METHODS: In-depth interviews were undertaken with stakeholders involved in HIV prevention, Ministry of Health, Religious Leaders and People Living with HIV, including transgender women. Thirty five participants were recruited using purposive sampling from June to December 2013 within Kuala Lumpur and surrounding vicinities. Interviews were in person, audiotaped, transcribed verbatim and used a framework analysis.
RESULTS: Five central themes emerged from the qualitative data; Perceptions of Transgender women and their place in Society; Reaching out to Transgender Women; Islamic doctrine; 'Cure', 'Correction' and finally, Stigma and Discrimination.
DISCUSSION: Islamic rulings about transgenderism were often the justification given by participants chastising transgender women, whilst there were also more progressive attitudes and room for debate. Pervasive negative attitudes and stigma and discrimination created a climate where transgender women often felt more comfortable with non-governmental organisations.
CONCLUSION: The situation of transgender women in Malaysia and HIV prevention is a highly sensitive and challenging environment for all stakeholders, given the Muslim context and current legal system. Despite this apparent impasse, there are practically achievable areas that can be improved upon to optimise HIV prevention services and the environment for transgender women 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.
METHODS: Patient demography, pre-operative visual acuity, intra-operative complications, post-operative complications and post-operative visual acuity were recorded for two hundred and forty seven of the 400 patients who underwent cataract surgery during a 2-week period. The cost of surgery, which included capital, staff and overhead, and patient care consumable costs were assessed prospectively in 8 randomly sampled patients over a 3-month period. Cost efficiency refers to cost per cataract surgery. Cost effectiveness refers to cost per successful cataract surgery. This is estimated by the ratio of cost efficiency to the proportion of successful cataract surgery. Successful surgery was defined as best-corrected visual acuity (BCVA) of better than 6/12 at 3 months post-operatively.
RESULTS: Proportion of patients who had post-operative visual acuity of 6/12 or better was higher in phacoemulsification group (94%) than in the ECCE group (81%). Conventional extracapsular cataract surgery with intraocular lens implant costs RM3442 (USD 905.79) and phacoemulsification with intraocular lens implant costs RM4288 (USD 1128.42).
DISCUSSION: There was no significant difference in cost effectiveness between ECCE and phacoemulsification. The cost of cataract surgery in the MOH hospital was found to be high due to the high overhead costs.