<?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>0871-3413</journal-id>
<journal-title><![CDATA[Arquivos de Medicina]]></journal-title>
<abbrev-journal-title><![CDATA[Arq Med]]></abbrev-journal-title>
<issn>0871-3413</issn>
<publisher>
<publisher-name><![CDATA[ArquiMed - Edições Científicas AEFMUP ]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0871-34132008000200007</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Medicamentos Manipulados em Pediatria Estado Actual e Perspectivas Futuras]]></article-title>
<article-title xml:lang="en"><![CDATA[Paediatric Compounding Medicines]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pinto]]></surname>
<given-names><![CDATA[Susana]]></given-names>
</name>
<xref ref-type="aff" rid="A01"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Barbosa]]></surname>
<given-names><![CDATA[Carlos Maurício]]></given-names>
</name>
<xref ref-type="aff" rid="A02"/>
<xref ref-type="aff" rid="A03"/>
</contrib>
</contrib-group>
<aff id="A01">
<institution><![CDATA[,Instituto Português de Oncologia Francisco Gentil  ]]></institution>
<addr-line><![CDATA[Porto ]]></addr-line>
</aff>
<aff id="A02">
<institution><![CDATA[,Universidade do Porto Faculdade de Farmácia Serviço de Tecnologia Farmacêutica]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<aff id="A03">
<institution><![CDATA[,Universidade do Porto CEQUIMED - Centro de Química Medicinal ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2008</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2008</year>
</pub-date>
<volume>22</volume>
<numero>2-3</numero>
<fpage>75</fpage>
<lpage>84</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.pt/scielo.php?script=sci_arttext&amp;pid=S0871-34132008000200007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.pt/scielo.php?script=sci_abstract&amp;pid=S0871-34132008000200007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.pt/scielo.php?script=sci_pdf&amp;pid=S0871-34132008000200007&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Com frequência, na farmacoterapêutica pediátrica há necessidade de administrar substâncias activas que apenas são disponibilizadas pela indústria farmacêutica sob a forma de especialidades farmacêuticas com dosagens e/ou em formas farmacêuticas destinadas a adultos. Nestas situações, a prescrição de fórmulas magistrais e a sua preparação nas farmácias comunitárias e hospitalares permite obter medicamentos, em regra apresentados sob a forma de líquidos para uso oral, adaptados às necessidades especí&#64257;cas de cada doente. No futuro, os incentivos que têm vindo a ser disponibilizados à indústria farmacêutica europeia e americana deverão contribuir para aumentar o número de medicamentos pediátricos produzidos industrialmente. Contudo, por várias razões, não é expectável que estes venham a preencher todas as necessidades terapêuticas em Pediatria, muitas das quais continuarão a ser resolvidas através do recurso à prescrição e preparação de fórmulas magistrais.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Frequentely, in paediatric pharmacotherapy it is necessary to administrate active substances which are only available by pharmaceutical industry under the form of pharmaceutical specialities with dosages and/or dosage forms for adults. In these cases, the prescription of magistral formulations and their preparation by community pharmacies or hospital pharmacies leads to medicines, usually available as liquids for oral use, adaptated to the specific needs of each patient. In the future, the incentives that have been given to European and American pharmaceutical industry should contribute to increase the number of industrialized paediatric medicines. However, for several reasons, it is not expectable that these medicines will fullfil all the paediatric therapeutic needs, many of which will be solved by means of the prescription and preparation of magistral formulations.