Drug-induced Adverse Events

Identifying the Risks of Unproven Regenerative Medicine Therapies.

Fri, 2020-10-23 07:07
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Identifying the Risks of Unproven Regenerative Medicine Therapies.

JAMA. 2020 Jul 21;324(3):241-242

Authors: Marks PW, Hahn S

PMID: 32629463 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Pharmacists' knowledge and counselling on fall risk increasing drugs in a tertiary teaching hospital in Nigeria.

Fri, 2020-10-23 07:07
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Pharmacists' knowledge and counselling on fall risk increasing drugs in a tertiary teaching hospital in Nigeria.

BMC Health Serv Res. 2020 Mar 30;20(1):259

Authors: Akande-Sholabi W, Ogundipe FS, Adisa R

Abstract
BACKGROUND: Falls and fall-related injuries are a foremost health concern among older adults aged 60 years and above. Fall-risk-increasing drugs (FRIDs) use by older adults is one related cause of falling, and it is frequently used among older adults. Pharmacist-led counselling is an aspect of patient education that has been associated with improved therapeutic outcome and quality of life in high income countries with scarcity of information in low-middle income countries. This study therefore aims to assess hospital pharmacists' knowledge and counselling on fall-related medications using the list compiled by the Swedish National Board of Health and Welfare on FRIDs and orthostatic drugs (ODs).
METHODS: A cross-sectional survey was carried out among 56 pharmacists working in a teaching hospital in Nigeria, between July and August 2019, using a self-administered questionnaire. Data were summarized with descriptive statistics while chi-square test was used for categorical variables at p < 0.05.
RESULTS: Thirty-five (62.5%) were within 10 years of practice experience. Two-third (62.5%) of the pharmacists possessed an additional qualification to Bachelor of Pharmacy degree. Twenty-two (40.0%) were aware of the FRIDs and ODs list. In all, (89.3%) had "unsatisfactory" knowledge of classes of medications and specific medicines that could cause a fall. Most pharmacists 42 (80.8%) focused counsel on appropriate medication use, adverse effects of drugs and storage of medications. Knowledge score of both FRIDs and ODs were neither significantly associated with pharmacists' years of qualification (χ2 = 1.282; p = 0.733), (χ2 = 2.311; p = 0.510) nor with possession of additional qualification (χ2 = 0.854; p = 0.836), (χ2 = 2.996; p = 0.392). Majority, 53 (98.1%) believed that patients will benefit from effective counselling on FRIDs and ODs. About half (25; 51.0%) suggested training through seminar presentation as a measure for FRIDs and ODs sensitization.
CONCLUSION: A substantial gap in knowledge and awareness of FRIDs and ODs was noted among the hospital pharmacists. However, engagement of pharmacists on counsel that focus on medication use, adverse effect and storage was relatively better. Thus, there is a general need to create awareness about fall-risk-increasing drugs among hospital pharmacists, so as to help improve the therapeutic outcome particularly in the older adults.

PMID: 32228567 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Adverse Events, Drug Interactions, and Treatment Adherence.

Fri, 2020-10-23 07:07
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Adverse Events, Drug Interactions, and Treatment Adherence.

J Psychosoc Nurs Ment Health Serv. 2020 Feb 01;58(2):9-13

Authors: Limandri BJ

Abstract
Many clients do not take their medications as prescribed. One of the reasons may be the common adverse drug effects and drug-drug interactions of certain medications. This article reviews adverse drug effects (including less serious side effects), the pharmacokinetics and pharmacodynamics involved in adverse effects, and the pharmacokinetics of drug interactions. For medications to be effective in treating mental disorders, nurses need to carefully assess clients and their motivations for taking medications, routinely inquire about when and how they are taking their prescriptions, any adverse effects they are experiencing, and how they are managing common, less severe adverse effects. [Journal of Psychosocial Nursing and Mental Health Services, 58(2), 9-13.].

PMID: 32003860 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Drugs to Treat Hypertension.

Fri, 2020-10-23 07:07
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Drugs to Treat Hypertension.

