Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies.

BACKGROUND: Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence. OBJECTIVES: The study aimed to describe and assess the recommendations of published position statements regarding several aspects of biosimilars across specialties and determine whether these positions have changed with the emergence of new evidence. METHODS: We systematically searched for published position statements of biosimilars in online databases and included statements written in English. The search was from the inception of the databases until May 2023. Two reviewers independently extracted the data. Only position statements that included recommendations to guide the use of biosimilars in clinical practice and were issued by health organisations and societies, including expert panels, were included. We synthesised recommendations on five aspects: prescribing practice, extrapolation of indication, interchangeability, treatment initiation with biosimilars in biologic-naïve patients, and pharmacovigilance. RESULTS: The review included 25 papers involving eight specialties, 16 of which were from European countries, 1 from an international organisation representing 49 countries, and 6 from various countries. The papers were published between 2009 and 2020, with 19 published between 2015 and 2020. Of the five aspects of biosimilars assessed, nearly half (11 of 25) of the papers at the time they were published did not base their positions on a scientific or evidence-based approach. Only 4 of the 25 position papers were identified as revisions of their previous papers. With increasing experience in biosimilars and the emergence of new evidence, about 60% (16 of 25) of the papers contained outdated recommendations, particularly on two aspects. They were extrapolations of indications and interchangeability (including switching). The recommendations for most papers for three other aspects were still appropriate. These were prescribing biosimilars by their brand name and active ingredient, initiating treatment with biosimilars in biologic-naïve patients, and monitoring the long-term safety of biosimilars through pharmacovigilance. For four of the revised papers, their position evolved from opposing indication extrapolation for biosimilars to accepting it, while the position of two papers shifted from not recommending biosimilar switching to permitting the practice. Meanwhile, most papers were against automatic substitution by pharmacists because the evidence for this practice was still limited. CONCLUSIONS: Across specialties, the variability among the position statements is seen for extrapolation of indications for biosimilars and interchangeability (including switching). This requires a revision, considering the latest evidence and growing experience with the use of biosimilars in extrapolated indications and with switching.

The use of technology in vaccine safety communication: A systematic review of randomised controlled trials.

OBJECTIVES: To identify technologies used in vaccine safety communication and evaluate their impact on vaccination intention, uptake, knowledge, attitude, and perceptions of consumers. METHODS: We searched 6 electronic databases to identify randomised controlled trials assessing the impact of using technology in vaccine safety communication. The Cochrane Collaboration's tool for assessing risk of bias was used to evaluate each study. RESULTS: We included 22 studies involving 27,109 participants from 8 countries; 15 studies assessed the use of videos and 7 examined innovative technologies. Using videos significantly improved knowledge (n = 3) and participant engagement (n = 2) compared to printed material. Among the innovative technologies, the use of virtual reality, and smartphone applications incorporating social networking or gamification significantly increased vaccination knowledge, confidence, and engagement. The studies showed that narrative messaging increased perceived disease severity (n = 2) and vaccination intention (n = 2). CONCLUSIONS: While the use of innovative technologies is increasing, videos currently remain the most popular technology for vaccine safety communication. Communication technology, particularly with narrative messaging, improves patient engagement and comprehension. PRACTICE IMPLICATIONS: Health authorities should increase focus on using videos and smartphone applications for vaccine safety communication. Collaboration among stakeholders is essential to develop guidelines on effective message content to complement the technology.

Malaysian Hospital Pharmacists' Perspectives and Their Role in Promoting Biosimilar Prescribing: A Nationwide Survey.

