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1.
PLoS One ; 15(1): e0227736, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31999752

RESUMO

BACKGROUND: Antimicrobial resistance, which is commonly observed in the management of pneumonia, is a major threat to public health and is driven by inappropriate antimicrobial use. The aim of this study was therefore to assess the current practice of antimicrobial utilization and clinical outcomes in the management of adult pneumonia at Tikur Anbessa Specialized Hospital. METHOD: A prospective observational study was conducted in the internal medicine wards of Tikur Anbessa Specialized Hospital. The study was conducted from 1 September 2016 to 30 June 2017 and patients aged ≥ 14 years and diagnosed with pneumonia were included. Chart review and self-administered questionnaire were used to collect data regarding pneumonia diagnosis and management as well as clinical outcomes (stable, complications, and in-hospital mortality). Descriptive statistics and binary logistic regressions were performed for data analyses. RESULTS: Out of 200 enrolled patients, clinical diagnosis was supported by microbiologic testing and imaging in 75 (37.5%) and 122 (61.0%) cases, respectively. The treatment approach in almost all patients (99.5%) was empirical and no de-escalation therapy was made even after acquiring culture results. The total duration of antimicrobial therapy was 12.05±5.09 days and vancomycin was the most commonly prescribed antimicrobial agent (25%), with 70% of the patients receiving this drug empirically. Nearly, 30% of the patients missed their antimicrobial doses during the course of treatment and stock-out (36.7%) was the major reason. Close to 113 (66%) of the treating physicians used reference books to prescribe antimicrobial agents. Patients' outcomes were found to be stable (66%), in-hospital mortality (18.5%), and ending up in complications (17%). Poor clinical outcome (death and complicated cases) was found to be associated with recent antimicrobial use history (p = 0.007, AOR 2.86(1.33-6.13)), cancer (p = 0.023, AOR 3.46(1.18-10.13)), recent recurrent upper respiratory tract infection (p = 0.046, AOR 3.70(1.02-13.40)), respiratory rate >24 breaths/min or <12 breaths/min (p = 0.013, AOR 2.45(1.21-4.95)) and high level of serum creatinine after initiation of antimicrobial therapy (>1.4mg/dl) (p = 0.032, AOR 2.37(1.07-5.20)). CONCLUSION: Antimicrobials are empirically prescribed without sufficient evidence of indication and microbiological or radiological findings. The practice also is not based on local guidelines and no multidisciplinary approach is apparent. [How about: "It is likely that these factors contributed to higher rates of mortality (18.5%) when compared with similar studies in other countries" instead of this "As a result, there were higher rates of mortality (18.5%) when compared with other similar studies"]. Hence, the hospital requires a coordinated intervention to improve rational use of antimicrobials and clinical outcomes through establishing an antimicrobial stewardship program.


Assuntos
Antibacterianos/uso terapêutico , Gestão de Antimicrobianos/normas , Uso de Medicamentos/estatística & dados numéricos , Pneumonia Bacteriana/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Adulto , Idoso , Antibacterianos/farmacologia , Gestão de Antimicrobianos/organização & administração , Gestão de Antimicrobianos/estatística & dados numéricos , Farmacorresistência Bacteriana , Uso de Medicamentos/normas , Etiópia/epidemiologia , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Pneumonia Bacteriana/microbiologia , Pneumonia Bacteriana/mortalidade , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Estudos Prospectivos , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/normas , Centros de Atenção Terciária/estatística & dados numéricos , Resultado do Tratamento , Adulto Jovem
2.
BMJ ; 367: l6461, 2019 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-31826860

