ABSTRACT
<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.
ABSTRACT
<b>Objective: </b>Currently, post marketing surveillance (PMS) for prescription-only to over-the-counter (OTC) switched products is conducted based on questionnaires to patients. These questionnaires appear in the form of postcards and are completed and posted voluntarily by patients. With such a method, however, it is not possible to select samples randomly and there may be a bias in respondents. In addition, the response rate of questionnaire postcards tends to be low. It is not really credible that the efficacy and safety of OTC switches are confirmed by such a method. An investigation was therefore conducted with the aim of developing an effective method of PMS for OTC switches in order to achieve the intended objective of PMS.<br><b>Method and Subjects: </b>Famotidine purchasers were asked to complete a questionnaire form. The pharmacists asked the subjects to complete the questionnaire form again on their second visit and also checked patient compliance with drug treatment. The effectiveness of this method was evaluated by reviewing responses to the questionnaire on the first and second visits.<br><b>Results and Discussion: </b>It was suggested that the method tested in this investigation may possibly facilitate evaluation of the efficacy of OTC switched products, detection of adverse drug reactions and monitoring of patient compliance with drug treatment. However, the questionnaire used in the investigation was not suited for detecting symptoms that triggered patients to purchase famotidine. It was considered necessary to prepare additional questions specifically designed to detect such symptoms.