BACKGROUND: With the increasing availability biosimilars, the role of pharmacists as drug information specialists has expanded to include promoting biosimilar acceptance among prescribers. OBJECTIVES: Our study aimed to determine Malaysian hospital pharmacists' perspectives on biosimilars and to identify factors influencing the successful promotion of biosimilars to prescribers. METHODS: This was a cross-sectional, web-based survey of hospital pharmacists across Malaysia. Multivariate logistic regression analysis was used to identify factors associated with pharmacists successfully promoting biosimilar use. RESULTS: Of the 913 responses, over 60% of pharmacists believed that patients may safely be switched from the originator product to a biosimilar and would have the same clinical outcome. Many lacked training in biosimilars (62.8%); yet most (80.6%) perceived pharmacists to play a critical role in promoting biosimilar prescribing. Multivariate logistic regression analysis showed that the strongest factor associated with pharmacists' successful promotion of biosimilars to prescribers was having confidence (odds ratio [OR], 3.33; 95% confidence interval [CI] 2.10-5.26). Respondents who had prior experience handling biosimilars were more likely to be successful in promoting biosimilar use than those without (OR, 1.76; 95% CI 1.16-2.66). The pharmacists' top perceived barrier to promote biosimilars in clinical practice was efficacy concerns. CONCLUSION: Although Malaysian pharmacists are in favour of biosimilars, they lack training to promote biosimilar use. Among the factors associated with successful promotion of biosimilars to prescribers are pharmacist confidence, their previous experience handling biosimilars, and prior biosimilar training.

Pharmacists' Perspectives of Biosimilars: A Systematic Review.

BACKGROUND AND OBJECTIVE: While biosimilars are less expensive than their originator biologics, various factors are known to impede their uptake in clinical practice including concerns regarding their interchangeability, efficacy, and safety. Pharmacists are well positioned to promote the adoption of biosimilars, thus, the aim of the review was to assess pharmacists' knowledge and perceptions of biosimilars to identify the need for pharmacist-directed biosimilar education. METHODS: We conducted a systematic literature search for published articles indexed in MEDLINE via EBSCOHOST, Web of Science, Scopus, Cochrane Library, Dimensions, and Google Scholar databases. We included studies written in English from their earliest publication dates until December 2021. Only studies concerning pharmacists' perspectives on biosimilars were included. Two reviewers extracted data from the studies that included pharmacists' knowledge, perceptions, and opinions about interchangeability and automatic substitution of biosimilars. We also assessed the methodological quality of the included studies using the Joanna Briggs Institute Analytical Cross-Sectional Studies Assessment (JBI-ACSSA) for quantitative studies and the Critical Appraisal Skills Programme (CASP) for qualitative studies. RESULTS: Out of the 22 studies included in the review, 19 were cross-sectional quantitative studies, and the other three were qualitative studies. The sample size of the included studies ranged from 19 to 1500 participants. The level of knowledge of biosimilars graded as good, considerable, above average, or excellent among pharmacists varied from study to study, with a range of 47-86%. Only 22-51% of pharmacists were comfortable if biosimilars were prescribed for all of the indications previously used for the originator products. Pharmacists' acceptability of switching from the originator to a biosimilar also varied, with a range of 26-84%. However, most pharmacists viewed the substitution of the originator with a biosimilar without physicians' permission as unacceptable. Data from three studies reported that 22-74% of pharmacists had attended biosimilar training. They obtained information about biosimilars from scientific publications, pharmaceutical companies, and continuing education. Based on the criteria of JBI-ACSSA and CASP, the overall methodological quality of the studies ranged from moderate to high. The majority of the studies did not describe the sampling methods used and the strategies to deal with confounding factors. CONCLUSIONS: Pharmacists' knowledge and perception about biosimilars varied and were limited, especially about interchangeability and substitution, efficacy, safety, and indication extrapolation. A better understanding of biosimilars amongst pharmacists could help them to encourage prescribers' acceptance of biosimilars.

Enhancing medication risk communication in developing countries: a cross-sectional survey among doctors and pharmacists in Malaysia.

