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This study evaluated the psychometric properties of the Mandarin version of the HeartQoL questionnaire, a core ischemic heart disease (IHD) health-related quality of life (HRQL) instrument, in patients with angina, myocardial infarction (MI), and ischemic heart failure (IHF).The English version of HeartQoL was translated into Mandarin. A cross-sectional study was then conducted in mainland China using the Mandarin HeartQoL, Short Form-12 Health Survey, and Hospital Anxiety and Depression Scale. Factor analysis was used to establish the HeartQoL structure and internal consistency reliability and construct validity were assessed.Patients with IHD (n = 412; angina = 112, MI = 151, and IHF = 149) were enrolled. Significantly higher HeartQoL HRQL scores were reported by patients with either angina or MI than by patients with IHF. The 2-factor structure was confirmed by Mokken scale analysis in the total group with strong H coefficients on the global scale (0.64) and both the physical (0.70) and emotional (0.80) subscales. Internal consistency reliability was strong with Cronbach's α ranging from 0.90 to 0.95. Convergent validity was confirmed with strong correlations between similar physical and mental HeartQoL and Short Form-12 Health Survey subscales ranging from 0.77 to 0.82 with divergent validity confirmed with significantly lower correlations between dissimilar constructs. Discriminative validity was confirmed for 72% of the a priori sociodemographic and clinical hypotheses.The Mandarin version of the HeartQoL HRQL questionnaire demonstrates acceptable internal consistency reliability and convergent, divergent, and discriminative validity in patients with IHD and in each diagnostic subgroup. The data support the use of the HeartQoL to assess and compare HRQL in Mandarin-speaking patients with IHD.

Unintentional medication discrepancies (UMDs) are common in geriatric patients during care transitions, resulting in frequent undesirable consequences. Medication reconciliation could be a useful practice to prevent or ameliorate UMD. However, this practice in Vietnamese hospitals has not been well established or standardized. This study aims to determine the effect of pharmacist-initiated educational interventions on improving medication reconciliation practice.This prospective 6-month pre-and post-study was conducted in two internal medicine wards in a Vietnamese 800-bed public hospital. Pharmacists provided training and short-term support to physicians on medication reconciliation. Primary outcome measures were the proportions of patients with at least one UMD at admission. Secondary outcome measures were the proportions of patients with preventable adverse drug events (pADEs) score ≥0.1 due to these UMDs. Odds ratio and 95% confidence intervals were assessed based on a multivariate logistic regression model.One hundred fifty-two patients were recruited in the pre-intervention phase, and 146 in the post-intervention phase. Following the intervention, the proportion of geriatric patients with ≥1 UMD at admission significantly decreased from 55.3 to 25.3 % (ORadj 0.255, 95% CI: 0.151-0.431). Similarly, the proportion of patients with a pADE ≥0.1 at admission reduced from 44.1 to 11.6% [ORadj 0.188, 95% CI: 0.105-0.340] post-intervention.Our pharmacist-initiated educational interventions have demonstrated the ability to produce substantial improvement in medication reconciliation practice, reducing UMDs and potential harm. Our approach may provide an alternate option to implement medication reconciliation for jurisdictions with limited healthcare resources.

Observational studies have demonstrated that the pneumococcal polysaccharide vaccine (PPV) is associated with reduced risk of cardiovascular events. This may be mediated through IgM antibodies to OxLDL, which have previously been associated with cardioprotective effects. The Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE) is a double-blind, randomised controlled trial (RCT) of PPV in preventing ischaemic events. Participants received PPV or placebo once at baseline and are being followed-up for incident fatal and non-fatal myocardial infarction or stroke over 6 years.A subgroup of participants at one centre (Canberra; n = 1,001) were evaluated at 1 month and 2 years post immunisation for changes in surrogate markers of atherosclerosis, as pre-specified secondary outcomes: high-sensitive C-reactive protein (CRP), pulse wave velocity (PWV), and carotid intima-media thickness (CIMT). In addition, 100 participants were randomly selected in each of the intervention and control groups for measurement of anti-pneumococcal antibodies (IgG, IgG2, IgM) as well as anti-OxLDL antibodies (IgG and IgM to CuOxLDL, MDA-LDL, and PC-KLH).Concentrations of anti-pneumococcal IgG and IgG2 increased and remained high at 2 years in the PPV group compared to the placebo group, while IgM increased and then declined, but remained detectable, at 2 years. There were statistically significant increases in all anti-OxLDL IgM antibodies at 1 month, which were no longer detectable at 2 years; there was no increase in anti-OxLDL IgG antibodies. There were no significant changes in CRP, PWV or CIMT between the treatment groups at the 2-year follow-up.PPV engenders a long-lasting increase in anti-pneumococcal IgG, and to a lesser extent, IgM titres, as well as a transient increase in anti-OxLDL IgM antibodies. However, there were no detectable changes in surrogate markers of atherosclerosis at the 2-year follow-up. Long-term, prospective follow-up of clinical outcomes is continuing to assess if PPV reduces CVD events.

Elderly patients are at high risk of unintentional medication discrepancies during transition of care as they are more likely to have multiple comorbidities and chronic diseases that require multiple medications. The aim of the study was to assess the frequency of unintentional medication discrepancies and identify the associated risk factors and potential clinical impact of them in elderly inpatients during hospital admission. A prospective observational study was conducted from July to December 2018 in an 800-bed geriatric hospital in Hanoi, North Vietnam. Patients over 60 years of age, admitted to one of selected internal medicine wards, taking at least one chronic medication before admission, and staying at least 48 h were eligible for enrollment. Medication discrepancies of chronic medications before and after admission of each participant were identified by a pharmacist using a step-by-step protocol for the medication reconciliation process. The identified discrepancies were then classified as intentional or unintentional by an assessment group comprising a pharmacist and a physician. A logistic regression model was used to identify risk factors of medication discrepancies. Among 192 enrolled patients, 328 medication discrepancies were identified, with 87 (26.5%) identified as unintentional. Nearly a third of enrolled patients (32.3%) had at least one unintentional medication discrepancy. The most common unintentional medication discrepancy was omission of drugs (75.9% of 87 medication discrepancies). The logistic regression analysis revealed a positive association between the number of discrepancies at admission and the type of treatment wards. Medication discrepancies are common at admission among Vietnamese elderly inpatients. This study highlights the importance of obtaining a comprehensive medication history at hospital admission and supports implementing a medication reconciliation program to reduce the negative impact of medication discrepancy, especially for the elderly population.

Understanding the consequences of poor chelation compliance is crucial given the enormous burden of post-transfusional iron overload complications. We systematically reviewed iron-chelation therapy (ICT) compliance, and the relationship between compliance with health outcome and health-related quality of life (HRQoL) in thalassaemia patients. Several reviewers performed systematic search strategy of literature through PubMed, Scopus, and EBSCOhost. The preferred reporting items of systematic reviews and meta-analyses (PRISMA) guidelines were followed. Of 4917 studies, 20 publications were included. The ICT compliance rate ranges from 20.93% to 75.3%. It also varied per agent, ranging from 48.84-85.1% for desferioxamine, 87.2-92.2% for deferiprone and 90-100% for deferasirox. Majority of studies (N=10/11, 90.91%) demonstrated significantly negative correlation between compliance and serum ferritin, while numerous studies revealed poor ICT compliance linked with increased risk of liver disease (N=4/7, 57.14%) and cardiac disease (N=6/8, 75%), endocrinologic morbidity (N=4/5, 90%), and lower HRQoL (N=4/6, 66.67%). Inadequate compliance with ICT therapy is common. Higher compliance is correlated with the lower serum ferritin, lower risk of complications, and higher HRQoL. These findings should be interpreted with caution given the few numbers of evidence.

Objective: This systematic review aimed to evaluate the cost-effectiveness of medication adherence-improving interventions in patients with asthma.Data source: Search engines including PubMed, Scopus and EBSCOhost were used to locate relevant studies from the inception of the databases to 19 October 2018. Drummond's checklist was used to appraise the quality of the economic evaluation.Study selection: Economic studies evaluating the cost-effectiveness of medication adherence enhancing interventions for asthmatic patients were selected. Relevant information including study characteristics, quality assessment, health outcomes and costs of intervention were narratively summarized. The primary outcome of interest was cost-effectiveness (CE) values and the secondary outcomes were costs, medication adherence and clinical consequences.Results: Twenty studies including 11 randomized controlled trials, 6 comparative studies and 3 modeled studies using Markov models were included in the review. Among these, 15 studies evaluated an educational intervention with 13 showing cost-effectiveness in improving health outcomes. The CE of an internet-based intervention showed similar results between groups, while 3 studies of simplified drug regimens and adding a technology-based training program achieved the desirable cost-effectiveness outcome.Conclusion: Overall, our results would support that all of the identified medication adherence-enhancing interventions were cost-effective considering the increased adherence rate, improved clinical effectiveness and the reduced costs of asthma care. However, it was not possible to identify the most cost-effective intervention. More economic studies with sound methodological conduct will be needed to provide stronger evidence in deciding the best approach to improve medication adherence.

Background and Objectives The US Preventative Services Taskforce recommends screening adults for depression in primary care where adequate systems are established to ensure accurate diagnosis, effective treatment and follow-up. However, there is currently no consensus on which screening tool is most suitable for use in primary healthcare. We aim to systematically review the literature for operating characteristics of depression screening tools capable of self-administration in primary healthcare and meta-analyse the psychometric characteristics of these tools to determine their performance and accuracy. Methods An electronic literature search of EMBASE, Medline and CINAHL Complete was conducted from January 1982 to September 15, 2019 using the keywords: depression, screening, primary healthcare and adult. General and psychometric characteristics were extracted for screening tools studied in primary healthcare only when assessed against a ‘reference-standard’. Results Eighty-one studies from 22 countries were included in the review. Forty unique depression screening tools suitable for self-administration were identified in studies yielding 138 psychometric data sets. Based on ease of administration, 18 screening tools were suitable for use in primary healthcare. Of the tools meta-analysed, only the PHQ-9 and WHO-5 displayed superior accuracy and were easily administered. Conclusion Although numerous depression screening tools are suitable for use in primary care based on ease of administration, the PHQ-9 was the most widely assessed tool and displayed superior DOR, a-ROC, specificity and LR + . Our review supports the use of the PHQ-9 as a brief, easily administered depression screening tool with superior discriminatory performance and robust psychometric characteristics in primary care settings.

Phuong Thi Xuan Dong,1,2 Van Thi Thuy Pham,1,3 Chi Thi Dinh,3 Anh Van Le,3 Ha Thi Hai Tran,4 Huong Thi Lien Nguyen,1 Susan Hua,2 Shu Chuen Li2 1Department of Clinical Pharmacy, Hanoi University of Pharmacy, Hanoi, Vietnam; 2School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, NSW, Australia; 3Department of Pharmacy, Friendship Hospital, Hanoi, Vietnam; 4Department of Internal Cardiology, Friendship Hospital, Hanoi, VietnamCorrespondence: Shu Chuen Li, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, NSW, Australia, Tel +061 0249215921, Fax +061 0249217903, Email shuchuen.li@newcastle.edu.auPurpose: Geriatric inpatients generally have a high risk of drug-related problems (DRP) in prescribing following hospital admission, which are likely to cause negative clinical consequences. This is particularly evident in developing countries such as Vietnam. Therefore, clinical pharmacy service (CPS) aims to identify and resolve these DRPs to improve the quality use of medicines in the older population following hospital admission.Patients and Methods: The study was conducted as a prospective, single-center study implemented at a general public hospital in Hanoi. Patients aged ≥ 60 years with at least three chronic diseases admitted to the Internal Medicine Department between August 2020 and December 2020 were eligible to be enrolled. A well-trained clinical pharmacist provided a structured CPS to identify any DRP in prescribing for each patient in the study. Clinical pharmacist interventions were then proposed to the attending physicians and documented in the DRP reporting system.Results: A total of 255 DRP were identified in 185 patients during the study period. The most frequent types of DRP were underuse (21.2%), dose too high (12.2%), and contraindication (11.8%). There was a very high rate of approval and uptake by the physicians regarding the interventions proposed by the clinical pharmacist (82.4% fully accepted and 12.5% partially accepted). Of the interventions, 73.4% were clinically relevant (pADE score ≥ 0.1). In general, 9 out of 10 physicians agreed that CPS has significant benefits for both patients and physicians.Conclusion: Improving clinical pharmacy services can potentially have a positive impact on the quality of prescribing in elderly inpatients. These services should officially be implemented to optimize the quality use of medicines in this population group in Vietnam.Keywords: pharmacy practice, quality use of medicine, geriatrics

After the inclusion of more high-cost orphan drugs in China's National Reimbursement Drugs List, this study investigated issues relating to patient access to the 7 medicines for 4 rare diseases after listing.This study collected data from a national survey conducted in China. Three aspects associated with the accessibility of medicines, namely, approachability, availability, and affordability, were analyzed using descriptive statistics. In addition, multilevel logistic regression models were used to investigate the associations between patient characteristics and the accessibility of surveyed orphan drugs.Of the 999 completed responses included in the study, 15% of the patients (n = 150) did not use the medicines because of non-medicine-related issues. Among the 849 patients using the surveyed medications, 64.4% (n = 547) encountered the problem of unavailability, whereas 51.2% (n = 435) reported affordability as an issue, and 49.6% (n = 320) had health expenditure beyond the catastrophic threshold. The data also indicated that Commercial Medical Insurance helped patients to relieve the cost burden on orphan drugs, but the payout of Commercial Medical Insurance failed to influence patients' decisions to continue the treatments.Accessibility of orphan drugs has improved in China after their inclusion in the National Reimbursement Drugs List. Nevertheless, the availability and affordability of medicines remained the barriers for patients to access the desired treatments. It is recommended that further policy refinement in conjunction with the collaboration among healthcare stakeholders is required to deliver better care for patients with rare disease.

