Displaying publications 1 - 20 of 36 in total

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  1. Health Technology Assessment and Its Use in Drug Policy in Malaysia
    Shafie AA, Chandriah H, Yong YV, Wan Puteh SE
    Value Health Reg Issues, 2019 May;18:145-150.
    PMID: 31082794 DOI: 10.1016/j.vhri.2019.03.003
    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.

    Matched MeSH terms: Drug and Narcotic Control/methods; Drug and Narcotic Control/trends*
  2. Regulations and policies on pharmaceuticals in Malaysia: its impact on healthcare
    Abdul Latiff SB
    Kaohsiung J. Med. Sci., 1999;15 Suppl:S75-8.
    PMID: 10422428
    Matched MeSH terms: Drug and Narcotic Control*
  3. Drug standards in Malaysia
    Goldstein G
    Med J Aust, 1980 Jan 12;1(1):39.
    PMID: 7360078
    Matched MeSH terms: Drug and Narcotic Control*
  4. Fulltext Drug control and formulary management in Malaysia
    Hussain SH
    Value Health, 2008 Mar;11 Suppl 1:S158-9.
    PMID: 18387060 DOI: 10.1111/j.1524-4733.2008.00381.x
    Matched MeSH terms: Drug and Narcotic Control/history*
  5. Development and application of a system for monitoring drug abuse: the Malaysian experience
    Navaratnam V, Foong K
    Bull Narc, 1989;41(1-2):53-65.
    PMID: 2765720
    Monitoring systems are useful epidemiological instruments for assessing the problem of drug abuse. The rapid growth of the drug dependence problem in Malaysia led to increased awareness of the need for a system for continuous monitoring of the situation. Preliminary work on the design of an appropriate monitoring system was initiated in 1976. A fully integrated national reporting system was established in 1978, linking all public services and agencies coming into contact with drug-dependent persons, including law enforcement agencies, drug abuse treatment and rehabilitation centres, and social and welfare institutions. The information system included a mechanism for systematic gathering, processing, analysing and presenting essential data on the prevention, control and management of drug abuse problems. It also included reporting on drug-related events, such as hospitalizations and arrests, as well as data on known drug-dependent persons and new cases of dependence. The system has been used for routine monitoring of the extent, trends, patterns and other characteristics of drug abuse problems in Malaysia, providing basic information for policy-making and programme planning. On the basis of data generated by the system, it was estimated that the prevalence rate of drug-dependent persons per 100,000 population increased from 84.3 in 1976 to 754.6 in 1986. It was estimated that there were 119,001 drug-dependent persons in Malaysia in 1986.
    Matched MeSH terms: Drug and Narcotic Control/methods
  6. Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia
    Lin OA, Chuang PJ, Tseng YJ
    Regul Toxicol Pharmacol, 2023 Feb;138:105338.
    PMID: 36642324 DOI: 10.1016/j.yrtph.2023.105338
    New psychoactive substances (NPS) are substances of abuse that easily evade existing controlled drug regulations. This study conducted a systematic review on controlled drug regulations and analyzed the numbers of new psychoactive substances (NPS) reported in six East and Southeast Asian countries in comparison to US and UK from 2009 to 2020. Generally, more NPS were reported in the US (551) and UK (400), compared to Japan (379), China (221), Singapore (142), South Korea (99), Malaysia (41), and Taiwan (35). Legislative mechanisms including the specific listing of individual substances, generic control of a family of substances, analogue control of similar substances, temporary bans of new substances were evaluated. In this review, countries that have adopted a combination of legislative mechanisms were able to identify higher numbers of NPS for regulatory control, such as the US, UK, Japan, Singapore, and South Korea. These findings can provide references to countries like Malaysia and Taiwan, to strengthen NPS-related regulations nationally. Countries in the East and Southeast Asian region should be encouraged to collaborate more closely and to implement additional legislative approaches most relevant to the regional NPS trends to bridge the regulatory gap and to prevent the spread of emerging NPS.
    Matched MeSH terms: Drug and Narcotic Control*
  7. Fulltext The fate of the new pharmacy bill: going backwards or forwards?
    Lee KS, Lim YW, Ming LC
    J Pharm Policy Pract, 2016;9:25.
