Abstract
Background: Generic drugs account for approximately 40% of the Korean prescription drug market, despite limited generic substitution at the point of dispensing. This suggests that switching between originator and generic drugs often occurs at the point of prescription. Physicians, in fact, have opposed pharmacy-level substitution due to concerns about the clinical equivalence of generics, despite the regulatory confirmation of their bioequivalence. Importantly, multi-source prescription switching (MSPS) may reflect discretionary prescribing behavior, underscoring the need for targeted benefit policies to enhance substitutability and promote effective competition among multi-source drugs. This study aimed to quantify the extent of physician-initiated MSPS among adults with hypertension or diabetes and to identify factors associated with these switching behaviors. Methods: We conducted a retrospective cohort study using Korean National Health Insurance claims data. The studied cohort consisted of patients newly initiated, between January and June 2014, on a pharmaceutically equivalent and bioequivalent antihypertensive or antidiabetic drug. Patients were followed for up to 24 months to identify MSPS episodes occurring during drug therapy courses, which were defined as 12 ± 3 consecutive visits resulting in prescriptions for pharmaceutically equivalent, bioequivalent multi-source drugs. An MSPS episode was defined as a change in product code-uniquely identifying a multi-source drug-within the same pharmaceutically equivalent drug code between any two consecutive prescriptions within the course. We estimated the mean MSPS rate and assessed variation by patient characteristics, drug types, physician practices, and geographic regions. Results: Among 1,325,334 identified drug therapy courses, 17.06% involved at least one MSPS. Switching rates varied substantially (coefficient of variation = 227%) by physician practice setting (e.g., public health center branches: 26%; tertiary hospitals: 15%) and by drug market size (e.g., glimepiride: 29%; cilnidipine: 1%). In contrast, patient age and gender were not associated with switching behavior. Conclusions: In Korea, physicians frequently switch prescriptions between originator and generic drugs, even as generic substitution at the pharmacy level remains uncommon. The substantial variation in MSPS across provider settings and drug markets-but not by patient characteristics-underscores the need for targeted pharmacy benefit policies to promote effective substitutability and competition among multi-source drugs.