Malaysian Journal of Pharmacy Vol.4 Issue 1, July 2018 ______
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Vol. 2 Issue 2. August 2016 Vol.4 Issue 1. July 2018 MALAYSIANMALAYSIAN JOURNALJOURNALof ofPHARMACY PHARMACY Supplement: Proceedingsofthe9th National Pharmacy R&D In this issue:Conference 2016 Serial Drama: Seven Steps to Avoid Falling Foul of Falsified Medicines Directive (FMD) Management of Mild Valproic Acid Toxicity with Hemodialysis – A Case Report Stability of Extemporaneously Compounded Chloral Hydrate Oral Solution Supplement Proceedings of the 10th National Pharmacy R&D Conference 2018 APublicationoftheMalaysianPharmaceuticalSociety EDITORIAL BOARD A Publication of the Malaysian Pharmaceutical Society Malaysian Journal of Pharmacy Vol.4 Issue 1, July 2018 ___________________________________________________________________ The Official Journal of the Malaysian Pharmaceutical Society Editor-in-Chief: Assoc. Prof. Dr. Asrul Akmal Shafie Managing Editor: Mr. Ho Rhu Yann International Advisory Board: Assoc. Prof. Dr. Chua Siew Siang Prof. Dr. Mohd Baidi Bahari Associate Editors: Mr. Lam Kai Kun Prof. Dr. Mohamed Azmi Ahmad Hassali Assoc. Prof. Dr. Mohamad Haniki Nik Mohamed Ms. Syireen Alwi Prof. P T Thomas Dr. Wong Tin Wui Assoc. Prof. Dr. Vikneswaran a/l Murugaiyah Prof. Dr. Yuen Kah Hay Publisher: Malaysian Pharmaceutical Society 16-2 Jalan OP 1/5, 1-Puchong Business Park Off Jalan Puchong 47160 Puchong Malaysia Tel: 6-03-80791861 Fax: 6-03-80700388 Homepage: www.mps.org.my Email: [email protected] The Malaysian Journal of Pharmacy is a publication of the Malaysian Pharmaceutical Society. Enquiries are to be directed to the publisher at the above address. The Publisher reserves copy- right and renewal on all published materials, and such material may not be reproduced in any form without the written permission of the Publisher. ISSN 1675-3666 9 771675 366005 Table of Contents Editorial Research papers Serial drama: seven steps to avoid falling foul of falsified medicines directive (FMD) Management of mild valproic acid toxicity with hemodialysis – a case report Stability of extemporaneously compounded chloral hydrate oral solution Acknowledgement Reviewers of abstracts List of oral presentations Abstracts of oral presentations List of poster presentations Abstracts of poster presentations Editorial ENHANCING ACCESS TO MEDICINES THROUGH VALUE-BASED APPROACHES Abdul Haniff b Mohamad Yahaya, PhD Department of Pharmacy, Hospital Teluk Intan, Perak, Ministry of Health Malaysia In the last decade, value has played a key role in healthcare system. The value-based approach refers to a personalized care, where patient’ expectations and needs are included in a holistic approach of medicine that considers physical, mental, and spiritual well-being1. Nowadays, the paradigm has shifted from evidence-based medicine (EBM) to value-based medicines (VBM). The term “value-based” was first introduced by Brown et al as “the practice of medicines incorporating the highest level of evidence-based data with patient perceived value conferred by healthcare interventions for the resource expended”2. The aim of introduction of VBM is to improve the quality of healthcare by efficient utilization of resources. The key principle in VBM is the integration between best clinical evidence and patient preferences in the decision making process. Therefore, there are needs for changes in point of views between healthcare providers and patients. As healthcare management is clearly moving towards patient-centered system, we should emphasize on the patients’ empowerment. This enables the patients to be an active and effective participant in their own process of care and to be part of the decision. Thus, the utilization of healthcare especially the access to medicines could be enhanced. Our National Medicines Policy (2012) emphasizes on the improvement of access to medicines for the patients. The equitable access and rational use of safe, effective and affordable good quality essential medicines to improve health outcomes of the population are the main objective of the policy. In addition, it emphasizes the quality use of medicines by patients’ empowerment on the information. This indirectly sets up a platform to initiate the implementation of VBM. However, the resources are still lacking in terms of research especially this country, to enable the success of the implementation of VBM. Research in patients’ preferences coupled with clinical expertise is fundamental towards a value-based system. The current emerging trend in research has captivated pharmacy