Displaying all 14 publications

  1. Yap YY, Wong CP, Lee KS, Ming LC, Khan TM
    Ther Innov Regul Sci, 2017 Jul;51(4):446-459.
    PMID: 30227055 DOI: 10.1177/2168479017697253
    This article aims to discuss the main consequences of the implementation of the Trans-Pacific Partnership Agreement (TTPA) in the pharmaceutical sector in regard to public health, focusing on the accessibility and affordability of medicines. This paper also looks at the likely impact of the TPP agreement on access to affordable medicines. The potential effects of provisions in the final text are explored based on the context of developed and developing countries. A meta-synthesis study design was used. The thematic analysis technique was used to generate themes and a decision tree of the TTPA meta-synthesis. PubMed, EBSCOhost, Ovid, and Scopus databases from inception until the first week of January 2016 were used. Only peer-reviewed journals that discussed TPPA's impact on the pharmaceutical sector were included. Data were extracted by 2 reviewers and then verified by 3 senior researchers. The extracted data were imported into Excel spreadsheets and coded line by line. Codes were organized into descriptive themes. The identified themes were cross-checked against original articles to ensure consistency. A total of 85 full articles and reports were reviewed and, finally, 32 of them were used in the meta-synthesis. Two central themes to the TTPA emerged: intellectual property rights and transparency. Five subthemes were identified under intellectual property rights: patent subject matter (representing scope of patentability), patent term adjustment for patent office delays (representing patent term extension), protection of undisclosed test or other data (representing data exclusivity), protection of undisclosed test or other data (representing patent linkage), and compulsory licensing. Meanwhile, transparency and anti-corruption-procedural fairness, which presents restriction of coverage program and reimbursement, were identified as the subthemes of transparency. Findings indicate that the TPPA could potentially hinder the affordability and accessibility of medicine, which could increase risks to public health.
  2. Ting CY, Loo SC, Ting H, Ang WC, Jabar AHAA
    Ther Innov Regul Sci, 2017 Jul;51(4):439-445.
    PMID: 30227047 DOI: 10.1177/2168479017699531
    BACKGROUND: Compliance of community pharmacists (CPs) and private general medical practitioners (GPs) with Malaysian Laws on Poisons and Sale of Drugs is crucial in encouraging rational supply of medicine to patients that will subsequently lead to rational use of medicine, especially controlled medicine and psychotropic substances. This study aims to identify the trend of yearly compliance rate of both CPs and GPs with the Malaysian Laws on Poisons and Sale of Drugs, and to quantify the effectiveness of disciplinary actions in improving their compliance level.

    METHODS: This is a retrospective observation study from the Sarawak state Pharmaceutical Enforcement Division (PED) inspection reports on CPs and GPs from January 1, 2012, to December 31, 2014. Descriptive statistics in numbers and percentages are used to present the results.

    RESULTS: From years 2012 to 2014, the compliance rate of GPs increased from 34% to 51%, while the compliance rate of CPs remained almost constant, with a slight drop from 53% (2012) to 50% (2014). The most common noncompliance found among CPs is with the Poison Acts 1952 Section 26 Condition 2: "Records for the supply of preparations containing Pseudoephedrine, Ephedrine and Dextromethorphan," and among GPs, it is the Regulation 12 of Poisons Regulation 1952: "labeling of dispensed medicines." Warning letter is the most effective disciplinary action for both CPs (75% improvement) and GPs (67.8% improvement).

    CONCLUSION: This study serves as a baseline that provides valuable insights to policy makers, researchers, and other stakeholders in developing better enforcement strategies.

  3. Ming LC, Hameed MA, Lee DD, Apidi NA, Lai PSM, Hadi MA, et al.
    Ther Innov Regul Sci, 2016 Jul;50(4):419-426.
    PMID: 30227023 DOI: 10.1177/2168479015624732
    BACKGROUND: Handheld computers (HHCs) such as smartphones and tablets are providing a variety of drug information (DI) applications to assist pharmacists' decision making in the clinical and hospital setting. However, little is known about the extent of their use among Malaysian pharmacists. The current study aimed to assess the use of electronic DI resources via HHCs by pharmacists in Malaysia. This study also aimed to investigate the pharmacists' perception toward the DI content and functions of mobile medical applications.