J Psychosoc Nurs Ment Health Serv. 2020 02 01;58(2):7-8

Authors:

PMID: 32003859 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

A Severe Case of Drug-Induced Liver Injury after Gemcitabine Administration: A Highly Probable Causality Grading as Assessed by the Updated RUCAM Diagnostic Scoring System.

Thu, 2020-10-22 09:37

A Severe Case of Drug-Induced Liver Injury after Gemcitabine Administration: A Highly Probable Causality Grading as Assessed by the Updated RUCAM Diagnostic Scoring System.

Case Reports Hepatol. 2020;2020:8812983

Authors: Mascherona I, Maggioli C, Biggiogero M, Mora O, Marelli L

Abstract
Gemcitabine is an antineoplastic drug used in several forms of advanced pancreatic, lung, breast, ovarian, and bladder cancer. Common side effects include bone marrow suppression, fatigue, diarrhea, nausea, gastrointestinal upset, rash, alopecia, and stomatitis. Transient serum enzyme elevations could be observed during therapy, but clinically significant acute liver injury has been rarely associated with its use. Few cases of acute liver injury have been reported in the literature. We reported the clinical case of a 73--year-old man who developed clinically significant acute hepatic injury after using gemcitabine. Possible causes, clinical presentation, and treatments are discussed. According to the updated RUCAM score, the case was rated 10 points and became a suspected drug-induced liver injury. Moreover, on the liver biopsy, there were histological findings of mild-to-moderate portal hepatitis, eosinophilia, bile duct injury, and mild perisinusoidal fibrosis, suggesting drug damage.

PMID: 33083070 [PubMed]

Categories: Literature Watch

Steroid emergency cards: action needed.

Thu, 2020-10-22 06:32

Steroid emergency cards: action needed.

Drug Ther Bull. 2020 Oct 20;:

Authors:

Abstract
Every month, DTB scans sources of information on treatments, disease management and other healthcare topics for key items to bring to our readers' attention and help them keep up to date. To do this, we produce succinct, contextualised summaries of the information concerned.

PMID: 33082160 [PubMed - as supplied by publisher]

Categories: Literature Watch

Recurrent blisters on the lip.

Thu, 2020-10-22 06:32

Recurrent blisters on the lip.

BMJ. 2020 10 01;371:m3390

Authors: Xie F, Divekar P

PMID: 33004337 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

A stratification method based on clustering for the minimization of data masking effect in signal detection.

Thu, 2020-10-22 06:32
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A stratification method based on clustering for the minimization of data masking effect in signal detection.

BMC Med Inform Decis Mak. 2020 02 03;20(1):18

Authors: Wei JX, Ding Y, Li M, Sun J

Abstract
BACKGROUND: Data masking is an inborn defect of measures of disproportionality in adverse drug reactions (ADRs) signal detection. Many previous studies can be roughly classified into three categories: data removal, regression and stratification. However, frequency differences of adverse drug events (ADEs) reports, which would be an important factor of masking, were not considered in these methods. The aim of this study is to explore a novel stratification method for minimizing the impact of frequency differences on real signals masking.
METHODS: Reports in the Chinese Spontaneous Reporting Database (CSRD) between 2010 and 2011 were selected. The overall dataset was stratified into some clusters by the frequency of drugs, ADRs, and drug-event combinations (DECs) in sequence. K-means clustering was used to conduct stratification according to data distribution characteristics. The Information Component (IC) was adopted for signal detection in each cluster respectively. By extracting ADRs from drug product labeling, a reference database was introduced for performance evaluation based on Recall, Precision and F-measure. In addition, some DECs from the Adverse Drug Reactions Information Bulletin (ADRIB) issued by CFDA were collected for further reliability evaluation.
RESULTS: With stratification, the study dataset was divided into 21 clusters, among which the frequency of DRUGs, ADRs or DECs followed the similar order of magnitude respectively. Recall increased by 34.95% from 29.93 to 40.39%, Precision reduced by 10.52% from 54.56 to 48.82%, while F-measure increased by 14.39% from 38.65 to 44.21%. According to ADRIB after 2011, 5 DECs related to Potassium Magnesium Aspartate, 61 DECs related to Levofloxacin Hydrochloride and 26 DECs related to Cefazolin were highlighted.
CONCLUSIONS: The proposed method is effectively and reliably for the minimization of data masking effect in signal detection. Considering the decrease of Precision, it is suggested to be a supplement rather than an alternative to non-stratification method.

