| 4. In which ways is the initiative creative and innovative?
Strategic Element 1: Hearings, Public Consultations, Legal and Policy Change
A series of nationwide consultations were needed to create the legal and policy foundation for DUR.
•A 2002 study provides for the first time in Korea evidence of problems in prescription and dispensing practices. The controlled research study utilized a basic automated system to assess nearly 8 million prescriptions. They found that 5% of drugs were prohibited or improperly prescribed.
•In September 2003, the Ministry of Health, HIRA, and the MFDS launched a series of consultations and public hearings. Key groups involved were medical associations, academic experts, government agencies, as well as the Federation of Green Consumers – an alliance of 10 consumer advocacy groups.
•In December 2003, an administrative regulation introduced by MOHW provides the basis for DUR.
•MOHW also mandates the creation of a DUR committee. This committee held 10 meetings in 2004, 5 meetings in 2005, and in 2006 completed their mission.
•In September 2005, MOHW assigns HIRA the responsibility to evaluate drug prescriptions and link it to insurance reimbursements.
•In October 2006, National Assembly mandates HIRA to develop a system to prevent prescriptions of prohibited drugs and therapeutic duplication.
Strategic Element 2: Design and Implementation of DUR System
2004-2005 – Assessment and development of list of prohibited drugs and ingredients
•In January 2004, the MFDS assesses and develops for the first time comprehensive list of prohibited items and contraindications for drugs. This document is published by the MOHW and shared nationwide with healthcare providers.
•In August 2004, HIRA tests for the first-time a basic automated system based on the list to check prescriptions. The automatic system checks resulted in a 50% improvement in detection of drug safety problems. Provides further evidence for a comprehensive nationwide system.
2007-2008: Leadership and strategic guidance from DUR taskforce
•The DUR task force develops strategy for DUR that is based on the fundamental objective that the system must prevent drug prescribing and dispensing problems and not just detect them after they occur.
•In September and October 2007, DUR task force convenes a series of consultations with major medical and consumer groups.
•DUR taskforce gathers the key information on technical requirements, specifications, and challenges to implement DUR in healthcare facilities nationwide.
•Following discussions, DUR task force and medical groups agree to conduct first phase of project.
•In June 2008, HIRA begins informational sessions with stakeholder groups to explain the rationale and legal basis for the DUR, the DUR system, and what the prescription practice will be like in the future.
Strategic Element 3: Pilot project to Nationwide Expansion
•In November 2008, HIRA launched pilot projects on Jeju island (pop. 560,000) and Goyang City (pop. 938,000) to implement a basic DUR system.
•HIRA staff conducted training workshops in Goyang and Jeju for doctors, pharmacists, associations, medical staff.
•After successful testing and implementation in pilot areas, HIRA staff provided over 600 training workshops in over 16 provinces and all general hospitals in Korea.
•In November 2010, the DUR system was scaled-up to the national level covering over 85,000 healthcare facilities and approximately 48 million citizens.
Strategic Element 4: DUR Service Established and Ongoing Activities
•DUR is firmly established as a HIRA service and system is maintained and updated as new drug safety changes are made.
•In 2011, a survey of general public found low awareness of DUR system. HIRA subsequently launched a consumer campaign promoting DUR through advertisements in public spaces (buses, subway) as well as media (TV, radio).
•In 2011, the DUR smartphone application was launched that allows patients to access their personal drug history and safety information.
| 5. Who implemented the initiative and what is the size of the population affected by this initiative?
The design and implementation of the DUR initiative was primarily carried out by the following entities:
•HIRA: HIRA personnel were involved in the DUR initiative at three levels: 1) the DUR task force – senior HIRA officials provided leadership, strategic guidance, and oversight, 2) HIRA high-level DUR committee – senior representatives of each department ensured that full range of expertise and consistency in creation of DUR system and implementation, 3) DUR implementation – HIRA operational staff were responsible for creating of DUR system and implementing it nationwide. Currently, a DUR department is integrated into HIRA as permanent public service.
•MOHW – The Ministry of Health and Welfare was a major stakeholder in providing the political leadership to initiate the creation of the DUR system, including convening major stakeholders to establish legal and policy foundation for DUR system and granting HIRA the necessary authority for regulation and compliance.
•During the implementation of the initiative, members of the MOHW served in the DUR task force.
•MOHW currently provides high-level oversight and monitoring of DUR. HIRA reports to the MOHW regularly on DUR activities and updates and holds an annual meeting for comprehensive reporting.
•Ministry of Food and Drug Safety – The Ministry of Food and Drug Safety provides high-level and technical guidance e.g. specific items to be covered in database (drugs, ingredients), and ensures that DUR system is comprehensive, consistent, and compliant with drug safety regulations.
Other stakeholders groups such as the major medical associations and consumer groups were involved through continual consultations. However, they did not directly participate in the design or implementation of DUR.
| 6. How was the strategy implemented and what resources were mobilized?
The initial investment for the activities related to the design and pilot the DUR system was approximately $3 million. The operation and maintenance of the DUR system itself is approximately $5 million annually.
As mandated by law, the funding for the DUR initiative was mobilized through the National Health Insurance Service, which generates its fees through payments of health insurance premiums. The DUR department and system is a permanent category of the annual budget for HIRA.
