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1.
J Food Sci ; 84(9): 2499-2506, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31393020

RESUMO

As many of the maternal and child health complications result from folic acid, iron, and iodine deficiencies; it makes sense to combat these simultaneously. We have developed cost-effective technology to deliver these three micronutrients simultaneously through salt. Our goal was to retain at least 70% of the micronutrients during 6 months of storage. The fortified salt was formulated by spraying a solution that contained 2% iodine and 0.5% or 1% folic acid onto salt and adding encapsulated ferrous fumarate. The formulated triple fortified salt contained 1,000 ppm iron, 50 ppm iodine, and 12.5 or 25 ppm folic acid. The spray solution and the salt were stored for 2 and 6 months respectively at 25, 35, and 45 °C 60 to 70% relative humidity. Even at 45 °C, over 70% of both iodine and folic acid were retained in the salt. The best formulation based on the color of the salt and stability of iodine and folic acid contained 12.5 ppm folic acid, 50 ppm iodine, and 1,000 ppm iron. These results indicate that iron, iodine, and folic acid can be simultaneously delivered to a vulnerable population through salt using the technology described. Also, the quality control of the process can be developed around pteroic acid that was detected as a primary degradation product of folic acid. PRACTICAL APPLICATION: The technology developed is already transferred to India for industrial scale up. When fully operational, the technology will simultaneously solve iron, iodine, and folic acid deficiencies in vulnerable populations at a very low cost.


Assuntos
Composição de Medicamentos/métodos , Compostos Ferrosos/química , Ácido Fólico/química , Iodo/química , Cloreto de Sódio/química , Composição de Medicamentos/economia , Estabilidade de Medicamentos , Alimentos Fortificados/análise , Alimentos Fortificados/economia , Índia , Micronutrientes/química
2.
Am J Health Syst Pharm ; 76(8): 551-553, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-31420984

RESUMO

PURPOSE: A cost-reduction strategy for isoproterenol use in radiofrequency catheter ablation procedures was evaluated. SUMMARY: A medication-use evaluation at a 454-bed tertiary medical center revealed that the cardiac catheterization laboratory was the highest user of isoproterenol. Isoproterenol was removed from all AcuDose-Rx machines Omnicell, Mountain View, CA, and compounding was performed by pharmacy personnel. It was initially provided to the cardiac catheterization laboratory as an 8-µg/mL concentration in 20-mL 0.9% sodium chloride injection syringes with a 24-hour beyond-use date. This resulted in an initial cost savings but with an unacceptably high rate of wastage. Isoproterenol was then compounded as a 4-µg/mL concentration in 30 mL 5% dextrose in water syringes with a 9-day beyond-use date after a thorough literature search supported longer stability with this admixture. After 12 months of our current process, isoproterenol use during radio frequency catheter ablations (RFCAs) in the cardiac catheterization laboratory was reduced by 85%, decreasing the number of ampules used from 11.15 to 1.66 per week. CONCLUSION: A pharmacy-initiated process to mitigate an extraordinary increase in isoproterenol acquisition cost resulted in a reduction in usage in a tertiary care community hospital. Isoproterenol usage was reduced 85% after two different interventions were implemented, which is estimated to save $1,839 per procedure.


Assuntos
Ablação por Cateter/métodos , Redução de Custos , Composição de Medicamentos/métodos , Isoproterenol/economia , Serviço de Farmácia Hospitalar/economia , Ablação por Cateter/economia , Ablação por Cateter/instrumentação , Composição de Medicamentos/economia , Custos de Medicamentos/estatística & dados numéricos , Estabilidade de Medicamentos , Armazenamento de Medicamentos/economia , Registros Eletrônicos de Saúde/estatística & dados numéricos , Custos Hospitalares/estatística & dados numéricos , Humanos , Isoproterenol/administração & dosagem , Estudos Retrospectivos , Centros de Atenção Terciária/economia , Centros de Atenção Terciária/estatística & dados numéricos , Fatores de Tempo
3.
Am J Health Syst Pharm ; 76(12): 895-901, 2019 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-31361850