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[medicamentos pediátricos]]></kwd>
<kwd lng="pt"><![CDATA[medicamentos manipulados]]></kwd>
<kwd lng="pt"><![CDATA[preparações extemporâneas]]></kwd>
<kwd lng="pt"><![CDATA[fórmulas magistrais]]></kwd>
<kwd lng="en"><![CDATA[paediatric medicines]]></kwd>
<kwd lng="en"><![CDATA[compounding medicines]]></kwd>
<kwd lng="en"><![CDATA[extemporaneous preparations]]></kwd>
<kwd lng="en"><![CDATA[magistral formulations]]></kwd>
</kwd-group>
</article-meta>
</front><body><![CDATA[ <p   align="justify" ><B>Medicamentos Manipulados em Pediatria </b></p >    <p   align="justify" ><b>Estado Actual e Perspectivas Futuras </b></p >     <P   align="justify" >Susana Pinto*, Carlos Maur&iacute;cio Barbosa&dagger;&#8224;</P >     <P   align="justify" >&nbsp; </P >     <P   align="justify" ><I>*Instituto Portugu&ecirc;s de Oncologia Francisco Gentil, EPE, Porto; &dagger;&#8224;    Servi&ccedil;o de Tecnologia Farmac&ecirc;utica, Faculdade de Farm&aacute;cia    da Universidade do Porto e CEQUIMED - Centro de Qu&iacute;mica Medicinal da    Universidade do Porto </I></P >     <P   >Com frequ&ecirc;ncia, na farmacoterap&ecirc;utica pedi&aacute;trica h&aacute;    necessidade de administrar subst&acirc;ncias activas que apenas s&atilde;o disponibilizadas    pela ind&uacute;stria farmac&ecirc;utica sob a forma de especialidades farmac&ecirc;uticas    com dosagens e/ou em formas farmac&ecirc;uticas destinadas a adultos. Nestas    situa&ccedil;&otilde;es, a prescri&ccedil;&atilde;o de f&oacute;rmulas magistrais    e a sua prepara&ccedil;&atilde;o nas farm&aacute;cias comunit&aacute;rias e    hospitalares permite obter medicamentos, em regra apresentados sob a forma de    l&iacute;quidos para uso oral, adaptados &agrave;s necessidades espec&iacute;&#64257;cas    de cada doente. No futuro, os incentivos que t&ecirc;m vindo a ser disponibilizados    &agrave; ind&uacute;stria farmac&ecirc;utica europeia e americana dever&atilde;o    contribuir para aumentar o n&uacute;mero de medicamentos pedi&aacute;tricos    produzidos industrialmente. Contudo, por v&aacute;rias raz&otilde;es, n&atilde;o    &eacute; expect&aacute;vel que estes venham a preencher todas as necessidades    terap&ecirc;uticas em Pediatria, muitas das quais continuar&atilde;o a ser resolvidas    atrav&eacute;s do recurso &agrave; prescri&ccedil;&atilde;o e prepara&ccedil;&atilde;o    de f&oacute;rmulas magistrais. </P >     <P   ><B>Palavras-chave: </B>medicamentos pedi&aacute;tricos; medicamentos manipulados;    prepara&ccedil;&otilde;es extempor&acirc;neas; f&oacute;rmulas magistrais.</P >     <P   >&nbsp;</P >     <P   ><b>Paediatric Compounding Medicines</b></P >     <P   >Frequentely, in paediatric pharmacotherapy it is necessary to administrate active    substances which are only available by pharmaceutical industry under the form    of pharmaceutical specialities with dosages and/or dosage forms for adults.    