    METHODS: A convenience sampling method was adopted to invite pharmacists (N = 450) working in various sectors such as hospitals, the drug approval authority, and academia to participate in this online survey. A 36-item questionnaire was administered, and data were summarized and presented using descriptive statistics.

    RESULTS: The response rate to this survey was 49.8% (n = 224). Overall, 213 respondents (95.1%) were active HHCs users in their daily clinical practice. About 194 respondents (86.6%) disclosed that they often use HHCs for searching DI. Dosage recommendations (n = 198; 88.4%), adverse drug reactions (n = 153; 68.3%), and drug interactions (n = 146; 65.2%) were the most common DI retrieved. Meanwhile, general dosage recommendation, pediatric dosage recommendations and dosage recommendations for renal failure were ranked as the most important DI in mobile medical applications. Gaining access to the latest information on drugs and clinical practice were regarded as the most important functions of the mobile medical app.

    CONCLUSIONS: The use of HHCs for DI among pharmacists in Malaysia was high. The use of locally produced DI sources is still low compared to overseas sources. The most popular applications used for drug-related medical information were Micromedex, followed by Lexicomp and Medscape.

  4. Apidi NA, Murugiah MK, Muthuveloo R, Soh YC, Caruso V, Patel R, et al.
    Ther Innov Regul Sci, 2017 Jul;51(4):480-485.
    PMID: 30227053 DOI: 10.1177/2168479017696266
    BACKGROUND: There is a need for a collation and comparison of the content of the mobile medical applications (apps) to allow health care professionals to know precisely which app they can rely on to gain access to appropriate drugs references. This study aims to evaluate the features of mobile medical apps based on 3 major functions: Dosage recommendation, drug adverse Reaction, And Drug Interaction (DoReADI).

    METHOD: A review and comparison of mobile apps available in Google's Play Store (Android system) and Apple's App Store (iOS system) were performed. The comparison was based on the availability of options, especially DoReADI functionalities. The assessment criteria were as follows: requirement for an Internet connection, subscription fee charged, size of app, dose recommendation, drug indication, dose calculator, drug picture, dose adjustment, pregnancy safety, interaction checker, interaction classification, clinical teaching advice, contraindicated drug, black box warning, adverse effect, contraindication or precaution, as well as toxicology and pharmacology information.

    RESULTS: Eight mobile medical apps were included and used to compare their features and functionalities. The 4 apps that scored the highest (14/17 points) are: Lexicomp®, Epocrates®, Micromedex®, and Drugs.com ®. Lexicomp and Micromedex do not provide the image of the drug and have an access subscription fee. Epocrates does not provide interaction classification and clinical teaching advice, and occupies a large space in the memory to be installed. Meanwhile, My Blue Book® scored the lowest (9/17 points) because certain features such as toxicology information, drug interaction, clinical teaching advice, contraindicated drug, and black box warning were not included.

    CONCLUSION: Based on the features assessment criteria of each mobile medical application, Lexicomp, Epocrates, Micromedex, and Drugs.com are the apps that scored the highest. Epocrates and Micromedex are useful for checking drug interactions. In addition, some of the apps have additional features for the DoReADI criteria, for example, dose calculator and interaction classification.

