The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

BACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. METHODS: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). RESULTS: Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. CONCLUSIONS: As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.Peer reviewedFinal Published versio

Interpretasi Efikasi Obat Dalam Pengobatan Anak Dengan Infeksi Saluran Pernafasan Atas Di Depok, Indonesia

ISPA (Infeksi Saluran Pernafasan Akut) adalah (Acute Respiratory Infection) salah satu penyakit utama pada anak. Pada umumnya perilaku pencarian pengobatan untuk ISPA berakhir dengan penggunaan obat. Efikasi obat tidak hanya merupakan pengetahuan medis tetapi merupakan konstruksi budaya. Penelitian dilakukan untuk memahami bagaimana obat diinterpretasikan oleh orang awam di wilayah kumuh perkotaan. Penelitian dilakukan pada bulan Oktober 2009 di sebuah komunitas pemulung yang tinggal di kota Depok. Data dikumpulkan dengan melakukan wawancara mendalam terhadap 20 orang ibu yang memiliki Balita dengan gejala ISPA dalam waktu paling lama sebulan sebelum penelitian dilakukan. Informan diwawancarai mengenai pengalaman dalam menangani Balita dengan gejala ISPA, pengobatan yang dilakukan dan bagaimana mereka mengevaluasi obat yang digunakan. Hasil menunjukkan bahwa dalam menghadapi Balita ISPA, para ibu melakukan pengobatan sendiri, membawa anak ke Puskesmas atau praktek swasta yang semuanya berujung pada penggunaan obat. Istilah “cocok” merupakan kata kunci dalam mengevaluasi efikasi dan kompatibilitas obat

Impact of Universal Health Insurance Coverage in Thailand on Sales and Market Share of Medicines for Non-Communicable Diseases: an Interrupted Time Series Study

Objective: In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes. Design: Interrupted time-series design, with a non-equivalent comparison group. Setting: Thailand, 1998–2006. Data: Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006. Intervention: UCS implementation, April–October 2001. Outcome measures Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status. Results: The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors. Conclusions: Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed

Exploring the implementation of the school-based mental health program for adolescents in Indonesia: A mixed-methods study

Background: Mental health issues among adolescents have become a public concern in Indonesia. The Indonesian government introduced the School-Based Mental Health (SBMH) program in 2017 and has implemented it in all public junior high schools in Jakarta. However, there is a relative scarcity of evidence regarding how schools have implemented the SBMH. Objective: This study aimed to explore the SBMH program and its implementation in public junior high schools. Methods: Mixed methods were employed in 12 public junior high schools (6 from East Jakarta and 6 from West Jakarta) using a purposive sampling method from May 6 to August 30, 2021. Descriptive statistics and content analysis were applied to the data analysis. Results: The main inhibiting factor for the implementation of the SBMH program was the school curriculum. Schools that received the Health School Award had more trained teachers to facilitate the SBMH program compared to schools without the award. Consequently, schools with the award successfully implemented regular mental health education in the classroom, screening, and counseling for students with mental health issues more effectively than schools without the award. Conclusion: The government should gradually strengthen resources to facilitate the SBMH program in the long term. In the short and medium term, the government should develop a collaboration network by supporting external mental health providers, professionals, and counselors

Promoting Quality Use of Medicines in South-East Asia: Reports from Country Situational Analyses

Irrational use of medicines is widespread in the South-East Asia Region (SEAR), where policy implementation to encourage quality use of medicines (QUM) is often low. The aim was to determine whether public-sector QUM is better in SEAR countries implementing essential medicines (EM) policies than in those not implementing them

Introduction

As waves of emerging and re-emerging diseases send repercussions around the world time and again, the global community has come to realize the interconnectedness of our world, of its countries, peoples, and activities. Today, what happens in one place can have an impact far beyond the boundary of a geographical locale. The world community pulls together to examine the many interrelated factors causing epidemics that are difficult to contain, and to re-examine old issues in a new light. Medici..

Drug Regulation and Incentives for Innovation: The Case of ASEAN

The focus of this paper is to examine the ways in which regulatory framework affect the pharmaeutical innovations in developing countries using member countries of the Association of South-east Asian Nations (ASEAN) as case study. The paper employs a wide angle view of drug regulation in the region whose members possess varying levels of research and development capacities, supplemented by a zoomed view using data from Thailand where more detailed data are available to author. Data collection relied mainly on review of documents from various sources. Interviews and personal communication were carried out for added information and deeper understanding.data collection, pahrmaceutical innovations, developing countries, thailand, interviews, personal communications, risk management, drug regulation, research, ASEAN, south east, asia, nations,

The State of Medicine Quality in the Mekong Sub-Region

This study aims to increase awareness and interest on the pharmaceutical quality and counterfeit medicines issues in the Mekong Subregion. It provides a review of existing empirical findings regarding the state of medicine quality in the region. It also analyzes data on quality testing of drug samples from the five countries (Cambodia, China, Lao PDR, Thailand and Vietnam) in the region, in order to develop a conceptual framework for addressing the issue at the regional level, and to suggest areas for further study