<?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>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942019000300001</article-id>
<article-id pub-id-type="doi">10.30827/ars.v60i0.9454</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Informe sobre el Uso de los Tests Genéticos Directos al Consumidor]]></article-title>
<article-title xml:lang="en"><![CDATA[Report on the Use of Direct-to-Consumer Genetic Test]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández-Rodríguez]]></surname>
<given-names><![CDATA[María]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Granada Grupo de Investigación en Atención Farmacéutica CTS-131 ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Spain</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2019</year>
</pub-date>
<volume>60</volume>
<fpage>7</fpage>
<lpage>14</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942019000300001&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942019000300001&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942019000300001&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Los tests genéticos directos al consumidor (TGDC), proporcionan acceso a la información genética de una persona sin que necesariamente intervenga un médico ni ningún otro personal de salud en el proceso. Pueden promover la concienciación pública de enfermedades de origen genético, ya que, al acercar este tipo de información a la población general, y no sólo a un paciente determinado, la sociedad toma más conciencia de las mismas. Por tanto, se promueve también un estilo de vida más saludable, una medicina personalizada y una promoción del auto-cuidado. Siendo el principio de autonomía el argumento fundamental por el que se alude a favor de la no limitación del acceso a los mismos, no cabe admitir que el consumidor que lo adquiere sea verdaderamente autónomo. Las empresas que los comercializan no poseen actualmente de una vía de calidad acerca del valor predictivo de los tests ofrecidos. Por ello, también habría de prevalecer el principio de precaución, para evitar un daño a quien se ve expuesto, sin disponer de la necesaria información. La no regulación de los TGDC puede suponer un riesgo para el consumidor por dos motivos: por un lado, la ausencia de asesoramiento genético pre y post test por personal cualificado en centros acreditados -tal y como está establecido en la Ley de Investigación Biomédica 14/2007-, y la ausencia de una correcta interpretación de los resultados por un profesional puede suponer un riesgo médico y psicológico para el usuario Si un consumidor decide adquirir una de estas pruebas genéticas por internet, el test se le envía directamente, y será él quien reciba los resultados de la misma y decida qué hacer con ellos. Estas nuevas posibilidades de información médico-sanitaria, llevan asociadas estos nuevos planteamientos ético-legales a los que es necesario prestar atención en España. La farmacia comunitaria, como centros sanitarios de proximidad a la población general y por su estructura organizada, su implicación en la educación, consejo profesional, y su participación en programas de salud, se convierten en los perfectos aliados en materia de una posible regulación sanitaria de los TGDC. Los protocolos y estudios de cribado que se llevan a cabo en España hacen de la farmacia comunitaria actual, una opción ventajosa para la regulación de los TGDC, integrando con esta medida a la farmacia como establecimiento sanitario privado de interés público, dentro del Sistema Sanitario Nacional.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The Direct-To-Consumer Genetic Tests (TGDC) provide access to genetic information without necessarily involving a physician or any other health personnel in the process. TGDC can promote public awareness of genetic origin about some diseases, as, by bringing this type of information to general population, and not only to a specific patient, society becomes more aware of them. Therefore, a healthier lifestyle, personalized medicine and promotion of self-care are also increased. Nevertheless, being the principle of autonomy the main argument alluded to in favor of the unlimited access to TGDC, it is not possible to affirm that the consumer acquiring them, is truly autonomous. The companies commercializing them do not currently have a quality track on the predictive value of their tests. Therefore, the precautionary principle should also operate, by preventing damage to whoever is exposed, without having the necessary information. The non-regulation of TGDC may pose a risk to the consumer for two reasons: firstly, the absence of pre and post test genetic counseling by qualified personnel in accredited centers - as established by the Biomedical Research Law 14 / 2007-, and secondly, the absence of a correct interpretation of the results by a professional can pose a medical and psychological risk to the user If a consumer decides to acquire one of these genetic tests online, the test is directly sent to home, and he/she will receive the results of the test and deciding what to do with them. These new possibilities for medical-health information are associated to these new ethical-legal approaches to which it is necessary paying attention in Spain. The community pharmacy, as a health center and organized structure, next to general population and involved in education, professional advice, and participation in health programs, become the perfect allies in matters of possible health regulation of the TGDC. The protocols and screening studies carried out in Spain make the current community pharmacy an advantageous option for the regulation of TGDC, integrating with the pharmacy as a private health facility of public interest, within the National Health System.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Tests Genéticos Directos al Consumidor]]></kwd>
<kwd lng="es"><![CDATA[Farmacia Comunitaria]]></kwd>
<kwd lng="es"><![CDATA[Dispensación]]></kwd>
<kwd lng="es"><![CDATA[Política Sanitaria]]></kwd>
<kwd lng="en"><![CDATA[Direct-To-Consumer Genetic Tests]]></kwd>
<kwd lng="en"><![CDATA[Community Pharmacy]]></kwd>
<kwd lng="en"><![CDATA[Dispensing Act]]></kwd>
<kwd lng="en"><![CDATA[Health Policies]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Direct-to-consumer genetic tests, government oversight, and the First Amendment what the government can (and can't) do to protect the public's health]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Javitt]]></surname>
<given-names><![CDATA[GH]]></given-names>
</name>
<name>
<surname><![CDATA[Stanley]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Hudson]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
</person-group>
<source><![CDATA[Oklahoma Law Rev]]></source>
<year>2004</year>
<volume>57</volume>
<page-range>251-302</page-range></nlm-citation>
</ref>
<ref id="B2">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Direct-to-consumer genetic testing where and how does genetic counseling fit?]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Middleton]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Mendes]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Benjamin]]></surname>
<given-names><![CDATA[CM]]></given-names>
</name>
<name>
<surname><![CDATA[Howard]]></surname>
<given-names><![CDATA[HC]]></given-names>
