How to start an antimicrobial stewardship programme in a hospital.

BACKGROUND: Antimicrobial stewardship (AMS) describes a coherent set of actions that ensure optimal use of antimicrobials to improve patient outcomes, while limiting the risk of adverse events (including antimicrobial resistance (AMR)). Introduction of AMS programmes in hospitals is part of most national action plans to mitigate AMR, yet the optimal components and actions of such a programme remain undetermined. OBJECTIVES: To describe how health-care professionals can start an AMS programme in their hospital, the components of such a programme and the evidence base for its implementation. SOURCES: National and society-led guidelines on AMS, peer-reviewed publications and experience of AMS experts conducting AMS programmes. CONTENT: We provide a step-by-step pragmatic guide to setting up and implementing a hospital AMS programme in high-income or low-and-middle-income countries. IMPLICATIONS: Antimicrobial stewardship programmes in hospitals are a vital component of national action plans for AMR, and have been shown to significantly reduce AMR, particularly when coupled with infection prevention and control interventions. This step-by-step guide of 'how to' set up an AMS programme will help health-care professionals involved in AMS to optimally design and implement their actions.

Government policy interventions to reduce human antimicrobial use: A systematic review and evidence map.

BACKGROUND: Growing political attention to antimicrobial resistance (AMR) offers a rare opportunity for achieving meaningful action. Many governments have developed national AMR action plans, but most have not yet implemented policy interventions to reduce antimicrobial overuse. A systematic evidence map can support governments in making evidence-informed decisions about implementing programs to reduce AMR, by identifying, describing, and assessing the full range of evaluated government policy options to reduce antimicrobial use in humans. METHODS AND FINDINGS: Seven databases were searched from inception to January 28, 2019, (MEDLINE, CINAHL, EMBASE, PAIS Index, Cochrane Central Register of Controlled Trials, Web of Science, and PubMed). We identified studies that (1) clearly described a government policy intervention aimed at reducing human antimicrobial use, and (2) applied a quantitative design to measure the impact. We found 69 unique evaluations of government policy interventions carried out across 4 of the 6 WHO regions. These evaluations included randomized controlled trials (n = 4), non-randomized controlled trials (n = 3), controlled before-and-after designs (n = 7), interrupted time series designs (n = 25), uncontrolled before-and-after designs (n = 18), descriptive designs (n = 10), and cohort designs (n = 2). From these we identified 17 unique policy options for governments to reduce the human use of antimicrobials. Many studies evaluated public awareness campaigns (n = 17) and antimicrobial guidelines (n = 13); however, others offered different policy options such as professional regulation, restricted reimbursement, pay for performance, and prescription requirements. Identifying these policies can inform the development of future policies and evaluations in different contexts and health systems. Limitations of our study include the possible omission of unpublished initiatives, and that policies not evaluated with respect to antimicrobial use have not been captured in this review. CONCLUSIONS: To our knowledge this is the first study to provide policy makers with synthesized evidence on specific government policy interventions addressing AMR. In the future, governments should ensure that AMR policy interventions are evaluated using rigorous study designs and that study results are published. PROTOCOL REGISTRATION: PROSPERO CRD42017067514.

Phage Therapy Regulation: From Night to Dawn.

After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of any patient customization and intended for large-scale distribution. Accordingly, the resulting regulatory framework is hardly reconcilable with the concept of sustainable phage therapy, involving tailor-made medicinal products in the global perspective of both evolutionary and personalized medicine. The repeated appeal for a dedicated regulatory framework has not been heard by the European legislature, which, in this matter, features a strong resistance to change despite the precedent of the unhindered implementation of advanced therapy medicinal product (ATMPs) regulation. It is acknowledged that in many aspects, phage therapy medicinal products are quite unconventional pharmaceuticals and likely this lack of conformity to the canonical model hampered the development of a suitable regulatory pathway. However, the regulatory approaches of countries where phage therapy traditions and practice have never been abandoned are now being revisited by some Western countries, opening new avenues for phage therapy regulation. As a next step, supranational and international organizations are urged to take over the initiatives originally launched by national regulatory authorities.

