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1.
Expert Opin Ther Pat ; 29(8): 653-662, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31298053

RESUMO

Introduction: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. Areas covered: The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. Expert opinion: The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Licenciamento/economia , Indústria Farmacêutica/economia , Equador , Acesso aos Serviços de Saúde , Humanos , Propriedade Intelectual , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução
3.
Ann Pharm Fr ; 77(3): 205-211, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30670298

RESUMO

OBJECTIVES: Many signs point to the growing importance of drug shortages in Canada and around the world. Although drug shortages affect clinicians and patients every day, there is a paucity of literature describing the specific problems experienced and their clinical consequences. To describe the drug shortage situation in Canada in 2016-2017 and to discuss this issue in the Canadian context. METHODS: This retrospective study was based on data from one Canadian wholesaler (McKesson Canada) and the official Drug Shortages Canada website. RESULTS: From August 31, 2016, to September 4, 2017, the McKesson database showed 583 drug shortages, averaging 160 (standard deviation [SD] 180) days, and the drug shortage website showed 2,129 shortages, averaging 118 (SD 113) days. Of these shortages, 26% in the McKesson database and 14% at the official drug shortage website were for parenteral products. In both the McKesson database and the Canadian drug shortage database, the leading drug classes with shortages were central nervous system drugs (26.4% and 31.8%, respectively), cardiovascular drugs (12.0% and 21.9%), anti-infective agents (11.2% and 8.5%), gastrointestinal drugs (7.9% and 6.2%) and antineoplastic agents (7.4% and 5.1%). CONCLUSIONS: This descriptive study highlights the high number of shortages in Canada in 2016-2017. The new federal regulation requiring declaration of drug shortages should lead to better monitoring of this problem at the national level. Although the causes of shortages are often identified, manufacturers and regulators are frequently unable to address or effectively prevent drug shortages.


Assuntos
Preparações Farmacêuticas/provisão & distribução , Canadá , Bases de Dados Factuais , Indústria Farmacêutica , Humanos , Legislação de Medicamentos , Estudos Retrospectivos
4.
Glob Public Health ; 14(1): 122-134, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29734843

RESUMO

When pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implications for attempting CL relevant for middle-income countries in the era of high-cost medicines. CL is not only a politically well-devised measure to achieve universal health coverage, but also a tentative commitment, which is determined both at the country level and at the global level. At the country level, political will, with catalytic roles of civil activism, is important in order to guarantee the right to health. Through this will, the governments can achieve universal health coverage. In addition, electoral systems, political leaders, and a constitution are necessary to attempt CL. In addition, CL should operate along with other policy instruments, including a comprehensive essential medicines list, CL-friendly phrasing in patent law, and a competent pharmaceutical industry. At the global level, the balance of power between the WTO regime and the global justice movement is critical. This provides global-level context that can either encourage or prevent CL.


Assuntos
Legislação de Medicamentos , Licenciamento , Brasil , Humanos , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução , Tailândia
5.
Cancer Treat Res ; 171: 75-92, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30552658

RESUMO

Drug shortages pose a significant public health concern in the United States, and cancer drugs are among those most affected. Shortages present serious safety risks for patients and substantial burden on providers and the healthcare system. Multifaceted drivers of this complex problem include manufacturing disruptions, raw material shortages, regulatory issues, market dynamics, and limited financial incentives that reward quality and production of off-patent drugs. Oncology drugs in short supply have resulted in substitution of less effective or more toxic alternatives, medication errors, and treatment delays, and are especially concerning for medications with no adequate substitute. Consequently, patient outcomes such as disease progression and survival have been adversely affected. Furthermore, emerging gray markets have contributed to cost-prohibitive markups and introduction of counterfeit products that compromise patient safety. The Food and Drug Administration plays a key role in preventing and managing pharmaceutical shortages, largely through regulations requiring early notification of manufacturing interruptions. Other proposed strategies similarly target upstream causes and center on reducing regulatory hurdles for manufacturers and increasing incentives for market entry and quality improvement. Despite progress in preventing supply disruptions, continued exploration of underlying systemic drivers remains critical to informing long-term solutions and alleviating the clinical and economic impact of drug shortages.


Assuntos
Indústria Farmacêutica/normas , Neoplasias/tratamento farmacológico , Preparações Farmacêuticas/provisão & distribução , Indústria Farmacêutica/estatística & dados numéricos , Recursos em Saúde/provisão & distribução , Humanos , Segurança do Paciente , Estados Unidos , United States Food and Drug Administration
9.
Value Health ; 21(5): 553-560, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29753352

RESUMO

BACKGROUND: The number of authorized orphan and non-orphan medicines for rare diseases has increased in Europe. Patient access to these medicines is affected by high costs, weak efficacy/safety evidence, and societal value. European health care systems must determine whether paying for expensive treatments for only a few patients is sustainable. OBJECTIVES: This study aimed to evaluate patient access to orphan and non-orphan medicines for rare diseases in 22 European countries during 2005 to 2014. METHODS: Medicines for rare diseases from the Orphanet list, authorized during 2005 to 2014, were searched for in the IMS MIDAS Quarterly Sales Data, January 2005 - December 2014 (IQVIA, Danbury, CT). The following three measures were determined for each country: number of available medicines, median time to continuous use, and medicine expenditure. A medicine was considered available if uninterrupted sales within a 1-year period were detected. RESULTS: From 2005 to 2014, 125 medicines were authorized and 112 were found in the search. Of those, between 70 (63%) and 102 (91%) were available in Germany, the United Kingdom, Italy, France, and the Scandinavian countries. These countries were also the fastest to enable continuous use (3-9 mo). Only 27% to 38% of authorized medicines were available in Greece, Ireland, Bulgaria, Romania, and Croatia, which took 1 to 2.6 years to begin continuous use. A country's expenditure on medicines for rare diseases in 2014 ranged between €0.2 and €31.9/inhabitant. CONCLUSIONS: Patient access to medicines for rare diseases varies largely across Europe. Patients in Germany, Scandinavian countries, Switzerland, France, and the United Kingdom can access larger numbers of medicines in shorter time.


Assuntos
Custos de Medicamentos , Acesso aos Serviços de Saúde/economia , Produção de Droga sem Interesse Comercial/economia , Preparações Farmacêuticas/provisão & distribução , Doenças Raras/economia , Europa (Continente) , Acesso aos Serviços de Saúde/normas , Humanos , Preparações Farmacêuticas/economia , Doenças Raras/tratamento farmacológico
10.
Drug Discov Today ; 23(8): 1547-1555, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29803932

RESUMO

The pharmaceutical industry stands on the brink of a revolution, calling for the recognition and embracement of novel techniques. 3D printing (3DP) is forecast to reshape the way in which drugs are designed, manufactured, and used. Although a clear trend towards personalised fabrication is perceived, here we accentuate the merits and shortcomings of each technology, providing insights into aspects such as the efficiency of production, global supply, and logistics. Contemporary opportunities for 3DP in drug discovery and pharmaceutical development and manufacturing are unveiled, offering a forward-looking view on its potential uses as a digitised tool for personalised dispensing of drugs.


Assuntos
Descoberta de Drogas/métodos , Preparações Farmacêuticas/síntese química , Impressão Tridimensional , Animais , Composição de Medicamentos , Humanos , Estrutura Molecular , Preparações Farmacêuticas/provisão & distribução , Relação Estrutura-Atividade
13.
Int J Qual Health Care ; 30(6): 472-479, 2018 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-29617833

RESUMO

Objective: Examine the relationship between patients' perceptions of quality and the objective level of quality at government health facilities, and determine whether the pre-existing attitudes and beliefs of patients regarding health services interfere with their ability to accurately assess quality of care. Design: Cross-sectional, visit-level analysis. Setting: Three regions (Nord-Ubangi, Kasai/Kasai-Central and Maniema/Tshopo) of the Democratic Republic of Congo. Participants: Data related to the inpatient and outpatient visits to government health facilities made by all household members who were included in the survey was used for the analysis. Data were collected from patients and the facilities they visited. Main Outcome Measures: Patients' perceptions of the level of quality related to availability of drugs and equipment; patient-centeredness and safety serve compared with objective measures of quality. Results: Objective measures and patient perceptions of the drug supply were positively associated (ß = 0.16, 95% CI = 0.03, 0.28) and of safety were negatively associated (ß = -0.12, 95% CI = -0.23, -0.01). Several environmental factors including facility type, region and rural/peri-urban setting were found to be significantly associated with respondents' perceptions of quality across multiple outcomes. Conclusions: Overall, patients are not particularly accurate in their assessments of quality because their perceptions are impacted by their expectations and prior experience. Future research should examine whether improving patients' knowledge of what they should expect from health services, and the transparency of the facility's quality data can be a strategy for improving the accuracy of patients' assessments of the quality of the health services, particularly in low-resourced settings.


