Adverse Drug Reactions Assessment in DRUG GROUP: INTRAVENOUS ANTICOAGULANT NORHAYATI BT YAACOB

1. Adverse Drug Reactions Assessment in DRUG GROUP:INTRAVENOUS ANTICOAGULANT NORHAYATI BT YAACOB MARZIRAH BT IBRAHIM SHAHARUDDIN BIN ABDUL RASHID WAN MOHD HAMIDI WAN SULAIMAN MASTER IN PHARMACY PRACTICE, FACULTY OF PHARMACY OVERVIEW Importing Photographs The National Drug Safety Monitoring Centre (National ADR Centre) is one of the main section under The Centre For Post Registration Of Products in National Pharmaceutical Control Bureau (NPCB),a division under The Ministry Of Health (MOH) Malaysia, which bears the responsibility to received, collect, analyze, documented and propose recommendation regarding pharmaceuticals, biotechnology products, vaccines, traditional medicines, health supplements and cosmetics products, registered with Drug Control Authority (DCA) Malaysia, for any unwanted health effects or adverse drugs reactions (ADR) occurred after the administration, taken or used of the said registered products to consumers or patients in Malaysia. Malaysian Adverse Drug Reactions Advisory Committee (MADRAC), is a committee to review ADR reporting either accepted, rejected or amended any necessary recommendation, submit their recommendation to the Drug Control Authority (DCA) for further action. MADRAC are required to forward the report to the central WHO Global ICSR (individual case safety report) database, which is maintained by the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre in Uppsala, Sweden. Research Poster Design Services INTRODUCTION OBJECTIVES STUDY DESIGN & SAMPLE DATA SELECTION CRITERIA Define by the Asscher et al at year 1995; ADVERSE DRUG REACTION is any undesirable effect of a drug beyond its anticipated therapeutic effects occurring during clinical use. In contrast, an adverse drug event is an untoward occurrence after exposure to a drug that is not necessarily caused by the drug (Asscher AW, 1995). Pharmacovigilance is the process of monitoring products as being used in everyday practice to identify previously unrecognised adverse reactions during clinical trials or changes in the patterns of their adverse effects due to larger and varied ethnic and population usage. • To examine the type of ADR that caused by intravenous anticoagulant group. • Specific objectives • To determine the rate, type and • severity of the reported ADR. • To determine the association between • ADR, drug-drug interaction and • contribution factors. This is a retrospective study at a single setting center. Data were collected at Pusat Pasca Pendaftaran Produk – Seksyen Farmakovigilans (Unit Pengendalian ADR), Bahagian Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia, Petaling Jaya. Data on reported ADR from year 2000 to 2012 of heparin, enoxaparin, fondaparinux were collected from a database system called Quest 2 System and transferred to Microsoft Excel 2010. Any incomplete data were excluded from the analysis. . RESULTS & DISCUSSION Figure 2; Number of cases reported 2001- 2012 Figure 3; Number of ADR cases by Gender Figure 4; Number of ADR cases reported by Race Figure 5; Number of ADR cases reported by Age group Figure 6 Number in outcome of ADR Figure 7; Number of ADR report by reporters Figure 7; Number of ADR report by System Organ Class CONCLUSION Overall the findings show that a group of Intravenous Anticoagulant have a similar in number of ADR report by System Organ Class. This study has many limitations especially for incomplete ADR form. No further discussion can be made since data only collected retrospectively and the reports were not fully completed. Descriptive analysis can only be done without further reasoning of the cases occurred. Hypothesis cannot be tested. Confounding cannot be predicted and controlled. Therefore, further research using appropriate study design should be conducted in the future. ACKNOWLEDGEMENT REFERENCES The study was done in The National Drug Safety Monitoring Centre (National ADR Centre) in National Pharmaceutical Control Bureau (NPCB), Malaysia . We wishes to thank to all the staff for giving us opportunity to work with them as well as for the advice, knowledge and resources provided. • *Asscher AW, P. G., Whitmarsh VB. (1995). Towards the safer use of medicines. BMJ, 311, 1003-1005. • *Cohen, A. T., Alikhan, R., Arcelus, J. I., Bergmann, J.-F., Haas, S., Merli, G. J., . . . Turpie, A. G. G. (2005). Assessment of venous thromboembolism risk and the benefits of thromboprophylaxis in medical patients. Thrombosis and Haemostasis. • * Alquwaizani, M., Buckley, L., Adams, C., & Fanikos, J. (2013). Anticoagulants: A Review of the Pharmacology, Dosing, and Complications. Current emergency and hospital medicine reports, 1(2), 83–97. • www.bpfk.gov.my/‎