BACKGROUND: Medication risk communication is essential to ensure the safe use of medicines. However, very few nations worldwide have established effective risk communication systems. To date, the effectiveness of risk communication among healthcare professionals in Malaysia has never been evaluated. Our study aimed to (i) evaluate doctors' and pharmacists' awareness of regulatory risk communication methods; (ii) identify factors predicting the usefulness of these methods; and (iii) compare respondents' preferences for risk communication to outline suggestions for enhancement. METHODS: We conducted a nationwide cross-sectional survey covering four commonly used risk communications, namely a national drug bulletin, safety alerts, Direct Healthcare Professional Communication letters (DHPCs), and educational materials. Multiple logistic regression analysis was used to determine the association between independent variables and the usefulness of risk communication. We performed qualitative analysis of free-text responses to gain insights on respondents' perspectives on risk communication. RESULTS: Of the 1146 responses received, 650 were from pharmacists (56.7%). Among the four methods surveyed, 71.5% of respondents were aware of educational materials, while awareness of the other three methods ranged from 20.7 to 53.9%. Pharmacists had higher awareness of all four methods compared to doctors. Private sector respondents were more aware of DHPCs compared to those from the public sector. The strongest predictors for finding risk communication useful were being a pharmacist [odds ratio (OR) = 18.2; 95% CI: 10.98-30.07; p <  0.001], having ≥30 years' work experience [OR = 4.9; 95% CI: 1.98-12.08; p <  0.001], and working in the pharmaceutical industry [OR = 4.6; 95% CI: 1.08-19.72; p = 0.039]. Both doctors and pharmacists preferred risk communication in the English-language and electronic format. However, other preferences differed between the professions and sectors. Analysis of free-text comments revealed five core themes to guide risk communication enhancement strategies. CONCLUSIONS: Risk communication awareness differed between public and private sector doctors and pharmacists depending on communication source. Integrating our findings with the theory of effective communication, we provide suggestions for developing strategic plans on enhancing risk communication. Public-private sector collaboration is key in ensuring risk communication effectiveness.

Disposal practice and factors associated with unused medicines in Malaysia: a cross-sectional study.

BACKGROUND: The improper disposal of unused medicines is a worldwide concern because of its impact on the environment, economy, and health. This study aims to describe the disposal practice of unused medicine and identify factors associated with unused medicines in Malaysia. METHODS: This was a cross-sectional, face to face interview-based survey using a structured questionnaire. We used a convenience sampling method to recruit participants from Kuala Lumpur and Selangor in Malaysia. RESULTS: We interviewed 1184 participants, and the response rate was 96%. Out of the total respondents, 995 (84%) reported having unused medicines. About a quarter of respondents kept unused medicines in the cabinet, and another quarter disposed of them into the trash or toilet. Only half of the respondent who used medicines for chronic illnesses had unused medicines compared to about 90% of respondents who used medicines for acute illnesses. The main reason for having unused medicines among those who used medicines for chronic illness was non-adherence (69%, p <  0.05). Only 27% of these respondents returned unused medicines under the "Medicine Return Programme (MRP)". The other group who used medicines for acute illnesses had unused medicines because their health conditions improved. Thus, most of the unused medicines will eventually end up in household waste. A multivariate logistic regression analysis identified respondents who used medicines for acute illnesses as the strongest predictor of having unused medicines (Odds Ratio (OR) = 29.8; p <  0.001), followed by those who pay for their medicines (OR = 6.0; p < 0.001) and those who were willing to participate the Medicine Return Programme (OR = 2.5; p = 0.009). CONCLUSION: The prevalence of unused medicines and their improper disposal were high in Malaysia. Unused medicines are associated with people who use medicines for acute illnesses, pay for their medication, and are willing to participate in an MRP. Rationale prescription and optimal dispensing practice, together with a broader MRP facilities coverage, could reduce unused medicine possession.

Methodological quality of guidelines for the management of opioid use disorder: A systematic review.