RESUMO

PURPOSE: The benefits of technology-assisted workflow (TAWF) compared with manual workflow (non-TAWF) on i.v. room efficiency, costs, and safety at hospitals with more than 200 beds are evaluated. METHODS: Eight hospitals across the United States (4 with TAWF, 4 without) were evaluated, and the characteristics of medication errors and frequency of each error type were measured across the different institutions. The average turnaround time per workflow step and the cost to prepare each compounded sterile preparation (CSP) were also calculated, using descriptive statistics. RESULTS: The TAWF hospital sites detected errors at a significantly higher rate (3.13%) than the non-TAWF hospital sites (0.22%) (p < 0.05). The top error reporting category for the TAWF sites was incorrect medication (63.30%), while the top error reporting category for the non-TAWF sites was incorrect medication volume (18.34%). Use of TAWF was associated with a preparation time decrease of 2.82 min/CSP, a compounding time decrease of 2.94 min/CSP, and a decrease in overall cost to prepare of $1.60/CSP. CONCLUSION: The use of TAWF in the i.v. room was associated with the detection of 14 times more errors than the use of non-TAWF, demonstrating different frequency of error in the results. TAWF also led to a faster preparation time that had a lower cost for preparation.


Assuntos
Composição de Medicamentos/métodos , Eficiência Organizacional , Erros de Medicação/prevenção & controle , Serviço de Farmácia Hospitalar/organização & administração , Fluxo de Trabalho , Análise Custo-Benefício , Composição de Medicamentos/economia , Composição de Medicamentos/estatística & dados numéricos , Custos Hospitalares/estatística & dados numéricos , Humanos , Infusões Intravenosas/efeitos adversos , Infusões Intravenosas/economia , Erros de Medicação/economia , Erros de Medicação/estatística & dados numéricos , Serviço de Farmácia Hospitalar/economia , Serviço de Farmácia Hospitalar/estatística & dados numéricos , Avaliação de Programas e Projetos de Saúde , Avaliação da Tecnologia Biomédica , Fatores de Tempo , Estados Unidos
4.
J Manag Care Spec Pharm ; 25(7): 743-751, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31232208

RESUMO

BACKGROUND: Although medically necessary in some cases, there is growing concern that compounded medications are being overprescribed, leading to questions about safety and necessity for high use and cost. Safety concerns regarding compounded medications were highlighted by the 2013 contamination of steroid injections by the New England Compounding Center, which caused serious infections and other injuries to at least 751 patients and resulted in at least 64 patient deaths. A study contributed to our understanding of compounded medication use and cost, finding in a sample of commercially insured population that the average ingredient cost for compounded medication prescriptions was $710.36, which is 130% higher than for noncompounded medication prescriptions. The literature on use and cost of compounded medications in noncommercially insured populations and related regulations, however, is sparse. The California Workers' Compensation System (CAWCS)-the largest U.S. workers' compensation system and a public health system experiencing high compounded medication costs-provided an opportunity for additional analysis of these issues. Furthermore, CAWCS data on compounded medication use and cost allow for the exploration of alternative pricing mechanisms that may control costs. OBJECTIVES: To (a) examine use, cost, and billing and reimbursement practices for compounded medications in a public health system-CAWCS- and (b) evaluate regulations and recommend an alternative pricing mechanism that could control costs in California. METHODS: Descriptive statistics for use, cost, and reimbursement patterns of all compounded medication prescriptions included in CAWCS's Workers Compensation Information System claims datasets from 2011 to 2013 were determined. This study coded a unique dataset that (a) identified compounded medications at the ingredient level; (b) grouped compounded medications from ingredient level to compounded medications as a whole; and (c) categorized compounded medications into applicable Colorado pricing categories. T-tests assessed if regulation AB 378, which targets compounded medications, was associated with a difference in mean cost. The Colorado pricing scheme was applied to estimate cost and provide recommendations. RESULTS: Despite the AB 378 requirement for compounded medications to be billed at the ingredient level for reimbursement, 15% of pharmacy-dispensed and 6% of physician-dispensed medications were not billed at the ingredient level. For pharmacy-dispensed compounded medications billed at the ingredient level, mean amount paid (SD) per ingredient was $45.40 (195.97), and for those medications billed at the single compounded medication level, mean amount paid (SD) per medication was $95.20 (326.33) over all years. For physician-dispensed medications billed at the ingredient level, mean amount paid (SD) per ingredient was $75.47 (205.51), and when billed at the single medication level was $204.83 (221.01). T-tests showed a mean increase in compounded medication mean amount paid between pre- and post-AB 378 groups of $12.27 (P < 0.001) for pharmacy-dispensed medications and $11.34 (P < 0.001) for physician-dispensed medications, suggesting that AB 378 did not curb compounded medication mean amount paid. CONCLUSIONS: The average cost of CAWCS pharmacy- and physician-dispensed compounded medications consistently increased. Various factors may have influenced this increase, but AB 378 did not achieve its full regulatory intent to standardize billing and reimbursement and control cost. Grouping of ingredients into compounded medications allowed for application of the Colorado pricing scheme to CAWCS claims data. Adoption of Colorado pricing would save 46% of current compounded medication cost for less complicated medications, while increasing cost for more complicated medications. The analyses recommended a revised Colorado pricing scheme, which would provide improved incentives for accurate billing and lead to savings for CAWCS. DISCLOSURES: Funding for this study was provided by the California Workers' Compensation System. The authors had final control regarding study design, study conduct, and writing of the manuscript. The authors report no conflicts of interest.