RESUMO

OBJECTIVES: To identify the frequency with which antibiotics are prescribed in the absence of a documented indication in the ambulatory care setting, to quantify the potential effect on assessments of appropriateness of antibiotics, and to understand patient, provider, and visit level characteristics associated with antibiotic prescribing without a documented indication. DESIGN: Cross sectional study. SETTING: 2015 National Ambulatory Medical Care Survey. PARTICIPANTS: 28 332 sample visits representing 990.9 million ambulatory care visits nationwide. MAIN OUTCOME MEASURES: Overall antibiotic prescribing and whether each antibiotic prescription was accompanied by appropriate, inappropriate, or no documented indication as identified through ICD-9-CM (international classification of diseases, 9th revision, clinical modification) codes. Survey weighted multivariable logistic regression was used to evaluate potential risk factors for receipt of an antibiotic prescription without a documented indication. RESULTS: Antibiotics were prescribed during 13.2% (95% confidence interval 11.6% to 13.7%) of the estimated 990.8 million ambulatory care visits in 2015. According to the criteria, 57% (52% to 62%) of the 130.5 million prescriptions were for appropriate indications, 25% (21% to 29%) were inappropriate, and 18% (15% to 22%) had no documented indication. This corresponds to an estimated 24 million prescriptions without a documented indication. Being an adult male, spending more time with the provider, and seeing a non-primary care specialist were significantly positively associated with antibiotic prescribing without an indication. Sulfonamides and urinary anti-infective agents were the antibiotic classes most likely to be prescribed without documentation. CONCLUSIONS: This nationally representative study of ambulatory visits identified a large number of prescriptions for antibiotics without a documented indication. Antibiotic prescribing in the absence of a documented indication may severely bias national estimates of appropriate antibiotic use in this setting. This study identified a wide range of factors associated with antibiotic prescribing without a documented indication, which may be useful in directing initiatives aimed at supporting better documentation.


Assuntos
Instituições de Assistência Ambulatorial , Antibacterianos/farmacologia , Uso de Medicamentos/normas , Prescrição Inadequada/estatística & dados numéricos , Padrões de Prática Médica , Estudos Transversais , Humanos , Fatores de Risco , Estados Unidos
3.
Rev Chilena Infectol ; 36(3): 253-264, 2019 Jun.
Artigo em Espanhol | MEDLINE | ID: mdl-31859743

RESUMO

BACKGROUND: Nowadays about half of antibiotic prescriptions are inadequate, increasing bacterial resistance. Both cephalosporins and fluoroquinolones are associated with this phenomenon: increase of ß-lactamase producing bacteria and Clostridioides difficile infections, which is why regulatory agencies seek to rationalize their use. AIM: To evaluate the effect of use recommendations on the proportion of inadequate prescriptions of ceftriaxone and fluoroquinolones. METHODS: A prospective and interventional study was developed, comparing the quality and quantity of use of ceftriaxone and fluoroquinolones before and after the implementation of use recommendations for treatments of infectious diseases acquired at the community. The outcomes were: proportion of inadequate prescriptions and defined daily dose (DDD). Data were analyzed using the Chi-square test, Fisher's correction and Student's test. RESULTS: A total of 206 patients were evaluated, a 35% decrease in inadequate prescriptions, a decline in the consumption of ceftriaxone and levofloxacin, and a significant increase in the use of ampicillin/ sulbactam was observed. CONCLUSIONS: The implementation of use recommendations based on scientific evidence and local susceptibility allowed to reduce the proportion of inadequate prescriptions and to reduce de consumption of ceftriaxone and fluoroquinolones.


Assuntos
Antibacterianos/administração & dosagem , Gestão de Antimicrobianos/normas , Ceftriaxona/administração & dosagem , Prescrições de Medicamentos/normas , Fluoroquinolonas/administração & dosagem , Hospitais Universitários/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Uso de Medicamentos/normas , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Prescrição Inadequada/estatística & dados numéricos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
5.
Ann Clin Microbiol Antimicrob ; 18(1): 26, 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31551088