PMID: 32013983 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Characterization of adverse drug events identified by trigger in Brazilian pediatric inpatients.

Thu, 2020-10-22 06:32
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Characterization of adverse drug events identified by trigger in Brazilian pediatric inpatients.

J Pediatr (Rio J). 2020 May - Jun;96(3):393-401

Authors: Silva LT, Modesto ACF, Martins RR, Lopes FM

Abstract
OBJECTIVE: To describe the frequency and characteristics of adverse drug events in pediatric inpatients in a Brazilian tertiary teaching hospital.
METHODS: A cross-sectional study was conducted by retrospective and manual chart review of 240 pediatric admissions to identify adverse drug events using 17 triggers. When triggers were detected in the chart, reviewers investigated the chart in depth to decide whether an event occurred. Consensus about the occurrence of the event was obtained in meeting with a healthcare team. Events were classified by harm category and drugs were classified according to the Anatomical Therapeutic Chemical Classification. Patients who had suffered were compared to those who had not experienced events using the chi-squared test and the Mann-Whitney U test.
RESULTS: A total of 62 adverse events were found, and 18.8% of the patients had at least one event. Adverse events rates were 25.83 per 100 admissions, 20.27 per 1000 patient-days, 25.94 per 1000 drugs, and 2.12 per 1000 drug doses. All events found were classified as temporary harm, and cardiovascular drugs were most frequently related to events. Groups of patients with and without event were segregated (p<0.05) by the length of stay, number of drugs, and drug doses.
CONCLUSION: The use of triggers demonstrated its utility in a pediatric setting by identifying harm. Adverse events rates were found to be higher than those of previous studies, but the harm rate was lower than other studies. This study enables the measurement of adverse events in order to define strategies to mitigate or reduce harm.

PMID: 30817896 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

A Quality Improvement Initiative to Improve Medication Management in an Acute Care for Elders Program Through Integration of a Clinical Pharmacist.

Thu, 2020-10-22 06:32
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A Quality Improvement Initiative to Improve Medication Management in an Acute Care for Elders Program Through Integration of a Clinical Pharmacist.

J Pharm Pract. 2020 Feb;33(1):55-62

Authors: Chowdhury TP, Starr R, Brennan M, Knee A, Ehresman M, Velayutham L, Malanowski AJ, Courtney HA, Stefan MS

Abstract
PURPOSE: To describe the implementation and impact of integrating a clinical pharmacist into interdisciplinary Acute Care for Elderly (ACE) rounds at a teaching hospital.
METHODS: Pre- and postanalyses were performed 6 months before and 12 months after the intervention. We report the total number, type, and frequency of recommendations made by the clinical pharmacist, the acceptance rate by the physician, and interventions on potentially inappropriate medications (PIM).
RESULTS: Among the 588 patients who met the ACE inclusion criteria, mean age was 81.2 years, 54.9% were female, and 79.8% were of white race. A total of 1243 pharmacy recommendations were recorded. The median number of recommendations per patient increased from a median of 1 (range: 1-7) in the preintervention to 2 (1-13) in the postintervention period, resulting in an incidence rate ratio of 1.25 (95% confidence interval [CI]: 1.10-1.40). The main categories of recommendations were dose adjustment, avoidance of inappropriate therapy, and prevention of adverse drug events. In the postintervention period, there was an increase in recommendations among analgesics (from 3.7% to 7.5%), PIMs (from 12% to 14%), and, in particular, antidepressant/antipsychotics (from 1.9% to 6.0%). The acceptance rate of the recommendations remained roughly the same (86.5% vs 84.4%).
CONCLUSION: Proactive involvement of a clinical pharmacist in ACE rounds resulted in a substantial increase in recommendation for medication changes, most notably for PIMs. These recommendations generally were accepted by physicians. The integration of a clinical pharmacist requires significant dedicated time but leads to increased recognition of drug-related problems in the acute-care setting, resulting in improved patient outcomes.

