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1.
BMJ Open ; 11(9): e048000, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479934

RESUMO

OBJECTIVE: To examine sex differences in age-standardised rates (ASR) of overall and drug-specific drug poisoning deaths in Ireland between 2004 and 2017. DESIGN: Repeated cross-sectional study. SETTING: Drug poisoning deaths in Ireland. PARTICIPANTS: National Drug-Related Deaths Index and pharmacy claims database (Primary Care Reimbursement Service-General Medical Services) data from 2004 to 2017. OUTCOME MEASURES: The primary outcome was trends in drug poisoning death rates by sex. The secondary outcomes were trends in drug poisoning death rates involving (1) any CNS (Central Nervous System) depressants, (2) ≥2 CNS depressants and (3) specific drugs/drug classes (eg, prescription opioids, benzodiazepines, antidepressants, alcohol, cocaine and heroin) by sex. Joinpoint regression was used to examine trends, stratified by sex, in the ASR of drug poisoning deaths (2004-2017), change points over time and average annual percentage changes (AAPCs) with 95% CI. RESULTS: Increased ASR for all drug poisoning deaths from 6.86 (95% CI 6.01 to 7.72) per 100 000 in 2004 to 8.08 (95% CI 7.25 to 8.91) per 100 000 in 2017 was mainly driven by increasing deaths among men (AAPC 2.6%, 95% CI 0.2 to 5.1), with no significant change observed among women. Deaths involving ≥2 CNS depressants increased for both men (AAPC 5.6%, 95% CI 2.4 to 8.8) and women (AAPC 4.0%, 95% CI 1.1 to 6.9). Drugs with the highest significant AAPC increases for men were cocaine (7.7%, 95% CI 2.2 to 13.6), benzodiazepines (7.2%, 95% CI 2.9 to 11.6), antidepressants (6.1%, 95% CI 2.4 to 10.0) and prescription opioids (3.5%, 95% CI 1.6 to 5.5). For women, the highest AAPC was for antidepressants (4.2%, 95% CI 0.2 to 8.3), benzodiazepines (3.3%, 95% CI 0.1 to 6.5) and prescription opioids (3.0%, 95% CI 0.7 to 5.3). CONCLUSION: Drugs implicated in drug poisoning deaths vary by sex. Policy response should include prescription monitoring programmes and practical harm reduction information on polydrug use, especially CNS depressant drugs.


Assuntos
Overdose de Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Envenenamento , Analgésicos Opioides , Estudos Transversais , Feminino , Humanos , Irlanda/epidemiologia , Masculino
2.
Indian Pediatr ; 58(8): 753-755, 2021 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-34465658

RESUMO

OBJECTIVES: To assess the adverse effects of propranolol therapy in infantile hemangioma. METHODS: An ambispective study was conducted from August 2011 to December 2019. In retrospective arm all children managed for infantile hemangioma with propranolol were included and case records were assessed for adverse reactions. In prospective arm the adverse reactions were identified on the basis of predefined criteria. RESULTS: A total of 514 patients (358 retrospective records) were included. A majority, 378 (73.5%) patients had an excellent response, 75 (14.5%) had partial response and 61 (11.8 %) had no response. A total of 82 (15.9%) patients experienced at least one adverse effect. Diarrhea with weight loss (27, 32.9%) and irritability with decreased sleep (21, 25.6%) were the most common adverse effects. The adverse effects in 22 (4.2%) cases lead to the discontinuation of propranolol. Younger age, low body weight and early onset were risk factors for development of severe adverse reactions. CONCLUSIONS: Young children with low body weight were at higher risk for adverse effects of propranolol.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hemangioma , Neoplasias Cutâneas , Administração Oral , Antagonistas Adrenérgicos beta/efeitos adversos , Criança , Pré-Escolar , Hemangioma/tratamento farmacológico , Humanos , Lactente , Propranolol/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos , Neoplasias Cutâneas/tratamento farmacológico , Resultado do Tratamento
3.
JNMA J Nepal Med Assoc ; 59(233): 22-25, 2021 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-34508460