Assuntos
Composição de Medicamentos/economia , Medicamentos sob Prescrição/economia , Saúde Pública/economia , Mecanismo de Reembolso/economia , Indenização aos Trabalhadores/economia , California , Custos e Análise de Custo , Custos de Medicamentos , Prescrições de Medicamentos , Humanos , Assistência Farmacêutica/economia
5.
Pharm Dev Technol ; 24(6): 775-787, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31023115

RESUMO

This paper addresses the relevance of automated content testing for the rapid automated process development (RAPD). Our previous work demonstrated that RAPD allowed a fast and efficient development of a continuous capsule-filling process. Target was the mean weight and the relative standard deviation of the weight. Likewise important are the content and the content uniformity. However, an implementation demands a certain level of automation. In general, technology is available that can detect active pharmaceutical ingredient (API) inside the capsules but the final application is linked to additional development and investment in machinery. To eliminate doubts regarding the benefits of an automated content check within the RAPD we present an application example. First, an X-ray system was used to detect barium sulfate accurately inside capsules. Second, a process was developed where barium sulfate was filled. The concentration of excipients was modified in the experiments, as well as the setting of the process parameter. The obtained model provided an explicit understanding of the process. Subsequently, the content uniformity model was compared to a model of the capsule weight relative standard deviation, confirming the benefits of an automated content check in the RAPD. Moreover, we presented another example illustrating the advantages of a connected continuous filling process, which permits evaluation of all process steps and their interactions (i.e. evaluation of the entire process).


Assuntos
Sulfato de Bário/análise , Composição de Medicamentos/métodos , Excipientes/química , Gelatina/química , Cápsulas/química , Composição de Medicamentos/economia , Radiografia/economia , Radiografia/métodos , Tecnologia Farmacêutica/economia , Tecnologia Farmacêutica/métodos , Fatores de Tempo , Raios X
6.
Drug Dev Ind Pharm ; 45(6): 869-881, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30767577

RESUMO

Among lipid-based nanocarriers, multi-layered cochleates emerge as a novel delivery system because of prevention of oxidation of hydrophobic and hydrophilic drugs, enhancement in permeability, and reduction in dose of drugs. It also improves oral bioavailability and increases the safety of a drug by targeting at a specific site with less side effects. Nanostructured cochleates are used as a carrier for the delivery of water-insoluble or hydrophobic drugs of anticancer, antiviral and anti-inflammatory action. This review article focuses on different methods for preparation of cochleates, mechanism of formation of cochleates, mechanism of action like cochleate undergoes macrophagic endocytosis and release the drug into the systemic circulation by acting on membrane proteins, phospholipids, and receptors. Advanced methods such as calcium-substituted and ß-cyclodextrin-based cochleates, novel techniques include microfluidic and modified trapping method. Cochleates showed enhancement in oral bioavailability of amphotericin B, delivery of factor VII, oral mucosal vaccine adjuvant-delivery system, and delivery of volatile oil. In near future, cochleate will be one of the interesting delivery systems to overcome the stability and encapsulation efficiency issues associated with liposomes. The current limiting factors for commercial preparation of cochleates involve high cost of manufacturing, lack of standardization, and specialized equipments.