WHAT IS KNOWN AND OBJECTIVE: Opioid Use Disorder (OUD) has a high mortality rate and affects millions of people worldwide. Many organizations and societies develop Clinical Practice Guidelines (CPGs) to serve as a framework for healthcare providers to decide and support best practice to manage and treat OUD. However, not all CPGs sufficiently address all the important aspects of optimal care for managing OUD. This study aims to review current CPGs for management of OUD, evaluate their methodological quality and summarize their recommendations. METHODS: We conducted this systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Various databases were searched for CPGs and Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument was used to assess the methodological quality. We also summarized the treatments plans of CPGs across continuum of care (diagnosis and assessment, treatment initiation, pharmacotherapy and psychosocial). RESULTS: This review included 28 CPGs of varying qualities. CPGs from high-income countries and international organizations rated high for their methodological quality. Most CPGs scored high for the scope and purpose domain and scored low for applicability domain. Recommendations for the continuum of care for OUD varied across CPGs. Buprenorphine was recommended in most of the CPGs, followed by methadone. Recommendations for psychosocial interventions also varied, with cognitive behaviour therapies and counselling or education being the common recommendations in many CPGs WHAT IS NEW AND CONCLUSION: We found most CPGs have scope and purpose and clarity of presentation. However, the methodological rigour and applicability scored low. CPGs need to frame health questions in a comprehensible manner and provide an update as evidence grows. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations.

Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects.

INTRODUCTION: Biosimilars are a cost-effective alternative to original biologic medicines that allow patients access to biologic therapies for various chronic diseases. Our paper aims to provide an overview of biosimilars in Malaysia with emphasis on the comparison of Malaysian guidelines with guidelines from well-established regulatory agencies, a review of biosimilars' market approval and their reported adverse effects (AEs) as well as clinical trials conducted in Malaysia. METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials. RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing. CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.

Allopurinol-induced severe cutaneous adverse drug reactions: Risk minimization measures in Malaysia.

PURPOSE: To describe risk minimization measures (RMMs) implemented in Malaysia for allopurinol-induced severe cutaneous adverse drug reactions (SCARs) and examine their impact using real-world data on allopurinol usage and adverse drug reaction (ADR) reports associated with allopurinol. METHODS: Data on allopurinol ADR reports (2000-2018) were extracted from the Malaysian ADR database. We identified RMMs implemented between 2000 and 2018 from the minutes of relevant meetings and the national pharmacovigilance newsletter. We obtained allopurinol utilization data (2004-2018) from the Pharmaceutical Services Programme. To determine the impact of RMMs on ADR reporting, we considered ADR reports received within 1 year of RMM implementation. We used the Pearson χ2 test to examine the relation between the implementation of RMMs and allopurinol ADR reports. RESULTS: The 16 RMMs for allopurinol-related SCARs implemented in Malaysia involved nine risk communications, four prescriber or patient educational material, and three health system innovations. Allopurinol utilization decreased by 21.5% from 2004 to 2018. ADR reporting rates for all drugs (n = 144 507) and allopurinol (n = 1747) increased. ADR reports involving off-label use decreased by 6% from 2011. SCARs cases remained between 20% and 50%. RMMs implemented showed statistically significant reduction in ADR reports involving off-label use for August 2014 [χ2(1, N = 258) = 5.32, P = .021] and October 2016 [χ2(1, N = 349) = 3.85, P = .0499]. CONCLUSIONS: RMMs to promote the appropriate use of allopurinol and prescriber education have a positive impact. We need further measures to reduce the incidence and severity of allopurinol-induced SCARs, such as patient education and more research into pharmacogenetic screening.

The effects of palm oil on serum lipid profiles: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVES: Current guidelines recommend reducing intake of diets rich in saturated fats and replacing it with diets rich in unsaturated fats. Palm oil contains a high amount of saturated fatty acids, but its effect on serum lipid levels is unclear. The study aimed to compare the effects of palm oil consumption with other edible oils rich in monounsaturated fatty acids (MUFAs) and polyunsaturated fatty acids (PUFAs) on serum lipid profiles. METHODS AND STUDY DESIGN: We searched Medline, Embase, Cochrane Central Registry of Controlled Trials and CINAHL. Clinical trials were eligible if they compared palm oil-rich diets with diets rich in MUFAs or PUFAs. We pooled results of included studies using a random effects model and assessed the quality of the evidence and certainty of conclusions using the GRADE approach. RESULTS: Intake of palm oil intake compared to oils rich in MUFA was associated with increased levels of total cholesterol (TC) [mean difference (MD)=0.27 mmol/L; 95% CI 0.08 to 0.45], LDL-C (MD=0.20 mmol/L; 95% CI 0.02 to 0.37) and HDL-C (MD=0.06 mmol/L; 95% CI 0.02 to 0.10). Similarly, for comparison with oils rich in PUFAs, palm oil showed increased in TC (MD=0.38 mmol/L; 95% CI 0.14 to 0.62), LDL-C (MD= 0.44 mmol/L; 95% CI 0.01 to 0.88) and HDL-C (MD=0.08 mmol/L; 95% CI 0.03 to 0.13). For both comparisons, there were no significant effects on triglycerides. CONCLUSIONS: Even though palm oil increases marginally the level of serum lipids, the evidence is mostly of low to moderate quality.