Medication adherence is an important factor in the management of chronic obstructive pulmonary disease (COPD). However, the rate of non-adherence to medications is high in COPD and is associated with worsened clinical outcomes and health-related quality of life for patients.Our study aimed to evaluate the impact of a pharmaceutical care program led by pharmacists in the improvement of medication adherence and quality of life for COPD patients in Vietnam.A pre- and post-intervention study was conducted over 12 months. Pharmacists provided brief counselling which focused on the role of COPD medications and the importance of adherence. Morisky Medication Adherence Scale was used to evaluate patients' adherence. Quality of life was assessed using the EQ-5D-5L questionnaire and clinical outcomes were evaluated by symptom scores. These outcomes were reassessed at baseline (T0), after 3 months (T1), 6 months (T2) and 12 months (T3).Study participants consisted of 211 COPD patients (mean age: 66.6 ± 8.2 years). The percentage of patients with good adherence significantly increased from 37.4% to 53.2% (p 0.001) after the program. Mean medication adherence scores improved from 6.7 (T0) to 7.4 (T2) and 7.4 (T3) (p 0.001). EQ-5D-5L index values also increased from 0.47 (T0) to 0.59 (T3) (p 0.001). There was no significant change in symptom scores across the duration of the study.Medication adherence and quality of life of COPD patients improved considerably after implementation of a pharmaceutical care program, thus supporting a vital role for pharmacists alongside physicians in the management of COPD.

e19587 Background: The treatment landscape in patients with mantle cell lymphoma (MCL) is changing with the introduction of Bruton’s tyrosine kinase inhibitors (BTKis) and bendamustine in Australia. We sought to analyze the practice impact of the introduction of publicly funded novel agents in MCL. The objective of this study was to describe the evolving treatment patterns of Australian patients with MCL over the last 10 years using population-wide prescription records. Methods: Patients who initiated a treatment for MCL between 01/01/2011 and 07/31/2021 were extracted from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset, which includes the dispensing records for 10% of the Australian population. This dataset captures all publicly funded treatments in Australia. The index date was defined as the commencement of any drug for MCL. First-line (1L) therapy was defined as the first treatments prescribed for MCL. A patient was defined as relapsed/refractory (R/R) if they had commenced a drug which was in a different therapeutic category, or if they re-started the same regimen after a gap of more than 180 days. Descriptive analyses were conducted to examine the use of treatment regimens for the overall 10-year population by line of therapy. Analyses by calendar year were also performed to assess the changes in the treatment patterns. Results: Overall, 241 patients with MCL were identified over the study period. The majority of patients were male (68.4%), age > 60 years (84.9%), and most being aged 70-79 years (42.1% of total). Many patients were receiving comedications at baseline, including antihypertensives (44.1%), anticoagulants (14.5%), and/or antipsychotics or antidepressants (12.5%). In the overall population (2011-2021), the majority of patients had received 1L treatment with bendamustine-rituximab (BR, 53.9%), rituximab plus other regimens (27.6%), or rituximab monotherapy (11.2%). The most commonly used regimens in R/R patients at any subsequent episode of treatment included BTKi (66.3%), rituximab monotherapy (52.8%) or rituximab plus other regimens (31.5%). A trend in adoption of novel agents was observed throughout the years following their PBS listing. Analysis by calendar year showed that from 2011 to 2020 for 1L therapy, the use of BR increased from 0% to 50% and use of rituximab-containing regimen except BR decreased from 100% to 16.7%; use of BTKi increased in R/R patients from 0% to 74.7%. Conclusions: MCL treatment patterns have significantly changed in Australia since the introduction of BTKis and bendamustine-containing regimens. The use of rituximab-containing regimens except BR in 1L MCL has decreased and use of BTKis in R/R patients has increased.

e19518 Background: The treatment landscape in patients with chronic lymphocytic leukemia (CLL) is changing with the approvals of Bruton’s tyrosine kinase inhibitors (BTKis) in Australia. We sought to understand the practice impact of the introduction of publicly funded novel agents for the treatment of CLL. The objective of this study was to describe the evolving treatment patterns of Australian patients with CLL over the last 10 years using population-wide prescription records. Methods: Patients who initiated a treatment for CLL between 01/01/2011 and 07/31/2021 were extracted from the Services Australia 10% Pharmaceuticals Benefits Scheme (PBS) dataset. This dataset includes the dispensing records for 10% of the Australian population and captures all publicly funded treatments in Australia. The index date was defined as the commencement of any drug for the treatment of CLL. First-line (1L) therapy was defined as the first treatments prescribed for CLL. A patient was defined as relapsed/refractory (R/R) if they had commenced a drug which was in a different therapeutic category, or if they re-started the same regimen after a gap of more than 180 days. Descriptive analyses were conducted to examine the use of treatment regimens for the overall 10-year population by line of therapy. Analyses by calendar year were also performed to assess changes in treatment patterns. Results: Overall, 803 patients with CLL were identified. The majority of patients were male (65%) and age > 60 years (77%), with most being aged 70-79 years (33% of total). Many patients were receiving comedications at baseline, including antihypertensives (47%), antipsychotics or antidepressants (17%), and/or anticoagulants (13%). In the overall population (2011-2021), the majority of patients had received 1L treatment with fludarabine-cyclophosphamide-rituximab (FCR, 49%), chlorambucil ± CD20 (27%), or CD20 monotherapy (17%). The most commonly used regimens in R/R patients at any subsequent episode of treatment included CD20 monotherapy (56%), BTKi (41%) or FCR (33%). A trend in adoption of novel agents was observed throughout the years following their PBS listing. Analysis by calendar year showed that from 2011 to 2020 use of FCR in 1L decreased from 78% to 10%; and use of BTKis in R/R increased from 0% to 62%. Conclusions: CLL treatment patterns have significantly changed in Australia since the introduction of the BTKis (e.g., ibrutinib, acalabrutinib). The use of FCR in 1L CLL has decreased and use of BTKis in R/R patients has increased.

Background Elderly patients are at high risk of unintentional medication discrepancies during transition care as they are more likely to have multiple comorbidities and chronic diseases that require multiple medications. The main objective of the study was to measure the occurrence and identify risk factors for unintentional medication discrepancies in elderly inpatients during hospital admission.Methods A prospective observational study was conducted from July to December 2018 in a 800-bed geriatric hospital in Hanoi, North Vietnam. Patients over 60 years of age, admitted to one of selected internal medicine wards, taking at least one chronic medication before admission, and staying at least 48 hours were eligible for enrolment. Medication discrepancies of chronic medications before and after admission of each participant were identified by a pharmacist using a step-by-step protocol for the medication reconciliation process. The identified discrepancies were then classified as intentional or unintentional by an assessment group comprised of a pharmacist and a physician. A logistic regression model was used to identify risk factors of medication discrepancies.Results Among 192 enrolled patients, 328 medication discrepancies were identified; of which 87 (26.5%) were unintentional. 32.3% of patients had at least one unintentional medication discrepancy. The most common unintentional medication discrepancy was omission of drugs (75.9% of 87 medication discrepancies). The logistic regression analysis revealed a positive association between the number of discrepancies at admission and the type of treatment wards. Conclusions Medication discrepancies are common at admission among Vietnamese elderly inpatients. This study confirms the importance of obtaining a comprehensive medication history at hospital admission and supports implementing a medication reconciliation program to reduce the negative impact of medication discrepancy, especially for the elderly population.

