Health Technology Assessment and Its Use in Drug Policy in Malaysia.

OBJECTIVE: To describe the process and role of health technology assessment (HTA) in the context of drug policy in Malaysia. METHODS: We summarized the HTA process through review of documents and reports available in the public domain combined with the authors' experience. RESULTS: Health technology assessment plays an integral part in prioritizing treatment in public health facilities in Malaysia, particularly for the Ministry of Health Medicines Formulary (MOHMF). The MOHMF is the reference list of drugs allowed to be prescribed in the Ministry of Health (MOH) facilities. There are 2 organizations within the MOH that conduct HTA as their core activities, namely the Malaysian Health Technology Assessment Section and the Formulary Management Branch of Pharmacy Practice & Development Division. The assessment of pharmaceuticals for the purpose of listing medicines into the MOHMF is under the purview of the Formulary Management Branch. The evidence-based assessment focuses on safety, efficacy, effectiveness, and budget impact of the drug. Cost-effectiveness evidence is currently not mandatory but is of interest to the decision makers. The assessment outcomes are considered by the MOH Medicines List Review Panel for formulary decisions. CONCLUSIONS: Health technology assessment has supported formulary decisions in MOH. Evidence generation needs to progress beyond efficacy or effectiveness, safety, and budget impact to incorporate cost-effectiveness. Nevertheless, there are challenges to be met to achieve this. The impact of the HTA process is currently unknown and is yet to be evaluated formally.

Effectiveness and safety of a 10mg warfarin initiation nomogram in Asian population.

Anticoagulant responses to warfarin vary among patients, based on genetic factors, diet, concomitant medications, and disease state. We evaluated the effectiveness and safety of a 10mg warfarin initiation nomogram in an Asian population. Retrospective cross-sectional audit studies were conducted from March 2009 to March 2010. The use of a 10mg-loading dose to initiate warfarin treatment resulted in 33(84.6%) patients attaining a therapeutic INR within four days (mean time, 2.6 days). There was no significant correlation between age, gender, race, and serum albumin for the time to reach a therapeutic INR. A significant correlation was noted for patient's baseline INR and time to reach a therapeutic INR (P<0.05). No significant differences were observed in time to reach a therapeutic INR in patients treated with specific class of concomitant drugs or patients with specific disease states. The overall incidence of over-anticoagulation was 35.9%; however, no bleeding episodes were encountered. In conclusion, the use of a 10mg warfarin nomogram was effective in rapidly achieving a therapeutic INR. However, the nomogram's safety is debatable owing to the high over-anticoagulation rate warfarin-administered patients. Caution is recommended in the initiation of warfarin treatment using the 10mg nomogram.