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Active surveillance of severe cutaneous adverse reactions: A case‐population approach using a registry and a health care database
Author(s) -
RodríguezMartín Sara,
MartínMerino Elisa,
Lerma Victoria,
RodríguezMiguel Antonio,
González Olga,
GonzálezHerrada Carlos,
Ramírez Elena,
Bellón Teresa,
Abajo Francisco J.
Publication year - 2018
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4622
Subject(s) - medicine , toxic epidermal necrolysis , odds ratio , confidence interval , population , pharmacoepidemiology , pharmacovigilance , amoxicillin , pediatrics , intensive care medicine , emergency medicine , adverse effect , pharmacology , dermatology , medical prescription , environmental health , antibiotics , microbiology and biotechnology , biology
Purpose The “case‐population” design has been proposed for the surveillance of rare events like Stevens‐Johnson 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‐new users of drugs, which for the study of hypersensitivity reactions is of utmost importance. Methods 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 44 000 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. Results AORs (95% CI) were estimated for phenytoin, 4618 (434‐49112); cotrimoxazole, 1142 (163‐8015); allopurinol, 160 (36‐709); dexamethasone, 38 (1.33‐1077); ibuprofen, 33 (8.6‐124); lorazepam, 27 (5.8‐124); paracetamol, 13 (2.8‐62); levofloxacine, 12 (1.24‐120); amoxicillin, 6.9 (1.39‐35); pantoprazole, 6.5 (0.10‐420); metamizole, 6.3 (0.69‐57); amoxicillin clavulanic acid, 4.2 (0.53‐34); and omeprazole, 1.34 (0.06‐31). The inclusion of non‐new users dramatically decreased the AORs for all drugs. Conclusions The case‐population approach using a registry of cases and a primary health care database proved feasible and efficient for the active surveillance of SJS/TEN.