RECENT FINDINGS: The prevalence of HIV and HCV are several-fold higher in the criminal justice system than within the broader community particularly in regions with high prevalence of injecting drug use, such as Asia, Eastern Europe and North America and where drug use is criminalized. Strategies to optimize management for these infections include routine screening linked to treatment within these settings and medication-assisted treatments for opioid dependence and access to syringe services programs. We build upon the 2016 WHO Consolidated Guidelines through the lens of the key populations of prisoners. Linkage to treatment postrelease, has been universally dismal, but is improved when linked to medication-assisted therapies like methadone, buprenorphine and overdose management. In many prisons, particularly in low-income and middle-income settings, provision of even basic healthcare including mental healthcare and basic HIV prevention tools remain suboptimal.
SUMMARY: In order to address HIV and HCV prevention and treatment within criminal justice settings, substantial improvement in the delivery of basic healthcare is needed in many prisons worldwide together with effective screening, treatment and linkage of treatment and prevention services to medication-assisted therapies within prison and linkage to care after release.
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.
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.
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.