RESUMO

BACKGROUND: Infections result from invasions of an organism into body tissues leading to diseases and complications that might eventually lead to death. Inappropriate use of antimicrobials has led to development of antimicrobial resistance (AMR) which has been associated with increased mortality, morbidity and health costs. Antimicrobial stewardship (AMS) programs are designed to ensure appropriate selections of an effective antimicrobial drugs and optimizing antibiotic use to minimize antibiotic resistance by implementing certain policies, strategies and guidelines. The aim of this study was to investigate practitioners' perceptions regarding AMS implementation and to identify challenges and facilitators of these programs execution. METHODS: Cross-sectional study among health care providers in Eastern province of Saudi Arabia Hospitals. The data was collected using a survey including questions about demographic data and information about clinicians' (physicians, pharmacists and nurses) previous experience with AMS and prescribing of antibiotics, the level of knowledge and attitudes regarding AMS programs' implementation. RESULTS: More than 50% of clinicians (N = 184) reported lack of awareness of AMS programs and their components, whereas 71.2% do not have previous AMS experience. The majority of clinicians (72.3%) noticed increasing number of AMR infections over the past 5 years and (69.6%) were involved in care of patients with an antibiotic-resistant infection. Around 77.2% of respondents reported that formulary management can be helpful for AMS practice and majority of respondents (79.9%) reported that the availability of pathogens and antimicrobial susceptibility testing can be helpful for AMS. Major barriers to AMS implementation identified were lack of internal policy/guidelines and specialized AMS information resources. Lack of administrative awareness about AMS programs; lack of personnel, time limitation, limited training opportunities, lack of confidence, financial issue or limited funding and lack of specialized AMS information resources were also reported 65.8%, 62.5%, 60.9%, 73.9%, 50%, 54.3 and 74.5%, respectively. CONCLUSION: Our study identified comprehensive education and training needs for health care providers about AMS programs. Furthermore, it appears that internal policy and guidelines need revision to ensure that the health care providers work consistently with AMS. Future research must focus on the benefit of implementing AMS as many hospitals are not implementing AMS as revealed by the clinicians. We recommend policy makers and concerned health authorities to consider the study findings into account to optimize AMS implementation.


Assuntos
Antibacterianos/uso terapêutico , Gestão de Antimicrobianos , Atitude do Pessoal de Saúde , Uso de Medicamentos/normas , Pessoal de Saúde/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Arábia Saudita , Inquéritos e Questionários
7.
Ann Clin Microbiol Antimicrob ; 18(1): 24, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31434563

RESUMO

BACKGROUND: Antimicrobial resistance is a widely recognized public health threat, and stewardship interventions to combat this problem are well described. Less is known about antifungal stewardship (AFS) initiatives and their influence within the United States. The purpose of this study was to evaluate evidence on the impact of AFS interventions on clinical and performance measures. METHODS: A systematic review of English language studies identified in the PubMed and EMBASE databases was performed through November 2017. The review was conducted in accordance with PRISMA. Search terms included antifungal stewardship, antimicrobial stewardship, Candida, candidemia, candiduria, and invasive fungal disease. Eligible studies were those that described an AFS program or intervention occurring in the US and evaluated clinical or performance measures. RESULTS: Fifty-four articles were identified and 13 were included. Five studies evaluated AFS interventions and reported clinical outcomes (mortality and length of stay) and performance measures (appropriate antifungal choice and time to therapy). The remaining eight studies evaluated general stewardship interventions and reported data on antifungal consumption. All studies were single center, quasi-experimental with varying interventions across studies. AFS programs had no impact on mortality (3 of 3 studies), with an overall rate of 27% in the intervention group and 23% in the non-intervention group. Length of stay (5 of 5) was also similar between groups (range, 9-25 vs. 11-22). Time to antifungal therapy improved in 2 of 5 studies, and appropriate choice of antifungal increased in 2 of 2 studies. Antifungal consumption was significantly blunted or reduced following stewardship initiation (8 of 8), although a direct comparison between studies was not possible due to a lack of common units. CONCLUSION: The available evidence suggests that AFS interventions can improve performance measures and decrease antifungal consumption. Although this review did not detect improvements in clinical outcomes, significant adverse outcomes were not reported.


Assuntos
Antifúngicos/uso terapêutico , Gestão de Antimicrobianos/métodos , Uso de Medicamentos/normas , Pesquisa sobre Serviços de Saúde , Infecções Fúngicas Invasivas/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Análise de Sobrevida , Estados Unidos , Adulto Jovem
8.
Diagn Microbiol Infect Dis ; 95(3): 114857, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31327622

RESUMO

In response to the antimicrobial resistance crisis, pharmaceutical industry reinvested in and produced new antibiotics. Antimicrobial stewardship programs influence optimal antimicrobial use, which often places them at the cross-roads of resistance and treatments. We surveyed a clinical administration database of US medical centers between 2014 and 2018 for index antimicrobial utilization date of six Qualified Infectious Diseases Products (QIDP). Among 132 hospitals identified, the median time to use any agent was 398 days (range 13 to >1478 days). QIDP antibiotic use was more likely among academic medical centers (range 34%-88%) and hospitals >400 beds (range 39%-86%) compared to non-academic medical center (3-51%) and smaller and hospitals (range 0-61%). The South was quickest to use all QIDP (median 733 days), while the Northeast was longest at 1370 days. New antimicrobials have limited clinical use, which impacts manufacturers' ability to stay in the antimicrobial market and further risking a depleted antimicrobial pipeline.