    PMID: 27688885 DOI: 10.1186/s40545-016-0081-7
    The proposed Pharmacy Bill of Malaysia which served to consolidate and harmonise the existing pharmacy legislation which has been used for more than 60 years. This new Pharmacy Bill contains 17 parts and a total of 170 legislative sections covering laws governing pharmacy practice, medicinal products classification, registration, sale, supply, licensing etc. Our article could serve as a case study on pharmacy jurisprudence and drug regulation as well as the governance for medicines.
    Matched MeSH terms: Drug and Narcotic Control
  8. Fulltext Monitoring medicines use to support national medicines policy development and implementation in the Asia Pacific region
    Roughead EE, Lhazeen K, Socialine E, Bahri S, Park BJ, Holloway K
    WHO South East Asia J Public Health, 2013 Apr-Jun;2(2):113-117.
    PMID: 28612769 DOI: 10.4103/2224-3151.122946
    Critical to the successful implementation of a national medicines strategy is evaluation of the policy and ongoing monitoring of medicine use. Methods for monitoring medicines use within countries vary depending on the country and its stage of medicines policy development and implementation. In this paper, we provide four case studies on monitoring medicines use to support national medicines policy development and implementation. Cases come from Bhutan, Indonesia, Malaysia and the Republic of Korea.
    Matched MeSH terms: Drug and Narcotic Control
  9. Fulltext Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators
    Sasongko TH, Othman NH, Hussain NHN, Lee YY, Abdullah S, Husin A, et al.
    Malays J Med Sci, 2017 Aug;24(4):1-4.
    PMID: 28951684 DOI: 10.21315/mjms2017.24.4.1
    The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.
    Matched MeSH terms: Drug and Narcotic Control
  10. Pharmaceutical Policy Reforms to Regulate Drug Prices in the Asia Pacific Region: The Case of Australia, China, India, Malaysia, New Zealand, and South Korea
    Hasan SS, Kow CS, Dawoud D, Mohamed O, Baines D, Babar ZU
    Value Health Reg Issues, 2019 May;18:18-23.
    PMID: 30414506 DOI: 10.1016/j.vhri.2018.08.007
    Medicine price directly affects affordability and access to medicines particularly in countries where a major portion of pharmaceutical spending is through out-of-pocket payment, such as in the Asia Pacific region. We have undertaken a detailed appraisal of the pharmaceutical policy reforms to regulate drug prices in 3 developed (Australia, New Zealand, and South Korea) and 3 emerging (China, India, and Malaysia) economies of the Asia Pacific region. Despite continuous efforts by the authorities in adopting a wide range of reformatory pharmaceutical pricing policies to ensure affordability of medicines, these policies may not be optimal where drug prices were not lowered as expected (eg, in Korea). On the contrary, considerable price reductions of various pharmaceuticals have been observed in New Zealand and India because of the reform in pharmaceutical pricing policy. This review of pharmaceutical pricing reforms reinforces the need for constant monitoring by policy makers in Asia Pacific countries to regulate drug prices and to undertake reform in pharmaceutical pricing policies when necessary to ensure affordability and access to medicines.
    Matched MeSH terms: Drug and Narcotic Control/economics*; Drug and Narcotic Control/methods
  11. Malaysia and Singapore: new export centers for the Southeast Asian heroin trade
    Solomon R
    J Psychedelic Drugs, 1979 10 1;11(4):283-8.
    PMID: 522169
    Matched MeSH terms: Drug and Narcotic Control
  12. Fulltext Mathematical Model for Estimating Parameters of Swelling Drug Delivery Devices in a Two-Phase Release
    Setapa A, Ahmad N, Mohd Mahali S, Mohd Amin MCI
    Polymers (Basel), 2020 Dec 05;12(12).
    PMID: 33291495 DOI: 10.3390/polym12122921
    Various swelling drug delivery devices are promising materials for control drug delivery because of their ability to swell and release entrapped therapeutics, in response to physiological stimuli. Previously, many mathematical models have been developed to predict the mechanism of drug release from a swelling device. However, some of these models do not consider the changes in diffusion behaviour as the device swells. Therefore, we used a two-phase approach to simplify the mathematical model considering the effect of swelling on the diffusion coefficient. We began by defining a moving boundary problem to consider the swelling process. Landau transformation was used for mitigating the moving boundary problem. The transformed problem was analytically solved using the separation of variables method. Further, the analytical solution was extended to include the drug release in two phases where each phase has distinct diffusion coefficient and continuity condition was applied. The newly developed model was validated by the experimental data of bacterial cellulose hydrogels using the LSQCURVEFIT function in MATLAB. The numerical test showed that the new model exhibited notable improvement in curve fitting, and it was observed that the initial effective diffusion coefficient of the swelling device was lower than the later effective diffusion coefficient.
    Matched MeSH terms: Drug and Narcotic Control
  13. Fulltext Generic medicines policies in the Asia Pacific region: ways forward
    Nguyen TA, Hassali MAA, McLachlan A
    WHO South East Asia J Public Health, 2013 Jan-Mar;2(1):72-74.
    PMID: 28612828 DOI: 10.4103/2224-3151.115849
    Generic medicines are a key strategy used by governments and third-party payers to contain medicines costs and improve the access to essential medicines. This strategy represents an important opportunity provided by the global intellectual property regimes to discover and develop copies of original products marketed by innovator companies once the patent protection term is over. While there is an extensive experience regarding generic medicines policies in developed countries, this evidence may not translate to developing countries. The generic medicines policies workshop at the Asia Pacific Conference on National Medicines Policies 2012 provided an important opportunity to discuss and document country-specific initiatives for improving access to and the rational of use of generic medicines in the Asia Pacific region. Based on the identified barriers and enablers to implementation of generic medicines policies in the region, a set of future action plans and recommendations has been made.
    Matched MeSH terms: Drug and Narcotic Control
  14. Fulltext Psychoactive plant abuse: the identification of mitragynine in ketum and in ketum preparations
    Chan KB, Pakiam C, Rahim RA
    Bull Narc, 2005;57(1-2):249-56.
    PMID: 21338025
    Recently, the abuse of ketum, an indigenous psychoactive plant, has received a lot of attention in Malaysia. To help national law enforcement agencies control its abuse, the laboratory of the Forensic Division has developed a procedure for its positive identification. Botanical identification may not be practical or conclusive, owing to the wide range of ketum materials available on the market, including dry macerated leaves, powdered leaves and drinks. In order to confirm that a substance is, in fact, ketum or that a preparation is derived from ketum, gas chromatography-mass spectrometry is used to definitively identify the presence of the psychoactive principle mnitragynine.
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence*
  15. Despair over nurse's death sentence
    Coombes R
    Nurs Times, 2000 Jul;96(28):12.
    PMID: 11963128
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence*
  16. Forfeiture of the profits and proceeds derived from drug trafficking: thoughts on future action in Malaysia
    Vohrah KC
    Bull Narc, 1984 Oct-Dec;36(4):31-41.
    PMID: 6570698
    While the Dangerous Drugs Act 1952 of Malaysia has been amended to take into account changing patterns of drug abuse and trafficking, it lacks provisions for the mandatory forfeiture of proceeds derived from drug trafficking. Nor do the general powers of forfeiture in the Criminal Procedure Code of the country extend to such proceeds. To meet further changing patterns of drug trafficking involving criminal syndicate leaders, who rarely incriminate themselves through overt and detectable acts, Malaysia has a bill in Parliament the purpose of which, when it becomes law, is to detain without trial, upon cogent evidence, persons who have been associated with any activity relating to or involving drug trafficking, and to prevent them from further committing drug crimes. In addition, serious thinking has been given to the possibility of adopting, within the constraints of the Malaysian Constitution, a law on forfeiture of the proceeds derived from drug trafficking. There are, in this respect, several problems to be resolved, such as the secrecy of bank accounts and taxpayers' returns, which might make it difficult to trace proceeds and to keep track of tainted money being remitted abroad, although it is believed that such problems could be overcome by domestic measures. A more serious problem is the lack of international co-operation for investigations to be carried out outside national borders to trace, seize, freeze and secure the forfeiture of the proceeds of drug crimes located abroad.
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence
  17. Forfeiture of proceeds of drug-related crimes: a British Commonwealth perspective
    Chatterjee SK
    Bull Narc, 1983 Apr-Jun;35(2):3-19.
