The Guidance of Package Insert Development for Self-monitoring Blood Glucose System for Lay Person

Abstract

This study aimed to develop the guidance of package insert of Self-Monitoring Blood Glucose System (SMBGs) for Lay person. The study was started by analyzing of draft guidance for industry and food and drug administration staff; SMBGs for over-the-counter use in the topic of labeling. The reviewed information was compared to the 11 leaflets of SMBGs (7companies) searched from Thai Food and Drug Administration database. Then, the in-depth interview was preceded with 5 purposive selected key informants about their opinions on the practicability of SMBGs leaflets used in Thailand. The triangulation was rendered to check and confirm the accuracy of all data collected from the key informants by repeating the interviewing the similar participants. All information from the key informants was analyzed using the criteria of the same opinion. Finally, the SMBGs package insert guidance for lay person was composing 17 approaches.