. Ninety-four papers were included, of which study methods for quantifying postural control, and the effects of FRIDs on postural control were abstracted. Postural control was assessed with a variety of instruments, mainly evaluating aspects of body sway during quiet standing. In general, postural control was impaired, indicated by an increase in parameters quantifying body sway, when using psychotropic FRIDs. The effects were more pronounced when people were of a higher age, used psychotropics at higher daily doses, with longer half-lives, and administered for a longer period. From the present literature review, it can be concluded that psychotropic drugs cause impairments in postural control, which is probably one of the mediating factors for the increased fall risk these FRIDs are associated with. The sedative effects of these drugs on postural control are reversible, as was proven in intervention studies where FRIDs were withdrawn. The findings of the present literature review highlight the importance of using psychotropic drugs in the older population only at the lowest effective dose and for a limited period of time.

Topics: Accidental Falls; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Posture; Psychotropic Drugs; Risk

This article introduces fundamental concepts to guide the analysis and interpretation of drug-target interaction networks. An overview of the generation and integration of interaction networks is followed by key strategies for extracting biologically meaningful information. The article highlights how this information can enable novel translational and clinically motivated applications. Important advances for the discovery of new treatments and for the detection of adverse drug effects are discussed. Examples of applications and findings originating from cardiovascular research are presented. The review ends with a discussion of crucial challenges and opportunities.

Topics: Cardiovascular Agents; Cardiovascular System; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Precision Medicine; Systems Biology

Older adults are about four to seven times more likely than younger persons to experience adverse drug events (ADEs) that cause hospitalization, especially if they are women and take multiple medications. The prevalence of drug-related hospitalizations has been reported to be as high as 31%, with large heterogeneity between different studies, depending on study setting (all hospital admissions or only acute hospital admissions), study population (entire hospital, specific wards, selected population and/or age groups), type of drug-related problem measured (adverse drug reaction or ADE), method of data collection (chart review, spontaneous reporting or database research) and method and definition used to detect ADEs. The higher risk of drug-related hospitalizations in older adults is mainly caused by age-related pharmacokinetic and pharmacodynamic changes, a higher number of chronic conditions and polypharmacy, which is often associated with the use of potentially inappropriate drugs. Other factors that have been involved are errors related to prescription or administration of drugs, medication non-adherence and inadequate monitoring of pharmacological therapies. A few commonly used drugs are responsible for the majority of emergency hospitalizations in older subjects, i.e. warfarin, oral antiplatelet agents, insulin and oral hypoglycaemic agents, central nervous system agents. The aims of the present review are to summarize recent evidence concerning drug-related hospitalization in older adults, to assess the contribution of specific medications, and to identify potential interventions able to reduce the occurrence of these drug-related events, as they are, at least partly, potentially preventable.

Topics: Adrenal Cortex Hormones; Analgesics; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Hospitalization; Humans; Hypoglycemic Agents; Platelet Aggregation Inhibitors

Aging is associated with numerous alterations in body composition and organ function that result in substantial changes in the absorption, distribution, metabolism, and elimination of virtually all drugs. In addition, older patients with heart failure (HF) almost invariably have multiple coexisting medical conditions for which they are receiving medications. This article reviews common adverse drug effects and drug interactions associated with HF therapy in older patients and discusses strategies for reducing the risk of adverse drug events. In order to minimize these risks, it is essential that clinicians avoid prescribing unnecessary medications, adjust medication dosages to optimally balance benefits and side effects, and remain ever vigilant to the potential for medications to cause or contribute to clinically important adverse events and impaired quality of life. In treating older HF patients, the oft-cited dictum "start low, go slow" clearly applies. Despite the inherent challenges, with careful management and close follow-up, most older HF patients can be successfully treated through the judicious use of guideline-recommended HF therapies.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Heart Failure; Humans; Polypharmacy; Risk Factors

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing 'Cardiovascular Toxicity of Medicines'. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: • Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process. • Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome. • Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data. • Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes. • Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers.

Topics: Animals; Cardiovascular Agents; Cardiovascular System; Drug Discovery; Drug Evaluation, Preclinical; Drug-Related Side Effects and Adverse Reactions; Humans

Aging is characterized by progressive impairment of functional capacities of all system organs, reduction in homeostatic mechanisms, and altered response to receptor stimulation. These age-related physiologic changes influence both pharmacokinetics and pharmacodynamics of drugs in elderly patients. Pharmacokinetic and pharmacodynamics changes as well as polypharmacy and comorbidities may alter significantly the effect of pharmacological treatment with advancing age. With the same drug concentration at the site of action, significant differences in the response to several drugs have been observed in older patients as compared to younger patients. Elderly patients are particularly suceptibles to the effects of frequently prescribed drugs acting on central nervous system, such as benzodiazepines, antidepressants, antipsychotics and lithium, with high potential for adverse drug reactions. Moreover, in older patients increased sensitivity to warfarin resulting in increased risk of bleeding has been previously documented. On the other hand, reduced effectiveness of conventional doses of cardiovascular drugs, such as diuretics and β-blockers, has been observed. Due to pharmacodynamic changes, therefore, dose adjustment of the above mentioned cardiovascular and psychotropic drugs is recommended in elderly. Clinicians should be aware of the age-related physiologic changes affecting several organ systems and their implications on the effect of drugs that are commonly prescribed to elderly patients.

Topics: Aged; Aging; Animals; Cardiovascular Agents; Central Nervous System; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmaceutical Preparations

Despite the FDA guidelines for studies to be performed to rule out potential cardiac toxicity, many drugs have nevertheless entered the market only to be later withdrawn from the market owing to cardiac toxicity. Cardiac toxicity may result from drugs causing impaired function or death of cardiomyocytes, valvular damage, myocardial ischemia and/or ventricular arrhythmias. Negative cardiovascular events have been implicated in 28% of drug withdrawals in the USA. The significance for patients, regulators and the pharmaceutical industry is immense.. We address whether a more rigorous and integrative approach is needed for cardiovascular safety screening of all new drug candidates. Furthermore, we will present a cardionomics approach that looks at several in vitro and in vivo models that can be applied to all drugs independent of category, therapeutic area or class.. We present examples of drugs demonstrating cardiac toxicity and provide an in-depth review of how calcium homeostasis may be a unifying theme in clinically observed cardiotoxic events. We introduce a cardionomics approach that detects clinical cardiac toxicity early in the drug discovery process, thus, preventing costly late attrition.. The consequences of a failure to detect potential cardiovascular safety issues before clinical launch can have an enormous cost for the pharmaceutical industry, when major drugs are withdrawn due to lawsuits as well as loss of time and resources. An integrated cardionomics approach may reduce the risk of drug withdrawals as a result of unexpected clinical cardiac safety issues.

Topics: Animals; Arrhythmias, Cardiac; Biomedical Research; Cardiovascular Agents; Cardiovascular Diseases; Drug Evaluation, Preclinical; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmaceutical Preparations

All patients should undergo surgical procedures in the most stable and favourable condition with a continuation of chronic medication. Accordingly, this medication should be continued until the day before surgery in most patients. The preoperative period should be used to evaluate the completeness and quality of the medical treatment. Are all patient with cardiological indications for beta-receptor blocking agents, ACE-inhibitors and statins treated with these drugs? Is diabetes being adequately treated? Are the doses of the medication for the treatment of thyroid dysfunction within the optimal range? If there is room for improvement, adjustments should be done cautiously and well in advance. In contrast, there are no recognised situations in which a medication should be started preoperatively in the absence of a pre-established chronic indication. Management of antiplatelet agents and cumarins requires careful consideration. The hazards of continuing and withholding treatment must be evaluated. In patients who have suffered a cardiovascular event and/or have undergone (coronary) revascularisation, elective surgery must be delayed for weeks or months depending on the circumstances and the devices used.

Topics: Anticoagulants; Cardiovascular Agents; Central Nervous System Agents; Chronic Disease; Cooperative Behavior; Drug-Related Side Effects and Adverse Reactions; Health Status Indicators; Humans; Hypoglycemic Agents; Insulin; Interdisciplinary Communication; Pharmaceutical Preparations; Preoperative Care

Drugs can affect the skeleton in different ways. Antiepileptic drugs were not associated with any major fracture risk. Lithium was associated with a decreased fracture risk. Insulin, sulphonylureas and metformin were associated with a decreased risk, whereas glitazones were associated with an increased risk. Blood pressure lowering drugs, thiazide diuretics and nitroglycerin were associated with a decreased risk of fractures, whereas amiodarone and loop diuretics were associated with an increased risk. Pain medication varied from no effect to an increased fracture risk.

Topics: Analgesics; Antineoplastic Agents; Bone Density; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Fractures, Spontaneous; Humans; Hypoglycemic Agents; Osteoporosis; Risk Factors

Topics: Anti-Infective Agents; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Azathioprine; Cardiovascular Agents; Didanosine; Drug-Related Side Effects and Adverse Reactions; Humans; Pancreatitis; Psychotropic Drugs; Reference Standards; Time Factors; Valproic Acid

Understanding the role that medication has on sleep is difficult for many reasons. Most medications have not been sufficiently studied to determine their primary effects on sleep and waking behavior. Because of the increased awareness of the importance of sleep to health and well being, the effects of a new drug on sleep and waking behavior should be a mandatory element of the clinical trials process. Even when the effects of a drug are known, the medication may act differently in normal individuals and individuals who are ill. The interaction of many medications would be difficult to predict,and acute effects may be quite different from chronic use. Even a general idea about the effects of a medication will help the sleep medicine specialist understand and interpret the polysomnogram and MSLT accurately.

Topics: Cardiovascular Agents; Central Nervous System Agents; Cocaine; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Ethanol; Humans; Nicotine; Polysomnography; Sleep

This perspective outlines the challenges to joint development of a predictive genetic diagnostic with a drug to enhance the efficacy or safety of therapy with the targeted drug. Joint development requires a discovery approach to identify the genetic marker(s), followed by a replication or validation process confirming the clinical utility of the genetic marker(s) in predicting response to the targeted drug. The promise of overcoming these hurdles is that combined use of the genetic diagnostic linked to the drug provides additional scientific information to assist the clinician in their choice of therapeutic interventions on a patient-by-patient basis.

Topics: Cardiovascular Agents; Clinical Laboratory Techniques; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Genetic Variation; Humans; Pharmacogenetics; Pharmacology

Topics: Analgesics; Anti-Infective Agents; Anticonvulsants; Cardiovascular Agents; Chemical and Drug Induced Liver Injury; Cholestasis; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycemic Agents; Hypolipidemic Agents; Liver; Pharmaceutical Preparations; Psychotropic Drugs

Topics: Adverse Drug Reaction Reporting Systems; Anti-Inflammatory Agents; Cardiovascular Agents; Central Nervous System Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Heart Failure; Humans; Hypoglycemic Agents; Polypharmacy; Risk Factors

Atrial fibrillation (AF) is the most common sustained rhythm disorder observed in clinical practice and predominantly associated with cardiovascular disorders such as coronary heart disease and hypertension. However, several classes of drugs may induce AF in patients without apparent heart disease or may precipitate the onset of AF in patients with preexisting heart disease. We reviewed the literature on drug-induced AF, using the PubMed/Medline and Micromedex databases and lateral references. Successively, we discuss the potential role in the onset of AF of cardiovascular drugs, respiratory system drugs, cytostatics, central nervous system drugs, genitourinary system drugs, and some miscellaneous agents. Drug-induced AF may play a role in only a minority of the patients presenting with AF. Nevertheless, it is important to recognize drugs or other agents as a potential cause, especially in the elderly, because increasing age is associated with multiple drug use and a high incidence of AF. This may contribute to timely diagnosis and management of drug-induced AF.

Topics: Anti-Arrhythmia Agents; Antineoplastic Agents; Atrial Fibrillation; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Erectile Dysfunction; Humans; Male; Respiratory System Agents; Tocolytic Agents

Although not very common, medication-induced neuropathy is a treatable condition and, therefore, is important to identify. Medications continue to grow in number and expand in usage; consequently, toxic neuropathy continues to be relevant to neurologists. Many agents have toxicities that are tolerated because the treatments are necessary, such as therapies for HIV and malignancy. Additional agents to prevent or ameliorate the toxic neuropathy are being sought and trials are ongoing. Certain patients, however, may be at high risk for peripheral nerve toxicity due to genetic factors or another underlying neuropathy. Newer drug-delivery methods, such as viral transfection, may produce less toxicity in the future. The underlying pathomechanisms remain incompletely elucidated; however, apoptosis is emerging as an important final pathway in some forms of toxic neuropathy. Although most cases demonstrate acute or subacute onset after exposure, recent experiences with statin drugs raise the possibility of occult toxic causes of chronic idiopathic neuropathy.

Topics: Animals; Anti-Bacterial Agents; Anti-HIV Agents; Antineoplastic Agents; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Peripheral Nervous System Diseases; Risk Factors

Patients often present to otolaryngologists with nasal symptoms where no cause is apparent. A number of patients seen in outpatient departments are taking medication for other conditions and the adverse affects of these drugs may potentially be the source of these symptoms. In this short review, we present an overview of the more common drugs that may be responsible and outline the possible mechanisms where these are known.

Topics: Analgesics; Anti-Infective Agents; Cardiovascular Agents; Central Nervous System Agents; Contraceptives, Oral, Hormonal; Drug-Related Side Effects and Adverse Reactions; Hormone Replacement Therapy; Humans; Nasal Mucosa

"Torsade de pointes" (TdP) is a clinico-electrocardiographic syndrome characterized by an abnormally prolonged QT interval and the occurrence of potentially life-threatening ventricular tachyarrhythmias. Two mayor causes can be distinguished: congenital and acquired long QT syndrome. Whereas the former has recently been identified as an ion channelopathy, the mechanisms underlying acquired long QT syndrome are far from being understood. It has been suggested that patients with the acquired form of the disease may suffer from a clinically hidden form of the congenital variant. However, recent studies have yielded only a small number of individual cases in whom genetic analyses revealed the presence of an ion channel gene mutation. Since acquired long QT syndrome is most often induced by drugs prolonging myocardial repolarization, it is largely an iatrogenic disease. In order to prevent unwitting exposure to risk, physicians prescribing agents that may prolong repolarization need to be aware of the typical clinico-electrocardiographic characteristics of drug-induced TdP, and its diagnosis and management. A clearer delineation of the risk factors predisposing to abnormal prolongation of repolarization, and a more precise quantification of the torsadogenic potency of individual drugs appear mandatory in order to prevent or at least minimize the occurrence of this potentially fatal adverse effect of certain drugs.

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Humans; Iatrogenic Disease; Long QT Syndrome; Risk Factors; Torsades de Pointes

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Erectile Dysfunction; Humans; Male; Phosphodiesterase Inhibitors; Psychotropic Drugs; Substance-Related Disorders; Vasodilator Agents

With aging comes an increasing prevalence of diseases and symptoms that frequently require pharmaceutical treatment. However, aging also brings about bodily changes that result in increased effects and prolonged action of many drugs. Multiple drug use--often termed polypharmacy--seen in many elderly individuals, is the most important risk factor for adverse drug reactions (ADR) and increases the risk of drug interactions and poor compliance. ADR's are responsible for about 10% of all hospital admissions of elderly patients. The drugs most commonly involved are cardiovascular, psychotropics and anti-inflammatory agents. Many of these ADR's are dose-dependent and preventable. Drug use has increased over the last few years, largely thanks to the availability of new and effective agents. This calls for increased vigilance and prudence in prescribing for the elderly.

Topics: Aged; Aging; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Cognition Disorders; Dose-Response Relationship, Drug; Drug Interactions; Drug Prescriptions; Drug Utilization; Drug-Related Side Effects and Adverse Reactions; Humans; Polypharmacy; Psychotropic Drugs; Risk Factors

Prescribing medications for a breast-feeding mother requires weighing the benefits of medication use for the mother against the risk of not breast-feeding the infant or the potential risk of exposing the infant to medications. A drug that is safe for use during pregnancy may not be safe for the nursing infant. The transfer of medications into breast milk depends on a concentration gradient that allows passive diffusion of nonionized, non-protein-bound drugs. The infant's medication exposure can be limited by prescribing medications to the breast-feeding mother that are poorly absorbed orally, by avoiding breast-feeding during times of peak maternal serum drug concentration and by prescribing topical therapy when possible. Mothers of premature or otherwise compromised infants may require altered dosing to avoid drug accumulation and toxicity in these infants. The most accurate and up-to-date sources of information, including Internet resources and telephone consultations, should be used.

Topics: Analgesics; Anesthetics; Anti-Asthmatic Agents; Anti-Bacterial Agents; Anticonvulsants; Antidepressive Agents; Breast Feeding; Cardiovascular Agents; Contraceptives, Oral, Hormonal; Drug Administration Routes; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Female; Histamine H1 Antagonists; Humans; Hypoglycemic Agents; Pharmaceutical Preparations

Hepatic impairment can alter the pharmacokinetic profiles of cardiovascular drugs, which can lead to unwanted toxicity. In the presence of cirrhosis, portosystemic shunting occurs and cytochrome P450 activity is reduced. Impaired oxygen uptake caused by changes in the liver's sinusoids, as proposed by the oxygen limitation theory, may also explain the alteration of drug metabolism seen in cirrhosis. With congestive heart failure, sinusoidal congestion and hypoperfusion of the liver are seen. Similar to cirrhosis, the common pathway for hepatic damage in congestive heart failure seems to be liver hypoxia, which may explain the disease's effect on drug metabolism. Since routine hepatic function tests do not always relate to the liver's ability to eliminate drugs, existing guidelines for dosing cardiovascular drugs in patients with hepatic impairment are limited. This article provides guidance for dosing cardiovascular drugs in cirrhotic and heart failure patients based on available research data. Altered drug metabolism, especially in congestive heart failure, tends to be overlooked or not realized in clinical practice. Therefore, further research is needed in congestive heart failure to better elucidate safe prescribing patterns.