</name>
</person-group>
<source><![CDATA[Per Med]]></source>
<year>2017</year>
<volume>14</volume>
<page-range>249-57</page-range></nlm-citation>
</ref>
<ref id="B3">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[The regulation of direct-to-consumer genetic tests]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Kaye]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<source><![CDATA[Hum Mol Genet]]></source>
<year>2008</year>
<volume>17</volume>
<page-range>R180-3</page-range></nlm-citation>
</ref>
<ref id="B4">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Genetic tests obtainable through pharmacies the good, the bad, and the ugly]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Patrinos]]></surname>
<given-names><![CDATA[GP]]></given-names>
</name>
<name>
<surname><![CDATA[Baker]]></surname>
<given-names><![CDATA[DJ]]></given-names>
</name>
<name>
<surname><![CDATA[Al-Mulla]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Vasiliou]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
<name>
<surname><![CDATA[Cooper]]></surname>
<given-names><![CDATA[DN]]></given-names>
</name>
</person-group>
<source><![CDATA[Hum Genomics]]></source>
<year>2013</year>
<volume>7</volume>
<page-range>17</page-range></nlm-citation>
</ref>
<ref id="B5">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Concordance study of 3 direct-to-consumer genetic-testing services]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Imai]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Kricka]]></surname>
<given-names><![CDATA[LJ]]></given-names>
</name>
<name>
<surname><![CDATA[Fortina]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
</person-group>
<source><![CDATA[Clin Chem]]></source>
<year>2011</year>
<volume>57</volume>
<page-range>518-21</page-range></nlm-citation>
</ref>
<ref id="B6">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Medicine, market and communication ethical considerations in regard to persuasive communication in direct-to-consumer genetic testing services]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schaper]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Schicktanz]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
</person-group>
<source><![CDATA[BMC Med Ethics]]></source>
<year>2018</year>
<volume>19</volume>
<page-range>56</page-range></nlm-citation>
</ref>
<ref id="B7">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Current ethical and legal issues in health-related direct-to-consumer genetic testing]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Niemiec]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Kalokairinou]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Howard]]></surname>
<given-names><![CDATA[HC]]></given-names>
</name>
</person-group>
<source><![CDATA[Per Med]]></source>
<year>2017</year>
<volume>14</volume>
<page-range>433-45</page-range></nlm-citation>
</ref>
<ref id="B8">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Henneman]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Timmermans]]></surname>
<given-names><![CDATA[DR]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Public experiences, knowledge and expectations about medical genetics and the use of genetic information]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[Wal]]></surname>
<given-names><![CDATA[G van der]]></given-names>
</name>
</person-group>
<source><![CDATA[Community Genet]]></source>
<year>2004</year>
<volume>7</volume>
<page-range>33-43</page-range></nlm-citation>
</ref>
<ref id="B9">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Attitudes about regulation among direct-to-consumer genetic testing customers]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bollinger]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Green]]></surname>
<given-names><![CDATA[RC]]></given-names>
</name>
<name>
<surname><![CDATA[Kaufman]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
</person-group>
<source><![CDATA[Genet Test Mol Biomarkers]]></source>
<year>2013</year>
<volume>17</volume>
<page-range>424-8</page-range></nlm-citation>
</ref>
<ref id="B10">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Public reaction to direct-to-consumer online genetic tests Comparing attitudes, trust and intentions across commercial and conventional providers]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Critchley]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Nicol]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
<name>
<surname><![CDATA[Otlowski]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Chalmers]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
</person-group>
<source><![CDATA[Public Underst Sci]]></source>
<year>2015</year>
<volume>24</volume>
<page-range>731-50</page-range></nlm-citation>
</ref>
<ref id="B11">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA["I would rather have it done by a doctor"-laypeople's perceptions of direct-to-consumer genetic testing (DTC GT) and its ethical implications]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schaper]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Wohlke]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Schicktanz]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
</person-group>
<source><![CDATA[Med Health Care Philos]]></source>
<year>2019</year>
<page-range>22-31</page-range></nlm-citation>
</ref>
<ref id="B12">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Direct-to-Consumer Genetic Testing The Implications of the US FDA's First Marketing Authorization for BRCA Mutation Testing]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gill]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Obley]]></surname>
<given-names><![CDATA[AJ]]></given-names>
</name>
<name>
<surname><![CDATA[Prasad]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
</person-group>
<source><![CDATA[JAMA]]></source>
<year>2018</year>
<volume>319</volume>
<page-range>2377-8</page-range></nlm-citation>
</ref>
<ref id="B13">
<nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[Comprehension and Data-Sharing Behavior of Direct-To-Consumer Genetic Test Customers]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[McGrath]]></surname>
<given-names><![CDATA[SP]]></given-names>
</name>
<name>
<surname><![CDATA[Coleman]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Najjar]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Fruhling]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Bastola]]></surname>
<given-names><![CDATA[DR]]></given-names>
</name>
</person-group>
<source><![CDATA[Public Health Genomics]]></source>
<year>2016</year>
<volume>19</volume>
<page-range>116-24</page-range></nlm-citation>
</ref>
<ref id="B14">
<nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Skirton]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Jackson]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Goldsmith]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Are health professionals ready for direct-to-consumer genetic and genomic testing]]></article-title>
<person-group person-group-type="editor">
<name>
<surname><![CDATA[O'Connor]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<source><![CDATA[Per Med]]></source>
<year>2013</year>
<volume>10</volume>
<page-range>673-82</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