Assuntos
Composição de Medicamentos/métodos , Sistemas de Liberação de Medicamentos/métodos , Bicamadas Lipídicas/química , Adjuvantes Imunológicos/administração & dosagem , Adjuvantes Imunológicos/química , Adjuvantes Imunológicos/farmacocinética , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/química , Anti-Inflamatórios/farmacocinética , Antineoplásicos/administração & dosagem , Antineoplásicos/química , Antineoplásicos/farmacocinética , Antivirais/administração & dosagem , Antivirais/química , Antivirais/farmacocinética , Disponibilidade Biológica , Cálcio/química , Química Farmacêutica/métodos , Composição de Medicamentos/economia , Estabilidade de Medicamentos , Microfluídica/métodos , Tamanho da Partícula , Vacinas/administração & dosagem , Vacinas/química , Vacinas/farmacocinética , beta-Ciclodextrinas/química
7.
Skeletal Radiol ; 48(3): 445-448, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29846755

RESUMO

OBJECTIVE: To assess the impact of shifting arthrogram injectate compounding from the fluoroscopy suite to the main hospital sterile pharmacy on cost, examination delays, and infection rates. MATERIALS AND METHODS: All arthrograms from the 12 months before (629 in total) and the 12 months after (699 in total) the change in arthrogram preparation procedure were compared to identify differences in examination delays and infection rate. The arthrogram formulation was sent to the Compounder's International Analytical Laboratory for stability testing. Finally, cost per injection analysis was performed to compare fluoroscopy suite with sterile pharmacy compounding. RESULTS: In the 699 arthrograms performed in the 12 months following transfer of arthrogram preparation to the main hospital pharmacy, there were 0 reported examination delays, 0 reported infections, and a 53% decrease in the material cost per arthrogram. There were three recorded instances of fluoroscopy suite preparation of arthrogram injectate due to unexpected add-on patients. Outside stability testing determined that the arthrogram injectate retained at least 90% potency 30 h post-preparation. CONCLUSION: Shifting the compounding of the arthrogram injectate from the fluoroscopy room to the main hospital sterile pharmacy provides a modest cost saving and can be accomplished without examination delays or any increase in infection rate. It brought our practice into compliance with USP797, which is the current guideline for compounding practitioners, by transferring the compounding preparation of the arthrogram injectate from a procedure room to the sterile pharmacy.


Assuntos
Meios de Contraste/química , Composição de Medicamentos/normas , Gadolínio DTPA/química , Iopamidol/química , Imagem por Ressonância Magnética , Serviço de Farmácia Hospitalar/normas , Meios de Contraste/economia , Redução de Custos , Composição de Medicamentos/economia , Fluoroscopia , Gadolínio DTPA/economia , Fidelidade a Diretrizes , Humanos , Iopamidol/economia , Serviço de Farmácia Hospitalar/economia
8.
Yakugaku Zasshi ; 138(12): 1549-1559, 2018.
Artigo em Japonês | MEDLINE | ID: mdl-30504671

RESUMO

Maintaining medication adherence is a critical issue in determining health outcomes in patients with chronic diseases. However, many patients do not adhere to their prescribed regimens. This study aimed to determine the effects of using adherence score sheets according to application timing in improving medication adherence among non-adherent outpatients. In community pharmacies, both patients and pharmacists evaluated medication adherence based on application timing (morning, noon, evening, and before going to bed) in 11 levels (0-10) for >4 months. A total of 58 outpatients were included in the study. The median scores among application timing at intermediate (patient 9.3, pharmacist 9.0) and final (patient 9.5, pharmacist 9.5) analyses were significantly higher than that at baseline (patient 7.6, pharmacist 7.0). At the end of the investigation, the ratio of non-adherent patients prescribed with hyperlipidemic medications was higher than those prescribed with medications for other lifestyle diseases. Approximately 80% of the patients reported improved medication adherence based on the questionnaires regarding their understanding on diseases and medications, medication awareness, and communication with pharmacists. Therefore, the utilization of an adherence score sheet according to application timing improved medication adherence of patients with chronic diseases.


Assuntos
Adesão à Medicação/estatística & dados numéricos , Pacientes Ambulatoriais/psicologia , Pacientes Ambulatoriais/estatística & dados numéricos , Conscientização , Comunicação , Redução de Custos/métodos , Composição de Medicamentos/economia , Composição de Medicamentos/estatística & dados numéricos , Humanos , Hipolipemiantes , Japão/epidemiologia , Estilo de Vida , Prescrições/economia , Prescrições/estatística & dados numéricos , Relações Profissional-Paciente , Inquéritos e Questionários , Tempo
10.
Pharmazie ; 73(12): 683-687, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30522549

RESUMO

Ulinastatin vaginal suppositories, used to prevent threatened premature delivery, are frequently used in hospitals. However, there is no established method for quantifying ulinastatin contained in suppositories. Therefore, we investigated a simple and efficient method for quantifying ulinastatin contained in suppositories. Our analytical method involved removal of the base; optimising the enzyme inhibition reaction time and enzyme reaction time; and measuring the absorbance. The modified method was reproducible, operation time was significantly shortened, and cost was reduced to approximately 1/17 of that of the previously reported method. This simple and rapid quantitative method could contribute to the improvement of quality control of ulinastatin vaginal suppositories as an extemporaneous hospital preparation.


Assuntos
Química Farmacêutica/métodos , Composição de Medicamentos/métodos , Glicoproteínas/análise , Controle de Qualidade , Química Farmacêutica/economia , Composição de Medicamentos/economia , Glicoproteínas/química , Glicoproteínas/normas , Serviço de Farmácia Hospitalar/economia , Serviço de Farmácia Hospitalar/métodos , Reprodutibilidade dos Testes , Supositórios , Fatores de Tempo , Inibidores da Tripsina/análise , Inibidores da Tripsina/química , Inibidores da Tripsina/normas
11.
J Comp Eff Res ; 7(12): 1145-1152, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30427724

RESUMO

AIM: To provide a framework for optimizing the development and use of real-world evidence (RWE) in drug coverage decisions. Materials & methods: The Institute for Clinical and Economic Review convened a Policy Summit with representatives from 23 payer and life science companies that compose the Institute for Clinical and Economic Review membership. RESULTS: Summit participants helped refine a new conceptual framework that emphasizes the central role of contextual considerations and the evidentiary argument that the RWE is intended to support in designing the process for the development and interpretation of RWE. CONCLUSION: This framework may provide a structured way for pharmaceutical manufacturers and payers to develop a shared understanding of the best way to develop RWE that will ultimately be useful in informing coverage and formulary decisions.


Assuntos
Tomada de Decisões , Composição de Medicamentos/economia , Cobertura do Seguro/economia , Seguro Saúde/economia , Medicamentos sob Prescrição/economia , Pesquisa Comparativa da Efetividade/métodos , Humanos
12.
Int J Pharm Compd ; 22(6): 471-473, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30384347

RESUMO

The International Academy of Compounding Pharmacists Foundation held a student essay contest in the Spring of 2018. Two great submissions were chosen to receive an award. This article features one of the chosen essays, which discusses some of the challenges that compounding pharmacies face in the competitive profession of pharmacy.


Assuntos
Atitude do Pessoal de Saúde , Serviços Comunitários de Farmácia/economia , Composição de Medicamentos/economia , Custos de Medicamentos , Competição Econômica , Conhecimentos, Atitudes e Prática em Saúde , Estudantes de Farmácia/psicologia , Humanos , Satisfação do Paciente/economia
13.
Yakugaku Zasshi ; 138(10): 1313-1322, 2018.
Artigo em Japonês | MEDLINE | ID: mdl-30270277

RESUMO

 The increase in medical expenditure has been worsening and poses a serious social problem. Commonly, leftover drugs are retained by patients. We estimated the possible reduction in prescription rates by appropriately reusing leftover drugs, and investigated the medication efficacy classifications that render leftover drugs due to the medication non-adherence. A retrospective cross-sectional survey of prescription data was performed at community pharmacies engaged in the appropriate reuse of leftover drugs through the SETSUYAKU-BAG campaign. We evaluated the drug costs and number of drugs originally prescribed, the reduction in expenditure and numbers after the use of leftover drugs, and then calculated the prescription reduction ratio (PRR) based on the number of drugs. Factors contributing to non-adherence were analyzed by the PRR. After reviewing the prescription information of 1792 patients, the reduction rate in drug expenditure was found to be 20.1%. Purgatives, Chinese medicines, and agents for peptic ulcer had higher PRRs and belonged to the top ten medications according to the prescription efficacy classifications. Non-adherence associated with the medication efficacy classifications was assessed by analyzing 5466 formulations. Thirty percent of formulations were found to be non-adherent. According to the medication efficacy classifications, six medications including agents for hyperlipidemias, peptic ulcer, psychotropics agents, and others, were less adherent than antihypertensives. These results suggest that adjusting prescriptions by appropriately reusing leftover drugs in community pharmacies could reduce medical costs. Further considerations are necessary for improving medication adherence in Japan. Healthcare providers should monitor medication adherence more carefully, with the results identified in this study.