Topics: Cardiovascular Agents; Comorbidity; Drug-Related Side Effects and Adverse Reactions; Heart Failure; Humans; Liver Diseases; Pharmacokinetics

Topics: Breast Feeding; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Illicit Drugs; Infant; Iodine; Milk, Human; Pharmaceutical Preparations; Psychotropic Drugs; Risk

Although the incidence and prevalence of serious adverse drug reactions (ADRs) in the elderly cannot be accurately stated, published estimates appear to be unchanged since the earliest reports in the 1960s. Whereas heightened awareness of the problem may weigh in favour of a reduction in ADR frequency, the dramatic increase in the number and availability of therapeutic agents has undoubtedly contributed to the observed high proportion of drug-induced morbidity among acute geriatric hospital admissions. No single drug or drug class is of particular concern since none appears to cause serious morbidity out of proportion with its use. Although numerous studies have sought to identify risk factors for ADRs, the only truly independent predictor is the absolute number of concurrently used medications. However, other studies indicate that there is poor doctor-patient agreement regarding a patient's drug regimen, and interventions that aim to reduce the incidence of ADRs have failed to demonstrate a positive effect. Thus at present the most rational approach would appear to be to establish an accurate knowledge of the patients drug regimens: once this is known one can attempt to rationally minimise the number of medications without compromising therapeutic goals.

Topics: Age Factors; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Psychotropic Drugs

While usually not the only factor in obese patients, prescription medications, which may increase appetite or body weight, can be important in some individuals. The cause of weight gain in such cases may go unrecognized or lead to cessation of medication with or without the practitioner's knowledge or approval.. We found illustrative cases among patients treated at the Johns Hopkins Weight Management Center, searched MEDLINE and the Micromedex Drug Information database, and organized this information by drug mechanism and indications for use.. Most reports of medication-induced weight gain are anecdotal or gleaned from clinical trials. Notable offenders include hormones (especially corticosteroids and insulinotropic agents), and psychoactive medications (especially tricyclic antidepressants, lithium, and some antipsychotics).. Medication-related increases in appetite and body weight are under-recognized and cause noncompliance with pharmacotherapy. A high index of awareness of the known mechanisms by which medications can lead to weight gain has the potential to prevent most medication-related contributions to weight gain and obesity.

Topics: Adult; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Glucocorticoids; Humans; Hypoglycemic Agents; Male; Obesity; Patient Compliance; Psychotropic Drugs; Weight Gain

Topics: Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Enterocolitis, Pseudomembranous; Humans; Intestinal Diseases; Prognosis

Topics: Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmaceutical Preparations; Physical Exertion; Physical Fitness

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Humans; Inactivation, Metabolic; Pharmacokinetics; Pharmacology; Psychotropic Drugs

Topics: Affect; Anti-Infective Agents; Behavior; Cardiovascular Agents; Central Nervous System Depressants; Central Nervous System Stimulants; Drug-Related Side Effects and Adverse Reactions; Gastrointestinal Agents; Hormones; Humans; Mental Disorders

Oral drug reactions have many clinical manifestations and are produced by numerous medications. These reactions may be the result of an allergic reaction to systemically administered drugs or as an indirect effect of the action of the drug on other tissues. Other oral drug reactions may be the result of local or topical medications. These reactions are either a result of an allergic, delayed-type hypersensitivity, or a local primary irritation. The appearance may be nonspecific or it may resemble several distinct clinical entities. The diagnosis of these oral drug reactions is made with a good clinical history and examination, along with a high index of suspicion. Often there are multiple factors involved that complicate the clinical picture. The clinician who is familiar with the types of oral drug reactions caused by medications, the mechanisms by which these reactions occur, and which medications are most likely to cause the reaction will be prepared to make the correct diagnosis and treatment recommendations.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Mouth Diseases

More than 75 drugs are known to have adverse effects on the bronchopulmonary pleural system. Many of these drug reactions are fatal unless they are recognized, administration is stopped, and other measures are instituted. No data exist on the number of adverse drug reactions on the lung, because there is no mandatory reporting system in the United States. Probably less than 5% are reported. The clinician should be aware of the drugs that can produce adverse reactions on the lungs and stop the administration as soon as possible. In this article, I have classified the drugs known to produce adverse pulmonary effects as follows: chemotherapeutic, cardiovascular, antibiotic, and anti-inflammatory agents, drugs known to induce systemic lupus erythematosus, inhalants, illicit drugs such as heroin, and miscellaneous drugs. There are no blood tests or other means of diagnosing adverse drug effects on the lung. Chest roentgenographic findings are nonspecific. Pulmonary function abnormalities generally correlate with the degree of dyspnea and chest roentgenographic changes. Therefore, the clinician trying to explain the onset of pulmonary symptoms must be aware of the drugs the patient is taking.

Topics: Animals; Anti-Bacterial Agents; Anti-Inflammatory Agents; Bronchial Diseases; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Illicit Drugs; Lung Diseases; Pleural Diseases

Chronic ingestion of ethanol in alcoholic beverages can impair drug therapy, lead to sometimes hazardous interactions, or compromise adherence to a well-planned drug treatment program. Various drugs consistently interact with alcohol: CNS depressants, such as benzodiazepines, barbiturates, muscle relaxants, antihistamines, and psychotropic agents; analgesics, including aspirin and narcotics; anticoagulants and other cardiovascular drugs, namely digitalis glycosides, diuretics, antihypertensives, and antiarrhythmics; and antidiabetic agents. Abstinence from alcohol by elderly patients receiving these drugs is recommended.

Topics: Aged; Alcohol Drinking; Analgesics; Cardiovascular Agents; Central Nervous System Depressants; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Histamine H1 Antagonists; Humans; Hypoglycemic Agents; Psychotropic Drugs

Topics: Aged; Animals; Anti-Bacterial Agents; Anticonvulsants; Cardiovascular Agents; Chloroquine; Drug-Related Side Effects and Adverse Reactions; Hormones; Humans; Motor Endplate; Myasthenia Gravis; Neuromuscular Junction; Penicillamine; Postoperative Complications; Psychotropic Drugs; Respiratory Insufficiency; Synaptic Transmission; Syndrome

Topics: Aged; Cardiovascular Agents; Drug Prescriptions; Drug-Related Side Effects and Adverse Reactions; Environment; Humans; Patient Compliance; Pharmaceutical Preparations

Given the importance of patient safety and well-being, we quantified the likelihood and type of medication changes observed after 5 possible adverse effects (AE) perceived by heart failure (HF) patients.. We conducted a retrospective cohort study using 18 months follow-up data from the Coordinating study evaluating Outcomes of Advising and Counseling in HF study on 754 patients previously hospitalized for HF (NYHA II-IV, mean age 70 years). Data used for this secondary analysis included problem checklists that patients had completed at 3 points in time, and medication data collected from chart review. Changes in potential causal cardiovascular medication and relevant alleviating medication were classified. Within group and relative risks (RR) for medication changes were calculated. Of the 754 patients, 50% reported dizziness, 44% dry cough, 19% nausea, 19% diarrhea, and 12% gout on the first checklist. Overall, the likelihood of a medication change was increased by 38% after a perceived AE. Dry cough had the highest increased likelihood of an associated cardiovascular medication change (RR 1.83, CI 1.35-2.49). Patients reporting gout had a four fold higher likelihood of alleviating medication started or intensified.. A considerable number of HF patients perceived possible AE. However, the likelihood of medication being changed after a possible AE was rather low. There seems to be room for improving the management of AE.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cohort Studies; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Heart Failure; Humans; Male; Medication Adherence; Middle Aged; Patient Education as Topic; Perception; Retrospective Studies

This study adds the dimension of a T-wave morphology composite score (MCS) to the QTc interval-based evaluation of drugs that affect cardiac repolarization. Electrocardiographic recordings from 62 subjects on placebo and 400 mg moxifloxacin were compared with those from 21 subjects on 160 and 320 mg D,L-sotalol. T-wave morphology changes, as assessed by DeltaMCS, are larger after 320 mg D,L-sotalol than after 160 mg D,L-sotalol; and the changes associated with 160 mg D,L-sotalol are, in turn, larger than those associated with moxifloxacin and placebo. Covariate analyses of DeltaQTc and DeltaMCS showed that changes in T-wave morphology are a significant effect of D,L-sotalol. By contrast, moxifloxacin was found to have no significant effect on T-wave morphology (DeltaMCS) at any given change in QTc. This study offers new insights into the repolarization behavior of a drug associated with low cardiac risk vs. one associated with a high risk and describes the added benefits of a T-wave MCS as a covariate to the assessment of the QTc interval.

Topics: Adolescent; Adult; Algorithms; Anti-Arrhythmia Agents; Anti-Bacterial Agents; Aza Compounds; Cardiovascular Agents; Data Interpretation, Statistical; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Female; Fluoroquinolones; Heart; Humans; Male; Middle Aged; Moxifloxacin; Quinolines; Risk Assessment; Sotalol; Torsades de Pointes; Young Adult

To describe the prevalence, types, and consequences of adverse drug events (ADEs) in older outpatients with polypharmacy.. A cohort study.. General Medicine Clinic at the Durham Veterans Affairs Medical Center.. A total of 167 high risk (taking > or = 5 scheduled medications) ambulatory older veterans who participated in a year long health service intervention trial.. Potential ADEs were identified by asking patients during closeout interviews whether, in the past year, they had experienced any side effects, unwanted reactions, or other problems from any medication. All reported medications and corresponding adverse experiences were assessed for plausibility by a research clinical pharmacist using two standard pharmacological textbooks and categorized by predictability, therapeutic class, and organ system.. Eighty self-reported ADEs involving 72 medications taken by 58 (35%) of 167 patients were textbook confirmed. Seventy-six of 80 (95%) ADEs were classified as Type A (predictable) reactions. Cardiovascular (33.3%) and central nervous system (27.8%) medication classes were most commonly implicated. Gastrointestinal (30%) and central nervous system (28.8%) ADE symptoms were common. Sixty-three percent of patients with ADEs required physician contacts, 10% emergency room visits, and 11% hospitalization. Twenty percent of medications implicated with ADEs required dosage adjustments, and 48% of ADE-related medications were discontinued. No significant differences (P > .05) were observed when ADE reporters (n = 58) and nonreporters (n = 109) were compared.. Predictable ADEs are common in high risk older outpatients, resulting in considerable medication modification and substantial healthcare utilization.

Topics: Aged; Ambulatory Care; Cardiovascular Agents; Central Nervous System Agents; Cohort Studies; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Emergencies; Follow-Up Studies; Forecasting; Gastrointestinal Agents; Hospitalization; Humans; Longitudinal Studies; Pharmaceutical Preparations; Polypharmacy; Prevalence; Risk Factors

Topics: Amiodarone; Anti-Arrhythmia Agents; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Liver Failure, Acute

Medication error is a common cause of patient harm. The study aims to propose a way to manage the risk of medication errors in a novel way, by identifying practice areas where mitigating patient harm should be prioritized using a risk management approach.. Suspected Adverse Drug Reactions (sADRs) in Eudravigilance database over three years were reviewed to identify preventable medication errors. These were classified using a new method based upon the root cause underlying pharmacotherapeutic failure. The correlation between severity of harm and type of medication error, and other clinical parameters was investigated.. Overall, 2294 medication errors were identified from Eudravigilance, of which 1300 (57%) were due to pharmacotherapeutic failure. Most cases of preventable medication error involved prescribing (41%) and administration (39%). The variables which significantly predicted severity of medication errors were pharmacological group, patient age, number of drugs prescribed, and route of administration. The drug classes most strongly associated with harm included cardiac drugs, opioids, hypoglycaemics, antipsychotics, sedatives, and antithrombotic agents.. The findings of this study highlight the feasibility of using a novel conceptual framework to identify areas of practice at risk of pharmacotherapeutic failure where Interventions by healthcare professionals in these areas are most likely to improve medication safety.

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Medication Errors; Pharmaceutical Preparations; Risk Management

Pharmacogenetics can improve clinical outcomes by reducing adverse drug effects and enhancing therapeutic efficacy for commonly used drugs that treat a wide range of cardiovascular diseases. One of the major barriers to the clinical implementation of cardiovascular pharmacogenetics is limited education on this field for current healthcare providers and students. The abundance of pharmacogenetic literature underscores its promise, but it can also be challenging to learn such a wealth of information. Moreover, current clinical recommendations for cardiovascular pharmacogenetics can be confusing because they are outdated, incomplete, or inconsistent. A myriad of misconceptions about the promise and feasibility of cardiovascular pharmacogenetics among healthcare providers also has halted clinical implementation. Therefore, the main goal of this tutorial is to provide introductory education on the use of cardiovascular pharmacogenetics in clinical practice. The target audience is any healthcare provider (or student) with patients that use or have indications for cardiovascular drugs. This tutorial is organized into the following 6 steps: (1) understand basic concepts in pharmacogenetics; (2) gain foundational knowledge of cardiovascular pharmacogenetics; (3) learn the different organizations that release cardiovascular pharmacogenetic guidelines and recommendations; (4) know the current cardiovascular drugs/drug classes to focus on clinically and the supporting evidence; (5) discuss an example patient case of cardiovascular pharmacogenetics; and (6) develop an appreciation for emerging areas in cardiovascular pharmacogenetics. Ultimately, improved education among healthcare providers on cardiovascular pharmacogenetics will lead to a greater understanding for its potential in improving outcomes for a leading cause of morbidity and mortality.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Health Personnel; Humans; Pharmacogenetics

Topics: Cardiovascular Agents; Digoxin; Disease Progression; Drug-Related Side Effects and Adverse Reactions; Humans; Immunoglobulin Fab Fragments

Topics: Cardiovascular Agents; Digoxin; Disease Progression; Drug-Related Side Effects and Adverse Reactions; Humans

Topics: Anesthetics, Local; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Lidocaine; Lipectomy

Although some studies have shown the average side effects of cardiovascular medication, the short-term effect after newly initiated cardiovascular medications has not been studied in any detail. We aim to determine the effect of newly initiated cardiovascular medications resulting in unintentional poisoning and to identify those at high risk.. A case-crossover design was used. From the Swedish National Patient Register, a total of 9,354 persons aged ≥ 50 and hospitalized with a first event of unintentional poisoning between July 2006 and September 2018 were identified. Through linkage to the Prescribed Drug Register, exposure to newly initiated cardiovascular medication during the case period (1-28 days prior to the onset date of unintentional poisoning) was compared with that in a corresponding control period (113-140 days prior to the onset date). Conditional logistic regression was used to determine the associations in total, for different time periods as well as by age, sex, underlying comorbidity, and use of other medications.. Newly initiated cardiovascular medications were associated with a higher risk of unintentional poisoning, especially during the first week after initiation (odds ratio [OR]=1.39), (95% confidence interval [CI]=1.08-1.79). The risk of unintentional poisoning was comparable across age groups, sex, underlying comorbidities, and medications with OR (95% CI) ranging from 1.15 (0.75-1.74) to 2.00 (1.15-3.47).. This large population-based case-crossover study showed that newly initiated cardiovascular medication is associated with an increased risk of unintentional poisoning, particularly during the first week after initiation. The risk is comparable across age, sex, underlying comorbidity, and medications.

Topics: Aged; Cardiovascular Agents; Case-Control Studies; Cross-Over Studies; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Odds Ratio; Registries; Risk Assessment; Sweden

Drug-related problems (DRPs) lead to substantial morbidity and mortality and increase healthcare costs. Several interventions have been developed to reduce DRPs and improve the outcome of drug therapy.. To investigate DRPs identified through a pharmacist-led intervention and to assess patient satisfaction with the intervention.. Patients received two pharmacist consultations 1-2 weeks and 3-5 weeks after collecting a new cardiovascular medicine. Information about patient characteristics, beliefs about medicines (BMQ), DRPs, and patient evaluations were collected using questionnaires.. Pharmacists identified DRPs among 52.4% and 43.1% of the 633 patients at consultation 1 and 2, respectively. Of the DRPs reported in consultation 1, 43.7% were solved at consultation 2. Among patients with side effects, patients who received advice on managing these in consultation 1 where more likely to have solved problems at consultation 2 (61.2% vs. 42.6%, p = 0.008). Female gender, high BMQ concern and the number of new medicines were associated with DRPs. Patients were highly satisfied with the intervention. Predictors of satisfaction were female gender, older age, higher BMQ necessity, face-to-face consultations, longer duration of consultation 1, and solved problems in consultation 2.. The results indicate that the pharmacist-led follow-up intervention can aid early identification and solving of DRPs in patients prescribed new cardiovascular drugs. Knowledge of factors associated with DRPs and patients' satisfaction may allow further improvement of the intervention.

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Patient Satisfaction; Personal Satisfaction; Pharmacists; Referral and Consultation

Topics: Cardiovascular Agents; Digoxin; Disease Progression; Drug-Related Side Effects and Adverse Reactions; Heart Rate; Hospitalization; Humans; Immunoglobulin Fab Fragments; Potassium

Signal detection yields confirmed signals in only 2.1%, which imposes a heavy burden on the pharmacovigilance system in the European Union.. We aimed to develop a network theoretical metric to increase the confirmed signal ratio of individual case safety report (ICSR) networks.. ICSRs of five cardiovascular adverse events were requested from EudraVigilance. We developed Vigilace™, a web-based application to build network representation of ICSRs. Three network-based signal scores, which we termed NEWS (normalized edge weight for signals) scores, were calculated by normalizing the weight of each edge in the report-based weighted network by the weight of the same edge in topological weighted networks. Depending on the third node in topological network edges, we defined full-, adverse event-, and drug-type NEWS scores. Area under the receiver operating characteristic curves (AUROC) were analyzed to compare the reporting odds ratio (ROR) and NEWS scores.. Overall, 72,475 ICSRs were accessed from EudraVigilance. Drug-type NEWS (NEWS. This is the first demonstration that report-based weighting normalized by topological weighting of co-reported drugs, which we termed as NEWS

Topics: Adverse Drug Reaction Reporting Systems; Cardiovascular Agents; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; European Union; Humans; Long QT Syndrome; Pharmacovigilance

Between 2012 and 2017, the FDA approved 29 therapies for a cardiovascular disease (CVD) indication. Due to the limited literature on patient safety outcomes for recently approved CVD medications, this study investigated adverse drug reports (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).. A disproportionality analysis of spontaneously reported ADR was conducted. Reports in FAERS from Quarter 1, 2012, through Quarter 1, 2019, were compiled, allowing a 2-year buffer following drug approval in 2017. Top 10 reported ADRs and reporting odds ratios (ROR; confidence interval (CI)), a measure of disproportionality, were analyzed and compared to drugs available prior to 2012 as appropriate.. Of 7,952,147 ADR reports, 95,016 (1.19%) consisted of reports for newly approved CVD medications. For oral anticoagulants, apixaban had significantly lower reports for anemia and renal failure compared to dabigatran and rivaroxaban but greater reports for neurological signs/symptoms, and arrhythmias. Evaluating heart failure drugs, sacubitril/valsartan had greater reports for acute kidney injury, coughing, potassium imbalances, and renal impairment but notably, lower for angioedema compared to lisinopril. Assessing familial hypercholesterolemia drugs, alirocumab had greater reports for joint-related-signs/symptoms compared to other agents in this category. A newer pulmonary arterial hypertension treatment, selexipag, had greater reports of reporting for bone/joint-related-signs/symptoms but riociguat had greater reports for hemorrhages and vascular hypotension.. Pharmacovigilance studies allow an essential opportunity to evaluate the safety profile of CVD medications in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved CVD medications.

