Analysis of Decision-making Data for Payment of Adverse Drug Reaction Relief System to Over-the-counter Drugs to Promote Their Proper Use / 社会薬学

Adverse Drug Reaction Relief System is intended for people who suffer adverse health effects from drugs despite their proper use, including over-the-counter (OTC) drugs. The decision-making data for the payment of relief benefits associated with OTC drugs and the instructions-for-use provided by community pharmacists and registered retailers were investigated. The results showed that the relief benefit nonpayment rate for OTC drugs was 3.9% and the number of cases was 9, of which 5 were due to improper use. Among the OTC drugs covered by relief benefits, the most common were schedule II pharmaceuticals, which were sometimes used in combination with prescription drugs. These results suggest that pharmacists and registered retailers should check for the use of concomitant drugs (e.g., with drug notebooks) at the time of the OTC drug sale. Pharmacists and registered retailers should provide a detailed explanation of the drugs to consumers and confirm that the information is understood, especially when schedule II pharmaceuticals or psychotropic drugs are sold. Additionally, information on the initial symptoms of an adverse drug reaction and treatment should be provided to prevent serious reactions. Follow-up with consumers during OTC drug use may also reduce the risk of misuse.

Attitude Survey about Adverse Drug Reactions Relief System for Pharmacists of Insurance Dispensing Pharmacies and Examination of Its Problems / 医薬品情報学

Objectives: “Adverse Drug Reaction Relief System” (hereinafter called the Relief System) has been established to provide prompt relief to patients experiencing health damage caused by adverse drug reactions. Since 2018, the Relief System has required community pharmacies that acquire additional points as local support system to actively report adverse drug reactions. Here, we investigated the recognition and utilization of the relief system among community pharmacists.Method: A questionnaire survey was conducted among community pharmacists between August 1 and September 30, 2019.Results: The survey achieved a response rate of 58.1%. The recognition rates of the relief system and Pharmaceuticals and Medical Devices Agency (PMDA) as its application destination were 98.9 and 74.5%, respectively. Of the community pharmacists, 2.6% had experience in utilizing the relief system; and 8.8% did not want to recommend the utilization of the relief system for patients mainly because of the “low recognition of the system” and “the complicated and troublesome preparation of the necessary documents such as medical certificates.” The community pharmacists who acquire additional points as local support system, compared with those who do not, achieved significantly higher rates in two items, including that for preparation of the documented procedures pertaining to adverse drug reactions.Conclusion: Despite the high recognition of the relief system among community pharmacists, the percentage of pharmacists with experience in actually utilizing the relief system and applying to the PMDA was low. One reason that the use of the relief system was not widespread was the low recognition particularly of the destination and procedures of reports on adverse drug reactions. In the future, educational campaigns to improve pharmacists’ comprehension of the relief system will be needed. Moreover, pharmacists must play a central role in enhancing the recognition of the public relief system and promoting medical safety.

Comparison of Brand-Name and Generic Products of Latanoprost Timolol Maleate Ophthalmic Solution with Respect to the Formulation and Usability / 医薬品情報学

Objectives: The long treatment duration of glaucoma and multiple drug use have decreased patient adherence to anti-glaucoma drugs. This has prompted the recent marketing of a combination drug, Xalacom ® Combination Eye Drops (hereinafter referred to as the original drug), and its generic drugs (3 generics). In this study, we compared these eye drops from a pharmaceutical viewpoint,conducted research on usability, and evaluated the selection criteria for generics.Methods: The viscosity and pH of the original drug and its generics were measured. The total number of drops per container, mean mass per drop, and the squeeze force needed for one drop of individual eye drops were measured using a digital force gauge. In addition, a questionnaire survey on the usability of each eye drop was conducted in patients.Results: The total number of drops in the contain of the original drug and generics tested almost the same. The mean mass per drop of generics from two companies was significantly lower than that of the original drug, and the squeeze force of the generic from one company was significantly lower than that of the original drug. The usability of the containers some generics was significantly higher than that of the original drug.Conclusion: No difference was observed in the total number of available drops between the original drug and generics. However,differences in squeeze force and usability were observed between the original drug and generics and among the generics. This information should preferably be described in the interview form, patient instruction manual, etc. for providing medication instructions to pharmacists. All products investigated in this study contained more than 100 drops in the containers. The expiration date of tested eye drops after opening is about one month. Reducing the volume of filling into a container may be contribute to the medical economy and avoid the risk of microbial contamination.