Monitoring Antimicrobial Drug Usage in Animals: Methods and Applications.

Monitoring antimicrobial drug usage in animals at the national and international levels is important for identification and tracking if and how often quantities are used. This information can be used for many purposes, including raising awareness, comparing use patterns across countries, identifying trends over time, integrating with antimicrobial resistance data, conducting risk assessment, and evaluating the effectiveness of measures to manage antimicrobial usage. The goal of this article is to describe how monitoring systems for antimicrobial drug usage in animals are set up and conducted, using examples from specific countries as well as international efforts. Several key figures and variables are used to describe and evaluate antimicrobial consumption in animals, including the amount in kilograms of active ingredient, standardized units (e.g., number of defined daily dose animals, DDDAs) and number of treatments (e.g., number of used daily doses, UDDA). Data can be collected from a variety of sources including pharmaceutical sales, pharmacy dispensing, veterinary prescriptions, and farm records. In many countries, data analysis and reporting at the national level provide statistics on overall quantities used in animals, in some cases by animal species. Antimicrobial consumption data should be contrasted to the respective animal population, for example, the weight of different categories of livestock and slaughtered animals. Several countries have established antimicrobial usage monitoring systems. Most report overall sales data, but some provide usage data to the levels of animal species and production type. At the international level, several organizations (e.g., European Union, World Organization for Animal Health, World Health Organization) have initiatives to support the development of antimicrobial consumption data collection and reporting. However, these initiatives are ongoing and so far lack harmonization, which will be the biggest challenge for the future.

The infection risk scan (IRIS): standardization and transparency in infection control and antimicrobial use.

Background: Infection control needs user-friendly standardized instruments to measure the compliance to guidelines and to implement targeted improvement actions. This abstract describes a tool to measure the quality of infection control and antimicrobial use, the Infection Risk Scan (IRIS). It has been applied in a hospital, several nursing homes and a rehabilitation clinic in the Netherlands. Method: The IRIS consists of a set of objective reproducible measurements, combining patient- and healthcare related variables, such as: hand hygiene compliance, environmental contamination using ATP measurements, prevalence of resistant microorganisms by active screening, availability of infection control preconditions, personal hygiene of healthcare workers, appropriate use of indwelling medical devices and appropriate use of antimicrobials. Results are visualized in a spider plot using traffic light colors to facilitate the interpretation. Results: The IRIS provided ward specific results within the hospital that were the basis for targeted improvement programs resulting in measurable improvements. Hand hygiene compliance increased from 43% to 66% (more than 1000 observations per IRIS, p < 0.000) and ATP levels were significantly reduced (p < 0.000). In the nursing homes, large differences were observed with environmental contamination as common denominator. Most remarkable were the difference in Extended Spectrum Beta-Lactamase Enterobacteriaceae (ESBL-E) prevalence (mean 11%, range 0-21%). Conclusion: The bundle approach and visualization of the IRIS makes it a useful infection prevention tool providing standardization and transparency. Targeted interventions can be started based on the results of the improvement plot and repeated IRIS can show the effect of interventions. In that way, a quality control cycle with continuous improvement can be achieved.

