Publications

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

    DOI: 10.52494/VYVT3145
    by Davison M.
    Vol. 4 No. 1 (2018): Malaysian Journal of Pharmacy / Published: July 25, 2018
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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.

    Exploration of EQ-5D-5L Bolt-On Items among Malaysian Population

      DOI: 10.52494/SJOA9420
      by Thakumar AV, Shafie AA and Lim CJ.
      Vol. 3 No. 1 (2017): Malaysian Journal of Pharmacy / Published: November 1, 2017
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      Abstract

      This study aimed to assess the adequacy of EQ-5D-5L in defining health as perceived by Malaysians using a mixed methodology approach. Potential additional dimensions (i.e. bolt-on items) to supplement the current instrument were also explored. This study was carried out in two phases. In phase one, focus group discussions (N = 6-8 in each group) were employed to gauge the perception of Malaysians on the dimensions deemed important additions to the EQ-5D-5L instrument. Phase two involved further validation of bolt-ons to the EQ-5D-5L using a cross-sectional survey of 100 general public in Penang, Malaysia. A total of 11 bolt-ons were identified from phase 1. These bolt-ons were sleep, vitality, happiness, close relationships, stress, mental abilities, social support, religion, vision, hearing, and speaking. In phase 2, the bolt-ons of ‘vitality’ and ‘stress’ stood out with 70% (n=70) and 64% (n=64) participants reported facing most problems with, respectively. Both phases of study suggest that additional dimensions for the existing EQ-5D-5L instrument may be useful to better capture the HRQoL among Malaysians. Larger scale study is warranted to further validate the bolt-ons identified in this study.

      Stability of an Extemporaneously Prepared Alcohol-Free Phenobarbitone Oral Suspension

        DOI: 10.52494/IZAL8545
        by Lian Thye Chan and Lucy Yeoh.
        Vol. 2 No. 1 (2015): Malaysian Journal of Pharmacy / Published: November 1, 2015
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        Abstract

        Many drugs used in paediatric are often not available in suitable dosage forms and have to be extemporaneously prepared by pharmacists to make them suitable for the body weight, body surface area, or age of the children. Phenobarbitone is the main anti-epileptic drug (AED) for the treatment of seizure in paediatric patients. The objective of this study is to evaluate the physicochemical and microbiological stability of an extemporaneously prepared Phenobarbitone Oral Suspension using commercially available tablets and X-temp Oral Suspension System. The Phenobarbitone Oral Suspension (10mg/ml) was stored at 4oC and 30oC / 75%RH protected from light and were examined at the interval of 0, 1, 2, 3 and 6 months. The content of Phenobarbitone was determined using a validated high-performance liquid chromatography (HPLC) method. The visual appearance, odour, pH and specific gravity remained fairly unchanged throughout the study period and the content of Phenobarbitone remained above 98% of the original concentration throughout the course of the study for both temperatures. The extemporaneous preparation was not susceptible to microbial contamination. The results from the stability studies confirmed that X-temp Oral Suspension is a suitable suspending vehicle for preparing extemporaneous liquid formulation of Phenobarbitone Oral Suspension with the added advantage of alcohol-free, colourant-free and sugar-free. Based on the data collected, the shelf-life of this liquid formulation is at least 6 months when stored at 4oC (refrigeration) and 30oC / 75%RH (room temperature).

        Cost Analysis on Ticagrelor Utilisation in the Treatment of Patients with Acute Coronary Syndrome: A Preliminary Study

          DOI: 10.52494/ZFJX9831
          by L Anchah, AYY Fong and TK Ong.
          Vol. 2 No. 1 (2015): Malaysian Journal of Pharmacy / Published: November 1, 2015
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          Abstract

          Background: Dual therapy with aspirin and clopidogrel is the standard treatment for acute coronary syndrome (ACS). Dual antiplatelet therapy plays an important role in reducing major acute, short- and long-term adverse clinical outcomes. Currently, the economic evaluation of ticagrelor, a reversible and direct-acting oral antagonist of adenosine diphosphate receptor P2Y12 remains unknown.

          Objective: To compare the annual cost of ticagrelor versus branded clopidogrel in patients with ACS from a Malaysian health care perspective.

          Methods: The data required for this analysis was obtained from a 2007 study carried out by Fong et al. in ACS patients (n=57). Assumptions used for the present analysis were based on data from the Cardiac Rehabilitation Program (CRP) study, the Study of Platelet Inhibition and Patient Outcomes (PLATO) and the National Cardiovascular Disease ACS (NCVD ACS) registry of Malaysia. For all calculations, the Ringgit Malaysia (RM) currency and prices as of 2007 were considered.