Assuntos
Anti-Infecciosos , Gestão de Antimicrobianos/estatística & dados numéricos , Gestão de Antimicrobianos/tendências , Desenvolvimento de Medicamentos/estatística & dados numéricos , Desenvolvimento de Medicamentos/tendências , Indústria Farmacêutica/economia , Indústria Farmacêutica/tendências , Resistência Microbiana a Medicamentos , Uso de Medicamentos/normas , Uso de Medicamentos/estatística & dados numéricos , Registros Eletrônicos de Saúde , Hospitais , Humanos , Estados Unidos
10.
Clin Drug Investig ; 39(11): 1057-1066, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31325111

RESUMO

BACKGROUND AND OBJECTIVE: Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures. METHODS: In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM. Four DUS sensitivity analyses (scenarios) evaluated uncertainty regarding domperidone treatment duration and indication. RESULTS: Among 1805 physicians participating in the survey, most were aware of the approved indication (nausea and vomiting, 80%), treatment duration (≤ 7 days, 70%), and maximum adult daily dose (10 mg three times daily, 84%). Only 33% selected the on-label indication from a list of indications for which they would prescribe domperidone. Awareness was low for medications contraindicated for concomitant use (26%) and contraindicated conditions (4%). In the DUS, under the optimistic scenario, a large improvement in labeling compliance from pre- to post-implementation period was observed in France (27% vs. 69%), while Belgium, Germany, Spain, and the UK showed small improvements (< 10%). In the other scenarios, there was little to no improvement in compliance with the revised labeling from the pre- to post-implementation periods in most countries. CONCLUSIONS: The survey findings documented that most physicians in all five countries were aware of the main aspects of the revised labeling. Results of the DUS were inconclusive regarding the effect of the RMM and compliance with the revised labeling for all countries except France.


Assuntos
Antieméticos/uso terapêutico , Domperidona/uso terapêutico , Rotulagem de Medicamentos/normas , Uso de Medicamentos/normas , Médicos/normas , Adulto , Antieméticos/efeitos adversos , Arritmias Cardíacas/induzido quimicamente , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/prevenção & controle , Doença do Sistema de Condução Cardíaco/induzido quimicamente , Doença do Sistema de Condução Cardíaco/epidemiologia , Doença do Sistema de Condução Cardíaco/prevenção & controle , Estudos Transversais , Morte Súbita Cardíaca/etiologia , Domperidona/efeitos adversos , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/tratamento farmacológico , Náusea/epidemiologia , Estudos Retrospectivos , Medição de Risco , Inquéritos e Questionários , Vômito/tratamento farmacológico , Vômito/epidemiologia
11.
Int J Antimicrob Agents ; 54(3): 367-370, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31202924

RESUMO

Recent estimates of inpatient antibiotic use in the USA suggest that broad-spectrum antibiotic use has increased significantly. The objective of this study was to assess the impact of a selective antibiotic susceptibility reporting intervention on broad-spectrum intravenous (i.v.) antibiotic use in seven hospitals of a health system in New Jersey. This was a retrospective pre- and post-intervention ecological study. Standardised selective antibiotic susceptibility reporting rules were developed and implemented between January 2016 and June 2017. The 8 months before and after each individual hospital's implementation constituted the pre- and post-intervention study periods. The primary outcome was the rate of broad-spectrum i.v. antibiotic use for hospital-onset/multidrug-resistant infections (broad MDR). Secondary outcome measures were the use rates of non-glycopeptide anti-methicillin-resistant Staphylococcus aureus (anti-MRSA) agents, carbapenems, non-carbapenem antipseudomonal ß-lactams, third-generation cephalosporins, first/second-generation cephalosporins, fluoroquinolones and narrow-spectrum penicillins. Antibiotic use data were collected as inpatient i.v. antibiotic days of therapy per 1000 patient days (DOT/1000-PD). Interrupted time series analysis with segmented regression was used to compare outcomes. There was no significant change in the use of broad MDR agents (slope change, +0.54 DOT/1000-PD per month, 95% confidence interval -1.78 to 2.87) or other antibiotic classes. Whilst the implementation of selective antibiotic susceptibility reporting across seven hospitals had no impact on overall broad-spectrum i.v. antibiotic use, further study is needed to determine the long-term impact of this intervention.


