Drug-related problems with targeted/immunotherapies at an oncology outpatient clinic

2019 ◽  
Vol 26 (3) ◽  
pp. 595-602
Author(s):  
Esra Kucuk ◽  
Aygin Bayraktar-Ekincioglu ◽  
Mustafa Erman ◽  
Saadettin Kilickap
Keyword(s):  
Adverse Drug Event ◽  
Clinical Pharmacist ◽  
Adverse Drug Events ◽  
Drug Event ◽  
Targeted Chemotherapy ◽  
Drug Related Problems ◽  
Patients With Cancer ◽  
Common Drug ◽  
Oncology Care ◽  
The Impact

Background Some studies in the literature describe drug-related problems in patients with cancer, although few studies focused on patients receiving targeted chemotherapy and/or immunotherapy. To identify the incidence of drug-related problems in patients receiving targeted chemotherapy and/or immunotherapy, and demonstrate the impact of a clinical pharmacist in an outpatient oncology care setting. Methods Prospective study was conducted in a hospital outpatient oncology clinic between October 2015 and March 2016. Patients greater than 18 years old receiving cetuximab, nivolumab, ipilimumab, or pembrolizumab were included in the study and monitored over a three-month period by a clinical pharmacist. Drug-related problems were analyzed using the Pharmaceutical Care Network Europe classification system. The main outcome measures were the frequency and causes of drug-related problems and the degree of resolution achieved through the involvement of a clinical pharmacist. Results A total of 54 patients (mean age: 57 ± 12 years) were included. There were 105 drug-related problems and 159 associated causes. Among the planned interventions (n = 149), 92 interventions were at the patient-level with 88 (96%) being accepted by the doctors. This resulted in 68 (65%) drug-related problems being completely resolved and 9 (8.6%) being partially resolved. The most common drug-related problem identified was “adverse drug event” (n = 38, 36%). Of the 105 drug-related problems, 63 (60%) related to targeted chemotherapy and/or immunotherapy with 34 (54%) classified as an “adverse drug event.” Conclusion Adverse drug events were the most common drug-related problems in patients with cancer. The involvement of a clinical pharmacist improved the identification of drug-related problems and helped optimize treatment outcomes in patients receiving targeted chemotherapy/immunotherapy.

scholarly journals Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeffrey P. Hau ◽  
Penelope M. A. Brasher ◽  
Amber Cragg ◽  
Serena Small ◽  
Maeve Wickham ◽  
...  
Keyword(s):  
Health Information ◽  
Adverse Drug Event ◽  
Primary Outcome ◽  
Adverse Drug Events ◽  
Primary Objective ◽  
Drug Event ◽  
Controlled Trials ◽  
Drug Reactions ◽  
Main Trial ◽  
Randomized Controlled

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: A Mixed Methods Study (Preprint)

2021 ◽  
Author(s):  
Erina Chan ◽  
Serena S Small ◽  
Maeve E Wickham ◽  
Vicki Cheng ◽  
Ellen Balka ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Adverse Drug Event ◽  
Adverse Drug Events ◽  
Retrospective Chart Review ◽  
Drug Event ◽  
Free Text ◽  
Snomed Ct ◽  
Data Standards ◽  
Data Standard ◽  
Research Assistants

BACKGROUND Existing systems to document adverse drug events often use free text data entry, producing non-standardized, unstructured data prone to misinterpretation. Standardized terminology may improve data quality, but it is unclear which data standard is most appropriate to document adverse drug event symptoms and diagnoses. OBJECTIVE Our objective was to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. METHODS We performed a mixed-methods sub-study of a multicenter retrospective chart review. We reviewed research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. Two pharmacy research assistants independently entered symptoms and/or diagnoses for adverse drug events using 4 standards: MedDRA, SNOMED CT, SNOMED Adverse Reaction, and ICD-11. Disagreements between research assistants regarding case-specific utility of data standards were discussed until reaching consensus. We used consensus ratings to determine proportion of adverse drug events covered by a data standard, and coded and analyzed field notes from consensus sessions. RESULTS We reviewed 573 adverse drug events and found MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and/or diagnoses. While MedDRA had the highest number of matches between the research assistants, ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. Research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, and least likely with MedDRA. CONCLUSIONS Usability, comprehensiveness, and accuracy are important features of data standards for documenting ADE symptoms and diagnoses. Based on our results, we would recommend the use of MedDRA.