RESUMO

INTRODUCTION: Doctors and nurses have a significant role in the detection of serious and unusual drug reactions. Effective implementation of an adverse drug reaction reporting system is required to ensure patient safety and quality care. This study's objective was to find the prevalence of good knowledge of adverse drug reaction reporting among the Doctors and nurses working in a tertiary care hospital. METHODS: A descriptive cross-sectional study was conducted among doctors and nurses from 15 February 2020 to 15 July 2020 at Birat Medical College and Teaching Hospital. The convenience sampling method was used to select 192 study participants. A semi-structured questionnaire was used to know the knowledge concept of adverse drug reaction reporting. Ethical clearance was taken from IRC (PA-047/2076-77) of Birat Medical College and Teaching Hospital. Written informed consent was taken from each study participant. Collected data were entered in Microsoft Excel 2010 and analyzed by Statistical Package for the Social Sciences v23. RESULTS: In total, 192 doctors and nurses, the questionnaires were distributed to 52 (27.1%) doctors and 140 (72.9%) nurses. The mean age of study participants was 28.14 years (SD±4.5). To know the prevalence of knowledge, 15 knowledge related questions of adverse drug reaction had asked. The majority of doctors and nurses had good knowledge about adverse drug reaction reporting, 75% and 64%, respectively. CONCLUSIONS: Overall, doctors and nurses have had good knowledge of adverse drug reaction reporting. Data shows there is still more gap in training and experience on adverse drug reaction reporting systems.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Enfermeiras e Enfermeiros , Médicos , Adulto , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Inquéritos e Questionários , Centros de Atenção Terciária
4.
FP Essent ; 508: 25-32, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34491709

RESUMO

Drug-drug interactions (DDIs) occur when one drug adds to or diminishes the effect of another drug (ie, pharmacodynamic interaction) or affects the absorption, distribution, metabolism, or excretion of another drug (ie, pharmacokinetic interaction). Such interactions cause 26% of all adverse drug events (ADEs) and are associated with a significant burden on the health care system through increased hospitalizations. Some of the most common DDIs result from alterations in drug metabolism through interactions with cytochrome P450 enzymes and absorption through interactions with P-glycoproteins. Other common DDIs occur because of additive effects, including combinations of drugs that increase the risk of seizures, prolong the QT interval, increase central nervous system depression, and increase the risk of serotonin syndrome. Drug-related clinical decision support has been shown to improve the quality of patient care and decrease ADE rates. However, alerts generated by such systems should be interpreted using clinical judgment to determine the risks and benefits of certain drugs on a patient-specific basis. Family physicians can prevent clinically significant DDIs and optimize drug safety by using drug interaction software, along with a general understanding of common DDI mechanisms and collaboration with pharmacists.


Assuntos
Sistemas de Apoio a Decisões Clínicas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Interações Medicamentosas , Prescrições de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos
5.
FP Essent ; 508: 33-40, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34491710

RESUMO

Polypharmacy, defined as concurrent use of five or more drugs, can occur in patients of all ages. Polypharmacy may be appropriate or inappropriate. Appropriate polypharmacy is defined as "use of the correct drugs under appropriate conditions [in order] to treat the right diseases." A prescribed drug becomes inappropriate when its benefits no longer outweigh its risks. Inappropriate polypharmacy has been shown to increase the risks of hospitalization, adverse drug events, clinically relevant drug interactions, and all-cause mortality. Many tools are available to aid physicians in identifying inappropriate polypharmacy. Implicit tools, such as the Medication Appropriateness Index (MAI), provide guidance to be used alongside clinical judgement. Explicit tools, such as the American Geriatrics Society (AGS) Beers Criteria, provide lists of potentially inappropriate drugs and recommend alternatives. Collaboration with pharmacists is important in assessing drug appropriateness. It has been shown to reduce drug-related problems, emergency department visits, and hospitalizations and to improve overall patient health. A patient-centered, team-based approach is recommended in the process of deprescribing inappropriate drugs. Deprescribing should be approached in the same stepwise manner as prescribing of new drugs, and should include patient agreement to changes, evidence-based rationales, and use of dosage tapering strategies.