In these cases, the prescription of magistral formulations and their preparation    by community pharmacies or hospital pharmacies leads to medicines, usually available    as liquids for oral use, adaptated to the specific needs of each patient. In    the future, the incentives that have been given to European and American pharmaceutical    industry should contribute to increase the number of industrialized paediatric    medicines. However, for several reasons, it is not expectable that these medicines    will fullfil all the paediatric therapeutic needs, many of which will be solved    by means of the prescription and preparation of magistral formulations.</P >     ]]></body>
<body><![CDATA[<P   ><b> Key-words:</b> paediatric medicines; compounding medicines; extemporaneous    preparations; magistral formulations.</P >     <P   >&nbsp;</P >     <P   >&nbsp;</P >     <P   >Texto completo dispon&iacute;vel apenas em PDF.</P >     <P   >Full text only available in PDF format.</P >     <P   >&nbsp;</P >     <P   >&nbsp;</P >     <!-- ref --><P   >1 - Barbosa CM, Pinto S. Estudo Comparativo de Formul&aacute;rios Gal&eacute;nicos.    Lisboa: Publica&ccedil;&otilde;es Farm&aacute;cia Portuguesa; 2001.</P >     &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[&#160;<a href="javascript:void(0);" onclick="javascript: window.open('/scielo.php?script=sci_nlinks&ref=000020&pid=S0871-3413200800020000700001&lng=','','width=640,height=500,resizable=yes,scrollbars=1,menubar=yes,');">Links</a>&#160;]<!-- end-ref --><P   > 2 - Pinto S. Desenvolvimento Gal&eacute;nico de um Ve&iacute;culo para a Prepara&ccedil;&atilde;o    Extempor&acirc;nea de Suspens&otilde;es de Benzoato de Metronidazol. Tese de    Mestrado em Tecnologia Farmac&ecirc;utica. Porto: Faculdade de Farm&aacute;cia    da Universidade do Porto; 2006.</P >     <P   >3 - Barbosa CM, Pinto S. Medicamentos Manipulados: Que Perspectivas? Farm&aacute;cia    Portuguesa 2000;123:54-60.</P >     ]]></body>
<body><![CDATA[<P   >4 - Barbosa CM, Pinto S. Medicamentos Manipulados: Ponto da Situa&ccedil;&atilde;o.    Farm&aacute;cia Portuguesa 2001;131:46-52.</P >     <P   >5 - Allen L. The Art, Science, and Technology of Pharmaceutical Compounding.    Washington DC: American Pharmaceutical Association; 1998.</P >     <P   >6 - Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral    medicines for children in European hospitals. Acta P&aelig;diatr 2003;92:486-90.</P >     <P   >7 - &#8216;t Jong GW, Vulto AG, De Hoog M, Schimmel K, Tibboel D, Van der Anker    JN. Unapproved and off-label use of drugs in a children&#8217;s hospital. N    Engl J Med 2000;343:1125.</P >     <P   >8 - &#8216;t Jong GW, Eland IA, Sturkenboom MCJM, Van der Anker JN, Stricker    BHCh. Unlicensed and off label prescriptions of drugs to children; a population-based    cohort study. Br Med J 2002;324:313-4. </P >     <P   >9 - Schirm E, Tobi H, De Jong-van den Berg LTW. A cross-sectional study on unlicensed    and off-label drug use by children outside the hospital. Br Med J 2002;324:312-3.</P >     <P   >10 - Shirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LTW. Lack    of appropriate formulations of medicines for children in the community. Acta    P&aelig;diatr 2003;92:1486-9.</P >     <P   >11 - M&eacute;ndez Esteban ME, Antequera Rodr&iacute;guez-Rabad&aacute;n J, Puebla    Garc&iacute;a V, Pardo de Torres J, Gallego Lago V, Herreros de Tejada A. Formulaciones    orales acuosas: una administraci&oacute;n m&aacute;s segura para pediatr&iacute;a.    Rev O.F.I.L. 2006;16:4:15-28.</P >     <P   >12 - Conroy S. Choonara I. Impicciatore P. Mohn A. Arnell H. Rane A. et al. Survey    of unlicensed and off label drug use in paediatric wards in European countries.    Br Med J 2000;320:79-82.</P >     <P   >13 - Nahata MC. Lack of pediatric drug formulations. Pediatrics 1999;104:607-9.</P >     ]]></body>
