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[PMID]:29172981
[Au] Autor:Peterson J; Budlong H; Affeldt T; Skiermont K; Kyllo G; Heaton A
[Ad] Endereço:1 Fairview Pharmacy Services, Minneapolis, Minnesota.
[Ti] Título:Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape.
[So] Source:J Manag Care Spec Pharm;23(12):1255-1259, 2017 Dec.
[Is] ISSN:2376-1032
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Biosimilars have the potential to greatly reduce medication costs in the United States. As of July 1, 2017, 5 biosimilars have been approved by the FDA, but only 2 are available for purchase. This commentary outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications. We highlight the implementation of a health plan policy and how a health system's formulary committee can encourage use while considering provider perceptions and operational challenges. In addition, we provide our perspective on potential implications for pricing, site of care, and pharmacy dispensing practices based on our experience with regulatory hurdles and market trends. Overall, we believe biosimilars are a good thing for the health care system, but their expected benefit may not be realized for years to come. DISCLOSURES: No outside funding supported this work. Affeldt reports advisory board membership with Janssen, and Skiermont reports membership with Amgen and McKesson. The other authors have nothing to disclose. Peterson and Budlong contributed the study concept and design and wrote the manuscript. Affeldt, Skiermont, Kyllo, and Heaton reviewed and revised the manuscript.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/administração & dosagem
Prestação Integrada de Cuidados de Saúde/organização & administração
Aprovação de Drogas
[Mh] Termos MeSH secundário: Medicamentos Biossimilares/economia
Prestação Integrada de Cuidados de Saúde/economia
Custos de Medicamentos
Formulários Farmacêuticos como Assunto
Acesso aos Serviços de Saúde
Seres Humanos
Assistência Farmacêutica/organização & administração
Comitê de Farmácia e Terapêutica
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biosimilar Pharmaceuticals)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.18553/jmcp.2017.23.12.1255


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[PMID]:28776442
[Au] Autor:Matlala M; Gous AG; Godman B; Meyer JC
[Ad] Endereço:a School of Pharmacy , Sefako Makgatho Health Sciences University , Pretoria , South Africa.
[Ti] Título:Structure and activities of pharmacy and therapeutics committees among public hospitals in South Africa; findings and implications.
[So] Source:Expert Rev Clin Pharmacol;10(11):1273-1280, 2017 Nov.
[Is] ISSN:1751-2441
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used. The findings were converged during the interpretation phase. Expert commentary: Most professionals were represented in the PTCs, with variations across hospitals. Membership of PTCs included a pharmacist, who in the majority of cases was the secretary. PTC activities included dissemination of decisions (100%) and formulary management (89.5%). However, reporting of adverse drug reactions (ADRs) and medication errors was typically poor at all hospital levels. Lack of expertise of pharmacoeconomic analysis and evidence-based decision-making in formulary management was identified as a key challenge in formulary management. In conclusion, future programmes should strengthen PTCs in specialised aspects of formulary management. Further training in the principles of pharmacovigilance is needed to enhance ADR reporting, as well as to ensure compliance with both WHO and provincial guidelines.
[Mh] Termos MeSH primário: Hospitais Públicos/organização & administração
Farmacêuticos/organização & administração
Serviço de Farmácia Hospitalar/organização & administração
Comitê de Farmácia e Terapêutica/organização & administração
[Mh] Termos MeSH secundário: Sistemas de Notificação de Reações Adversas a Medicamentos
Tomada de Decisões
Formulários de Hospitais
Seres Humanos
Erros de Medicação
Papel Profissional
África do Sul
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171108
[Lr] Data última revisão:
171108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170805
[St] Status:MEDLINE
[do] DOI:10.1080/17512433.2017.1364625