Assuntos
Antibacterianos/uso terapêutico , Gestão de Antimicrobianos/métodos , Terapia Comportamental/métodos , Doenças Transmissíveis/tratamento farmacológico , Uso de Medicamentos/normas , Testes de Sensibilidade Microbiana/métodos , Padrões de Prática Médica/estatística & dados numéricos , Hospitais , Humanos , Análise de Séries Temporais Interrompida , New Jersey , Estudos Retrospectivos
12.
Surgery ; 166(5): 752-757, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31229314

RESUMO

BACKGROUND: Open inguinal hernia repair is thought to cause worse postoperative pain than minimally invasive surgery, and thus patients are often prescribed more opioids at discharge. This study evaluates opioid use in inguinal hernia repair patients to optimize discharge prescribing practices for this common procedure. METHODS: Opioid-naive adults undergoing open or minimally invasive surgery inguinal hernia repair were identified prospectively from 3 centers to complete a 29-question telephone interview after discharge as part of a larger initiative. Opioid prescription and consumption data were converted into morphine milligram equivalents and compared between minimally invasive surgery and open inguinal hernia repair. Univariate χ2, Fisher exact test, univariate, and multivariable logistic regression were used. RESULTS: Of 249 contacted patients, 195 (74%) completed the survey (n = 97 open, n = 98 minimally invasive surgery). Patients undergoing open inguinal hernia repair were slightly older (71 vs 65 years, P < .001) and less likely to be female (3% vs 17%, P = .001) than minimally invasive surgery patients. Open patients were more likely to have a unilateral inguinal hernia repair (95% open vs 52% minimally invasive surgery, P < .001). Discharge pain scores using the 10-point, patient-reported Numeric Pain Rating scale were similar (open 2.3 ± 1.7 vs minimally invasive surgery 2.4 ± 1.6; P = .80), and most patients were satisfied with postoperative pain control (open 86% vs minimally invasive surgery 95%; P = .13). Open inguinal hernia repair patients were just as likely to receive opioids at discharge as those undergoing minimally invasive surgery inguinal hernia repair (98% vs 91% minimally invasive surgery; P = .06) and were prescribed similar amounts of opioids (open 155 [IQR 113, 225] morphine milligram equivalents vs 150 [IQR 100, 210] minimally invasive surgery; P = .08). There was no difference in opioid use by approach (open 15 [IQR 0, 60] morphine milligram equivalents vs 9 [IQR 0, 50] minimally invasive surgery; P = .33). More than one-third of patients used no opioids (open 38% vs minimally invasive surgery 44%; P = .42). Bilateral repair was not associated with increased opioid use (univariate odds ratio 1.23, P = .58). On multivariable analysis, low discharge pain and normal body mass index were independently associated with needing no opioids at discharge. Overall, 75% of prescribed opioids remained unused at time of survey, yet only 12% of patients had disposed of unused opioids at the time of survey. CONCLUSION: Postdischarge opioid utilization was clinically similar between patients undergoing open and minimally invasive surgery inguinal hernia repair and those requiring unilateral or bilateral repair. Given that more than one-third of patients required no opioids after discharge, 0 to 8 tablets of 5 mg oxycodone is sufficient for most opioid-naive patients undergoing inguinal hernia repair.


Assuntos
Analgésicos Opioides/uso terapêutico , Uso de Medicamentos/estatística & dados numéricos , Herniorrafia/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Idoso , Relação Dose-Resposta a Droga , Prescrições de Medicamentos/normas , Prescrições de Medicamentos/estatística & dados numéricos , Uso de Medicamentos/normas , Feminino , Hérnia Inguinal/cirurgia , Herniorrafia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Oxicodona/uso terapêutico , Dor Pós-Operatória/etiologia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas , Padrões de Prática Médica/estatística & dados numéricos , Estudos Prospectivos , Estudos Retrospectivos
13.
Int J Antimicrob Agents ; 54(3): 338-345, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31200022