<body><![CDATA[<P   >14 - McIntyre J, Conroy S, Avery A, Corns H, Choonara I.Unlicensed and off label    prescribing of drugs in general practice. Arch Dis Child 1999;83:498-501.</P >     <P   >15 - Fontan JE, Combeau D, Brion F. Les pr&eacute;parations p&eacute;diatriques    dans les h&ocirc;pitaux fran&ccedil;ais. Arch Pediatr 2000;7:825-32.</P >     <P   >16 - Standing JF,Tuleu C. Paediatric formulations &#8212; Getting to the heart    of the problem. Int J Pharm 2005;300:56&#8211;66.</P >     <P   >17 - Resolu&ccedil;&atilde;o do Conselho de 14 de Dezembro de 2000 relativa aos    medicamentos pedi&aacute;tricos. Jornal Oficial das Comunidades Europeias, 2001/C17/01,    19-01-01.</P >     <P   >18 - Permanand G, Mossialos E, McKee M. The EU's new paediatric medicines legislation:    Serving children's needs? Arch Dis Child 2007;92:808-11.</P >     <P   >19 - NIH News Alert. National Institute of Child Health and Human Development.    Bethesda MD: National Institute of Health, November, 25, 1997.</P >     <P   >20 - Nunn AJ. Making medicines that children can take. Arch Dis Child 2003;88:369-71.</P >     <P   >21 - Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE.    Developmental pharmacologydrug disposition, action, and therapy in infants and    children. N Engl J Med 2003;349:1157-67.</P >     <P   >22 - de Zwart LL, Haenen HE, Versantvoort CH, Wolterink G, van Engelen JG, Sips    AJ. Role of biokinetics in risk assessment of drugs and chemicals in children.    Regul Toxicol Pharmacol 2004;39:282-309.</P >     <P   >23 - Nahata M. Advances in Paediatric Pharmacotherapy. J Clin Pharm Therap 1992;17:141-6.</P >     ]]></body>
<body><![CDATA[<P   >24 - Leeder JS. Developmental Aspects of Drug Metabolism in Children. Drug Inf    J 1996;30:1135-43.</P >     <P   >25 - Paediatric Preparations In: The Pharmaceutical Codex- Principles and Pratice    of Pharmaceutics, 12th ed., Lund W. editor. London: Royal Pharmaceutical Society    of Great Britain: The Pharmaceutical Press; 1994. p.432-5.</P >     <P   >26 - Conroy S. Paediatric pharmacy&#8211;drug therapy. Hospital Pharmacist 2003;10:49-57.</P >     <P   >27 - Conroy S. Children&#8217;s portions. Chemist and Druggist 16th October 2004;    25-27.</P >     <P   >28 - Anonimo. A Farm&aacute;cia e a Pediatria. Rev. Ordem Farm. 2001;41:49-52.</P >     <P   >29 - Vale MC. Medicamentos para as crian&ccedil;as. Acta Pediatr Port 2006;37:6:231-5.</P >     <P   >30 - Danish M, Kottke MK. Pediatric and Geriatric Aspects of Pharmaceutics. In:    Banker GS. Rhodes CT. Editors. Modern Pharmaceutics. New York; Marcel Dekker:1986.    p. 809-42.</P >     <P   >31 - Committee on Human Medicinal Products. CHMP reflection paper: formulation    of choice for the paediatric population, EMEA/CHMP/PEG/194810/2005. London:    European Medicines Agency; 2005.</P >     <P   >32 - Johnson TN. The problems in scaling adult drug doses to children. Arch Dis    Child 2008;93:207-11.</P >     <P   >33 - Informa&ccedil;&atilde;o sobre medicamentos do INFARMED consultada em www.infarmed.pt/infomed/inicio.php    acedida em 2008/03/04.</P >     ]]></body>
