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<title xml:lang="en">Specific features of medicines safety and pharmacovigilance in Africa</title>
<author>
<name sortKey="Isah, Ambrose O" sort="Isah, Ambrose O" uniqKey="Isah A" first="Ambrose O." last="Isah">Ambrose O. Isah</name>
</author>
<author>
<name sortKey="Pal, Shanthi N" sort="Pal, Shanthi N" uniqKey="Pal S" first="Shanthi N." last="Pal">Shanthi N. Pal</name>
</author>
<author>
<name sortKey="Olsson, Sten" sort="Olsson, Sten" uniqKey="Olsson S" first="Sten" last="Olsson">Sten Olsson</name>
</author>
<author>
<name sortKey="Dodoo, Alexander" sort="Dodoo, Alexander" uniqKey="Dodoo A" first="Alexander" last="Dodoo">Alexander Dodoo</name>
</author>
<author>
<name sortKey="Bencheikh, Rachida Soulayami" sort="Bencheikh, Rachida Soulayami" uniqKey="Bencheikh R" first="Rachida Soulayami" last="Bencheikh">Rachida Soulayami Bencheikh</name>
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<idno type="wicri:source">PMC</idno>
<idno type="pmid">25083223</idno>
<idno type="pmc">4110828</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110828</idno>
<idno type="RBID">PMC:4110828</idno>
<idno type="doi">10.1177/2042098611425695</idno>
<date when="2012">2012</date>
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<title xml:lang="en" level="a" type="main">Specific features of medicines safety and pharmacovigilance in Africa</title>
<author>
<name sortKey="Isah, Ambrose O" sort="Isah, Ambrose O" uniqKey="Isah A" first="Ambrose O." last="Isah">Ambrose O. Isah</name>
</author>
<author>
<name sortKey="Pal, Shanthi N" sort="Pal, Shanthi N" uniqKey="Pal S" first="Shanthi N." last="Pal">Shanthi N. Pal</name>
</author>
<author>
<name sortKey="Olsson, Sten" sort="Olsson, Sten" uniqKey="Olsson S" first="Sten" last="Olsson">Sten Olsson</name>
</author>
<author>
<name sortKey="Dodoo, Alexander" sort="Dodoo, Alexander" uniqKey="Dodoo A" first="Alexander" last="Dodoo">Alexander Dodoo</name>
</author>
<author>
<name sortKey="Bencheikh, Rachida Soulayami" sort="Bencheikh, Rachida Soulayami" uniqKey="Bencheikh R" first="Rachida Soulayami" last="Bencheikh">Rachida Soulayami Bencheikh</name>
</author>
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<series>
<title level="j">Therapeutic Advances in Drug Safety</title>
<idno type="ISSN">2042-0986</idno>
<idno type="eISSN">2042-0994</idno>
<imprint>
<date when="2012">2012</date>
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<front>
<div type="abstract" xml:lang="en">
<p>The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.</p>
</div>
</front>
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<pmc article-type="review-article">
<pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Ther Adv Drug Saf</journal-id>
<journal-id journal-id-type="iso-abbrev">Ther Adv Drug Saf</journal-id>
<journal-id journal-id-type="publisher-id">TAW</journal-id>
<journal-id journal-id-type="hwp">sptaw</journal-id>
<journal-title-group>
<journal-title>Therapeutic Advances in Drug Safety</journal-title>
</journal-title-group>
<issn pub-type="ppub">2042-0986</issn>
<issn pub-type="epub">2042-0994</issn>
<publisher>
<publisher-name>SAGE Publications</publisher-name>
<publisher-loc>Sage UK: London, England</publisher-loc>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">25083223</article-id>
<article-id pub-id-type="pmc">4110828</article-id>
<article-id pub-id-type="doi">10.1177/2042098611425695</article-id>
<article-id pub-id-type="publisher-id">10.1177_2042098611425695</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Reviews</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Specific features of medicines safety and pharmacovigilance in Africa</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Isah</surname>
<given-names>Ambrose O.</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Pal</surname>
<given-names>Shanthi N.</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Olsson</surname>
<given-names>Sten</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Dodoo</surname>
<given-names>Alexander</given-names>
</name>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bencheikh</surname>
<given-names>Rachida Soulayami</given-names>
</name>
</contrib>
</contrib-group>
<author-notes id="author-notes1-2042098611425695">
<corresp id="corresp1-2042098611425695">Ambrose O. Isah, MBBS, FMCP, FWACP, MD (UK) Department of Medicine, School of Medicine College of Medical Sciences, University of Benin, Benin City, Nigeria, and Department of Medicine, Clinical Pharmacology and Therapeutics Unit, University of Benin Teaching Hospital, Benin City, Edo State, PMB 1111, Nigeria
<email>ambroseisah@yahoo.com</email>
</corresp>
<corresp id="corresp2-2042098611425695">Shanthi N. Pal, M Pharm, PhD Quality Assurance and Safety: Medicines Department of Essential Medicines and Pharmaceutical Policies, WHO, Geneva, Switzerland</corresp>
<corresp id="corresp3-2042098611425695">Sten Olsson, MSc Pharm WHO-UMC, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden</corresp>
<corresp id="corresp4-2042098611425695">Alexander Dodoo, PhD Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana Medical School, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, Accra, Ghana</corresp>
<corresp id="corresp5-2042098611425695">Rachida Soulayami Bencheikh, MD Moroccan Poison and Pharmacovigilance Centre, Moroccan Pharmacovigilance Centre, Rabat, Morocco</corresp>
<fn fn-type="conflict">
<p>The authors declare no conflicts in preparing this article.</p>
</fn>
</author-notes>
<pub-date pub-type="epub-ppub">
<month>2</month>
<year>2012</year>
</pub-date>
<pmc-comment>Fake ppub date generated by PMC from publisher pub-date/@pub-type='epub-ppub' </pmc-comment>
<pub-date pub-type="ppub">
<month>2</month>
<year>2012</year>
</pub-date>
<volume>3</volume>
<issue>1</issue>
<fpage>25</fpage>
<lpage>34</lpage>
<permissions>
<copyright-statement>© The Author(s), 2011</copyright-statement>
<copyright-year>2011</copyright-year>
<copyright-holder content-type="sage">SAGE Publications</copyright-holder>
</permissions>
<abstract>
<p>The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.</p>
</abstract>
<kwd-group>
<kwd>adverse drug reactions</kwd>
<kwd>Africa</kwd>
<kwd>medicines safety</kwd>
<kwd>pharmacovigilance</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>

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