Use of Failure Mode and Effects Analysis (FMEA) for Risk Analysis of Drug Use in Patients with Lung Cancer.

It is crucial to investigate the risk factors inherent in the medication process for cancer patients since improper antineoplastic drug use frequently has serious consequences. As a result, the Severity, Occurrence, and Detection rate of each potential failure mode in the drug administration process for patients with lung cancer were scored using the Failure Mode and Effect Analysis (FMEA) model in this study. Then, the risk level of each failure mode and the direction of improvement were investigated using the Slacks-based measure data envelopment analysis (SBM-DEA) model. According to the findings, the medicine administration process for lung cancer patients could be classified into five links, with a total of 60 failure modes. The risk of failure modes for patient medication and post-medication monitoring ranked highly, with unauthorized use of traditional Chinese medicine and folk prescription and unauthorized drug addition (incorrect self-medication) ranking first (1/60); doctor prescription was also prone to errors. The study advises actively looking at ways to decrease the occurrence and difficulty of failure mode detection to continually enhance patient safety when using medications.

Comparison of Three Different Data Sources of Adverse Drug Reactions Using Adverse Drug Reaction Data of Fluorouracil for Gastric Cancer as an Example.

Various sources of information are available for identifying and evaluating adverse drug reactions (ADRs). However, some studies only used the ADR data from spontaneous reporting databases to evaluate the safety of post-marketing drugs. This study was performed to identify an appropriate method for evaluating the safety of post-marketing drugs by comparing the frequencies of ADRs among three datasets: randomized controlled trials, published case reports, and spontaneous reports. Taking ADR data for fluorouracil as an example, we collected the three types of data and extracted their ADR information. All listed ADRs were sorted by frequency from high to low, and the top five ADRs were chosen from each dataset. We assigned an index value of 1.0 to the frequency of one specific ADR (diarrhea) and then calculated the index values of the other ADRs relative to diarrhea. Ten different ADRs were mentioned in the top five ADRs of the three datasets, and only diarrhea and nausea/vomiting were included in all three datasets. The rank orders of the top five ADRs varied among the three datasets. Nausea and vomiting was the most frequent ADR in all three datasets; the remaining ADRs differed among the datasets. There were significant differences in the recording of ADRs and the frequency distributions among the three datasets. A comprehensive and reliable safety profile for post-marketing drugs should not be based on any one source. Spontaneous reports from monitoring institutions provided the most ADR data. Randomized controlled trials and case reports published in the literature can supplement the results from spontaneous reports.

Analysis and retention behavior of isoflavone glycosides and aglycones in Radix Astragali by HPLC with hydroxypropyl-ß-cyclodextrin as a mobile phase additive.

In order to determine isoflavone glycosides (calycosin-7-O-ß-D-glucoside and formononetin-7-O-ß-D-glucoside) and aglycones (calycosin and formononetin), a simple HPLC method with isocratic elution employing hydroxypropyl-ß-cyclodextrin (HP-ß-CD) as a mobile phase additive was developed. Various factors affecting the retention of isoflavone glycosides and aglycones in the C(18) reversed-phase column, such as the nature of cyclodextrins, HP-ß-CD concentration, and methanol concentration, were systematically studied. The results show that HP-ß-CD, as a very effective mobile phase additive, can markedly reduce the retention of isoflavone glycosides and aglycones, and the decrease magnitudes of isoflavone aglycones are more than those of their glycosides. The role of HP-ß-CD in the developed HPLC method is attributed to the formation of the inclusion complexes between isoflavone glycosides (or aglycones) and HP-ß-CD. So, the apparent formation constants of the isoflavone glycosides (or aglycones)/HP-ß-CD inclusion complexes also were investigated. Isoflavone glycosides (and aglycones) form the 1:1 inclusion complexes with HP-ß-CD, and the isoflavone aglycones/HP-ß-CD complexes are more stable than the isoflavone glycosides/HP-ß-CD complexes. Finally, the optimized method was successfully applied for the determination of isoflavone glycosides and aglycones in Radix Astragali samples.

Matrine-imprinted monolithic stationary phase for extraction and purification of matrine from Sophorae flavescentis Ait.

A matrine-imprinted monolithic stationary phase (MIP monolith) was prepared by in situ polymerization for extraction and purification of matrine from Sophorae flavescentis Ait. Matrine was used as the template molecule, methacrylic acid as the function monomer, ethylene glycol dimethacrylate as the cross-linking agent, and toluene and dodecanol as the porogenic solvents. Scanning electron microscope study revealed that a monolithic structure with mesopores and 36 µm diameter nodules was obtained. The molecular recognition process and the effect of varying chromatographic conditions on separation were examined by high-performance liquid chromatography (HPLC). Hydrogen bonding, electrostatic, hydrophobic interactions and the molecular shape matching in MIP monolith cavities were proposed to be responsible for the recognition mechanism. The use of MIP monolith as a solid-phase extraction (SPE) sorbent for extraction and purification of matrine from S. flavescentis Ait was investigated. The extraction yield was 89.2% (for 3.0 mmol l(-1) matrine) with enrichment factor 29.