{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T13:29:33Z","timestamp":1780579773673,"version":"3.54.1"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,7,27]],"date-time":"2018-07-27T00:00:00Z","timestamp":1532649600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI12\/02267 (co\u2010funded by FEDER)"],"award-info":[{"award-number":["PI12\/02267 (co\u2010funded by FEDER)"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The \u201ccase\u2010population\u201d design has been proposed for the surveillance of rare events like Stevens\u2010Johnson syndrome\/toxic epidermal necrolysis (SJS\/TEN), wherein a registry of cases is combined with sales data from the source population in order to estimate crude odds ratios (ORs). A major drawback of this method is the inability to distinguish between new and non\u2010new users of drugs, which for the study of hypersensitivity reactions is of utmost importance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We have explored an approach in which the exposure to the drugs of interest in the source population is inferred from a primary health care database (BIFAP), which helped us to identify drug initiators among all users and additionally adjust for potential confounders. A total of 44 SJS\/TEN cases from the Registry and 44\u00a0000 controls randomly sampled from BIFAP and matched with cases for index date were included. We estimated the adjusted ORs (AORs) and 95% confidence intervals (CI) of SJS\/TEN associated with the new use of 13 drugs (for which we had at least two exposed cases) through a conditional logistic regression model.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>AORs (95% CI) were estimated for phenytoin, 4618 (434\u201049112); cotrimoxazole, 1142 (163\u20108015); allopurinol, 160 (36\u2010709); dexamethasone, 38 (1.33\u20101077); ibuprofen, 33 (8.6\u2010124); lorazepam, 27 (5.8\u2010124); paracetamol, 13 (2.8\u201062); levofloxacine, 12 (1.24\u2010120); amoxicillin, 6.9 (1.39\u201035); pantoprazole, 6.5 (0.10\u2010420); metamizole, 6.3 (0.69\u201057); amoxicillin clavulanic acid, 4.2 (0.53\u201034); and omeprazole, 1.34 (0.06\u201031). The inclusion of non\u2010new users dramatically decreased the AORs for all drugs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The case\u2010population approach using a registry of cases and a primary health care database proved feasible and efficient for the active surveillance of SJS\/TEN.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4622","type":"journal-article","created":{"date-parts":[[2018,7,27]],"date-time":"2018-07-27T10:58:51Z","timestamp":1532689131000},"page":"1042-1050","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Active surveillance of severe cutaneous adverse reactions: A case\u2010population approach using a registry and a health care database"],"prefix":"10.1002","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3539-1470","authenticated-orcid":false,"given":"Sara","family":"Rodr\u00edguez\u2010Mart\u00edn","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Unit Pr\u00edncipe de Asturias University Hospital  Madrid Spain"},{"name":"Department of Biomedical Sciences University of Alcal\u00e1  Madrid Spain"},{"name":"Pharmacoepidemiology Research Group Institute for Health Research IRYCIS  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3576-8605","authenticated-orcid":false,"given":"Elisa","family":"Mart\u00edn\u2010Merino","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacovigilance Spanish Agency of Medicines and Medical Devices  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Lerma","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit Pr\u00edncipe de Asturias University Hospital  Madrid Spain"},{"name":"Pharmacoepidemiology Research Group Institute for Health Research IRYCIS  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Rodr\u00edguez\u2010Miguel","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit Pr\u00edncipe de Asturias University Hospital  Madrid Spain"},{"name":"Department of Biomedical Sciences University of Alcal\u00e1  Madrid Spain"},{"name":"Pharmacoepidemiology Research Group Institute for Health Research IRYCIS  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Dermatology Department University Hospital of Getafe  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Gonz\u00e1lez\u2010Herrada","sequence":"additional","affiliation":[{"name":"Dermatology Department University Hospital of Getafe  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Ram\u00edrez","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Department La Paz University Hospital  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0138-6879","authenticated-orcid":false,"given":"Teresa","family":"Bell\u00f3n","sequence":"additional","affiliation":[{"name":"Drug Hypersensitivity Laboratory Institute for Health Research IdiPAZ, La Paz University Hospital  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9119-8646","authenticated-orcid":false,"given":"Francisco J.","family":"de Abajo","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit Pr\u00edncipe de Asturias University Hospital  Madrid Spain"},{"name":"Department of Biomedical Sciences University of Alcal\u00e1  Madrid Spain"},{"name":"Pharmacoepidemiology Research Group Institute for Health Research IRYCIS  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,7,27]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13989"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470061596.risk0599"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jid.5701033"},{"key":"e_1_2_9_5_1","unstructured":"The RegiSCAR Project. 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