Assuntos
Desprescrições , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Prescrições de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Prescrição Inadequada/prevenção & controle , Polimedicação , Lista de Medicamentos Potencialmente Inapropriados
6.
Ann Palliat Med ; 10(8): 8701-8708, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34488359

RESUMO

BACKGROUND: There is a lack of data on drug-related problems (DRPs) occurring in nephrology department in China. The objective of this study was to identify and categorize the types and causes of DRPs and to assess their severity. DRPs were examined by clinical pharmacists and the results of their interventions were rated. METHODS: Clinical pharmacists reviewed all medication orders for patients and documented clinical pharmacy services within a nine-month study period. The Pharmaceutical Care Network Europe (PCNE) classification (Version 9.00) was used to identify DRPs. Our Primary outcomes measured the number, causes, types, potential hazards of DRPs and the types and success rate of intervention. RESULTS: Admission medication reconciliation data of 113 patients with chronic kidney disease (CKD) were collected and all of the medications were reviewed retrospectively. Exclude 26 patients who did not occurred DRPs, 87 patients (77%) identified 101 DRPs. The average DRP number per patient was 1.16. The most common type of problem was "treatment effectiveness P1" (84.16%; 85/101). The most common causes were "drug selection C1" (36.00%; 45/125), "dose selection C3" (29.60%; 37/125), and "patient related C7" (26.40%; 33/125). Clinical pharmacists totally proposed 249 interventions, of which 190 (76.31%) were fully accepted and implemented. CONCLUSIONS: DRPs are common among CKD patients in the nephrology department. Hence the necessity for pharmaceutical care to be improved to ensure the ongoing safety of patients.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Nefrologia , Preparações Farmacêuticas , Humanos , Farmacêuticos , Estudos Retrospectivos , Centros de Atenção Terciária
8.
Lancet Neurol ; 20(9): 709-720, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34418398

RESUMO

BACKGROUND: Progressive disability in multiple sclerosis occurs because CNS axons degenerate as a late consequence of demyelination. In animals, retinoic acid receptor RXR-gamma agonists promote remyelination. We aimed to assess the safety and efficacy of a non-selective retinoid X receptor agonist in promoting remyelination in people with multiple sclerosis. METHODS: This randomised, double-blind, placebo-controlled, parallel-group, phase 2a trial (CCMR One) recruited patients with relapsing-remitting multiple sclerosis from two centres in the UK. Eligible participants were aged 18-50 years and had been receiving dimethyl fumarate for at least 6 months. Via a web-based system run by an independent statistician, participants were randomly assigned (1:1), by probability-weighted minimisation using four binary factors, to receive 300 mg/m2 of body surface area per day of oral bexarotene or oral placebo for 6 months. Participants, investigators, and outcome assessors were masked to treatment allocation. MRI scans were done at baseline and at 6 months. The primary safety outcome was the number of adverse events and withdrawals attributable to bexarotene. The primary efficacy outcome was the patient-level change in mean lesional magnetisation transfer ratio between baseline and month 6 for lesions that had a baseline magnetisation transfer ratio less than the within-patient median. We analysed the primary safety outcome in the safety population, which comprised participants who received at least one dose of their allocated treatment. We analysed the primary efficacy outcome in the intention-to-treat population, which comprised all patients who completed the study. This study is registered in the ISRCTN Registry, 14265371, and has been completed. FINDINGS: Between Jan 17, 2017, and May 17, 2019, 52 participants were randomly assigned to receive either bexarotene (n=26) or placebo (n=26). Participants who received bexarotene had a higher mean number of adverse events (6·12 [SD 3·09]; 159 events in total) than did participants who received placebo (1·63 [SD 1·50]; 39 events in total). All bexarotene-treated participants had at least one adverse event, which included central hypothyroidism (n=26 vs none on placebo), hypertriglyceridaemia (n=24 vs none on placebo), rash (n=13 vs one on placebo), and neutropenia (n=10 vs none on placebo). Five (19%) participants on bexarotene and two (8%) on placebo discontinued the study drug due to adverse events. One episode of cholecystitis in a placebo-treated participant was the only serious adverse event. The change in mean lesional magnetisation transfer ratio was not different between the bexarotene group (0·25 percentage units [pu; SD 0·98]) and the placebo group (0·09 pu [0·84]; adjusted bexarotene-placebo difference 0·16 pu, 95% CI -0·39 to 0·71; p=0·55). INTERPRETATION: We do not recommend the use of bexarotene to treat patients with multiple sclerosis because of its poor tolerability and negative primary efficacy outcome. However, statistically significant effects were seen in some exploratory MRI and electrophysiological analyses, suggesting that other retinoid X receptor agonists might have small biological effects that could be investigated in further studies. FUNDING: Multiple Sclerosis Society of the United Kingdom.


