Questions/Answers

As pharmaceuticals have a major, direct effect on human health and quality of life, it is critical for the government to impose institutional control and supervision. Especially, the Republic of Korea is in urgent need of drug management as per capita drug sales (USD 690.9 PPP) in 2019 were 30 percent higher than the OECD average and drugs accounted for 20.9 percent of total medical expenses, 4.2 percentage points higher than the OCED average (16.7 percent), in the same year. Moreover, population aging, which increases the already high demand for medicines, is rising 1.7 times faster than the OECD average. Korea’s Health Insurance Review & Assessment Service (HIRA) monitors information on the tracking, tracing, and prescription of pharmaceuticals through a pharmaceutical management system, which consists of the Korea Pharmaceutical Information Service (KPIS) and Drug Utilization Review (DUR), and provides necessary information to stakeholders in real time to ensure that patients can use medicines safely. HIRA utilizes the real-time information delivery system in diverse ways through an IT network for data delivery that is linked to over 90,000 medical institutions and pharmacies across the nation. We provide medical institutions and pharmacies with important information necessary for responding to infectious diseases, such as MERS in 2015 and COVID-19 in 2019. Especially, we provide real-time notification regarding harmful faulty drugs that have already been distributed to relevant institutions to ensure prompt drug recalls. We also share information on prescription drugs for each patient of the Korean Red Cross on a daily basis to facilitate the management of patients not eligible for blood donation by relevant institutions and utilize the collected data to produce drug-related statistics and aid the government’s decision-making, contributing to enhancing drug-related public safety. Through this process HIRA improves public access to medicines, ensures the transparent distribution, and safe use.

Our initiative is related to Category 2. With limited financial resources, HIRA built a system that delivers real-time information via the DUR through a network comprised of 99.4 percent of all medical institutions and pharmacies nationwide. We also manage a network of wholesale and retail drug distributors across the nation to ensure supply. Moreover, we use the national standard barcode system and RFID technology to conserve human resources and time. We have saved USD 2.25 million by preventing social losses associated with drug misuse and abuse and cut USD 77 million in medical costs caused by drug-induced adverse effects.

Goal 3: To Ensure healthy lives and promote well-being for all at ages. HIRA focuses on “preventing and treating drug misuse and abuse” (SDGs 3.5) and “making safe, effective, and affordable essential medicines and vaccines readily accessible” (SDGs 3.8). The DUR is responsible for preventing drug misuse and abuse and improving treatment by providing up-to-date drug safety information on over 33,000 medicines to doctors and pharmacists every year for the purpose of preventing the inappropriate use of drugs by the public and promoting the use of safe drugs. The KPIS enhances the accessibility of medicines for the public by managing the inventory of essential medicines in Korea through drug distribution management and works to prevent spikes in medication prices. It also monitors the distribution of illegal and dangerous drugs to ensure that the public has ready access to safe and effective medicines. In 2018, for instance, HIRA implemented emergency recall measures for 115 drugs containing valsartan that were contaminated with a cancer-causing agent and had been put into circulation, collecting 99.6 percent of such drugs from 363,870 patients who had been prescribed valsartan and exchanging them for safe drugs.

Despite stakeholders’ objection to the introduction of a pharmaceuticals management system, HIRA used the system to create a safe healthcare environment, leading stakeholders to eventually recognize the project’s importance. The installation of the system in Korea resulted in HIRA preventing (as of 2020) the misappropriation of USD 77 million in pharmaceuticals, which also resulted in environmental conservation due to the decrease in discarded medicines. This financial effect became the driving force of the sustainability of the system, which is expected to remain useful in the future.

Despite the direct relationship between drugs and the life and health of patients, it remains true that information on drugs is imperfect and asymmetrical between medical experts and patients. Accordingly, the majority of drug consumers with limited access to information are forced to rely on doctors, pharmacists, and other relevant professionals. The WHO also regards ensuring the quality control and regulation of drugs and access to essential medicines as the important duty of the government. As a public institution, HIRA plays a vital role in enhancing public access to safe medicines. We utilize the pharmaceutical management system to improve public access to safe drugs throughout the entire process, from drug distribution to prescription. We also provide medical personnel who treat patients and prescribe drugs with drug information in real time, as they are unable to keep abreast of the latest information on the safety of the over 30,000 drugs that are used in the Republic of Korea on their own. Over the past three years, we have issued over 140 million safety alerts to doctors and pharmacists across the nation every year and prevented them from re-prescribing over 73,000 discontinued drugs.

Although the effects and risks of drugs vary between men and women due to physical and genetic characteristics, clinical studies for drug development are most often conducted on men. Therefore, women, who are reported to use drugs more frequently than men, especially expecting mothers, need to be well informed to promote safer drug use. To this end, we provide doctors and pharmacists with the latest information on drug interactions and drugs that should be avoided by expecting mothers, the elderly, and specific age groups. We are also continuously working to expand the scope of the information we provide.

HIRA’s pharmaceutical management system is applied equally to all, without excluding any specific groups. However, we pay special attention to specific groups with high demand for drugs, such as the elderly and children, economically underprivileged people, expecting mothers, and vulnerable groups in healthcare who should take extra care to practice safe drug use, by providing a broader scope of information relevant to them. We provided notification of 314 drug ingredients that should be avoided during pregnancy in 2008, 60 drugs that should not be given to babies in 2012, and 20 drugs ingredients that older people should avoid or use with caution in 2015. And we plan to continue providing information for the safe use of drugs. In 2020, we applied the DUR system to medical institutions related to correctional facilities to prevent drug-induced accidents among inmates.

In 2000, the Republic of Korea separated drug prescription and dispensing, requiring doctors to prescribe drugs and pharmacists to supply them. Despite this change, however, the misuse of drugs increased. In 2005, a patient died by taking drugs that were not permitted to be taken together, resulting in growing calls for the control of drug overuse and safety management. In 2007, the Korean government finalized its plan for the gradual introduction of the DUR for safer drug use. To ease the medical community’s concerns, the government carried out two trial DUR projects. The first was completed in 2009, involving 1,023 medical institutions and pharmacies, and the second was conducted with 665 medical institutions and pharmacies. In December 2010, the DUR was implemented nationwide with the participation of 7,986 medical institutions (12.2 percent). For the project, HIRA introduced the DUR to doctors and pharmacists nationwide and held a wide range of promotional activities. We also laid the legal foundation for the mandatory use of the DUR and succeeded in having relevant laws passed in 2016. As a result, 99.4 percent of relevant institutions now use the DUR. The KPIS, for drug distribution management, was built in 2007. For the effective operation of the KPIS, we started assigning a number for each drug type in 2008 and made the assignment of serial numbers to all prescription drugs mandatory in 2015. As of 2020, we collected over 168,624 pieces of information on the distribution of 55,693 drugs worth USD 6.325 billion, achieving advanced drug management through the regulation of drug distribution. As of 2020, 95.6 percent of drug distributers are providing up-to-date information on drug distribution.

The biggest challenge was the opposition from the medical and industrial communities. The medical community was concerned that drug information provision through the DUR would negatively affect medical professionals’ autonomy and standardize drug prescription. We showed the necessity of the DUR by conducting two pilot projects, urging medical professionals to participate, and working to lay the legal foundation for DUR implementation. The industrial community worried that the drug-tracking system would result in stronger governmental intervention. To overcome this, we offered incentives by providing the information needed by industrial circles through the data we collected, attracting their participation.

The pharmaceutical management system delivers necessary information in real time through HIRA’s computerized network of over 90,000 medical institutions and pharmacies, helping address chronic issues related to information asymmetry. With the system’s capacity to deliver real-time information, we have promptly recalled harmful medications and taken preemptive measures to prevent medical personnel from being exposed to patients suspected of having an infectious disease such as MERS or COVID-19. With the expansion of the scope of information, such as information on patients requiring medical services such as surgery, the system can now be applied in more diverse ways.