Topics: Adverse Drug Reaction Reporting Systems; Aminobutyrates; Arrhythmias, Cardiac; Biphenyl Compounds; Cardiovascular Agents; Cardiovascular Diseases; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; United States; United States Food and Drug Administration

Topics: Cardiovascular Agents; Digoxin; Drug-Related Side Effects and Adverse Reactions; Humans; Immunoglobulin Fab Fragments; Poisoning

For acute digoxin poisoning, it has been recommended to give bolus doses of 10-20 vials or potentially larger than needed doses calculated from dose ingested or the measured concentration. However, a recent revision of internal Poisons Information Centre guidelines prompted a change of our recommendations, specifically instead of large boluses, to use titrating repeated low doses of digoxin antibodies(Digoxin-Fab) based on bedside assessment of cardiac toxicity.. This is a prospective observational study of patients with acute digoxin poisoning identified through two Poisons Information Centres and three toxicology units. Patient demographics, signs and symptoms of digoxin toxicity, doses and response to Digoxin-Fab, free and bound serum digoxin concentrations. Outcomes were recorded and analysed.. From September 2013 to September 2020, 23 patients with 25 presentations (median age 56 years, females 56%) were recruited. Median dose ingested was 13 mg(IQR: 9.5-25). Median heart rate (HR) was 41 beats/min before treatment. Initial median digoxin and potassium concentrations were 14.5 nmol/L (IQR: 10.9-20) [11.2 µg/L(IQR: 8.4-15.4)] and 5 mmol/L (IQR: 4.5-5.4 mmol/L), respectively. Gastrointestinal symptoms and acute kidney injury were present in 22 patients (88%) and 5 patients (20%), respectively. Four patients received an initial bolus dose of Digoxin-Fab of 5-20 vials. Twenty-one patients received repeated titrated doses (1-2 vials) of Digoxin-Fab and the median total dose was 4 vials (IQR: 2-7.5). Median maximal change in HR post-Digoxin-Fab was 19 beats/min. The median potassium concentration decrease post-Digoxin-Fab was 0.3 mmol/L. Total dose used in the titration group was 25% and 35% of the predicted doses based on the amount of digoxin ingested or measured serum concentration, respectively. Twelve had free digoxin concentrations measured. Free digoxin concentrations dropped to almost zero after any dose of Digoxin-Fab. Ten patients had a rebound of digoxin >2.6 nmol/L (2 µg/L). There were no deaths from acute digoxin toxicity.. The new practice of using small, titrated doses of Digoxin-Fab led to a considerable reduction in total usage and major savings. The clinical response to titrated doses was safe and acceptable in acute digoxin poisoning.

Topics: Cardiovascular Agents; Digoxin; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Immunoglobulin Fab Fragments; Middle Aged; Poisoning; Potassium

Colchicine is one of the more ancient drugs of vegetal origin still in use in clinical practice. It has been used for centuries as drug to treat gout, but its anti-inflammatory effects made it efficacious also in different cardiovascular indications (e.g. pericarditis, acute and chronic coronary syndromes, atrial fibrillation), that are well beyond its original indication. The treatment and prevention of pericarditis is the only registered cardiovascular indication in Italy (allowing prescription in class A by the National Healthcare System), while other indications are off-label. When used at low doses (0.5 mg/day), the drug is safe and efficacious with limited side effects, mainly gastrointestinal. Gastrointestinal absorption is fast since the drug is a small lipophilic molecule that is eliminated by cells through P-glycoprotein. Colchicine is metabolized by cytochrome P450 in the liver and mainly excreted into the biliary tract. It is also excreted, essentially unmodified, by the kidneys. It is concentrated in white blood cells, especially neutrophils, that are without P-glycoprotein. In these cells, blocking tubulin polymerization, colchicine reduces their function, also interfering with endothelial adhesion and platelet interactions. Moreover, it is responsible for a non-specific inhibition of the inflammasome, thus reducing the generation of pro-inflammatory cytokines, such as interleukin-1. The aim of this paper is to provide concise replies to the most common clinical questions on the use of colchicine for cardiovascular indications.

Topics: Atrial Fibrillation; Cardiovascular Agents; Colchicine; Drug-Related Side Effects and Adverse Reactions; Humans; Pericarditis

Guideline-based management of cardiovascular disease often involves prescribing multiple medications, which contributes to polypharmacy and risk for adverse drug events in older adults. Deprescribing is a potential strategy to mitigate these risks. We sought to characterize and compare clinician perspectives regarding deprescribing cardiovascular medications across three specialties.. National cross-sectional survey.. Ambulatory.. Random sample of geriatricians, general internists, and cardiologists from the American College of Physicians.. Electronic survey assessing clinical practice of deprescribing cardiovascular medications, reasons and barriers to deprescribing, and choice of medications to deprescribe in hypothetical clinical cases.. In each specialty, 750 physicians were surveyed, with a response rate of 26% for geriatricians, 26% for general internists, and 12% for cardiologists. Over 80% of respondents within each specialty reported that they had recently considered deprescribing a cardiovascular medication. Adverse drug reactions were the most common reason for deprescribing for all specialties. Geriatricians also commonly reported deprescribing in the setting of limited life expectancy. Barriers to deprescribing were shared across specialties and included concerns about interfering with other physicians' treatment plans and patient reluctance. In hypothetical cases, over 90% of physicians in each specialty chose to deprescribe when patients experienced adverse drug reactions. Geriatricians were most likely and cardiologists were least likely to consider deprescribing cardiovascular medications in cases of limited life expectancy (all P < .001), such as recurrent metastatic cancer (84% of geriatricians, 68% of general internists, and 45% of cardiologists), Alzheimer dementia (92% of geriatricians, 81% of general internists, and 59% of cardiologists), or significant functional impairment (83% of geriatricians, 68% of general internists, and 45% of cardiologists).. While barriers to deprescribing cardiovascular medications are shared across specialties, reasons for deprescribing, especially in the setting of limited life expectancy, varied. Implementing deprescribing will require improved processes for both physician-physician and physician-patient communication. J Am Geriatr Soc 68:78-86, 2019.

Topics: Aged; Cardiologists; Cardiovascular Agents; Cardiovascular Diseases; Chronic Disease; Cross-Sectional Studies; Deprescriptions; Drug-Related Side Effects and Adverse Reactions; Female; Frail Elderly; Geriatricians; Humans; Life Expectancy; Male; Surveys and Questionnaires; United States

The 'My Experience of Taking Medicines' (MYMEDS) questionnaire is a self-reporting tool for identifying modifiable adherence barriers among individuals prescribed post-myocardial infarction (MI) secondary prevention medicines (SPM) in clinical practice. It was found to be a useful tool to support the conduction of patient-centred consultation in cardiology outpatient leading to improved outcomes including better adherence to SPM and patient satisfaction. This study describes the rationale and development of the MYMEDS tool, its performance and usefulness in identifying modifiable barriers to adherence in cardiology medical practice including user feedback of 204 consecutive post-MI patients who completed an evaluation based on MYMEDS.. Modifiable non-adherence factors were initially identified based on literature review and stakeholder feedback. A draft MYMEDS questionnaire was piloted in 10 patients and adapted accordingly. The final version comprises six sections, covering current medicines, understanding and satisfaction with medicines, concerns about medicines, practical adherence barriers, fitting medicines into daily routine, and adherence to individual SPMs. The questionnaire was mailed to post-MI patients who then attended an outpatient medicines optimisation clinic.. Mean age was 70.5 years and 67.6% were male. The tool was effective in revealing modifiable adherence barriers that could be addressed during the consultation. There were high rates of concern that SPMs could be harmful (33.2%) or overprescribed (43.2%), practical issues with swallowing medicines (8.2%), opening packaging (7.3%) or accessing repeat prescriptions (5.2%), forgetfulness (19.7%), and concerns about inconvenience (13.5%). Mean number of barriers per patient was 1.8 ± 1.5. The medications most commonly associated with non-adherence were statins (21.5%), angiotensin II receptor blockers (21.1%), and antiplatelet agents (18.5%). In total, 42.5% of patients acknowledged non-adherence behaviour. Patient feedback on MYMEDS was positive, with near-unanimous agreement that it was simple, clear and not too long, and that it enabled them to raise any concerns they had about their medicines. Patients reported that their individual medicines related needs were better addressed.. MYMEDS is a practical tool that can successfully identify modifiable barriers to SPM adherence which can be addressed in a clinical setting. It can be easily rolled out in daily clinical practice to enable individualised person-centred medicines optimisation consultation.

Topics: Administration, Oral; Aged; Aged, 80 and over; Biofeedback, Psychology; Cardiovascular Agents; Decision Making, Shared; Deglutition; Drug Packaging; Drug-Related Side Effects and Adverse Reactions; Female; Health Knowledge, Attitudes, Practice; Humans; Inappropriate Prescribing; Male; Medication Adherence; Middle Aged; Myocardial Infarction; Patient Satisfaction; Predictive Value of Tests; Secondary Prevention; Self Report; Surveys and Questionnaires

Topics: Age Factors; Aged; Aged, 80 and over; Aging; Cardiovascular Agents; Cardiovascular Diseases; Drug Interactions; Drug Prescriptions; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Medication Adherence; Polypharmacy

The severity of cardiotropic agents overuse is related to the risk of cardiac and hemodynamic life-threatening situations. Toxicity is attributed to their narrow therapeutic spectrum and pharmacodynamic properties. The clinical presentation, however, remains polymorphic and represents a challenge for the emergency physician to relate accountability to the exact agent.. To evaluate epidemiological, clinical and prognostic profile of patients visiting emergency department in whom iatrogeny secondary to cardiotropic use was diagnosed.. This was a single-center prospective study over 12 months. We included successively all patients aged over 18 years in whom diagnosis of cardiotropic iatrogeny was made. Cardiotropic related drug-induced events were selected after collegial decision making processing. Prognosis was evaluated in terms of severity and mortality at day 30. Univariate analysis was conducted. P<0.05 was significant.. We enrolled 51 patients. Median age was 72 years with IQR (25,75) of (62,78). Sex ratio was 0.64. Twenty cases of misuse were identified (39%) with 51% of cases being related to the physician. Accountability of the adverse drug event (ADE) was 51%. The ADE was considered severe in 45% of cases and the death rate on day 30 was 12%. Drug classes were dominated by beta-blockers in 20 patients (39%) and anti-arrhythmic agents (Amiodarone ®) in 18 patients (35%). Beta-blockers were significantly the most incriminated in the occurrence of severe ADE. A double iatrogeny was found in 13 patients (25%). Misuse and physician-related ADE were found to be predictive of the severity of ADE in univariate analysis with respectively: For misuse:(OR brut=22, CI95%=[5.2;93.5] ; p<0.001) and for related physician ADE (OR brut = 3,7 ; CI95%=[1.1;12] ; P= 0.015). Predictive factors of mortality at day 30 in the univariate analysis were: Past renal failure : OR brut 5,8; CI95%[1,3-26,5]; p=0,015 ; misuse with OR brut=16.7, 95% CI=[1.9-143.5], p=0.002 and severe ADE with OR brut=15, 95% CI=[1.75-129], p=0.032.. This study showed that ADE related to Cardiotropic agents are frequent and remain a serious condition especially in elderly. Betablockers agents were the mostly incriminated therapeutic class in the severity of the clinical condition by its hemodynamic repercussions responsible of a high rate of hospitalizations and mortality. Misuse and physician-related ADE were found to be predictive of the severity. Whereas, occurrence of severe ADE, misuse and past renal failure were predictive of mortality. Moreover, in 51% patients, ADE was preventable and related to the prescription of physician showing the main role of the preventability and the role of the prescriber in the genesis of this severe condition.

Topics: Adult; Aged; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Humans; Male; Middle Aged; Prognosis; Prospective Studies

Hypomagnesemia has been associated with diabetes, cardiovascular disease, and other disorders. Drug use has been suggested as one of the risk factors for low magnesium (Mg) levels. In the elderly population, prone to polypharmacy and inadequate Mg intake, hypomagnesemia might be relevant. Therefore, we aimed to investigate associations between drug use and plasma Mg.. Cross-sectional data of 343 Dutch geriatric outpatients were analysed by Cox and linear regression, while adjusting for covariates. Drug groups were coded according to the Anatomical Therapeutic Chemical classification system; use was compared to non-use. Hypomagnesemia was defined as plasma Mg < 0.75 mmol/l and <0.70 mmol/l.. Prevalence of hypomagnesemia was 22.2% (Mg < 0.75 mmol/l) or 12.2% (Mg < 0.70 mmol/l); 67.6% of the patients used ≥5 medications (polypharmacy). The number of different drugs used was inversely linearly associated with Mg level (beta -0.01; p < 0.01). Fully adjusted Cox regression showed significant associations of polypharmacy with hypomagnesemia (Mg < 0.75 mmol/l) (prevalence ratio (PR) 1.81; 95%CI 1.08-3.14), proton pump inhibitors (PR 1.80; 95%CI 1.20-2.72), and metformin (PR 2.34; 95%CI 1.56-3.50). Moreover, stratified analyses pointed towards associations with calcium supplements (PR 2.26; 95%CI 1.20-4.26), insulins (PR 3.88; 95%CI 2.19-6.86), vitamin K antagonists (PR 2.01; 95%CI 1.05-3.85), statins (PR 2.44; 95%CI 1.31-4.56), and bisphosphonates (PR 2.97; 95%CI 1.65-5.36) in patients <80 years; selective beta blockers (PR 2.01; 95%CI 1.19-3.40) if BMI <27.0 kg/m. As polypharmacy and several medications are associated with hypomagnesemia, Mg merits more attention, particularly in diabetes, cardiovascular disease, and in side-effects of proton pump inhibitors and calcium supplements.

Topics: Aged; Aged, 80 and over; Ambulatory Care; Cardiovascular Agents; Cross-Sectional Studies; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Hypoglycemic Agents; Magnesium; Magnesium Deficiency; Male; Polypharmacy; Prevalence; Risk Factors

Cardiovascular diseases (CVDs) are extremely common among the elderly, but information on the use of potentially inappropriate medications (PIMs) with cardiovascular risk is scarce. We aimed to determine the prevalence of PIMs with risk of cardiac and cerebrovascular adverse events (CCVAEs), including major adverse cardiac and cerebrovascular events (MACCE).. A cross-sectional study was performed using a convenience sample from four long-term care facilities and one community pharmacy in Portugal. Patients were included if they were aged 65 or older and presented at least one type of medication in their medical and pharmacotherapeutic records from 2015 until December 2017. The main outcome was defined as the presence of PIMs with risk of MACCE and was assessed by applying a PIM-MACCE list that was developed from a previous study. All medications included in this list were assessed for their availability in Portugal.. A total of 680 patients were included. Of those, 428 (63%) were female with a mean age of 78.4±8.1 years. Four-hundred and four (59.4%) patients were taking medications associated with CCVAEs risk (mean =1.7±1.0 drugs/patient), including 264 patients (38.8%) who used drugs with MACCE risk (mean =1.4±0.8 drugs/patient). Fifty percent of patients with a previous history of CVD (n=521) were taking PIMs with risk of CCVAEs, including 30.0% with risk of MACCE.. Our findings show that 50% of patients with previous history of CVD were taking drugs with risk of CCAVEs and 30% with risk of MACCE. More tailored tools for the management of drug therapy in elderly patients with CVD are of major importance in clinical practice.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Inappropriate Prescribing; Long-Term Care; Male; Portugal; Potentially Inappropriate Medication List; Prevalence; Retrospective Studies; Skilled Nursing Facilities

Predicting adverse drug reactions (ADRs) has become very important owing to the huge global health burden and failure of drugs. This indicates a need for prior prediction of probable ADRs in preclinical stages which can improve drug failures and reduce the time and cost of development thus providing efficient and safer therapeutic options for patients. Though several approaches have been put forward for in silico ADR prediction, there is still room for improvement.. In the present work, we have used machine learning based approach for cardiovascular (CV) ADRs prediction by integrating different features of drugs, biological (drug transporters, targets and enzymes), chemical (substructure fingerprints) and phenotypic (therapeutic indications and other identified ADRs), and their two and three level combinations. To recognize quality and important features, we used minimum redundancy maximum relevance approach while synthetic minority over-sampling technique balancing method was used to introduce a balance in the training sets.. This is a rigorous and comprehensive study which involved the generation of a total of 504 computational models for 36 CV ADRs using two state-of-the-art machine-learning algorithms: random forest and sequential minimization optimization. All the models had an accuracy of around 90% and the biological and chemical features models were more informative as compared to the models generated using chemical features.. The results obtained demonstrated that the predictive models generated in the present study were highly accurate, and the phenotypic information of the drugs played the most important role in drug ADRs prediction. Furthermore, the results also showed that using the proposed method, different drugs properties can be combined to build computational predictive models which can effectively predict potential ADRs during early stages of drug development.

Topics: Algorithms; Cardiovascular Agents; Computer Simulation; Databases as Topic; Drug-Related Side Effects and Adverse Reactions; Humans; Machine Learning; Phenotype; Reproducibility of Results

Medication use during pregnancy is gradually increasing; however, the safety of this practice remains largely unknown.We investigated medications with the most adverse drug reactions (ADRs) among pregnant women and the clinical features of those medications.Reports of ADRs among pregnant women were extracted from the Korea Adverse Events Reporting System (January 2012-December 2015). We analyzed the data of drugs frequently reported to cause ADRs and their clinical features among 3 age groups.A total of 5642 ADRs among 3428 patients were analyzed. The number of ADR reports increased annually. The most common drug categories causing ADRs were analgesics, followed by gynecologic, uterotocolytic, anti-infective, antidiabetic, analgesic, and antihypertensive drugs. Analgesics comprised 6 opioids (morphine, fentanyl, hydromorphone, oxycodone, tramadol, pethidine) and an anti-pyretics (nefopam and ketorolac). As an individual drug, ritodrine (24.4%) was the most frequently reported, followed by morphine, 5-HT3 serotonin antagonist, nefopam, fentanyl, magnesium sulfate, insulin lispro, cefazedone, sodium chloride, hydromorphone, oxycodone, cefotetan, nifedipine, human insulin, tramadol, ketorolac, pethidine, methylergometrine, metoclopramide, and misoprostol (in that order). ADRs most frequently occurred in women aged 25 to 34 years, and the trend of ADR with the 20 most commonly reported medications significantly differed among the age groups (P = .011). In addition, the kind of common causative drugs was different among the age groups.Knowledge of medications and clinical conditions resulting in the highest ADR rates among pregnant women is necessary for medical practitioners to administer proper care.

