Questions/Answers

According to the Global Health Observatory Data, over 160,000 death worldwide were caused by unintentional poisonings in 2016 especially in low- and middle-incomes countries. The mortality rate was 2.7, 1.8, 1.5, 1.1 0.7 and 0.6 in Africa, South East Asia, Eastern Mediterranean, Western Pacific, Europe and USA respectively. In Thailand, before 2010, many patients suffered from hazardous substances. Particularly in 2006, in Nan province, there was massive outbreak of botulism due to contaminated home-canned bamboo shoots which effected 209 patients, 134 were in a severe stage with paralysis, 42 of them required mechanical ventilation. There was no botulinum antitoxin available at that time. Fortunately, due to the help of WHO, many vials of botulinum antitoxin were sent to Thailand from USA, UK, Japan and Canada within 6 weeks after the brake of the issue. There were an inefficient antidote stock system and inefficient delivery system at any health care level. Many healthcare workers were lack of skills and experiences for diagnosis and treatment due to rare case context and result in delay treatment, suboptimal management and increase the complication and mortality. National Health Security Office (NHSO) tried to encourage many stake holders, such as toxicologists from Ramathibodi poison Center, The Thai Red Cross Society (TRCS), The Government Pharmaceutical Organization (GPO) and the Ministry of Public Health (MOPH) to work together as the Orphan Drugs and drug Shortage Steering Committee to increase the access to antidotes and essential orphan drugs. The responsibility of this committee is as follow: 1) to develop the system of antidote selection, stockpile and delivery system 2) consultant system 3) health care worker training 4) community prevention and protection. It has given rise to starting the new benefit package, The National Antidote Project of Thailand (NAPT), in 2010.

Although Antidotes are enrolled in WHO list of essential medicines, the pharmaceutical industries pay no intention to produce these medicines due to unpredictable demand and low profit margin result in antidote shortage in the worldwide. To manage the system needs, NHSO takes action to invest in the National antidote project to assure health security for all in Thailand. Not only in Thailand, some antidotes were sent to save lives in other countries as well e.g. 200 vials of Methylene blue were sent to Taiwan for methemoglobinemia treatment, 4 vials of botulinum antitoxin were sent to treat botulism in Nigeria.

Since the Sustainable Development Goals adopted by all United Nation member states in 2015, it becomes the main duty of Thai government and NHSO to ensure healthy lives and promoting the well-being at all ages as states in SDG. The work of NHSO to increase the access to essential medicines is not cover only high cost medicines. It’s also included antidotes and anti-venom. To manage the system, these medicines are enlisted in the National list of essential medicines (NLEM) of Thailand by the NLEM sub-committee and become the benefit package for all. There are more collaborative among many stakeholders while health information system and budget for the antidote procurement are supported by NHSO. Some antidotes are manufacture by Thai Red Cross Society or imported by GPO and Pharmaceutical industries, Ramathibodi Poison Center take action as a 7 days 24 hours consultant team for treatment and healthcare worker trainer. Result in the increasing of number of patients access to antidotes from 49 in 2011 to 6,917 in 2017.

The The National Antidote Project of Thailand (NAPT) contained all stakeholder related to antidote supply chain. These supply chain including drug selection, drug production and procurement, drug distribution and drug use. The Orphan Drugs and drug Shortage Steering Committee was the center to established the system of antidote selection, stockpile and delivery system, consultant system, health care worker training, community prevention and protection. NHSO have played the role to add antidotes to medical benefit package and support budget continuous for 9 years. This structure make sustainable of NAPT.

In Thailand, before 2010, many patients suffered from hazardous substances. Particularly in 2006, in Nan province, there was massive outbreak of botulism due to contaminated home-canned bamboo shoots which effected 209 patients, 134 were in a severe stage with paralysis, 42 of them required mechanical ventilation. There was no botulinum antitoxin available at that time. Fortunately, due to the help of WHO, many vials of botulinum antitoxin were sent to Thailand from USA, UK, Japan and Canada within 6 weeks after the brake of the issue. There were an inefficient antidote stock system and inefficient delivery system at any health care level. Many healthcare workers were lack of skills and experiences for diagnosis and treatment due to rare case context and result in delay treatment, sub-optimal management and increase the complication and mortality.

