Characteristics of Drug Labels in Private Medical Clinics: A Cross-sectional Study in Mueang District, Udonthani

Abstract

Objective: To investigate the compliance of complete drug labeling as required by law, including the details of drug labeling in medical clinics located at Mueang District, Udonthani. Methods: This research was a cross-sectional study collecting data through online questionnaires and onsite visits between July 1, 2022, and July 10, 2023, in general and specialty medical clinics registered by March 16, 2022, and located within Mueang District, Udon Thani. Information related to drug dispensers, clinic facilities, and actual drug labels provided to patients was collected, including 1) clinic’s contact details, 2) patient’s name and date of dispensing, 3) drug name, 4) dosage forms and strength, 5) instruction on drug use, 6) indication, 7) warnings and precautions, and 8) expiry date. The outcomes in the study included the completeness of drug labeling as mandated by law, the presentation of essential components on drug labels, and the number of components on drug labels. Results: Among 89 surveyed clinics, only 3.4% fully complied with legal requirement on drug labeling, while 12.4% had complete essential components on the labels. Most common components on drug labels were instructions on drug use (89.9%), details on clinic facilities (82.0%), expiration dates (57.3%), and English drug names (56.2%). Assessment of the presence of each component on drug labels by staff in the clinics and law enforcement officers showed generally low agreement (kappa statistics -0.03 to 0.38). Furthermore, having more than one practicing physicians was associated with an increased number of components on drug labels (adjusted beta-coefficient 1.29; 95% CI: 0.42 to 2.17) and an increased tendency to have all essential components on drug labels (adjusted odds ratio 42.50; 95% CI 2.96 to 610.86). Conclusion: Most of the surveyed medical clinics did not fully comply drug labeling regulations. Improving staff understanding of required label components could serve as a crucial initial step before the law will be rigorously enforced in the near future.