PMID: 29973110 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +32 new citations

Wed, 2020-10-21 09:08

32 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/10/21

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +34 new citations

Wed, 2020-10-21 06:00

34 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/10/21

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects"); +35 new citations

Mon, 2020-10-19 20:22

35 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/10/19

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Categories: Literature Watch

The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: A randomized controlled trial.

Wed, 2020-10-14 14:57

The effect of multiple-dose oral versus intravenous tranexamic acid in reducing postoperative blood loss and transfusion rate after adolescent scoliosis surgery: A randomized controlled trial.

Spine J. 2020 Oct 10;:

Authors: Zhang Z, Wang LN, Yang X, Liu LM, Xiu P, Zhou ZJ, Wang L, Song YM

Abstract
BACKGROUND CONTEXT: Tranexamic acid (TXA) is widely used in surgery for adolescent idiopathic scoliosis (AIS) and has been proved to be efficacious in reducing intraoperative blood loss (IBL) and the transfusion rate. However, the routine TXA regimen was intraoperative administration alone, in which the concentration of TXA could not cover the whole process of hyperfibrinolysis. And, its ability to control the massive postoperative blood loss (PBL) may be insufficient. Thus, we promoted a multiple-dose regimen of TXA for patients with AIS who underwent surgical correction.
PURPOSE: The primary aims were (1) to determine whether the multiple-dose regimen of TXA could reduce PBL and the postoperative transfusion rate, and (2) to compare the efficacy of oral administration with intravenous administration. The secondary aims were (3) to evaluate whether this regimen could alleviate inflammatory response, and (4) to assess the occurrence of drug-related side effects.
STUDY DESIGN: Prospective, double-blinded, randomized controlled trial PATIENT SAMPLE: A total of 108 patients with AIS who underwent posterior scoliosis correction and spinal fusion (PSS) were enrolled in this study.
OUTCOME MEASURES: The primary parameters were PBL and postoperative transfusion rate. Other parameters such as total blood loss (TBL), maximum hemoglobin (Hb) decrease, volume of drainage, inflammation markers [interleukin-6 (IL-6) and C-reactive protein (CRP)], and occurrence of complications were also collected and compared. Multiple regression analysis was used to examine the variables that affected PBL.
METHOD: Patients were randomized into three groups. All patients received intravenous TXA 50 mg/kg loading dose and 10 mg/kg/h maintenance dose during surgery. Group A received 1 g oral TXA at 4 h, 10 h, and 16 h postoperatively; group B received 0.5 g intravenous TXA at 6 h, 12 h, and 18 h postoperatively; group C received placebo.
RESULTS: The mean PBL and postoperative transfusion rate in group A (957.8±378.9 mL, 13.89%) and B (980.3±491.8 mL, 11.11%) were significantly lower than those in group C [1495.9±449.6 mL, mean differences = 538.1 mL, 95% confidence interval (CI), 290.1-786.1 mL, p<0.001; 515.6 mL, 95% CI, 267.6-763.6 mL, p<0.001]; (36.11%, p=0.029, p=0.013). Meanwhile, the mean TBL, maximum Hb decrease, and volume of drainage were also significantly lower in group A and B than in group C. IL-6 and CRP in group A and B were significantly lower than in group C from postoperative days 1 to 3. All these differences were not significant between groups A and B. No drug-related complications were observed in any patient. Multiple regression showed that the application of postoperative TXA and number of screws were significant parameters affecting PBL.
CONCLUSION: A multiple-dose regimen of TXA, either by oral or intravenous application, could be a safe and effective means of controlling PBL and decreasing the postoperative transfusion rate in patients with AIS who underwent scoliosis surgery. In addition, it could inhibit postoperative inflammatory response.

PMID: 33049411 [PubMed - as supplied by publisher]

Categories: Literature Watch

Acute Pancreatitis Induced by Polatuzumab-Vedotin-Piiq in Combination With Bendamustine and Rituximab for Diffuse Large B-Cell Lymphoma.

Wed, 2020-10-14 14:57

Acute Pancreatitis Induced by Polatuzumab-Vedotin-Piiq in Combination With Bendamustine and Rituximab for Diffuse Large B-Cell Lymphoma.

