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First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities

BACKGROUND: Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Per...

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Autores principales: Trap, Birna, Kikule, Kate, Vialle-Valentin, Catherine, Musoke, Richard, Lajul, Grace Otto, Hoppenworth, Kim, Konradsen, Dorthe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4857441/
https://www.ncbi.nlm.nih.gov/pubmed/27152199
http://dx.doi.org/10.1186/s40545-016-0068-4
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author Trap, Birna
Kikule, Kate
Vialle-Valentin, Catherine
Musoke, Richard
Lajul, Grace Otto
Hoppenworth, Kim
Konradsen, Dorthe
author_facet Trap, Birna
Kikule, Kate
Vialle-Valentin, Catherine
Musoke, Richard
Lajul, Grace Otto
Hoppenworth, Kim
Konradsen, Dorthe
author_sort Trap, Birna
collection PubMed
description BACKGROUND: Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Performance Assessment, and Recognition Strategy) to build GPP and medicines management capacity in the public sector. METHODS: The study includes 455 public facilities: 417 facilities were inspected after at least four SPARS visits by trained managerial district staff (SPARS group), 38 before any exposure to SPARS. NDA inspectors measured 10 critical, 20 major, and 37 minor GPP indicators in every facility and only accredited facilities that passed all 10 critical and failed no more than 7 major indicators. Lack of compliance for a given indicator was defined as less than 75 % facilities passing that indicator. We assessed factors associated with certification using logistic regression analysis and compared number of failed indicators between the SPARS and comparative groups using two sample t-tests with equal or unequal variance. RESULTS: 57.4 % of inspected facilities obtained GPP certification: 57.1 % in the SPARS and 60.5 % in the comparative group (Adj. OR = 0.91, 95 % CI 0.45–1.85, p = 0.802). Overall, facilities failed an average of 10 indicators. SPARS facilities performed better than comparative facilities (9 (SD 6.1) vs. 13 (SD 7.7) failed indicators respectively; p = 0.017), and SPARS supported facilities scored better on indicators covered by SPARS. For all indicators but one minor, performance in the SPARS group was equal to or significantly better than in unsupervised facilities. Within the SPARS (intervention) group, certified facilities had < 75 % compliance on 7 indicators (all minor), and uncertified facilities on 19 (4 critical, 2 major, and 13 minor) indicators. CONCLUSIONS: Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of inspected public health facilities meet GPP standards. SPARS facilities tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. None compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular NDA inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40545-016-0068-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-48574412016-05-06 First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities Trap, Birna Kikule, Kate Vialle-Valentin, Catherine Musoke, Richard Lajul, Grace Otto Hoppenworth, Kim Konradsen, Dorthe J Pharm Policy Pract Research BACKGROUND: Since its inception, the Uganda National Drug Authority (NDA) has regularly inspected private sector pharmacies to monitor adherence to Good Pharmacy Practices (GPP). This study reports findings from the first public facility inspections following an intervention (SPARS: Supervision, Performance Assessment, and Recognition Strategy) to build GPP and medicines management capacity in the public sector. METHODS: The study includes 455 public facilities: 417 facilities were inspected after at least four SPARS visits by trained managerial district staff (SPARS group), 38 before any exposure to SPARS. NDA inspectors measured 10 critical, 20 major, and 37 minor GPP indicators in every facility and only accredited facilities that passed all 10 critical and failed no more than 7 major indicators. Lack of compliance for a given indicator was defined as less than 75 % facilities passing that indicator. We assessed factors associated with certification using logistic regression analysis and compared number of failed indicators between the SPARS and comparative groups using two sample t-tests with equal or unequal variance. RESULTS: 57.4 % of inspected facilities obtained GPP certification: 57.1 % in the SPARS and 60.5 % in the comparative group (Adj. OR = 0.91, 95 % CI 0.45–1.85, p = 0.802). Overall, facilities failed an average of 10 indicators. SPARS facilities performed better than comparative facilities (9 (SD 6.1) vs. 13 (SD 7.7) failed indicators respectively; p = 0.017), and SPARS supported facilities scored better on indicators covered by SPARS. For all indicators but one minor, performance in the SPARS group was equal to or significantly better than in unsupervised facilities. Within the SPARS (intervention) group, certified facilities had < 75 % compliance on 7 indicators (all minor), and uncertified facilities on 19 (4 critical, 2 major, and 13 minor) indicators. CONCLUSIONS: Half of the Ugandan population obtains medicines from the public sector. Yet, we found only 3/5 of inspected public health facilities meet GPP standards. SPARS facilities tended to perform better than unsupervised facilities, substantiating the value of supporting supervision interventions in GPP areas that need strengthening. None compliant indicators can be improved through practices and behavioral changes; some require infrastructure investments. We conclude that regular NDA inspections of public sector pharmacies in conjunction with interventions to improve GPP adherence can revolutionize patient care in Uganda. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40545-016-0068-4) contains supplementary material, which is available to authorized users. BioMed Central 2016-05-04 /pmc/articles/PMC4857441/ /pubmed/27152199 http://dx.doi.org/10.1186/s40545-016-0068-4 Text en © Trap et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Trap, Birna
Kikule, Kate
Vialle-Valentin, Catherine
Musoke, Richard
Lajul, Grace Otto
Hoppenworth, Kim
Konradsen, Dorthe
First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title_full First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title_fullStr First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title_full_unstemmed First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title_short First regulatory inspections measuring adherence to Good Pharmacy Practices in the public sector in Uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
title_sort first regulatory inspections measuring adherence to good pharmacy practices in the public sector in uganda: a cross-sectional comparison of performance between supervised and unsupervised facilities
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4857441/
https://www.ncbi.nlm.nih.gov/pubmed/27152199
http://dx.doi.org/10.1186/s40545-016-0068-4
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