Assuntos
Redução de Custos/métodos , Custos de Medicamentos/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Farmácias/estatística & dados numéricos , Prescrições/economia , Prescrições/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos Transversais , Composição de Medicamentos/economia , Composição de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Lactente , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
14.
Bull Cancer ; 105(7-8): 679-685, 2018.
Artigo em Francês | MEDLINE | ID: mdl-29958654

RESUMO

INTRODUCTION: Dose-banding is needed to rationalise cytotoxic drugs preparations. A new step was recently crossed: gemcitabine is the first molecule to be sold in ready-to-administer bag. What's the pharmaco-economic impact of gemcitabine ready-to-administer bags versus manufacturing in preparation unit? METHODS: A retrospective analysis of gemcitabine dosage prepared over three months permitted to explain our consumption of this drug, and by modelling, to characterize the good prescription interval for each dosage. Compared costs study assessed cost of medicine, preparation kit and preparation time. RESULTS: Over the study period, for 5%, 7.5% and 10% of deviation, respectively 67%, 75% and 76% of preparations were covered by standard doses. We chose 7.5% interval. The manufacturing cost of gemcitabine infusions is around 30,000€/year for vials with solution for infusion, 32,300€ for vials with powder, versus 67,300€ for ready-to-administer bag. Approximately 7.75minutes of pharmacy technician time would be saved by preparation. DISCUSSION: Ready-to-administer bags of gemcitabine allow relevant coverage of manufacturing doses. The annual extra cost would reach 37,200€ for our establishment. But, it can be justified by expected benefits: safer medication circuit, saving time of pharmacy technician….


Assuntos
Antimetabólitos Antineoplásicos/economia , Custos e Análise de Custo , Desoxicitidina/análogos & derivados , Composição de Medicamentos/economia , Antimetabólitos Antineoplásicos/química , Desoxicitidina/química , Desoxicitidina/economia , Formas de Dosagem , Estudos Retrospectivos , Fatores de Tempo
15.
Int J Pharm ; 547(1-2): 469-479, 2018 Aug 25.
Artigo em Inglês | MEDLINE | ID: mdl-29885512

RESUMO

Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control strategy. In this work the residence time distributions (RTD) of single unit operations (blender, roller compactor and tablet press) of a continuous dry granulation tableting line were captured with NIR based methods at selected mass flow rates to create training data. RTD models for continuous operated unit operations and the entire line were developed based on transfer functions. For semi-continuously operated bucket conveyor and pneumatic transport an assumption based the operation frequency was used. For validation of the parametrized process model, a pre-defined API step change and its propagation through the manufacturing line was computed and compared to multi-scale experimental runs conducted with the fully assembled continuous operated manufacturing line. This novel approach showed a very good prediction power at the selected mass flow rates for a complete continuous dry granulation line. Furthermore, it shows and proves the capabilities of process simulation as a tool to support development and control of pharmaceutical manufacturing processes.


Assuntos
Química Farmacêutica/métodos , Composição de Medicamentos/métodos , Modelos Químicos , Análise Custo-Benefício , Composição de Medicamentos/economia , Composição de Medicamentos/instrumentação , Controle de Qualidade , Comprimidos , Fatores de Tempo
16.
J Pharm Pract ; 31(4): 370-373, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29905083

RESUMO

Hundreds of oral and injectable generic drugs have seen dramatic price increases during the 2010s. Several reasons for the astronomic price increases have been postulated, ranging from reduced competition, shortages in the manufacturing supply chain, very small markets, market consolidation, the Unapproved Drugs Initiative of 2006, and unanticipated manufacturing safety issues. In one survey, over 90% of hospital administrators reported that higher drug prices had a moderate or severe impact on their budgets. Whereas compounding pharmacies may present an effective solution to high drug prices, it is a potentially dangerous one, as the case of New England Compounding Center makes clear. The risks make a meticulous vetting process necessary.