Assuntos
Bexaroteno/farmacologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde , Remielinização/efeitos dos fármacos , Receptores X de Retinoides/agonistas , Adulto , Bexaroteno/administração & dosagem , Bexaroteno/efeitos adversos , Método Duplo-Cego , Potenciais Evocados Visuais/fisiologia , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem , Esclerose Múltipla Recidivante-Remitente/fisiopatologia
9.
Artigo em Inglês | MEDLINE | ID: mdl-34444320

RESUMO

There are various trigger tools for detecting adverse drug events (ADEs), however, a drug-related emergency department (ED) visit trigger tool (DrEDTT) has not yet been developed. We aimed to develop and validate a DrEDTT with a multi-center cohort. In this cross-sectional study, we developed the DrEDTT consisting of 28 triggers through a comprehensive literature review and three phase expert group discussion. Next, we evaluated the performance of the DrEDTT by applying it to relevant medical records retrieved from four hospitals from January 2016 to June 2016. Two experts performed an in-depth chart review of a 25% of random sample of trigger flagged and unflagged ED visits and a true ADE was determined through causality assessment. Among 66,564 patients who visited the ED for reasons other than traffic accident and trauma during the study period, at least one trigger was found in 21,268 (32.0%) patients. A total of 959 true ADE cases (5.8%) were identified from a randomly selected 25% of ED visit cases. The overall positive predictive value was 14.0% (range: 8.3-66.7%). Sensitivity and specificity of DrEDTT were 77.7% and 70.4%, respectively. In conclusion, this newly developed trigger tool might be helpful to detect ADE-related ED visits.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Serviço Hospitalar de Emergência , Humanos , Registros Médicos
10.
Trials ; 22(1): 570, 2021 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-34454572

RESUMO

BACKGROUND AND AIM: Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medicines, especially polyherbal formulations like Nilavembu Kudineer (NVK) and Kaba Sura Kudineer (KSK) of the Siddha system of medicine, have been used as public health interventions for controlling viral epidemics like dengue and Chikungunya. These traditional therapies have been found safe, effective, and widely accepted. The current study evaluates the comparative efficacy of NVK and KSK as opposed to the placebo, in the management of mild to moderate COVID-19 disease. METHODS: The study was a double-blind, placebo-controlled comparative clinical trial, with the primary objective of determining the efficacy of KSK and NVK. Patients (n=125) diagnosed with mild to moderate COVID-19 symptoms were enrolled in the study over a period of 4 months (Aug 2020-Dec 2020). Participants were randomized into 3 arms; placebo-decaffeinated tea in Arm I, NVK in Arm II, and KSK in Arm III. Each arm received 60 ml of the respective treatment twice a day, post morning and evening meals, along with standard allopathy treatment for a maximum of 10 days. The main outcome measures of the study were the reduction in SARS-CoV-2 viral load, hospital stay, and time taken by the patients to become asymptomatic from symptomatic. Efficacy assessments included clinical symptoms (fever, cough, and breathlessness) each day and real-time reverse transcription-polymerase chain reaction (RT-PCR), liver function test (LFT), renal function test (RFT), and electrolytes and electrocardiogram (ECG) at baseline (day 0) and days 3, 6, and 10. Post-treatment, participants were followed up for 30 days via phone for adverse effects if any. Effects of drugs on inflammatory markers (IL6) at the end of treatment were also recorded. Adverse events (AE) were monitored throughout the study. RESULTS: The results revealed that when compared to patients in the placebo arm, those in NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and the time taken to become symptomatic from asymptomatic. Out of 125 COVID-19 patients recruited, 120 completed the study; two from the placebo group developed severe symptoms and were shifted to the intensive care unit (ICU) and three patients from Arms II and III withdrew from the study. The mean age of females (n=60) and males (n=60) enrolled was between 40.2 and 44.3 years, respectively. Results were more promising for all the patients in NVK and KSK arms as all enrolled participants (100%) under this group got discharged by day 6 as compared to only 42.5% (n=17) from the placebo group on that day. The hospital stay time for patients in Arm I was significantly longer (mean [SD]=8.4 [2.0] days) as compared to the Arms II and III (mean [SD]=4.7 [1.5] and 4.2 [1.5] days, respectively (Kruskal-Wallis test, P=0.0001). Patients in the three groups took a significantly different number of days to become asymptomatic. While Arm II and III patients took mean of 2.5 and 1.7 days, respectively, Arm I, patients took a mean of 4.2 days (Kruskal-Wallis test, P=0.0001). In all, two adverse events were recorded, one for vomiting and one for diarrhea lasting a day in Arm I and Arm II, respectively. The mean value of interleukin-6 (IL6) was significantly different in comparison to the placebo-decaffeinated tea arm (NVK=2.6 and KSK=2.2, placebo=4.0, P=0.02). The other blood biochemical parameters like C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, and D-dimer that were analyzed at the baseline and at the time of discharge from the hospital, were not significantly different in the three arms. CONCLUSION: NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and time taken for patients to become asymptomatic from symptomatic, when compared to the placebo (decaffeinated tea). The primary outcome measures of the KSK arm were significantly better than those in the NVK arm.


