Korean Drug Utilization Review (DUR)
Health Insurance Review & Assessment

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
Safeguarding public health is a core responsibility and challenge of governments worldwide. In the early 2000s, a series of events and reports highlighted significant concerns regarding misuse or abuse in drug prescribing practices and use in South Korea and the need for improvement to ensure patient safety. Specifically, in 2003, the Government was catalyzed to action following the first ruling by Korea’s Supreme Court in favor of a patient who died because of excess prescription drug use. This case brought nationwide attention to this issue and the need for a concerted response by government, healthcare providers, and citizens to prevent future tragedies. A series of National Assembly hearings further reaffirmed the need to protect citizens and support medical professionals by preventing harmful prescription writing, dispensing, or use including: -Excess drug prescription or duplication -Adverse effects due to multiple drug interactions (drug-drug contraindications) or drugs that shouldn’t be taken if the patient has a particular disease (drug-disease contraindications) -Contraindications in pregnant women, children, and the elderly. South Korea has a robust system of excellent healthcare provided largely by private healthcare providers who ensure that the vast majority of prescription practices are appropriate and safe. They are supported by the Ministry of Food and Drug Safety (MFDS, formerly the Korean FDA), which reviews, regulates, and provides oversight for drug safety. However, prior to the initiative, the following conditions increased the potential for error in prescription writing, dispensing, and use: Fragmented Patient Drug History •In Korea, most patients do not have a sole primary care physician to which they consistently consult for their healthcare needs; instead many go to multiple doctors for each visit based on convenience or confidence in the provider’s diagnosis and treatment. •In particular, underprivileged populations like the elderly, disabled, or poor need or solicit greater drug treatment than the average population and will “shop around” for multiple providers. •There was no way for doctors or pharmacists to have a clear and accurate record of patient drug history; they had to rely on patient memory. Excessive Use •Global studies have shown higher rates of prescription drug use in Korea compared to the worldwide average. •Physicians often prefer to prescribe rather than withhold medication to be prudent and ensure that they are doing what is medically possible to treat a patient’s condition. •Doctors respond to pressure from patients who feel they have only been treated when prescribed one or more medications. Awareness of Safety Guidelines •A 2002 study that reviewed Drug Safety Standards based on US guidelines indicated that nearly 5% of drugs prescribed in South Korea had safety concerns. •Given the staggering number of drugs on the market, it was difficult to ensure that all doctors and pharmacists are up-to-date on the latest guidelines. •Although the MFDS issued drug warnings, the dissemination or implementation of the new guidelines could be delayed by several months or longer.

B. Strategic Approach

 2. What was the solution?
High-level political leadership and civil society played a critical role in spurring action to protect the health of Korean citizens. The Korean Ministry of Health and Welfare (MOHW) convened a series of hearings hosted at the National Assembly and created a task force of key stakeholders to gain a comprehensive understanding of the problem and recommend a course of action. This task-force proposed the creation of a Drug Utilization Review (DUR) System to be developed and implemented by HIRA in cooperation with key government agencies and stakeholders. The main objectives of the DUR system is to improve drug safety and prevent misuse and abuse of drugs by prescreening inappropriate use of drugs in prescription and dispensing. The target audience was doctors at the point of prescription writing, pharmacists at the point of prescription dispensing, and patients at the point of prescription use. The task-force mandated that DUR had to have the following features: •Comprehensive database of all MFDS FDA-approved drugs •Coverage of entire Korean population in DUR database •DUR system software to be used by all Korean healthcare facilities and pharmacies. •An alert system of contraindications for pregnant women, children, elderly. •The full prescription history of each patient that can be accessed by provider and patient •A real-time system of alerts that prevent errors both at the point of prescription writing and dispensing. •A database that is updated continuously and immediately when the MFDS issues new guidelines and safety warnings. •Security safeguards to protect sensitive patient information. The DUR system operates as follows: First Checkpoint 1)The doctor issues a prescription and enters the details into the DUR system through her computer, which includes the name of drugs, number of daily doses, administration methods, and number of prescription days. 2)This information is sent to HIRA to cross-check with its database which includes patient prescription history and potential contraindications. 3)If there is any problem in the prescription, the doctor will receive a warning message from HIRA on the computer screen within 0.5 seconds. Second Checkpoint 4)The patient visits the pharmacy with the prescription. The pharmacist similarly enters the details into her computer. 5)If there is warning message, the pharmacists checks with the doctor to dispense the prescription as written or make changes. 6)The final dispensing information is sent to HIRA. To date, the DUR established by HIRA responded to the concerns and adhered to guidelines put forth the task-force with a system that: •Covers 35, 000 items including drug-drug interaction and contraindications related to pregnancy and age (elderly, children). •Covers over 27,000 drugs registered and approved by the Korean FDA and is updated on a real-time basis. •DUR system use in about 99% of health facilities in Korea. •Covers the drug histories of over 48 million citizens, nearly the entire general population •Supports healthcare providers in preventing medical errors. In 2013, among all inspected prescriptions, 4% received warning messages. •Improves health equity and access: DUR availability in all healthcare facilities standardizes and maximizes safety and care regardless of income-level or background. For example, rural or low-income patients who do not have access to the top hospitals receive the same quality of care at the same price as wealthier or urban counterparts. •A DUR smartphone application now allows patients to access in real-time their own prescription drug history and can look up specific information about their medication. Thus, a provider or pharmacist can access the complete drug history of patients regardless of which health facilities they visited. Moreover, the provider has the additional safety of an automated checking system to ensure that the prescription is safe.

