National post-market surveillance assessment of veterinary medicines in Korea during the past decade
Identifieur interne : 000126 ( Pmc/Curation ); précédent : 000125; suivant : 000127National post-market surveillance assessment of veterinary medicines in Korea during the past decade
Auteurs : Jeongwoo Kang ; Hae-Chul Park ; Yang Ho Jang ; Md Akil Hossain ; Kyunghun Jeong ; Mi Young Jeong ; Seon-Jong Yun ; Sung-Won Park ; Dae Gyun Kim ; Kwang-Jick LeeSource :
- BMC Veterinary Research [ 1746-6148 ] ; 2017.
Abstract
Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine.
In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the “national post-market surveillance (NPMS) system” over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A.
The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good quality of medicine.
Url:
DOI: 10.1186/s12917-017-1054-z
PubMed: 28532461
PubMed Central: 5441046
Links toward previous steps (curation, corpus...)
- to stream Pmc, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000126
Links to Exploration step
PMC:5441046Curation
No country items
Jeongwoo Kang<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">National post-market surveillance assessment of veterinary medicines in Korea during the past decade</title>
<author><name sortKey="Kang, Jeongwoo" sort="Kang, Jeongwoo" uniqKey="Kang J" first="Jeongwoo" last="Kang">Jeongwoo Kang</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Park, Hae Chul" sort="Park, Hae Chul" uniqKey="Park H" first="Hae-Chul" last="Park">Hae-Chul Park</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jang, Yang Ho" sort="Jang, Yang Ho" uniqKey="Jang Y" first="Yang Ho" last="Jang">Yang Ho Jang</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hossain, Md Akil" sort="Hossain, Md Akil" uniqKey="Hossain M" first="Md Akil" last="Hossain">Md Akil Hossain</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jeong, Kyunghun" sort="Jeong, Kyunghun" uniqKey="Jeong K" first="Kyunghun" last="Jeong">Kyunghun Jeong</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jeong, Mi Young" sort="Jeong, Mi Young" uniqKey="Jeong M" first="Mi Young" last="Jeong">Mi Young Jeong</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Yun, Seon Jong" sort="Yun, Seon Jong" uniqKey="Yun S" first="Seon-Jong" last="Yun">Seon-Jong Yun</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Park, Sung Won" sort="Park, Sung Won" uniqKey="Park S" first="Sung-Won" last="Park">Sung-Won Park</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kim, Dae Gyun" sort="Kim, Dae Gyun" uniqKey="Kim D" first="Dae Gyun" last="Kim">Dae Gyun Kim</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Lee, Kwang Jick" sort="Lee, Kwang Jick" uniqKey="Lee K" first="Kwang-Jick" last="Lee">Kwang-Jick Lee</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">28532461</idno>
<idno type="pmc">5441046</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5441046</idno>
<idno type="RBID">PMC:5441046</idno>
<idno type="doi">10.1186/s12917-017-1054-z</idno>
<date when="2017">2017</date>
<idno type="wicri:Area/Pmc/Corpus">000126</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000126</idno>
<idno type="wicri:Area/Pmc/Curation">000126</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000126</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">National post-market surveillance assessment of veterinary medicines in Korea during the past decade</title>
<author><name sortKey="Kang, Jeongwoo" sort="Kang, Jeongwoo" uniqKey="Kang J" first="Jeongwoo" last="Kang">Jeongwoo Kang</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Park, Hae Chul" sort="Park, Hae Chul" uniqKey="Park H" first="Hae-Chul" last="Park">Hae-Chul Park</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jang, Yang Ho" sort="Jang, Yang Ho" uniqKey="Jang Y" first="Yang Ho" last="Jang">Yang Ho Jang</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hossain, Md Akil" sort="Hossain, Md Akil" uniqKey="Hossain M" first="Md Akil" last="Hossain">Md Akil Hossain</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jeong, Kyunghun" sort="Jeong, Kyunghun" uniqKey="Jeong K" first="Kyunghun" last="Jeong">Kyunghun Jeong</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Jeong, Mi Young" sort="Jeong, Mi Young" uniqKey="Jeong M" first="Mi Young" last="Jeong">Mi Young Jeong</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Yun, Seon Jong" sort="Yun, Seon Jong" uniqKey="Yun S" first="Seon-Jong" last="Yun">Seon-Jong Yun</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Park, Sung Won" sort="Park, Sung Won" uniqKey="Park S" first="Sung-Won" last="Park">Sung-Won Park</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Kim, Dae Gyun" sort="Kim, Dae Gyun" uniqKey="Kim D" first="Dae Gyun" last="Kim">Dae Gyun Kim</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Lee, Kwang Jick" sort="Lee, Kwang Jick" uniqKey="Lee K" first="Kwang-Jick" last="Lee">Kwang-Jick Lee</name>
<affiliation><nlm:aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</nlm:aff>
<wicri:noCountry code="subfield">Gyeongsangbuk-do 39660 Republic of Korea</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series><title level="j">BMC Veterinary Research</title>
<idno type="eISSN">1746-6148</idno>
<imprint><date when="2017">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine.</p>
</sec>
<sec><title>Results</title>
<p>In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the “national post-market surveillance (NPMS) system” over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A.</p>
</sec>
<sec><title>Conclusion</title>
<p>The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good quality of medicine.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Kramer, Db" uniqKey="Kramer D">DB Kramer</name>
