The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya
Identifieur interne : 000572 ( Pmc/Curation ); précédent : 000571; suivant : 000573The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya
Auteurs : Francis Wafula [Kenya] ; Timothy Abuya [Kenya] ; Abdinasir Amin [Kenya] ; Catherine Goodman [Kenya, Royaume-Uni]Source :
- BMC Health Services Research [ 1472-6963 ] ; 2014.
Abstract
Specialized drug shops (SDSs) are popular in Sub-Saharan Africa because they provide convenient access to medicines. There is increasing interest in how policymakers can work with them, but little knowledge on how their operation relates to regulatory frameworks. This study sought to describe characteristics and predictors of regulatory practices among SDSs in Kenya.
The regulatory framework governing the Kenya pharmaceutical sector was mapped, and a list of regulations selected for inclusion in a survey questionnaire. An SDS census was conducted, and survey data collected from 213 SDSs from two districts in Western Kenya.
The majority of SDSs did not comply with regulations, with only 12% having a refrigerator and 22% having a separate dispensing area for instance. Additionally, less than half had at least one staff with pharmacy qualification (46%), with less than a third of all interviewed operators knowing the name of the law governing pharmacy.
Regulatory infringement was more common among SDSs in rural locations; those that did not have staff with pharmacy qualifications; and those whose operator did not know the name of the pharmacy law. Compliance was not significantly associated with the frequency of inspections, with over 80% of both rural and urban SDSs reporting an inspection in the past year.
While compliance was low overall, it was particularly poor among SDSs operating in rural locations, and those that did not have staff with pharmacy qualification. This suggested the need for policy to introduce levels of practice in recognition of the variations in resource availability. Under such a system, rural SDSs operating in low-resource setting, and selling a limited range of medicines, may be exempted from certain regulatory requirements, as long as their scope of practice is limited to certain essential services only. Future research should also explore why regulatory compliance is poor despite regular inspections.
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DOI: 10.1186/1472-6963-14-394
PubMed: 25227916
PubMed Central: 4175572
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya</title><author><name sortKey="Wafula, Francis" sort="Wafula, Francis" uniqKey="Wafula F" first="Francis" last="Wafula">Francis Wafula</name><affiliation wicri:level="1"><nlm:aff id="Aff7">KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Abuya, Timothy" sort="Abuya, Timothy" uniqKey="Abuya T" first="Timothy" last="Abuya">Timothy Abuya</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Population Council, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Population Council, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Amin, Abdinasir" sort="Amin, Abdinasir" uniqKey="Amin A" first="Abdinasir" last="Amin">Abdinasir Amin</name><affiliation wicri:level="1"><nlm:aff id="Aff9">ICF International, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>ICF International, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Goodman, Catherine" sort="Goodman, Catherine" uniqKey="Goodman C" first="Catherine" last="Goodman">Catherine Goodman</name><affiliation wicri:level="1"><nlm:aff id="Aff7">KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff10">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25227916</idno><idno type="pmc">4175572</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4175572</idno><idno type="RBID">PMC:4175572</idno><idno type="doi">10.1186/1472-6963-14-394</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000573</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000573</idno><idno type="wicri:Area/Pmc/Curation">000572</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000572</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya</title><author><name sortKey="Wafula, Francis" sort="Wafula, Francis" uniqKey="Wafula F" first="Francis" last="Wafula">Francis Wafula</name><affiliation wicri:level="1"><nlm:aff id="Aff7">KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Abuya, Timothy" sort="Abuya, Timothy" uniqKey="Abuya T" first="Timothy" last="Abuya">Timothy Abuya</name><affiliation wicri:level="1"><nlm:aff id="Aff8">Population Council, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>Population Council, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Amin, Abdinasir" sort="Amin, Abdinasir" uniqKey="Amin A" first="Abdinasir" last="Amin">Abdinasir Amin</name><affiliation wicri:level="1"><nlm:aff id="Aff9">ICF International, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>ICF International, Nairobi</wicri:regionArea></affiliation></author><author><name sortKey="Goodman, Catherine" sort="Goodman, Catherine" uniqKey="Goodman C" first="Catherine" last="Goodman">Catherine Goodman</name><affiliation wicri:level="1"><nlm:aff id="Aff7">KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi, Kenya</nlm:aff><country xml:lang="fr">Kenya</country><wicri:regionArea>KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff10">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Health Services Research</title><idno type="eISSN">1472-6963</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Specialized drug shops (SDSs) are popular in Sub-Saharan Africa because they provide convenient access to medicines. There is increasing interest in how policymakers can work with them, but little knowledge on how their operation relates to regulatory frameworks. This study sought to describe characteristics and predictors of regulatory practices among SDSs in Kenya.</p></sec><sec><title>Methods</title><p>The regulatory framework governing the Kenya pharmaceutical sector was mapped, and a list of regulations selected for inclusion in a survey questionnaire. An SDS census was conducted, and survey data collected from 213 SDSs from two districts in Western Kenya.</p></sec><sec><title>Results</title><p>The majority of SDSs did not comply with regulations, with only 12% having a refrigerator and 22% having a separate dispensing area for instance. Additionally, less than half had at least one staff with pharmacy qualification (46%), with less than a third of all interviewed operators knowing the name of the law governing pharmacy.