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.
METHODS: All new pharmaceutical products approved between January 2015 and March 2021 were examined (n = 136) using publicly available information. Factors associated with drug approval lag were determined using multiple linear regression.
RESULTS: The median drug approval lag was 855 days. Drug approval lag was associated with drug characteristics and regulatory factors. Median submission lag and median review time for products which fulfilled the requirement for the new regulations (Conditional Registration/ Facilitated Registration Pathway) were shorter compared to products which did not fulfil the requirement.
CONCLUSION: Drug approval lag may delay the access of innovative medicine to patients, and this may lead to an increase in morbidity, mortality and healthcare costs. Good Regulatory Practices ensure efficient and transparent regulatory system which support the public health policy objectives in the most efficient way. The new regulations in Malaysia reduced the median submission lag and review time. The findings may be useful for regulators to consider for future policy development for medication access.
OBJECTIVES: We aimed to identify risk factors for allopurinol-induced SCARs and to assess their impact on fatality.
METHODS: Adverse drug reaction (ADR) reports with allopurinol as suspected drug were extracted from the Malaysian pharmacovigilance database from year 2000 to 2018. Multiple logistic regression analysis was used to identify significant predictors of allopurinol-induced SCARs. We further analysed the association between covariates and SCARs-related fatality in a separate model. Level of significance was set at p value
METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017.
RESULTS: In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses.
CONCLUSIONS: As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.
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.
METHODS: As one voice, 13 main industry associations under the umbrella of APAC sent joint letters to our National Regulatory Authorities (NRAs) with a call to maintain regulatory agility and consider new ways of working. Consequently, APAC surveyed its member associations to measure regulatory agilities implemented by the NRAs during 2020 and 2021 in view of the pandemic.
RESULTS: This paper reports progress in implementing regulatory agility, e.g. the number of economies that can accept electronic Certificate of Pharmaceutical Products (eCPP) has reached 100% for the economies that require CPP and more than 90% can waive onsite inspection in the presence of Good Manufacturing Practice (GMP) certificate and/or inspection report. The paper also features the progress made in Malaysia, the Philippines, and the ASEAN (Association of South East Asian Nations) regional reliance initiative to reduce inefficiencies and duplications.
CONCLUSIONS: We have demonstrated the power of working together to enable regulatory agilities and efficiencies. APAC will continue to track the progress of all economies including India within the areas for improvement prioritized and discussed in this paper. APAC is also committed to working with key stakeholders including our NRAs in Asia to sustain and enable a new era of innovation ushered in by COVID-19 to benefit patients.
METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.
RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.
CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.
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.
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.
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.
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.
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.