Objective There is evidence that the pneumococcal polysaccharide vaccine (PPV) may reduce cardiovascular disease. We aimed to evaluate the cost-effectiveness of PPV for primary prevention of acute coronary syndrome (ACS) in the elderly in Australia. Methods A Markov model was developed to investigate the costs, QALYs and ICERs of PPV administration in those aged ≥65 years without a history of ACS from the perspective of Australian healthcare system, using elderly-specific clinical data and local costs from Australian Heart Foundation and Australian Institute of Health and Welfare databases. A ten-years horizon was used, and all costs and health outcomes were discounted at 5% annually. The impact of various assumptions was tested with sensitivity analyses. Results In the base-case analysis, interventional strategy (100% PPV coverage) prevented an additional five incident ACS events among 1000 “healthy” elderly individuals compared with standard of care (50% PPV coverage) over 10 years. 100% PPV was the dominant strategy, resulting in a QALY gain of 0.0075 and cost saving of AU$ 179 per person. The results were most sensitive to effectiveness of PPV at preventing ACS and reducing hospital bed-days, and cost of ACS admission, but in all sensitivity analyses 100% PPV remained the dominant strategy. Shortening the time horizon from ten to five years resulted in further cost saving. Conclusion PPV for the prevention of ACS in those aged ≥65 is a dominant intervention strategy, with cost saving and minor improvements in QALY. Healthcare providers should promote PPV administration for all eligible populations.

Background: The association between preterm delivery (PTD) and maternal risk of cardiovascular disease (CVD) was demonstrated, but the economic burden of CVD in these women was unknown. Methods: A ...

Background: In Singapore, the Health Sciences Authority (HSA) reviews an average of 20,000 spontaneous adverse event (AE) reports yearly. Potential safety signals are identified manually and discussed on a weekly basis. In this study, we compared the use of four quantitative data mining (QDM) methods with weekly manual review to determine if signals of disproportionate reporting (SDRs) can improve the efficiency of manual reviews and thereby enhance drug safety signal detection. Methods: We formulated a QDM triage strategy to reduce the number of SDRs for weekly review and compared the results against those derived from manual reviews alone for the same 6-month period. We then incorporated QDM triage into the manual review workflow for the subsequent two 6-month periods and made further comparisons against QDM triage alone. Results: The incorporation of QDM triage into routine manual reviews resulted in a reduction of 20% to 30% in the number of drug–AE pairs identified for further evaluation. Sequential Probability Ratio Test (SPRT) detected more signals that mirror human manual signal detection than the other three methods. Conclusions: The adoption of QDM triage into our manual reviews is a more efficient way forward in signal detection, avoiding missing important drug safety signals.

Background The pneumococcal polysaccharide vaccine (PPV) has been associated with reduced risk of cardiovascular events in human observational studies. Animal studies suggest that the phosphorylcholine epitope in the Streptococcus pneumoniae cell wall is structurally similar to oxidized low-density lipoprotein (oxLDL), hence PPV induces the production of antibodies that cross-react with anti-oxLDL and may cause regression of atherosclerotic plaque. We set out to determine the strength of association between PPV administration and reduction in cardiovascular events. Methods A longitudinal, population-based cohort study of older Australians, from the Hunter Community Study, with up to 11 years of follow-up. We included participants aged ≥ 65 years at baseline (2004–2008), without a history of cardiovascular disease (CVD). History of PPV administration at baseline was the main exposure of interest. “Total number of hospital bed-days with CVD primary diagnosis” was one of the main outcomes measured. Models were adjusted for age, diabetes, alcohol intake, and smoking status. Influenza vaccine was the control exposure used and fracture bed-days was the control outcome used, to investigate the potential for residual confounding. Results 91 of the total 1074 participants (mean age = 72, male = 45%) experienced a CVD event during follow-up. PPV (regardless of influenza vaccine) was associated with a significant reduction in CVD bed-day, (n = 863, incident rate ratio, IRR = 0.65, 95%CI: 0.45–0.94, p = 0.02), but influenza vaccine (regardless of PPV) was not (n = 864, IRR = 0.86, 95%CI: 0.54–1.35, p = 0.51). Furthermore, PPV adjusted for influenza vaccine remained associated with CVD bed-days (IRR = 0.64, 95%CI: 0.43–0.96, p = 0.03) but was not associated with fracture bed-days (IRR = 0.75, 95%CI: 0.28–2.00, p = 0.56). Conclusion PPV demonstrated a 35% reduction in CVD bed-days. This finding was robust to residual confounding, using a control exposure and a control outcome, eliminating the concern for healthy-user bias. A large double-blinded placebo-controlled RCT is underway to confirm our finding and to explore the proposed mechanism of action (ACTRN12615000536561).

Community pharmacists can make significant contributions and be an indispensable member in the asthma therapy chain. The present study aimed to investigate the current knowledge level of Vietnamese community pharmacists in asthma counselling and the impact of a short training program on asthma knowledge and practice.300 community pharmacists participated in the study. A knowledge questionnaire about asthma medications and a standardized inhaler checklist were designed to evaluate their knowledge before and after a 4-h training program. Six to eight weeks later, 10 simulated patients were sent to the community pharmacies to evaluate the pharmacists' knowledge and practice.The training program significantly improved the asthma knowledge score of pharmacists from 5.3 to 17.2 out of a maximum score of 20 (p 0.001). After the training, the percentage of pharmacists performing correctly inhaler devices increased significantly (0% vs.∼50%, p 0.001). In the simulated patient study, pharmacists who attended the training demonstrated better asthma knowledge with higher scores (5.4 vs 1.7 out of a maximum score of 7.0, p 0.001), as well as much better inhaler technique scores (6.1 vs 4.3, out of a maximum score of 8, p 0.001). These pharmacists achieved higher scores in all aspects encompassing distinguishing controllers and relievers, counselling correctly about adherence, and common side effects.Our results revealed significant knowledge deficiency about asthma among Vietnamese community pharmacists. However, a short training program was effective in upskilling the pharmacists to effectively counsel asthmatic patients about the management of their condition and medications.

Background Improving the identification of depression in adults in primary care can produce clinical and economic benefits. Community Pharmacists may play a role in screening for depression. Objective To systematically review and evaluate the evidence for the feasibility, impact and cost-effectiveness of community pharmacists screening adults for depression. Methods An electronic literature search using the databases EMBASE, PubMed and CINAHL Complete from January 2000 to September 2019 was undertaken to identify studies involving community pharmacists screening for depression. Data relating to sample size, population demographics and medical conditions of adults screened were extracted. Details around the screening model, process-related outcomes, clinical outcomes and economic outcomes were also extracted. Results Ten studies using eight unique depression screening tools were identified. Ease of administration was the most common selection criterion (n = 4) while no reason was given in four studies. Seven studies reported that through screening, pharmacists could identify adults with undiagnosed depression. Pharmacists referred adults screening positive for assessment in seven studies and followed up participants in two studies. No study assessed the impact of screening on depressive symptoms or the cost-effectiveness of pharmacists screening for depression. Conclusion Community pharmacists are able to use depression screening tools to identify undiagnosed adults having symptoms of depression. However, there is little evidence around the impact of this screening on clinical and economic outcomes. Larger, well-designed studies that use a highly accurate, easily administered screening tool and include patient referral and follow-up and pharmacist training are warranted to provide evidence on the impact of community pharmacists screening adults for depression.