Topics: Adolescent; Adult; Age Factors; Analgesics; Analgesics, Opioid; Anti-Bacterial Agents; Antiemetics; Blood Substitutes; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Hypoglycemic Agents; Middle Aged; Pregnancy; Republic of Korea; Ritodrine; Severity of Illness Index; Young Adult

Adverse drug effects (ADEs) are one of the leading causes of death in developed countries and are the main reason for drug recalls from the market, whereas the ADEs that are associated with action on the cardiovascular system are the most dangerous and widespread. The treatment of human diseases often requires the intake of several drugs, which can lead to undesirable drug-drug interactions (DDIs), thus causing an increase in the frequency and severity of ADEs. An evaluation of DDI-induced ADEs is a nontrivial task and requires numerous experimental and clinical studies. Therefore, we developed a computational approach to assess the cardiovascular ADEs of DDIs. This approach is based on the combined analysis of spontaneous reports (SRs) and predicted drug-target interactions to estimate the five cardiovascular ADEs that are induced by DDIs, namely, myocardial infarction, ischemic stroke, ventricular tachycardia, cardiac failure, and arterial hypertension. We applied a method based on least absolute shrinkage and selection operator (LASSO) logistic regression to SRs for the identification of interacting pairs of drugs causing corresponding ADEs, as well as noninteracting pairs of drugs. As a result, five datasets containing, on average, 3100 potentially ADE-causing and non-ADE-causing drug pairs were created. The obtained data, along with information on the interaction of drugs with 1553 human targets predicted by PASS Targets software, were used to create five classification models using the Random Forest method. The average area under the ROC curve of the obtained models, sensitivity, specificity and balanced accuracy were 0.837, 0.764, 0.754 and 0.759, respectively. The predicted drug targets were also used to hypothesize the potential mechanisms of DDI-induced ventricular tachycardia for the top-scoring drug pairs. The created five classification models can be used for the identification of drug combinations that are potentially the most or least dangerous for the cardiovascular system.

Topics: Cardiovascular Agents; Databases, Factual; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans

The management of drug-drug interactions (DDIs) is a complex process in which risk-benefit assessments should be combined with the patient's perspective.. The aim of this study was to determine patients' and pharmacists' preferences regarding DDI management.. We conducted a choice-based conjoint survey about a fictitious DDI concerning the combination of a cardiovascular drug and an antibiotic for pneumonia. Patients and pharmacists had to choose 12 times between two management options. The options were described by five attributes, including risk, benefit and practical consequences. Each attribute could have two different levels, which were varied over the choice tasks. Latent class analysis was used to identify potential classes of respondents with distinct patterns of similar preferences.. In total, 298 patients and 178 pharmacists completed the questionnaire. The latent class model for both patients and pharmacists resulted in three classes. For patients, in one class the most importance was attached to avoiding switch of medication (class probability 20%), in a second class to fewer adverse events (41%), and in a third class to blood sampling (39%). For pharmacists, again one class attached the highest importance to avoiding switch of medication (31%). The other classes gave priority to curing pneumonia (31%) and avoiding blood sampling (38%).. The results showed diverging preferences regarding DDI management among both patients and pharmacists. Different groups attached different value to risk and benefit versus practical considerations. Awareness of existing variability in preferences among and between pharmacists and patients is a step towards shared decision making in DDI management.

Topics: Anti-Bacterial Agents; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Pharmacists; Pneumonia; Risk; Surveys and Questionnaires

To study the association between the potential inappropriate prescriptions (PIP) and the 30 and 180-day adverse event rate after discharge from a Short Stay Unit (SSU).. A retrospective cohort observational study was conducted on patients aged ≥75years discharged from an SSU from February to April, 2014. STOPP-START criteria version2 was used. The main outcome was 30 and 180-day adverse event rate after being discharged.. A total of 179 patients, with a mean age of 84 (SD5) years were included. The presence of ≥1PIP after being discharged was not associated with a 30 and 180-day composite adverse event. Patients with ≥1PIP related to a cerebro-cardiovascular process were at higher risk of an adverse event at 30 days after discharge (adjusted OR, 2.1; 95%CI: 1.0-3.2; P=.045), those with ≥1PIP related to neuropsychiatric process and risk of fall were at higher risk of increased 30-day functional impairment (adjusted OR, 6.3; 95%CI: 1.7-22.5; P=.005), and those with ≥1PIP related to omission of cardiovascular system were at higher risk of 180-day hospital readmission (adjusted OR, 3.6; 95%CI: 1.5-8.3; P=.003).. The presence of adverse events in older patients discharged from SSU may be associated with PIP, identified by STOPP-START criteria, and more specifically with drugs related to cardiovascular, neuropsychiatric disorders, and falls.

Topics: Accidental Falls; Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Humans; Inappropriate Prescribing; Length of Stay; Male; Patient Discharge; Patient Readmission; Psychotropic Drugs; Retrospective Studies; Time Factors

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases.. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends.. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01).. Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported.

Topics: Adverse Drug Reaction Reporting Systems; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Drugs, Generic; Humans; Interrupted Time Series Analysis; United States; United States Food and Drug Administration

Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation.. Information was obtained from risk management plans, study protocols, clinical study reports, and assessment reports of 157 medicinal products authorized for cardiovascular, endocrinology, and metabolic indications. We selected observational studies measuring, as outcomes of interest, the relationship between the RMMs in place and (1) implementation measures, such as clinical knowledge or physicians` compliance to recommendations contained in the RMMs; and (2) occurrence or reduced severity of the adverse drug reactions for which the RMMs were required.. Of 59 eligible studies (24 completed, 35 ongoing), 44 assessed implementation measures, whereas only 15 assessed safety outcomes (1 study as a single endpoint and 14 studies with other endpoints). Fifty-one studies used non-experimental designs and 25 studies employed electronic healthcare databases for analysis. Of the 24 completed studies, 17 were considered satisfactory and supported immediate regulatory decision making, 6 were considered inconclusive and required new evaluations, and 1 was terminated early because new safety restrictions were required, thereby necessitating a new evaluation. Compliance with agreed deadlines was considered acceptable in 21 of 24 completed studies; the average time for a submission was 37 months (standard deviation ± 17), with differences observed by type of data source employed.. Three important gaps in the evaluation plans of RMMs were identified: lack of early feedback on implementation, limited evaluation of safety outcomes, and inability to provide information on the effectiveness from an integrated measurement of different elements of a set of risk minimization tools. More robust evidence is needed to advance regulatory science and support more rapid adjustment of risk minimization strategies as needed.

Topics: Cardiovascular Agents; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Endocrinology; Humans; Observational Studies as Topic; Pharmaceutical Preparations; Research Design; Risk

The management of drug-drug interactions (DDIs) involves a complex risk-benefit assessment, in which patients' preferences should be taken into account. The aim of this study was to examine the aspects influencing patients' preferences with regard to DDI management options.. A qualitative study consisting of five focus groups with patients chronically using cardiovascular drugs was conducted. Key questions concerned preferences regarding DDI management options for a provided fictitious DDI. Thematic analysis of the verbatim transcripts was performed.. Despite their limited knowledge with respect to DDIs, patients easily chose a management option for the presented DDI. When additional information was provided, preferences showed to be fluid. Ten interdependent aspects influencing preferences were derived from patients' argumentations: risk perception, fear, acceptance of uncertainty, openness to change, willingness to take risk, trust in health care professional, financial & practical burdens, health condition, experience, and knowledge & assumptions.. Patients' preferences regarding DDI management options were often determined by provided information. Preferences were dependent on an interplay of diverse aspects.. Tailored provision of information and individualized counseling is needed for active patient involvement in DDI decision making.

Topics: Adult; Cardiovascular Agents; Cardiovascular Diseases; Community Pharmacy Services; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Focus Groups; Humans; Male; Middle Aged; Patient Participation; Patient Preference; Pharmacists; Qualitative Research

Adults aged >65 years are susceptible to intentional and unintentional poisoning, with contributing factors that include polypharmacy, comorbidity, susceptibility to medication error, and gaps in research. Although toxicologists are often tasked with managing and preventing poisoning among older adults, little is known about sex differences in these poisonings. The aim of this study was to review sex differences in poisonings among older adults managed at the bedside by medical toxicologists.. All case subjects aged >65 years in the Toxicology Investigators Consortium (ToxIC) registry between January 2010 and December 2016 were reviewed. Data included reasons for exposure and consultation, exposure agents and routes, presenting clinical findings, and treatment provided. Cases missing age, sex, or primary reason for toxicology consultation data were excluded. We used χ. Among 51,441 total registry cases, 542 (1.05%) were excluded because of missing data. Among the remaining 50,899 cases, 2930 (5.8%) were included for age >65 years; 52.3% of older adults were female. Race was missing or unknown for 49.2% of cases. Adverse drug reactions were more commonly encountered in female subjects than in their male counterparts (9.6% vs 6.4%; P = 0.001). No statistically significant sex differences were observed for total numbers of intentional, unintentional pharmaceutical, and nonpharmaceutical exposures. The most common medications involved were cardiovascular (16.8%) and analgesics/opioids (14.8%). Female subjects were more likely than male subjects to be evaluated by a toxicologist for cardiovascular medications (18.7% vs 14.7%; P = 0.004) and analgesics/opioids (17.6% vs 11.8%; P < 0.001). Male subjects were more likely than female subjects to be evaluated for ethanol toxicity (7.4% vs 1%; P < 0.001) and for envenomations (4.2% vs 1.8%; P < 0.001). The most common route of exposure was oral ingestion (81.3%). Signs/symptoms were noted in 54.8% of cases, with the most common abnormal vital sign being bradycardia (17.2%). Pharmacologic support was the most common intervention and was more common in male subjects than in female subjects (17.7% vs 12.3%; P < 0.001). Deaths were reported in 38 female subjects (2.45%) and 46 male subjects (3.34%); there was no statistically significant difference in death rate according to sex (P = 0.148).. Older female adults were more commonly evaluated by a medical toxicologist for an adverse drug reaction than older male adults. Female patients were more likely than male patients to be evaluated for poisoning related to analgesic/opioids and cardiovascular medications, and older male patients more frequently received pharmacologic support than older female patients. No significant sex differences were observed in numbers of toxicology consultations for intentional, unintentional pharmaceutical, and nonpharmaceutical exposures.

Topics: Aged; Analgesics, Opioid; Bites and Stings; Cardiovascular Agents; Drug Overdose; Drug-Related Side Effects and Adverse Reactions; Ethanol; Female; Humans; Male; Medication Errors; Poisoning; Polypharmacy; Registries; Sex Factors; United States

Genome-wide association studies have identified multiple loci associated with coronary artery disease and myocardial infarction, but only a few of these loci are current targets for on-market medications. To identify drugs suitable for repurposing and their targets, we created 2 unique pipelines integrating public data on 49 coronary artery disease/myocardial infarction-genome-wide association studies loci, drug-gene interactions, side effects, and chemical interactions.. We first used publicly available genome-wide association studies results on all phenotypes to predict relevant side effects, identified drug-gene interactions, and prioritized candidates for repurposing among existing drugs. Second, we prioritized gene product targets by calculating a druggability score to estimate how accessible pockets of coronary artery disease/myocardial infarction-associated gene products are, then used again the genome-wide association studies results to predict side effects, excluded loci with widespread cross-tissue expression to avoid housekeeping and genes involved in vital processes and accordingly ranked the remaining gene products.. These pipelines ultimately led to 3 suggestions for drug repurposing: pentolinium, adenosine triphosphate, and riociguat (to target CHRNB4, ACSS2, and GUCY1A3, respectively); and 3 proteins for drug development: LMOD1 (leiomodin 1), HIP1 (huntingtin-interacting protein 1), and PPP2R3A (protein phosphatase 2, regulatory subunit b-double prime, α). Most current therapies for coronary artery disease/myocardial infarction treatment were also rediscovered.. Integration of genomic and pharmacological data may prove beneficial for drug repurposing and development, as evidence from our pipelines suggests.

Topics: Algorithms; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug Discovery; Drug Evaluation, Preclinical; Drug Interactions; Drug Repositioning; Drug-Related Side Effects and Adverse Reactions; Gene-Environment Interaction; Genetic Loci; Genetic Predisposition to Disease; Genome-Wide Association Study; Humans; Molecular Docking Simulation; Molecular Targeted Therapy; Pharmacogenomic Testing; Polymorphism, Single Nucleotide; Risk Factors

Prior studies have not examined national trends and characteristics of unintentional non-health care facility (HCF) medication errors associated with cardiovascular drugs.. To investigate non-HCF medication errors associated with cardiovascular drugs reported to poison control centers in the United States.. A retrospective analysis of non-HCF medication errors associated with cardiovascular drugs from 2000 to 2012 was conducted using the National Poison Data System database.. There were 278 444 medication errors associated with cardiovascular drugs reported to US poison control centers during the study period, averaging 21 419 exposures annually. The overall rate of cardiovascular medication errors per 100 000 population increased 104.6% from 2000 to 2012 ( P < 0.001) and the highest rates were among older adults. Most cases (83.6%) did not require treatment at a HCF. Serious medical outcomes were reported in 4.0% of exposures. The cardiovascular drugs most commonly implicated in medication errors were β-blockers (28.2%), calcium antagonists (17.7%), and angiotensin-converting enzyme inhibitors (15.9%). Most of the 114 deaths were associated with cardiac glycosides (47.4%) or calcium antagonists (29.8%). Most medication errors involved taking or being given a medication twice (52.6%).. This study describes characteristics and trends of non-HCF cardiovascular medication errors over a 13-year period in the United States. The number and rate of cardiovascular medication errors increased steadily from 2000 to 2012, with the highest error rates among older adults. Further research is needed to identify prevention strategies for these errors, with a particular focus on the older adult population.

Topics: Adult; Adverse Drug Reaction Reporting Systems; Cardiovascular Agents; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Information Systems; Male; Medication Errors; Poison Control Centers; Retrospective Studies; United States

The use of potentially inappropriate medications (PIMs) may pose more risks than benefits to patients and is a major factor contributing to the likelihood of serious adverse drug reactions and negative health outcomes among older patients.. A retrospective chart review was conducted in a tertiary care center in USA where home medications of the older patients were reviewed and analyzed upon hospital admission over three months, from March till May 2016. Inclusion criteria were age of 65 years and above, history of cardiovascular disease, and admission to the cardiology service. The aim of our study was to determine the frequency and factors associated with PIMs, by applying the updated Beers 2015 criteria.. A total of 404 patients were included in the study and were taking a total of 4669 medications at home, an average of 11.6 ± 4.5 medications per patient. The proportion of PIMS was 20% of all medications reported, with an average of 2.4 PIM per patient, and 87.4% of patients were receiving at least one PIM. Significant association was found between use of PIMs and number of home medications, female gender, and number and types of comorbidities. Comorbidities associated with more PIMs were heart failure, atrial fibrillation/flutter, history of falls/fractures, cerebrovascular accident, and depression. The most commonly prescribed PIMs were: drugs that may exacerbate or cause syndrome of inappropriate antidiuretic hormone secretion or hyponatremia (29.7%), scheduled use of proton pump inhibitors (PPIs) > 8 weeks in non-high-risk patients (11.3%), and benzodiazepines (8.1%).. A high prevalence of PIMs in older patients with cardiovascular disease was observed. Provider education and detailed assessment of medication lists upon hospital admission by multidisciplinary teams can help in preventing the use of PIMs.

Topics: Age Factors; Aged; Aged, 80 and over; Alabama; Cardiology Service, Hospital; Cardiovascular Agents; Cardiovascular Diseases; Comorbidity; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Patient Admission; Polypharmacy; Potentially Inappropriate Medication List; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Tertiary Care Centers; Time Factors

With increased usage of cardiovascular drugs (CVDs) for treating cardiovascular diseases, it is important to analyze CVD-associated adverse events (AEs). In this study, we systematically collected package insert-reported AEs associated with CVDs used in China, and developed and analyzed an Ontology of Cardiovascular Drug AEs (OCVDAE). Extending the Ontology of AEs (OAE) and NDF-RT, OCVDAE includes 194 CVDs, CVD ingredients, mechanisms of actions (MoAs), and CVD-associated 736 AEs. An AE-specific drug class effect is defined to exist when all the drugs (drug chemical ingredients or drug products) in a drug class are associated with an AE, which is formulated as a new proportional class level ratio ("PCR") = 1. Our PCR-based heatmap analysis identified many class level drug effects on different AE classes such as behavioral and neurological AE and digestive system AE. Additional drug-AE correlation tests (i.e., class-level PRR, Chi-squared, and minimal case reports) were also modified and applied to further detect statistically significant drug class effects. Two drug ingredient classes and three CVD MoA classes were found to have statistically significant class effects on 13 AEs. For example, the CVD Active Transporter Interactions class (including reserpine, indapamide, digoxin, and deslanoside) has statistically significant class effect on anorexia and diarrhea AEs.

