MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No: 2174/QD-BYT | Hanoi, June 21, 2013 |
DECISION
RATIFICATION OF THE NATIONAL ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE FROM 2013 TO 2020
MINISTER OF HEALTH
Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;
At the proposal of the Director of Ministry of Health's Medical Services Administration
HEREBY DECIDES:
Article 1. Issue together with this ratification Decision the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020.
Article 2. This Decision is in effect from the date of signing.
Article 3. Chief of the Ministry Office, Ministerial Chief Inspector, Director Generals of the following Administrations: Medical Services, Drug, Science, Technology and Training, HIV/AIDS Control, Food Safety, Preventive Healthcare, Health Environment Management; Director Generals of the following Departments: Planning and Finance, Communications and Reward, Medical Insurance; Directors of provincial Departments of Health, Directors of hospitals affiliated with the Ministry of Health and Heads of relevant units shall be responsible for implementation of this Decision./.
| MINISTER |
NATIONAL ACTION PLAN
TO COMBAT ANTIMICROBIAL RESISTANCE
From 2013 to 2020
(issued together with the Minister of Health’s Decision No. 2174/QD-BYT dated June 21, 2013)
INDEX
Section 1: THE NECESSITY FOR A PLAN
PROPOSITION
I. CURRENT SITUATION
1. The state of antimicrobial resistance
1.1. Global antimicrobial resistance situation
1.2. Antimicrobial use and resistance situation in Vietnam
2. Causes of antimicrobial resistance
3. Consequences and burdens of antimicrobial resistance
II. LEGAL BASIS
Section 2: THE PLAN’S SPECIFICS
I. OBJECTIVES
1. Common objectives:
2. Specific objectives:
II. ACTIVITIES TO BE UNDERTAKEN
1. Raise awareness of antimicrobial resistance among the public and health staff
2. Enhance, improve and perfect the national surveillance capacity for antimicrobial use and resistance
3. Ensure adequate supply of essential drugs with good quality
4. Step up safe and appropriate drug use
5. Step up infection control
6. Step up appropriate and safe use of antimicrobials in crop farming, animal husbandry and aquaculture
Section 3: SOLUTIONS
I. Mechanisms, policies and management
II. Information, communication, education
III. Technical expertise and training
IV. Finance
V. Scientific research and international cooperation
Section 4: IMPLEMENTATION
I. Establishment of Steering Committee
II. Allocation of implementation responsibilities
ABBREVIATIONS
Abbreviation | Vietnamese | English |
AFB | Trực khuẩn kháng cồn kháng toan | Acid - Fast Bacilli |
ANSORP | Mạng lưới giám sát của châu Á về sự kháng thuốc của vi khuẩn gây bệnh thường gặp | Asian Network for Surveillance of Resistant Pathogens |
AMR | Kháng thuốc | Antimicrobial resistance |
ARV | Kháng retro vi rút | Antiretrovirus |
AZT - ZDV | Zidovudine |
|
DDD | Liều xác định trung bình trong ngày | Defined Daily Dose |
ESBL | Men Beta - Lactamase phổ rộng | Extended - Spectrum Beta - Lactamase |
HAART | Liệu pháp kháng retro vi rút hoạt tính cao |
|
HIV/AIDS | Vi rút suy giảm miễn dịch ở người/Hội chứng suy giảm miễn dịch mắc phải | Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome |
KONSAR | Mạng lưới giám sát quốc gia về kháng thuốc của Hàn Quốc | Korean Nationwide Surveillance of Antimicrobial Resistance |
KSNK | Kiểm soát nhiễm khuẩn | Infection Control |
NDM1 | Men làm cho vi khuẩn kháng với các kháng sinh nhóm beta-lactam | New Delhi metallo - beta – lactamase 1 |
NKBV | Nhiễm khuẩn bệnh viện | Hospital Infection |
NNRTI | Ức chế men sao chép ngược không nucleosid |
|
NRTI | Ức chế men sao chép ngược nucleosid và nucleotid |
|
NVP | Nevirapine |
|
MDR-TB | Bệnh lao đa kháng thuốc | Multidrug - resistant tuberculosis |
MIC | Nồng độ ức chế tối thiểu | Minimum Inhibitor Concentration |
MRSA | Staphylococcus aureus kháng methicillin | Methicillin Resistance Staphylococcus aureus |
3TC | Lamivudine |
|
d4T | Stavudine |
|
PLTMC | Phòng lây truyền mẹ con |
|
TCYTTG | Tổ chức Y tế Thế giới | World Health Organization |
XDR-TB | Bệnh lao siêu kháng thuốc | