<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1699-714X</journal-id>
<journal-title><![CDATA[Revista de la OFIL ]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. OFIL·ILAPHAR]]></abbrev-journal-title>
<issn>1699-714X</issn>
<publisher>
<publisher-name><![CDATA[Organización de Farmacéuticos Ibero-Latinoamericanos]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1699-714X2021000100006</article-id>
<article-id pub-id-type="doi">10.4321/s1699-714x2021000100006</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Automatização em nutrição parentérica: controlo de qualidade antes e após a sua implementação]]></article-title>
<article-title xml:lang="en"><![CDATA[Automation in parenteral nutrition: quality control of the process before and after it`s implementation]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Barbosa]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Capela]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sampaio]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fraga]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Soares]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Hospitalar e Universitário de São João Serviços Farmacêuticos ]]></institution>
<addr-line><![CDATA[Porto ]]></addr-line>
<country>Portugal</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<volume>31</volume>
<numero>1</numero>
<fpage>24</fpage>
<lpage>27</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1699-714X2021000100006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1699-714X2021000100006&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1699-714X2021000100006&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[RESUMO A nutrição parentérica (NP) desempenha um papel vital em doentes críticos, sendo muitas vezes necessária a sua preparação personalizada, ajustada às necessidades de doentes com carências específicas. A manipulação de NP poderá ser realizada de forma manual ou automatizada, requerendo sempre condições asséticas e pessoal treinado. A implementação de um sistema automatizado requer uma análise cuidada da sua necessidade/justificação, de forma a que, baseado em fundamentação adequada, se estruture um plano exequível. A monitorização do desempenho do sistema automatizado é um processo fundamental de validação farmacêutica. Nos Serviços Farmacêuticos (SF) do Centro Hospitalar e Universitário de São João (CHUSJ), elaborou-se um estudo de controlo de qualidade gravimétrico antes e após implementação do sistema automatizado, no sentido de monitorizar a precisão dos resultados obtidos para este ensaio de verificação. Como resultados estatísticos, o método de enchimento automatizado relacionou-se com a menor média para o desvio ao peso teórico, assim como menor desvio padrão, corroborando uma menor percentagem de erro e também uma menor dispersão dos resultados. Da análise dos resultados obtidos concluiu-se que a implementação da automatização se traduziu em melhorias a nível de precisão de resultados para o controlo gravimétrico das bolsas nutritivas, aumentando a segurança das misturas produzidas e, consequentemente, a qualidade dos cuidados prestados ao doente. É de elevada importância que se implementem procedimentos de validação do desempenho do sistema automatizado, como foi o caso, sendo que deverão ser complementados com outro tipo de avaliações, preferencialmente realizadas por entidades externas à instituição em causa.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY Parenteral nutrition (PN) plays a vital role in critically ill patients and custom preparation is often necessary, adjusted to the needs of patients with specific needs. Compounding PN handling can be performed manually or automated, always requiring aseptic conditions and trained personnel. The implementation of an automated system requires a careful analysis of its need/ justification, so that, based on adequate rationale, a feasible execution plan may be structured. Monitoring the performance of the automated system is a key process which requires of pharmaceutical validation. In the Pharmaceutical Service of the Centro Hospitalar e Universitário de São João (CHUSJ), a study of gravimetric quality control was carried out before and after the implementation of the automated system, in order to monitor the accuracy of the results obtained for this verification test. As statistical results, the automated filling method was related to the lower average for the deviation to the theoretical weight, as well as lower standard deviation, corroborating a lower percentage of error but also a smaller dispersion of the results with this method. From the analysis of the results obtained, it was concluded that the implementation of automation resulted in improvements in the accuracy of results for the gravimetric control of nutritional bags, increasing the safety of the mixtures produced and, consequently, the quality of care provided to the patient. It is of highly importance that procedures for validating the performance of the automated system are implemented, as was the case, and these should be complemented by other types of evaluations, preferably performed by external entities to the institution in question.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[Automatização]]></kwd>
<kwd lng="pt"><![CDATA[monitorização]]></kwd>
<kwd lng="pt"><![CDATA[nutrição parentérica]]></kwd>
