Yegnaneh Anley, Yeniewa Kerie Anagaw, Fasika Mekete Alemu
et al.
Local pharmaceutical production reduces dependency on imports. It also strengthens country-based medicine supply. In Ethiopia, there are government policies in place that aim to support local manufacturers. However, most of them operate below capacity, supplying only 15-20% of national pharmaceutical needs. This study assessed internal, external, and production-related factors that influence the productivity and competitive performance of local pharmaceutical manufacturing companies. A mixed concurrent triangulation design was conducted from October 2021 to February 2022. Quantitative data were collected from 40 employees across ten local manufacturers, while qualitative data were obtained through 29 key informant interviews with representatives from manufacturers, the Ethiopian Food and Drug Authority (EFDA), the Food, Beverage, Pharmaceuticals Industry Development Institute (FBPIDI), and the Ethiopian Pharmaceuticals and Medical Supplies Manufacturing Association (EPMSMA). Quantitative data were analyzed using SPSS version 25, and qualitative data were analyzed thematically. Internal factors, including material handling (β = 0.57, P < 0.036) and production planning and machine maintenance (β = 0.16, P < 0.047), were significantly associated with manufacturing performance. Among external factors, policy and economic conditions (β = -0.07, P < 0.042) significantly affected performance. Only three manufacturers fully complied with cGMP standards. Most government policies designed to support local production were not yet implemented, resulting in underutilization of capacity (<50%). The major challenges are limited foreign currency, technology transfer hurdles, shortage of qualified personnel, raw materials inadequacy and tax policies favoring imports. Both internal and external factors significantly influence the performance of local pharmaceutical manufacturers. Although government policy directions exist to support them, incomplete implementation limits their impact.
The Pakistani pharmaceutical industry cannot ignore the contribution of pharmaceutical multinational corporations (MNCs) in terms of innovation and access to advanced treatments. The sale of a pharmaceutical manufacturing plant by an MNC to a Pakistani company has again sparked a debate on why MNCs are closing manufacturing operations in the country. National firms are currently giving MNCs a tough time in Pakistan. Besides competition, MNCs face mergers and acquisitions that hinder the expansion of existing facilities. In the recent past, there has been a noticeable shift in the market shares of multinational corporations (MNCs) and local companies. The market share of national firms has gradually increased, reaching 74.51%, while the market share of MNCs has decreased, falling to 25.49%. These local companies have increasingly partnered with foreign companies through joint ventures, which has had a positive impact on their growth and market share. Nevertheless, the federal government recently deregulated prices for non-essential medicines, so it is expected that MNCs will show their commitment to Pakistan by investing in the country. Investing in new molecules and infrastructure is necessary for MNCs in order to maintain their position in the market. Infrastructure investment is crucial for the smooth operation of pharmaceutical firms. This includes the construction of state-of-the-art manufacturing facilities, the establishment of research and development centres, and the upgrading of technology.
Therapeutics. Pharmacology, Pharmacy and materia medica
Davi Carvalho Medeiros, Érika Maria Henriques Monteiro, Igor Rosa Meurer
et al.
Introdução
O avanço da ciência permitiu que, em alguns anos, o uso de antirretrovirais (ARVs) reduzisse o índice de mortalidade relacionado à doença e ampliasse a qualidade de vida dos indivíduos acometidos pelo HIV. Apesar dos inúmeros progressos neste sentido, existe atualmente uma baixa quantidade de pesquisas voltadas à uma análise mais aprofundada sobre a aprovação de ARVs no mundo. Embora o escopo do que se categorizava como “tecnologia de saúde” fosse amplo, a ATS aglutinou sua atenção inicial às tecnologias de produtos, como medicamentos, materiais e equipamentos. Traçando uma trajetória ao longo das últimas décadas, a ATS expandiu sua presença e visibilidade, transcendendo o velho continente para ecoar nos rincões globais fomentando ainda mais as nações em desenvolvimento. O Objetivo deste estudo foi avaliar o impacto orçamentário em um cenário global de aprovações dos ARVs para tratamento do HIV.