Topics: Biological Ontologies; Cardiovascular Agents; Cardiovascular Diseases; China; Data Interpretation, Statistical; Drug-Related Side Effects and Adverse Reactions; Humans; Medicine, Chinese Traditional; Product Labeling

Topics: Antibodies; Cardiovascular Agents; Chronic Disease; Digoxin; Drug-Related Side Effects and Adverse Reactions; Humans

Topics: Cardiovascular Agents; Chronic Disease; Digoxin; Drug-Related Side Effects and Adverse Reactions; Humans

Patients hospitalized for first acute coronary syndrome (ACS) are frequently discharged on multiple new medications. The short-term tolerability of these medications is unknown.. This single-center cohort study assessed 30-day health-care utilization and how it may be impacted by medication prescribing trends. We included Olmsted County patients presenting with ACS and previously undiagnosed coronary artery disease in 2008 to 2009. All health-care contacts were reviewed 30 days after index hospital discharge for potential adverse medication effects including documented hypotension or bradycardia, or symptoms likely attributed to the medications.. The study included 86 patients; their mean age was 63 (standard deviation: 15.5 years). Antianginal or antihypertensive cardiovascular (CV) medications were prescribed to 98% of patients at discharge; 76% were prescribed 2 or more. There were 233 health-care contacts in 30 days; 90 (39%) of these contacts were unscheduled. More CV medications tended to be prescribed to patients with unscheduled contacts, both pre-ACS ( P = .045) and upon hospital discharge ( P = .051). Hypotension and/or bradycardia at follow-up occurred in 52 patients (60%). Surprisingly, there was no association between hypotension and/or bradycardia at follow-up and increased health-care utilization ( P = .12). Potential adverse drug effects were reported in 34 (40%) patients. These patients had significantly more total health-care contacts ( P < .001) and unscheduled health-care contacts (median 0 vs 1.5; P < .001).. Symptoms of adverse drug effects were associated with more frequent health-care utilization after ACS. Clinicians need to consider this while striving to increase patient compliance with post-ACS medications and optimize care transitions.

Topics: Acute Coronary Syndrome; Aged; Appointments and Schedules; Bradycardia; Cardiovascular Agents; Drug Prescriptions; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Health Resources; Humans; Hypotension; Male; Middle Aged; Minnesota; Office Visits; Patient Discharge; Patient Readmission; Polypharmacy; Practice Patterns, Physicians'; Time Factors

To determine the incidence and risk factors of hospital-acquired suspected adverse drug reactions (ADRs) among Ugandan inpatients. We also constructed risk scores to predict and qualitatively assess for peculiarities between low-risk and high-risk ADR patients.. Prospective cohort of consented adults admitted on medical and gynaecological wards of the 1790-bed Mulago National Referral Hospital. Hospital-acquired suspected ADRs were dichotomised as possible (possible/probable/definite) or not and probable (probable/definite) or not, using the Naranjo scale. Risk scores were generated from coefficients of ADR risk-factor logistic regression models.. The incidence of possible hospital-acquired suspected ADRs was 25% (194/762, 95% CI: 22% to 29%): 44% (85/194) experienced serious possible ADRs. The risk of probable ADRs was 11% (87/762, 95% CI 9% to 14%): 46% (40/87) had serious probable ADRs. Antibacterials-only (51/194), uterotonics-only (21/194), cardiovascular drugs-only (16/194), antimalarials-only (12/194) and analgesics-only (10/194) were the most frequently implicated. Treatment with six or more conventional medicines during hospitalisation (OR=2.31, 95% CI 1.29 to 4.15) and self-reported herbal medicine use during the 4 weeks preadmission (OR=1.96, 95% CI 1.22 to 3.13) were the risk factors for probable hospital-acquired ADRs. Risk factors for possible hospital-acquired ADRs were: treatment with six or more conventional medicines (OR=2.72, 95% CI 1.79 to 4.13), herbal medicine use during the 4 weeks preadmission (OR=1.68, 95% CI 1.16 to 2.43), prior 3 months hospitalisation (OR=1.57, 95% CI 1.09 to 2.26) and being on gynaecological ward (OR=2.16, 95% CI 1.36 to 3.44). More drug classes were implicated among high-risk ADR-patients, with cardiovascular drugs being the most frequently linked to possible ADRs.. The risk of hospital-acquired suspected ADRs was higher with preadmission herbal medicine use and treatment with six or more conventional medicines during hospitalisation. Our risk scores should be validated in large-scale studies and tested in routine clinical care.

Topics: Adult; Analgesics; Anti-Infective Agents; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Hospitalization; Hospitals; Humans; Incidence; Logistic Models; Male; Odds Ratio; Plant Extracts; Polypharmacy; Prospective Studies; Risk Factors; Uganda; Young Adult

Topics: Aged; Atrial Fibrillation; Cardiovascular Agents; Contraindications; Digoxin; Drug Substitution; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Female; Heart Failure, Diastolic; Humans; Hypertension; Renal Insufficiency, Chronic; Treatment Outcome; Withholding Treatment

Adverse drug reactions (ADRs) contribute to poorer patient outcomes and additional burden to the healthcare system. However, data on the true burden, relevant types and drugs causing ADRs are lacking. The aim of this study was to determine the prevalence of ADR-related hospitalization in the general adult population in Singapore and to investigate their characteristics.. We prospectively recruited 1000 adult patients with unplanned admission to a large tertiary-care hospital. Two independent reviewers evaluated all suspected ADRs for causality, type, severity and avoidability. The prevalence of ADR-related hospitalization was calculated based on 'definite' and 'probable' ADRs. Logistic regression was used to evaluate predictors for having an ADR at admission.. The prevalence of all ADRs at admission was 12.4% (95% CI: 10.5-14.6%) and ADRs causing admission was 8.1% (95% CI: 6.5-10.0%). The most common ADRs were gastrointestinal-related. The most common drug category causing ADRs were cardiovascular drugs. Patients with ADRs had a longer length of stay than those who did not (median 4 vs. 3 days, P = 1.70 × 10. We have quantified the burden and characteristics of clinically impactful ADRs in the Singaporean general adult population. Our results will provide vital information for efforts in reducing ADRs through targeted vigilance, patient education and pharmacogenomics in Singapore.

Topics: Adult; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Diseases; Humans; Male; Middle Aged; Patient Admission; Prevalence; Prospective Studies; Singapore; Tertiary Care Centers

Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW).. Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW. Case-defining features were considered relevant if the lower limit of the 99% CI > 0.5.. In SSA, 3773 (9%) of reported ADRs were for cardiometabolic drugs, in RoW for 18%. Of these, 79% originated from South Africa and 81% were received after 2007. Most reports were for drugs acting on the renin-angiotensin system (36% SSA & 14% RoW). Compared with RoW, reports were more often sent for patients 18-44 years old (log2 OR 0.95 [99 CI 0.80; 1.09]) or with non-fatal outcome (log2 OR 1.16 [99 CI 1.10; 1.22]). Eight ADRs (cough, angioedema, lip swelling, face oedema, swollen tongue, throat irritation, drug ineffective and blood glucose abnormal) and seven drugs (enalapril, rosuvastatin, perindopril, vildagliptin, insulin glulisine, nifedipine and insulin lispro) were disproportionally more reported in SSA than in the RoW.. 'In recent years, the number of adverse drug reactions (ADRs) reported in Sub-Saharan Africa (SSA) has sharply increased. The data showed the well-known population-based differential ADR profile of ACE inhibitors in the SSA population.'

Topics: Adolescent; Adult; Africa South of the Sahara; Aged; Cardiovascular Agents; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Female; Fibrinolytic Agents; Humans; Hypoglycemic Agents; Male; Middle Aged

Little is known about the emergency department (ED) visits from drug-related injury among older adults in Taiwan. This study seeks to identify risk factors associated with adverse drug events (ADEs) leading to ED visits.. We prospectively conducted a case-control study of patients 65years and older presenting to the ED. ED visits between March 1, 2009 and Feb 28, 2010 identified by investigators for suspected ADEs were further assessed by using the Naranjo Adverse Drug Reaction probability scale. For each patient with an ADE, a control was selected and time-matched from the ED population of the study hospital. The association between the risk of adverse drug events and triage, age, gender, serum alanine transaminase (ALT), serum creatinine, number of medications, and Charlson Comorbidity Index scores were analyzed using logistic regression.. Of 20,628 visits, 295 ADEs were physician-documented in older adults. Independent risk factors for ADEs included number of medications (adjusted odds ratio [OR]=4.1; 95% confidence interval [CI] 2.4-6.9 for 3-7 drugs; adjusted OR=6.4; 95% CI 3.7-11.0 for 8 or more drugs) and increased concentration of serum creatinine (adjusted OR=1.5; 95% CI 1.1-2.2). Diuretics, analgesics, cardiovascular agents, anti-diabetic agents and anticoagulants were the medications most commonly associated with an ADE leading to ED visits.. This study suggests that prevention efforts should be focused on older patients with renal insufficiency and polypharmacy who are using high risk medications such as anticoagulants, diuretics, cardiovascular agents, analgesics, and anti-diabetic agents.

Topics: Age Factors; Aged; Aged, 80 and over; Alanine Transaminase; Analgesics; Anticoagulants; Cardiovascular Agents; Case-Control Studies; Chemical and Drug Induced Liver Injury; Creatinine; Diuretics; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Humans; Hypoglycemic Agents; Logistic Models; Male; Polypharmacy; Prospective Studies; Renal Insufficiency; Risk Factors; Sex Factors; Taiwan

Medication errors may occur at any stage during the medication process and can lead to preventable adverse drug events and patients' harm. Pharmacists' support for reconcilable medication has been shown to be effective, rectifying errors and inaccuracies of the drug treatment and in the increase of medication safety. However, none of the previous studies focused on vascular patients. We investigated the nature and frequency of drug-related problems (DRPs) including the amount of potentially inappropriate medication (PIM) prescribed for elderly patients suffering from vascular diseases and the influence of pharmacists in the improvement of cardiovascular medication.. After the patients' routine admission process, medication reconciliation was performed. Therefore, a pharmacist obtained an accurate medication use history. The patients' drug therapy was critically screened for DRPs and referring to this, intervention was made by the pharmacist and communicated to the physician if necessary. Potentially inappropriate medication in the elderly was reviewed through a retrospective analysis using the Priscus-List. DRPs were documented anonymously and classified.. We identified 138 DRPs among 105 patients. Sixty-five patients experienced at least 1 DRP, accordingly 1.3 DRPs per patient. In total, 43 unintended discrepancies between current medication and admission medication were detected with an overall rate of 0.41 per patient; 100 interventions were made of which 56 resulted in explicit recommendations for prescription changes. Drug classes frequently affected by DRPs were antihypertensive in 23.9%, antithrombotic agents in 19.3% and lipid lowering agents in 12.1%. In a retrospective analysis of the home medication, 12 definite PIM were identified in 49 elderly patients.. DRPs are common in the medication of vascular surgery patients and may be improved by pharmacists.

Topics: Age Factors; Aged; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Inappropriate Prescribing; Medication Reconciliation; Middle Aged; Patient Admission; Pharmacists; Pharmacy Service, Hospital; Polypharmacy; Preoperative Care; Prospective Studies; Retrospective Studies; Risk Factors; Vascular Diseases; Vascular Surgical Procedures

Topics: Biomarkers; Cardiovascular Agents; Cardiovascular Diseases; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dose-Response Relationship, Drug; Drug-Related Side Effects and Adverse Reactions; Endpoint Determination; Heart Function Tests; Humans; Multicenter Studies as Topic; Quality of Life; Research Design; Sample Size; Stem Cell Transplantation

Adverse drug events (ADE) have been studied widely in hospitalised and emergency department (ED) patients. Less is known about the ED visits of drug-related injury in Taiwan. This study seeks to determine the incidence, risk and patient outcomes of ADE in an ED population.. We conducted a prospective observational cohort study of patients 18 years and older presenting to the ED of an urban, tertiary medical centre. ED visits between 1 March 2009 and 28 February 2010 identified by investigators for suspected ADE were further assessed by using the Naranjo Adverse Drug Reaction probability scale. Outcomes (ED disposition, injury severity and preventability) and associated variables (triage, gender, drug category, number of drugs, Charlson comorbidity index score and ADE mechanism) were measured.. Of 58,569 ED visits, 452 patients (0.77%) had physician-documented ADE. 24% of patients with ADE were hospitalised with life-threatening conditions, with a mortality rate of 10.0%. The majority of ADE were considered preventable (73.4%), and the unintentional overdose was the most common cause. Cardiovascular agents accounted for the most ADE (25.8%) and consisted of 65.3% of ADE in patients aged 65,years and older. Risk factors for ADE-related hospitalisation were elderly age (odds ratio (OR) 1.9, 95% confidence interval (CI) 1.1-3.4), severity of ADE (OR 6.9, 95% CI 3.3-14.5) and higher Charlson comorbidity index scores (OR 3.4, 95% CI 2.0-5.7).. ADE-related ED visits are not uncommon in Taiwan and many cases are preventable. ED-based surveillance may provide useful information for monitoring outpatient ADE.

Topics: Age Factors; Aged; Cardiovascular Agents; Comorbidity; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Hospitalization; Hospitals, Urban; Humans; Logistic Models; Male; Middle Aged; Prospective Studies; Risk Factors; Taiwan

Cell lines expressing ion channels (IC) and the advent of plate-based electrophysiology device have enabled a molecular understanding of the action potential (AP) as a means of early QT assessment. We sought to develop an in silico AP (isAP) model that provides an assessment of the effect of a compound on the myocyte AP duration (APD) using concentration-effect curve data from a panel of five ICs (hNav1.5, hCav1.2, hKv4.3/hKChIP2.2, hKv7.1/hminK, hKv11.1). A test set of 53 compounds was selected to cover a range of selective and mixed IC modulators that were tested for their effects on optically measured APD. A threshold of >10% change in APD at 90% repolarization (APD(90)) was used to signify an effect at the top test concentration. To capture the variations observed in left ventricular midmyocardial myocyte APD data from 19 different dogs, the isAP model was calibrated to produce an ensemble of 19 model variants that could capture the shape and form of the APs and also quantitatively replicate dofetilide- and diltiazem-induced APD(90) changes. Provided with IC panel data only, the isAP model was then used, blinded, to predict APD(90) changes greater than 10%. At a simulated concentration of 30 μM and based on a criterion that six of the variants had to agree, isAP prediction was scored as showing greater than 80% predictivity of compound activity. Thus, early in drug discovery, the isAP model allows integrating separate IC data and is amenable to the throughput required for use as a virtual screen.

Topics: Action Potentials; Animals; Calcium Channel Blockers; Calcium Channels, L-Type; Calibration; Cardiovascular Agents; Computer Simulation; Dogs; Dose-Response Relationship, Drug; Drug Evaluation, Preclinical; Drug-Related Side Effects and Adverse Reactions; Electrodes, Implanted; Electrophysiological Phenomena; ERG1 Potassium Channel; Ether-A-Go-Go Potassium Channels; Female; Fluorescence; Fluorescent Dyes; Heart; Myocytes, Cardiac; Potassium Channel Blockers; Risk Assessment; Threshold Limit Values

Infant and toddler poisonings are important to capture and may be challenging to manage. We aim to describe the Toxicology Investigators Consortium (ToxIC) Case Registry as a tool for toxico-surveillance of this problem in the United States. Using the ToxIC Case Registry database of the American College of Medical Toxicology, we identified infant and toddler poisonings over a 15-month period between April 1, 2010 and June 30, 2011 reported to the 31 Registry sites. Of 6,810 poisoning cases reported to the ToxIC registry, 248 (3.6 %) involved children younger than 2 years (51 % males). Fifty-four percent were hospital inpatients, 42 % were in the Emergency Department and 4 % were outpatients. Sixty-three percent were symptomatic. The most common ingested compounds were highly toxic-cardiac drugs (16 %), psychotropics (15 %), recreational drugs, alcohols, and controlled narcotic drugs (13 %), analgesics (9 %), and cleaning compounds (7 %). Fourteen percent of cases involved multiple agents. The ToxIC registry is a potentially useful toxico-surveillance tool to identify and trend clinically significant poisonings in young children, and potentially other populations. These data could be used to target specific preventive interventions.

Topics: Anticonvulsants; Antidepressive Agents; Antipsychotic Agents; Cardiovascular Agents; Cohort Studies; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; Hospitalization; Humans; Infant; Inpatients; Male; Outpatients; Poisoning; Prospective Studies; Psychotropic Drugs; Registries; Toxicology; United States

Cardiovascular disease in women is often underestimated. The effects of cardiovascular drugs differ between the sexes because of pharmacokinetic and pharmacodynamic differences. Adverse drug reactions (ADRs) within these drug classes may have serious consequences, leading to hospital admission. We aimed to study differences between men and women in hospital admissions for ADRs due to cardiovascular drugs.. We conducted a nationwide study of all hospital admissions between 2000 and 2005 with data from the Dutch National Medical Register. Relative risks were calculated of hospital admissions due to ADRs to the different cardiovascular drug groups for women compared with men. By an ecological design, risks were adjusted for the total number of Dutch inhabitants and the total number of prescriptions.. In total, 14 207 of the hospital admissions (34% of all ADR-related admissions) were attributed to cardiovascular drugs [7690 in women (54%; 95% confidence interval 53-55%)]. 'Anticoagulants and salicylates' (n= 8988), 'high- and low-ceiling diuretics' (n= 2242) and 'cardiotonic glycosides' (n= 932) were responsible for the majority of the ADR-related hospital admissions. The most pronounced sex differences were seen in users of low-ceiling diuretics (relative risk 4.02; 95% confidence interval 3.12-5.19), cardiotonic glycosides (relative risk 2.38; 95% confidence interval 2.06-2.74), high-ceiling diuretics (relative risk 2.10; 95% confidence interval 1.91-2.32) and coronary vasodilators (relative risk 0.77; 95% confidence interval 0.65-0.91).. Clear sex differences exist in ADRs requiring hospital admission for different cardiovascular drug groups. Sex differences should be taken into account in the prescription and evaluation of drugs.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Female; Hospitalization; Humans; Male; Middle Aged; Netherlands; Risk Factors; Sex Factors

To determine the incidence, diversity of adverse drug reactions (ADRs), and impact of pharmacovigilance on reporting it.. This prospective and retrospective study was carried out in the Department of Medicine, King Abdulaziz University Hospital, Jeddah, Kingdom of Saudi Arabia between January to December 2011 in 600 patients of ADR. Data regarding age and gender distribution of the patients, incidence rate, drugs, body systems/organs involved in ADR, time of occurrence of adverse drug reactions, total number of drugs administered, and impact of pharmacovigilance on finding the incidence rate of ADR were recorded. Comparison of the 2 data was carried out to determine the impact of pharmacovigilance.. Incidence rate of ADRs in retrospective study was 3.1% and 5.5% in the prospective study. The highest incidence of ADR (retrospective 15% and prospective 14.5%) was observed in both groups in patients receiving more than 10 drugs. The frequency of ADR in relation to age in both groups was highest in patients of age >60 years; it was 52.7% in retrospective study and 54.5% in prospective study. Antibiotics were the more frequently involved in ADR, (48.5% in prospective study and 36.9% in retrospective study). The system most commonly involved in ADR was gastrointestinal tract 47.4% in retrospective study and 57.6% in prospective study. None of the ADR proved to be fatal.. Low incidence of hospitalized ADR in our study (5.5%) is due to lack of awareness in healthcare professionals in reporting ADR. Undoubtedly, pharmacovigilance brought more patients with ADR to record.