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[PMID]:28366263
[Au] Autor:Poindessous JL; Basta M; Michel-Dhaine C
[Ad] Endereço:Service de rééducation et réadaptation neurologique, Hôpital de Meulan-Les Mureaux, 1 rue Baptiste-Marcet, 78130 Les Mureaux, France. Electronic address: jeanluc.poindessous@chimm.fr.
[Ti] Título:La commission médicale d'établissement..
[So] Source:Rev Infirm;66(230):47-48, 2017 Apr.
[Is] ISSN:1293-8505
[Cp] País de publicação:France
[La] Idioma:fre
[Mh] Termos MeSH primário: Instalações de Saúde
Comitê de Farmácia e Terapêutica
[Mh] Termos MeSH secundário: França
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170829
[Lr] Data última revisão:
170829
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:170404
[St] Status:MEDLINE


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[PMID]:27550482
[Au] Autor:Kim B; Kim J; Kim SW; Pai H
[Ad] Endereço:Department of Internal Medicine, Hanyang University of College of Medicine, Seoul, Korea.
[Ti] Título:A Survey of Antimicrobial Stewardship Programs in Korea, 2015.
[So] Source:J Korean Med Sci;31(10):1553-9, 2016 Oct.
[Is] ISSN:1598-6357
[Cp] País de publicação:Korea (South)
[La] Idioma:eng
[Ab] Resumo:The study was conducted to evaluate the Antibiotic Stewardship Program (ASP) in Korean hospitals compared with the previous two surveys in 2006 and 2012. The information on ASPs was collected through an online-based survey sent by e-mail to 192 infectious diseases specialists in 101 Korean hospitals in September 2015. Fifty-four hospitals (53.5%, 54/101) responded to the online survey. One infectious diseases specialist was employed in 30 (55.6%) of the 54 hospitals, and they were in charge of ASPs in hospitals with the program. Fifty of the 54 hospitals (92.6%) had ASPs and the same number of hospitals was conducting a preauthorization-of-antibiotics-use program. Although most hospitals adopted preauthorization strategies for more antibiotics in 2015 than in 2012 (median 14 in 2015; 13 in 2012), a limited number of antibiotics were under control. The number of per oral and parenteral antibiotics available in hospitals in 2015 decreased compared to 2006 and 2012. The number of hospitals performing a retrospective or prospective qualitative drug use evaluation of antibiotic use increased from 2006 to 2015. Manpower in charge of antibiotic stewardship in most hospitals was still very limited and ASPs heavily depended on preauthorization-of-antibiotics-use programs in this survey. In conclusion, there leaves much to be desired in ASPs in Korea in 2015.
[Mh] Termos MeSH primário: Prescrições de Medicamentos/estatística & dados numéricos
Comitê de Farmácia e Terapêutica/organização & administração
[Mh] Termos MeSH secundário: Antibacterianos/uso terapêutico
Anti-Infecciosos/uso terapêutico
Doenças Transmissíveis/tratamento farmacológico
Monitoramento de Medicamentos
Correio Eletrônico
Hospitais
Seres Humanos
Médicos/psicologia
República da Coreia
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Anti-Infective Agents)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170308
[Lr] Data última revisão:
170308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160824
[St] Status:MEDLINE
[do] DOI:10.3346/jkms.2016.31.10.1553


