Evaluation of a Newly Developed Post Marketing Surveillance Method to Verify the Efficacy and Safety of Rx-to-OTC Switch Drugs

抄録

Background: We report the results of the health check sheet survey on fexofenadine hydrochloride tablet (AllegraFX), conducted using a new health check sheet developed based on the results of the previously reported Loxonin(R)S survey.　In addition, we examined the utility of the health check sheet by comparing the results of the survey on AllegraFX with the post marketing surveillance (special survey) conducted by the pharmaceutical company manufacturing the drug.
Methods: The new health check sheet survey for AllegraFX was conducted in 41 pharmacies.　Efficacy, safety, and patient adherence were analyzed.
Results: The health check sheet survey for AllegraFX involved 190 purchasers, 143 (75.3%) of whom completed the second visit survey.　The efficacy rate for AllegraFX was 88.4% in the health check sheet survey.　Of the 16 symptoms reported over two cases in the special survey, 10 were also detected by the health check sheet survey.　Six symptoms were detected by the health check sheet survey but were not reported in the special survey.
Conclusion: Although conducted for a short survey period and in a small sample size, the health check sheet survey achieved results similar to the special survey in terms of identifying adverse events, indicating that a survey using the health check sheet can obtain results comparable to existing PMS protocols, with considerably lower labor.