METHODS: We performed a cross-sectional analysis of data from the Hospital Prescription Analysis Cooperation Project that is overseen by the Chinese
Pharmaceutical Association. Information was extracted from prescriptions of outpatients with
threatened miscarriage between January 2014 and December 2020. We quantified the types of medications using the first level anatomical therapeutic chemical (ATC) classification code and the frequency of use of medicines classified as category X by the United States Food and Drug Administration (FDA). We also calculated the prevalence of the most frequently used
progestogens by assessing prescription rates, determined the sum of the defined daily doses (DDDs) and defined daily cost (DDC) and evaluated the rationality of
progestogens according to
drug labels and guidelines.
RESULTS AND DISCUSSION: Of the 91,464 patients included in this study, 69.4% were from the eastern region, 92.5% were from tertiary hospitals, and 72.9% were between 25 and 34 years old. The average number of medications per patient was 1.4. The following types of medicines were the most prevalent: "genitourinary system and
sex hormones" (90.7%), "alimentary tract and metabolism" (10.8%) and "blood and blood-forming organs" (9.9%).
Progestogens were prescribed for 81,080 patients (88.6%), among which oral
progesterone (39.7%) was the most commonly used, followed by oral
dydrogesterone (34.4%),
progesterone injection (26.0%), oral
allylestrenol (0.7%) and
progesterone gel (0.4%). In other words, 10,991 (12.0%) patients used more than one
progestogen, and the top three combinations were oral
dydrogesterone plus
progesterone injection (5.6%), oral
progesterone plus
progesterone injection (4.7%) and oral
dydrogesterone plus oral
progesterone (1.1%). The prescription rate of
dydrogesterone increased gradually, whereas that of
progesterone, especially
progesterone injection, obviously decreased. Among 34,760 prescriptions of
progestogens with complete usage information, the primary errors of
progestogen use were "low frequency" (18.4%), "high single dose" (15.9%) and "low single dose" (11.3%). In addition, 137 prescriptions were identified with
drug-
progestogen interactions, and 61 were identified with
contraindications for
progestogens. A total of 4.5% of prescriptions included FDA category X medicines.
WHAT IS NEW AND CONCLUSION: Our findings are the first to provide information on medication use in patients with
threatened miscarriage over the last seven years in China. Medicines targeting the "genitourinary system and
sex hormones," especially
progestogens, were the most commonly prescribed medications, among which
dydrogesterone was the most prevalent. However, it is remarkable that the use of
progestogens for the treatment of
threatened abortion is still controversial; thus, high-quality large sample studies are still required, especially among Chinese patients. Since usage errors in
progestogen records and exposure to category X medicines were common, more efforts are needed to guarantee the safety and rationality of medicines used in pregnant women.