Safety analysis of therapeutic drugs for breast cancer patients and construction of a predictive model for serious adverse drug reactions.

OBJECTIVES: To explore the characteristics of the occurrence of antineoplastic drug adverse reactions (ADRs) in breast cancer and to utilize a computerized tool to identify early warning indicators of potentially serious ADRs. METHODS: We conducted descriptive statistical analyses of the demographic features, medication use characteristics, and clinical manifestations of suspected ADRs in ADR-exposed patients using data from the Shaanxi Provincial Adverse Drug Reaction Monitoring Center, China, from 2017 to 2021. Using disproportionality methods (reporting odds ratio, proportional reporting ratio, and comprehensive standard method), the relationship between drugs and ADRs was measured. Finally, a web-based clinical prediction model for serious ADRs based on binary logistic regression was developed to estimate individual event probabilities numerically. RESULTS: We developed a new computer-mineable breast cancer-ADR system. In total, 1119 ADR reports were received between 2017 and 2021, with an increasing trend in the number. Antineoplastic medications of natural sources made up the greatest portion of the drug category (530, 38.10%) while targeted drugs' part increased with time. The medicine with the greatest number of ADR cases was docetaxel. Bone marrow failure was the most reported ADR. The disproportionality methods produced 19 signals of disproportionate reporting, two signals of disproportionate reporting were unknown ADRs. The occurrence of serious ADRs was shown to be substantially correlated with gender, platinum drugs, and blood and lymphatic system disorders. The clinical prediction model for serious ADRs had above-moderate discriminatory power (C-index was 0.775). CONCLUSIONS: The number of ADRs to breast cancer antineoplastic drugs was constantly increasing, with docetaxel ranking first, with the majority of ADRs presenting as bone marrow suppression, nausea, and vomiting. Data mining identified 19 signals of disproportionate reporting.

The short- and long-term effects of community-family-doctor-based type 2 diabetes self-management interventions.

OBJECTIVES: The popularity of contracted family doctor services in China has been growing in recent years, but community-family-doctor-based type 2 diabetes mellitus (T2DM) intervention programs have yet to be adequately studied. This study was to evaluate the short- and long-term effects of community-family-doctor-based self-management interventions for T2DM and to explore strategies for long-term glycemic control. STUDY DESIGN: This was a randomized controlled trial. METHODS: A total of 144 eligible participants were randomly assigned to intervention and control groups. The control group received only routine community diabetes care, and the intervention group received community-family-doctor-based interventions involving the same standard of care. The interventions lasted for 3 months, and the follow-up was continued for 15 months. Intention-to-treat analysis and generalized estimation equations were then used to determine the short- and long-term effects of the interventions on glycated hemoglobin (HbA1c), diabetes self-management, and medication adherence. RESULTS: There were statistically significantly greater improvements in all aspects of the intervention group after 3 months of intervention. Compared with baseline, changes in the attitude (ß = 0.384, 95% confidence interval [CI; 0.194, 0.574], P < 0.001), practice (ß = 1.751, 95% CI [0.762, 2.739], P = 0.001), and knowledge, attitudes, practice total scores (ß = 2.338, 95% CI [0.682, 3.995], P = 0.006) of patients in the intervention group were statistically significant after 15 months, and the HbA1c (8.19 ± 1.73%), knowledge (16.42 ± 3.21), and medication adherence (5.53 ± 1.76) scores were slightly better than those at baseline, although not statistically significant (P > 0.05). CONCLUSIONS: T2DM self-management interventions based on community family doctors improved patients' HbA1c, diabetes self-management, and medication adherence, did not do so significantly in the long term.

Assessment of medication adherence, medication safety awareness and medication practice among patients with lung cancer: A multicentre cross-sectional study.

