Development of Post Marketing Surveillance Method for Nonprescription Drugs Immediately after Rx-to-OTC Switch / 医薬品情報学

<b>Introduction: </b>A health assessment sheet was developed to establish a new method for post marketing surveillance (PMS) for nonprescription drugs, the status of which has recently been switched from prescription (Rx) to over-the-counter (OTC) to confirm the efficacy and safety of Rx-to-OTC switched drugs.  The assessment sheet was designed to evaluate adverse reactions that may be possibly induced by the drugs and to elicit spontaneous complaints from consumers.  An investigation using the assessment sheet had been conducted earlier for famotidine tablets.  While the earlier investigation suggested the effectiveness of the assessment method, it also revealed some issues.  After making improvements in the assessment sheet, another investigation was conducted for Loxonin®S.<br><b>Method: </b>Purchasers of Loxonin®S were asked to tick symptoms that were applicable to them among those listed in the sheet.  They were asked to revisit the pharmacy and complete the sheet for the second time after drug administration.  The possibility of adverse reactions was considered for the symptoms additionally chosen at the second visit and they were then compared with the adverse reactions described in the package insert of Loxonin®S.<br><b>Results: </b>Total 284 people completed the health assessment sheet at their first and second visits.  Of them, 44 people (15.5%) reported additional symptoms at the second visit.  Commonly reported symptom was “frequent experience of sleepiness,” “persistent headaches” and “fatigability.”<br><b>Conclusion: </b>The study suggested that the health assessment sheet can be an effective tool for PMS for nonprescription drugs immediately after the Rx-to-OTC switch and contributes to detecting adverse reactions of the drugs.

Effects of the Antioxidant Sulforaphane on Hyperlocomotion and Prepulse Inhibition Deficits in Mice after Phencyclidine Administration

OBJECTIVE: Accumulating evidence suggests that oxidative stress plays a role in the pathophysiology of schizophrenia and that the potent antioxidants may be potential therapeutic drugs for schizophrenia. This study was undertaken to examine the effects of the potent antioxidant sulforaphane (SFN), found in cruciferous vegetables, on behavioral abnormalities (e.g., hyperlocomotion and prepulse inhibition [PPI] deficits) in mice after a single administration of the N-methyl-D-aspartate (NMDA)-receptor antagonist phencyclidine (PCP). METHODS: Effects of SFN (3, 10, and 30 mg/kg, intraperitoneally [i.p.]) on hyperlocomotion and PPI deficits in the adult male ddY mice after administration of PCP (3.0 mg/kg, subcutaneously [s.c.]) were examined. RESULTS: Administration of SFN (30 mg/kg, intraperitoneally [i.p.]), but not low doses (3 and 10 mg/kg, i.p.), significantly attenuated hyperlocomotion in mice after PCP administration (3.0 mg/kg, subcutaneously [s.c.]). Furthermore, administration of SFN (3, 10, and 30 mg/kg, i.p.) attenuated the PPI deficits in mice after PCP administration (3.0 mg/kg, s.c.) in a dose-dependent manner. CONCLUSION: These results suggest that SFN has antipsychotic activity in an animal model of schizophrenia. Therefore, it is likely that SFN may be a potential therapeutic drug for schizophrenia.