Authorization Process

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Michael R Gionfriddo - One of the best experts on this subject based on the ideXlab platform.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Michael Evans, Jove Graham, Michael R Gionfriddo
    Abstract:

    PURPOSE: The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. METHODS: Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. RESULTS: Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. CONCLUSION: Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Jove Graham, Michael A Evans, Michael R Gionfriddo
    Abstract:

    Purpose The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. Methods Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. Results Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. Conclusion Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

Laney K Jones - One of the best experts on this subject based on the ideXlab platform.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Michael Evans, Jove Graham, Michael R Gionfriddo
    Abstract:

    PURPOSE: The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. METHODS: Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. RESULTS: Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. CONCLUSION: Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Jove Graham, Michael A Evans, Michael R Gionfriddo
    Abstract:

    Purpose The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. Methods Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. Results Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. Conclusion Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

Piedad Ganan - One of the best experts on this subject based on the ideXlab platform.

  • the role of machine learning in centralized Authorization Process of nanomedicines in european union
    Current Topics in Medicinal Chemistry, 2021
    Co-Authors: Ricardo Santana, Enrique Onieva, Robin Zuluaga, Aliuska Duardosanchez, Piedad Ganan
    Abstract:

    BACKGROUND Machine Learning (ML) has experienced an increasing use, given the possibilities to expand the scientific knowledge of different disciplines, such as nanotechnology. This has allowed the creation of Cheminformatic models capable of predicting biological activity and physicochemical characteristics of new components with high success rates in training and test partitions. Given the current gaps of scientific knowledge and the need for efficient application of medicines products law, this paper analyzes the position of regulators for marketing medicinal nanoproducts in the European Union and the role of ML in the Authorization Process. METHODS In terms of methodology, a dogmatic study of the European regulation and the guidance of the European Medicine Agency on the use of predictive models for nanomaterials was carried out. The study has, as the framework of reference, the European Regulation 726/2004 and has focused on the analysis of how ML Processes are contemplated in the regulations. RESULTS As a result, we present a discussion of the information that must be provided for every case for simulation methods. The results show a favorable and flexible position for the development of the use of predictive models to complement the applicant's information. CONCLUSION It is concluded that Machine Learning has the capacity to help improve the application of nanotechnology medicine products regulation. Future regulations should promote this kind of information given the advanced state of the art in terms of algorithms that are able to build accurate predictive models. This especially applies to methods, such as Perturbation Theory Machine Learning (PTML), given that it is aligned with principles promoted by the standards of Organization for Economic Co-operation and Development (OECD), European Union regulations, and European Authority Medicine. To our best knowledge, this is the first study focused on nanotechnology medicine products and machine learning used to support technical European public assessment reports (EPAR) for complementary information.

  • the role of machine learning in centralized Authorization Process of nanomedicines in european union
    Current Topics in Medicinal Chemistry, 2021
    Co-Authors: Ricardo Santana, Enrique Onieva, Robin Zuluaga, Aliuska Duardosanchez, Piedad Ganan
    Abstract:

    BACKGROUND Machine Learning (ML) has experienced an increasing use given the possibilities to expand the scientific knowledge of different disciplines, such as nanotechnology. This has allowed the creation of Cheminformatic models, capable of predicting biological activity and physicochemical characteristics of new components with high success rates in training and test partitions. Given the current gaps of scientific knowledge and the need of efficient application of medicines products law, this paper analyzes the position of regulators for marketing medicinal nanoproducts in European Union and the role of ML in the Authorization Process. METHODS In terms of methodology, a dogmatic study of the European regulation and the guidances of the European Medicine Agency on the use of predictive models for nanomaterials was carried out. The study has, as the framework of reference, the European Regulation 726/2004 and has focused on the analysis of how ML Processes are contemplated in the regulations. RESULTS As result, we present a discussion of the information that must be provided for every case for simulation methods. The results show a favorable and flexible position for the development of the use of predictive models to complement the applicant's information. CONCLUSION It is concluded that Machine Learning has the capacity to help to improve the application of nanotechnology medicine products regulation. Future regulations should promote this kind of information given the advanced state of art in terms of algorithms that are able to build accurate predictive models. This especially applies to methods such as Perturbation Theory Machine Learning (PTML), given that it is aligned with principles promoted by the standards of Organization for Economic Co-operation and Development (OECD), European Union regulations and European Authority Medicine. To our best knowledge this is the first study focused on nanotechnology medicine products and machine learning use to support technical European public assessment report (EPAR) for complementary information.

Jove Graham - One of the best experts on this subject based on the ideXlab platform.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Michael Evans, Jove Graham, Michael R Gionfriddo
    Abstract:

    PURPOSE: The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. METHODS: Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. RESULTS: Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. CONCLUSION: Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Jove Graham, Michael A Evans, Michael R Gionfriddo
    Abstract:

    Purpose The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. Methods Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. Results Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. Conclusion Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

Christina Gregor - One of the best experts on this subject based on the ideXlab platform.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Michael Evans, Jove Graham, Michael R Gionfriddo
    Abstract:

    PURPOSE: The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. METHODS: Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. RESULTS: Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. CONCLUSION: Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.

  • understanding the medication prior Authorization Process a case study of patients and clinical staff from a large rural integrated health delivery system
    American Journal of Health-system Pharmacy, 2019
    Co-Authors: Laney K Jones, Ilene G Ladd, Christina Gregor, Jove Graham, Michael A Evans, Michael R Gionfriddo
    Abstract:

    Purpose The barriers and solutions to the current prior-Authorization (PA) Process at an integrated health system were evaluated. Methods Focus groups were conducted with patients at an integrated health system who also had insurance from an affiliated health plan and at least 1 denial for a medication in the past year. Semistructured interviews were conducted with medical staff (physicians, office staff, and PA experts). Both focus groups and interviews were audio-recorded and transcribed. Inductive analysis was used to code transcripts and develop themes. Results Three focus groups were conducted with 13 patients, and 9 medical staff (3 staff physicians, 2 office staff, and 4 PA staff) who have interactions with the PA Process interviewed. Several themes were identified including the complexity of the PA Process, consequences experienced, and ineffective communication between key stakeholders. A cross-cutting theme was that stakeholders expressed feelings of frustration, anxiety, and anger throughout the PA Process. All stakeholders offered insights on how the Process could be improved to better facilitate their preferences, such as access to the list of medications that require PA and the need for a patient advocate. Conclusion Results of this study revealed that the PA Process was frustrating, upsetting, and infuriating to patients and medical staff involved in the Process. Three main themes identified included the complexity of the PA Process, consequences experienced from the PA Process, and ineffective communication between stakeholders.