Agency Theory, Drug Formularies, and Drug Product Selection: Implications for Public Policy

1998 ◽  
Vol 17 (2) ◽  
pp. 287-295 ◽  
Author(s):  
David A. Mott ◽  
Jon C. Schommer ◽  
William R. Doucette ◽  
David H. Kreling
Keyword(s):  
Public Policy ◽  
Agency Theory ◽  
Drug Product ◽  
Goal Conflict ◽  
Drug Selection ◽  
Drug Products ◽  
Agency Relationships ◽  
Selection Decisions ◽  
Future Policy ◽  
Selection Of

The authors describe the pharmaceutical utilization system and present the conceptual framework for agency theory. They then apply agency theory to the selection of pharmaceuticals and the role of drug formularies in drug selection. The use of drug formularies can increase the goal conflict and uncertainty related to the selection of drug products. The authors address public policy and research directions to suggest ways of reducing the level of goal conflict and uncertainty associated with drug selection. Recognition of agency relationships and the environment surrounding agency relationships appear to be important for the development and analysis of future policy regarding selection decisions pertaining to pharmaceuticals.

The Pharmacist's Dilemma—Drug Product Selection Using Bioavailability Data

1973 ◽  
Vol 7 (10) ◽  
pp. 444-450
Author(s):  
George Kennedy Cawthorne ◽  
Fred M. Eckel
Keyword(s):  
Blood Level ◽  
Drug Product ◽  
Potential Usefulness ◽  
Product Selection ◽  
Wide Applicability ◽  
Drug Products ◽  
Drug Companies ◽  
Selection Decisions

One hundred fifty-six U.S. drug companies were surveyed to determine whether or not they would supply bioavailability data on 147 drugs marketed as 1894 drug products. The submitted data were analyzed for completeness, validity and potential usefulness to the pharmacist in making drug product selection decisions. Ninety (57.7 percent) companies responded to the survey. Thirty-eight (24.4 percent) sent data of which that from 29 (18.6 percent) was judged acceptable for use in drug product selection. Acceptable data were submitted on 59 drugs. Data on 46 drugs were considered blood-level bioavailability data while the data on 13 drugs were considered clinical bioavailability data. The results, though relatively limited in number of drugs, represented drugs in a number of different pharmacologic classes, so were judged to be of relatively wide applicability.

scholarly journals Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products

2021 ◽  
Author(s):  
Ian Aled Jones ◽  
Alex Bird ◽  
Nathaniel Lochrie
Keyword(s):  
Sample Size ◽  
Key Words ◽  
Visual Inspection ◽  
Drug Product ◽  
Sample Sizes ◽  
Sampling Plans ◽  
Drug Products ◽  
Product Manufacture ◽  
Selection Of ◽  
Parenteral Drug

This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture. Key Words: USP <1790>, visual inspection, AQL, power, sample size

Ethics and Public Policy

1981 ◽  
Vol 29 ◽  
pp. 1-9
Author(s):  
George J. Graham
Keyword(s):  
Public Policy ◽  
Policy Analysis ◽  
Policy Process ◽  
Policy Issue ◽  
Policy Choice ◽  
Single Text ◽  
Public Policy Analysis ◽  
The Government ◽  
New Framework ◽  
Selection Of

The purpose of this course is to introduce a new framework linking the humanities to public policy analysis as pursued in the government and the academy. Current efforts to link the particular contributions from the humanities to problems of public policy choice are often narrow either in terms of their perspective on the humanities or in terms of their selection of the possible means of influencing policy choice. Sometimes a single text from one of the humanities disciplines is selected to apply to a particular issue. At other times, arguments about the ethical dimensions of a single policy issue often are pursued with a single — or sometimes, no — point of access to the policy process in mind.

scholarly journals 669. Drug Selection of Hematopoietic Cells by Regulated MGMT Activity

2006 ◽  
Vol 13 ◽  
pp. S258
Author(s):  
Barbara Verbeek ◽  
Thomas D. Southgate ◽  
Michael D. Milsom ◽  
Amanda J. Watson ◽  
Lorna B. Woolford ◽  
...  
Keyword(s):  
Hematopoietic Cells ◽  
Drug Selection ◽  
Selection Of

A Control-Theoretic Approach to Neural Pharmacology: Optimizing Drug Selection and Dosing

2016 ◽  
Vol 138 (8) ◽  
Author(s):  
Gautam Kumar ◽  
Seul Ah Kim ◽  
ShiNung Ching
Keyword(s):  
Design Method ◽  
Target Space ◽  
Theoretic Approach ◽  
Time Varying ◽  
Drug Selection ◽  
Modeling Paradigm ◽  
Dosing Strategies ◽  
Dose Dependent ◽  
Optimal Construction ◽  
Selection Of

The induction of particular brain dynamics via neural pharmacology involves the selection of particular agonists from among a class of candidate drugs and the dosing of the selected drugs according to a temporal schedule. Such a problem is made nontrivial due to the array of synergistic drugs available to practitioners whose use, in some cases, may risk the creation of dose-dependent effects that significantly deviate from the desired outcome. Here, we develop an expanded pharmacodynamic (PD) modeling paradigm and show how it can facilitate optimal construction of pharmacologic regimens, i.e., drug selection and dose schedules. The key feature of the design method is the explicit dynamical-system based modeling of how a drug binds to its molecular targets. In this framework, a particular combination of drugs creates a time-varying trajectory in a multidimensional molecular/receptor target space, subsets of which correspond to different behavioral phenotypes. By embedding this model in optimal control theory, we show how qualitatively different dosing strategies can be synthesized depending on the particular objective function considered.

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

scholarly journals Exhibition Development in Auckland Libraries

2021 ◽  
Author(s):  
◽  
Timothy Mark Greenslade
Keyword(s):  
Public Policy ◽  
Cultural Heritage ◽  
Public Libraries ◽  
Public Library ◽  
Exhibition Design ◽  
Design Principles ◽  
Special Collections ◽  
Physical Layout ◽  
Selection Of

<p>Throughout New Zealand’s public library sector, librarians, particularly those responsible for special collections, maintain and create exhibitions. They aim to reflect the depth and richness of our history, cultural heritage and society. Due to the immeasurable value of cultural heritage, it needs to be presented effectively, not only for aesthetic and preservation purposes, but also for the betterment of society. Therefore the objective of this study is to explore how exhibition principles are being applied to exhibition development and presentation in Auckland Libraries. This study will not only focus on the principles behind physical layout of the exhibitions, and selection of objects on display, it will also attempt to place exhibition design into a wider context. It will do this by exploring how library exhibitions reflect public policy, and how exhibition designers perceive their social and cultural responsibilities as representatives of public libraries. Herein lies the value of the proposed study; it will allow better informed practices by exploring the use of exhibition design principles, and the application of public policy in public.</p>

scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

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