</p><p>Regulatory infringement was more common among SDSs in rural locations; those that did not have staff with pharmacy qualifications; and those whose operator did not know the name of the pharmacy law. Compliance was not significantly associated with the frequency of inspections, with over 80% of both rural and urban SDSs reporting an inspection in the past year.</p></sec><sec><title>Conclusion</title><p>While compliance was low overall, it was particularly poor among SDSs operating in rural locations, and those that did not have staff with pharmacy qualification. This suggested the need for policy to introduce levels of practice in recognition of the variations in resource availability. Under such a system, rural SDSs operating in low-resource setting, and selling a limited range of medicines, may be exempted from certain regulatory requirements, as long as their scope of practice is limited to certain essential services only. Future research should also explore why regulatory compliance is poor despite regular inspections.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Brieger, W" uniqKey="Brieger W">W Brieger</name></author><author><name sortKey="Unwin, A" uniqKey="Unwin A">A Unwin</name></author><author><name sortKey="Greer, G" uniqKey="Greer G">G Greer</name></author><author><name sortKey="Meek, S" uniqKey="Meek S">S Meek</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Ross Degnan, D" uniqKey="Ross Degnan D">D Ross-Degnan</name></author><author><name sortKey="Soumerai, Sb" uniqKey="Soumerai S">SB Soumerai</name></author><author><name sortKey="Goel, Pk" uniqKey="Goel P">PK Goel</name></author><author><name sortKey="Bates, J" uniqKey="Bates J">J Bates</name></author><author><name sortKey="Makhulo, J" uniqKey="Makhulo J">J Makhulo</name></author><author><name sortKey="Dondi, N" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Health Serv Res</journal-id><journal-id journal-id-type="iso-abbrev">BMC Health Serv Res</journal-id><journal-title-group><journal-title>BMC Health Services Research</journal-title></journal-title-group><issn pub-type="epub">1472-6963</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25227916</article-id><article-id pub-id-type="pmc">4175572</article-id><article-id pub-id-type="publisher-id">3492</article-id><article-id pub-id-type="doi">10.1186/1472-6963-14-394</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Wafula</surname><given-names>Francis</given-names></name><address><email>frankfula@yahoo.com</email></address><xref ref-type="aff" rid="Aff7"></xref></contrib><contrib contrib-type="author"><name><surname>Abuya</surname><given-names>Timothy</given-names></name><address><email>tabuya@popcouncil.org</email></address><xref ref-type="aff" rid="Aff8"></xref></contrib><contrib contrib-type="author"><name><surname>Amin</surname><given-names>Abdinasir</given-names></name><address><email>Abdinasir.Amin@icfi.com</email></address><xref ref-type="aff" rid="Aff9"></xref></contrib><contrib contrib-type="author"><name><surname>Goodman</surname><given-names>Catherine</given-names></name><address><email>Catherine.goodman@lshtm.ac.uk</email></address><xref ref-type="aff" rid="Aff7"></xref><xref ref-type="aff" rid="Aff10"></xref></contrib><aff id="Aff7"><label></label>KEMRI/Wellcome Trust Research Programme, P. O. Box 43640–00100, Nairobi, Kenya</aff><aff id="Aff8"><label></label>Population Council, Nairobi, Kenya</aff><aff id="Aff9"><label></label>ICF International, Nairobi, Kenya</aff><aff id="Aff10"><label></label>London School of Hygiene and Tropical Medicine, London, UK</aff></contrib-group><pub-date pub-type="epub"><day>16</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>16</day><month>9</month><year>2014</year></pub-date><pub-date pub-type="collection"><year>2014</year></pub-date><volume>14</volume><elocation-id>394</elocation-id><history><date date-type="received"><day>7</day><month>1</month><year>2013</year></date><date date-type="accepted"><day>11</day><month>9</month><year>2014</year></date></history><permissions><copyright-statement>© Wafula et al.; licensee BioMed Central Ltd. 2014</copyright-statement><license license-type="open-access"><license-p>This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0">http://creativecommons.org/licenses/by/2.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>Specialized drug shops (SDSs) are popular in Sub-Saharan Africa because they provide convenient access to medicines. There is increasing interest in how policymakers can work with them, but little knowledge on how their operation relates to regulatory frameworks. This study sought to describe characteristics and predictors of regulatory practices among SDSs in Kenya.</p></sec><sec><title>Methods</title><p>The regulatory framework governing the Kenya pharmaceutical sector was mapped, and a list of regulations selected for inclusion in a survey questionnaire. An SDS census was conducted, and survey data collected from 213 SDSs from two districts in Western Kenya.</p></sec><sec><title>Results</title><p>The majority of SDSs did not comply with regulations, with only 12% having a refrigerator and 22% having a separate dispensing area for instance. Additionally, less than half had at least one staff with pharmacy qualification (46%), with less than a third of all interviewed operators knowing the name of the law governing pharmacy.</p><p>Regulatory infringement was more common among SDSs in rural locations; those that did not have staff with pharmacy qualifications; and those whose operator did not know the name of the pharmacy law. Compliance was not significantly associated with the frequency of inspections, with over 80% of both rural and urban SDSs reporting an inspection in the past year.</p></sec><sec><title>Conclusion</title><p>While compliance was low overall, it was particularly poor among SDSs operating in rural locations, and those that did not have staff with pharmacy qualification. This suggested the need for policy to introduce levels of practice in recognition of the variations in resource availability. Under such a system, rural SDSs operating in low-resource setting, and selling a limited range of medicines, may be exempted from certain regulatory requirements, as long as their scope of practice is limited to certain essential services only. Future research should also explore why regulatory compliance is poor despite regular inspections.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Regulation</kwd><kwd>Pharmaceutical Services</kwd><kwd>Drug Shops</kwd><kwd>Kenya</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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