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Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies

OBJECTIVE: Creating an environment that supports conditions of routine clinical practice and enables an effectiveness trial design with a pre‐licensed medicine is extremely challenging. Here, we summarise our experiences and achievements with engaging and mobilising community pharmacies in and aroun...

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Detalles Bibliográficos
Autores principales: Leather, David A., Howard, Steve, Haydock, Gerry, Stephens, Linda
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7586830/
https://www.ncbi.nlm.nih.gov/pubmed/32589297
http://dx.doi.org/10.1111/ijpp.12647
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author Leather, David A.
Howard, Steve
Haydock, Gerry
Stephens, Linda
author_facet Leather, David A.
Howard, Steve
Haydock, Gerry
Stephens, Linda
author_sort Leather, David A.
collection PubMed
description OBJECTIVE: Creating an environment that supports conditions of routine clinical practice and enables an effectiveness trial design with a pre‐licensed medicine is extremely challenging. Here, we summarise our experiences and achievements with engaging and mobilising community pharmacies in and around Salford, United Kingdom, in the Phase III effectiveness Salford Lung Studies (SLS). METHODS: This article provides the authors’ personal experiences and viewpoints on community pharmacy involvement in the SLS. KEY FINDINGS: More than 130 community pharmacies were enabled, and >2500 pharmacy staff trained, for involvement in the SLS. Key to community pharmacy participation in the SLS was the formation of the SLS Pharmacy Steering Group (PSG), contributing to study oversight, and the development of a pharmacy standard operating procedure document, the major principle of which was to ensure minimum disruption to the normal medicine dispensing process while ensuring compliance with regulations, guidelines, good clinical practice and requirements for pharmacovigilance. The high level of commitment and collaboration of community pharmacy in the SLS demonstrated a willingness to work together and take on additional and novel roles beyond their everyday commercial functions for the benefit of patients, despite normally competing for prescription business. CONCLUSIONS: The involvement and integration of community pharmacy as a key partner in the SLS was pivotal in securing the delivery of these world‐first clinical effectiveness studies. To our knowledge, this has not been previously achieved in a study of a pre‐licensed maintenance therapy for a common disease in primary care.
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spelling pubmed-75868302020-10-30 Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies Leather, David A. Howard, Steve Haydock, Gerry Stephens, Linda Int J Pharm Pract Personal View OBJECTIVE: Creating an environment that supports conditions of routine clinical practice and enables an effectiveness trial design with a pre‐licensed medicine is extremely challenging. Here, we summarise our experiences and achievements with engaging and mobilising community pharmacies in and around Salford, United Kingdom, in the Phase III effectiveness Salford Lung Studies (SLS). METHODS: This article provides the authors’ personal experiences and viewpoints on community pharmacy involvement in the SLS. KEY FINDINGS: More than 130 community pharmacies were enabled, and >2500 pharmacy staff trained, for involvement in the SLS. Key to community pharmacy participation in the SLS was the formation of the SLS Pharmacy Steering Group (PSG), contributing to study oversight, and the development of a pharmacy standard operating procedure document, the major principle of which was to ensure minimum disruption to the normal medicine dispensing process while ensuring compliance with regulations, guidelines, good clinical practice and requirements for pharmacovigilance. The high level of commitment and collaboration of community pharmacy in the SLS demonstrated a willingness to work together and take on additional and novel roles beyond their everyday commercial functions for the benefit of patients, despite normally competing for prescription business. CONCLUSIONS: The involvement and integration of community pharmacy as a key partner in the SLS was pivotal in securing the delivery of these world‐first clinical effectiveness studies. To our knowledge, this has not been previously achieved in a study of a pre‐licensed maintenance therapy for a common disease in primary care. John Wiley and Sons Inc. 2020-06-26 2020-10 /pmc/articles/PMC7586830/ /pubmed/32589297 http://dx.doi.org/10.1111/ijpp.12647 Text en © 2020 The Authors. International Journal of Pharmacy Practice published by John Wiley & Sons Ltd on behalf of Royal Pharmaceutical Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Personal View
Leather, David A.
Howard, Steve
Haydock, Gerry
Stephens, Linda
Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title_full Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title_fullStr Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title_full_unstemmed Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title_short Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies
title_sort community pharmacy: a crucial enabler in creating the effectiveness study environment in the salford lung studies
topic Personal View
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7586830/
https://www.ncbi.nlm.nih.gov/pubmed/32589297
http://dx.doi.org/10.1111/ijpp.12647
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