<body><![CDATA[<P   >34 - Schell KH. Compliance Issues and Extemporaneous Preparation of Medications    for Pediatric Patientes. J Pharm Techonol 1992;8:158-61.</P >     <P   >35 - ZenK KE. Challenges in providing pharmaceutical care to pediatric patients.    Am J Hosp Pharm 1994;51:688-94.</P >     <P   >36 - Nunn T, Williams J. Formulation of medicines for children. Br J Clin Pharmacol    2005;59:674-6.</P >     <P   >37 - Paediatric Pharmacopoeia. Royal Children&#8217;s Hospital Melbourne and    Leicester Royal Infirmary Children&#8217;s Hospital: WB Saunders Company Ltd;    1998.</P >     <P   >38 - Fernandez M. Atienza J. Formulaci&oacute;n en Farm&aacute;cia Pedi&aacute;trica.    Sevilha: AEF2; 2002.</P >     <P   >39 - Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook. 11&ordf; ed.    Lexi-Comp Inc.;2004-5.</P >     <P   >40 - Regulamento (CE) n&ordm; 1901/2006 do Parlamento Europeu e do Conselho de    12 de Dezembro de 2006 relativo a medicamentos para uso pedi&aacute;trico, que    altera o Regulamento (CE) n&ordm; 1768/92, a Directiva 2001/20/CE, a Directiva    2001/83/CE e o Regulamento (CE) n&ordm; 726/2004.</P >     <P   >41 - Regulamento (CE) n&ordm; 1902/2006 do Parlamento Europeu e do Conselho de    20 de Dezembro de 2006 relativo a medicamentos para uso pedi&aacute;trico, que    altera o Regulamento (CE) n&ordm; 1901/2006.</P >     <P   >42 - Botstein P. Needs and New Policies for Medicines for Children: The FDA,    United States Incentives, and International Doings. Drug Inf J 2000;34:203-5.</P >     <P   >43 - Shacter E, DeSantis P. Labelling of Drug and Biologic Products for Pediatric    Use. Drug Inf J 1998;32:299-303.</P >     ]]></body>
<body><![CDATA[<P   >44 - Nahata M. New Regulations for Pediatric Labeling of Prescription Drugs.    Ann Pharmacother 1996;30:1032-3.</P >     <P   >45 - Roberts R, Maldonado S. FDA Center for Drug Evaluation and Research (CDER)    Pediatric Plan and New Regulations. Drug Inf J 1996;30:1125-7.</P >     <P   >46 - Formul&aacute;rio Gal&eacute;nico Portugu&ecirc;s. Lisboa: Centro Tecnol&oacute;gico    do Medicamento &#8212; Associa&ccedil;&atilde;o Nacional das Farm&aacute;cias;    2001-2005.</P >     <P   > 47 - Berman W Jr, Whitman V, Marks KH, Friedman Z, Maisels MJ, Musselman J.    Inadvertent overadministration of digoxin to low birthweight infants. J Pediatr    1978; 92:1024-5.</P >     <P   >48 - Zenk KE, Anderson S. Improving the accuracy of mini-volume injections. Infusion    1982;6:7-11.</P >     <P   >&nbsp;</P >     <P   ><strong>Correspond&ecirc;ncia:</strong></P >     <P   > Prof. Carlos Maur&iacute;cio Barbosa</P >     <P   > Faculdade de Farm&aacute;cia Universidade do Porto </P >     <P   >Rua An&iacute;bal Cunha, 164 </P >     ]]></body>
<body><![CDATA[<P   >4050-047 Porto</P >     <P   > e-mail: <a href="maito:mauricio.barbosa@ff.up.pt">Mauricio.Barbosa@ff.up.pt</a></P >      ]]></body><back>
<ref-list>
<ref id="B1">
<nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Barbosa]]></surname>
<given-names><![CDATA[CM]]></given-names>
</name>
<name>
<surname><![CDATA[Pinto]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
</person-group>
<source><![CDATA[Estudo Comparativo de Formulários Galénicos]]></source>
<year>2001</year>
<publisher-loc><![CDATA[Lisboa ]]></publisher-loc>
<publisher-name><![CDATA[Publicações Farmácia Portuguesa]]></publisher-name>
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</back>
</article>