 3. How did the initiative solve the problem and improve people’s lives?
One of the biggest challenges mandated by the DUR task force was the creation of a comprehensive drug review system that could respond in real-time with alerts to problems arising at the point of prescription writing or dispensing. When the task force made a recommendation of a real-time system, it was met with strong reservation at HIRA. It was believed that the technological capabilities did not exist for such a system. However, at the insistence of the task force, the innovative real-time function of the DUR system was achieved through concerted efforts by HIRA, stakeholders, and the software developers. Moreover, advances in broadband technology and general Korean IT services had further created the conditions that made the real-time responsiveness of DUR possible. Advances in IT technology have allowed for further enhancements to DUR. In 2011, a smartphone DUR application was also launched that allows patients to look up drugs, access their own drug history and safety warnings.

C. Execution and Implementation

 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: Public Sector •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.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
First and foremost, the DUR system is an important public health initiative that significantly improved the ability of the healthcare professionals and the government to protect the lives of Korean citizens. In one comprehensive real-time system, DUR is able to address many of the problems that created the conditions for unsafe drug prescriptions to occur. This initiative has had tremendous impact in the following areas: 1. Improved Safety for General Population and Vulnerable Groups The DUR database assesses all patients’ drug profiles for possible conflicting drugs and side effects because of existing health conditions and other drugs the patient may be taking. **As of 2013, the DUR warning system resulted in prescription adjustments in 5.06 million cases at medical institutions and 0.33 million cases at the pharmacy. Although we do not know how many of these cases would have resulted in serious or life-threatening complications, the sheer volume of cases detected indicates that these warnings could have prevented serious illness or death. A detailed evaluation of these adjustments in the future would shed light on the severity of prescription alerts. In particular, there are certain groups that warrant special safety considerations for which the DUR system is able to enhance protection. Many drugs are prohibited or prescribed under careful supervision to pregnant women given the potential harm or unknown effects on the unborn fetus. **In 2013, pregnancy precaution warnings led to 51.3% of those prescriptions being adjusted by healthcare providers and 66.5% by pharmacists. The elderly, which comprise about 12% of the general population in South Korea, represent over a third of healthcare drug consumers. As the demand healthcare services and medication is greater in this group, there is a greater likelihood of dangerous drug-drug and drug-disease contraindications prior to the DUR initiative. **In 2013, age precaution warnings led to 76.5% of those prescriptions being adjusted by healthcare providers and 28.7% by pharmacists. Low-income and rural citizens who are often elderly also benefit from improved safety from the DUR system. The DUR system is available across Korea and not just in the most expensive or best-equipped hospitals; thus, these groups have access to the same safety standards as everyone else. They do not have to find or pay for better healthcare facilities to ensure that these prescription safeguards are in place for them too. 2.Improve the Ability of Healthcare Providers to provide quality service The DUR initiative is a system which supports the clinical judgment and expertise of doctors and pharmacists by 1) providing them a complete profile of patient drug history, 2) maintaining an up-to-date database of changes in drug regulatory guidelines and safety, and 3) providing warnings in the case of any errors or oversight. 3. Improve Access for citizens of their drug history and safety The DUR smartphone application allows Korean citizens to access in real-time their drug history as well as information regarding any drug in the database. This allows citizens to look up this information at the healthcare providers’ office and at the pharmacy if they need it. They can also ensure that the price they are paying for the drugs is the fair market price. 4. Generate significant cost savings to tax-payers/government Incredibly, the DUR system has generated significant cost savings to tax-payers. Once the system was implemented, the annual operating cost is $5 million, which is entirely funded from the National Health Insurance System. It was estimated that the DUR system actually saved the Government $20 million dollars. Importantly, given the importance of the DUR functionality for safety, healthcare facilities may have considered on their own in introducing such a system to improve safety at their sites. However, because the government took on this initiative they did not have to worry about devising the solutions themselves. This nationwide initiative thus generated potentially huge cost savings and efforts for individual healthcare facilities as well.