In 2013, major expenditures included approximately:
DUR software system and support: $2.5 million
Promotion, training, information sessions: $600,000
External technical support: $500,000
Hardware maintenance and miscellaneous expenditures- $1.5 million
In 2009 during the initial stages of implementation, there were 9 full-time HIRA staff dedicated to DUR. Currently, the DUR department is staffed with 20 full time employees.
| 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
Overall, the DUR system is able to successfully protect the safety of the general Korean population due the highly comprehensive, robust, and secure DUR IT infrastructure. Both the DUR database and DUR software program have to be stable and reliable for the DUR service to function.
1)Comprehensive database of 27,000 drugs and 35,000 items.
A critical feature of the DUR database is the comprehensive inclusion of the vast majority of drugs and active ingredients available in Korea that must be scanned and cross-checked for contraindications. The basic database began only drugs, but experts felt that unsafe interactions among ingredients also needed to be assessed. The dual inclusion of drugs and ingredients further increases the safety for patients.
2)85,000 health facilities and 48 million citizens in DUR system. One of the most unique and impressive features of DUR is its coverage of 99% of healthcare facilities and nearly the entire Korean population. DUR includes the prescription histories of nearly 48 million citizens. This translates to nearly 1.1 billion prescription checks (at provider and pharmacy level) annually and 90 million prescriptions a month!
3)Immediate adjustments to DUR system following Korean MFDS regulatory changes.
The DUR system ensures that delays in awareness and implementation of new drug regulatory guidelines are reduced or nonexistent. In the past, healthcare providers and pharmacists had to wait to receive notification from the Korea MFDS or had to actively inquire about regulatory changes. Moreover, there was little guarantee that providers would comply (unintentionally or intentionally) would new regulations
4)Real-time alert system to catch medical errors within 0.5 seconds. The real-time alert system is a highly important feature of DUR as the main objective of the system was to prevent errors before the patient left the doctor’s office or received the drug. Currently, 99% of the DUR review is done on a real-time basis. This feature of DUR required sophisticated technology and a robust IT system that was compatible with existing IT infrastructure in the hospital.
5)Highly secure system with backup capability.
Given the sensitive nature of patient medical information, the DUR system has to have advanced security features in place to prevent data breeches and hacking. Protection of patient privacy and data is paramount, particularly in light of the fact that nearly the drug and demographic history of nearly the entire Korean population is stored.
| 8. What were the most successful outputs and why was the initiative effective?
The inter-departmental DUR committee met on a quarterly basis to assess the progress of DUR development and implementation. This committee oversaw the rollout of the DUR system and guided adjustments to the design and implementation based on feedback from HIRA staff, consultations, and training workshops. They ensured that the project was within budget and fulfilled each of the DUR features as recommended by the DUR task force. HIRA leadership in turn reported to the Ministry of Health and Welfare regarding the strategy of DUR for which it received approval and progress on the rollout.
Reports on the implementation of DUR service included key activities and indicators such as:
-# of drugs and items included in database
- progress on migration of drug and ingredient information (percentage of all drugs to be included)
- # of healthcare facilities that have received informational sessions
-# of healthcare facilities with DUR programs installed
-# of patients with information in DUR database
- identification of DUR process or database problems and recommendations for improvements.
Currently, a dedicated DUR department at HIRA continues to ensure that the system is maintained, up-dated with new drug information, and improved with new features that better serve the hospital providers and staff. An external medical ombudsman also conducts bimonthly monitoring to ensure that the DUR database reflects the most up-to-date list of prohibited medicines, changes in drug safety regulation, and discusses concerns only newly identified risks.
The Ministry of Health and Welfare provided high-level oversight and monitoring during the implementation of the initiative and continues to do so as a regular function of HIRA. HIRA reports on annual basis to the MOHW on the activities and evaluates the major results of DUR findings.
| 9. What were the main obstacles encountered and how were they overcome?
There were two obstacles that posed severe challenges to the very existence and functionality of the DUR system.
Extreme Opposition and Legal Challenge by the Medical Establishment
During the consultations in 2006, the medical establishment strongly felt that the DUR system was a threat to their clinical authority and judgment.
When the National Assembly passed the law mandating that all healthcare providers must use the DUR system by 2010, the Korean Doctor’s Association medical association brought the matter to the Supreme Court. They argued that the DUR system threatened their professional authority, judgment, and autonomy. The Constitutional Court upheld the law and ruled in favor of the Government to implement DUR to protect the health and safety of Korean citizens. The Court recognized the DUR system as not a replacement of clinical judgment but as a safety check where errors or misuse can occur.
Subsequently, HIRA undertook an active campaign work with the medical establishment to explain the value of DUR to healthcare providers, listen to their feedback and concerns, and incorporate their recommendations to the system.
Skepticism regarding real-time solution within HIRA
Within HIRA, there was strong opposition and skepticism regarding the technological feasibility of real-time alerts to catch prescription error. It was difficult to motivate resources and commitment for the real-time functionality as many felt that it would be impossible.
However, the DUR task force was committed to the idea of real-time alerts and intensified efforts to achieve it. Through close cooperation between the DUR task force, HIRA staff, medical professionals and IT specialists, the real-time alert system became a reality and huge achievement. Moreover, technological advances in broadband capability at the time created the right conditions for a real-time system.