OBJECTIVES: We aimed to explore the current status of medication adherence, safety awareness and practice among patients with lung cancer. METHODS: We conducted a questionnaire-guided cross-sectional study in Xi'an, Yulin, Hanzhong and Weinan in Shaanxi Province, China, from April to June 2021 for a period of 3 months. The study questionnaire was developed according to previous related studies reported in the literature, and includes basic demographic information and patients' medication safety questions. The data were double-entered using EpiData 3.1 software; descriptive statistics, t-test, analysis of variance, the Kruskal-Wallis test and the Mann-Whitney U-test were performed to analyse the data. RESULTS: A total of 567 participants were included, and 409 valid questionnaires were finally completed, with an effective response rate of 72.13%. More than 80% of patients showed good medication adherence; the average adherence score was 22 ± 2.68 of 25. The average score for medication safety awareness was 16.40 ± 4.41, which was significantly lower than that of medication adherence (p < .001). Only 22.74% of patients always checked their medicines before a nurse administered them; 17.60% of patients never checked their medicines. Few patients actively consulted an health care professional to understand safety information before taking a medication. A significant difference existed in safety awareness scores among age groups (p = .039) and geographic regions (p < .001). Patients with three or more comorbidities had the lowest awareness scores (p = .027). CONCLUSION: We found that patients with lung cancer showed better medication adherence, but their awareness about medication safety was poor. Older patients, those with comorbidities and patients in regions with poor medical resources may have worse awareness about safety. Current medication education for patients should not only aim to improve adherence but should also encourage patients to take greater responsibility for their own safety and to actively participate in their medication safety. Greater systematic and individualized medication safety information is needed for older patients, those with more comorbidities and patients in areas with poor medical resources. PATIENT CONTRIBUTION: We conducted a questionnaire-guided cross-sectional study on hospitalized lung cancer patients in Shaanxi Province to explore the patients' practices related to safety medication, including medication adherence and medication safety awareness.

A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China.

BACKGROUND: Adverse drug reactions (ADRs) cause a substantial clinical and economic burden. Spontaneous reporting of ADRs by the public is crucial. In some developed countries like the United States, Canada, consumers have been allowed to directly report ADRs, however, convenient channels for direct ADR reporting by the public are lacking in China. OBJECTIVE: We aimed to compare the knowledge, attitudes, and practice(KAP) regarding monitoring and reporting of adverse drug reaction (ADR) among the general public in eastern and western China. METHODS: A questionnaire-guided cross-sectional study was administered to participants in Nanjing and Xi'an during April-July 2019. A descriptive statistical analysis was used to describe respondents' demographic information and other results. The t-test and analysis of variance were used to test the differences in knowledge and attitudes among respondents with different demographic characteristics. P < 0.05 was considered statistically significant. Binary logistic regression analysis was used to examine factors associated with knowledge and attitudes. RESULTS: A total of 1085 questionnaires were distributed in this survey, 869 valid questionnaires were returned, the recovery rate was 80.09%. Respondents showed poor knowledge of the definition of ADRs and reporting criteria, with a significant difference in average knowledge scores according to education level, gender, and age group. Most respondents had positive attitudes toward ADR monitoring and reporting, with no significant differences in knowledge and attitude scores between the two cities. In total, 68.93% of respondents said they would feedback information to health care professionals, most (84.35%) would take the initiative to report ADRs if there were a convenient method. More than half (58.57%) of respondents were more likely to report ADRs by telephone. CONCLUSION: The findings of our study indicated that health care professionals should encourage patients to actively report ADR. China should also explore ways to facilitate direct public reporting of ADRs by improving relevant laws and regulations.

Predictors of Glycemic Control among Patients with Type 2 Diabetes in Western China: A Multi-center Cross Sectional Study.

The prevalence of type 2 diabetes mellitus (T2DM) is increasing rapidly in China. Glycemic control is vital in this patient population. We designed a cross-sectional questionnaire to investigate glycemic control and associated factors in T2DM patients in Western China. The survey included patients' medical history, blood glucose status, and therapeutic medications, as well as demographic data. The Chi-square test, Fisher's exact test, and logistic regression were performed to analyze the data. The STROBE checklist was used to check the procedure. Among 510 T2DM patients included in this study, 47.5% of them had blood glucose control within the normal range, defined as glycated hemoglobin A1c (HbA1c) ≤7% or fasting plasma glucose (FPG) <7.0 mmol/L. The mean age of participants was 60.58 ± 11.20 years, with a male to female ratio of 1.02 : 1. Glycemic control was significantly associated with region (p < 0.001), comorbidities (p < 0.001), monitoring frequency (p = 0.002), treatment with insulin (p = 0.003), and medication compliance (p < 0.001). Logistic regression analysis showed that unsuccessful glycemic control was significantly related to wealthier residence (p < 0.001), more comorbidities (p = 0.017), monitoring frequency (p = 0.003), and medication incompliance (p < 0.001). These results suggested that the level of glycemic control among T2DM patients in Western China was poor. It is necessary to carry out health management and nursing of diabetic patients from community, family and patients jointly.

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.

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study.

Pharmacovigilance is important to monitor the safety of drugs. There are, however, problems with the quality of adverse drug reaction reports in China. This study aimed to analyze the quality of adverse drug reaction reports in China, identify the factors affecting it, and propose measures to improve it. In our study, the western province of Shaanxi, the central province of Hubei and the eastern province of Jiangsu were chosen as typical, and adverse drug reaction reports from these three provinces from 2015 to 2017 were systematically sampled. The sampling reports were scored and graded to assess their quality. The results showed that only 10.18% were considered high quality in a total of 3429 reports. There were statistically significant differences in quality by year, province, report type, report source, and occupation of the reporter (p < 0.001). Reports from Shaanxi were slightly poorer quality, and "new" and "serious" reports and those from pharmacists were higher quality. Five indicators were particularly poor quality: patient information, adverse drug reaction, reporter information, drug information and vigilance. In conclusion, the quality of adverse drug reaction reports in China still needs improvement. Factors affecting quality included timing, location, report type, report source, and reporter's occupation. It may be helpful to publicize the importance of monitoring adverse drug reactions and improve the knowledge of reporters.

Safety analysis of antineoplastic drugs for lung cancer: a retrospective analysis based on Shaanxi Province in Western China.

BACKGROUND: China has the highest proportion of lung cancer-related deaths. Drug therapy is the main tool of comprehensive anticancer treatment. However, most studies to date have focused on certain types of targets or immunotherapeutic modalities for drug safety; few studies have addressed the factors that influence ADRs for each type of drug in patients with lung cancer, and even fewer studies have explored the risk factors for certain types of ADRs. Based on it, we comprehensively evaluate the drug safety of patients and provide a clinical reference with a focus on lung cancer. RESEARCH DESIGN AND METHODS: We examined 767 reports of adverse drug reactions (ADRs) in patients with lung cancer and conducted a logistic regression analysis on the risk factors that may cause different types of organ system damage and serious ADRs. RESULTS: The logistic regression identified various independent risk factors for system organ damage, and ADRs involving erythrocyte abnormalities (P < 0.001), respiratory system damage (P < 0.001), and leukocyte and reticuloendothelial system abnormalities (P < 0.001) were more likely to be severe. CONCLUSIONS: Rare adverse reactions and different Clinical medication guidelines for molecular-targeted drugs were identified. These findings had certain practical significance in clinical safe drug use.

Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study.

BACKGROUND: Establishing effective pharmacovigilance systems globally is challenging due to the need for comprehensive epidemiological data on pharmacovigilance-related events, particularly in countries at different stages of development. AIM: This study aimed to determine magnitude and drivers of change in the global and regional burden of pharmacovigilance-related events from 1990 to 2019, analyzing variations between age groups and sex, providing data support for policymakers to adjust their pharmacovigilance policies. METHOD: Pharmacovigilance-related events were defined as Adverse Effects of Medical Treatment (AEMT) and Drug Use Disorders (DUD) in the Global Burden of Diseases, Injuries, and Risk Factors Study 2019. Time trend analysis utilized joinpoint regression, age-period-cohort model, and decomposition method. Disease burden was measured in incidence, deaths, and disability-adjusted life years (DALYs). RESULTS: The global burden of pharmacovigilance-related events remained high, driven predominantly by population growth. Children and older adults were identified as particularly susceptible groups. Across various regions and periods of the socio-demographic index (SDI), the risk of death from AEMT showed a decreasing trend. In contrast, the incidence of AEMT and both the incidence and death rates from DUD showed a stable or worsening trend. Significant regional disparities in the burden of these diseases were noted between different SDI levels. CONCLUSION: The study underscores the critical need for robust pharmacovigilance systems worldwide. The observed trends in the burden of pharmacovigilance-related events offer a clear direction for countries to refine and strengthen their pharmacovigilance policies and practices.

Safety assessment of anti-B cell maturation antigen chimeric antigen receptor T cell therapy: a real-world study based on the FDA adverse event reporting system database.

Background: On April 18, 2024, the U.S. Food and Drug Administration officially required updating of the "boxed warning" for T cell malignancies for all chimeric antigen receptor T cell (CAR-T) therapies. Given the clinical significance of these therapies, a rigorous safety assessment is paramount. However, comprehensive real-world safety studies have been lacking for the newly marketed CAR-T products idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which target B cell maturation antigen, especially regarding the risk of secondary malignancies. Therefore, we aimed to thoroughly analyze the adverse events (AEs) information in the FDA Adverse Event Reporting System (FAERS) database to comprehensively understand the safety risks of ide-cel and cilta-cel. Methods: We extracted AE reports related to ide-cel and cilta-cel from the FAERS database (https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.) from January 1, 2019 to December 31, 2023. Disproportionality analysis and Bayesian analysis were used to identify risk signals across subgroups and specific cases (including for death and secondary malignancies). Weibull distribution analysis was employed to determine the time to AE onset. Results: A total of 695 AE reports for ide-cel and 848 for cilta-cel were included in the FAERS database. This analysis identified 81 positive signals for ide-cel and 74 for cilta-cel. Notably, comparisons with the drug labels revealed "unexpected signals," including febrile bone marrow aplasia (reporting odds ratio=69.10; confidence interval 39.12-122.03) and plasma cell myeloma (12.45; 8.18-18.95) for ide-cel, and increased serum ferritin (24.98; 8.0-77.58) and large intestine perforation (18.57; 5.98-57.69) for cilta-cel. Both drugs showed a higher AE incidence among male recipients and patients aged ≥65 years, although female recipients faced a greater risk. Most AEs occurred at the early stage of administration. However, secondary malignancies were detected for both drugs, primarily occurring one-year post-administration. Conclusion: This study provides a foundation for understanding the safety profile of CAR-T cell therapy, particularly in relation to the emergence of secondary malignancies. Such insights are helpful for clinical decision-making and the safe and effective utilization of these therapeutic agents.

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.

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.

Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised controlled trial.

INTRODUCTION: The management of diabetes has become a critical public health issue in China. The development of community-based type 2 diabetes management in China has not yet reached an ideal state, and the most suitable management methods for diabetic patients are still being explored. Few studies have used community-based family doctors to perform interventions of appropriate intensity. This protocol describes a planned randomised controlled trial to evaluate the effectiveness of a family doctor-led intervention model for diabetes self-management and medication adherence in type 2 diabetes mellitus patients. METHODS AND ANALYSIS: This is a Standard Protocol Items: Recommendations for Interventional Trials-compliant cluster randomised controlled trial. The study will be conducted at four CHCs (community health centers). The control group will receive conventional medical services and health education. The intervention group will receive an intervention led by community family doctors based on the conventional medical services and health education. It will include five parts: usual care, a medication reminder, a 4-week plan, a weekly phone interview and a monthly interview. The primary outcomes are changes in fasting blood glucose, glycosylated haemoglobin, self-management knowledge and behaviour, and medication adherence from baseline to the 3rd and 6th months. The secondary outcome is the proportion of people whose blood sugar and glycosylated haemoglobin are under control in the 3rd and 6th months. ETHICS AND DISSEMINATION: The study proposal was approved by the Biomedical Ethics Committee of the Medical Department of Xi'an Jiaotong University (no. 2021-1371). The findings will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2100051685.

Knowledge, attitude, and practice regarding pharmacovigilance among the general public in Western China: a cross-sectional study.

OBJECTIVES: Spontaneous reporting of adverse drug reactions (ADRs) to pharmacovigilance centers is a common and inexpensive method of ADR detection. Although China requires patients to report ADRs directly, the reporting rate is extremely low. We assessed public knowledge, attitudes, and practice (KAP) regarding pharmacovigilance in Shaanxi Province, China. METHODS: A self-administered questionnaire to evaluate the KAP of the general public regarding pharmacovigilance was designed and distributed in selected locations throughout Xi'an. The data were double input and statistical methods were used to analyze questionnaire responses. RESULTS: Knowledge scores among consumers regarding pharmacovigilance was low. Women and respondents in younger age groups had high knowledge scores. Over 85.0% of respondents had a positive attitude toward ADR monitoring. Most respondents said they would voluntarily report ADR to medical personnel, and 85.1% said they would report ADRs with easier policies. Further, 89.1% of respondents preferred reporting ADRs by phone or online whereas 10.9% preferred email or post. Regarding reasons for not reporting ADRs, 57.8 and 43.6% of respondents, respectively, did not know to whom to give feedback and felt that ADRs were not serious enough to report. Respondents had difficulty with portions of the ADR reporting form addressing drug information and description of ADR signals. CONCLUSIONS: The public has poor awareness about, but a positive attitude toward, pharmacovigilance. Unclear feedback pathways and lack of understanding about the seriousness of ADRs were the main reasons patients did not report ADRs, and respondents had difficulty with parts of the reporting form. The government should publicize the importance of ADR monitoring and develop more suitable forms and measures for patients to report ADR.

Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study.

BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81.8%. About 93% (n = 371) of pharmaceutical companies and medical institutions had established ADR monitoring departments/units. Few institutions (26%, n = 104) allocated an ADR budget; 7% (n = 30) had received ADR monitoring funding in the last year (2013). Almost all institutions (99%, n = 555) had computers and 47% (n = 263) had a network database. Many institutions conducted public education about drug safety (49%, n = 283), medicine utilization reviews/quality surveys (28%, n = 158), and medicine consultation services (88%, n = 511). Institutions in eastern, central, and western China differed significantly on implementation of existing regulations and pharmacovigilance activities. CONCLUSIONS: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.

The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China.

BACKGROUND: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality. RESEARCH DESIGN AND METHODS: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. ADR report quality was evaluated using an ADR report quality evaluation system. RESULTS: None of the reports were rated as excellent and 1.40% (n = 16) as good. Report quality was better for new and serious reports than for general reports. Medical institutions generated higher quality reports than pharmaceutical manufacturers. Nurses generated higher quality reports than doctors, pharmacists, and other professionals. Reporters of different occupations showed significant differences in the quality of the indicators Reporting time limit, Intervention ADR time, ADR termination time, ADR intervention measures, Original disease, and Cause of medication (P = 0.000). CONCLUSIONS: The ADR data quality was poor in western China, and of lower quality than reported data from previous research in other regions. Improvements in the quality and availability of ADR reports are urgently needed.

Factors that affect adverse drug reaction reporting among hospital pharmacists in Western China.