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[PMID]:27009401
[Au] Autor:Mikkelsen CM; Andersen SE
[Ad] Endereço:The Hospital Pharmacy, The Capital Region of Denmark, Bispebjerg Hospital, Copenhagen, Denmark.
[Ti] Título:A Regional Drug and Therapeutics Committee-led Intervention to Reduce the Hospital Costs of Expensive HIV Drugs.
[So] Source:Basic Clin Pharmacol Toxicol;119(3):278-83, 2016 Sep.
[Is] ISSN:1742-7843
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:In 2009, the regional Drug and Therapeutics Committee (DTC) began a series of meetings with lead specialists in infectious diseases. The role of the DTC was to engage clinicians and ensure commitment to prescribing the least expensive drugs among the clinically equivalent HAARTs (highly active antiretroviral therapy). DTC also led implementation of a national guideline. This study analyses the impact of this process on HAART consumption and expenditure. The HAART consumption and expenditure (2009-2013) was compared to forecasts produced by exponential smoothing (2004-2009). Abrupt switches between drug regimens coincided with the DTC-led meetings. Overall, HAART consumption rose 16%, while price per defined daily dose (DDD) fell 11% and the 2013 expenditure decreased 23%. The consumption of drugs addressed by the guideline rose 48%. Still, the 2013 expenditure was 41.5 million DKK (5.5 million €) (27%) lower than expected, reflecting a fall in price per DDD that coincided with the intervention. The consumption of drugs not addressed by the guideline rose 8.3%, while price per DDD fell 8.5% and the 2013 expenditure was 26.8 million DKK (3.6 million €) (19%) lower than expected. Despite a steadily increasing consumption, significant cost savings followed this DTC-led intervention. This multifaceted approach might be applicable to changing the prescribing of other expensive drug classes.
[Mh] Termos MeSH primário: Antirretrovirais/economia
Terapia Antirretroviral de Alta Atividade/economia
Custos de Medicamentos
Infecções por HIV/economia
Custos Hospitalares
Comitê de Farmácia e Terapêutica
[Mh] Termos MeSH secundário: Infecções por HIV/tratamento farmacológico
Seres Humanos
Guias de Prática Clínica como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Retroviral Agents)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170309
[Lr] Data última revisão:
170309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160325
[St] Status:MEDLINE
[do] DOI:10.1111/bcpt.12585


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[PMID]:27001376
[Au] Autor:Teng M; Khoo AL; Zhao YJ; Lin L; Lim BP
[Ad] Endereço:Pharmacy & Therapeutics Office,Group Corporate Development,National Healthcare GroupMonica_Teng@nhg.com.sg.
[Ti] Título:INTEGRATING HEALTH TECHNOLOGY ASSESSMENT PRINCIPLES IN FORMULARY MANAGEMENT.
[So] Source:Int J Technol Assess Health Care;32(1-2):81-7, 2016 Jan.
[Is] ISSN:1471-6348
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore. METHODS: A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary. RESULTS: Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists' proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management. CONCLUSIONS: Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.
[Mh] Termos MeSH primário: Tomada de Decisões
Custos de Medicamentos
Formulários de Hospitais
Comitê de Farmácia e Terapêutica/organização & administração
Avaliação da Tecnologia Biomédica/organização & administração
[Mh] Termos MeSH secundário: Seres Humanos
Capacitação em Serviço
Farmacêuticos/organização & administração
Singapura
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170531
[Lr] Data última revisão:
170531
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160323
[St] Status:MEDLINE
[do] DOI:10.1017/S0266462316000040