Effects of pomegranate on lipid profiles: A systematic review of randomised controlled trials.

OBJECTIVE: To present a systematic review of randomised controlled trials examining the effects of pomegranate (Punica granatum) on lipid profiles. METHOD: The Cochrane Central Register of Controlled Trials, MEDLINE, CINAHL, EMBASE, SCOPUS and conference proceedings were searched for relevant trials to June 2019. We included randomized controlled trials comparing pomegranate with placebo. The outcomes examined were effects on lipids level. Two authors screened titles for inclusion, extracted data and assessed the quality of the trials using the revised Cochrane risk of bias tool. We used a random effects model to pool data and stratified trials to examine sources of statistical heterogeneity. To assess the quality of the evidence, we used the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Seventeen trials recruiting 763 subjects met the inclusion criteria. These trials varied in terms of the dosage form of pomegranate used, subjects recruited and trials duration. Meta-analyses of data did not show pomegranate produced a significant effect on the lipids level examined. The quality of evidence for all outcomes was low due to the imprecision of the pooled effect and the inconsistency within the included trials. The limited data on safety suggest only mild, transient and infrequent adverse events with the short-term use of pomegranate. CONCLUSION: Current evidence does not show pomegranate has significant effects on serum lipid levels. The quality of evidence is poor to support the increasing use of pomegranate for hyperlipidaemia.

Complementary and alternative medicine: Pharmacovigilance in Malaysia and predictors of serious adverse reactions.

WHAT IS KNOWN AND OBJECTIVE: Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associated with the more serious reactions. METHODS: All ADR associated with the use of CAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR. RESULTS AND DISCUSSION: From a total of 74 997 reports in the database, 930 (1.2%) involved CAM products, and 242 (26%) were serious with 36 deaths. About a third of the reports involved used CAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the CAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02). WHAT IS NEW AND CONCLUSIONS: The prevalence of serious ADR associated with CAM products is high. Factors identified with serious ADR included ethnicity, CAM users with pre-existing diseases, use of CAM for chronic illnesses and concomitant use of CAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of CAM products.

Antibiotic de-escalation in patients with pneumonia in the intensive care unit: A systematic review and meta-analysis.

OBJECTIVES OF THE REVIEW: Antibiotic de-escalation is part of an antibiotic stewardship strategy to achieve adequate therapy for infections while avoiding the prolonged use of broad-spectrum antibiotics. However, there is a paucity of clinical evidence on the clinical impact of this strategy in pneumonia patients in the intensive care unit (ICU). This review aimed to evaluate the impact of antibiotic de-escalation therapy for adult patients diagnosed with pneumonia in the ICU. METHODS USED TO CONDUCT THE REVIEW: This review was conducted in accordance with the Meta-analysis of Observational Studies in Epidemiology (MOOSE) recommendation. Electronic databases including MEDLINE, CINAHL, PubMed, Embase, Cochrane Databases and Cochrane Central Register of Controlled Trials were searched up to March 2017 for relevant trials. The methodological quality of included trials was assessed by using a modified version of the Newcastle-Ottawa Quality Assessment Scale for Case-Control and Cohort Studies. A meta-analysis was conducted using the random-effect model to combine the rate of mortality and length of stay outcomes. FINDINGS OF THE REVIEW: Nine observational trials involving 2128 patients were considered eligible for inclusion. Although based on low quality evidence, there was a statistically significant difference in favour of the impact of de-escalation on hospital stay but not mortality (MD -5.96 days; 95% CI -8.39 to -3.52). INTERPRETATIONS AND IMPLICATIONS OF THE FINDINGS: This review highlights the need for more rigorous studies to be carried out before a firm conclusion on the benefit of de-escalation therapy is supported.