BACKGROUND: Hospital pharmacists can make a considerable contribution to the spontaneous reporting system of adverse drug reactions. The factors that influence adverse drug reaction reporting among hospital pharmacists remain largely unknown in China. OBJECTIVE: This study aims to identify factors that affect hospital pharmacist-led adverse drug reaction reporting in Xi'an, and to obtain suggestions from pharmacists about how to improve the current adverse drug reaction reporting system. SETTING: Hospital settings throughout Xi'an, a region of Western China. METHOD: A matched case-control study was conducted on a population of 2,814 hospital pharmacists in Xi'an during 2011. Cases included all pharmacists who had reported at least one adverse drug reaction between 2008 and 2010 and agreed to participate in the study (186/204; 91.2 %); controls (n = 372) were pharmacists who had not reported any adverse drug reaction during the same period. A self-administered questionnaire was distributed to the participants. Logistic regression was performed to evaluate the association between indicator variables and the outcome of having reported at least one adverse drug reaction. MAIN OUTCOME MEASURE: Pharmacists' knowledge, attitude and practice towards adverse drug reaction reporting and factors affecting reporting. RESULTS: Higher professional title (adjusted OR 1.44; 95 % CI 1.07-1.94; p = 0.018), having received training about adverse drug reaction reporting (1.64; 1.04-2.57; p = 0.032), better knowledge about reporting (1.53; 1.12-2.08; p = 0.007), "lack of access to adverse drug reaction reporting form" (0.29; 0.12-0.72; p = 0.008) was independently associated with adverse drug reaction reporting. Clinical pharmacists were more likely to report an adverse drug reaction than dispensary pharmacists (1/adjusted OR 5.26; p < 0.001), pharmacy administrators (5.00; p = 0.003), and other technicians (5.56; p = 0.001). CONCLUSIONS: Higher professional title, having received training, mastering knowledge about reporting, and being a clinical pharmacist were positive predictors of pharmacist-led adverse drug reaction reporting. Lack of access to reporting forms was a negative predictor. Continuous training and establishing incentive mechanisms are needed to promote adverse drug reaction reporting among hospital pharmacists.

Pharmacists' perception of pharmaceutical care in community pharmacy: a questionnaire survey in Northwest China.

The aim of this study was to explore the perceptions of community pharmacists towards the concept of pharmaceutical care, implementing frequencies of pharmaceutical care, and barriers to implementation of pharmaceutical care in China. A 38-item self-completion pre-tested questionnaire was administered to a quota sample of 130 pharmacists in community pharmacies in Xi'an, Shaanxi Province, northwest China in April 2008. Main outcome measures included understanding of pharmaceutical care; perceived frequency of pharmaceutical care activities; attitude towards pharmaceutical care; barriers to implementation of pharmaceutical care. A response rate of 77.7% (101/130) was achieved. The data were analysed descriptively. Factor analysis was used to explore potential barriers to the provision of pharmaceutical care. Respondents' understanding of the definition of pharmaceutical care was not entirely satisfactory: it was widely but incorrectly seen as a medication counselling service and many pharmacists appeared to misunderstand their role in the process. Respondents spent most of their work time performing prescription checks and providing patients with directions for drug administration, dosage, and precautions, but they tended to ignore health promotion within and outside of pharmacy settings. Factor analysis suggested four factors influencing the implementation of pharmaceutical care in the surveyed community pharmacies: lack of external conditions for developing or providing pharmaceutical care, lack of time and skills, absence of information and economic incentive, and lack of full support from other health professionals, with a cumulative variance of 64.7%. Cronbach's alpha for the four factors was 0.71, 0.72, 0.69 and 0.74, respectively. Although the respondent pharmacists had a certain degree of understanding of the definition, aim, function and use of pharmaceutical care, and carried out some activities currently, a range of barriers need to be overcome before comprehensive pharmaceutical care becomes a reality in China. These barriers could be overcome through participation in effective continuing educational programmes, availability of more resources, effective collaboration with other health professionals.

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.