    PMID: 6556074
    The forfeiture of the proceeds of drug-related offences does not seem to have received much attention as yet from British Commonwealth countries. Whereas in some of these countries specific legislation exists in relation to forfeiture, in many other countries the act of forfeiture falls within the purview of general criminal law. Forfeiture presupposes enquiry and search, two procedures which involve integral aspects of present-day human rights law, and which seem to be impeded at almost every stage of the process concluding in forfeiture. Time and the procedure for execution of judgments seem to be two significant factors in the successful enforcement of forfeiture judgments. Unfortunately, given the present practice of maintaining inviolability of bank secrecy, effective enforcement of forfeiture judgments is not possible. Perhaps an international convention may offer some assistance in the successful implementation of a forfeiture judgment, especially where the ill-gotten gains have been transferred to a foreign jurisdiction.
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence*
  18. Penal measures for drug offences: perspectives from some Asian countries
    Jayasuriya DC
    Bull Narc, 1984 Jul-Sep;36(3):9-13.
    PMID: 6570654
    The importance of penal measures in the control of drugs has been recognized by various Asian countries during the last three centuries. The countries of the Asian region referred to in this article have legislation providing for different penal measures against drug offences. Severe punitive sanctions, including the death penalty, have been prescribed for serious drug offences by Iran (Islamic Republic of), Malaysia, the Philippines, Singapore, Sri Lanka and Thailand. Several countries in the region have made legal provisions for the compulsory treatment and rehabilitation of drug dependent persons. There is, however, a paucity of research studies on the efficiency of penal measures and approaches in drug control. Given the long tradition of punitive measures and the wide variety of penal approaches adopted to cope with drug-related problems, various Asian countries can provide interesting cases for criminological research on the effectiveness of penal measures in combating drug problems.
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence*
  19. Summary of an eleven-country study of socio-legal measures to combat drug abuse and related crime
    Asuni T, Bruno F
    Bull Narc, 1984 Jul-Sep;36(3):3-8.
    PMID: 6570650
    In a comparative study of a group of experimental and control subjects in Argentina, Brazil, Costa Rica, Japan, Jordan, Italy, Malaysia, Singapore and the United States of America (State of New York), and of the results of independent studies conducted in Sweden and the United Kingdom of Great Britain and Northern Ireland, a rather close association was found to exist between drug abuse, criminal behaviour and social attitudes to such problems. Both drug abuse and the socio-legal systems varied greatly in the countries involved. No correlation was found between the level of foreseen or actual harshness of the socio-legal system and the level of seriousness of drug abuse and its associated criminality, but there was a significant correlation between knowledge of the law and the efficacy of the socio-legal system. In each country informal control systems, such as the family, church, school, neighbourhood and work environment, were active. Approximately one half of the subjects that were interviewed from countries with the most punitive socio-legal systems perceived informal controls as harsh and punitive while in the other countries such controls were generally perceived as positive. The study encouraged the review, testing and implementation of alternative measures to penal sanctions, particularly with a view to creating a genuine therapeutic approach to correcting the deviant behaviour of drug abusers.
    Matched MeSH terms: Drug and Narcotic Control/legislation & jurisprudence*
  20. Revisiting Roles of Health Technology Assessment on Drug Policy in Universal Health Coverage in Thailand: Where Are We? And What Is Next?
    Tanvejsilp P, Taychakhoonavudh S, Chaikledkaew U, Chaiyakunapruk N, Ngorsuraches S
    Value Health Reg Issues, 2019 May;18:78-82.
    PMID: 30641410 DOI: 10.1016/j.vhri.2018.11.004
    OBJECTIVES: To describe the process, challenges, and future direction of health technology assessment (HTA), focusing on the drug selection of the National List of Essential Medicines (NLEM) in Thailand.

    METHODS: Literature and government documents were reviewed and analyzed by authors with experiences in HTA and drug policy in the country.

    RESULTS: The structure of HTA and its process in the drug selection of the NLEM were described, followed by the outcomes of the use of HTA. Examples of lowering drug prices, as a result of price negotiation using HTA, were presented. A few examples were also provided to demonstrate how decisions were made from considering factors beyond cost-effectiveness findings. Finally, challenges on various issues including improvement of HTA structure and process were discussed for the future direction of HTA in Thailand.

    CONCLUSIONS: HTA has been adopted as a tool for the drug selection of the NLEM to help Thailand achieve universal health coverage. Nevertheless, various challenges exist and need to be addressed.

    Matched MeSH terms: Drug and Narcotic Control/methods*
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