Development of the Pharmaceutical Ingredient Importation Database and Signal Detection of the Importation for Potential Misuse of Active Pharmaceutical Ingredient

Abstract

Background: Most of pharmaceutical ingredients used for Thai drug manufacturing were imported
from oversea. The pharmaceutical ingredient importation database is important for tracing back,
quality control and monitoring misuse of active pharmaceutical ingredient.

Objectives: The aims of this research were to study the quality of the pharmaceutical ingredient
importation database in the Thai License per Invoice (LPI) system and to develope and test the
signal detection of the importation for potential misuse of active pharmaceutical ingredient.

Methods: This study was cross-sectional design. Population was the importation data of
pharmaceutical ingredient for manufacturing drug according to Drug Act B.E. 2510.

Results: Most of the importation data were qualified but some were ambiguous (5.1%),
inconsistently (26.8%) and incomplete (10.3%). It was difficult to use or cannot be analyzed
immediately, so the data needed to edit before utilization. The signal detection criteria of the
importation for potential misuse of active pharmaceutical ingredient were developed which
included the continuous increasing in importation not less than two consecutive years and public
misuse news. We used the criteria to explore the data from 2016 to 2018 and it found four signals including isotretinoin, hydrocortisone, tramadol and tranexamic acid. The intensive
surveillance should take place to monitor and prevent the importation of potential misuse of
active pharmaceutical ingredient.