Implementação da nova regulamentação para prescrição e dispensação de antimicrobianos: possibilidades e desafios / Implementation of new regulations for prescribing and dispensing of antibiotics: challenges and possibilities

Introdução: O uso e a prescrição inadequados de antimicrobianos e a pressão da indústria farmacêutica para a sua utilização transformaram a resistência bacteriana a esses medicamentos em um problema mundial de saúde pública. Objetivo: O objetivo do estudo foi analisar o processo de implantação da Resolução da Diretoria Colegiada (RDC) da Agência Nacional de Vigilância Sanitária (Anvisa) de nº 20/2011, que dispõe sobre o controle dos antimicrobianos. Método: Utilizou-se o Modelo de Múltiplos Fluxos de Kingdon para examinar a inserção do tema do controle dos antimicrobianos na agenda governamental e sua posterior conformação em política pública. Foram empregadas diversas estratégias metodológicas, como a revisão bibliográfica, a análise de documentos, a busca de notícias veiculadas na mídia e informações advindas de entrevistas com informantes-chave. Conclusão: Apesar da existência de legislações e regulamentações sobre o uso e a prescrição de antimicrobianos, além da ampliação do acesso da população aos profissionais de saúde para evitar a automedicação e promover o uso correto, esforços como a educação sanitária para profissionais e a população e o reforço da fiscalização sanitária devem ser efetivamente implementados, não apenas para alcançar o uso racional, mas também para diminuir a resistência aos antimicrobianos.(AU)

Introduction: Inappropriate use and prescription of antimicrobials and the pressure from the pharmaceutical industry for their use have turned bacterial resistance into a global public health problem. Objective: This study aimed to analyze the implementation process of ANVISA's Board of Directors Resolution (RDC) 20/2011 for antimicrobials control. Method: Kingdon's Multiple Streams Model was used to examine the inclusion of antimicrobial control into the government agenda and its subsequent shaping into public policy. Several methodological strategies were employed, such as bibliographic review, document analysis, the search for stories in the media and information from interviews with key informants. Conclusion: In addition to legislation and regulations of the use and prescription of antimicrobials, easier population's access to health professionals to avoid self-medication and promote correct use, it is necessary to implement efforts such as education of professionals and the general population, not only to achieve rational use, but also to reduce antimicrobial resistance.(AU)

Implementation and outcomes of hospital-wide computerized antimicrobial approval system and on-the-spot education in a traumatic intensive care unit in Taiwan.

BACKGROUND/PURPOSE: Inappropriate prescribing of antibiotics is a major health-care problem in intensive care units (ICUs). This study evaluates the impact of a direct hospital-wide computerized antimicrobial approval system (HCAAS) and on-the-spot education for practitioners in a neurosurgical ICU in Taiwan. METHODS: We retrospectively analyzed the medical records monthly of patients who were admitted to the neurosurgical ICU during a period of 7 years and 7 months. A pretest-post-test time series analysis, comparing the three periods: period I (no infectious disease (ID) physician), period II (part-time ID physicians), and period III (full-time ID physician). Antimicrobial consumption and expenditure, incidence of hospital-associated infections, prevalence of healthcare-associated bacterial isolates, in-hospital mortality rates, and indication of antibiotics usage were analyzed. RESULTS: Full-time ID physician can increase the consumption of narrow-spectrum antimicrobials (cefazolin, and cefuroxime), and decrease the consumptions of broad-spectrum antimicrobials (ceftazidime, cefepime, and vancomycin) compared to part-time ID physicians. From period I to period III, the expenditure of antimicrobials, incidence of hospital-associated pneumonia, and the in-hospital mortality rates (crude, sepsis-related, and overall infection-related mortality) decreased statistically. The prevalence of extended-spectrum ß-lactamase-producing Escherichia coli and Klebsiella pneumoniae, and Carbapenems-resistant Pseudomonas aeruginosa remained at low level after HCAAS implementation. From 2007 to 2009, the rational antibiotics usage continued to increase, resulting from to more prophylaxis and appropriate microbiologic proof, but less empiric antimicrobial therapy. CONCLUSION: Implementation of HCAAS and long-term on-the-spot education by full-time ID physician can reduce antimicrobial consumption, cost, and improve inappropriate antibiotic usage whilst not compromising healthcare quality.