For the introduction of the DUR, which supports the safe prescribing of drugs, we benchmarked the DUR of the United States. While the United States’ DUR is operated differently from state to state and used only in pharmacies, Korea’s DUR is government-operated and provides standardized safety information to hospitals and pharmacies nationwide. By utilizing the drug-tracking system of the KPIS, which was inspired by Turkey’s iTS system, the world’s first drug-tracking system, we continue to seek ways to make the best of drug distribution information for patients, who are the end users of drugs.

The DUR, a pharmaceutical management system patented in Korea in 2011, is capable of providing real-time information to over 90,000 hospitals and pharmacies in Korea. With its capacity to deliver real-time information, the DUR has provided drug-related safety information as well as information on patients vulnerable to COVID-19. In addition, the radio frequency identification (RFID) technology used for the KPIS is capable of accurately identifying the serial numbers assigned to individual drugs. It helps minimize the cost and human resources necessary for identifying individual drugs to be recalled when there are issues with drug quality.

HIRA worked with Bahrain in 2017 and 2018 on the Bahrain National Health Insurance System Reform Joint Project, through which it helped reform Bahrain’s health insurance system. The project began with Bahrain requesting HIRA’s help to build a pharmaceutical management system (based on a combination of the DUR and KPIS) for the safe use and efficient distribution of pharmaceuticals in Bahrain, which was previously reliant on imports. HIRA provided expertise on system design and project implementation. In November 2018, we successfully completed the project in Bahrain and agreed to support system maintenance and management to ensure the successful system establishment and operation. In the same year, the Bahrain government named the establishment of the drug management system a major achievement for national health insurance operation and safe drug management. Starting in 2021, HIRA plans to undertake an e-government system project using the DUR and KPIS for ASEAN nations. Considering the fact that ASEAN consists of low- and middle-income countries, we plan to build a future-oriented drug management system that, through cloud technology, can connect to the network without requiring any IT resources, including hardware and software, thus ensuring economic feasibility and flexibility. Currently, we are conducting a project feasibility study.

We built systems in other nations. The system was installed in Bahrain and is currently being reviewed for installation in several ASEAN countries.

From a financial perspective, for the DUR and KPIS we built in Bahrain in 2017 and 2018, respectively, we spent a total of USD 1.0 million for physical hardware and USD 1.3 for software over 22 months. From a human resource perspective, as of 2021, a total of 49 people, including 14 medical professionals and 14 computer experts with HIRA are finding ways to manage and upgrade the DUR and KPIS regularly. We are also continuing to work with 79,247 hospitals and pharmacies and over 3,500 drug suppliers as essential partners to promote the safer use of drugs.

The system has been operated consistently with government funds. The creation of a broad-ranging national database on pharmaceutical safety through this initiative has boosted financial sustainability through a high investment-profit ratio and low maintenance fee. Legally, an amendment was made that now requires doctors and pharmacists (when prescribing or filling a prescription) to check the safety information related to the pharmaceuticals in question. Also, a measure that requires real-time notification of the distribution/shipment of pharmaceuticals after they are manufactured/imported has increased the systemic sustainability of the DUR- and KPIS-based system.

Yes

The pharmaceutical management system’s outcomes were measured via outside research reports and industry surveys. The DUR’s effectiveness was assessed through a 2016 study by eight professors of medicine and pharmacology, which examined whether and to what extent issued prescriptions complied with the DUR standards. Two user satisfaction surveys were conducted: one on the DUR by an outside organization in 2014 of 1,220 pharmaceutical experts and one by HIRA on the KPIS in 2020 of 423 pharmaceutical distributors. In an external assessment conducted by the central government of public players who improve healthcare accessibility, HIRA received a very high score.