          Results: The cost of clopidogrel treatment in post-ACS patients for 30 days was calculated to be RM1,381,340 (n=2072; daily cost=RM5.50) and assuming treatment with ticagrelor, the cost would be RM1,554,000 (daily cost=RM8.70). Based on PLATO and NCVD ACS 2007, it was estimated that major adverse coronary event (MACE) in the form of unstable angina (UA) would occur in an additional 21 patients on clopidogrel, which could have been avoided with ticagrelor. Extrapolating cost data from CRP study, it was estimated that the annual costs for 21 additional cases of UA in terms of annual treatment and readmission would be more than RM400,000. Treatment with ticagrelor would thereby be associated with lesser number of MACE that can be translated in avoiding annual costs of treatment of UA and result in annual cost savings of RM238,856.

          Conclusion: Although direct comparisons were not made, this analysis suggests that ticagrelor therapy may be a more cost-saving alternative to clopidogrel in Malaysian patients with ACS. Keywords: ticagrelor, clopidogrel, acute coronary syndrome, cost analysis, major adverse coronary event.

          Formulation and Stability of Extemporaneously Prepared Morphine Oral Suspension

            DOI: 10.52494/AZQJ1743
            by Lian Thye Chan and Lucy Yeoh.
            Vol. 1 No. 11 (2014): Malaysian Journal of Pharmacy / Published: October 1, 2014
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            Abstract

            Morphine taken by mouth is an effective analgesic for most people with moderate or severe cancer pain. Hospital pharmacists commonly prepare morphine oral liquid extemporaneously for cancer patients who require tube feeding or have difficulties in swallowing because it is not available commercially in Malaysia. This study aims to provide the physical, chemical and microbiological stability data to determine the shelf-life and storage condition for the extemporaneous preparation of morphine oral suspension (10mg/5ml) using X-Temp Oral Suspension System. The samples were divided into 2 groups and were stored at 4°C (refrigeration) and 30°C / 75%RH (room temperature) protected from light for 12 months. The physical, chemical and microbiological stability were examined at the interval of months 0, 1, 2, 3, 4, 5, 6, 9 and 12. The content of morphine was determined using HPLC-UV method. The content of morphine remained above 95% of the original concentration throughout the study period. The colour, clarity and odour remained fairly unchanged throughout the study period and the pH values were steady at around pH 4. The extemporaneous preparation was not susceptible to microbial contamination. The results from the stability studies confirmed that the new formulation of morphine oral suspension is stable for up to 12 months when packed in HDPE bottles with polypropylene caps and stored at both 4°C and 30°C / 75%RH.

            Cost-Effectiveness Analysis of a Behavioral Risk Factor Reduction Program at a Worksite: Experience From a Public University in Malaysia

              DOI: 10.52494/PTWX9421
              by Siow Yen Liau, Asrul A Shafie, Mohamed Azmi A Hassali and Mohamed Izham Mohamed Ibrahim.
              Vol. 1 No. 11 (2014): Malaysian Journal of Pharmacy / Published: October 1, 2014
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              Abstract

              Objectives: The objectives of this study were to determine the cost of a behavioral risk factor reduction program at the worksite and to compare the cost-effectiveness of the program with a control group. Methodology: This was a quasi-experimental study conducted among employees of Universiti Sains Malaysia. The program targeted five primary risk factors (RF). Participants in the intervention program were subjected to schedule individualized counseling and seminars during the 6- month follow-up. Participants in the control group underwent health screening. Cost-effectiveness analysis was conducted from the payer’s perspective to determine the cost of 1% increase in proportion of participants who reach ideal targets for the RF. One-way sensitivity analysis was also conducted. Results: A total 136 participants were recruited in this study. At 6-month follow-up, significantly higher proportion of participants in the intervention group reached target for fruit and vegetable intake (P < 0.001) and physical activity (P = 0.017). The costs of the intervention program and control group were estimated to be MYR304.52 (USD92.28) and MYR169.90 (USD51.48) per participant respectively. The incremental cost-effectiveness ratio (ICER) of all the RF were lower than the World Health Organization recommendation based on the CHOICE analyses for relative cost-effectiveness of an intervention. Body mass index and alcohol consumption reported negative ICER which indicated control dominant. Sensitivity analyses showed that ICER was reported to be most sensitive to the change in participants’ salary. Conclusion: The proposed health promotion program was shown to be cost-effective in modifying most of the behavioral RF.