NHSO added antidote to medical benefit package under universal coverage scheme. National antidote project under universal coverage scheme covered all people in Thailand. Not only in Thailand, some antidotes were sent to save lives in other countries as well e.g. 200 vials of Methylene blue were sent to Taiwan for methemoglobinemia treatment, 4 vials of botulinum antitoxin were sent to treat botulism in Nigeria.

National antidote project under universal coverage scheme covered all people in Thailand. Due to the collaboration among many stakeholders. The Result of The National Antidote Project of Thailand are as followed: 1) The government policy was strong and Annual national budgets allocated full funding to the NHSO to ensure adequate supply of 17 antidotes and sustain covered all Thai and others in Thailand. 2) The cumulative number of patients access to antidote and antivenoms is 27,436 patients 3) The survival rate without complicated is 74.4% 4) Total cost saving especially for the antivenoms procurement is reduce to 40% when compare with the antivenoms procurement budget before 2013

The National Antidote Project of Thailand is processed by the Orphan Drugs and drug Shortage Steering Committee under the Board of the NHSO to increase the access to antidotes and essential orphan drugs. The responsibility of this committee is as follow: 1) to develop the system of antidote selection, stockpile and delivery system 2) consultant system 3) health care worker training 4) community prevention and protection. The implementation processes are: 1)Planning the Antidote selection, Procurement and distribution by the committee 2)GPO and TRCS act on antidote procurement. All antidotes and antivenoms are procured at central level, dived into 3 groups depend on the characteristic of antidote and distributed to each hospital depend on the criteria made by the committee. 3)NHSO response for the Health Information System. Geographic Information System or GIS was applied to the web-based application to control stockpile as a real time and support the decision making for the treatment plan of doctors. 4)There are now antidote networking completed in 13 NHSO’s regions that cover for all in Thailand.

1.The shelf-life of antidote is too short and there are still be the stockout of some raw materials result in stockout of antidotes. TRCS try to manufacture many items including study on the long-term stability of them. 2.Because of rare case context but high severity, quality of treatment is very important. The auditing system and training program have been established. 3.All Antidotes must be bought with the minimum orders, some of them are expired without usage whereas there are the needs in other area. Information sharing system and antidote pooled procurement system are the key to solve this problem.

The NAPT is innovation to manage the access to antidotes and support rational use of antidotes. The distribution of antidotes is depended on the characteristic of them and registered all stock information in the web-based registry program. In addition, the geographic information system is applied in this program, which shows an on-line stock. Therefore, each hospital, especially in remote areas, could make the treatment plan more efficiency, as well as referring the patient to the higher hospital. If not, they could request for the antidotes from the near hospitals.

The web-based registry program with geographic information system which shows an on-line stock was key principle to apply in this project. When people exposed toxicant, hospital can search location of antidote located using this web-based registry program. Hospital will contacts hospital which were antidote stockpile and ask for refer patients to antidote or antidote to patients depend on potential of hospital. NHSO support expenditure to refer patient to drug or refer drug to patient.

During 9 years of implementation, our results were published in the international journal e.g. Improving access to antidotes and antivenoms, Thailand. The Bulletin of the WHO 2018 (download at http://www.who.int/bulletin/volumes/96/12/18-217075/en/) , Cyanide poisoning in Thailand before and after estrablishment of the National Antidote Project in Clinical Toxicology volume 56,2018-issue 4 (down load at https:/www.tandfonline.com/doi/full/10.1080/15563650.2017.1370098). Besides these pulication, there is a new initiative on collaborative among WHO SERO, member states and NHSO Thailand to start the antidote pooled procurement by the existing system in Thailand. The Ramathibodi Poison Center presented the NAPT in the ASEAN Social Security Association meeting in Bruni last September 2018.

This project was published in the international journal.

1.The government policy that allocate continuous budget to the NHSO to ensure adequate supply of antidotes covered all Thai and non-Thai in Thailand after Antidotes were announced as the new benefit package. 2. All stake holders related to antidote supply chain were encouraged to own this system. 3. There are international, national and regional antidote networking with the new familiar antidote registry program and the support from Ramathibodi poison center. 4. The collaborative from the private industrial companies for joining the accident prevention.

The importance factors to sustain the NAPT are 1.The government policy that allocate continuous budget to the NHSO to ensure adequate supply of antidotes covered all Thai and non-Thai in Thailand after Antidotes were announced as the new benefit package. 2. All stake holders are encouraged to own this system. 3. There are inter and intra antidote networking with the new familiar antidote registry program and the support from Ramathibodi poison center. 5. The collaborative from the private industrial companies for joining the accident prevention.

Si

The NAPT are evaluated by 2 systems including 1) The Internal monitoring system of NHSO and 2) The External auditing system by the Ramathibodi poison Center. The main purpose of this is to assure the rational use of antidotes in each antidotes networking.

The NAPT are evaluated by 2 systems including 1. The Internal monitoring system of NHSO: All information are reported at http://drug.nhso.go.th/Antidotes/ e.g. 1) Report of the total use of antidotes, 2)Report of the individual use of patient from each hospital report of stock in each items of antidote / hospital 2.The External auditing system by the Ramathibodi poison Center. The main purpose of this is to assure the rational use of antidotes in each antidotes networking.

1. The cumulative number of patients access to antidote and antivenoms is 27,436 patients 2. The survival rate without complicated is 74.4% 3. Total cost saving especially for the antivenoms procurement is reduce to 40% when compare with the antivenoms procurement budget before 2013. 4. The shelf-life of antidote is too short and there are still be the stockout of some raw materials result in stockout of antidotes. 5. The appropriate use of antidotes was 90%. 6. Cyanide and hydrogen sulfide are common causes. Although these were hardly occurred, the severity is high.

1. The Orphan Drugs and drug Shortage Steering Committee had role for establishing the system of antidote selection, stockpile and delivery system, consultant system, health care worker training and community prevention and protection. 2. Thai Food and Drug administration (Thai FDA) had role for pre-marketing control included control of manufacturing facilities, product quality before product-launch to the market. 3. NLEM sub-committee had role for Antidotes selection in NLEM 4. NHSO had role for containing antidote lists in Medical Benefit Packages 5. GPO and TRCS had role for antidote production and procurement. 6. Ramathibodi Poison Center had role for consultation for poison treatment to healthcare worker and training 7. MOPH and hospital had role for provision of poison treatment

The NAPT contained all stakeholder related to antidote supply chain. These supply chain including drug selection, drug production and procurement, drug distribution and drug use. The Orphan Drugs and drug Shortage Steering Committee was the center to established the system of antidote selection, stockpile and delivery system, consultant system, health care worker training, community prevention and protection. This structure had high effectiveness to antidote management and solving of antidote shortage. 7 days 24 hours consultation system and health worker training by Ramathibodi Poison Center can increasing of number of patients access to antidote and improve rational use of antidotes.

1.All stakeholder related to antidote supply chain including drug selection, drug production and procurement, drug distribution and drug use is one key success factor to establish antidote system. The Orphan Drugs and drug Shortage Steering Committee is important structure to antidote management and solving of antidote shortage. 2.Antidotes have to contain in national list of essential medicines and health benefit package because government will must continuous support budget for antidotes procurement and management. 3.Local producers including GPO and TRCS are the key component to assure available of antidotes. Central procurement is powerful strategy to collect antidote needs from all health facilities and negotiates with suppliers 4.Web-based registry program with GIS support hospital to make the treatment plan more efficiency, as well as referring the patient to the higher hospital and request for the antidotes from the near hospitals. 5.7 days 24 hours consultation system and health worker training by Ramathibodi Poison Center can increasing of number of patients access to antidote and improve rational use of antidotes