Objectives In order to address the current deficiency of health utility evidence relevant for economic evaluations involving treatments for rheumatoid arthritis (RA) in the Chinese setting, this study aims to develop a mapping algorithm linking the Health Assessment Questionnaire (HAQ) and EQ-5D-5L in a Chinese population of patients with RA. Methods An estimation sample was obtained from a cross-sectional study that collected HAQ, the pain Visual Analogue Scale, and EQ-5D-5L in RA patients in two tertiary referral hospitals in China. Mapping algorithms were derived in this study using two alternative regression methods: the beta regression and a multivariate ordered probit regression. The internal validity of the mapping algorithms was assessed in each case by calculating predictive performance using a bootstrapping procedure. Results Of the several algorithms developed using these data, predictive performance was shown to be better when VAS pain was included as a predictor and when the multivariate ordered probit regression method was used, rather than the beta regression method. The algorithms developed were shown to be comparable, in terms of predictive performance, to existing mapping studies despite the small sample size of the estimation data. Conclusion It is hoped that the availability of these algorithms will facilitate the development of cost-effectiveness studies evaluating RA treatments in the Chinese health care setting. Electronic supplementary material The online version of this article (10.1007/s11136-018-1925-1) contains supplementary material, which is available to authorized users.

To examine the cost-effectiveness of lipegfilgrastim versus pegfilgrastim as primary prophylaxis in women with early stage breast cancer. Two Markov models including a chemotherapy and a post-chemotherapy models were constructed with a time horizon of 12 weeks and 30 years, respectively. All the transition probabilities and utility weights were derived from clinical trials and/or published literatures. The costs populated in the chemotherapy model were extracted from Medicare, Pharmaceutical Benefit Scheme and the Independent Hospital Pricing Authority. No cost was considered in the post-chemotherapy model. Sensitivity analyses were performed to test the robustness of the results. From the first chemotherapy model, lipegfilgrastim was associated with fewer episodes of severe neutropenia (SN) (N = 142 per 1000 patients treated), febrile neutropenia (FN) (N = 29 per 1000 patients treated), infection (N = 17 per 1000 patients treated) and chemotherapy delayed (N = 170 per 1000 patients treated) and lower cost ($116.88 less per patient treated). The post-chemotherapy model indicated lipegfilgrastim led to higher gains in both life years (18.72 versus 18.61) and quality-adjusted life years (17.28 versus 17.18) in comparison to pegfilgrastim. Sensitivity analysis showed that the results from the chemotherapy model is very sensitive to the baseline risk of SN; while from the probabilistic sensitivity analysis, lipegfilgrastim was likely to be more cost-effective than pegfilgrastim based on two models. Lipegfilgrastim was likely to be a cost-effective alternative to pegfilgrastim as primary prophylaxis. The sensitivity analysis showed the confidence interval for the cost and benefit outcomes overlapped to a great extent, suggesting an insignificant difference.

Objectives To review published studies of the use of health-related quality-of-life (HRQOL) instruments in patients with ischemic heart disease (IHD) in Chinese-speaking countries/regions, namely, mainland China, Hong Kong, Taiwan, and Singapore. Methods Overlapping searching strategy was used for searching three electronic databases—Cochrane Library, MEDLINE, and Embase—from January 1, 1990, to September 30, 2015. After culling, the identified publications were analyzed according to the publication date, the location where the study was conducted, the disease being studied, and the nature of the study (i.e., whether it was a validation study or an application study). Results There were 109 publications identified for review, of which 15 studies (13.8%) were for validation of HRQOL instruments. Among these studies, most were conducted in China. There were 35 instruments applied and validated in the studies. The most commonly used instruments were the Short Form 36-Item Health Survey and the Seattle Angina Questionnaire. Overall, the number of studies using HRQOL instruments has been increasing in recent years. But there were only two disease-specific instruments validated in Chinese patients with IHD—one was a chronic disease–specific instrument (QLICD-GM) and the other an IHD-specific instrument (QLICD-CHD) validated only in limited sample sizes without data on patients with the three IHD subgroup diseases (angina, myocardial infarction, and heart failure). Three disease-specific instruments were validated in patients with IHD in Hong Kong. No instrument was validated in patients with IHD in Taiwan and Singapore. This showed a lack of adequately validated core IHD instruments in Chinese-speaking countries/regions. Conclusions Considering the substantial negative impact of IHD from economical, clinical, and humanistic perspectives, psychometric evaluation of core IHD-specific instruments is still needed in patients with IHD and IHD subgroup diseases in Chinese-speaking countries/regions.

The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4.1 to detect signals of both common and rare adverse events in our small database. We compared SPRT with other methods in terms of number of signals detected and whether labelled adverse drug reactions were detected or the reaction terms were considered serious. The other methods used were reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS). The SPRT produced 2187 signals in common with all methods, 268 unique signals, and 70 signals in common with at least one other method, and did not produce signals in 178 cases where two other methods detected them, and there were 403 signals unique to one of the other methods. In terms of sensitivity, ROR performed better than other methods, but the SPRT method found more new signals. The performances of the methods were similar for negative predictive value and specificity. Using a combination of hRRs for SPRT could be a useful screening tool for regulatory agencies, and more detailed investigation of the medical utility of the system is merited.

To evaluate the quality of Chinese pharmacoeconomic-evaluation literature published between 2012-2014 retrieved from the Chinese National Knowledge Infrastructure (CNKI) in order to assess their adherence to recommendations of the Chinese Pharmacoeconomic Guidelines.Identified literature was screened according to pre-specified criteria to access legibility for inclusion. Each included piece of literature was systematically compared against the recommendations proposed by the relevant Chinese guidelines.After culling, 259 studies were included in the comparative analysis. When compared to a previous study evaluating the quality of similar literature published between 1997-2007, the results showed improvements in certain technical aspects over the years. Particularly, an improvement was observed in more diverse evaluation methods being used, increased use of cost-utility analysis (2.43% in 2012-2014 vs 0.26% in 1997-2007) and use of discounting (45% in 2012-2014 vs 4.35% in 1997- 2007). In addition, a small number of studies were starting to apply modeling.The quality of economic evaluation literature has improved in recent years, with more researchers realizing the importance and necessity of using discounting, sensitivity analysis, and modeling when conducting economic evaluation. This study also highlights certain important areas needing further attention when conducting economic evaluations in China. These include the ICER threshold of economic analysis, more detailed guidance in performing sensitivity analysis and modeling, as well as transferability of cost data across different regions. Overall, the results would support the positive contribution of the Chinese Economic Guideline in promoting economic evaluations in China.

Objective The HeartQoL is an ischemic heart disease (IHD) core questionnaire. This study aimed to map the HeartQoL to the EQ-5D to provide the specific patients’ health status and utility using one instrument. Methods We conducted a cross-sectional study investigating IHD patients in China using the Chinese HeartQoL and EQ-5D. Data based on the total group were fitted by 2 linear regression models with the utility score derived from the EQ-5D as a dependent variable and the HeartQoL total and subscale (physical and emotional) scores as independent variables, respectively. The 2 models were compared via modeling fitting statistics. Results In total, 406 IHD patients were enrolled in China. The mean HeartQoL global score for the total group was 1.75 (standard deviation [SD] = 0.85), whereas the mean physical and emotional scores were 1.65 (SD = 0.91) and 1.99 (SD = 0.93), respectively. The mean utility calculated by the EQ-5D for IHD patients was 0.66 (SD = 0.38), as compared with 0.95 (SD = 0.06) for healthy people. From the linear regression model with total score, the total score was a significant predictor for the EQ-5D utility, with the equation as EQ-5D = 0.085 – 0.3294 × total. In the linear regression model with physical and mental scores, both scores were significant predictors for the EQ-5D utility, with an equation as EQ-5D = 0.0671– 0.2091 × physical – 0.1248 × mental. The fitting statistics suggest that the model using the HeartQoL total score is preferred. Conclusion As the first effort to map the HeartQoL to EQ-5D, the linear relationship between these 2 instruments was explored, and this could potentially be useful in future health technology assessment decision making and clinical practice.