RESUMO

Antimicrobial stewardship programmes (ASPs) are designed to improve antibiotic use. A survey was systematically developed to assess ASP prerequisites, objectives and improvement strategies in hospitals. This study assessed the current state of ASPs in acute-care hospitals throughout Europe. A survey containing 46 questions was disseminated to acute-care hospitals: all Dutch (n = 80) and Slovenian (n = 29), 215 French (25%, random stratified sampling) and 62 Italian (49% of hospitals with an infectious diseases department, convenience sampling) acute-care hospitals, for a Europe-wide assessment. Response rates for the Netherlands (Nl), Slovenia (Slo), France (Fr) and Italy (It) were 80%, 86%, 45% and 66%. There was variation between countries in the prerequisites met and the objectives and improvement strategies chosen. A formal ASP was present mainly in the Netherlands (90%) and France (84%) compared with Slovenia (60%) and Italy (60%). Presence of an antimicrobial stewardship (AMS) team ranged from 42% (Fr) to 94% (Nl). Salary support for AMS teams was provided in 68% (Fr), 51% (Nl), 33% (Slo) and 12% (It) of surveyed hospitals. Quantity of antibiotic use was monitored in the majority of hospitals, ranging from 72% (Nl) to 100% (Slo and Fr) of acute-care hospitals. Participating countries varied substantially in the use of 'prospective monitoring and advice' as a strategy to improve AMS objectives. ASP prerequisites, objectives and improvement activities vary considerably across Europe, with room for improvement. Stimulating appropriate system prerequisites throughout Europe, e.g. by introducing staffing standards and financial support for ASPs, seems a first priority.


Assuntos
Antibacterianos/uso terapêutico , Gestão de Antimicrobianos/métodos , Doenças Transmissíveis/tratamento farmacológico , Uso de Medicamentos/normas , Serviços Médicos de Emergência/métodos , Estudos Transversais , Uso de Medicamentos/estatística & dados numéricos , Europa (Continente) , Hospitais , Humanos , Inquéritos e Questionários
14.
PLoS One ; 14(6): e0218617, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31216323

RESUMO

BACKGROUND: Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010. METHODS AND FINDINGS: In this study we conducted semi-structured interviews and performed document reviews. The main target group for our interviews was pharmaceutical companies. We interviewed 18 companies, including 64% of the total companies who had experienced the EAC joint product assessment procedure, and two EAC-based national medicines regulatory authorities. We found that generally pharmaceutical companies are supportive of the African-based MRH efforts and appreciative of the progress being achieved. However, many companies are now hesitant to use the joint product assessment procedure until efficiency improvements are made. Common frustrations were the length of time to receive the actual marketing authorization; unexpectedly higher quality standards than national procedures; and challenges in getting all EAC countries to recognize EAC approvals. Smaller, less attractive markets have not yet become more attractive from a corporate perspective, and there is no free trade of pharmaceuticals in the EAC region. CONCLUSIONS: Pharmaceutical companies agree that medicines regulatory harmonization is the way forward. However, regulatory medicines harmonization must actually result in quicker access to the harmonized markets for quality-assured medicines. At this time, improvements are required to the current EAC processes to meet the vision of harmonization.


Assuntos
Atitude , Indústria Farmacêutica , Uso de Medicamentos/normas , Acesso aos Serviços de Saúde/organização & administração , Programas Médicos Regionais/organização & administração , África Oriental , Países em Desenvolvimento , Acesso aos Serviços de Saúde/normas , Programas Médicos Regionais/normas
15.
Int J Antimicrob Agents ; 54(1): 16-22, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31085298

RESUMO

The global public health threat of antibiotic-resistant infections as well as the lack of new treatments in clinical development is a critical issue. Reasons for this include diminished commercial incentives for pharmaceutical companies to develop new antibiotics, which part-reflects a shift in antibiotic marketing paradigm from broad deployment to targeted therapy in relatively small patient populations. Such changes are encouraged by antimicrobial stewardship (AMS). Other factors include a lack of recognition in the traditional assessment of new antibiotics by regulators, health technology assessors and payers of the broad range of benefits of new agents, particularly their value to health care, economies and society. Recognising the seriousness of the situation, there have been recent changes and proposals by regulators for modification of the assessment process to accommodate a broader range of acceptable data supporting new drug applications. There is also increasing recognition by some payers of the societal benefit of new antibiotics and the need for financial incentives for those developing high-priority antibiotics. However, progress is slow, with recent publications focusing on industry and strategic perspectives rather than clinical implications. In this opinion piece, we therefore focus on clinicians and the practical steps they can take to drive and contribute to increasing awareness and understanding of the value of antibiotics. This includes identifying and gathering appropriate alternative data sources, educating on AMS and prescribing habits, and contributing to international antibiotic susceptibility surveillance models.