Política antimicrobiana. Necesidad imperiosa ante la creciente resistencia microbiana actual / Antimicrobial policy. Imperative need in view of the current increasing microbial resistance

Introducción: Los antimicrobianos constituyen uno de los grupos farmacológicos más utilizados en la práctica clínica y está demostrada su relación con la resistencia microbiana. El uso racional de antibióticos puede producir beneficios desde el punto de vista médico y social, pero su uso en ocasiones no es el más adecuado y debe ser objeto de una vigilancia especial y sistemática. Es necesaria una política antimicrobiana coherente en las unidades de salud. Objetivo: Revisar consensos y criterios nacionales e internacionales sobre política antimicrobiana para tratar de unificar criterios aplicables lo más uniforme posible en las instituciones de salud. Material y Método: Se realizó una búsqueda bibliográfica en diferentes bases de datos: Clinical Evidence, The Cochrane Library, PUBMED, Google Académico, MEDLINE, LIS, Scielo, Medscape, LILACS, Latindex, HINARI, MEDIGRAPHIC-NEWS, NIH Reporter y en la web de la OPS/OMS sobre política antimicrobiana, comisión de antibióticos, política de antibióticos. Desarrollo: Se consideraron conceptos de diferentes publicaciones cubanas y consensos internacionales, componentes humanos, objetivos, funciones, recursos, métodos, estrategias y control. Conclusiones: Introducir cualquier modificación terapéutica en la atención médica tiene que ser correctamente valorado en todas sus dimensiones: científica, tecnológica y social. La selección del antibiótico cuando no es posible el estudio microbiológico y/o se carece de antibiograma debe ser hecha sobre las bases clínicas y epidemiológicas locales. La creación de una Política Antimicrobiana con todos sus componentes, recursos y metodología es necesaria más que nunca en estos tiempos. Puede estar sujeta a modificaciones con nuevas evidencias; pero tiene que ser cumplida para disminuir la resistencia microbiana, los costos y obtener mejores resultados(AU)

Introduction: Antimicrobials are one of the most pharmacological groups used in the clinical practice, and its relation to microbial resistance is demonstrated. The rational use of antibiotics can be beneficial from the social and medical point of view, but occasionally, their use is not the most correct one and there should be a systematic and special surveillance. A rational antimicrobial policy is necessary in the health care centers. Objective: To review national and international consensuses and criteria on antimicrobial policy to try to unify criteria and apply them the most uniform way possible in health care centers. Material and method: A bibliographic review on antimicrobial policy, antibiotics commission, and antibiotics policy was made in different databases; some of them were: Clinical Evidence, The Cochrane Library, PUBMED, Academic Google, MEDLINE, LIS, Scielo, Medscape, LILACS, Latindex, HINARI, MEDIGRAPHIC-NEWS, NIH Reporter, and the Web sites of the PAHO/ WHO. Development: Concepts on different Cuban publications, international consensuses, human components, objectives, functions, resources, methods, strategies, and controls were considered. Conclusions: The implementation of any therapeutic modification in the medical attention has to be analyzed correctly in all its dimensions: scientific, technological, and social ones. When the microbiological study is not possible or there is no antibiogram, the selection of the antibiotic should be made on the local epidemiological and clinical basis. The creation of an Antimicrobial Policy with all its components, resources, and methodology is needed now more than ever. It can be submitted to modifications with new evidences, but it has to be fulfilled to reduce both microbial resistance and the costs, and obtain better results(AU)

Antimicrobial storage and antibiotic knowledge in the community: a cross-sectional pilot study in north-western Angola.

BACKGROUND: Antimicrobials are drugs that were once lifesavers and mainly curative. Nowadays their value is increasingly under pressure because of the rapid and worldwide emergence of antimicrobial resistance, which, in low-resource settings, frequently occurs in microorganisms that are likely to be transmitted in the community. METHODS: This was a cross-sectional pilot study including 102 households within the 10th Health and Demographic Surveillance System round in Dande, Bengo Province, Angola. RESULTS: Of the total 102 households piloted, 79 (77.45%) were urban. Fifty-seven respondents were female (56.44%), and the mean age of the respondents was 39.70±15.35years. Overall, storage of antimicrobials was found in 55/102 households (53.92%). More than 66% of the antimicrobials stored were prescribed by a health professional and the majority of antimicrobials were bought at pharmacies or at a street market. Penicillin and its derivatives, antimalarial drugs, and metronidazole were the antimicrobials most frequently stored. Households with female respondents reported storing any drugs at home more frequently (82.50%; p=0.002) and also storing antimicrobials more frequently (64.91%; p=0.016) as compared to households with male respondents. Reported use of antimicrobials was significantly higher in urban households (60.76%, 48/79) as compared to rural households (30.43%, 7/23) (p=0.010). Overall, 74 of 101 respondents (73.26%) reported having already heard about antibiotics. The common reasons given for their use were cough and other respiratory symptoms, wounds, flu and body muscle pain, fever, bladder complaints, and diarrhoea and/or presumed typhoid fever. Nearly 40% (28/74) of the respondents thought that antibiotics should be stopped as soon as the person does not feel sick anymore. CONCLUSIONS: Community interventions for appropriate use of antibiotics should be designed with a special focus on women. This should be done through public awareness campaigns and improving access to reliable medical services. Drug prescribers are key not only to appropriate antimicrobial prescription, but also to adequate dispensing, and are strong advocates for the possible misconceptions on antimicrobial usage by lay people.

Priorities for the Priority Review Voucher.

The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease that is approved by the U.S. Food and Drug Administration receives a bonus priority review voucher for another drug. As of 2016, four vouchers have sold for an average price of $200 million. Recent experience with the voucher program indicates strengths and weaknesses of the program, as well as a need for legislative changes.

Quality of Artemisinin-based Combination Therapy for malaria found in Ghanaian markets and public health implications of their use.

BACKGROUND: Ghana changed their antimalarial drug policy from monotherapies to Artemisinin-based Combination Therapies in 2004 in order to provide more efficacious medicines for treatment of malaria. The policy change can be eroded if poor quality Artemisinin-based Combination Therapies are allowed to remain on the Ghanaian market unchecked by regulatory bodies and law enforcement agencies. The presence and prevalence of substandard and counterfeit Artemisinin-based Combination Therapies need to be determined on open markets in Ghana; a review of the current policy; identifying any gaps and making recommendations on actions to be taken in addressing gaps identified are essential as the data provided and recommendations made will help in ensuring effective control of malaria in Ghana. METHODS: A field survey of antimalarial drugs was conducted in the central part of Ghana. The amount of active pharmaceutical ingredient in each Artemisinin-based Combination Therapy sample identified in the survey was measured using high performance liquid chromatographic analyses. Active pharmaceutical ingredient within the range of 85-115 % was considered as standard and active pharmaceutical ingredient results out of the range were considered as substandard. All samples were screened to confirm stated active pharmaceutical ingredient presence using mass spectrometry. RESULTS: A total of 256 Artemisinin-based Combination Therapies were purchased from known medicine outlets, including market stalls, hospitals/clinics, pharmacies, drug stores. Artemether lumefantrine (52.5 %) and artesunate amodiaquine (43.2 %) were the predominant Artemisinin-based Combination Therapies purchased. Of the 256 Artemisinin-based Combination Therapies purchased, 254 were tested, excluding two samples of Artesunate-SP. About 35 % of Artemisinin-based Combination Therapies were found to be substandard. Nine percent of Artemisinin-based Combination Therapies purchased were past their expiry date; no counterfeit (falsified) medicine samples were detected by either high performance liquid chromatographic or mass spectrometry. CONCLUSION: A high proportion of Artemisinin-based Combination Therapies sold in central Ghana were found to be substandard. Manufacturing of medicines that do not adhere to good manufacturing practices may have contributed to the poor quality of the Artemisinin-based Combination Therapies procured. A strict law enforcement and quality monitoring systems is recommended to ensure effective malaria case management as part of malaria control.

Evaluating the impact of a pharmacist's absence from an antimicrobial stewardship team.

PURPOSE: Results of a study to determine the impact of a clinical pharmacist's temporary absence from a hospital's antimicrobial stewardship team are presented. METHODS: A retrospective chart review was conducted to compare the appropriateness of the use of selected antimicrobial medications with and without regular pharmacist involvement on the hospital's antimicrobial stewardship team. The charts of two samples of patients were evaluated: (1) 119 patients who had received prolonged (≥72 hours) imipenem-cilastatin, linezolid, or micafungin therapy over a three-month period during which a clinical pharmacist routinely provided interventions to help ensure the drugs were used according to institutional guidelines and (2) 111 patients treated with one of the three drugs during a three-month period when the clinical pharmacist did not serve on the stewardship team. RESULTS: Relative to the period of active pharmacist involvement in antimicrobial stewardship, rates of inappropriate use of imipenem-cilastatin, linezolid, and micafungin during the pharmacist's absence were deemed to have increased by 27, 39, and 35 percentage points, respectively, with corresponding increases in the average duration of therapy of 0.7, 4.0, and 3.2 days; in addition, the number of cases of Clostridium difficile infection increased more than threefold (from 8 to 25) during the pharmacist's absence. CONCLUSION: The temporary absence of a pharmacist from the antimicrobial stewardship team was associated with increased rates of inappropriate use of restricted antimicrobial agents and consequent increases in average durations of therapy.

Development and assessment of disinfectant efficacy test methods for regulatory purposes.

The United States Environmental Protection Agency regulates pesticidal products, including products with antimicrobial activity. Test guidelines have been established to inform manufacturers of which methodology is appropriate to support a specific efficacy claim. This paper highlights efforts designed to improve current methods and the development and assessment of new test methods.

Responsibilities of regulatory agencies in the marketing of antimicrobials.

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

Shelf-life extension program (SLEP) as a significant contributor to Strategic National Stockpile Maintenance: the Israeli experience with ciprofloxacin.

In the past decade, the 2001 anthrax incident in the U.S. and the 2003 SARS epidemic have highlighted the biological threat to civilian populations. The risk posed by the natural or manmade spread of biological agents among the population dictates a need for better national preparedness. One key component of this preparation is the establishment of a Strategic National Stockpile (SNS) of pharmaceuticals that would provide appropriate medical countermeasures in case of an outbreak. However, to reduce the expense of such a stockpile and to make it worthwhile, there is also a need for a shelf-life extension program (SLEP) through which pharmaceuticals could be extended beyond manufacturer-ascribed shelf life, as long as they meet regulation standards. In this article, we review the Israeli experience with the national ciprofloxacin stockpile procurement and shelf-life extension program.

Economic consequences of the demography of MRSA patients and the impact of broad-spectrum antimicrobials.

