Vol. 4 No. 1 (2018): Malaysian Journal of Pharmacy


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Published: 1 July 2018

In this issue:

  • 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

Serial Drama: Seven Steps to Avoid Falling Foul of Falsified Medicines Directive (FMD)

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    Abstract

    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.

    Management of Mild Valproic Acid Toxicity with Hemodialysis – A Case Report

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      Abstract

      The management of Valproic Acid (VPA) toxicity is mainly supportive treatment. Invasive management such as hemodialysis (HD) and hemoperfusion were only used in isolated cases where patient is highly VPA toxic, which results in coma. We described a case of mild VPA toxicity (VPA serum concentration 326.42mcg/mL), where the patient was successfully treated with two hours of low-flux HD with no complication. While the guideline of indication of HD in VPA toxicity has yet to be published, low-flux HD can be an effective treatment in cases of mild VPA toxicity, if other supportive measures failed or not available.

      Stability of Extemporaneously Compounded Chloral Hydrate Oral Solution

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        Abstract

        The objective of this study is to look into the stability of Chloral Hydrate 40 mg per ml formulated as oral solution in X-temp Oral Suspension System in order to select proper storage conditions and establish beyond-use date. X-temp is a novel oral, flavoured sugar-free extemporaneous compounding vehicle to assist in the preparation of extemporaneous dosage forms.

        The compounded solution of 40 mg/ml was prepared by dissolving chloral hydrate powder in X-temp vehicle. The solution was then packed in amber HDPE containers, and were stored at refrigeration 5 ± 3°C and room temperature 30°C. Physical, chemical and microbiological parameters were evaluated at predetermined time-points up to 180 days. Samples were tested using a validated stability–indicating assay. Chloral hydrate concentration was assayed by high-performance liquid chromatography (HPLC).

        The stability results indicated that the solution remained unchanged in visual appearance or pH at both refrigeration and room temperature for up to 180 days. The HPLC results showed that all the stability studies maintained 90 – 100% of initial drug concentration. There was no substantial changes in the microbiological stability.

        Chloral hydrate solution prepared in X-temp Oral Suspension System was stable for up to 180 days when stored at room temperature and refrigeration conditions. These results demonstrated that X-temp is a suitable vehicle for extemporaneous compounding for chloral hydrate.