Cureus. 2020 Sep 07;12(9):e10299

Authors: Anderson K, Shehata M, Singh D, Al-Ourani M

Abstract
While alcohol and gallstones have been considered the most common causes of pancreatitis, we investigate two uncommon etiologies such as drug-induced and viral-induced. Pancreatitis, an inflammatory process, can lead to many complicated outcomes such as acute respiratory failure, sepsis, and death. Examining drug-induced pancreatitis poses a large challenge for physicians as majority of the data is extrapolated from case reports. This is made even more difficult for patients who are on large chemotherapeutic regimens which include multitude of drugs and various side effects. Besides patient medication regimens, other etiologies of pancreatitis must be ruled out such as viruses. We examine a case of a 48-year-old female undergoing treatment for diffuse large B-cell lymphoma with various chemotherapeutic agents and positive cultures for varicella zoster virus (VZV) presenting with diffuse epigastric abdominal pain.

PMID: 33047089 [PubMed]

Categories: Literature Watch

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China.

Wed, 2020-10-14 14:57

Efficacy and Safety of Fulvestrant 500mg in Hormone-receptor Positive Human Epidermal Receptor 2 Negative Advanced Breast Cancer: A Real-world Study in China.

J Cancer. 2020;11(22):6612-6622

Authors: Lei W, Li H, Song G, Zhang R, Ran R, Yan Y, Di L, Jiang H

Abstract
Background: Fulvestrant 500mg has proved its clinical effectiveness in previous trials as primary or second line treatment of hormone receptor positive, human epidermal receptor 2 negative (HR+/HER2-) post-menopausal advanced breast cancer. This real-world study aimed to investigate the efficacy and safety of Fulvestrant in HR+/HER2- Chinese advanced breast cancer patients. Method: HR+/HER2- advanced breast cancer patients who received Fulvestrant 500mg from January 2015 to December 2018 in Beijing Cancer Hospital were enrolled in this retrospective study. Progression free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), overall survival (OS) and adverse events (AEs) of Fulvestrant were investigated. Result: In total 303 enrolled patients [median age was 51 years (range: 21-82)], 255 (84.2%) patients were at postmenopausal status at the start of Fulvestrant treatment and 264 patients (87.1%) had advanced breast cancer. The median PFS (95% confidence interval) was 14.1 months (10.1-18.0) for the first-line, 11.2 months (2.2-20.3) for the second-line and 6.7 months (4.8-8.5) for ≥third-line of Fulvestrant. The ORR and CBR were 3.8% and 86.8% for the first-line, 5.5% and 75.4% for the second-line, 1.1% and 61.1% for ≥third-line of Fulvestrant. The multivariate subgroup analyses showed, PFS was significantly longer for the patients with light tumor burden, less palliative chemotherapy before Fulvestrant and long disease-free interval. For patients receiving Fulvestrant after palliative chemotherapy, the median PFS was numerically greater in maintenance treatment group than those who progressed after chemotherapy. Only 5.0% of patients (15/303) experienced adverse events and majority were grade 1-2. The most common adverse event was headache and palpitation, with merely one patient had severe adverse event (pulmonary embolism). Conclusion: Fulvestrant is an effective, safe and well-tolerated treatment regimen in endocrine therapy for HR+/HER2- metastatic breast cancer. Light tumor burden, less palliative chemotherapy before Fulvestrant and long disease-free survival (DFS) might be the ideal condition of Fulvestrant treatment. Fulvestrant can be effective for premenopausal patients with drug-induced menopause. Patients of different luminal subtypes can benefit from Fulvestrant. For patients with visceral metastases, presence of liver metastases rather than lung metastases was poor prognostic factor. Fulvestrant may also be considered as a maintenance treatment after first-line palliative chemotherapy.

PMID: 33046982 [PubMed]

Categories: Literature Watch

Anti-Aβ agents for mild to moderate Alzheimer's disease: systematic review and meta-analysis.

Wed, 2020-10-14 14:57

Anti-Aβ agents for mild to moderate Alzheimer's disease: systematic review and meta-analysis.