Drug-related problems identification in general internal medicine: The impact and role of the clinical pharmacist and pharmacologist

2015 ◽  
Vol 26 (6) ◽  
pp. 399-406 ◽  
Author(s):  
Bertrand Guignard ◽  
Pascal Bonnabry ◽  
Arnaud Perrier ◽  
Pierre Dayer ◽  
Jules Desmeules ◽  
...  
Keyword(s):  
Internal Medicine ◽  
General Internal Medicine ◽  
Clinical Pharmacist ◽  
Drug Related Problems ◽  
General Internal ◽  
The Impact

Evaluation of thromboembolic events in cancer patients receiving bevacizumab according to the Japanese Adverse Drug Event Report database

2016 ◽  
Vol 24 (1) ◽  
pp. 22-27 ◽  
Author(s):  
Chikako Matsumura ◽  
Yugo Chisaki ◽  
Satoko Sakimoto ◽  
Honoka Sakae ◽  
Yoshitaka Yano
Keyword(s):  
Risk Factors ◽  
Cancer Patients ◽  
Adverse Drug Event ◽  
Thromboembolic Event ◽  
Venous Thromboembolic Event ◽  
Drug Event ◽  
Thromboembolic Events ◽  
Event Report ◽  
Patients With Cancer ◽  
Venous Thromboembolic

Purpose We aimed to examine the risk factors, time of onset, incidence rates, and outcomes of thromboembolic events induced by bevacizumab in patients with cancer using the Japanese Adverse Drug Event Report (JADER) database of the Pharmaceuticals and Medical Devices Agency. Methods Adverse event data recorded in the JADER database between January 2004 and January 2015 were used. After screening the data using the generic drug name bevacizumab, patient data were classified into two groups by age and five groups by cancer type. The histories of disorders were also categorized. Arterial thromboembolic event and venous thromboembolic event were classified as “favorable” or “unfavorable” outcomes. Results In total, 6076 patients were reported to have developed adverse events during the sample period, of which 233 and 453 developed arterial thromboembolic event and venous thromboembolic event, respectively. Logistic analysis suggested that the presence of cancer was a significant risk factor for both arterial thromboembolic event and venous thromboembolic event. Age (≥70 years), histories of either hypertension or diabetes mellitus were also risk factors for arterial thromboembolic event. Median cumulative times of onset for arterial thromboembolic event and venous thromboembolic event were 60 and 80 days, respectively, and were not significantly different by the log-rank test. By the chi-square test, the rate of unfavorable outcomes was found to be higher after developing arterial thromboembolic event than after venous thromboembolic event. Conclusion Thromboembolism is a leading cause of mortality in patients with cancer. Patients should be monitored for the symptoms of thromboembolic events right from the initial stages of bevacizumab treatment.

Integrating clinical pharmacy services into patient care in an early-phase clinical trial clinic.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18228-e18228
Author(s):  
Dazhi Liu ◽  
Thu Oanh Dang ◽  
Stephen Harnicar ◽  
Katherine Kargus ◽  
Lauren A Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Clinical Pharmacist ◽  
Early Phase ◽  
Treatment Options ◽  
Cancer Center ◽  
Protocol Violation ◽  
Patients With Cancer ◽  
The Impact

e18228 Background: Early phase clinical trials have broadened treatment options for patients with cancer. Expert management of these new therapies is essential to positive patient outcomes. At Memorial Sloan Kettering Cancer Center, the Developmental Therapeutic Center (DTC) satisfies this need. Oncology clinical pharmacists collaborate with other healthcare professionals to maximize the benefits of drug therapy and minimize toxicities. The purpose of this project is to describe the interventions from a clinical pharmacist assigned to the DTC. Methods: A clinical pharmacist joined DTC to serve adult patients with cancer undergoing clinical trials. The clinical pharmacist acted as a liaison between pharmacy team and medical team, and sees patients during their trial eligibility screening and follow-up visits. The interventions were documented by the clinical pharmacist in patients’ medical charts and email communications. All interventions during 1 month were retrospectively collected and categorized into supportive care optimization, protocol violation prevention, and operational. Results: The oncology clinical pharmacist was involved in 115 patient visits for trial eligibility screening or protocol follow-up. A total of 769 interventions were addressed including supportive care optimization (40.2%), protocol violation prevention (24.7%), and operational (35.1%). Conclusions: The oncology clinical pharmacist is actively engaged in many aspects of cancer care at the early phase trial clinic. Our results demonstrate the vital role of an oncology clinical pharmacist. The impact of these categorized intervention areas would require a formal outcome and cost-saving analysis. [Table: see text]

scholarly journals Drug related problems in admitted geriatric patients: The impact of clinical pharmacist interventions

