To mine tacrolimus-related adverse event signals affecting the cardiovascular system based on an international authoritative database, aiming to provide a reference for clinical safe drug use.

Adverse event reports with tacrolimus as the primary suspected drug were retrieved and extracted from the U.S. Food and Drug Administration Adverse Event Reporting System(FAERS) database from January 1, 2004, to September 30, 2024, with a focus on cardiovascular system-related adverse events. Adverse events were categorized using the system organ class(SOC) and preferred terms(PTs) from the Medical Dictionary for Regulatory Activities(MedDRA). Signal mining for cardiovascular system-related adverse drug events(ADEs) was performed using the information component(IC), empirical Bayesian geometric mean(EBGM), and reporting odds ratio(ROR) methods.

A total of 58 357 ADE reports with tacrolimus as the primary suspected drug were retrieved, of which 3173 were related to cardiovascular system disorders. The top five most frequently reported cardiovascular adverse events were hypertension, cardiac arrest, heart failure, myocardial infarction, and atrial fibrillation. ADE signal detection identified correlations between tacrolimus and hypertension, cardiac arrest, heart failure, ventricular hypertrophy, cardiomyopathy, and cardiac hypertrophy. Regarding the outcomes of cardiovascular adverse events, "hospitalization or prolongation of existing hospitalization" was the most common(34.74%), followed by "death"(29.44%).

Tacrolimus carries the risk of inducing various cardiovascular diseases. In clinical practice, when using tacrolimus, attention should be paid to the patient's underlying diseases and concomitant medications, adverse reactions should be closely monitored during the initial and long-term treatment phases, and the dosage should be adjusted in a timely manner to ensure patient safety during long-term therapy.

To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions.

A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data.

A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%, and the effective rate was 94.17%. 51.19% of the respondents based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk anagement across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms.

The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.