Safety evaluation of cephalosporins based on utilization and adverse drug events: analysis of two databases in China.
Summary of "Safety evaluation of cephalosporins based on utilization and adverse drug events: analysis of two databases in China."
Objective: The aim of this study is to evaluate the safety of cephalosporins, based on utilization and adverse drug events (ADEs). Methods: This is a retrospective study using data on cephalosporins, obtained from Yangtze River hospital drug information and the Wuhan adverse drug reactions monitoring center database, from January 2009 to December 2010, in 30 hospitals in China. Results: 22/44 (55%) cephalosporins were third-generation, which accounted for more than 50% of total expenditure. The top five cephalosporins (sorted by their defined daily doses) were cefodizime sodium, cefoperazone/sulbactam sodium, cefaclor, cefixime and cefmenoxime hydrochloride, which were used 182.93, 110.63, 109.09, 101.47 and 100.05 defined daily dose per 10,000 days, respectively. Third-generation cephalosporins were responsible for 747/1337 ADEs (55.87%). In particular, 208 episodes (15.56%) were associated with ceftriaxone. The most frequently reported damages were involved in the skin and its appendages (967, 68.92%). 603 (45.10%) were identified as definite in causality evaluation. Cefaclor was found to be safer than other cephalosporins, whereas ceftriaxone was found to be less safe. Conclusion: This retrospective evaluation demonstrated that overused and misused cephalosporins caused a relatively high incidence of ADEs. Therefore, surveillance should be strengthened successfully to optimize the rational use of cephalosporins.
Huazhong University of Science and Technology, Tongji Medical College, Tongji Hospital, Department of Pharmacy , 1095 Jiefang Road, Wuhan, Hubei Province, 430030 , PR China +86 27 83663641 ; +86 27 83663643 ; firstname.lastname@example.org.
This article was published in the following journal.
Name: Expert opinion on drug safety
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22708900
- DOI: http://dx.doi.org/10.1517/14740338.2012.699037
Medical and Biotech [MESH] Definitions
The development of systems to prevent accidents, injuries, and other adverse occurrences in an institutional setting. The concept includes prevention or reduction of adverse events or incidents involving employees, patients, or facilities. Examples include plans to reduce injuries from falls or plans for fire safety to promote a safe institutional environment.
The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))
Safety-based Drug Withdrawals
Removal of a drug from the market due to the identification of an intrinsic property of the drug that results in a serious risk to public health.
Drug Utilization Review
Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.
The utilization of drugs as reported in individual hospital studies, FDA studies, marketing, or consumption, etc. This includes drug stockpiling, and patient drug profiles.
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