Assuntos
Hospitais Públicos/normas , Satisfação do Paciente , Qualidade da Assistência à Saúde/estatística & dados numéricos , Estudos Transversais , República Democrática do Congo , Equipamentos e Provisões Hospitalares/provisão & distribução , Humanos , Pacientes Internados/estatística & dados numéricos , Pacientes Ambulatoriais/estatística & dados numéricos , Segurança do Paciente/estatística & dados numéricos , Assistência Centrada no Paciente/estatística & dados numéricos , Preparações Farmacêuticas/provisão & distribução , Qualidade da Assistência à Saúde/economia , Inquéritos e Questionários
15.
BMC Health Serv Res ; 18(1): 218, 2018 03 27.
Artigo em Inglês | MEDLINE | ID: mdl-29587742

RESUMO

BACKGROUND: This study aimed to examine the availability, use, and affordability of medicines in urban China following the 2009 Health Care System Reform that included implementation of universal health coverage (UHC). METHODS: This longitudinal study was performed in Hangzhou (high income, eastern China) and Baoji (lower income, western China). Five yearly household surveys were conducted (one each year from 2009 to 2013) to evaluate the impact of UHC on medicines use and expenditure, and a health facility survey was conducted in 2013 to evaluate availability of medicines. A cohort of over 800 households in Hangzhou and Baoji was established in 2009, and 20 hospitals were included in the health facility survey. Medicines use was determined using data from health facility and household surveys. An average, two-week out-of-pocket medicines expenditure was calculated to assess the affordability of medicines. RESULTS: The number of medicines stocked in primary health facilities in Hangzhou decreased, while the number in Baoji increased. In Baoji, patients usually chose a pharmacy to buy medicines directly, despite the 48.2% increased availability of essential medicines in primary health care centers. The majority of survey respondents stated that their medicines need was basically met; however, medicines cost still accounted for a major part of their health expenditure. Medicines expenditure showed an increasing trend from 2009 to 2013. The average annual growth rate of household overall medical expenditure was significantly higher than that for household non-food consumption expenditure. CONCLUSIONS: Following China's Health Care System Reform and implementation of UHC, availability and use of medicines has improved in urban areas. However, the affordability of medicines is still a concern.


Assuntos
Tratamento Farmacológico/estatística & dados numéricos , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução , Cobertura Universal do Seguro de Saúde , População Urbana , China , Medicamentos de Ervas Chinesas , Medicamentos Essenciais/economia , Medicamentos Essenciais/provisão & distribução , Pesquisa Empírica , Reforma dos Serviços de Saúde , Pesquisas sobre Serviços de Saúde , Gastos em Saúde/estatística & dados numéricos , Humanos , Renda/estatística & dados numéricos , Estudos Longitudinais , Farmácias , Atenção Primária à Saúde
16.
BMC Public Health ; 18(1): 368, 2018 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-29554885

RESUMO

BACKGROUND: Utilization of Antenatal Care (ANC) is very low in Nigeria. Self-reported patient satisfaction may be useful to identify provider- and facility-specific factors that can be improved to increase ANC satisfaction and utilization. METHODS: Exit interview data collected from ANC users and facility assessment survey data from 534 systematically selected facilities in four northern Nigerian states were used. Associations between patient satisfaction (satisfied, not-satisfied) and patient ratings of the provider's interactions, care processes, out-of-pocket costs, and quality of facility infrastructure were studied. RESULTS: Of 1336 mothers, 90% were satisfied with ANC. Patient satisfaction was positively associated with responsive service (prompt, unrushed service, convenient clinic hours and privacy during consultation, AOR 2.42, 95% CI 2.05-2.87), treatment-facilitation (medical care-related provider communication and ease of receiving medicines, AOR 2.03, 95% CI 1.46-2.80), equipment availability (AOR 1.10, 95% CI 1.01-1.21), staff empathy (AOR 1.82, 95% CI 1.03-3.23), non-discriminatory treatment regardless of patient's socioeconomic status (AOR: 1.87, 95% CI 1.09-3.22), provider assurance (courtesy and patient's confidence in provider's competence, AOR 1.48, 95% CI 1.26-1.75), and number of clinical examinations received (AOR 1.28, 95% CI 1.10-1.50). ANC satisfaction was negatively impacted by out-of-pocket payment for care (vs. free care, AOR 0.44, 95% CI 0.23-0.82). CONCLUSIONS: ANC satisfaction in Nigeria may be enhanced by improving responsiveness to clients, clinical care quality, ensuring equipment availability, optimizing easy access to medicines, and expanding free ANC services.