Topics: Adolescent; Adult; Age Distribution; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Diuretics; Drug Eruptions; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Diseases; Glucocorticoids; Hospitals, Teaching; Humans; Incidence; Internal Medicine; Male; Middle Aged; Pharmacovigilance; Polypharmacy; Prospective Studies; Respiratory Tract Diseases; Retrospective Studies; Risk Management; Saudi Arabia; Sex Distribution; Young Adult

To determine the risk of diverticular perforation associated with current and ever use of corticosteroids, opiate analgesics, non-steroidal anti-inflammatory drugs, aspirin, cyclo-oxygenase-2 inhibitors, statins and calcium antagonists.. Case-control analysis using conditional logistic regression analysis of data from the UK General Practice Research Database. The study involved 899 cases of incident diverticular perforation and 8980 population controls from 1990 to 2005.. Odds ratios (ORs) are presented for perforation associated with use of corticosteroids, opiate analgesics, non-steroidal anti-inflammatory drugs, aspirin, cyclo-oxygenase-2 inhibitors, statins and calcium antagonists. Data were adjusted for smoking, comorbidity, prior abdominal pain and body mass index.. A total of 899 patients with an incident diagnosis of perforated diverticular disease were identified. Current use of opiate analgesics (OR=2.16; 95% CI 1.55 to 3.01) and oral corticosteroids (OR=2.74; 95% CI 1.63 to 4.61) was associated with a two- and threefold increase in the risk of diverticular perforation, respectively. Current use of a calcium antagonist and aspirin were not associated with an increased risk of diverticular perforation. Current statin use was associated with a reduction in the risk of perforation (OR=0.44; 95% CI 0.20 to 0.95).. Perforated diverticular disease is a serious surgical emergency with current opiate analgesics and oral corticosteroids being strongly associated with an increased risk of diverticular perforation.

Topics: Aged; Aged, 80 and over; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Comorbidity; Confounding Factors, Epidemiologic; Diverticulum, Colon; Drug-Related Side Effects and Adverse Reactions; Epidemiologic Methods; Female; Glucocorticoids; Humans; Intestinal Perforation; Male; Middle Aged; United Kingdom

Drug-related negative outcomes (DNOs) are health problems that patients experience due to drug use or nonuse. Heart failure (HF) patients are at high risk of experiencing DNOs owing to polypharmacy, comorbidities, and age.. Ninety-seven consecutive HF patients were enrolled and followed for 6 months. A pharmacist, integrated within a multidisciplinary HF team, reviewed the medication of each patient to detect, resolve, and/or prevent possible DNOs, risks of developing a DNO (rDNOs) and the drug-related problems (DRPs) that are associated with them. We detected 147 DNOs/rDNOs with a mean of 1.5 ± 1.4 per patient. Among DNOs, 45% were due to a lack of a pharmacologic treatment (need for a drug) and 24% were treatments with an insufficient drug dose (quantitative ineffectiveness). Among rDNOs, 33% were due to use of an unsafe drug (nonquantitative lack of safety) and 30% to quantitative ineffectiveness. Ninety-four percent of DNOs/rDNOs were preventable, and, importantly, 5.5% were classified as clinically serious. During follow-up, pharmacist interventions solved or prevented the health problem in 83% of cases. The most frequently identified DRPs were "insufficiently treated health problem" (31%), "inadequate dose, regimen, or duration of a drug" (22%), "probability of adverse effects" (16%), and "nonadherence" (14%). A significant relationship between the number of DNOs/rDNOs and the number of drugs was found (P < .013).. Chronic HF outpatients have a high incidence of preventable DNOs. The inclusion of a pharmacist in multidisciplinary HF teams should be considered, because it is clinically beneficial for patients and it increases HF specialists' awareness of DNOs, especially those beyond HF.

Topics: Aged; Aged, 80 and over; Ambulatory Care; Ambulatory Care Facilities; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Heart Failure; Humans; Interprofessional Relations; Male; Middle Aged; Patient Care Team; Pharmacists; Treatment Outcome

Efficacy, efficiency, value, and harm constitute the terminology that is used to decide about drug licensing and reimbursement. This article discusses to what extent legal requirements dictate the way clinical trials are planned and assessed. Cardiovascular disease is the best example of indications where efficacy and safety are described with the same set of endpoints. It is explained that the assessment of clinical trials must not be restricted to the assessment of primary endpoints. Instead components of a composite endpoint, secondary endpoints, and relevant subgroups of the patient population all require careful inspection. In cases where efficacy and safety are not two sides of the same medal, assessment is either trivial, or extremely difficult, and eventually benefit and risk can be balanced only for individual cases.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Approval; Drug-Related Side Effects and Adverse Reactions; Endpoint Determination; Germany; Humans; Hypoglycemic Agents; Insurance, Pharmaceutical Services; Product Surveillance, Postmarketing; Risk Assessment; Rosiglitazone; Survival Analysis; Thiazolidinediones

Most reviews of drug withdrawal effects focus on drugs of potential abuse such as opioids, benzodiazepines, etc. Abrupt discontinuation of many other drugs used in medicine cause withdrawal syndromes, some of which can be fatal. Discontinuation of a number of cardiovascular drugs can increase risk of cardiovascular events above that of people not taking these drugs. These include β-adrenergic receptor antagonists, aspirin, HMG-CoA reductase inhibitors (statins), and heparin. Rebound hypertension occurs after abrupt cessation of many antihypertensive drugs. The possibility of discontinuation syndromes has usually been neglected until adverse clinical events force them to be noticed. Attention to the possibility of drug discontinuation effects is an important part of drug safety evaluation.

Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Aspirin; Awards and Prizes; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Substance Withdrawal Syndrome

Reducing adverse drug reactions (ADRs) is a critical element in providing safe medication use to hospitalized patients. There is an abundance of literature describing ADRs and preventable ADRs (pADRs) in hospitalized patients; however, little has been published specific to psychiatric inpatients. Further knowledge of the most common pADRs in hospitalized psychiatric patients will allow targeted patient safety initiatives to be developed.. To determine the most frequent ADRs and pADRs in a psychiatric hospital, with emphasis on identifying factors for prevention.. Three years of ADRs at a psychiatric hospital were analyzed and evaluated according to type of medication, preventability, severity, and factors associated with preventability.. From July 1, 2006, to June 30, 2009, 93 ADRs were reported; 19 (20.4%) were classified as preventable. Psychiatric medications accounted for 45 (48.4%) of the ADRs and nonpsychiatric medications were associated with 48 (51.6%). Cardiovascular agents (n = 17) and antiepileptics (n = 17) were responsible for most ADRs. Of the 19 pADRs, lithium was the drug reported most frequently, followed by phenytoin and anxiolytics. Nine (47%) of the pADRs were severe and required a medical transfer for management; 3 of the 9 were lithium toxicity. The most common preventability factor involved drug interactions. A pharmacy intervention involving staff education to reduce lithium pADRs is presented.. Awareness of the most frequent drug classes associated with ADRs and pADRs in a psychiatric hospital allows opportunity for education, medication management system changes, and improved patient safety. Lithium, followed by phenytoin and anxiolytics, were the most common drugs associated with pADRs. A drug-drug interaction was the most frequent factor associated with pADRs.

Topics: Adverse Drug Reaction Reporting Systems; Anticonvulsants; Antipsychotic Agents; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Hospitalization; Hospitals, Psychiatric; Humans; Maryland; Mental Disorders; Probability; Retrospective Studies

Topics: Anti-Inflammatory Agents; Antineoplastic Agents; Cardiovascular Agents; Computer Simulation; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycemic Agents; Kinetics; Models, Statistical; Neoplasms; Pharmacology; Pharmacy; Renal Agents; Research Design; Systems Analysis; Therapeutic Equivalency

Topics: Biomedical Research; Cardiac Surgical Procedures; Cardiovascular Agents; Cardiovascular Diseases; Diagnostic Techniques, Cardiovascular; Drug-Related Side Effects and Adverse Reactions; Equipment Safety; Guidelines as Topic; Humans; Risk Assessment

In October 2008, in a public forum organized by the Cardiac Safety Research Consortium and the Health and Environmental Sciences Institute, leaders from government, the pharmaceutical industry, and academia convened in Bethesda, MD, to discuss current challenges in evaluation of short- and long-term cardiovascular safety during drug development. The current paradigm for premarket evaluation of cardiac safety begins with preclinical animal modeling and progresses to clinical biomarker or biosignature assays. Preclinical evaluations have clear limitations but provide an important opportunity to identify safety hazards before administration of potential new drugs to human subjects. Discussants highlighted the need to identify, develop, and validate serum and electrocardiogram biomarkers indicative of early drug-induced myocardial toxicity and proarrhythmia. Specifically, experts identified a need to build consensus regarding the use and interpretation of troponin assays in preclinical evaluation of myocardial toxicity. With respect to proarrhythmia, the panel emphasized a need for better qualitative and quantitative biomarkers for arrhythmogenicity, including more streamlined human thorough QT study designs and a universal definition of the end of the T wave. Toward many of these ends, large shared data repositories and a more seamless integration of preclinical and clinical testing could facilitate the development of novel approaches to both cardiac safety biosignatures. In addition, more thorough and efficient early clinical studies could enable better estimates of cardiovascular risk and better inform phase II and phase III trial design. Participants also emphasized the importance of establishing formal guidelines for data standards and transparency in postmarketing surveillance. Priority pursuit of these consensus-based directions should facilitate both safer drugs and accelerated access to new drugs, as concomitant public health benefits.

Topics: Arrhythmias, Cardiac; Biomarkers; Cardiovascular Agents; Cardiovascular Diseases; Critical Pathways; Drug Evaluation; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Heart Diseases; Humans; Research; Risk Management; Safety; Technology Transfer; Troponin

Falls in the elderly are common and often serious. Several drugs have been associated with increased fall risk. Older adults often take numerous medications for multiple chronic conditions, so are at increased risk for drugs that potentially cause falls.. We studied the association between drug use and falls in recently hospitalized older people in order to identify medications that may increase the risk of falls in this population.. A retrospective case control study was performed in the geriatric department of Bertinot Juel Hospital, Chaumont en Vexin, Picardy, France. We assessed the incidence of patient falls during hospitalization in 2004 and 2005 in an acute geriatric ward. We compared medications taken by all patients who fell (134 cases) with those taken by patients who did not fall (126 controls). The 260 participants were all aged >or=65 years.. 50% of falls occurred in the first week after admission. In 16% of cases, falls were classified as severe. The characteristics of the two groups (patients who fell and those who did not) were similar: no significant differences were observed in terms of age, sex, number of medicines or prevalence of hypertension or Parkinson's disease. The probability of falls increased when the patients used zolpidem (adjusted odds ratio [AOR] 2.59; 95% CI 1.16, 5.81; p = 0.02), meprobamate (AOR 3.01; 95% CI 1.36, 6.64; p = 0.01) or calcium channel antagonists (AOR 2.45; 95% CI 1.16, 4.74; p = 0.02).. Some drugs are associated with an increased risk of falls in the elderly and, when alternatives exist, should be avoided until cohort studies are conducted to confirm or refute these possible increased risks.

Topics: Accidental Falls; Aged, 80 and over; Analysis of Variance; Cardiovascular Agents; Case-Control Studies; Drug-Related Side Effects and Adverse Reactions; Female; Hospitalization; Humans; Male; Psychotropic Drugs; Regression Analysis; Retrospective Studies; Risk; Time Factors

(1) Photosensitivity reactions are cutaneous disorders due to exposure to ultraviolet (UV) radiation of natural or artificial origin. They occur or are more prevalent on unprotected skin. The main clinical manifestations are burns, eczema-like rash, urticaria, pigmentation, or onycholysis; (2) Many drugs increase cutaneous sensitivity to UV, sometimes for therapeutic purposes, but it is generally an unwanted effect.

Topics: Aminolevulinic Acid; Amiodarone; Anti-Arrhythmia Agents; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Dermatitis, Photoallergic; Dermatitis, Phototoxic; Dihematoporphyrin Ether; Diuretics; Doxycycline; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Eczema; Furocoumarins; Hematoporphyrin Photoradiation; Humans; Methotrexate; Onycholysis; Photochemotherapy; Photosensitivity Disorders; Photosensitizing Agents; Porphyrins; Psychotropic Drugs; Quinolines; Skin; Skin Aging; Skin Diseases; Skin Neoplasms; Skin Pigmentation; Sulfonamides; Sunscreening Agents; Tetracycline; Ultraviolet Rays; Urticaria; Verteporfin

To identify characteristics associated with four potential medication problems among older adults at risk for nursing home placement.. Cross-sectional survey.. Three sites of California's Multipurpose Senior Services Program (MSSP), a Medi-Cal waiver care management program.. Six hundred fifteen dual-eligible, functionally impaired, community-dwelling adults aged 65 years and older enrolled in MSSP between June 2004 and January 2006.. Medication screening using the Home Health Criteria that include medication use and clinical risk factors.. Demographic and health characteristics associated with four problem types: 1) unnecessary therapeutic duplication, 2) psychotropic medication use with concurrent falls or confusion, 3) cardiovascular medication problems, and 4) use of nonsteroidal anti-inflammatory drugs (NSAIDs) with risk of peptic ulcer complications. Independent measures included age, gender, race/ethnicity, living arrangement, number of medications, health status, and utilization.. Each problem type was associated with different characteristics, as identified by logistic regression modeling. Increased number of medications was associated with therapeutic duplication (odds ratio [OR] = 1.27; confidence interval [CI] 1.20-1.35; P < 0.001) and problematic psychotropic medication use (OR = 1.15; CI 1.08-1.22; P < 0.001). Psychotropic use was also associated with emergency department, hospital, or skilled nursing admission in the previous year (OR = 1.86; CI 1.15-3.00; P = 0.012), living with someone (OR = 0.57; CI 0.34-0.95; P = 0.032), and new care management enrollment (OR = 1.99; CI 1.22-3.24; P = 0.006). New enrollment was also associated with cardiovascular medication problems (OR = 2.15; CI 1.32-3.51; P = 0.002). There were no significant characteristics associated with NSAID problems (not shown).. Unique predictors of potential medication problems highlight the need for systematic medication screening and treatment planning. These should include medication therapy management for vulnerable community-dwelling elders (upon enrollment for care management) and for those taking multiple medications. Funding mechanisms via Medicare Part D (prescription drug program) should be explored in this population to increase identification of medication problems and their resolution.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; California; Cardiovascular Agents; Cross-Sectional Studies; Data Collection; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Logistic Models; Male; Medicaid; Medication Errors; Practice Patterns, Physicians'; Psychotropic Drugs; Residence Characteristics; Risk Factors; United States

Pharmacogenomics addresses the impacts of diverse and multiple genes in populations as determinants of responses of individual patients to drugs. The field has its roots in basic science, and is pivotal in drug development, elucidation of therapeutic efficacy, and constraining the risks of adverse drug reactions. Regulatory agencies are relying increasingly on pharmacogenomics for identification of patients who are particularly likely to benefit from treatment with specific agents and exclusion of those at risk of adverse drug reactions. Practical applications of pharmacogenomics already abound particularly in the use of drugs acting on the central nervous system and on the cardiovascular system. The Society for Experimental Biology and Medicine (SEBM) is proud and pleased to have devoted its 2008 symposium, presented at the annual Experimental Biology meeting in San Diego on April 6, 2008, to advances in pharmacogenomics with emphasis on drug development, regulatory agency considerations, and clinical applications.

Topics: Cardiovascular Agents; Cardiovascular System; Clinical Trials as Topic; Drug Design; Drug Industry; Drug-Related Side Effects and Adverse Reactions; Genomics; Genotype; Humans; Medicine; Pharmacogenetics; Polymorphism, Genetic; Technology, Pharmaceutical; United States; United States Food and Drug Administration

Adverse drug events (ADEs) are associated with inappropriate prescribing (IP) and result in increased morbidity, mortality and resource utilisation. We used Beers' Criteria to determine the three-month prevalence of IP in a non-selected community-dwelling population of acutely ill older people requiring hospitalisation.. A prospective, observational study of 597 consecutive acute admissions was performed. Diagnoses and concurrent medications were recorded before hospital physician intervention, and Beers' Criteria applied.. Mean patient age (SD) was 77 (7) years. Median number of medications was 5, range 0-13. IP occurred in 32% of patients (n = 191), with 24%, 6% and 2% taking 1, 2 and 3 inappropriate medications respectively. Patients taking >5 medications were 3.3 times more likely to receive an inappropriate medication than those taking < or =5 medications (OR 3.34: 95%, CI 2.37-4.79; P<0.001). Forty-nine per cent of patients with inappropriate prescriptions were admitted with adverse effects of the inappropriate medications. Sixteen per cent of all admissions were associated with such adverse effects.. IP is highly prevalent in acutely ill older patients and is associated with polypharmacy and hospitalisation. However, Beers' Criteria cannot be used as a gold standard as they do not comprehensively address all aspects of IP in older people.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Comorbidity; Cross-Sectional Studies; Drug Interactions; Drug Prescriptions; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Ireland; Male; Medication Errors; Patient Admission; Prospective Studies; Psychotropic Drugs; Risk Factors

What is already known about this subject. Studies conducted primarily in developed countries have shown that adverse drug reactions (ADRs) are a significant cause of hospital admission, prolong hospital stay and consequently increase the cost of disease management in patients. Cardiovascular medicines, hypoglycaemic agents, nonsteroidal anti-inflammatory drugs and antibiotics are the most frequently implicated medicines in these studies. A large proportion of these ADRs have been shown to be preventable through improved drug prescribing, administration and monitoring for adverse effects. What this paper adds. This is the first Sub-Saharan African study in the HIV/AIDS era that describes the contribution of ADRs to patient morbidity, hospitalisation and mortality. Cardiovascular medicines and antiretroviral therapy contributed the most to community-acquired ADRs at the time of hospital admission while medicines used for opportunistic infections (such as antifungals, antibiotics and antituberculosis medicines were most frequently implicated in hospital acquired ADRs. ADRs in HIV-infected patients were less likely to be preventable.. To describe the frequency, nature and preventability of community-acquired and hospital-acquired adverse drug reactions (ADRs) in a South African hospital serving a community with a high prevalence of human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome.. A 3-month prospective observational study of 665 adults admitted to two medical wards.. Forty-one (6.3%) patients were admitted as a result of an ADR and 41 (6.3%) developed an ADR in hospital. Many of the ADRs (46.2%) were considered preventable, although less likely to be preventable in HIV-infected patients than in those with negative or unknown HIV status (community-acquired ADRs 2/24 vs. 35/42; P < 0.0001; hospital-acquired ADRs 3/25 vs. 14/26; P = 0.003). Patients admitted with ADRs were older than patients not admitted with an ADR (median 53 vs. 42 years, P = 0.003), but 60% of community-acquired ADRs at hospital admission were in patients <60 years old. Among patients <60 years old, those HIV infected were more likely to be admitted with an ADR [odds ratio (OR) 2.32, 95% confidence interval (CI) 1.17, 4.61; P = 0.017]. Among HIV-infected patients, those receiving antiretroviral therapy (ART) were more likely to be admitted with an ADR than those not receiving ART (OR 10.34, 95% CI 4.50, 23.77; P < 0.0001). No ART-related ADRs were fatal. Antibiotics and drugs used for opportunistic infections were implicated in two-thirds of hospital-acquired ADRs.. ADRs are an important, often preventable cause of hospitalizations and inpatient morbidity in South Africa, particularly among the elderly and HIV-infected. Although ART-related injury contributed to hospital admissions, many HIV-related admissions were among patients not receiving ART, and many ADRs were associated with medicines used for managing opportunistic infections.

