NIPH Clinical Trials Search

Implementation and operational evaluation of an "Adverse Drug Reaction Early detection System" at pharmacies

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients who have used Littfulo, Torcap, Fruzakura, Omjara, Michiga, or Kelendia.
Date of first enrollment	02/09/2025
Target sample size	80
Countries of recruitment
Study type	Interventional
Intervention(s)	Use of an early adverse drug reaction detection system

Outcome(s)

Primary Outcome	Number of adverse drug reactions obtained by this system
Secondary Outcome	Number of adverse drug reactions reported to attending physicians, number of unknown adverse drug reactions detected (including trends by age and gender), and satisfaction of insurance pharmacy pharmacists when using this system

Key inclusion & exclusion criteria

Age minimum	>= 16age old
Age maximum	Not applicable
Gender
Include criteria	[Patients] 1. Individuals who bring a prescription containing one of the target drugs, "Litfulo," "Torcap," "Fruzakura," "Omjara," "Michiga," or "Kelendia," to a Sugi Pharmacy or Minaminihon Pharmaceutical Center pharmacy. 2. Individuals aged 16 years or older at the time of consent (regardless of gender). 3. Individuals who have received a full explanation of this study and, after fully understanding it, have given their voluntary written consent. [Pharmacists] 1. All pharmacists working at a Sugi Pharmacy or Minaminihon Pharmaceutical Center pharmacy. 2. Pharmacists who dispense prescriptions to patients who bring a prescription containing one of the target drugs, "Litfulo," "Torcap," "Fruzakura," "Omjara," "Michiga," or "Kelendia."
Exclude criteria	[Patients] 1. Those with a history of severe mental illness 2. Those who are mentally and physically unstable and whose physical condition may be adversely affected by participating in this study 3. Those who do not own a smartphone or other communication device and cannot have one provided by the pharmacy 4. Those deemed inappropriate by the pharmacy pharmacist [Pharmacists] *No exclusion criteria will be set.