</author>
<author><name sortKey="Tan, Yt" uniqKey="Tan Y">YT Tan</name>
</author>
<author><name sortKey="Sato, C" uniqKey="Sato C">C Sato</name>
</author>
<author><name sortKey="Kesselheim, As" uniqKey="Kesselheim A">AS Kesselheim</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Lee, Kj" uniqKey="Lee K">KJ Lee</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Jang, Hj" uniqKey="Jang H">HJ Jang</name>
</author>
<author><name sortKey="Park, Sw" uniqKey="Park S">SW Park</name>
</author>
<author><name sortKey="Yun, Sm" uniqKey="Yun S">SM Yun</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Kim, Mk" uniqKey="Kim M">MK Kim</name>
</author>
<author><name sortKey="Cho, Bh" uniqKey="Cho B">BH Cho</name>
</author>
<author><name sortKey="Lim, Cm" uniqKey="Lim C">CM Lim</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Kang, Jw" uniqKey="Kang J">JW Kang</name>
</author>
<author><name sortKey="Park, Hc" uniqKey="Park H">HC Park</name>
</author>
<author><name sortKey="Gedi, V" uniqKey="Gedi V">V Gedi</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Vet Res</journal-id>
<journal-id journal-id-type="iso-abbrev">BMC Vet. Res</journal-id>
<journal-title-group><journal-title>BMC Veterinary Research</journal-title>
</journal-title-group>
<issn pub-type="epub">1746-6148</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">28532461</article-id>
<article-id pub-id-type="pmc">5441046</article-id>
<article-id pub-id-type="publisher-id">1054</article-id>
<article-id pub-id-type="doi">10.1186/s12917-017-1054-z</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>National post-market surveillance assessment of veterinary medicines in Korea during the past decade</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Kang</surname>
<given-names>JeongWoo</given-names>
</name>
<address><email>hijach@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Park</surname>
<given-names>Hae-chul</given-names>
</name>
<address><email>sungpark@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jang</surname>
<given-names>Yang ho</given-names>
</name>
<address><email>boonmeri@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hossain</surname>
<given-names>Md Akil</given-names>
</name>
<address><email>mahossain@knu.ac.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jeong</surname>
<given-names>Kyunghun</given-names>
</name>
<address><email>xixer44@naver.com</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jeong</surname>
<given-names>Mi young</given-names>
</name>
<address><email>soccer459@hanmail.com</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yun</surname>
<given-names>Seon-Jong</given-names>
</name>
<address><email>paru33@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Park</surname>
<given-names>Sung-won</given-names>
</name>
<address><email>pasawa@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kim</surname>
<given-names>Dae gyun</given-names>
</name>
<address><email>kimdg@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0002-2785-6533</contrib-id>
<name><surname>Lee</surname>
<given-names>Kwang-jick</given-names>
</name>
<address><phone>+82-31-467-1770</phone>
<email>leekwj@korea.kr</email>
</address>
<xref ref-type="aff" rid="Aff1"></xref>
</contrib>
<aff id="Aff1">Veterinary drugs & Biologics Division, Animal and Plant Quarantine Agency (QIA), 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do 39660 Republic of Korea</aff>
</contrib-group>
<pub-date pub-type="epub"><day>22</day>
<month>5</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>22</day>
<month>5</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="collection"><year>2017</year>
</pub-date>
<volume>13</volume>
<elocation-id>136</elocation-id>
<history><date date-type="received"><day>13</day>
<month>2</month>
<year>2017</year>
</date>
<date date-type="accepted"><day>9</day>
<month>5</month>
<year>2017</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2017</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), 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 (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine.</p>
</sec>
<sec><title>Results</title>
<p>In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the “national post-market surveillance (NPMS) system” over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A.</p>
</sec>
<sec><title>Conclusion</title>
<p>The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good quality of medicine.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Veterinary medicine</kwd>
<kwd>Quality control</kwd>
<kwd>Post-market surveillance assay</kwd>
</kwd-group>
<funding-group><award-group><funding-source><institution>Animal and Plant Quarantine Agency</institution>
</funding-source>
<award-id>101-6200-6240-301-210</award-id>
<principal-award-recipient><name><surname>Lee</surname>
<given-names>Kwang-jick</given-names>
</name>
</principal-award-recipient>
</award-group>
</funding-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2017</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/CovidV1/Data/Pmc/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000126 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd -nk 000126 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Sante |area= CovidV1 |flux= Pmc |étape= Curation |type= RBID |clé= PMC:5441046 |texte= National post-market surveillance assessment of veterinary medicines in Korea during the past decade }}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Curation/RBID.i -Sk "pubmed:28532461" \ | HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Curation/biblio.hfd \ | NlmPubMed2Wicri -a CovidV1
This area was generated with Dilib version V0.6.33. |