Topics: Acquired Immunodeficiency Syndrome; Adult; Aged; Anti-Retroviral Agents; Cardiovascular Agents; Cohort Studies; Drug-Related Side Effects and Adverse Reactions; Female; HIV Infections; Hospital Mortality; Hospitalization; Hospitals, Teaching; Humans; Male; Middle Aged; Pharmaceutical Preparations; Prevalence; Prospective Studies; South Africa

The intake of medications is a major aetiologic factor of xerostomia. The purpose of this study was to investigate the selective influence of medication categories on flow rates of individual major salivary glands.. The effect of each medication category on salivary flow rates was determined by dichotomy comparisons between users and non-users. A total of 246 patients were included, 79 males and 167 females aged 13-92 years (mean 63 years). Of these, 200 used medications, which were grouped according to their category. A comprehensive medical and oral examination was performed. Both unstimulated and stimulated saliva was collected separately from the parotid and submandibular/sublingual glands.. Parotid flow rate was decreased among users of tranquillisers and sedatives (unstimulated flow), cardiovascular drugs and gastrointestinal drugs (stimulated flow). Submandibular/sublingual unstimulated output was lower in patients taking cardiovascular drugs, antihistamines, tranquillisers/sedatives and antidepressants, while the stimulated flow, in those taking cardiovascular drugs, antihistamines, tranquillisers/sedatives and gastrointestinal drugs.. Users of many common medication categories display significantly reduced unstimulated and/or stimulated salivary flow rate from the major salivary glands compared with non-users. A larger number of medication categories are associated with reductions in salivary flow rate from submandibular/sublingual glands than parotid glands.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Central Nervous System Agents; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Agents; Histamine Antagonists; Humans; Hypnotics and Sedatives; Male; Middle Aged; Parotid Gland; Polypharmacy; Saliva; Salivary Glands; Secretory Rate; Sublingual Gland; Submandibular Gland; Tranquilizing Agents; Young Adult

Adverse drug events (ADEs) are a substantial cause of hospital admissions. However, little is known about the incidence, preventability and severity of ADEs resulting in emergency department visits. To address this issue, we conducted a prospective survey in emergency departments of French public hospitals.. This study was performed over two periods of 1 week each, one in June 1999 and one in December 1999, in emergency departments of five university hospitals and five general hospitals throughout France. All patients aged>or=15 years presenting with medical complaints were included in the study. Trauma patients, those with gynaecological conditions and those with alcohol intoxication or intentional drug poisoning were excluded from the study. Each patient was assessed by two local emergency physicians to determine whether the visit was the result of an ADE. All medical records were subsequently validated by an independent group of medical lecturers in iatrogenic disorders.. Out of a total of 1937 patients consulting, 1562 were taking at least one drug during the previous week and were included for analysis; 328 (21%; 95% CI 19, 23) of these patients consulted an emergency physician because of an ADE. Patients with ADEs were older than those without (mean age 63.5 vs 54.8 years; p<0.0001). Furthermore, ADE patients were more likely to have a higher severity presentation than the non-ADE group (p=0.019). The number of drug exposures was significantly higher in patients with an ADE than in those without (mean number of medications 5.17 vs 3.82; p<0.0001). On multivariate analysis, only age and the number of medications taken were significantly associated with adverse events. In total, 410 drugs were incriminated in the occurrence of 328 ADEs. The most frequently incriminated drug classes were: (i) psychotropic agents (n=84; 20.5%); (ii) diuretics (n=48; 11.7%), anticoagulants (n=38; 9.3%) and other cardiovascular drugs (n=63; 15.4%); and (iii) analgesics, including NSAIDs (n=57; 13.9%). Preventability could be assessed in 280 of the 328 cases. In 106 cases (37.9%), the ADE was judged to be preventable.. ADEs leading to emergency department visits are frequent, and many are preventable, confirming that there is a need to develop prevention strategies.

Topics: Adult; Adverse Drug Reaction Reporting Systems; Aged; Analgesics; Anticoagulants; Cardiovascular Agents; Cardiovascular Diseases; Central Nervous System Agents; Diuretics; Dizziness; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Emergency Service, Hospital; Female; France; Gastrointestinal Diseases; Hospitals, General; Hospitals, University; Humans; Male; Middle Aged; Nervous System Diseases; Observer Variation; Prospective Studies; Time Factors

Older oncology patients with multiple comorbidities are at risk for adverse drug events associated with polypharmacy and drug-drug interactions due to patients' altered pharmacokinetic/pharmacodynamic status and the narrow therapeutic windows associated with anti-neoplastic agents. This study addresses the issue of polypharmacy and potential drug-drug interactions in outpatients in a community setting in the USA, and the prescribing behaviour of oncologists after being made aware of potential drug-drug interactions.. We performed a retrospective cohort study in patients with multiple comorbidities exposed to chemotherapy to profile the potential for adverse drug reactions and to define physicians' responses to risks arising from drug interactions. The medical records of 100 patients aged >or=70 years receiving chemotherapeutic agents at a community-based, university-affiliated medical practice were randomly selected and reviewed. Drug class usage was quantified, and potential drug-drug interactions were assessed and categorized. Treating oncologists were encouraged to modify their prescriptions on the basis of potential interactive drug evaluation reports. Physicians' responses were catalogued.. The mean age of the study population was 78 years (range, 70-90 years). Patients had an average of three comorbid conditions. Each patient received an average of 9 x 1 medications. Cardiovascular drugs were the most common medications that patients used to treat chronic conditions. Carboplatin and paclitaxel were the most frequently used chemotherapeutic agents. Inspite of the potential for drug-drug interactions, physicians made no adjustments to prescriptions.. Given that polypharmacy and the chronic use of multiple drugs are a reality for older patients with cancer and polymorbidities, outcome data need to be generated and motivations/incentives provided for physicians to optimize safe and effective supportive oncologic therapeutics.

Topics: Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Bronchodilator Agents; Cardiovascular Agents; Cardiovascular Diseases; Cohort Studies; Comorbidity; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Diseases; Health Services for the Aged; Humans; Interdisciplinary Communication; Lung Diseases; Male; Medical Records; Neoplasms; Nonprescription Drugs; Polypharmacy; Retrospective Studies; Surveys and Questionnaires; United States

Little information is available concerning adverse drug events (ADEs) in cardiac patients. Therefore, the investigators report the results of cardiac patients in an ADE surveillance program, with the intent of reducing the frequency of future events. All reported adverse drug reactions and medication errors in cardiac patients over a 5-year period at Brigham and Women's Hospital were reviewed. There were 547 ADEs in cardiac patients, a rate of 1.9 events for every 100 patient admissions. Preventable ADEs most often occurred during medication administration (34.2%), with wrong rate or frequency of medication administration the most widespread event. Cardiovascular agents (29.8%), anticoagulants (28.5%), and antimicrobial agents (10.8%) were the most common drug classes associated with ADEs. Injury or prolonged hospitalization occurred in 5.3% of patients. ADEs occurred most frequently on the admission day, on weekdays, and in the early morning hours. Peak frequencies of ADEs coincided with nursing shift changes. In conclusion, ADEs occur often in hospitalized cardiac patients and affect 2 of every 100 patient admissions. Given the high percentage of ADEs associated with drug administration, more resources should be directed at this step of medication use. Focusing interventions around nursing shift changes may further enhance preventive strategies.

Topics: Adverse Drug Reaction Reporting Systems; Anticoagulants; Boston; Cardiovascular Agents; Drug Utilization Review; Drug-Related Side Effects and Adverse Reactions; Heart Diseases; Hospitalization; Hospitals, University; Hospitals, Urban; Humans; Medication Errors; Nursing Staff, Hospital; Personnel Staffing and Scheduling; Time Factors

Cardiovascular biomarker research efforts have resulted in the identification of new risk factors and novel drug targets, as well as the establishment of treatment guidelines. Government agencies, academic research institutions, diagnostic industries, and pharmaceutical companies all recognize the importance of biomarkers in advancing therapies to improve public health. In drug development, biomarkers are used to evaluate early signals of efficacy and safety, to select dose, and to identify the target population. The United States Food and Drug Administration has relied on biomarkers to support clinical applications in many therapeutic fields, including cardiovascular disease. The appropriate application of cardiovascular biomarkers requires an understanding of disease natural history, the mechanism of the intervention, and the characteristics and limitations of the biomarker. Channels of communication among researcher, developer, and regulator must remain open to maximize the success of future biomarker efforts. In 2003, 2004, and 2005, an international panel of cardiovascular biomarker experts convened at the "Cardiovascular Biomarker and Surrogate Endpoints Symposia" held in Bethesda, Md, to discuss the use of biomarkers in the development of improved cardiovascular diagnostics and therapeutics. The information presented in the present report summarizes the authors' perspective distilled from these proceedings.

Topics: Atherosclerosis; Biomarkers; Cardiovascular Agents; Cardiovascular Diseases; Diagnostic Imaging; Drug Approval; Drug-Related Side Effects and Adverse Reactions; Endpoint Determination; Humans; Risk Factors; United States

The severity of hazards posed by medications implicated in poisoning in older adults was characterized.. Toxic Exposure Surveillance System (TESS) cases from 1993 through 2002 involving a single substance in patients age 60 years or older and coded as an adverse drug reaction (ADR) or therapeutic error were analyzed. Hazard factors were determined for each exposure reason by calculating the sum of the major effects and deaths for each substance category and subcategory and dividing this by the total number of exposures for the respective category or subcategory.. Hazard factors were calculated for 12,737 ADRs and 51,846 therapeutic errors. The overall rates of major effects and deaths were 7.5% and 1.6% in the ADR and therapeutic error groups, respectively. In the ADR group, five TESS categories had a hazard factor of > or =2.0: anesthetics, anticoagulants, antineoplastics, cardiovascular drugs, and radiopharmaceuticals. In the therapeutic error group, five drug categories also had a hazard factor of > or =2.0: anesthetics, anticoagulants, antineoplastics, asthma therapies, and serums/toxoids/vaccines. Six pharmaceutical categories were associated with hazard factors of > or =2.0 in both the ADR and therapeutic error groups.. An analysis of ADRs and therapeutic errors involving older adults and reported to poison control centers from 1993 through 2002 revealed overall rates of major effects and death of 7.5% and 1.6% in the ADR and therapeutic error groups, respectively. Antineoplastics, aminophylline or theophylline, cardiac glycosides, heparin, morphine, and warfarin were implicated in more than 50 cases and associated with hazard factors of > or =2.0 for both exposure groups.

Topics: Adverse Drug Reaction Reporting Systems; Age Distribution; Age Factors; Aging; Analgesics, Opioid; Anticoagulants; Antineoplastic Agents; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Factor Analysis, Statistical; Humans; Medication Errors; Middle Aged; Poison Control Centers; Proportional Hazards Models; Retrospective Studies; Risk Assessment; United States

A chronic adverse reaction may occur in some instances of drug-induced liver injury (DILI), even despite drug cessation. In our study, we obtained records from a Spanish registry and evaluated cases of DILI with biochemical evidence of long-term damage. Chronic outcome was defined as a persistent biochemical abnormality of hepatocellular pattern of damage more than 3 months after drug withdrawal or more than 6 months after cholestatic/mixed damage. Data on 28 patients with a chronic clinical evolution (mean follow-up 20 months) between November 1995 and October 2005 were retrieved (18 female; overall mean age 55 yr) and accounted for 5.7% of total idiosyncratic DILI cases (n = 493) submitted to the registry. The main drug classes were cardiovascular and central nervous system (28.5% and 25%, respectively), which, in contrast, represented only 9.8% and 13%, respectively, of all DILI cases. The most frequent causative drugs were amoxicillin-clavulanate (4 of 69 cases), bentazepam (3 of 7 cases), atorvastatin (2 of 7 cases), and captopril (2 of 5 cases). Patients with cholestatic/mixed injury (18 of 194 cases [9%]) were more prone to chronicity than patients with hepatocellular injury (10 of 240 cases; P < .031). In the case of chronic hepatocellular injury, 3 patients progressed to cirrhosis and 2 to chronic hepatitis. In the cholestatic/mixed group, liver biopsy indicated cirrhosis in 1 patient and ductal lesions in 3 patients. In conclusion, cholestatic/mixed type of damage is more prone to become chronic while, in the hepatocellular pattern, the severity is greater. Cardiovascular and central nervous system drugs are the main groups leading to chronic liver damage.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Atorvastatin; Azepines; Captopril; Cardiovascular Agents; Central Nervous System Agents; Chemical and Drug Induced Liver Injury; Chronic Disease; Disease Progression; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Heptanoic Acids; Humans; Liver; Liver Diseases; Male; Middle Aged; Pyrroles; Registries; Spain

Older adults consume more medications than any other segment of the population. Increasing lifespan means that more people will live into old age, frequently with disabilities and conditions man-aged by medications. Age-associated physiologic changes, medication use patterns, and adverse drug effects and interactions place the older adult at high risk for medication-related problems. Older adults living in institutions, those with complex medical problems,and those who do not adhere to medication regimens are at highest risk for negative health outcomes from medication mishaps. Dentists must be able to identify older adults who are susceptible to adverse drug events and to recognize which medications are most likely to precipitate problems.

Topics: Aged; Analgesics; Anti-Bacterial Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Endocrine System Diseases; Female; Gastrointestinal Agents; Humans; Hypnotics and Sedatives; Male; Polypharmacy; Psychotropic Drugs

To examine trends in adverse drug reactions (ADRs) in people aged 60 years or over causing admission to or an extended stay in Western Australian hospitals between 1981 and 2002.. Secondary data analysis of case series.. 43,380 patients admitted to WA public and private hospitals with an (International Classification of Diseases) ICD external cause code for an ADR, identified by the population-based WA Hospital Morbidity Data System.. Age-specific, age-standardised and drug-specific rates of ADR-related hospital stays.. The age-standardised rate of ADR-related hospital stays increased from 2.5 per 1000 person-years (py) in 1981 to 12.9 per 1000 py in 2002. The largest increases occurred in those aged 80 + years (tenfold in men and sevenfold in women). The most common drug group involved was cardiovascular agents (17.5%), while anticoagulants (7.5%), cytotoxics (7.4%) and antirheumatics (6.8%) were the more specific drug classes most often implicated. ADRs from the last three classes of drugs were still rising at the end of the study, whereas ADRs from corticosteroids and antihypertensives peaked in 1996 and from opioids in 2000.. Increases in hospital admissions or extended lengths of stay due to ADRs in WA have continued despite programs to promote rational and safer use of medicines. The sharp increase in ADRs from anticoagulants warrants attention to revised clinical guidelines.

Topics: Adrenal Cortex Hormones; Age Distribution; Aged; Aged, 80 and over; Analgesics; Anti-Bacterial Agents; Anticoagulants; Antirheumatic Agents; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Female; Hospitalization; Humans; Male; Middle Aged; Sex Distribution; Western Australia

The prevalence of risk factors for adverse drug events (ADEs) in patients discharged from the hospital to various care settings was studied.. Data on patient risk characteristics for ADEs were collected for hospital discharges for 2000. Differences in the prevalence of 10 risk characteristics among home health care (HHC), self-care (SC), and long-term-care (LTC) patients at the point of discharge were determined.. Data for 4250 discharges were analyzed. The three groups differed significantly in the distribution of risk characteristics. HHC patients had the highest prevalence of heart failure, cardiovascular medication use, and polypharmacy, and LTC patients had the highest prevalence of hypoalbuminemia, cognitive impairment, and psychiatric drug use.. The risk of ADEs in patients discharged to HHC appeared to be comparable to or higher than that in patients discharged to LTC.

