Active clinical trials for "Drug-Related Side Effects and Adverse Reactions"

We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. For targeted patients, we tested the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. This was studied using a randomized controlled trial of usual care (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy technicians to obtain an admission medication history. The overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Oral anticoagulant therapy with warfarin is essential for the prevention of strokes and other thromboembolic events related to various medical conditions; however, use of this therapy can be associated with an increased risk of serious bleeding. In a previous AHRQ-funded study, we have demonstrated that the prevalence of conditions for which warfarin is indicated is high among frail elderly nursing homes residents, use of warfarin in this setting is very common, and the quality and safety with which warfarin is used is far from optimal. The research described in this application resonates with AHRQ's stated priorities for FY2006. The premise underlying the proposed intervention study is that errors in prescribing and monitoring warfarin for nursing home residents are related more to problems in the system of care, than to deficits in the knowledge base of health care providers. We propose a low technology intervention for improving the quality and safety of anticoagulant therapy with warfarin in the nursing home setting. The intervention focuses on maximizing the effectiveness of communication between the nursing staff and physicians of nursing home residents on warfarin. The intervention will build on an established approach for situation briefing drawn from the U.S. armed forces: SBAR - Situation, Background, Assessment, Recommendation. We will test the effectiveness of this approach through a matched, cluster-randomized trial, with randomization at the level of the nursing home. Our study has the following specific aims: (1) to determine whether a nursing home warfarin management protocol emphasizing facilitated communication to physicians will improve the quality of anticoagulation management, which will be assessed using widely accepted quality measures; (2) to determine whether the intervention will lower the rates of adverse events (bleeds and thromboembolic events) among warfarin-treated residents of intervention group nursing homes compared to control nursing homes; and (3) to produce a toolkit for use by nursing homes that will allow dissemination of this approach to enhancing the quality and safety of warfarin for the frail elderly. If successful, this approach may serve as a model for improving the safety of other medication categories associated with high rates of preventable adverse drug events, and for protecting nursing home residents, and frail elderly cared for in other settings, who are at special risk for medication-related problems.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy.

RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of keratinocyte growth factor in preventing oral mucositis in patients who have hematologic cancers and who are undergoing radiation therapy and chemotherapy before autologous peripheral stem cell transplantation.

Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication. These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care. The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.

On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.

Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Providing drug safety must be one of the main goals to be achieved for every member of our society. In our study, we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients and to determine the risk factors that may affect them.

Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.

Polypharmacy has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. Many adverse drug reactions could be prevented with closer monitoring. This project will establish the effectiveness of the nurse-led intervention - the ADRe Profile - for medicines commonly prescribed in primary care and evaluate intervention implementation in general practices.