Métodos
Trata-se de um estudo de impacto orçamentário proveniente da base de dados de um estudo ecológico do cenário global de tratamento de HIV com ARVs. Foram considerados os custos diretos do medicamento para tratamento de HIV/AIDS seguindo o esquema terapêutico estabelecido pelos protocolos em cada região/país analisados: Brasil, Estados Unidos, Europa e Austrália. Os custos foram obtidos pela Câmara de Regulação do mercado de medicamentos (CMED) para o Brasil, a Base de données publique des médicaments para a Europa, simbolizando toda a União Europeia, para a Austrália foi utilizado instituições como a Pharmaceutical Benefits Scheme (PBS) e Australasian Socirty for HIV, Viral Hepatitis, and Sexual Health Medicine (ASHM). A análise de sensibilidade do IO foi realizada para 10.000 interações na simulação de Monte Carlo, pelo microssoft Excel® com Addin @Risk v8.05 da Palisade Corporation®.
Resultados
Foi verificado os custos médios direto para Austrália R$ 20.012,15 (IC95%, 10.006,08 - 30.018,23) em torno (0,333 - 1,001) por paciente em uma população de 30.000 contaminados; Brasil R$ 47.415,98 (IC 95%, 23.707,99 - 71.123,97) cerca de (0,028 - 0,085) por paciente em uma população de 841.000 contaminados; Estados Unidos R$ 39.204,73 (IC95%,19.602,36 - 58.807,09) aproximadamente (0,019 - 0,057) por paciente em um total de 1.031.191 contaminados.; Europa R$ 21.678,00 (IC95%, 10.839,00 - 32.517,00) cerca de (0,004 - 0,012) por paciente em um total de 2.800.000 contaminados. A avaliação do impacto orçamentário está em construção, a ser considerado para isso prevalência da doença, as demandas reprimidas e taxa de letalidade.
Discussões e conclusões
Conclui-se que, dos diferentes protocolos que regem o tratamento, os EUA foi o país que mais teve novas tecnologia incorporadas, havendo maior custo médio para o Brasil e menor para a Austrália. Contudo, a análise dos dados farmacoeconômicos e epidemiológicos das diferentes regiões oferece informações valiosas para a tomada de decisões em prol da ATS no tratamento do HIV. Esses dados destacam a importância da alocação eficaz de recursos, a necessidade de equilibrar custos e efetividade, e a urgência de abordar desigualdades na cobertura de acesso. Ao melhorar o acesso, enfatizar a prevenção e adotar uma abordagem baseada em evidências, é possível otimizar o impacto orçamentário e alcançar resultados mais eficazes no controle do HIV.
Pharmacy and materia medica, Pharmaceutical industry
Franciane Souza Guedes, Margareth Hamdan Melo Coelho, Lilia Maria Caldas Embiruçu
et al.
A terapia inalatória tem papel central no tratamento da doença pulmonar obstrutiva crônica (DPOC). O manejo correto dos dispositivos inalatórios é fundamental para deposição pulmonar eficiente dos agentes farmacológicos, e consequentemente, para a efetividade do tratamento da doença.1,2 Entretanto, muitos pacientes podem não utilizar corretamente os inaladores. A técnica inalatória incorreta é associada a desfechos negativos, pior qualidade de vida e maior utilização dos recursos de saúde em pacientes com DPOC.1-4 Dados sobre o manuseio dos dispositivos inalatórios entre indivíduos com DPOC são escassos em nosso meio, sobretudo, no contexto da prática clínica. O objetivo do estudo foi avaliar o domínio da técnica entre pacientes com DPOC grave em uso de dois diferentes dispositivos inalatórios (Respimat® e Diskus®).