Assuntos
Composição de Medicamentos/economia , Custos de Medicamentos/tendências , Medicamentos Genéricos/economia , Inflação/tendências , Controle de Custos , Humanos
17.
Am J Health Syst Pharm ; 75(11 Supplement 2): S51-S57, 2018 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-29802179

RESUMO

PURPOSE: The purpose of this study was to quantify the impact of robotic technology on efficiency, accuracy, and cost in a satellite oncology pharmacy. METHODS: A 33-week quasi-experimental study was conducted at an academic, quaternary care institution with 1,119 licensed beds from June 2016 to February 2017 to evaluate the turnaround time (TAT) for preparations compounded by automated robotic compounding technology (ARCT) versus historical procedures. Secondary endpoints included mean preparation time and percentage of doses with a TAT of <30 minutes before and after the implementation of ARCT and were evaluated using time-segmented regression analysis. The cost savings in the satellite oncology pharmacy was determined by comparing usage of closed-system transfer devices (CSTDs) and labor costs between study phases. Accuracy of the intervention was expressed through a descriptive analysis of mean ARCT dose preparation deviations and preparation failures. RESULTS: Data for 1,453 preparations were included for analysis. The mean ± S.D. preimplementation TAT was 64.1 ± 27.9 minutes, which decreased to 53.2 ± 32.2 minutes after ARCT implementation (p < 0.01). Financial benefit was demonstrated through supply cost savings. Breakeven was estimated at 8.6 years after capital expenditure, with an annualized projected savings of $129,477. The mean ± S.D. deviation of the doses compounded using ARCT was -0.58% ± 0.01% from the ordered dosage. CONCLUSION: Adoption of ARCT for compounding of admixtures containing 4 oncology agents reduced TAT and preparation time and led to lower expenditures for CSTDs.


Assuntos
Antineoplásicos/uso terapêutico , Composição de Medicamentos/métodos , Neoplasias/tratamento farmacológico , Serviço de Farmácia Hospitalar/métodos , Robótica , Composição de Medicamentos/economia , Eficiência Organizacional , Custos Hospitalares , Humanos , Oncologia/métodos , Serviço de Farmácia Hospitalar/economia , Robótica/economia , Robótica/métodos , Fatores de Tempo
18.
Am J Health Syst Pharm ; 75(11): 808-815, 2018 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-29802114

RESUMO

PURPOSE: Results of a study to determine time and cost requirements for final preparation of continuous renal replacement therapy (CRRT) products are reported. METHODS: A 3-phase observational study was conducted at a tertiary care university hospital to evaluate costs associated with manual addition of phosphate and/or potassium to 3 commercial 5-L CRRT products. In the first phase of the study, pharmacy workflow processes for solution preparation were established; in the second phase, pharmacist and pharmacy technician time spent in the CRRT workflow and all materials used were observed and recorded. In the third phase, time and personnel requirements were analyzed in economic terms to estimate final preparation costs. RESULTS: Through direct observation over 35 days, the CRRT workflow was observed and work times recorded for 511 bag preparations. The main cost contributors were the base CRRT solution and electrolyte additive prices. Technician compounding time differed substantially by solution brand and the need for electrolyte addition. Pharmacist verification time did not differ meaningfully by product. CONCLUSION: Preparation and verification of premade CRRT solutions that contained physiological electrolyte concentrations required less technician and pharmacist time than solutions that needed addition of electrolytes in the pharmacy. Personnel costs, which were a small part of the total cost of dispensed CRRT bags, were higher for technicians than pharmacists. The baseline costs of the solutions and the electrolyte additives, if needed, were the main contributors to total cost.


Assuntos
Composição de Medicamentos/economia , Soluções para Hemodiálise/economia , Terapia de Substituição Renal/economia , Custos de Medicamentos , Eletrólitos/economia , Humanos , Recursos Humanos em Hospital/economia , Farmacêuticos , Serviço de Farmácia Hospitalar/economia , Técnicos em Farmácia , Diálise Renal , Centros de Atenção Terciária , Estudos de Tempo e Movimento , Fluxo de Trabalho
19.
Farm Hosp ; 42(2): 62-67, 2018 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-29501057