 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
The DUR system is both sustainable and transferable. It currently operates at an annual cost of $5 million, which is entirely funded by the National Health Insurance System. After establishing a comprehensive nationwide drug safety database, the return on investment is significant and the low operating costs make the initiative sustainable in the future As the DUR system is now utilized in over 99% of health facilities, software maintenance and upgrades can be done easily and automatically. The DUR software is directly transferred to the healthcare facilities’ own computers and there is no need for additional equipment or hardware. Currently, HIRA has a dedicated DUR department staffed by 20 people who maintain the database and work on improvements and continued innovations. The DUR software has now been fully disseminated and integrated within Korea. HIRA is now leading efforts by the Government to share this system and technology with other countries. Namely, in 2014, the Government of Korea (KOICA and HIRA) is working with its counterparts at the Ministry of Health within the Government of Vietnam to introduce the DUR system at major health facilities within the country. The DUR system is appealing because it is easily transferable as software and can be adapted to the local context in accordance with the laws and regulatory guidelines of Vietnamese drug authorities. Korean development assistance will provide funds to purchase needed hardware for healthcare facilities to introduce the system, and will provide the software to Vietnam. A successful partnership between the two countries may serve as a model for further knowledge-sharing and transferability to other countries.

 12. Were special measures put in place to ensure that the initiative benefits women and girls and improves the situation of the poorest and most vulnerable? (If applicable)
There are three key lessons learned from the DUR initiative from its early days of conception to implementation: 1)The importance of stakeholder consultations, consensus, and cooperation The DUR initiative was an excellent example of the importance of close cooperation between government agencies, citizen advocacy groups and health professionals. Despite the importance of improving patient safety, it was not easy to gain full support for DUR in its conception and indeed was almost blocked by the medical establishment. Even though healthcare providers were obligated both by the law and courts to comply with the DUR system, the DUR task force, HIRA and other stakeholders took a very active campaign of information and consultations to gather the support from the medical community and sincerely listen to their concerns. Such a public and bitter opposition between the two groups undermined the public trust in both the government and medical community and could have also threatened the public’s faith in the DUR system. Thus publicity, information sessions, and public hearings were also an integral part of the DUR Initiative so citizens were also fully aware of how DUR could improve their access to safe and quality healthcare. It was also important that the public did not see DUR as bureaucratic initiative that overrides their doctor’s judgment or causes them to question their faith in the healthcare system. 2)Restore trust in government and health system The DUR initiative was also important in restoring the public’s faith in the Korean healthcare system and the ability of the government to protect public health by maximizing efforts to support the healthcare system to provide safe and quality care. High-profile deaths due to medical errors, negligence, or failures in the system threaten the strong trust that people must have with the healthcare system. Ill-health, disability, and death are when people are in their most vulnerable state and warrants support not just from individuals, families, but overall society: government, healthcare professionals, and their fellow citizens. Even if tragedies are rare, any person can wonder “What if it were me?” 3)High-level political leadership and commitment High-level leadership and commitment were absolutely critical to the success of the DUR initiative. This included initial leadership from members of the National Assembly and Ministry of Health and Family Welfare who convened the initial hearings to the high-level DUR task force composed of high-level government officials, top medical experts, and civil society groups. Despite the major obstacles that threatened the very existence and functionality of DUR, the strong commitment and unity of the DUR task force and the dedication of public service employees made the DUR system a reality.

Contact Information

Institution Name:   Health Insurance Review & Assessment
Institution Type:   Public Agency  
Contact Person:   Jongsu Ryu
Title:   Mr.  
Telephone/ Fax:   82-2-2182-2428/82-2-6710-5849
Institution's / Project's Website:  
E-mail:   johnryu@hiramail.net  
Address:   22 Banpo-Daero Seocho-Gu
Postal Code:   137-927
City:   Seoul
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