Pharmacy and materia medica, Pharmaceutical industry
This study presents a proposal to build and analyze a domain ontology as a tool to support the knowledge transfer process in the context of software requirements analysis in the medical/pharmaceutical industry. The proposal is to use ontologies as an engineering artifact with the objective of representing knowledge in a specific domain, which, in the context of this research, is software modeling. A domain ontology is built to represent the requirements of a data warehouse/business intelligence software in the medical/pharmaceutical industry. The ontology-building process is supported by a specific methodology, defined with the purpose of building such artifacts, named "Methondology," and selected based on the research requirements. A prototype is created in the implementation phase of the ontology-building process. The results demonstrate that ontology domains can contribute to the process of analyzing and representing software requirements, as well as serving as a tool for organizational knowledge transfer through continuous knowledge conversion, which is critical for business sustainability. This study is an attempt to understand the knowledge conversion process in software development projects. Tacit knowledge is complex to articulate through formal language once it has been embedded with individual experience.
Pharmaceutical industry owing to the social importance of the made production, high extent of state regulation of the branch market, knowledge intensity of production and investment attractiveness of business holds a specific place in the economic system of the country. The importance of her development in national economy is caused, first of all, by need of a solution of the problem of health of the population, social stability for society for modern conditions. The conclusion is drawn that a tendency of the Russian pharmaceutical industry is annually increasing dependence of the country on import of ready medicines in recent years.
Leucine dehydrogenase (LDH) is a NAD+-dependent oxidoreductase, which can selectively catalyze α-keto acids to obtain α-amino acids and their derivatives. It plays a key role in the biosynthesis of L-tert-leucine (L-Tle). As a non-naturally chiral amino acid, L-Tle can be used as an animal feed additive, nutrition fortifier, which is a perspective and important building block in the pharmaceutical, cosmetic, and food additive industry. In this study, four hypothetical leucine dehydrogenases were discovered by using genome mining technology, using the highly active leucine dehydrogenase LsLeuDH as a probe. These four leucine dehydrogenases were expressed in Escherichia coli BL21(DE3), respectively, and purified to homogeneity and characterized. Compared with the other enzymes, the specific activity of PfLeuDH also shows stronger advantage. In addition, the highly selective biosynthesis of L-Tle from trimethylpyruvic acid (TMP) was successfully carried out by whole-cell catalysis using engineered E. coli cells as biocatalyst, which can efficiently coexpress leucine dehydrogenase and formate dehydrogenase. One hundred-millimolar TMP was catalyzed for 25 h, and the yield and space-time yield of L-Tle reached 87.38% (e.e. >99.99%) and 10.90 g L–1 day–1. In short, this research has initially achieved the biosynthesis of L-Tle, laying a solid foundation for the realization of low-cost and large-scale biosynthesis of L-Tle.
Calcium-type montmorillonite, a phyllosilicate mineral, has diverse health benefits when introduced into the gastrointestinal tract or applied to the skin. However, the predominant use of this layered material has thus far been in traditional industries, despite its potential application in the pharmaceutical industry. We investigated the effects and mechanism of nano-montmorillonite (NM) on osteoblast and osteoclast differentiation in vivo and in vitro. We examined the osteogenic effects of NM with high calcium content (3.66 wt%) on alkaline phosphatase (ALP) activity, mineralization, bone microarchitecture, and expression level of osteoblast and osteoclast related genes in Ca-deficient ovariectomized (OVX) rats. Micro-computed tomography of OVX rats revealed that NM attenuated the low-Ca-associated changes in trabecular and cortical bone mineral density. It improved ALP activity and mineralization, as well as the expression of osteoblast and osteoclast differentiation associated genes. NM also activated the expression of runt-related transcription factor 2, osteocalcin, bone morphogenetic protein 2, and type 1 collagen via phosphorylated small mothers against decapentaplegic homolog 1/5/8 signaling. Further, NM repressed the expression of receptor activator for cathepsin K, nuclear factor kappa-B ligand and tartrate-resistant acid phosphatase. Therefore, NM inhibits osteoclastogenesis, stimulates osteoblastogenesis, and alleviates osteoporosis.
Marta Lomazzi, Michael Moore, April Johnson
et al.
Abstract Background When microorganisms (such as bacteria or viruses) are highly exposed to antimicrobial drugs, they can develop the capacity to defeat the drugs designed to eradicate them. Long-term accumulation of adaptations to survive drug exposure can lead to the development of antimicrobial resistance (AMR). The success of antibiotics has led to their widespread overuse and misuse in humans, animals and plants. Main text AMR is a global concern and solutions are not vertical actions in a single buy business model. Even if a transectoral approach is key, there is a lack of multi-disciplinary partnerships that allow for strategic cooperation between different sectors such as the pharmaceutical industry, agro-alimentary complex, patient care and education, NGOs and research and development. Global public health voices should lead this integration to align the progress of existing AMR successes. Maintaining the public’s trust in preventive medicine, health systems and food production safety, together with public health driven, non-profit drug development, is a key factor. In its “Call for integrated action on AMR”, signed by about 70 national and international organizations the World Federation of Public Health Associations (WFPHA) called “on all governments, the private sector, non-governmental organizations, health professionals, public and private research organizations, and all stakeholders to ensure that public health remains at the centre of all policy and scientific endeavours in the field of antimicrobial resistance”. Conclusions The “Global Charter for the Public’s Health”, developed by the WFPHA in association with WHO, is proposed in this article as a tool for implementation of complex public health actions such as AMR.
Vesela R. Veleva, Berkeley W. Cue, Svetlana Todorova
et al.
This paper provides the first benchmarking study of green chemistry (GC) adoption by the Indian pharmaceutical supply chain based on information from industry representatives leading such efforts. Results demonstrate that generic drug pharma and Active Pharmaceutical Ingredients (API) manufacturers in India exhibit significant interest and some advances in using GC principles. At the same time, majority (65%) of Indian companies rely on treatment and disposal of waste water instead of source reduction and one in five (20%) does not use any GC metrics. The study found that generic pharma is more advanced in adopting GC principles than API manufacturers. Regulatory risk and time pressures to deliver drugs were reported as the two most significant barriers for greater adoption of GC in India, while cost savings and environmental regulations were cited as the top two drivers. The paper concludes with some recommendations for advancing GC adoption in India.
Siritree Suttajit,1 Puckwipa Suwannaprom,1 Teeraporn Supapaan,2 Suntara Eakanunkul,3 Mayuree Tangkiatkumjai,4 Chuenjid Kongkaew,5 Claire Anderson,6 Payom Wongpoowarak7 1Department of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand; 2Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ubon Ratchathani University, Ubon Ratchathani, Thailand; 3Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand; 4Department of Clinical Pharmacy, Faculty of Pharmacy, Srinakharinwirot University, Nakhon Nayok, Thailand; 5Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; 6Division of Pharmacy Practice and Policy, School of Pharmacy, University of Nottingham, Nottingham, UK; 7Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand Purpose: To serve the higher demands of pharmaceutical services, pharmacy education in Thailand has shifted from 5-year BPharm program to 6-year PharmD program with two specialization tracks: pharmaceutical care (PC) and industrial pharmacy (IP). This study aimed to compare the perceptions regarding professional competencies, pharmacy profession, and planned workplace between graduates with 5-year BPharm and 6-year PharmD and between those with PC and IP specialty. Methods: A cross-sectional national survey using a paper–pencil self-administered questionnaire was distributed to all new graduates attending the pharmacy licensure examination in March 2015. Results: Of all 1,937 questionnaires distributed, 1,744 were returned and completed (90% response rate). Pharmacy graduates rated highest on their competencies in professional ethics, followed by PC services and system management. They rated low confidence in medication selection procurement and pharmaceutical industry competencies. The 6-year PharmD graduates showed higher confidence in ethics and professional pride than the 5-year BPharm graduates. Graduates with PC specialty rated higher perceived competency in PC, system management, primary care, and consumer protection domains, while the IP graduates were superior in IP and