Objectives To examine the cost-effectiveness of a triglyceride lowering medication–icosapent ethyl added on to statin from Australian healthcare system perspective. Methods A Markov-model was developed using data from the pivotal trial of icosapent ethyl in a secondary prevention population. Probabilities of CVD events were derived and extrapolated from the published Kaplan-Meier curve using a valid algorithm. Management cost of CVD, health-related quality of life, and background non-CVD mortality were extracted from publicly available sources. Acquisition cost of icosapent ethyl from the United States was used in the current analysis. Australian patients with histories of CVD were modelled for a 25 year time horizon and costs and benefits were discounted. Sensitivity analyses (SA) were undertaken. Value of perfect information (VPI) was quantified. Results Treatment with icosapent ethyl was associated with both higher costs and benefits (i.e. quality-adjusted life year [QALY] and life year [LY]), resulting in an incremental cost-effectiveness ratio (ICER) of AUD59,036/QALY or AUD54,358/LY. Using the often quoted willingness-to-pay (WTP)/QALY of AUD50,000/QALY, icosapent ethyl was not considered cost-effective. SA showed that time horizon, drug cost, and discount rate were the key drivers of the ICER. Total monetary VPI for icosapent ethyl was over AUD15 million over 5 years. Conclusions Patients with established CVD in whom level of triglycerides is high would benefit from the treatment using icosapent ethyl, however, it is not a cost-effective from an Australian healthcare system perspective. The government may consider subsidising this medication given the clinical need but at a discounted acquisition cost.

To evaluate essential medicines utilization in community health institutions to identify problems hindering the implementation of the Essential Medicine System at community level in Beijing, China. A total of 20 community health centers in Beijing were surveyed during September 2014 regarding stocking situation and utilization status of essential medicines. Opinions about essential medicines utilization were solicited from clinical staff at these centers. Average outpatient health expenditure was obtained from the Beijing Municipal Health Bureau to evaluate the financial impact. During our study, an average of 377 species of essential medicines was stocked by the community health institutions, accounting for 53.9% of Beijing Essential Medicine List, and 61.6% of the total medicines in the institutions. First-aid and low-price essential medicines were frequently out of stock. The average expense per outpatient visit increased yearly from 2009 to 2013. Feedback from clinical staff revealed patients’ negative perception of the essential medicines and major concerns about its quality. Our study found both the list and supply of essential medicines could not meet the clinical needs of patients at community health centers adequately. Furthermore, some existing drug policies had restricted the service capacity, thus affecting the centers’ function and bringing additional negative impact on essential medicines utilization. Financially, the inadequacy of essential medicine to meet clinical need and poor supply of many low-price drugs contributed much to the rise of average drug expenses, limiting the role of essential medicines to improve the quality of care at the community level.

Incorrect use of inhalers is very common and subsequently leads to poor control of COPD. Among health care providers, pharmacists are in the best position to educate patients about the correct use of inhaler devices.The objective of this study was to evaluate the impact of pharmacist-led training on the improvement of inhaler technique for COPD patients in Vietnam.For this pre- and post-intervention study, standardized checklists of correct use of metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) were used to evaluate the inhaler technique. A scoring system (maximum score =8) was applied before and after training to guarantee assessment uniformity among pharmacists. Three methods including "face-to-face training", "teach-back" and "technique reminder label" were used. After the baseline evaluation (T0), the inhaler technique was reassessed after 1 month (T1), 3 months (T2), 6 months (T3) and 12 months (T4).A total of 211 COPD patients participated in the study. Before the training, a high rate of errors was recorded. After the training, the percentage of patients using MDIs and DPIs perfectly increased significantly (Pharmacist-led comprehensive inhaler technique intervention program using an unbiased and simple scoring system can significantly improve the inhaler techniques in COPD patients. Our results indicated a 3-month period as the optimal time period between training and retraining for maintaining the correct inhaler technique. The training would be highly feasible and suitable for implementing in the clinical setting. Our model of pharmacist-led training should be considered as an effective solution for managing COPD patients and better utilization of health care human resources, especially in a developing country like Vietnam.

Tu-Son Nguyen,1,2 Thi Lien Huong Nguyen,1 Thi Thuy Van Pham,1 Susan Hua,2 Quy Chau Ngo,3 Shu Chuen Li2 1Department of Clinical Pharmacy, Hanoi University of Pharmacy, Hanoi, Vietnam; 2School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW, Australia; 3Respiratory Centre, Bach Mai Hospital, Hanoi, Vietnam Background: Incorrect use of inhalers is very common and subsequently leads to poor control of COPD. Among health care providers, pharmacists are in the best position to educate patients about the correct use of inhaler devices. Objective: The objective of this study was to evaluate the impact of pharmacist-led training on the improvement of inhaler technique for COPD patients in Vietnam. Patients and methods: For this pre- and post-intervention study, standardized checklists of correct use of metered-dose inhalers (MDIs) and dry powder inhalers (DPIs) were used to evaluate the inhaler technique. A scoring system (maximum score=8) was applied before and after training to guarantee assessment uniformity among pharmacists. Three methods including “face-to-face training”, “teach-back” and “technique reminder label” were used. After the baseline evaluation (T0), the inhaler technique was reassessed after 1month (T1), 3months (T2), 6months (T3) and 12months (T4). Results: A total of 211 COPD patients participated in the study. Before the training, a high rate of errors was recorded. After the training, the percentage of patients using MDIs and DPIs perfectly increased significantly (p

Objective Complementary and alternative medicine (CAM) has gained increasing popularity over the last several decades internationally, leading to an increasing interest from decision makers and researchers as to how to assess the effectiveness of CAM. The attempts, however, have been unsatisfactory. The most important reason is a lack of attention to the theoretical characteristics of CAM, which are completely different from those of allopathic medicine or biomedicine. This study attempted to survey expert Traditional Chinese Medicine (TCM) practitioners in China to elucidate critical issues when assessing the effectiveness of TCM. Methods A questionnaire (with 20 close-ended and 2 open-ended questions) about the influencing factors of measuring the cost and effectiveness of TCM was distributed to TCM practitioners who had been working in the field of research for at least 5 years and had published at least one related scientific article in the last 5 years. Internal consistency test was performed for all questions to verify the reliability of the questionnaire. Principal-component analysis was performed for remaining items after Kaiser-Meyer-Olkin (KMO) index and Bartlett's test of sphericity. A linear combination model was then built to evaluate the contribution of various factors involved for the selection of TCM into the health care reimbursement or insurance system. Results Of 429 questionnaires issued, 137 were returned from respondents from 31 medical and research institutions, giving a recovery rate of 31.93%. Internal consistency coefficient obtained was 0.745, indicating good reliability of this measurement scale, and the data passed the KMO test and Bartlett's test of sphericity (KMO index=0.691). In addition, eight common factors were extracted after the rotation of principal-component analysis with a cumulative variance of 70.92%. Conclusions Our findings suggested that factors to be considered during the selection of TCM in health care reimbursement or insurance system include patient preference, long-term outcomes, comparative study of alternative options between TCM and allopathic medicine or biomedicine, pharmacoeconomic evaluation results and the overall economic burden of patients, and side effects of TCM. In addition, the TCM experts stressed the need of cost-effectiveness assessment of the expensive TCM of similar therapeutic functions during the selection process. Moreover, during the evaluation of health-related quality of life of TCM, they warned to avoid overexaggeration of their roles and that the generic scale should be modified according to the clinical circumstances.