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[PMID]:25736942
[Au] Autor:Skledar SJ; Corman SL; Smitherman T
[Ad] Endereço:Susan J. Skledar, B.S.Pharm., M.P.H., is Associate Professor, Department of Pharmacy & Therapeutics, University of Pittsburgh School of Pharmacy, and Clinical Pharmacy Specialist, Health System Formulary Management and Drug Use Policy, University of Pittsburgh Medical Center (UPMC), Pittsburgh, PA; at the time of the project described herein, she was Director, Drug Use and Disease State Management Program, UPMC-Presbyterian, Pittsburgh. Shelby L. Corman, Pharm.D., M.S., BCPS, is Senior Clinical Outcomes Scientist, Pharmerit International, Bethesda, MD; at the time of the project, he was Assistant Professor, Department of Pharmacy & Therapeutics, University of Pittsburgh School of Pharmacy, and Clinical Specialist, Drug Information, UPMC. Thomas Smitherman, M.D., is Professor of Medicine, Division of Cardiology, University of Pittsburgh School of Medicine, and Cardiologist, UPMC-Presbyterian. skledarsj@upmc.edu.
[Ti] Título:Addressing innovative off-label medication use at an academic medical center.
[So] Source:Am J Health Syst Pharm;72(6):469-77, 2015 Mar 15.
[Is] ISSN:1535-2900
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: A large hospital's systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described. SUMMARY: In 2003 the University of Pittsburgh Medical Center (UPMC)-Presbyterian implemented a policy that created a formal process for the systematic evaluation of formulary requests and drug-utilization patterns indicating or suggesting off-label use. Explicit criteria were developed for differentiating "innovative off-label use" (i.e., use based on a reasonable rationale yet lacking definitive scientific support in the form of fully published randomized controlled trials) from medication use more appropriately classified as clinical research. The UPMC-Presbyterian policy also outlined a process for the development, implementation, and evaluation of guidelines on innovative off-label use, including the collection of efficacy and safety outcomes. As of October 2012, 31 proposals for off-label medication use had been evaluated by the medical center's pharmacy and therapeutics committee and formulary subcommittee. Thirteen requests resulted in a determination of innovative off-label use and the development of prescribing guidelines, and 10 prompted the extension of an agent's current formulary status; in 6 cases, proposed off-label uses were determined to constitute clinical research. In some instances, innovative off-label medication use generated safety and outcomes data that led to changes in local standards of care. An algorithm to guide decision-making with regard to requests and proposals for off-label medication use is provided. CONCLUSION: The UPMC-Presbyterian experience indicates that off-label medication use can be effectively managed using evidence-based principles and peer review mechanisms.
[Mh] Termos MeSH primário: Medicina Baseada em Evidências
Uso Off-Label/normas
Serviço de Farmácia Hospitalar/organização & administração
[Mh] Termos MeSH secundário: Centros Médicos Acadêmicos
Algoritmos
Tomada de Decisões
Seres Humanos
Política Organizacional
Revisão por Pares
Comitê de Farmácia e Terapêutica
Guias de Prática Clínica como Assunto
Padrões de Prática Médica/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1511
[Cu] Atualização por classe:150304
[Lr] Data última revisão:
150304
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150305
[St] Status:MEDLINE
[do] DOI:10.2146/ajhp140306


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[PMID]:25550131
[Au] Autor:Anagnostis E
[Ad] Endereço:Thomas Jefferson University HospitalPhiladelphia, PAellena.anagnostis@jefferson.edu.
[Ti] Título:Writing meeting minutes for a pharmacy and therapeutics committee and its subcommittees.
[So] Source:Am J Health Syst Pharm;72(2):95-6, 98-9, 2015 Jan 15.
[Is] ISSN:1535-2900
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Formulários de Hospitais/normas
Comitê de Farmácia e Terapêutica/normas
Redação/normas
[Mh] Termos MeSH secundário: Seres Humanos
Relatório de Pesquisa/normas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1509
[Cu] Atualização por classe:141231
[Lr] Data última revisão:
141231
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150101
[St] Status:MEDLINE
[do] DOI:10.2146/ajhp130639