medication selection and procurement domains, and most graduates (PC and IP) intended to work mainly in a hospital or a community pharmacy. Hospital was preferred for the PC graduates, and the IP graduates were more likely to work in pharmaceutical industry, regulation and consumer protection, sales and marketing, and academia. Conclusion: With some gaps still to be filled, the transition from 5-year BPharm to 6-year PharmD program with specialty tracks gave extra confidence to graduates in their specialty competencies and professional pride, leading to differences in preferred workplace. The findings of this study reflect that Thai pharmacy education continues to adjust to the needs of the society and the changing health care environments. Longitudinal monitoring to observe this transition is needed for both curriculum adjustment and competency of the graduates. Keywords: attitude, pharmacy education, PharmD curriculum, competency, transition, Thailand
At the global level, there are many challenges and opportunities for pharmaceutical personnel (professionals, technologists and technicians), mainly for those working at the outpatient pharmacies (Pharmaceutical Retail Establishments, in the context of the Colombian health system). Overall, Colombian outpatient pharmacies have limited their activities to selling medicines, while the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) have promoted their evolution toward a more patient-oriented practice. This focusing ranges from the procurement and supplying of medicines to pharmaceutical care services, oriented to ensure the best treatment for patients. Therefore, outpatient pharmacies play an important role in the improvement of pharmacotherapy and patient outcomes, promoting rational use of medicines and reducing healthcare costs. This kind of results have been gradually demonstrated in other countries. In that way, in Colombia there is a considerable need to create outpatient pharmacies which allow us improve outcomes for patients care, increase access to healthcare system care (specially for vulnerable populations) and, to provide specific-medication tools for reach successful therapies. By including patient education, it is possible to ensure the best health outcomes, to improve patient satisfaction and to enhance cost‐effectiveness relationship.
Food processing and manufacture, Pharmaceutical industry
Polycaprolactone (PCL) is a biodegradable synthetic polymer that is currently widely used in many pharmaceutical and medical applications. In this paper we describe the coordination ring-opening polymerization of ε-caprolactone in the presence of two newly synthesized catalytic systems: diethylzinc/gallic acid and diethylzinc/propyl gallate. The chemical structures of the obtained PCLs were characterized by 1H- or 13C-NMR, FTIR spectroscopy and MALDI TOF mass spectrometry. The average molecular weight of the resulting polyesters was analysed by gel permeation chromatography and a viscosity method. The effects of temperature, reaction time and type of catalytic system on the polymerization process were examined. Linear PCLs with defined average molecular weight were successfully obtained. Importantly, in some cases the presence of macrocyclic products was not observed during the polymerization process. This study provides an effective method for the synthesis of biodegradable polyesters for medical and pharmaceutical applications due to the fact that gallic acid/propyl gallate are commonly used in the pharmaceutical industry.
Ana Cláudia Elias Pião Benedetti, Eliana Dantas da Costa, Caio Casale Aragon
et al.
A strain of the filamentous fungus Aspergillus niger was isolated and shown to possess extracellular xylanolytic activity. These enzymes have biotechnological potential and can be employed in various industries. This fungus produced its highest xylanase activity in a medium made up of 0.1% CaCO3, 0.5% NaCl, 0.1% NH4Cl, 0.5% corn steep liquor and 1% carbon source, at pH 8.0. A lowcost hemicellulose residue (powdered corncob) proved to be an excellent inducer of the A. niger xylanolytic complex. Filtration of the crude culture medium with suspended kaolin was ideal for to clarify the extract and led to partial purification of the xylanolytic activity. The apparent molecular mass of the xylanase was about 32.3 kDa. Maximum enzyme activity occurred at pH 5.0 and 55-60ºC. Apparent Km was 10.41 ± 0.282 mg/mL and V max was 3.32 ± 0.053 U/mg protein, with birchwood xylan as the substrate. Activation energy was 4.55 kcal/mol and half-life of the crude enzyme at 60ºC was 30 minutes. Addition of 2% glucose to the culture medium supplemented with xylan repressed xylanase production, but in the presence of xylose the enzyme production was not affected.
Pharmaceutical industry, Pharmacy and materia medica