<kwd lng="pt"><![CDATA[controlo de qualidade]]></kwd>
<kwd lng="pt"><![CDATA[controlo gravimétrico]]></kwd>
<kwd lng="en"><![CDATA[Compounding]]></kwd>
<kwd lng="en"><![CDATA[automation]]></kwd>
<kwd lng="en"><![CDATA[monitorization]]></kwd>
<kwd lng="en"><![CDATA[parenteral nutrition]]></kwd>
<kwd lng="en"><![CDATA[quality assurance]]></kwd>
<kwd lng="en"><![CDATA[gravimetric control]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<nlm-citation citation-type="confpro">
<source><![CDATA[Pharmaceutical Compounding. Sterile Preparations]]></source>
<year>2008</year>
<conf-name><![CDATA[ The United States Pharmacopeial Convention]]></conf-name>
<conf-loc> </conf-loc>
</nlm-citation>
</ref>
<ref id="B2">
<nlm-citation citation-type="confpro">
<source><![CDATA[PIC/S Guide to good practices for the preparation of medicinal products in healthcare establishments]]></source>
<year>2014</year>
<conf-name><![CDATA[ Pharmaceutical Inspection Convention]]></conf-name>
<conf-loc> </conf-loc>
</nlm-citation>
</ref>
<ref id="B3">
<nlm-citation citation-type="journal">
<collab>European Comission</collab>
<article-title xml:lang=""><![CDATA[Good Manufacturing Practice Guidelines]]></article-title>
<source><![CDATA[EudraLex, The Rules Governing Medicinal Products in the European Union]]></source>
<year></year>
<volume>4</volume>
</nlm-citation>
</ref>
<ref id="B4">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Curtis]]></surname>
<given-names><![CDATA[Caitlin]]></given-names>
</name>
<name>
<surname><![CDATA[Sacks]]></surname>
<given-names><![CDATA[Gordon]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Compounding Parenteral Nutrition: Reducing the Risks]]></article-title>
<source><![CDATA[Nutrition in Clinical Practice]]></source>
<year>2009</year>
<volume>24</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>441-6</page-range></nlm-citation>
</ref>
<ref id="B5">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bonnabry]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Cingria]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Sadeghipour]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Ing]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Fonzo-Christe]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Pfister]]></surname>
<given-names><![CDATA[RE]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions]]></article-title>
<source><![CDATA[Qual Saf Health Care]]></source>
<year>2005</year>
<volume>14</volume>
<page-range>93-8</page-range></nlm-citation>
</ref>
<ref id="B6">
<nlm-citation citation-type="journal">
<collab>American Society of Health-System Pharmacists</collab>
<article-title xml:lang=""><![CDATA[ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures]]></article-title>
<source><![CDATA[Am J Health-Syst Pharm]]></source>
<year>2000</year>
<volume>57</volume>
<page-range>1343-8</page-range></nlm-citation>
</ref>
<ref id="B7">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Llop]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Martorell]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Mercadal]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Badía]]></surname>
<given-names><![CDATA[MB]]></given-names>
</name>
<name>
<surname><![CDATA[Rancaño]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Abascal]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Tubau]]></surname>
<given-names><![CDATA[Mª]]></given-names>
</name>
<name>
<surname><![CDATA[Jódar]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Automatización de la elaboración de nutrición parenteral: adecuación a la legislación actual]]></article-title>
<source><![CDATA[Nutr Hosp]]></source>
<year>2006</year>
<volume>21</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>184-8</page-range></nlm-citation>
</ref>
<ref id="B8">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Collins]]></surname>
<given-names><![CDATA[Chelsey]]></given-names>
</name>
<name>
<surname><![CDATA[Krämer]]></surname>
<given-names><![CDATA[Irene]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Evaluation of a Process Monitoring Method for Compounding Parenteral Nutrition with the Baxter EM2400 in a Hospital Pharmacy Department]]></article-title>
<source><![CDATA[Pharm. Technol. Hosp. Pharm]]></source>
<year>2017</year>
<volume>2</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>107-15</page-range></nlm-citation>
</ref>
<ref id="B9">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Cardona Pera]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Consenso Espanol sobre la preparacion de mezclas nutrientes parenterales 2008]]></article-title>
<source><![CDATA[Fam Hosp]]></source>
<year>2009</year>
<volume>33</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>81-107</page-range></nlm-citation>
</ref>
<ref id="B10">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Crill]]></surname>
<given-names><![CDATA[Catherine]]></given-names>
</name>
<name>
<surname><![CDATA[Hak]]></surname>
<given-names><![CDATA[Emily]]></given-names>
</name>
<name>
<surname><![CDATA[Helms]]></surname>
<given-names><![CDATA[Richard]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Accuracy of parenteral nutrition solutions compounded with automated systems and by hand]]></article-title>
<source><![CDATA[AJHSP]]></source>
<year>2005</year>
<volume>62</volume>
<page-range>2345-8</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