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[PMID]:25041043
[Au] Autor:Penm J; Chaar B; Moles R
[Ad] Endereço:Faculty of Pharmacy, World Hospital Pharmacy Research Consortium, The University of Sydney, Camperdown, New South Wales, Australia.
[Ti] Título:Hospital pharmacy services in the Pacific Island countries.
[So] Source:J Eval Clin Pract;21(1):51-6, 2015 Feb.
[Is] ISSN:1365-2753
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:RATIONALE, AIMS AND OBJECTIVES: Non-communicable diseases have become an increasing problem in the Pacific Island countries (PICs). With the medical supply system often attached to hospitals in PICs, the training of hospital pharmacy staff has become increasingly important. This study aimed to explore hospital pharmacy services in the PICs using these validated surveys (BS26-27 and BS28-31 surveys) focusing upon hospital pharmacists' influence on prescribing and quality use of medicines. METHOD: The BS26-27 and BS28-31 surveys were distributed online to pharmacy directors in hospitals in the PICs in 2011 and 2013, respectively. Surveys were made available in both English and French. RESULTS: In total, data from 55 hospitals were received (77% of the hospital sample in PICs) for either the BS26-27 or BS28-31 survey. From the responses received, 97% (36/37) of hospitals had a formulary, with 81% (26/32) of hospitals having a Pharmacy and Therapeutics (P&T) committee. Furthermore, 67% (24/36) of respondents stated that they provided some sort of clinical pharmacy service. On average, hospitals had two pharmacists involved in clinical pharmacy services. In BS28-31, over 75% (n=27) of respondents believed having a strong relationship with other health care professionals, having effective communication skills and taking professional responsibility for the medicines prescribed as 'mostly' or 'strongly' facilitating clinical services. CONCLUSIONS: Hospital pharmacists' participation on P&T committee and clinical services is common in the PICs. Such services enhance medication selection and reduce wastage. Although there are still too few hospital pharmacists in PICs, additional support aimed at enhancing their team building and communication skills will allow them to expand their roles and continue to improve patient health outcomes.
[Mh] Termos MeSH primário: Recursos Humanos em Hospital
Farmacêuticos/organização & administração
Serviço de Farmácia Hospitalar/organização & administração
Papel Profissional
[Mh] Termos MeSH secundário: Atitude do Pessoal de Saúde
Comunicação
Formulários de Hospitais
Seres Humanos
Relações Interprofissionais
Ilhas do Pacífico
Comitê de Farmácia e Terapêutica/estatística & dados numéricos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1511
[Cu] Atualização por classe:150226
[Lr] Data última revisão:
150226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140722
[St] Status:MEDLINE
[do] DOI:10.1111/jep.12227


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[PMID]:25453374
[Au] Autor:Sawabata N
[Ad] Endereço:General Thoracic Surgery, Hoshigaoka Medical Center, Japan Community Health Care Organization, 4-8-1 Hoshigaoka, Hirakata City, Osaka 573-8511, Japan; Osaka University Graduate School of Medicine, 2-7 Yamadaoka, Suita City, Osaka 565-0871, Japan. Electronic address: nsawabata@hoshigaoka-hp.com.
[Ti] Título:Prognosis of lung cancer patients in Japan according to data from the Japanese Joint Committee of Lung Cancer Registry.
[So] Source:Respir Investig;52(6):317-21, 2014 Nov.
[Is] ISSN:2212-5353
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:An organ-based lung cancer registry is currently maintained by the Japan Joint Committee of Lung Cancer Registry; this registry contributes to the development of lung cancer treatments and provides TNM classification data. In Japan, the overall 5-year survival rate has improved over time to 52% in 2004; the corresponding rates for each pathologic stage have also improved. Previously, separate registries were maintained for surgical and non-biased cases, whereas a prospective registry for non-surgical cases was added in 2012, and a follow-up examination of those data will be conducted in 2016. In addition, a registry of surgical cases from 2010 will be constructed in 2016. The information provided by these registries should better reveal the status of lung cancer patients in Japan.
[Mh] Termos MeSH primário: Neoplasias Pulmonares/cirurgia
Comitê de Farmácia e Terapêutica/organização & administração
Sistema de Registros
[Mh] Termos MeSH secundário: Idoso
Feminino
Seguimentos
Seres Humanos
Japão
Neoplasias Pulmonares/classificação
Neoplasias Pulmonares/mortalidade
Neoplasias Pulmonares/patologia
Masculino
Meia-Idade
Estadiamento de Neoplasias
Prognóstico
Taxa de Sobrevida
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1508
[Cu] Atualização por classe:141203
[Lr] Data última revisão:
141203
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141203
[St] Status:MEDLINE



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