  5. Zainal INA, Karim NAA, Soh YC, Suleiman AK, Khan TM, Hameed MA, et al.
    Ther Innov Regul Sci, 2017 Jul;51(4):419-425.
    PMID: 30227049 DOI: 10.1177/2168479017701977
    The Internet and rapid development of technology has led to the application of pharmacoinformatic technologies in improving the efficiency of the medication use process. By integrating pharmacoinformatics in pharmacy education, a qualified workforce of pharmacists well trained in the perspective of both pharmacy practice and informatics for safe and positive health-related outcomes can be produced. This survey assessed the level of importance of the suggested topics for pharmacoinformatics courses for pharmacy bachelor's and master's degrees by giving a questionnaire to pharmacy lecturers in both public and private universities, and to pharmacists registered with the Ministry of Health, Malaysia. Briefly the study of pharmacoinformatics was classified into 5 major areas: Drug Information Services, Information Technology & Internet, Drug Formulary Management, Supply Chain Management, and Health Policy. The relative importance of all relevant topics were evaluated and reported. It was found that compared with the undergraduate level, master's degree had higher expectations, and thus a more in-depth pharmacoinformatics curriculum content. In addition, the experiential method of learning instead of formal lectures alone was used on pharmacy master's courses. The findings from this survey could serve as a guide to improve pharmacoinformatics curricula in order to produce pharmacists who can safely and effectively utilize pharmacy informatics to disseminate information in drug use.
  6. Khan TM, Emeka P, Suleiman AK, Alnutafy FS, Aljadhey H
    Ther Innov Regul Sci, 2016 Mar;50(2):236-240.
    PMID: 30227009 DOI: 10.1177/2168479015609648
    From inception, the health care system in Saudi Arabia has ensured the availability of health care facilities to its people. This article discusses the pharmaceutical pricing policies and the impact of health drug prices on the public in the Kingdom of Saudi Arabia. A review of government and Saudi Food and Drug Authority (SFDA) policy documents, guidelines, and articles published in PubMed and other indexed journals (N = 10) was performed to identify the relevant literature. Results showed that the government appears poised and focused on the availability of better health care facilities to the Saudi population. The pharmaceutical market in Saudi Arabia commands a large portion of the pharmaceuticals market share in the entire Middle East region. The government, through the SFDA, sets the prices of pharmaceutical products. There are occasional price variations, which are induced by a number of factors. However, because the Saudis enjoy free health care coupled with the recent introduction of a compulsory health insurance policy, the impact of price variation is not felt. In addition, the Saudis prefer using branded medicines. The SFDA plays a major role in price regulation by setting up rules for pharmaceutical product pricing. However, there appears to be little or no impact of pharmaceutical price variation in Saudi Arabia because of better earning power among the population and free health care access to public health facilities.
  7. Khan TM, Emeka P, Khan AH
    Ther Innov Regul Sci, 2013 Mar;47(2):198-202.
    PMID: 30227531 DOI: 10.1177/2168479012462214
    Providing drug information has become one of the essential job functions of a community pharmacist. To ensure the availability of up-to-date information, pharmacists should have access to reliable drug information. The current study was an effort to explore the use of drug information resources at a community pharmacy in Penang Island, Malaysia. This study also explores nonprescription requests, with a special emphasis on pharmacists' agreement to dispense medicines without a prescription. A cross-sectional study was performed among the community pharmacists practicing in 3 populous areas of Penang Island. Face-to-face interviews were conducted using a 24-item questionnaire. The response rate was 67.3%. Online drug information, compared with other resources, was preferred by a majority of pharmacists (n = 19, 51.4%). Of the pharmacists, 28 (75.7%) mentioned that patients often make a nonprescription drug request for anti-inflammatory agents, painkillers, and medicines for cough and flu. In about 59.5% of the cases, pharmacists dispensed the requested medicine without question. Most of the pharmacists stated they have dispensed painkillers, creams and ointments, antifungals, body tonics, and inhalers without prescription.
  8. Khoo YSK, Tang TY, Goh PS, Halimi HM, Ab Ghani A
    Ther Innov Regul Sci, 2017 Jan;51(1):55-59.
    PMID: 30236002 DOI: 10.1177/2168479016664774
    BACKGROUND: Because of its structure and complex manufacturing process, every biotherapeutic product (BTP; medicinal products made by or derived from living organisms and produced by biotechnology) adheres to stringent quality assurance and control requirements, in addition to extensive nonclinical and clinical study data. Similarly, copy products of original biotherapeutics (termed as "biosimilars") are subjected to equally strict regulatory control. BTPs have been registered in Malaysia since the 1990s; however, registration of biosimilars started only in 2008.

    METHODS: This research aims to compare evaluation practice on biosimilar and novel BTPs at the Biological Product Registration Section in Malaysia. Evaluation activities were studied in terms of evaluation questions, evaluation timeline, nonclinical and clinical requirements, and local requirements on product label (including package insert). Six biosimilar product dossiers and 6 novel BTP dossiers evaluated in 2013-2015 were sampled. Parameters for comparison were determined and analyzed using data collection forms. Specific to the biosimilar products, the evaluation practice on labels and package inserts were dissected and described in a qualitative arm of this research.

    RESULTS: Generally, the registration requirements of novel BTPs and biosimilar products are in agreement with international regulatory practices. However, some labeling and package insert requirements, and registration conditions are unique to the Malaysian regulatory context.

    CONCLUSIONS: Study findings revealed some similarities and differences in current evaluation practice (timeline and requirements) for biosimilar versus novel BTPs. The findings of this research also provide an insight on current evaluation practice on biosimilar product labeling.

  9. Ting CY, Abd Wahab MS, Lee KS, Tan RT, Ming LC
    Ther Innov Regul Sci, 2017 Mar;51(2):212-220.
    PMID: 30231729 DOI: 10.1177/2168479016674041
    BACKGROUND: Because of the large size of Sarawak and the high proportion of people residing in rural areas in this Malaysian state, disseminating drug-related information there can be challenging. It is, therefore, important to recognize the type of mass media for drug-related information that are salient to the people of Sarawak. This study was aimed at identifying the use of and the preferences for mass media to obtain drug-related information among the public in Sarawak. We also aimed to recognize the media perceived as the most reliable for drug-related information.

    METHODS: This was a cross-sectional study using a self-administered questionnaire carried out from September to October 2013. Survey respondents were recruited from 4 divisions in Sarawak: Kuching, Sibu, Miri, and Bintulu.

    RESULTS: A total of 433 completed questionnaires were obtained at the end of the study period. All respondents had access to common mass media such as television (89.8%, 389/433), radio (68.6%, 297/433), and the Internet (66.1%, 286/433). Among all respondents, television (71.4%, 309/433) was noted as the most preferred media for drug-related information. Compared with rural respondents, urban respondents were significantly more likely to have access to and prefer the Internet to obtain drug-related information. On the other hand, rural respondents were more likely to have access to and prefer radio for such information compared to their urban counterparts.

    CONCLUSIONS: Television can be an important and attractive choice of mass media in a quality use of medicines (QUM) campaign. The Internet can be used to disseminate drug-related information in urban areas, whereas radio can be used in a QUM campaign targeting the rural public.

  10. Wong ZY, Alrasheedy AA, Hassali MA, Saleem F
    Ther Innov Regul Sci, 2017 Mar;51(2):221-223.
    PMID: 30231714 DOI: 10.1177/2168479016680256
    In Malaysia, the goods and services tax (GST) was implemented in 2015. Within this context, medicines are subjected to GST. However, essential medicines are exempted. In fact, exempting essential medicines from tax is in line with the Malaysian National Medicines Policy which aims to promote equitable access to affordable essential medicines of good quality to improve health outcomes of the people. The implementation of GST on medicines can generate a stable source of revenue for the nation. However, there are some ways/actions that could be considered to ensure the affordability and accessibility of all medicines post-implementation of GST in Malaysia.
  11. Uyama Y, Yamazaki E, Clark K, Wang CY, Woro E, Tong FY, et al.
    Ther Innov Regul Sci, 2015 Mar;49(2):249-253.
    PMID: 30222411 DOI: 10.1177/2168479014551646
    In response to the globalization of drug development, regulatory inspection of Good Clinical Practice (GCP) has recently been conducted not only by International Conference on Harmonisation (ICH) regions but also non-ICH regions. To promote the international implementation of GCP, consistent understanding and interpretation of its concept among regions are important. This article summarizes the background and past activities of the E6 Discussion Group, established under the Regulators Forum.
  12. Morse SS, Murugiah MK, Soh YC, Wong TW, Ming LC
    Ther Innov Regul Sci, 2018 05;52(3):383-391.
    PMID: 29714538 DOI: 10.1177/2168479017725557
    BACKGROUND: Despite the surge in mobile health (mHealth) applications (apps) about pediatric care in commercial app stores, to our knowledge, reviews of the quality of such apps are lacking. Consequently, it is a great challenge for health care professionals (HCPs) to identify appropriate and reliable mHealth apps for delivering health care services. Thus, we performed a structured review of the extant literature about mHealth apps in pediatric care and quality assessment of selected apps found in commercial app stores.

    METHODS: A review and comparison of mHealth apps in pediatric care found in Google's Play Store (Android system) and Apple's App Store (iOS system) were performed. For the structured review of the available literature, Google Scholar, PubMed, IEEE Xplore Digital Library, and Science Direct online databases were used for the literature search. The assessment criteria used for comparison included requirement for Internet connection, size of application, information on disease, diagnostic tools, medical calculator, information on disease treatments, dosage recommendations, and drug interaction checker.

    RESULTS: Fifty mHealth apps for general pediatric care and 8 mHealth apps for specific pediatric diseases were discussed in the literature. Of the 90 mHealth apps we reviewed, 27 that fulfilled the study criteria were selected for quality assessment. Medscape, Skyscape, and iGuideline scored the highest (score=7), while PediaBP scored the lowest (score=3).

    CONCLUSIONS: Medscape, Skyscape, and iGuideline are the most comprehensive mHealth apps for HCPs as quick references for pediatric care. More studies about mHealth apps in pediatric care are warranted to ensure the quality and reliability of mHealth apps.

  13. Anthony Berauk VL, Murugiah MK, Soh YC, Chuan Sheng Y, Wong TW, Ming LC
    Ther Innov Regul Sci, 2018 05;52(3):374-382.
    PMID: 29714532 DOI: 10.1177/2168479017725556
    BACKGROUND: Mobile devices and applications (apps) that act as access tools for health care management aid in the improvement of clinical decision making and patient outcomes. However, the tremendous amount of mobile health (mHealth) apps available in commercial app stores makes it hard for the lay users as well as health care professionals to choose the right one for their individual needs. The contents and features of these apps have not been systematically reviewed and compared. This study aims to assess the contents and features of mHealth apps for caring of older people.

    METHODS: A review and comparison of mHealth apps for caring of older people available in Google's Play Store (Android system) and Apple's App Store (iOS system) were performed. Systematic review of previous relevant literature were conducted. The assessment criteria used for comparison were requirement for Internet connection, information of disease, size of app, diagnostics and assessment tools, medical calculator, dosage recommendations and indications, clinical updates, drugs interaction checker, and information on disease management.

    RESULTS: Twenty-five mHealth apps were assessed. Medscape and Skyscape Medical Library are the most comprehensive mHealth apps for general drug information, medical references, clinical score, and medical calculator. Alzheimer's Disease Pocketcard and Confusion: Delirium & Dementia: A Bedside Guide apps are recommended for clinical assessment, diagnosis, drug information, and management of geriatric patients with Alzheimer disease, delirium, and dementia.

    CONCLUSIONS: More studies about mHealth apps for caring of older people are warranted to ensure the quality and reliability of the mHealth apps.

  14. Hariraj V, Aziz Z
    Ther Innov Regul Sci, 2018 11;52(6):757-763.
    PMID: 29714567 DOI: 10.1177/2168479017745025
    BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs.

    METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting.

    RESULTS: Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1).

    CONCLUSIONS: Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.

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