ObjectivesTo assess the health-related quality of life (HRQOL) and willingness to pay (WTP) per quality-adjusted life-year (QALY) amount of patients with epilepsy in China.MethodsAdults with epilepsy and a healthy control were recruited in two tertiary hospitals in China. Participants completed two indirect utility elicitation instruments (Quality of Well-being Scale-self administered version and EuroQol five-dimensional questionnaire) and a WTP questionnaire. Correlations between sociodemographic or epilepsy-specific variables (age of epilepsy onset, duration of epilepsy, seizure types, types of antiepileptic drug treatment, etc.) and HRQOL or WTP/QALY were assessed to identify the candidate predictor. Multiple linear regression models were adopted to investigate the predictive performances of identified candidate predictors. Data analyses were performed on SPSS 20.0 (SPSS, Inc., Chicago, IL).ResultsFor utilities of both the Quality of Well-being Scale-self administered version and the EuroQol five-dimensional questionnaire, patients with epilepsy had statistically lower values than did the control group (P < 0.0001). In terms of the WTP/month, the percentage of WTP accounting for the monthly income and the WTP/QALY values from the epilepsy group were substantially higher than those from the control group (P < 0.0001).WTP/QALY=12×WTPMonth1−Utility(CurrentHealth)The multiple linear regression model identified working status (P = 0.05), seizure types (P = 0.022), income (P = 0.006), and self-rating health state (P < 0.05) as predictors of HRQOL while income (P = 0.000) and self-rating health state (P < 0.05) statistically contributed to the variations in WTP/QALY value for the epilepsy group.ConclusionsPatients with epilepsy had substantially lower HRQOL than did the healthy population.

Objective To review the use of health-related quality-of-life (HRQOL) instruments as patient-reported outcome in patients with rheumatoid arthritis (RA) in studies that have been published in Chinese-speaking populations. Methods Overlapping searching strategy was used using four publication databases: PubMed and EMBASE for English publications and Wanfang and CNKI for Chinese publications. Entries published between January 1, 1990, and July 31, 2014, were retrieved and then reviewed independently by two researchers. The identified studies were summarized according to information source, publishing year, study location, and study type. The validation studies were examined closely in terms of their sample sizes and psychometric properties. Results There were 99 studies from the databases selected for review. Among the studies reviewed, most studies were conducted in Mainland China. There was a clear overall increasing trend in the number of studies in recent years. Generic instruments were more frequently used by researchers outside China. Another observation was that most instruments were used without previous validation either in any Chinese-speaking population with RA or in the specific country that it was used. Conclusions The importance of patient-reported quality of life as an outcome indicator in patients with RA is more and more realized in Chinese-speaking regions during the past two decades. To facilitate the use of HRQOL for better management of patients, and improve the quality of research, there is a strong need of validating the HRQOL instruments in more locations with a larger population, more comprehensive validity, and potential cross-cultural validation in future.

OBJECTIVES: We aimed to gauge the burden of epilepsy in China from a societal perspective by estimating the direct, indirect and intangible costs. METHODS: Patients with epilepsy and controls were enrolled from two tertiary hospitals in China. Patients were asked to complete a Cost-of-Illness (COI), Willingness-to-Pay (WTP) questionnaires, two utility elicitation instruments and Mini Mental State Examination (MMSE). Healthy controls only completed WTP questionnaire, and utility instruments. Univariate analyses were performed to investigate the differences in cost on the basis of different variables, while multivariate analysis was undertaken to explore the predictors of cost/cost component. RESULTS: In total, 141 epilepsy patients and 323 healthy controls were recruited. The median total cost, direct cost and indirect cost due to epilepsy were US$949.29, 501.34 and 276.72, respectively. Particularly, cost of anti-epileptic drugs (AEDs) (US$394.53) followed by cost of investigations (US$59.34), cost of inpatient and outpatient care (US$9.62) accounted for the majority of the direct medical costs. While patients' (US$103.77) and caregivers' productivity costs (US$103.77) constituted the major component of indirect cost. The intangible costs in terms of WTP value (US$266.07 vs. 88.22) and utility (EQ-5D, 0.828 vs. 0.923; QWB-SA, 0.657 vs. 0.802) were both substantially higher compared to the healthy subjects. CONCLUSIONS: Epilepsy is a cost intensive disease in China. According to the prognostic groups, drug-resistant epilepsy generated the highest total cost whereas patients in seizure remission had the lowest cost. AED is the most costly component of direct medical cost probably due to 83% of patients being treated by new generation of AEDs.

Objectives: To synthesize the efficacy and safety outcomes from randomized-controlled trials (RCTs) regarding new oral anticoagulant, protease-activated receptor-1 (PAR-1) antagonist, and warfarin adjunctive to aspirin for patients after acute coronary syndrome (ACS) via pair-wise and network meta-analyses. Methods: A comprehensive literature search was performed in Embase, Medline, Cochrane Library Web of Knowledge, and Scopus. The pair-wise meta-analysis was undertaken respectively to each agent/treatment category via Revmen 5.1. In order to estimate the relative efficacy of each agent/treatment category whilst preserving the randomized comparisons within each trial, a Bayesian network meta-analysis was conducted in WinBUGS using both fixed- and random-effects model. Covariate analysis was performed to explore the effects of length of follow-up and age of subject on the final results. Results: In total, 23 RCTs were included in the meta-analysis. As shown by the results (OR,95%CI) for the pair-wise meta-analysis, new oral anticoagulants (0.85, [0.78, 0.93] and 3.04, [2.21, 4.19]), PAR-1 antagonists (0.80, [0.52, 1.22] and 1.55, [1.25, 1.93]) and warfarin (0.87, [0.74, 1.02] and 1.77, [1.46, 2.14]) might be able to provide better outcome in the incidences of major adverse events (MAE) but with higher bleeding risk comparing to aspirin treatment alone. Based on the model fit assessment, the random-effects model was adopted. The network meta-analysis (treatment effect comparing to aspirin lone) identified ximelagatran (-0.3044, [-0.8601, 0.2502]), dabigatran (-0.2144, [-0.8666, 0.4525]), rivoroxaban (-0.2179, [-0.5986, 0.1628]) and vorapaxar (-0.2272, [-0.81, 0.1664]) produced better improvements in MAE incidences whereas vorapaxar (0.3764, [-0.4444, 1.124]), warfarin (0.663, [0.3375, 1.037]), ximelagatran (0.7509, [-0.4164, 2.002]) and apixaban (0.8594, [-0.0049, 1.7]) produced less major bleeding events. The indirect comparisons among drug category (difference in incidence comparing to aspirin lone) showed new oral anticoagulants (-0.1974, [-0.284, -0.111]) and PAR-1 antagonists (-0.1239, [-0.215, -0.033]) to besuperior to warfarin (-0.1004, [-0.166, -0.035]) in the occurrences of MAE whereas PAR-1 antagonists (0.4292, [0.2123, 0.6476]) afforded better outcomes in major bleeding events against warfarin (0.5742, [0.3889, 0.7619]) and new oral anticoagulants (1.169, [0.8667, 1.485]). Conclusion: Based on the study results, we cannot recommend the routine administration of new oral anticoagulant as add-on treatment for patients after ACS. However, for ACS patients comorbid with atrial fibrillation, new oral anticoagulant might be superior to warfarin in both efficacy and safety outcomes.