To assess the DUR’s effectiveness, we used two indicators: information provision rate and prescription revision rate. The former is the proportion of prescriptions that need to be adjusted in accordance with the DUR standards, while the latter is the proportion of prescriptions that are corrected based on the DUR. As the participation of stakeholders, including doctors, pharmacists, and drug distributors, in the pharmaceutical management system is important, we conducted a stakeholder satisfaction survey on the DUR and KPIS projects and collected subjective opinions on the areas participants were satisfied with in each field and problems to be addressed.

The information provision rate and prescription revision rate both decreased around the time the DUR was introduced, which can be interpreted as a significant improvement resulting from the introduction of the DUR and consequent provision of education. For instance, after the DUR was introduced, the information provision rate for drugs that should be avoided by specific age groups decreased by 23.7 percentage points, while the prescription revision rate increased by 2.16 percentage points in the case of drug interactions. Also, according to the satisfaction survey results, the pharmaceutical management system received positive responses from stakeholders. In addition, the pharmaceutical management system received a Government 3.0 Best Practice award in 2016 from the Ministry of Health and Welfare and various other government awards in recognition of its value. The above outcomes of internal and external assessments convinced stakeholders who initially objected to the system’s installation, raising satisfaction with this initiative and bringing about social consensus on its necessity. The active and continued cooperation of stakeholders for this initiative will be a foundational source of support for its sustainability.

The pharmaceutical management system is run by the government and operated through partnership between relevant stakeholders and institutions. Government organizations that oversee public health and medicine are responsible for the project, laying the legal and political foundation for project implementation. HIRA operates the pharmaceutical management system, which includes the DUR and KPIS. KIDS(Korea institute of Drug Safety&Risk Management) and the Ministry of Food and Drug Safety provide information on approved medications and their safety to medical institutions and pharmacies through the DUR and work to upgrade the DUR by holding regular meetings. We also collect and monitor information on drug distribution through the KPIS, which is linked to wholesale and retail drug suppliers. We also utilize the pharmaceutical management system to provide real-time information in diverse areas relevant to public health, such as immigration information in partnership with the Ministry of Justice and information on patients at risk of infectious diseases and information for the management of patients not eligible for blood donation in cooperation with the Korean Red Cross. To tighten the control of narcotics in Korea, we are also incorporating the Narcotics Information Management System run by the Ministry of Food and Drug Safety into the DUR.

The participation and cooperation of stakeholders is essential for the success of the pharmaceutical management system. To build the DUR system, we held regular meetings with the medical community, including the Korean Medical Association, Korean Hospital Association, Korean Pharmaceutical Association, and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), in order to get their feedback. We then carried out two pilot projects prior to implementation and provided the software developer with financial support, as software was essential for the success of the pilot projects. In 2008, HIRA built the Korean Drug Code System for drug identification in partnership with the Ministry of Food and Drug Safety, which oversees drug approval and pharmaceutical manufacturer codes, and Korea Chamber of Commerce and Industry. From 2014 to 2015, we consulted with a working-level consultative body comprising drug manufacturers and distributers as well as the medical community to lay the foundation for pharmaceutical serialization and the real-time drug distribution information delivery system. We also met with drug distributors, who were concerned about the possibility of the government monitoring their business activities after the introduction of the system, and reached an agreement to disclose the statistical data we had collected.

HIRA’s pharmaceutical management system is an information system designed to support the safe use of drugs by the public using the limited resources available. To achieve our common goals, we collaborate with government bodies as well as the medical community and relevant industrial circles to build an information system that shares the data collected by each institution. The recent pandemic has shown the positive effect that our nation’s capacity to utilize data has on public health. The Republic of Korea has made the best use of data in diverse areas through the DUR and KPIS and, as a result, is now lauded for its successful response to COVID-19. HIRA will continue to use IT to improve the efficiency of public institutions and support the achievement of the SDGs. HIRA is working toward a platform that goes beyond a unilateral, task-centric method of information provision by the state or public institutions to encourage individuals’ participation. Through these efforts, HIRA will facilitate participation-based, individually-centric health management.