An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

INTRODUCTION: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements. 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.

Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

The authors have revised Figure 1. The revised figure is presented below.

Prescribing patterns for upper respiratory tract infections: a prescription-review of primary care practice in Kedah, Malaysia, and the implications.

INTRODUCTION AND AIMS: It is necessary to ascertain current prescribing of antibiotics for upper respiratory tract infections (URTIs) to address potential overuse. A retrospective analysis was conducted of all prescriptions for URTIs among 10 public primary healthcare centers in Kedah, Malaysia, from 1 January to 31 March 2014. RESULTS: A total of 123,524 prescriptions were screened and analyzed. Of these, 7129 prescriptions were for URTI, with 31.8% (n = 2269) containing antibiotics. Macrolides were the most commonly prescribed antibiotic, constituting 61% (n = 1403) of total antibiotics prescribed. There was a statistically significant association between different prescribers and diagnoses (p = 0.001) and a weak positive trend suggesting family medicine specialists are more competent in antibiotic prescribing, followed by medical officers and assistant medical officers (τ = 0.122). CONCLUSIONS: Prescribing practices of some prescribers were inconsistent with current guidelines encouraging resistance development. National antimicrobial stewardship programs and further educational initiatives are ongoing in Malaysia to improve antibiotic use.

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

Pharmaceutical care issues identified by pharmacists in patients with diabetes, hypertension or hyperlipidaemia in primary care settings.

BACKGROUND: The roles of pharmacists have evolved from product oriented, dispensing of medications to more patient-focused services such as the provision of pharmaceutical care. Such pharmacy service is also becoming more widely practised in Malaysia but is not well documented. Therefore, this study is warranted to fill this information gap by identifying the types of pharmaceutical care issues (PCIs) encountered by primary care patients with diabetes mellitus, hypertension or hyperlipidaemia in Malaysia. METHODS: This study was part of a large controlled trial that evaluated the outcomes of multiprofessional collaboration which involved medical general practitioners, pharmacists, dietitians and nurses in managing diabetes mellitus, hypertension and hyperlipidaemia in primary care settings. A total of 477 patients were recruited by 44 general practitioners in the Klang Valley. These patients were counselled by the various healthcare professionals and followed-up for 6 months. RESULTS: Of the 477 participants, 53.7% had at least one PCI, with a total of 706 PCIs. These included drug-use problems (33.3%), insufficient awareness and knowledge about disease condition and medication (20.4%), adverse drug reactions (15.6%), therapeutic failure (13.9%), drug-choice problems (9.5%) and dosing problems (3.4%). Non-adherence to medications topped the list of drug-use problems, followed by incorrect administration of medications. More than half of the PCIs (52%) were classified as probably clinically insignificant, 38.9% with minimal clinical significance, 8.9% as definitely clinically significant and could cause patient harm while one issue (0.2%) was classified as life threatening. The main causes of PCIs were deterioration of disease state which led to failure of therapy, and also presentation of new symptoms or indications. Of the 338 PCIs where changes were recommended by the pharmacist, 87.3% were carried out as recommended. CONCLUSIONS: This study demonstrates the importance of pharmacists working in collaboration with other healthcare providers especially the medical doctors in identifying and resolving pharmaceutical care issues to provide optimal care for patients with chronic diseases.

Estimating an EQ-5D value set for Malaysia using time trade-off and visual analogue scale methods.

OBJECTIVES: To estimate a EQ-5D value set for Malaysia by using time trade-off (TTO) and visual analogue scale (VAS) valuation methods. METHODS: TTO and VAS valuations were obtained from face-to-face surveys of a convenience sample of patients, caregivers, and health professionals conducted at nine government hospitals in 2004 and 2005. Forty-five EQ-5D questionnaire health states were valued, divided into five sets of 15 health states. Analysis was conducted by using linear additive regression models applying N3 and D1 specifications. Model selection was based on criteria of coefficient properties, statistical significance, and goodness of fit. RESULTS: One hundred fifty-two respondents were interviewed, yielding 2174 TTO and 2265 VAS valuations. Respondents found TTO valuations to be more difficult than VAS valuations, and there were more inconsistencies in TTO valuations. All the independent variables in the models were statistically significant and consistent with expected signs and magnitude, except for the D1 specification modeled on TTO valuations. The N3 model provided the best fit for the VAS valuation data, with a mean absolute error of 0.032. CONCLUSION: This study provides a Malaysian EQ-5D questionnaire value set that can be used for cost-utility studies despite survey limitations.