profession to shift their focus to “Enhancing Access to Medicines through Value-based Approaches”. This issue of Malaysian Journal of Pharmacy encompasses the collection of abstract proceedings that is presented either as oral or poster presentation at the 10th National Pharmacy R&D Conference on 9 – 11 July 2018. On behalf of the scientific committee, I would like to express my sincerest gratitude to all pharmacist researchers who have shown immense passion by submitting their interesting research findings for us. 1Marzorati C, Pravettoni G. Value as a concept in the health care system. Journal of Multidisciplinary Healthcare 2017;10: 101-106 2Brown MM, Brown GC, Sharma S. Evidence-based to value-based medicine. Chicago: AMA Press; 2005, p. 5- 7, 125-149, 151-181, 193-217, 267-279, 319-324 SERIAL DRAMA: SEVEN STEPS TO AVOID FALLING FOUL OF FALSIFIED MEDICINES DIRECTIVE (FMD) Davison M* rfxcel Corporation, 12667 Alcosta Boulevard, Suite 375, San Ramon, California 94583, the United States of America. *Author for correspondence INTRODUCTION The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. This article outlines everything you need to know and what you need to do for a seamless serialisation process – before regulators remove your right to trade. Pharmaceutical manufacturers are currently the main actors in a serial drama where getting their lines right is paramount. Well, four lines of data, to be precise; in (and next to) DataMatrix barcodes applied to every pack of prescription medicines. The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. But there is a twist in the plot. Failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No barcode, no trade. That is when a serial drama turns into a tragedy. And time is running out to be ready. The unfolding story of the Falsified Medicines Directive (FMD), which was first introduced in 2011, is into its final episodes. The denouement arrives on February 9, 2019, when the Directive is fully enforced and the penalties for non-compliance officially come into play. FMD is an attempt to prevent inauthentic, substandard or harmful medicines entering the supply chain. It imposes strict serialisation, traceability and verification requirements on pharmaceutical manufacturers and their associated wholesalers, distributors and contract manufacturers. In particular, it mandates companies to print a unique identifier on the packaging of prescription medicines. Furthermore, companies are not just responsible for the data that goes on the packaging, they are responsible for submitting it to the central data hub that will enable pharmacists to authenticate products before they dispense them. It is a complex undertaking that could be easily underestimated - but not if you understand some key steps. The implementation of serialisation is not an overnight task – it encompasses processes that have multiple touch-points across global organisations, partner networks and the wider supply chain. Yet despite this – and despite the enormous implications of getting it wrong – many companies are still some distance from being fit for purpose. Indeed, in some organisations, the Directive has not yet hit their radar. It needs to – because the clock is ticking. But all is not lost. Here are seven steps to successful serialisation. 1: GET EXECUTIVE BUY-IN The significance of serialisation is often underestimated. It is typically considered a production issue and punted to manufacturing as an operational challenge. Yet serialisation is a board level issue, with ramifications that could directly affect business performance. Indeed, it is not a manufacturing cost – it is a business continuity risk that touches every aspect of an organisation. So the first step towards serialisation – one that is often overlooked – is to appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy. Implementation will naturally be delegated to project teams, but executive leadership will be crucial to making things happen quickly. 2: ASSEMBLE A MULTI-DISCIPLINARY TEAM Multi-disciplinary engagement is essential. Many organisations do not understand all their business processes in sufficient detail to overlay serialisation. It is therefore vital that a multi- disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. An MDT should actively engage representatives from manufacturing, supply chain, information technology, legal/regulatory and partner/contract management. 3: ESTABLISH LONG-TERM USER REQUIREMENTS TO ENSURE YOU RE ‘FUTURE READY’ The next step is to define your user requirements and establish a template for the solution that will