Assuntos
COVID-19 , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Diarreia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , SARS-CoV-2
11.
J Clin Pharmacol ; 61 Suppl 2: S129-S141, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34396559

RESUMO

Use of US Food and Drug Administration-approved substances of abuse has innate risks due to pharmacologic and pharmacokinetic properties of the medications, but the risk when using nonapproved drug products is much greater. Unbeknownst to the user, the dose of active ingredients in substances of abuse can vary substantially between different products because of manufacturing practices or improper storage. Even naturally occurring substances of abuse can have extensive dosage variability because of effects of the growing season and conditions, or differences in harvesting, storage, or manufacture of the finished products. Many illicit substances are adulterated, to make up for intentional underdosing or to enhance the effect of the intended active ingredient. These adulterants can be dangerous and produce direct cardiovascular, neurologic, hematologic, or dermatologic reactions or obscure adverse effects. Finally, an illicit substance can be contaminated or substituted for another one during its manufacture, leading to differences in adverse events, adverse event severity, or the drug interaction profile. Substances can be contaminated with microbes that induce infections or heavy metals that can damage organs or cause cancer. This milieu of undisclosed substances can also induce drug interactions. For reasons that are discussed, individuals who use substances of abuse are at increased risk of morbidity or mortality if they develop coronavirus disease 2019. Health professionals who treat patients with acute, urgent events associated with substances of abuse, or those treating the chronic manifestations of addiction, need to appreciate the complex and variable composition of substances of abuse and their potential health effects.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Drogas Ilícitas/efeitos adversos , Transtornos Relacionados ao Uso de Substâncias/complicações , COVID-19/mortalidade , Interações Medicamentosas/fisiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Humanos , Transtornos Relacionados ao Uso de Substâncias/mortalidade , Estados Unidos , United States Food and Drug Administration
12.
BMC Health Serv Res ; 21(1): 779, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34362367

RESUMO

BACKGROUND: A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. FDA is encouraging "the research community to develop novel methods for assessing REMS," conveying the unmet need for a standardized evaluation method of these regulatory-mandated healthcare programs. The objective of this research is to evaluate FDA REMS assessment plans using established implementation science frameworks and identify opportunities for strengthening REMS evaluation. METHODS: A content analysis was conducted of publicly available assessment plans for all REMS programs (N = 23) approved 1/1/2014-12/31/2018 for new drug applications (NDAs) and biologics license applications (BLAs) requiring FDA-mandated Elements to Assure Safe Use (ETASU). Blinded reviewers critically appraised REMS assessment measures (n = 674) using three established implementation science frameworks: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance); PRECEDE-PROCEED (Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation - Policy, Regulatory, and Organizational Constructs in Educational and Environmental Development); and CFIR (Consolidated Framework for Implementation Research). Framework constructs were mapped to REMS Assessment categories as defined by FDA Guidance for Industry to evaluate congruence. RESULTS: REMS assessment measures demonstrated strong congruence (> 90% mapping rate) with the evaluative constructs of RE-AIM, PRECEDE-PROCEED, and CFIR. Application of the frameworks revealed that REMS assessment measures heavily emphasize implementation and operations, focus less on health outcomes, and do not evaluate program context and design assumptions. CONCLUSIONS: Implementation science frameworks have utility for evaluating FDA-mandated drug safety programs including the selection of primary measures to determine whether REMS goals are being met and of secondary measures to evaluate contextual factors affecting REMS effectiveness in varying organizational settings.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Avaliação de Risco e Mitigação , Humanos , Ciência da Implementação , Medição de Risco , Estados Unidos , United States Food and Drug Administration
13.
Trials ; 22(1): 521, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34362410