Efficacy and tolerability of micronized purified flavonoid fractions (MPFF) for haemorrhoids: A systematic review and meta-analysis.

OBJECTIVE: To present a systematic review of randomised controlled trials (RCTs) examining the effects of MPFF in the management of haemorrhoid symptoms. METHODS: Electronic databases including CENTRAL, CINAHL, EMBASE, MEDLINE were searched up to April 2018 for relevant RCTs. Journal and conference proceedings were also searched. Two review authors independently selected trials, extracted data, assessed the risks of bias in included trials and graded the quality of evidence. Meta-analyses were conducted for studies presenting similar outcomes. RESULTS: Ten RCTs involving 1164 participants were included. These RCTs varied in terms of patients' grade of haemorrhoids, length of trials, and outcome assessed. Most of the studies did not describe adequately the process of randomisation and allocation concealment. The pooled analysis of data from three studies indicated that there was significant difference between groups for the bleeding outcome, favoring the MPFF group (RR 1.46; 95% CI 1.10-1.93; p = 0.008). Except for bleeding, the current evidence did not show MPFF has significant effects on all the other outcomes examined when compared with placebo. Even then, the quality of evidence for bleeding was judged as low due to the small number and inconsistent results among the included studies. CONCLUSION: This review highlights the need for further rigorous research if MPFF was to be routinely used for the treatment of haemorrhoid symptoms.

Patient Reporting of Adverse Drug Reactions (ADRs): Survey of Public Awareness and Predictors of Confidence to Report.

BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs. METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting. RESULTS: Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1). CONCLUSIONS: Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.

A retrospective study of antibiotic de-escalation in patients with ventilator-associated pneumonia in Malaysia.

Background Antibiotic de-escalation is an important strategy to conserve the effectiveness of broad-spectrum antibiotics. However, the outcome of this strategy for the treatment of ventilator-associated pneumonia (VAP) has not been widely studied in developing countries. Objectives To evaluate the outcome on intensive care unit (ICU) mortality, 28 days mortality, and length of ICU stay among VAP patients who receive de-escalation therapy. Setting This study was conducted in an ICU of a Malaysian public hospital. Method The electronic medical records of patients who developed VAP in the ICU were retrieved and relevant data was collected. Records of antibiotic prescriptions were also reviewed to collect the details of changes to antibiotic therapy (de-escalation). Main outcome measure Impact of antibiotic de-escalation on mortality. Results The mean age of the 108 patients was 46.2 ± 18.2 years; the majority being males (80%). The antibiotic de-escalation rate was about 30%. Out of this, 84% involved a change from broad to narrow-spectrum antibiotics and the remaining, withdrawal of one or more antibiotics. ICU mortality was 23% while 28 days mortality was 37%. There was no statistically significant difference in mortality rate, survival probability and the mean length of ICU stay between the de-escalation and the non-de-escalation group. However, patients with Simplified Acute Physiology Score II of ≥50 were significantly associated with ICU mortality and 28 days mortality. Conclusions In VAP patients, antibiotic de-escalation provides an opportunity to promote the judicious use of antibiotics without affecting the clinical outcomes.

Efficacy of Cordyceps sinensis as an adjunctive treatment in kidney transplant patients: A systematic-review and meta-analysis.