RESUMO

OBJECTIVE: To evaluate the efficiency of the protocolization and centralization of  the preparation of intravenous vasoactive drug mixtures in the treatment of  critically ill patients. METHOD: A prospective interventional study (July 2012-December 2014) was  conducted to measure the impact of different vasoactive drug protocols on costs  in the treatment of critically ill patients. The economic impact was measured by  comparing the direct costs (fixed and variable) of the preparation of intravenous  vasoactive drug mixtures in the Pharmacy Department with their traditional  preparation in hospital care units. The variables time and cost of preparation of  an intravenous mixture were measured. Costs included pharmaceutical product,  diluent, medical supplies, cost of manpower, and use of laminar flow cabinets in  the Pharmacy Department. Costs were measured in Euros. RESULTS: A statistically significant difference was found between processing times in the Pharmacy Department and those in the hospital care unit (2.10 vs 2.86 minutes). Centralized preparation in the Pharmacy Department  was more efficient. The average cost of preparation was €5.24±1.45 in the  Pharmacy Department and €5.62±1.55 in the hospital care unit, although this  difference did not reach statistical significance. If the analysis had included the  cost of intravenous mixtures that had expired prior to their use, the centralized  preparation of the mixtures in the Pharmacy Department would have entailed a  higher cost (€2 174/y). CONCLUSIONS: The centralized preparation of intravenous mixtures in the Pharmacy Department entails significant time savings compared with their preparation in the hospital care unit.


Assuntos
Protocolos Clínicos , Estado Terminal/terapia , Conduta do Tratamento Medicamentoso/organização & administração , Vasoconstritores/uso terapêutico , Vasodilatadores/uso terapêutico , Administração Intravenosa , Estado Terminal/economia , Estado Terminal/enfermagem , Combinação de Medicamentos , Composição de Medicamentos/economia , Composição de Medicamentos/métodos , Custos de Medicamentos , Humanos , Conduta do Tratamento Medicamentoso/economia , Serviço de Farmácia Hospitalar/economia , Serviço de Farmácia Hospitalar/organização & administração , Estudos Prospectivos , Centros de Atenção Terciária , Vasoconstritores/administração & dosagem , Vasodilatadores/administração & dosagem
20.
J Int AIDS Soc ; 21 Suppl 12018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29485727

RESUMO

INTRODUCTION: Despite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower. Therefore, accelerating processes for developing and commercializing optimal paediatric drug formulations for HIV and other disease areas is urgently needed. DISCUSSION: The Global Accelerator for Paediatric Formulations (GAP-f) is an innovative collaborative model that will accelerate availability of optimized treatment options for infectious diseases, such as HIV, tuberculosis and viral hepatitis, affecting children in low- and middle-income countries (LMICs). It builds on the HIV experience and existing efforts in paediatric drug development, formalizing collaboration between normative bodies, research networks, regulatory agencies, industry, supply and procurement organizations and funding bodies. Upstream, the GAP-f will coordinate technical support to companies to design and study optimal paediatric formulations, harmonize efforts with regulators and incentivize manufacturers to conduct formulation development. Downstream, the GAP-f will reinforce coordinated procurement and communication with suppliers. The GAP-f will be implemented in a three-stage process: (1) development of a strategic framework and promotion of key regulatory efficiencies; (2) testing of feasibility and results, building on the work of existing platforms such as the Paediatric HIV Treatment Initiative (PHTI) including innovative approaches to incentivize generic development and (3) launch as a fully functioning structure. CONCLUSIONS: GAP-f is a key partnership example enhancing North-South and international cooperation on and access to science and technology and capacity building, responding to Sustainable Development Goal (SDG) 17.6 (technology) and 17.9. (capacity-building). By promoting access to the most needed paediatric formulations for HIV and high-burden infectious diseases in low-and middle-income countries, GAP-f will support achievement of SDG 3.2 (infant mortality), 3.3 (end of AIDS and combat other communicable diseases) and 3.8 (access to essential medicines), and be an essential component of meeting the global Start Free, Stay Free, AIDS Free super-fast-track targets.


Assuntos
Fármacos Anti-HIV/economia , Países em Desenvolvimento/economia , Composição de Medicamentos/economia , Infecções por HIV/tratamento farmacológico , Pediatria/economia , Adulto , Fármacos Anti-HIV/química , Fármacos Anti-HIV/uso terapêutico , Criança , Desenvolvimento de Medicamentos/economia , Medicamentos Genéricos/economia , Infecções por HIV/economia , Humanos , Lactente , Cooperação Internacional , Pobreza
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