RESUMO

BACKGROUND: Adverse drug events (ADE) represent one of the main causes of admission to emergency department (ED). Their detection, documentation, and reporting are essential to avoid readmission. We hypothesize that a pharmacist-initiated multidisciplinary transition of care program combining ED pharmacist contribution and medications' data transfer between inpatient and outpatient caregivers will reduce emergency visits related to ADE METHOD/DESIGN: This is a prospective, open-label, randomized controlled trial. The primary aim of the study is 6-month ED readmission related to the same ADE. Three hundred forty-six adult patients with an ADE detected by a binomial pharmacist-physician will be recruited from the ED of an University Hospital and will be randomized in two groups: [1] experimental group (multidisciplinary transition of care program and medications' data transfer between inpatient and outpatient caregivers) and [2] control group (usual care). Patients will be followed up over a period of 6 months. Endpoints will be carried out blindly of the randomization arm. The primary endpoint is the rate of patients who had at least one readmission in the ED for the same reason at 6 months (data collected during a phone call with the patient and the general practitioner). Trials registered NCT03725046. DISCUSSION: The trial results will have implications for the role of the clinical pharmacist in an emergency department. If successful, the intervention could be considered for implementation across other hospitals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03725046 . Registered on 30 October 2018.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preparações Farmacêuticas , Adulto , Comunicação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Serviço Hospitalar de Emergência , Seguimentos , Hospitais , Humanos , Readmissão do Paciente , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
East Mediterr Health J ; 27(7): 693-697, 2021 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-34369584

RESUMO

Background: The concept of pharmacovigilance is not well known in Libya and its practice is still in the early stages. Aims: This study aimed to determine the knowledge, attitudes and practices of pharmacists in Tripoli, Libya about pharmacovigilance and the reporting of adverse drug reactions. Methods: A cross-sectional study was conducted from October 2019 to February 2020 of working pharmacists randomly selected from pharmacies in Tripoli. Participants were eligible for inclusion if they had a degree or diploma in pharmacy from a recognized university or institute. Data were collected using a validated self-administered questionnaire. Results: Of 500 pharmacists selected, 408 completed the questionnaire. The pharmacists' knowledge of pharmacovigilance and reporting of adverse drug reactions was poor overall: only 28.9% correctly defined pharmacovigilance and 14.7% knew about the existence of a centre for pharmacovigilance in Libya. The attitudes of the pharmacists to pharmacovigilance was positive: 77.2% believed that pharmacovigilance needed to be included in the pharmacy curriculum and 73.0% said that they would practice pharmacovigilance if trained. Pharmacists depended mostly on drug information leaflets to update their knowledge on adverse drug reactions. Conclusion: Given the pharmacists' low level of knowledge about pharmacovigilance but their readiness to become involved if trained, training programmes should be introduced for practising pharmacists to improve their knowledge and encourage their active participation in pharmacovigilance. Regulators need to reinforce the importance of reporting adverse drug reactions and implement pharmacovigilance policies in the Libyan health care system.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos , Atitude do Pessoal de Saúde , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Líbia , Farmacêuticos , Inquéritos e Questionários
15.
Elife ; 102021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34340747

RESUMO

The discovery of a drug requires over a decade of intensive research and financial investments - and still has a high risk of failure. To reduce this burden, we developed the NICEdrug.ch resource, which incorporates 250,000 bioactive molecules, and studied their enzymatic metabolic targets, fate, and toxicity. NICEdrug.ch includes a unique fingerprint that identifies reactive similarities between drug-drug and drug-metabolite pairs. We validated the application, scope, and performance of NICEdrug.ch over similar methods in the field on golden standard datasets describing drugs and metabolites sharing reactivity, drug toxicities, and drug targets. We use NICEdrug.ch to evaluate inhibition and toxicity by the anticancer drug 5-fluorouracil, and suggest avenues to alleviate its side effects. We propose shikimate 3-phosphate for targeting liver-stage malaria with minimal impact on the human host cell. Finally, NICEdrug.ch suggests over 1300 candidate drugs and food molecules to target COVID-19 and explains their inhibitory mechanism for further experimental screening. The NICEdrug.ch database is accessible online to systematically identify the reactivity of small molecules and druggable enzymes with practical applications in lead discovery and drug repurposing.