Traditional Chinese medicine (TCM) has been commonly used by Chinese practitioners to treat irritable bowel syndrome (IBS). However, the effectiveness of combining TCM with Western medicine in managing IBS has not been evaluated systematically. In this study, we evaluated the clinical effectiveness of combining TCM and Western medicine in the treatment of IBS via meta-analyses. We reviewed 72 eligible randomized controlled trials from January 2009 to December 2013 investigating the effectiveness of integrated TCM and Western medicine in the management of IBS. In the meta-analyses, the relative risks (RRs) and 95% confidence interval (95%CI) were calculated using raw data from each study, and low heterogeneity was detected. When compared to the Western medicine treatment alone, our result showed TCM combined with Western interventions significantly improved IBS global symptoms (RR, 1.21; 95%CI: 1.18–1.24). Additionally, there was no significant difference in therapeutic effects of the integrated approach in the meta-analyses involving the various IBS subtypes. Likewise, both Chinese proprietary herbal medicine plus conventional treatment and compound herbal preparations plus conventional treatment showed similar and statistically significant effects on global improvement compared with western treatment alone, with RRs of 1.22 (95%CI: 1.14–1.30) and 1.22 (95%CI: 1.18–1.27), respectively. These results demonstrated that treating IBS with integrated traditional Chinese and Western medicines showed better effectiveness than conventional Western medicine alone. Although due to the quality of the included studies, our results might possess a high risk of bias. TCM, particularly Chinese proprietary medicine, with the benefits of low-cost, easy to use, and good palatability, would be an attractive option to be used in conjunction with conventional Western medicine to manage IBS patients.

Introduction Glucocorticoid therapy is associated with an appreciable risk of bone loss leading to fractures that require expensive treatments. This study aimed to evaluate the cost-effectiveness of bisphosphonates for prevention of hip fracture in glucocorticoid-induced osteoporosis (GIOP) in Malaysia. Method Retrospective data were collected from GIOP patients referred to the Universiti Kebangsaan Malaysia Medical Centre. Fracture events and direct medical costs were compared between bisphosphonates and calcium/vitamin D combination. Results Fracture events were reported in 28 out of 93 included patients, with hip and vertebral fractures representing 42.9% and 35.7%, respectively. Overall, the use of bisphosphonates could not be considered cost-effective for treatment of all GIOP patients. The presence of certain fracture risk factors was able to modify the cost-effectiveness of bisphosphonates. Bisphosphonates was considered cost-effective if started in patients more than 60 years old. However, the use of bisphosphonates was not cost-effective in GIOP patients with secondary osteoporosis. The incremental cost-effectiveness ratios (ICER) of bisphosphonates in patients with risk factors of previous fracture or rheumatoid arthritis were Malaysian Ringgits (MYR) 108 603.40 and MYR 25 699.21, respectively. Conclusion Fracture risk factors of age, previous fracture, rheumatoid arthritis and secondary osteoporosis may modify the cost-effectiveness outcomes of bisphosphonates. Bisphosphonates would be considered cost-effective in patients more than 60 years old as compared to calcium/vitamin D treatments. Further evaluation of the impact of fracture risk factors in larger populations would provide more precise information to better assist rational and economical use of anti-osteoporosis treatment in GIOP patients.

Aim This study conducted a systematic review evaluating the effectiveness of newer antiepileptic drugs (AEDs) (namely, lamotrigine, levetiracetam, topiramate, vigabatrin, zonisamide, oxcarbazepine, perampanel, gabapentin, and stiripentol) as add-on for treatment of focal epilepsy in children. Methods Articles were retrieved from EMBASE, Medline and Cochrane Library from inception to January 2016. Treatment outcomes were analysed based on responder, seizure-free, withdrawal and adverse event rates. Quality of each study was also assessed. Results Twelve articles fulfilled the inclusion criteria. Heterogeneity and quality of the included studies were considered acceptable. Overall, newer AEDs as adjunct therapy in children with inadequate control of focal seizure showed a trend of better seizure outcomes. The pooled ORs for responder, seizure-free and withdrawal rates were 2.15 (95%CI:1.72, 2.69), 1.99 (95%CI:0.72, 5.48) and 0.69 (95%CI:1.13, 2.39) respectively. Adverse events of newer AEDs were comparatively higher than placebo (OR:1.64, 95%CI:1.13, 2.39). Conclusion In our updated review, newer AEDs as adjunct therapy for focal epilepsy in children have trends of better effectiveness compared to placebo. Newer AEDs are associated with statistically more children with >50% seizure reduction, and a trend of better seizure freedom. Their tolerability would also be considered acceptable with the observed low withdrawal rate. However, the relative lack of well-conducted RCTs evaluating their effectiveness against other active AED treatment in children would not facilitate evidence-based practice. This highlights the knowledge gap and the need for more well-conducted RCTs against active treatments to ascertain the long term effectiveness and the role of newer AEDs in managing epilepsy in children.

Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

Aim To provide a comprehensive estimation of the economic burden of rheumatoid arthritis (RA) in China, especially for patients from less developed areas, and to explore the cost transferability between regions to assist healthcare decision-making. Methods The study was conducted in south and north China from May 2013 to December 2013. The burden of RA was investigated by interviewing participants with a questionnaire battery containing socio-demographic, cost of illness (COI) and medical treatments. The COI questionnaire captured direct, indirect and intangible costs. Direct costs included hospitalizations, outpatient visits and medications. Indirect costs were estimated using the human capital approach, and intangible costs valued through the willingness-to-pay approach. All cost data were converted to 2013 US dollars by purchasing power parity, and then summarized descriptively and analyzed with mixed models. Results Questionnaires were administered to 133 RA patients. The average direct costs were $1917.21 ± $2559.06 per patient year, with medications at $1283.89 ± $1898.15 comprising more than 50% of the total. The average indirect costs were $492.88 ± $1739.74 per patient year, while intangible costs were $20396.30 ± $31145.10. There was no significant difference detected between regions. Recent hospitalization was tested as a significant predictor of the direct costs. Age and income were significantly associated with indirect and intangible costs. Conclusions Besides the substantial burden in terms of direct medical costs and productivity lost, there were notable intangible costs, especially among older patients. This conclusion could be potentially expanded to other provinces in China or even other countries through the adjustments for transferability.