Assuntos
Mães/psicologia , Satisfação do Paciente/estatística & dados numéricos , Cuidado Pré-Natal , Adulto , Comunicação , Estudos Transversais , Equipamentos e Provisões/provisão & distribução , Feminino , Pesquisas sobre Serviços de Saúde , Gastos em Saúde/estatística & dados numéricos , Humanos , Mães/estatística & dados numéricos , Nigéria , Preparações Farmacêuticas/provisão & distribução , Relações Médico-Paciente , Gravidez , Cuidado Pré-Natal/economia , Cuidado Pré-Natal/organização & administração , Cuidado Pré-Natal/estatística & dados numéricos , Qualidade da Assistência à Saúde , Adulto Jovem
17.
BMC Health Serv Res ; 18(1): 125, 2018 02 20.
Artigo em Inglês | MEDLINE | ID: mdl-29458428

RESUMO

BACKGROUND: Despite recent reforms, distorting funding mechanisms and over-prescribing still maintain severe financial barriers to medicines access in China. Complicated and interrelated problems in the pharmaceutical sector require a common framework to be resolved as fragmented solutions do not work. We present a preliminary assessment of the impact of the national healthcare reforms on access to medicines, and propose policy recommendations for promoting universal access to medicines in China. METHODS: Drawing on multiple sources of information, including a review of published literatures and official national data, field investigations in six provinces and interviews with key opinion leaders, this paper presents a preliminary assessment of the impact of the national healthcare reforms on access to medicines, and proposes policy recommendations for promoting universal access to medicines in China. RESULTS: Public expenditure on medicines has been strictly controlled since the national healthcare reforms of 2009. Yet total pharmaceutical expenditure (TPE) and total health expenditure growth rates continuously outpaced the growth of gross domestic product (GDP). With 2.4% of GDP, TPE now exceeds that of most high income countries. The distorted provider and consumer incentives in the Chinese health system have not fundamentally changed. Price-setting and reimbursement mechanisms do not promote cost-effective use of medicines. Inappropriate price controls and perverse financial incentives are the un-resolved root causes of preference of originator brands for some major diseases and shortages of low-cost and low-consumption medicines. In addition, access to expensive life-saving medicines is yet systematically addressed. CONCLUSIONS: The complicated and interdependent problems interact in a way that leads to significant system problems in China, which create dual challenges that both the developing country and the developed countries are facing. To further promote access to medicines, China should speed up the re-assessment of the quality and efficacy of domestically produced generic medicines; coordinate various reforms of price determination, insurance payments, and procurement policies; address medicine shortages through comprehensive policies and legislation; establish specific mechanisms to achieve sustainable equitable access to expensive essential medicines with health technology assessment as a tool to ensure that policy and priority setting are created in a coherent and evidence-based way.


Assuntos
Reforma dos Serviços de Saúde , Acesso aos Serviços de Saúde/organização & administração , Preparações Farmacêuticas/provisão & distribução , China , Custos de Medicamentos , Gastos em Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde , Humanos , Preparações Farmacêuticas/economia
18.
Int Health ; 10(2): 133-136, 2018 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-29401248

RESUMO

Background: Donation of returned medicines is a debated health policy issue as it is discouraged by WHO, but accepted in some countries. Methods: Lessons learned from a donation programme of returned medicines carried out in Europe were documented. Results: The donation programme we reviewed followed a strict protocol for collection, sorting and distribution of returned drugs, in order to avoid the major limitations associated with unused medicine donations. Over a period of 3 years, 23 145 boxes of medicines were donated to 14 organizations operating in Europe, Africa and Latin America. Conclusions: The donations covered about one-third of the volume of medicines used by beneficiary organizations. The programme helped to decrease expenditure by both patients and health facilities.


