ABSTRACT
BACKGROUND: Febuxostat and allopurinol are the most commonly used uric acid-lowering medications, and their safety is of great concern, especially the cardiovascular adverse reactions associated with febuxostat. We propose to study the cardiovascular toxicity of febuxostat and allopurinol using the FDA Adverse Event Reporting System (FAERS) database. METHODS: A total of 64 quarters of FAERS data were downloaded from 2004 to 2019. Febuxostat- and allopurinol-related cardiovascular adverse events were extracted after data cleaning. Signal detection was conducted by reporting odds ratio (ROR) and proportional reporting ratio (PRR). RESULTS: There were 2939 and 25,219 reports of febuxostat- and allopurinol-related cardiovascular adverse events (CVAEs), respectively. The most frequent CVAEs with febuxostat and allopurinol were edema peripheral (14.38%) and peripheral swelling (8.76%), respectively. In elderly gout patients, febuxostat is associated with an increased risk of heart failure, ischemic heart disease, hypertension, and cardiomyopathy. Febuxostat in combination with acetic acid derivatives nonsteroidal anti-inflammatory drug (NSAIDS) also increases the risk of cardiovascular adverse events. CONCLUSIONS: Compared with allopurinol, febuxostat may increase cardiovascular toxicity in patients with gout.
ABSTRACT
Background: Online pharmacies have gradually penetrated the market, but pose risks to patients' health. Failure Mode and Effect Analysis (FMEA) is an effective and reliable method for reducing pharmacy and medication risks. The purpose of this study was to conduct a prospective risk analysis of the process of purchasing prescription drugs from online pharmacies in China to guarantee drug quality and patient safety. Methods: The FMEA was performed at Sichuan University, China. A multidisciplinary team was assembled comprising a leader, four regulators, four pharmacists, two experts, etc. The process was composed of eight subprocesses: searching for prescription drugs, submitting medication requirements, completing patient information forms, dispensing, delivering, etc. Brainstorming was used to identify and prioritize failure modes, propose corrective actions, and reduce risks. Risk priority numbers were the main criterion and were obtained by multiplying three scores: severity, occurrence and detectability, which were scored by the team The team proposed corrective actions for each selected failure mode. Results: A total of forty-one potential failure modes were identified, and the causes, effects, and corrective actions of the 30 top failure modes were analyzed. The highest risk value was assigned to "photocopies of paper prescriptions uploaded were reused by patients." Three failure modes for the S value of 5 were: "drugs are eroded and polluted by moisture or insects in the process of transportation," "the qualification information of the pharmacies were absent or fake," and "pharmacists fail to check prescriptions in accordance with Prescription Administrative Regulation." Of the top failure modes, 36.67% were from Step 5, delivering the drug. After taking corrective measures to control risks, the risks reduced by 69.26%. Conclusion: The results of this study proves that the FMEA is a valuable tool for identifying and prioritizing the risks inherent in online pharmacies. This study shows that there are many potential risks in the process of purchasing prescription drugs from online pharmacies, especially in the drug delivery stage. Enhanced training and the introduction of smart devices may minimize risks. Online pharmacies and Chinese regulators should consider these findings for risk mitigation and the improvement of regulations pertaining to online pharmacies.
ABSTRACT
Objectives: To evaluate the implementation effect of hepatitis C medical insurance reimbursement policy in China from the view of medical institutions. Methods: The electronic medical record of a top tertiary hospital in Chengdu from January 2014 to December 2020 were extracted, and the interrupted time series model was used to analyze the changes in diagnosis and treatment behavior and disease burden of hepatitis C patients after the implementation of HCV insurance reimbursement policy. Results: In terms of diagnosis and treatment, the number of visits (ß2 = 19.290, P < 0.001) and treatments (ß2 = 14.291, P < 0.01) increased instantaneously after the implementation of the outpatient reimbursement policy in Chengdu in 2018, and there was no significant change after the implementation of the single line payment policy for oral direct antiviral (DAA) drugs in 2019 (P > 0.05); in terms of medical expenses, the total treatment cost (ß2 = 21439.3, P < 0.001), out-of-pocket expenses (ß2 = 6109.44, P < 0.001) and drug expenses (ß2 = 21889.8, P < 0.001) of hepatitis C patients have been significantly reduced after the implementation of the single-line payment policy. Conclusion: Hepatitis C medical insurance reimbursement policy can promote hepatitis C patients to actively seek medical treatment, promote the widespread use of DAA scheme, reduce the burden of patients, and improve the treatment efficiency of hepatitis C.
