Importation and distribution of unregistered medicines in the public sector: similarities, differences, and shared challenges among Southern African Development Community (SADC) countries.
Implementation
Importation
Legal provisions
SADC
Unregistered medicines
Journal
BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677
Informations de publication
Date de publication:
28 Apr 2022
28 Apr 2022
Historique:
received:
14
12
2021
accepted:
26
04
2022
entrez:
28
4
2022
pubmed:
29
4
2022
medline:
3
5
2022
Statut:
epublish
Résumé
The purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries. The study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package. Approximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4 to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively. Implementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.
Sections du résumé
BACKGROUND
BACKGROUND
The purpose of the study was to assess the requirements for approval of the importation of unregistered medicines for use in the public sector in the Southern African Development Community (SADC) countries.
METHODS
METHODS
The study reviewed the legal provisions and requirements to be fulfilled when importing unregistered medicines for the public sector in SADC countries relative to two comparators drawn from countries with stringent regulatory systems through extant document analysis. The relative implementation index score was calculated and used to measure the level of implementing legal provisions and requirements to be fulfilled. Analysis was performed using the STATA software package.
RESULTS
RESULTS
Approximately 13 out of 16 SADC countries had a relative implementation index below 50%. The aggregated implementation index across all SADC countries was 44%, ranging from 4 to 54%, while the two comparators had a relative implementation index of 81% and 85%, respectively.
CONCLUSION
CONCLUSIONS
Implementing the minimum requirements for importing unregistered medicines for the public sector was deficient compared to the jurisdictions with stringent regulatory systems, and wide implementation gaps also existed within the SADC region.
Identifiants
pubmed: 35484525
doi: 10.1186/s12913-022-07995-3
pii: 10.1186/s12913-022-07995-3
pmc: PMC9047363
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
570Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
© 2022. The Author(s).
Références
BMJ Glob Health. 2020 Aug;5(8):
pubmed: 32784212
Front Pharmacol. 2018 Dec 04;9:1407
pubmed: 30618735
Front Med (Lausanne). 2020 Aug 19;7:457
pubmed: 32974367
Clin Pharmacol Ther. 2011 Feb;89(2):176-8
pubmed: 21252936
Pharmaceut Med. 2017;31(6):383-397
pubmed: 29200865
PLoS One. 2016 Oct 25;11(10):e0165183
pubmed: 27780218
PLoS One. 2017 Jun 28;12(6):e0179479
pubmed: 28658307
Eur J Clin Pharmacol. 2015 Sep;71(9):1029-35
pubmed: 26153083
Perspect Clin Res. 2011 Jan;2(1):34-7
pubmed: 21584180
BMC Med. 2016 Sep 29;14(1):124
pubmed: 27683105
J Antimicrob Chemother. 2007 Aug;60(2):214-36
pubmed: 17550892
BMC Health Serv Res. 2021 Dec 14;21(1):1337
pubmed: 34903223
BMC Public Health. 2021 Jan 21;21(1):187
pubmed: 33478421
Am J Health Syst Pharm. 2011 Oct 1;68(19):1811-9
pubmed: 21930639
Front Pharmacol. 2019 Jul 19;10:763
pubmed: 31379565
BMC Health Serv Res. 2020 Mar 19;20(1):234
pubmed: 32192481
Anesth Analg. 2017 Aug;125(2):616-619
pubmed: 28682949
Healthc Policy. 2012 May;7(4):10-7
pubmed: 23634158
Front Pharmacol. 2018 Jan 18;8:942
pubmed: 29403372
PLoS Med. 2020 Aug 12;17(8):e1003133
pubmed: 32785273
Global Health. 2018 Nov 1;14(1):102
pubmed: 30382856