Assuntos
Cooperação Internacional , Preparações Farmacêuticas , África , Europa (Continente) , Gastos em Saúde/estatística & dados numéricos , Humanos , América Latina , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução , Avaliação de Programas e Projetos de Saúde
19.
PLoS One ; 13(2): e0191778, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29401474

RESUMO

BACKGROUND: Accessibility and affordability of evidence-based medicines are issues of global concern. For low-income countries like Nepal, it is crucial to have easy and reliable access to affordable, good-quality, evidence-based medicines, especially in the aftermath of natural or manmade disasters. Availability of affordable and evidence-based high quality medicines depends on the medicine procurement procedure, which makes it an important aspect of healthcare delivery. In this study, we aimed to investigate medicine procurement practices in hospital pharmacies of Nepal within the framework of International Pharmaceutical Federation [FIP] hospital pharmacy guidelines "the Basel Statements". METHOD: We conducted semi-structured interviews with hospital pharmacists or procurement officers in hospital pharmacies of four major regions in Nepal to explore procurement practices. Data were collected until saturation of themes, analysed using the framework approach, and organised around the statements within the procurement theme of the Basel Statements. RESULTS: Interviews conducted with 53 participants revealed that the procurement guidelines of the Basel Statements were adopted to a certain extent in hospital pharmacies of Nepal. It was found that the majority of hospital pharmacies in Nepal reported using an expensive direct-procurement model for purchasing medicines. Most had no formulary and procured medicines solely based on doctors' prescriptions, which were heavily influenced by pharmaceutical companies' marketing strategies. Whilst most procured only registered medicines, a minority reported purchasing unregistered medicines through unauthorised supply-chains. And although the majority of hospital pharmacies had some contingency plans for managing medicine shortages, a few had none. CONCLUSIONS: Procurement guidelines of the Basel Statements were thus found to be partially adopted; however, there is room for improvement in current procurement practices in hospital pharmacies of Nepal. Adoption and regulation of national and international policies is recommended for enhancing medicine accessibility, as well as improving preparedness for health emergencies during natural disasters and health epidemics.


Assuntos
Preparações Farmacêuticas/provisão & distribução , Serviço de Farmácia Hospitalar/organização & administração , Humanos , Nepal , Pesquisa Qualitativa
20.
BMC Pregnancy Childbirth ; 18(1): 44, 2018 01 30.
Artigo em Inglês | MEDLINE | ID: mdl-29382306

RESUMO

BACKGROUND: The high level of maternal mortality and morbidity as a result of complications due to childbirth is unacceptable. The impact of quality medicines in the management of these complications cannot be overemphasized. Most of those medicines are sensitive to environmental conditions and must be handled properly. In this study, the quality of oxytocin injection, misoprostol tablets, magnesium sulfate, and calcium gluconate injections was assessed across the six geopolitical zones of Nigeria. METHOD: Simple, stratified random sampling of health facilities in each of the political zones of Nigeria. Analysis for identification and content of active pharmaceutical ingredient was performed using high-performance liquid chromatography procedures of 159 samples of oxytocin injection and 166 samples of misoprostol tablets. Titrimetric methods were used to analyze 164 samples of magnesium sulfate and 148 samples of calcium gluconate injection. Other tests included sterility, pH measurement, and fill volume. RESULTS: Samples of these commodities were procured mainly from wholesale and retail pharmacies, where these were readily available, while the federal medical centers reported low availability. Approximately, 74.2% of oxytocin injection samples failed the assay test, with the northeast and southeast zones registering the highest failure rates. Misoprostol tablets recorded a percentage failure of 33.7%. Magnesium sulfate and Calcium gluconate injection samples recorded a failure rate of 6.8% and 2.4%, respectively. CONCLUSION: The prevalence of particularly of oxytocin and misoprostol commodities was of substandard quality. Strengthening the supply chain of these important medicines is paramount to ensuring their effectiveness in reducing maternal deaths in Nigeria.


Assuntos
Ocitócicos/normas , Preparações Farmacêuticas/normas , Controle de Qualidade , Tocolíticos/normas , Gluconato de Cálcio/normas , Gluconato de Cálcio/provisão & distribução , Parto Obstétrico/normas , Feminino , Humanos , Sulfato de Magnésio/normas , Sulfato de Magnésio/provisão & distribução , Misoprostol/normas , Misoprostol/provisão & distribução , Nigéria , Ocitócicos/provisão & distribução , Ocitocina/normas , Ocitocina/provisão & distribução , Preparações Farmacêuticas/provisão & distribução , Farmácias/normas , Gravidez , Tocolíticos/provisão & distribução
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