2019 ◽  
Author(s):  
Berhane Yohannes Hailu ◽  
Derbew Fikadu Berhe ◽  
Esayas Kebede Gudina ◽  
Kidu Gidey ◽  
Mestwat Getachew
Keyword(s):  
Clinical Pharmacist ◽  
Geriatric Patients ◽  
Medical Center ◽  
Optimization Methods ◽  
Acceptance Rate ◽  
Drug Related Problems ◽  
Treatment Optimization ◽  
Pharmacist Interventions ◽  
Age Related ◽  
The Impact

Abstract Background: Geriatric patients are at high risk of Drug Related Problems (DRPs) due to multi- morbidity associated polypharmacy, age related physiologic changes, pharmacokinetic and pharmacodynamics alterations. These patients are often excluded from premarketing trials that can further increase the occurrence of DRPs. This study was aimed to identify DRPs and determinants in geriatric patients admitted to medical and surgical wards, and to evaluate the impact of clinical pharmacist interventions for treatment optimization. Methods: A prospective observational study was conducted among geriatric patients admitted to medical and surgical wards of Jimma University Medical Center from April to July 2017. Clinical pharmacists reviewed patients drug therapy, identified drug related problems and provided interventions. Data were analyzed by using SPSS statistical software version 20.0. Descriptive statistics were performed to determine the proportion of drug related problems. Logistic regression analyses were performed to identify the determinants of drug related problems. Results: A total of 200 geriatric patients were included in the study. The mean age of the participants was 67.3 years (SD7.3). About 82% of the patients had at least one drug related problems. A total of 380 drug related problems were identified and 670 interventions were provided. For the clinical pharmacist interventions, the prescriber acceptance rate was 91.7%. Significant determinants for drug related problems were polypharmacy (adjusted odds ratio [AOR]=4.350, 95% C.I: 1.212-9.260, p = 0.020) and number of comorbidities (AOR=1.588, 95% C.I: 1.029-2.450, p = 0.037). Conclusions: Drug related problems were substantially high among geriatric inpatients. Geriatric patients with polypharmacy and comorbidities need special attention to prevent drug related problems. Involving clinical pharmacist in the clinical team resulted in the improved acceptance rate of treatment optimization.

scholarly journals A Survey of Nursing Home Physicians to Determine Laboratory Monitoring Adverse Drug Event Alert Preferences

2014 ◽  
Vol 05 (04) ◽  
pp. 895-906 ◽  
Author(s):  
S. Perera ◽  
D.A. Nace ◽  
C.M. Culley ◽  
S.M. Handler ◽  
R.D. Boyce
Keyword(s):  
Nursing Home ◽  
Adverse Drug Event ◽  
Adverse Drug Events ◽  
Clinical Event ◽  
Drug Event ◽  
Specific Information ◽  
Laboratory Monitoring ◽  
Term Care ◽  
Home Setting ◽  
Communication Modalities

SummaryObjective: We conducted a survey of nursing home physicians to learn about (1) the laboratory value thresholds that clinical event monitors should use to generate alerts about potential adverse drug events (ADEs); (2) the specific information to be included in the alerts; and (3) the communication modality that should be used for communicating them.Methods: Nursing home physician attendees of the 2010 Conference of AMDA: The Society for Post-Acute and Long-Term Care Medicine.Results: A total of 800 surveys were distributed; 565 completed surveys were returned and seven surveys were excluded due to inability to verify that the respondents were physicians (a 70% net valid response rate). Alerting threshold preferences were identified for eight laboratory tests. For example, the majority of respondents selected thresholds of ≥ 5.5 mEq/L for hyperkalemia (63%) and ≤ 3.5 without symptoms for hypokalemia (54%). The majority of surveyed physicians thought alerts should include the complete active medication list, current vital signs, previous value of the triggering lab, medication change in the past 30 days, and medication allergies. Most surveyed physicians felt the best way to communicate an ADE alert was by direct phone/voice communication (64%), followed by email to a mobile device (59%).Conclusions: This survey of nursing home physicians suggests that the majority prefer alerting thresholds that would generally lead to fewer alerts than if widely accepted standardized laboratory ranges were used. It also suggests a subset of information items to include in alerts, and the physicians’ preferred communication modalities. This information might improve the acceptance of clinical event monitoring systems to detect ADEs in the nursing home setting.Citation: Boyce RD, Perera S, Nace DA, Culley CM, Handler SM. A survey of nursing home physicians to determine laboratory monitoring adverse drug event alert preferences. Appl Clin Inf 2014; 5: 895–906http://dx.doi.org/10.4338/ACI-2014-06-RA-0053

scholarly journals Drug related problems in admitted geriatric patients: the impact of clinical pharmacist interventions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Berhane Yohannes Hailu ◽  
Derebew Fikadu Berhe ◽  
Esayas Kebede Gudina ◽  
Kidu Gidey ◽  
Mestawet Getachew
Keyword(s):  
Clinical Pharmacist ◽  
Geriatric Patients ◽  
Drug Related Problems ◽  
Pharmacist Interventions ◽  
The Impact