BACKGROUND: Studies have determined the societal impact of methicillin-resistant Staphylococcus aureus (MRSA) by modelling its impact on labour supply and productivity. In addition, most of the studies on the topic conclude that the problem of resistance should be counteracted on the macro level by reducing overall antibacterial consumption. OBJECTIVE: Two major questions have been raised in the present work. Firstly, is MRSA impairing labour supply and productivity? Secondly, is it the overall use of antibacterials that may be seen as crucial to the spread of MRSA infections? METHODS: The age distribution of MRSA patients is compared with the age distribution of the entire patient population at a German teaching hospital. In addition, the age distribution of MRSA patients was applied to the age distribution of the German population in the year 2050 in order to identify the effects of the double-ageing process on the spread of MRSA. Furthermore, recent epidemiological studies were reviewed on the impact of overall antibacterial consumption on MRSA infection rates. RESULTS: Based on available data, we show that patients infected or colonized with MRSA are, for the most part, beyond retirement age and thus not responsible for changes in labour supply or productivity. Application of age distribution of MRSA patients to the age distribution of the German population in the year 2050 gives a 24% increase in the number of MRSA cases to a total of 182 778 due to an ageing population. In addition, we show that a 32% reduction in the cost of MRSA to the German healthcare system could be reached if use of fluoroquinolones and third-generation cephalosporins was reduced by just 10% and, correspondingly, use of antiseptics for hand disinfection was increased by 10%. CONCLUSIONS: MRSA is a phenomenon that, to a larger degree, affects the elderly population rather than the labour force. When it comes to policy options to counteract MRSA on the macro level, most economic research on the topic is biased in assuming that the overall use of antibacterials is responsible for the spread of MRSA infections.

The pattern of antimicrobial use for palliative care in-patients during the last week of life.

BACKGROUND: In terminally ill cancer patients approaching the dying phase, liberal use of antimicrobials is often viewed by palliative care experts as irrational. No previous reports have reviewed current antimicrobial use in palliative care settings in Saudi Arabia. OBJECTIVE: The objective of this study was to explore the pattern of antimicrobial use in a tertiary palliative care unit (TPCU) during the last week of patients' life. METHODS: Medical records of all patients who died in the TPCU over a 14-month period were reviewed for demographics as well as the frequency and rationale of antimicrobial use during the patients' last week of life. Information on antimicrobial use was obtained from a computerized pharmacy database. RESULTS: Of 138 patients who died with advanced cancer in the TPCU, 87 (63%) were on one or more antimicrobials during their last week of life. Antibiotics were more frequently used as compared to antifungal and antiviral agents, 64 (46.4%); 45 (32.6%); and 2 (1.5%), respectively. About one third (31.3%) of patients who received antibiotics during their last week of life were prescribed more than one antibiotic. Antimicrobials were mostly given systemically (79%) rather than topically (21%). The most common rationales for antimicrobial prescribing were oral thrush in 36 patients (25.4%), wound care in 29 patients (20.4%), and on empirical basis in 29 patients (20.4%). CONCLUSIONS: The current practice of antimicrobial prescribing, especially for patients who are eminently dying, may need to be reviewed. Initiation of antimicrobial treatment in this group of patients should be based on clear treatment goals and desired outcomes, considering views of patients and families.

Improving patient care through implementation of an antimicrobial stewardship program.

PURPOSE: The implementation of an antimicrobial stewardship program at a health system is described. SUMMARY: In 2008, the Center for Antimicrobial Stewardship and Epidemiology (CASE) was formed at St. Luke's Episcopal Hospital (SLEH) to improve the quality of care for patients as it related to antimicrobial therapy. The charter of CASE contained specific aims for improving patient care, furthering clinical research, and training the next generation of clinical infectious diseases pharmacists. The CASE team consists of at least two infectious diseases pharmacists and one physician (the medical director) who provide direct oversight for antimicrobial utilization within the hospital. The CASE medical director, an infectious diseases physician, is responsible for overseeing the activities of the center. With the oversight of the CASE advisory board, the medical director develops and implements the antimicrobial stewardship and management policies for SLEH. Another key innovative feature of CASE is its extensive involvement in training new infectious diseases pharmacists and conducting research. CASE uses a model in which a clinical scenario or problem is identified, a research project is undertaken to further elucidate the problem, and policy changes are made to improve patient outcomes. The CASE team is supported by a CASE advisory board, a CASE research collaborative including university faculty, and a dedicated training program for pharmacy fellows, residents, and students. CONCLUSION: Implementation of an antimicrobial stewardship program at a health system helped decrease the inappropriate use of antibiotics, improve patient care and outcomes, further clinical research, and increase training opportunities for future clinical infectious diseases pharmacists.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.