              Self-medication practices among Malaysian consumer: A questionnaire- based study

                DOI: 10.52494/KNEA2553
                by Guat See Ooi, Chee Ping Chong and Mohd Baidi Bahari.
                Vol. 1 No. 10 (2012): Malaysian Journal of Pharmacy / Published: October 1, 2012
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                Abstract

                This study was carried out to assess the prevalence of self-medication practice among Malaysian consumers who visit to community pharmacies. The data was collected using structured questionnaires which were randomly distributed to 500 consumers who visited to 10 conveniently selected community pharmacies in Sungai Petani, Kedah between August to October 2007. Out of the 500 questionnaire distributed, 105 responses were received for a response rate of 21.0%. Approximately 45% of the respondents have practiced self-medication in the preceding six months. The respondents mainly practiced self-medication for fever (35.2%), colds and flu (35.2%) and cough (31.4%). The most popular classes of medicines used by the consumers were analgesic/NSAIDs (32.4%), cold and flu medicines (23.8%) and antacids (18.1%). Only 27.6% of respondents were confident in self-managing medications or dietary supplements. The consumers mostly agreed that more advice on medications should be given by pharmacist (75.2%) and pharmacist has high level of professionalism on medication (65.7%). The study concluded that the practice of self-medication mostly involved management of minor ailments using non-prescription and over-the-counter medicines.

                Stability of Folic Acid in an Extemporaneously Prepared Oral Suspension

                  DOI: 10.52494/RJQH7327
                  by Lian Thye Chan and Lucy Yeoh.
                  Vol. 1 No. 10 (2012): Malaysian Journal of Pharmacy / Published: October 1, 2012
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                  Abstract

                  Many drugs are not available in suitable dosage forms for paediatric use and have to be extemporaneously prepared by pharmacist for the individual patient. This study is conducted to investigate the physicochemical and microbiological stability of an extemporaneous oral suspension containing 1mg/ml of folic acid. The oral suspension was prepared using commercially available tablets and vehicle from the hospital. The folic acid oral suspension was stored for 60 days at 4°C (refrigeration) and 25°C (room temperature) protected from light. The physical, chemical and microbial stability were examined at day 0, 14, 28 and 60. The content of folic acid was determined using HPLC- UV method. The analytical results showed that the content of folic acid was above 90% in all the samples tested throughout the study period. The visual appearance, colour, odour and pH remained fairly unchanged throughout the study period and the oral suspension was not susceptible to microbial contamination. The results indicated that the extemporaneous formulation was stable at both temperatures and 60 days expiration date could be recommended for this formulation.

                  Evaluation of the Tablet Splitting Practices among Malaysian Community Pharmacists

                    DOI: 10.52494/FTLZ3502
                    by Chee Ping Chong, Mohamed Azmi A Hassali and Mohd Baidi Bahari.
                    Vol. 1 No. 10 (2012): Malaysian Journal of Pharmacy / Published: October 1, 2012
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                    Abstract

                    Tablet splitting practices have been shown to reduce the medication cost in many countries. This study was aimed to evaluate the tablet splitting practices among community pharmacists in Penang, Malaysia. A two-month cross-sectional descriptive survey was carried out in forty randomly chosen community pharmacies in Penang. The pharmacists were required to document all their tablet splitting recommendations during the study period. The data collected includes the appropriateness of the tablet splitting recommendations by pharmacists; the extent of communication between pharmacists and physicians when recommending tablet splitting; the physicians‟ and patients‟ acceptance towards the tablet splitting; and the documentation of cost-saving achieved from the tablet splitting. The result showed that the tablet splitting was recommended by 31.0% of the pharmacists who receives prescriptions eligible for this practice. Tablets of patent- protected innovator brands were more likely to be recommended for splitting. Majority (92.9%) of the splitting recommendations were appropriate except two cases which involve unscored combination tablet. The pharmacists requested consent from the physicians for 42.9% of the splitting recommendations and majority (91.7%) of the requests were accepted. Meanwhile, the patients‟ acceptance rate for splitting recommendation was 82.1%. Through acceptance of tablet-splitting, the patients‟ monthly expenses on drugs reduced by 36.5% and this correspond to a monthly saving of RM39.05 (US$10.30, US$1.00 = RM 3.80) per patient. The study concluded that the tablet splitting is not a common practice among the community pharmacists, however both the physicians and patients highly accept pharmacists‟ suggestion on splitting. The findings also revealed that tablet splitting can be used as a cost-containment measure for patient as well.

                    Assessment of Malaysian Clinical Practice Guidelines

                      DOI: 10.52494/FUNL2762
                      by B. Rugayah, M.D. Noormah, M.M. Mohamed and S.F.K. Shahnaz.
                      Vol. 1 No. 10 (2012): Malaysian Journal of Pharmacy / Published: October 1, 2012
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                      Abstract

                      The Ministry of Health Malaysia (MOH) coordinates the development of Clinical Practice Guidelines (CPGs) in Malaysia, in collaboration with the Academy of Medicine of Malaysia (AMM). This study assessed the methodological quality of 29 Malaysian national CPGs which were developed since 2000 to 2003 using Appraisal of Guidelines for Research & Evaluation (AGREE) Instrument. The study showed high score for only domains on Scope & Purpose as well as Clarity & Presentation (68%, 75% respectively).