PP88 Intravenous Medication Delivery System Cost-Effectiveness Analysis

2018 ◽  
Vol 34 (S1) ◽  
pp. 99-99
Author(s):  
Antonio Peregrino ◽  
Roberto Silva ◽  
Alexander Itria ◽  
Carlos Silva ◽  
Ana Tolentino ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Adverse Drug Event ◽  
Adverse Drug Events ◽  
Cost Effective ◽  
Drug Event ◽  
Base Case ◽  
Infusion Pumps ◽  
System Perspective ◽  
Medication Delivery ◽  
Intravenous Medication

Introduction:Medication delivery is one of the most common interventions in clinical practice. It requires the direct involvement of nurses and high precision infusion pumps in order to increase the infusion accuracy. Any mistake in the medication delivery process can lead to a medication error, resulting in adverse events with considerable increases in hospital length of stay and cost. Research studies should analyze this area more in emerging countries, as their realities differ from the realities of developed countries, where most of the literature of this area has been developed. This research study analyses this area in Brazil, a leading emerging country. The incorporation of these technologies in health services have caused two major problems: uncertainty around its effectiveness in reducing adverse drug event rates related to infusion dose errors, and the high cost of their inputs. The objective of this study was to analyze the cost-effectiveness of intelligent drug library infusion pumps to reduce adverse drug events during intravenous medication delivery in pediatric and neonatal patients.Methods:Cost-effectiveness was evaluated using a decision-tree framework, considering two scenarios as the base case: the reference one, which uses conventional infusion pumps for intravenous medication delivery with a volume greater than 60 mL, and an alternative one, which uses the drug library infusion pumps. The analysis is with the Unified Health System (Brazil's publicly funded health care system) perspective. The Monte Carlo simulations addressed the uncertainties of the framework. The effectiveness measure was avoidance of adverse drug events.Results:The probabilistic analysis showed the drug library infusion pumps to be more cost-effective than conventional pumps. This ratified what had already been revealed by acceptance curve, which demonstrated that the drug library infusion pumps are more likely to be cost-effective compared to the conventional infusion pumps (with a minimum of the incremental cost-effectiveness of USD 1,501.28).Conclusions:The study demonstrated that the use of the drug library infusion pumps in the pediatric and the neonatal intensive care unit can improve the results of the adverse drug event reduction strategy.

scholarly journals The Influence of Pharmacogenetics on the Clinical Relevance of Pharmacokinetic Drug–Drug Interactions: Drug–Gene, Drug–Gene–Gene and Drug–Drug–Gene Interactions

2021 ◽  
Vol 14 (5) ◽  
pp. 487
Author(s):  
Martina Hahn ◽  
Sibylle C. Roll
Keyword(s):  
Drug Therapy ◽  
Drug Interactions ◽  
Clinical Relevance ◽  
Adverse Drug Events ◽  
Current Evidence ◽  
Drug Event ◽  
Gene Interactions ◽  
Genetic Profile ◽  
The Impact ◽  
Pharmacokinetic Drug

Drug interactions are a well-known cause of adverse drug events, and drug interaction databases can help the clinician to recognize and avoid such interactions and their adverse events. However, not every interaction leads to an adverse drug event. This is because the clinical relevance of drug–drug interactions also depends on the genetic profile of the patient. If inhibitors or inducers of drug metabolising enzymes (e.g., CYP and UGT) are added to the drug therapy, phenoconcversion can occur. This leads to a genetic phenotype that mismatches the observable phenotype. Drug–drug–gene and drug–gene–gene interactions influence the toxicity and/or ineffectivness of the drug therapy. To date, there have been limited published studies on the impact of genetic variations on drug–drug interactions. This review discusses the current evidence of drug–drug–gene interactions, as well as drug–gene–gene interactions. Phenoconversion is explained, the and methods to calculate the phenotypes are described. Clinical recommendations are given regarding the integratation of the PGx results in the assessment of the relevance of drug interactions in the future.

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