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.

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.

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.

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.

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.

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 venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis or varicose ulcers) comprise 80% to 85% of all leg ulcers. Electromagnetic therapy (EMT) is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of EMT on the healing of venous leg ulcers. SEARCH METHODS: For this fourth update, we searched The Cochrane Wounds Group Specialised Register (searched 30 January 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 12). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham-EMT or other treatments. DATA COLLECTION AND ANALYSIS: Standard Cochrane Collaboration methods were employed. At least two review authors independently scrutinised search results and obtained full reports of potentially eligible studies for further assessment. We extracted and summarised details of eligible studies using a data extraction sheet, and made attempts to obtain missing data by contacting study authors. A second review author checked data extraction, and we resolved disagreements after discussion between review authors. MAIN RESULTS: Three randomised controlled trials (RCTs) of low or unclear risk of bias, involving 94 people, were included in the original review; subsequent updates have identified no new trials. All the trials compared the use of EMT with sham-EMT. Meta-analysis of these trials was not possible due to heterogeneity. In the two trials that reported healing rates; one small trial (44 participants) reported that significantly more ulcers healed in the EMT group than the sham-EMT group however this result was not robust to different assumptions about the outcomes of participants who were lost to follow up. The second trial that reported numbers of ulcers healed found no significant difference in healing. The third trial was also small (31 participants) and reported significantly greater reductions in ulcer size in the EMT group however this result may have been influenced by differences in the prognostic profiles of the treatment groups. AUTHORS' CONCLUSIONS: It is not clear whether electromagnetic therapy influences the rate of healing of venous leg ulcers. Further research would be needed to answer this question.

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.

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.

Electromagnetic therapy for treating venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis or varicose ulcers) comprise 80% to 85% of all leg ulcers. Electromagnetic therapy (EMT) is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of EMT on the healing of venous leg ulcers. SEARCH METHODS: For this third update, we searched The Cochrane Wounds Group Specialised Register (searched 12 November 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 10); Ovid MEDLINE (2011 to November Week 1 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, November 12, 2012); Ovid EMBASE (2011 to 2012 Week 45); and EBSCO CINAHL (2011 to 9 November 2012). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham-EMT or other treatments. DATA COLLECTION AND ANALYSIS: At least two review authors independently scrutinised search results and obtained full reports of potentially eligible studies for further assessment. We extracted and summarised details of eligible studies using a data extraction sheet, and made attempts to obtain missing data by contacting study authors. A second review author checked data extraction, and we resolved disagreements after discussion between review authors. MAIN RESULTS: Three randomised controlled trials (RCTs) of variable quality involving 94 people were included in the original review; subsequent updates have identified no new trials. All the trials compared the use of EMT with sham-EMT. In the two trials that reported healing rates; one small trial (44 participants) reported that significantly more ulcers healed in the EMT group than the sham-EMT group however this result was not robust to different assumptions about the outcomes of participants who were lost to follow up. The second trial that reported numbers of ulcers healed found no significant difference in healing. The third trial was also small (31 participants) and reported significantly greater reductions in ulcer size in the EMT group however this result may have been influenced by differences in the prognostic profiles of the treatment groups. AUTHORS' CONCLUSIONS: There is no high quality evidence that electromagnetic therapy increases the rate of healing of venous leg ulcers, and further research is needed.

Flavonoids for treating venous leg ulcers.

BACKGROUND: Venous leg ulcers are a major health burden: annually, in the UK alone, they contribute an estimated cost to the NHS of GBP 400 million. Flavonoids are a diverse group of naturally-occurring venotonic compounds that address certain microcirculatory parameters involved in venous leg ulcer pathophysiology. OBJECTIVES: To evaluate the clinical effects of flavonoids on the healing of venous leg ulcers. SEARCH METHODS: In February 2013 we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 1); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. No date or language restrictions were applied. We checked reference lists of included trials, and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) that investigated the efficacy of any flavonoid-containing compound on venous leg ulcer healing in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for the review and disagreements were referred to a third author. All rejected articles were double-checked by a third author. Assessment of risk of bias and data extraction were performed independently by two authors, discrepancies were resolved by referring to the third author. MAIN RESULTS: Of the nine studies (1075 participants): five investigated Micronised Purified Flavonoid Fraction (MPFF), and four investigated hydroxyethylrutosides (HR).Meta-analysis involving 723 participants from five trials - four of which were characterised by poor reporting - showed more venous leg ulcers were healed in the MPFF groups than in the control groups (RR 1.36; 95% CI 1.07 to 1.74). However, the most rigorously conducted trial, which was at low risk of bias, did not show any additional benefit of MPFF (RR 0.94; 95% CI 0.73 to 1.22). Since this trial was unpublished, the possibility of publication bias in trials involving flavonoids must be acknowledged. Overall, the quality of reporting of trials on HR was also poor. Pooling three trials, all at unclear risk of bias, involving 279 participants showed a statistically significant effect in favour of HR with respect to number of ulcers healed (RR 1.70; 95% CI 1.24 to 2.34). AUTHORS' CONCLUSIONS: Although the overall estimate of the number of healed ulcers appeared to show a significant effect in favour of flavonoids (both MPFF and HR), this result needs to be interpreted cautiously, as most of these trials were poorly reported, and so had an unclear risk of bias for randomisation, allocation concealment, blinding and methods for addressing incomplete outcome data. There was also a possibility of publication bias.

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.

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.

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 12 July 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7); Ovid MEDLINE (2010 to July Week 1 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, July 11, 2012); Ovid EMBASE (2010 to 2012 Week 27); and EBSCO CINAHL (2010 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.

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.

Electromagnetic therapy for treating venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis or varicose ulcers) comprise 80% to 85% of all leg ulcers. Electromagnetic therapy (EMT) is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of EMT on the healing of venous leg ulcers. SEARCH STRATEGY: For this second update, Cochrane Wounds Group Specialised Register (searched 16 February 2011); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1); Ovid MEDLINE (1950 to February Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations February 15, 2011); Ovid EMBASE (1980 to 2011 Week 06); and EBSCO CINAHL (1982 to 11 February 2011). We applied no date or language restrictions. SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham-EMT or other treatments. DATA COLLECTION AND ANALYSIS: At least two review authors independently scrutinised search results and obtained full reports of potentially eligible studies for further assessment. We extracted and summarised details of eligible studies using a data extraction sheet, and made attempts to obtain missing data by contacting study authors. A second review author checked data extraction, and we resolved disagreements after discussion between review authors. MAIN RESULTS: Three randomised controlled trials (RCTs) of variable quality involving 94 people were included in the original review; subsequent updates have identified no new trials. All the trials compared the use of EMT with sham-EMT. In the two trials that reported healing rates; one small trial (44 participants) reported that significantly more ulcers healed in the EMT group than the sham-EMT group however this result was not robust to different assumptions about the outcomes of participants who were lost to follow up. The second trial that reported numbers of ulcers healed found no significant difference in healing. The third trial was also small (31 participants) and reported significantly greater reductions in ulcer size in the EMT group however this result may have been influenced by differences in the prognostic profiles of the treatment groups. AUTHORS' CONCLUSIONS: There is no high quality evidence that electromagnetic therapy increases the rate of healing of venous leg ulcers, and further research is needed.

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.

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 STRATEGY: For this update we searched the Cochrane Wounds Group Specialised Register (2 June 2010); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 2); Ovid MEDLINE (2007 to May Week 3 2010); Ovid EMBASE (2007 to Week 21 2010) and EBSCO CINAHL (2007 to 1 June 2010). 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. 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.