Assuntos
Desenho de Fármacos , Descoberta de Drogas/métodos , Reposicionamento de Medicamentos , Preparações Farmacêuticas/metabolismo , Animais , Antimetabólitos Antineoplásicos/química , Antimetabólitos Antineoplásicos/metabolismo , Antivirais/química , Antivirais/farmacologia , COVID-19/tratamento farmacológico , Bases de Dados de Produtos Farmacêuticos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/metabolismo , Fluoruracila/química , Fluoruracila/metabolismo , Humanos , Preparações Farmacêuticas/química , Fluxo de Trabalho
16.
Int J Mol Sci ; 22(15)2021 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-34360853

RESUMO

Long QT syndromes can be either acquired or congenital. Drugs are one of the many etiologies that may induce acquired long QT syndrome. In fact, many drugs frequently used in the clinical setting are a known risk factor for a prolonged QT interval, thus increasing the chances of developing torsade de pointes. The molecular mechanisms involved in the prolongation of the QT interval are common to most medications. However, there is considerable inter-individual variability in drug response, thus making the application of personalized medicine a relevant aspect in long QT syndrome, in order to evaluate the risk of every individual from a pharmacogenetic standpoint.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Síndrome do QT Longo/induzido quimicamente , Torsades de Pointes/induzido quimicamente , Humanos , Preparações Farmacêuticas , Fatores de Risco
19.
Medicine (Baltimore) ; 100(29): e26673, 2021 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-34398033

RESUMO

BACKGROUND: Since the combination of chemotherapy and immunotherapy, such as new molecular targeted drugs or vaccines, is controversial in terms of survival advantages compared with chemotherapy therapy alone, we conducted a meta-analysis to compare the efficacy and safety of immunotherapy combined with chemotherapy and chemotherapy alone for advanced pancreatic cancer. METHODS: We searched PubMed, Embase, and Cochrane Library from the establishment of the database to November 2020. We included some studies that reported pancreatic cancer patients receiving immunotherapy, and we excluded duplicate publications, research without full text, incomplete information or inability to conduct data extraction, animal experiments, reviews, and systematic reviews. RESULTS: The risk ratio of the objective response rate and disease control rate was 1.10 (95% confidence interval [CI]: 0.88-1.38) and 1.17 (95% CI: 1.06-1.31), respectively, indicating that there was no significant difference between the objective response rate of combination therapy and chemotherapy alone, while the disease control rate of the combined treatment was higher than that of chemotherapy alone. The hazard ratio of overall survival and progression-free survival was 0.91 (95% CI: 0.82-1.01) and 0.87 (95% CI: 0.77-0.98), respectively, indicating that there was no significant difference between the overall survival of combination therapy and chemotherapy alone, while progression-free survival of the combined treatment was longer than that of chemotherapy alone. We also found that in addition to the combination treatment, the incidence of vomiting in pancreatic cancer was higher than that of chemotherapy alone, and the incidence of other complications was not significantly different from that of treatment alone. CONCLUSION: Chemotherapy combined with immunotherapy for pancreatic cancer not only improves treatment efficiency but also does not cause serious adverse reactions. This treatment strategy should be widely used clinically.


Assuntos
Neoplasias Pancreáticas/terapia , Protocolos de Quimioterapia Combinada Antineoplásica , Intervalo Livre de Doença , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Imunoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto
20.
Rev Med Suisse ; 17(746): 1374-1376, 2021 Aug 04.
Artigo em Francês | MEDLINE | ID: mdl-34397185

RESUMO

Tizanidine is an alpha2 agonist with central action whose myorelaxant effects are often used off-label against primary backpain in clinical practice. It is mainly metabolized by the liver. The concomitant use of CYP1A2 inhibitor drugs increases the plasmatic concentration and thus can cause serious adverse effects. Severe hypotension is the most memorable example. Its narrow therapeutic range and the interindividual different sensitivity to the molecule justify using it wisely. A clinical case is reported as illustration.


Assuntos
Clonidina , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Clonidina/análogos & derivados , Humanos , Atenção Primária à Saúde
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