Topics: Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Cardiovascular Agents; Cognition Disorders; Continuity of Patient Care; Drug-Related Side Effects and Adverse Reactions; Female; Heart Failure; Home Care Services; Hospitalization; Humans; Hypoalbuminemia; Long-Term Care; Male; Middle Aged; Patient Discharge; Polypharmacy; Risk Factors; Tranquilizing Agents

Topics: Aged; Analgesics; Cardiovascular Agents; Cholinergic Agents; Delirium; Drug-Related Side Effects and Adverse Reactions; Humans; Hypnotics and Sedatives; Psychotropic Drugs; Risk Factors

Recent studies show that nearly half of the hospitalized patients are readmitted within 6 months from discharge. No data exist about the relationship between adverse drug reactions (ADRs) and readmittance to a department of internal medicine.. The primary aims of the study were to determine if ADRs could be used as predictors for recurrent hospitalizations in internal medicine and to evaluate the economic impact of ADRs on hospitalization costs.. A cohort-based, prospective, 18-month pharmacoepidemiological survey was conducted in the Department I of Internal Medicine at the University Hospital of Erlangen. All patients were intensively monitored for ADRs by a pharmacoepidemiological team. ADRs were evaluated for their offending drugs, probability, severity, preventability and classified by WHO-ART. During a 6-month period ADR-positive patients were matched to non-ADR patients applying diagnosis-related group categorization in order to measure the impact of ADRs on the duration and frequency of hospitalization.. Of 1000 admissions 424 patients had single admissions and 206 patients had recurrent readmissions (min 1, max 9). The prevalence of readmissions was 37% (n = 370). In 145 (23%) of 630 patients, 305 ADRs were observed. The ADR incidence was similar in first admissions and readmissions. ADRs were not found to predict further readmissions and lack of ADRs did not preclude readmissions. ADRs caused hospitalizations in 6.2% of first admissions and in 4.2% of readmissions. According to the Schumock algorithm 135 (44.3%) ADRs were found to be preventable. The occurrence and numbers of ADRs per admission were found to prolong hospitalization period significantly (r = 0.48 and 0.51, P < 0.001, n = 135). Of 9107 treatment days 20% were caused by in-house (1130 days) and community-acquired ADRs (669 days). In admissions and readmissions 11% (>973 days) of all treatment days were judged to be preventable.. Intensified drug monitoring supported by information technology in internal medicine is essential for early detecting and prevention of ADRs and saving hospital resources.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Infective Agents; Cardiovascular Agents; Central Nervous System Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Electrolytes; Gastrointestinal Agents; Hormones; Humans; Length of Stay; Middle Aged; Patient Readmission; Prospective Studies; Time Factors

One of the consultant's roles is to make recommendations regarding the use of medications in the perioperative period. Unfortunately, the data in this area are often insufficient to provide evidence-based recommendations. In this article, we have provided advice considering the pharmacokinetics of the drug, the effect on the primary disease of stopping medications, and the effect of the medication on perioperative risk, including potential drug interactions with anesthetic agents.

Topics: Anti-HIV Agents; Antirheumatic Agents; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Hematologic Agents; Hormones; Humans; Insulin; Intraoperative Complications; Pharmacokinetics; Phytotherapy; Postoperative Complications; Preoperative Care; Psychotropic Drugs; Respiratory System Agents

To examine the risk of suicide in users of beta-adrenoceptor blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors.. We conducted a cohort study based on linkage of a population-based prescription registry in North Jutland County, Denmark, and the nationwide Death Registry. From 1989 to 1995 there were 58 529 users of beta-adrenoceptor blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors. The mortality rates from suicides in the cohort members were compared with the rates in the general population.. One hundred and four suicides occurred in the cohorts. The standardized mortality ratio for suicide in users of beta-adrenoceptor blockers was 1.6 (95% confidence interval: 1.2-2.1), in users of calcium channel blockers 1.2 (95% confidence interval: 0.8-1.7), and in users of angiotensin converting enzyme inhibitors 1.2 (95% confidence interval: 0.7-1.8). In users of beta-adrenoceptor blockers, the risk of suicide was increased during the first 12 months after the start of therapy, standardized mortality ratio 2.1 (95% confidence interval: 1.2-3.5). There was a trend in the standardized mortality ratio of suicide from 0.9 (95% confidence interval: 0.4-1.9) in users of beta-adrenoceptor blockers with low lipid solubility, to 1.6 (0.8-2.8) and 2.7 (1.7-4.1) in users of beta-adrenoceptor blockers with medium and high lipid solubility, respectively.. Users of medium and high lipid soluble beta-adrenoceptor blockers may have an increased risk of suicide. Users of calcium channel blockers and angiotensin converting enzyme inhibitors do not seem to have a significantly increased risk of suicide.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers; Cardiovascular Agents; Cohort Studies; Denmark; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Middle Aged; Risk Factors; Suicide

Hospital admissions due to adverse drug reactions are an important concern, but there are few data concerning the specific situation in Switzerland. During one year we therefore prospectively studied all admissions to our medical department to determine the profile. 138 of 2168 patients presented a total of 150 adverse drug reactions at hospitalisation (6.4%) and among them 65% of the admissions were directly related to adverse drug reaction. Age stratification revealed that with each decade of age there was an increasing risk of adverse drug reactions and that the patients were sicker (more diagnoses), were consuming more drugs and had longer stays. The majority of adverse drug reactions were type A reactions and therefore potentially preventable. Cardio- and cerebrovascular drugs (diuretics, ACE-inhibitors, platelet aggregation inhibiting therapy) accounted for 65% of the side effects. Analysed by affected organ system, the most frequent adverse drug reactions were gastrointestinal complications followed by dehydration (contracted extracellular fluid volume) and hypo-/hyperkalaemia. Non-compliance by the patients was less frequently at the origin of the admission than iatrogenic causes related to physician errors. The patients generally did not know the reasons, details and side effects of their medical treatment. Based on our data, we estimate that the national number of drug-related hospital admissions caused by inappropriate or unnecessary treatment is 12,000-16,000, with direct annual extra costs of 70-100 million Swiss francs. Adverse drug reactions therefore represent a serious medical and financial problem. Specialised computing systems designed to reduce these events should be introduced in hospitals and ambulatory care.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Cross-Sectional Studies; Diuretics; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Incidence; Italy; Male; Middle Aged; Patient Admission; Patient Education as Topic; Platelet Aggregation Inhibitors; Prospective Studies

Topics: Anti-Bacterial Agents; Cardiovascular Agents; Drug Approval; Drug-Related Side Effects and Adverse Reactions; Europe; Histamine H1 Antagonists; Humans; Long QT Syndrome; Psychotropic Drugs; Torsades de Pointes

To review spontaneous reports of drug-associated adverse hepatic reactions.. Reports of drug-associated adverse hepatic reactions received by the New Zealand Centre for Adverse Reactions Monitoring over the 21 year period January 1974 to December 1994 were reviewed. Subdivision into three 7 year periods was undertaken to compare patterns.. Of a total of 22,455 adverse medicine reaction (AMR) reports there were 943 reports of liver injury (4.2%). Two hundred and five drugs were associated with hepatic reactions. The top 20 drugs accounted for 57% of all liver reactions. Fifty-seven percent were reported in females. Hepatotoxicity was most commonly reported among patients 50-80 years old. Liver reactions were associated with a 3.3% mortality, but were responsible for 7.4% of all fatal occurrences. There was a steady increase in the number of reports over the 21 years. Although the largest number of reports of liver injury were received between 1988 and 1994, mortality was lowest during this period. There were substantial differences in the medicines associated with hepatic reactions during each of the three periods, although erythromycin was the commonest cause throughout. Erythromycin was associated with two deaths. Halothane and perhexilene were the most frequent cause of death and were two of the most important causes of liver injury during the first and second periods. Diclofenac, Augmentin and flucloxacillin were important causes of hepatotoxicity during period 3 but were not associated with a fatal outcome.. Hepatic reactions accounted for 4.2% of all adverse medicine reactions and 7.4% of all fatal occurrences. The top 20 drugs were responsible for 57% of all liver reactions. Despite a steady increase in the number of reports during the 21 years, mortality was lowest during the last 7 years. Differences in the medicines causing liver injury during the three periods influenced the number of fatalities. Erythromycin was the most commonly reported cause of hepatic reactions but was usually associated with a favourable outcome. There were no reported deaths with diclofenac, Augmentin or flucloxacillin.

Topics: Adult; Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anesthetics, Inhalation; Anti-Bacterial Agents; Anti-Inflammatory Agents; Calcium Channel Blockers; Cardiovascular Agents; Cause of Death; Clavulanic Acids; Diclofenac; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Erythromycin; Female; Floxacillin; Halothane; Humans; Liver; Male; Middle Aged; New Zealand; Penicillins; Perhexiline; Steroids

A 14-month (1992/3) prospective study was performed in two departments of the University Hospital Centre (UHC) in Zagreb. The aim of the study was to assess the rate of drug-related hospitalizations, drugs that caused adverse drug reactions (ADRs), and all factors which could have been of importance for their appearance. One hundred and thirty (2.5%) of 5,227 patients were admitted to hospital because of ADRs. The most frequently ADR-related drugs were nonsteroidal anti-inflammatory drugs and analgesics (64.6%). They were followed by cardiovascular agents (20.8%) and antimicrobials (3.8%). Acetylsalicylic acid (aspirin) caused 38.5% of hospital admissions, other nonsteroidal anti-inflammatory drugs (NSAIDs) 23.1% and medigoxin 15.4% of hospitalizations. The most frequent ADRs were upper gastro-intestinal tract bleeding (64.6%), cardiac rhythm disturbances (13.9%), blood cell disorders (4.6%) and hypoglycemia (2.3%). Regarding the patients' age, 52.3% of patients was younger and 47.7% older than 65. Sixty-one point five percent of patients was taking more than one drug, older patients (48 patients--77.4%) have been taking a significantly higher number of drugs than the younger (32 patients--47.1%) (p < 0.0001) ones. Drug interactions caused 23.8% of ADRs. Only 11 (8.5%) of patients suspected themselves that the drug might have caused the ADR. Improvement was observed in the majority of patients (65.4%), 25.4% recovered completely, 4 (3.0%) died in the hospital because of ADRs. 3.0% of patients as well died of their underlying diseases, 2.3% were transferred to other departments for their underlying diseases, and one patient left the hospital on his free will.

Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cardiovascular Agents; Drug Monitoring; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Hemorrhage; Humans; Length of Stay; Male; Medigoxin; Middle Aged; Patient Admission; Prospective Studies

The records of 268 patients were used to assess the effects of five disease/drug complexes on the number of postinsertion visits in complete denture wearers. The data were analyzed with SAS and BMDP computer packages. The results showed a statistically significant increase in the number of postinsertion visits in patients who had central nervous system or psychiatric disorders. Practitioners are alerted to consider the ergonomic implications at the outset of treatment.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Cardiovascular Diseases; Central Nervous System Agents; Central Nervous System Diseases; Chi-Square Distribution; Dental Care for Aged; Dental Care for Chronically Ill; Denture Retention; Denture, Complete; Diabetes Complications; Diabetes Mellitus; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Masticatory Muscles; Mental Disorders; Metabolic Diseases; Middle Aged; Mouth Diseases; Movement; Office Visits; Pain; Prosthesis Fitting; Respiratory Tract Diseases; Retrospective Studies; Xerostomia

The increasing proportion of elderly people in American society offers a challenge to dental hygienists. It is important that dental hygienists possess a basic knowledge of medications generally prescribed for the elderly. The purpose of this paper is to inform the practicing hygienist about the drugs most commonly used by the elderly. General physiological results of aging that affect drug therapy, four basic categories of drugs prescribed for the elderly, and drug-induced oral conditions are discussed. In addition, reference manuals are recommended for use at chairside by the practicing hygienist.

Topics: Aged; Analgesics; Antidepressive Agents; Cardiovascular Agents; Dental Care for Aged; Dental Hygienists; Drug-Related Side Effects and Adverse Reactions; Humans; Hypnotics and Sedatives; Mouth Diseases

Topics: Aged; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Humans; Patient Compliance; Psychotropic Drugs

Three hundred and sixty-six consecutive patients admitted to a department of cardiology were evaluated for drug events as a cause of admission. The drug events considered were adverse drug reactions (ADR) and dose-related therapeutic failures (DTF). 'Definite' or 'probable' drug events accounted for 15 admissions (4.1%, 95% confidence limits 2.3-6.7%), of which eleven were ADR and four were DTF. With the inclusion of six 'possible' drug events, the rate of drug-related hospitalizations (DRH) was 5.7%. DRHs were characterized by a preponderance of acute admissions and elderly patients. Hypokalaemia (less than 3.5 mM) was observed in 27 (16%) patients receiving diuretics, and could be related to four cases of arrhythmias (two 'probable' and two 'possible' ADR). The average serum potassium level was similar in diuretic treated patients with or without drugs to counteract hypokalaemia, irrespective of the drugs chosen. Among the 15 'definite'/'probable' DRHs, five were considered to be due to an error in prescription, and a further five cases were judged to have been avoidable had appropriate measures been taken by prescribing physicians. A DRH educational intervention programme should primarily deal with non-compliance or with prescription of diuretics or digoxin, since these problems constitute the majority of cases of DRH. No specific group of doctors could be targeted as responsible for DRH, avoidable or not.

Topics: Cardiovascular Agents; Denmark; Diuretics; Drug-Related Side Effects and Adverse Reactions; Female; Hospital Departments; Hospitalization; Humans; Hypokalemia; Male; Middle Aged

The drug therapy prescribed for 412 diabetic patients attending an outpatient clinic over a 12 week period was recorded to try and identify potential therapeutic problems. Over 90% of the patients were prescribed at least one drug (including insulin) with oral hypoglycaemic agents prescribed for 86% of non-insulin requiring diabetics. 19% of patients were prescribed more than three drugs and few patients took drug combinations. Of patients prescribed either glibenclamide or chlorpropamide, 63% were aged 65 yr or older. Despite their potential adverse clinical and biochemical effects, diuretics and beta-blockers were commonly prescribed, especially in hypertension. The prescribing of "newer" anti-hypertensive drugs, combination products in patients taking a multiple drug regimen, and the potential dangers of sulphonylureas in the elderly are three areas where alteration of prescribing habits may be of value.

Topics: Adrenergic beta-Antagonists; Cardiovascular Agents; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diuretics; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Humans; Hypoglycemic Agents; Insulin; Medical Audit; Patient Compliance

Myasthenia gravis is an uncommon disease. The emergency physician should be cautious when prescribing medications to myasthenics for problems not related to myasthenia gravis. We have discussed some of those agents (Figure 3) that are recognized to cause exacerbation of MG or that may have the potential to exacerbate MG. We recommend that management of any medical or surgical problem of the myasthenic be done in consultation with a managing neurologist, and that either early follow-up or admission is necessary when these agents are used in the patient with myasthenia gravis.

Topics: Anti-Bacterial Agents; Anticonvulsants; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Glucocorticoids; Humans; Myasthenia Gravis; Neuromuscular Blocking Agents; Psychotropic Drugs

Topics: Adult; Cardiovascular Agents; Counseling; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Libido; Male; Psychotropic Drugs; Sexual Behavior

Topics: Anti-Infective Agents; Anti-Inflammatory Agents; Cardiovascular Agents; Drug Interactions; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Humans

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Emergencies; Humans; Nursing Care; Pharmaceutical Preparations

Topics: Adrenal Cortex Hormones; Anti-Bacterial Agents; Anticoagulants; Cardiovascular Agents; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacology; Psychotropic Drugs

Topics: Anti-Inflammatory Agents; Benzodiazepines; Cardiovascular Agents; Drug Therapy; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Vitamins

Elderly Americans make up 11 percent of the population but consume 25 percent of all prescription medications. The incidence of adverse drug effect is 1.5 to 3 times higher in older patients and accounts for numerous hospitalizations. The basic pharmacokinetic parameters of absorption, distribution, metabolism, and excretion are all significantly altered in geriatric patients. Certain specific drug side effects, such as orthostatic hypotension and anticholinergic effects, can be particularly hazardous in older patients. This paper describes general therapeutic principles for geriatric patients. Commonly used drug categories are considered separately. A thorough knowledge of these principles will allow the physician to prescribe drugs more effectively, improve patient compliance, and minimize adverse drug effects.

Topics: Aged; Aging; Anti-Bacterial Agents; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Female; Gastrointestinal Agents; Geriatrics; Humans; Male; Middle Aged; Parasympatholytics; Pharmaceutical Preparations; Psychotropic Drugs; Sympatholytics

Topics: Biological Assay; Cardiovascular Agents; Digitalis Glycosides; Digitoxin; Digoxin; Drug-Related Side Effects and Adverse Reactions; Humans; Rabbits; Research; Sex Characteristics; Toxicology

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Electroretinography; Eye Diseases; Humans; Quinine; Toxicology

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Poisoning; Quinine; Toxicology

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Pharmacology; Poisoning; Quinine; Toxicology

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Quinidine; Quinine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Health; Quinine

Topics: Atropine; Cardiovascular Agents; Child; Drug-Related Side Effects and Adverse Reactions; Fever; Humans; Infant; Muscle Relaxants, Central; Seizures

Topics: Blindness; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Quinine

Topics: Atrial Flutter; Cardiovascular Agents; Cardiovascular Diseases; Digitalis; Drug-Related Side Effects and Adverse Reactions

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Eye; Eye Diseases; Humans; Quinine

Topics: Cardiovascular Agents; Child; Drug-Related Side Effects and Adverse Reactions; Humans; Infant; Methemoglobinemia; Nitrates; Nitrogen Oxides; Water

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Lactates; Procainamide; Quinidine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Gas Poisoning; Irritants; Nitrates; Prednisolone; Prednisone

Topics: Calcium; Calcium, Dietary; Cardiovascular Agents; Chelating Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Edetic Acid; Humans

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Humans; Syncope

Topics: Bismuth; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Heavy Metal Poisoning; Humans; Infant; Metals, Heavy; Methemoglobinemia; Nitrates; Poisoning

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Humans

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Quinacrine; Quinine

Topics: Blindness; Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Humans

Topics: Blindness; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Quinine

Topics: Cardiovascular Agents; Digitalis; Digitoxin; Drug-Related Side Effects and Adverse Reactions; Lactic Acid; Lactones

Topics: Amblyopia; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Poisoning; Quinine

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Humans; Poisoning

Topics: Amblyopia; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Electroretinography; Humans; Quinine; Research

Topics: Amblyopia; Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Poisoning; Quinine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Nitrates; Poisoning

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Nitrates; Poisoning; Potassium; Potassium Compounds; Suicide; Suicide, Attempted

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Humans; Poisoning; Quinine

Topics: Animals; Cardiovascular Agents; Dogs; Drug-Related Side Effects and Adverse Reactions; Electrocardiography; Heart; Quinine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Hemorrhagic Disorders; Humans; Quinine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Eye; Eye Diseases; Humans; Quinine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Quinine

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions

Topics: Cardiovascular Agents; Child; Cyanosis; Drug-Related Side Effects and Adverse Reactions; Humans; Infant; Methemoglobinemia; Nitrates

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions

Topics: Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions

Topics: Animals; Asian People; Cardiovascular Agents; Down Syndrome; Drug-Related Side Effects and Adverse Reactions; Gerbillinae; Humans; Intellectual Disability; Pregnancy; Quinine

Topics: Cardiovascular Agents; Child; Drug-Related Side Effects and Adverse Reactions; Heart; Humans; Quinidine

Topics: Cardiovascular Agents; Drug-Related Side Effects and Adverse Reactions; Humans; Nitrates; Water Wells

Topics: Atrioventricular Block; Cardiovascular Agents; Digitalis; Drug-Related Side Effects and Adverse Reactions; Optic Neuritis