J Neurol Neurosurg Psychiatry. 2020 Oct 12;:

Authors: Lu L, Zheng X, Wang S, Tang C, Zhang Y, Yao G, Zeng J, Ge S, Wen H, Xu M, Guyatt G, Xu N

Abstract
OBJECTIVE: To assess the efficacy and safety of Aβ-targeting agents for mild to moderate Alzheimer's disease.
METHODS: The MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, ClinicalTrials.gov and the WHO's International Clinical Trials Registry Platform search portal were searched from their inception to April 2020. We generated pooled estimates using random effects meta-analyses.
RESULTS: Nineteen randomised controlled trials, of which 17 had a low risk of bias, included 12 903 participants. The meta-analysis showed no difference in the cognitive subscale of Alzheimer's Disease Assessment Scale (ADAS-Cog) between anti-Aβ drugs and placebo (mean difference (MD): 0.20, 95% CI -0.40 to 0.81; I 2=99.8%; minimal important difference 3.1-3.8 points, moderate-certainty evidence). For ADAS-Cog, results suggested that one drug that increases Aβ clearance may differ in effect (MD: -0.96, 95% CI -0.99 to -0.92) from drugs that reduce Aβ production (MD: 0.78, 95% CI 0.25 to 1.32) (interaction p<0.000001); this difference also existed in the outcome of MMSE and CDR-SOB. Compared with placebo, anti-Aβ drug-related adverse events were as follows: anxiety, depression, diarrhoea, fatigue, rash, syncope and vomit.
DISCUSSION: From current evidence, anti-Aβ interventions are unlikely to have an important impact on slowing cognitive or functional decline. Although the subgroup analysis suggested possible benefits from Aβ clearance drugs, the analysis has limited credibility, and a benefit from drugs that increase clearance, if real, is very small.
TRIAL REGISTRATION NUMBER: PROSPERO registration number CRD42019126272.

PMID: 33046560 [PubMed - as supplied by publisher]

Categories: Literature Watch

Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.

Wed, 2020-10-14 14:57

Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.

BMJ Open. 2020 Oct 12;10(10):e041125

Authors: Ie K, Hirose M, Sakai T, Motohashi I, Aihara M, Otsuki T, Tsuboya A, Matsumoto H, Hashi H, Inoue E, Takahashi M, Komiya E, Itoh Y, Tsuchida T, Kurosu E, Albert SM, Okuse C, Matsuda T

Abstract
INTRODUCTION: Whether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.
METHODS AND ANALYSIS: We report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.
ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: UMIN000035265.

PMID: 33046478 [PubMed - in process]

Categories: Literature Watch

The my experience of taking medicines (MYMEDS) questionnaire for assessing medicines adherence barriers in post-myocardial infarction patients: development and utility.

Wed, 2020-10-14 14:57
Related Articles

The my experience of taking medicines (MYMEDS) questionnaire for assessing medicines adherence barriers in post-myocardial infarction patients: development and utility.

BMC Cardiovasc Disord. 2020 02 03;20(1):46

Authors: Khatib R, Patel N, Hall AS

Abstract
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

PMID: 32013880 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

Surveillance of adverse drug reactions and drug-drug interactions with pediatric oncology patients in a south Indian tertiary care hospital.

Wed, 2020-10-14 14:57
Related Articles

Surveillance of adverse drug reactions and drug-drug interactions with pediatric oncology patients in a south Indian tertiary care hospital.

J Oncol Pharm Pract. 2020 Jul;26(5):1103-1109

Authors: Joseph B, Scott JX, Rajanandh MG

Abstract
OBJECTIVE: The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug-drug interaction in a pediatric oncology unit of a tertiary care hospital.
METHODS: A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug-drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug-drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction.
RESULTS: Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are "probable" (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug-drug interaction, 38.13% of the prescription needs to be monitored and 10 drug-drug interactions were under the risk category of "X." The majority of the adverse drug reaction was moderately severe in nature and those were preventable.
CONCLUSION: Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug-drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

PMID: 31653180 [PubMed - indexed for MEDLINE]

Categories: Literature Watch

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