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.
METHODS: Patients (n = 94) scheduled for gynaecological laparotomy received i.v. fentanyl infusion (3 μg/kg/h) after induction of general anaesthesia. Post-operative fentanyl requirements were quantified by using a patient-controlled analgesia and the number of i.v. fentanyl rescue analgesia required were recorded. Pain control was assessed using visual analogue scores (VAS) and fentanyl's adverse effects were documented. CYP3A4*4, CYP3A4*5 and CYP3A4*18 alleles of cytochrome P450 3A4 were identified by polymerase chain reaction-restriction fragment length polymorphism. Differences in fentanyl requirements, VAS scores and adverse effects among the various genotypes were compared.
RESULTS AND DISCUSSION: No CYP3A4*4 and CYP3A4*5 alleles were detected. Eighty-nine patients (94·7%) were wild-type, five (5·3%) were heterozygous and none was homozygous. No significant difference was demonstrated between the genotype groups in terms of fentanyl consumption, pain control and adverse effects.
WHAT IS NEW AND CONCLUSION: CYP3A4*4 and CYP3A4*5 are rare in the Malaysian Malay population. Genetic polymorphism of CYP3A4*18 may not play an important role in influencing postoperative fentanyl requirements.
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.