OBJECTIVES: Cordyceps sinensis (cordyceps) is a fungus used in traditional Chinese medicine as adjuvant immunosuppressive agent in patients with kidney transplant. This review evaluates current evidence on the efficacy and safety of natural and fermented cordyceps preparations in patients with kidney transplant. METHODS: English and Chinese electronic databases including The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE, and CNKI (China National Knowledge Infrastructure) were searched up to December 2015 for relevant randomized controlled trials. Journals and conference proceedings were also searched. Two review authors independently selected trials for inclusion, extracted data, and assessed methodological quality. The primary outcome measures were incidence of acute graft rejection in the first year post-transplantation, one-year graft survival rate (defined as the percentage of patients with functioning grafts) and patient survival rate (or all-cause mortality). RESULTS: Nine studies were eligible for inclusion. These studies were considered to be at moderate risk of bias due to poor reporting of methods. Four studies that compared cordyceps-based therapy with azathioprine-based therapy gave comparable acute rejection rates, and graft and patient survival. The cordyceps-treated group however showed better kidney function and lower incidences of hyperuricemia, hyperlipidemia, hyperglycemia and liver injury. Cordyceps used with different combinations of immunosuppressant therapy showed significant reduction in proteinuria after 6-12 months. Compared to the group receiving cyclosporine A monotherapy, treatment with a combination of cordyceps and cyclosporine A showed less treatment-induced nephrotoxicity. Adverse events were either not monitored or poorly documented in most trials. CONCLUSIONS: Current evidence shows that cordyceps as an adjuvant to routine immunosuppressant therapy may benefit kidney transplant patient, however, better quality evidence is still required.

The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns.

Systematic review of red yeast rice compared with simvastatin in dyslipidaemia.

WHAT IS KNOWN AND OBJECTIVE: Red yeast rice is believed to be a useful alternative in the management of dyslipidaemia. However, the comparative effectiveness of red yeast rice and simvastatin for the management of dyslipidaemia is unknown. This review assesses the efficacy and safety of red yeast rice versus simvastatin in dyslipidaemia. METHODS: Electronic databases were searched up to May 2015 without publication date and language restriction. The Cochrane Risk of Bias Assessment Tool was used to assess the quality of included trials. Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides were examined. RESULTS AND DISCUSSION: Ten randomized controlled trials involving 905 Chinese subjects with dyslipidaemia were systematically reviewed. Overall, red yeast rice and simvastatin did not show any statistically significant difference in any of the outcomes examined. WHAT IS NEW AND CONCLUSION: A number of small trials show that red yeast rice and simvastatin produce similar lipid-lowering effects. Larger trials with increased methodological rigour and trials with clinical outcomes are necessary for more robust inferences.

Electromagnetic therapy for treating pressure ulcers.

BACKGROUND: Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". Electromagnetic therapy (EMT), in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers. OBJECTIVES: To assess the effects of EMT on the healing of pressure ulcers. SEARCH METHODS: For this update we searched the Cochrane Wounds Group Specialised Register (searched 10 June 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 6); Ovid MEDLINE (2014 to 10 June 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 10 June 2015); Ovid EMBASE (2014 to 10 June 2015); and EBSCO CINAHL (2014 to 6 July 2012). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham EMT or other (standard) treatment. DATA COLLECTION AND ANALYSIS: For this update two review authors independently scrutinised the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. In previous versions of the review we made attempts to obtain missing data by contacting study authors. A second review author checked data extraction and disagreements were resolved after discussion between review authors. MAIN RESULTS: We identified no new trials for this update.Two randomised controlled trials (RCTs), involving 60 participants, at unclear risk of bias were included in the original review. Both trials compared the use of EMT with sham EMT, although one of the trials included a third arm in which only standard therapy was applied. Neither study found a statistically significant difference in complete healing in people treated with EMT compared with those in the control group. In one trial that assessed percentage reduction in wound surface area, the difference between the two groups was reported to be statistically significant in favour of EMT. However, this result should be interpreted with caution as this is a small study and this finding may be due to chance. Additionally, the outcome, percentage reduction in wound area, is less clinically meaningful than complete healing. AUTHORS' CONCLUSIONS: The results provide no strong evidence of benefit in using EMT to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out because there were only two included trials, both with methodological limitations and small numbers of participants. Further research is recommended.