Assuntos
Antibacterianos/uso terapêutico , Gestão de Antimicrobianos/métodos , Infecções Bacterianas/tratamento farmacológico , Farmacorresistência Bacteriana , Uso de Medicamentos/normas , Médicos , Antibacterianos/farmacologia , Hospitais , Humanos , Padrões de Prática Médica
16.
J Vet Intern Med ; 33(4): 1677-1685, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31119803

RESUMO

BACKGROUND: Carbapenems are a class of antimicrobials reserved for resistant infections or systemically ill people, yet the extent and context in which they are prescribed in the small animals is understudied. HYPOTHESIS/OBJECTIVE: To describe cases in dogs and cats treated with carbapenems to establish baseline data regarding the types of infections, outcomes, and resistance profiles of target infections. We hypothesize that prescribing practices for carbapenems at a veterinary tertiary care hospital would not comply with the recommended use guidelines in human medicine. METHODS: Retrospective study of veterinary medical records from all dogs and cats prescribed carbapenems between May 1, 2016, and April 30, 2017. RESULTS: A total of 81 infections (71 in dogs and 10 in cats) representing 68 animals (58 dogs and 10 cats) involving carbapenem use were identified. Cultures were performed in 65/81 (80%) infections, and antimicrobial use was de-escalated or discontinued in 10/81 (12%) infections. The average duration of treatment was 27.5 days and ranged from 1 to 196 days. Resistance to more than 3 antimicrobial classes was present in 57/115 (50%) isolates. Resistance to carbapenems was found in 2/64 (3%) of the bacterial isolates with reported carbapenem susceptibility. CONCLUSIONS AND CLINICAL IMPORTANCE: The majority of carbapenem use at a veterinary tertiary care hospital was prescribed in conjunction with culture and sensitivity determination, with de-escalation performed in a minority of cases, and treatment durations longer than typically recommended in human medicine.


Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/veterinária , Carbapenêmicos/uso terapêutico , Doenças do Gato/tratamento farmacológico , Doenças do Cão/tratamento farmacológico , Animais , Bactérias/classificação , Infecções Bacterianas/tratamento farmacológico , Doenças do Gato/microbiologia , Gatos , Doenças do Cão/microbiologia , Cães , Farmacorresistência Bacteriana , Uso de Medicamentos/normas , Feminino , Hospitais Veterinários/estatística & dados numéricos , Masculino , Testes de Sensibilidade Microbiana , Estudos Retrospectivos
19.
Clin Microbiol Infect ; 25(11): 1356-1363, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30910716

RESUMO

BACKGROUND: Antimicrobial resistance (AMR) is one of the greatest threats in 21st century medicine. AMR has been characterized as a social dilemma. A familiar version describes the situation in which a collective resource (in this case, antibiotic efficacy) is exhausted due to over-exploitation. The dilemma arises because individuals are motivated to maximize individual payoffs, although the collective outcome is worse if all act in this way. OBJECTIVES: We aim to outline the implications for antimicrobial stewardship of characterizing antibiotic overuse as a social dilemma. SOURCES: We conducted a narrative review of the literature on interventions to promote the conservation of resources in social dilemmas. CONTENT: The social dilemma of antibiotic over-use is complicated by the lack of visibility and imminence of AMR, a loose coupling between individual actions and the outcome of AMR, and the agency relationships inherent in the prescriber role. We identify seven strategies for shifting prescriber behaviour and promoting a focus on the collectively desirable outcome of conservation of antibiotic efficacy: (1) establish clearly defined boundaries and access rights; (2) raise the visibility and imminence of the problem; (3) enable collective choice arrangements; (4) conduct behaviour-based monitoring; (5) use social and reputational incentives and sanctions; (6) address misalignment of goals and incentives; and (7) provide conflict resolution mechanisms. IMPLICATIONS: We conclude that this theoretic analysis of antibiotic stewardship could make the problem of optimizing antibiotic prescribing more tractable, providing a theory base for intervention development.


Assuntos
Anti-Infecciosos/uso terapêutico , Gestão de Antimicrobianos/organização & administração , Resistência Microbiana a Medicamentos , Uso de Medicamentos/normas , Humanos
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