Term of References
“The Importance of Big Data in Improving the Quality of Healthcare” vol. II
Applying Real World Data and Real-World Evidence to Improve the Quality of Healthcare: Experience, Challenges, and Future Directions
Online Zoom Meeting and Youtube Livestreaming
Saturday, 23 January 2021, 14.55 – 17.15 WIB (GMT+7)
Background
The utilization of digital technology in healthcare is increasing. In the healthcare provider standpoint, there has been a higher application of electronic medical records along with electronic prescribing by healthcare facilities. In the meantime, healthcare users have been using various apps from various gadgets through their mobile networks to access healthcare. Electronic health data transactions, including data collection regarding drug types, doses, and quantities dispensed to patients or health consumers will be increasing along with the improvement in digital infrastructure, technology adoption, and more supportive regulation.
In this context, the concepts of real-world data (RWD) and real-world evidence (RWE) have become the new paradigm in healthcare practice. The Food and Drug Administration (FDA) has published the Framework for FDA’s Real-World Evidence Program (2018), in which RWD is defined as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”. Meanwhile, RWE is defined as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD”. In this framework, FDA describes the use of RWD and RWE in generating health information data and evidence to be utilized by regulators. Furthermore, this document also explains the framework to evaluate RWD and RWE, including electronic data sources, study designs using RWD sources, regulatory considerations, and data standard.
There have been good examples of the use of RWD/RWE for improving healthcare. One of them is the utilization of UK CPRD database to inform clinical practice and decisions regarding healthcare, including treatment guideline development, drug reimbursement and pricing decisions, vaccination program monitoring, pharmacovigilance, and improvement of GP quality of care by generating prescribing reports for individual GP practice.
These are important questions to be addressed: What are best practices that we can obtained from experience in using UKD CPRD database for improving healthcare? How are the practices of RWD and RWE in Indonesia? How far these practices are managed and established? What are the roles of regulators in supporting the practice of RWD and RWE as one of the components to support the effort in improving the quality of healthcare?
These questions will be discussed in this webinar, where speakers are representatives from UK MHRA, and from the hospitals applying electronic medical records, electronic prescribing, and patient registries with available data that have been used by clinicians. A discussion about “Better Financing, Better Health” will also be given by the Center for Health Financing Policy and Health Insurance, Secretariat General, Ministry of Health, Indonesia.
Topic of the Meeting
Topic: “The Importance of Big Data in Improving the Quality of Healthcare” volume II
Subtopic: Applying Real World Data and Real-World Evidence to Improve the Quality of Healthcare: Experience, Challenges, and Future Directions
Participants
- Staffs from the Ministry of Health (from several Directorates)
- Staffs from BPJS Kesehatan (Healthcare and Social Security Agency)
- Staffs from Badan POM (Indonesian FDA)
- Organizers and members of PERSI (Indonesian Hospital Association)
- Members of IDI (Indonesian Medical Doctor Association)
- Members of IAI (Indonesian Pharmacist Association)
- Academia
- Organizers and Members of IPMG (International Pharmaceutical Manufacturers Group)
- Organizers and Members of GP Farmasi (National Association of Local Pharmaceutical Manufacturer Companies)
- Other participants
Agenda
| Time | Topic | Speaker |
| 14.55 – 15.00
(5’) |
Opening | The Head of Department of Pharmacology, Faculty of Medicine, Nursing, and Public Health, Universitas Gadjah Mada |
| 15.00 – 15.30
(30’) |
The use of RWD and RWE for improving healthcare
|
Eleanor L. Axson, MPH, PhD
CPRD, The Medicines & Healthcare products Regulation Agency, UK |
| 15.30 – 15.45
(15’) |
Discussion (session 1) | Moderator:
dr. Alfi Yasmina, M.Kes., M.M.Ed, Ph.D. Faculty of Medicine, Universitas Lambung Mangkurat |
| 15.45 – 16.00
(15’) |
Clinical – Electronic Medical Record
|
dr. Yohanes Yanson Purnawan, MARS
Sanglah Hospital |
| 16.00 – 16.15
(15’) |
Electronic prescribing | Yustika Novianti, Apt, MPH
Dr. Cipto Mangunkusumo Hospital |
| 16.15 – 16.30
(15’) |
Stroke Registry
|
Dr. dr. Rizaldy Taslim Pinzon, Sp.S, M.Kes
Bethesda Hospital |
| 16.30 – 16.45
(15’) |
Better Financing Better Health
|
dr. Kalsum Komaryani, MPPM
Head of Center for Health Financing and National Health Insurance, Ministry of Health, Indonesia |
| 16.45 – 17.15
(30’) |
Discussion (session 2) | Moderator:
Anis Fuad, S.Ked, DEA Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada |
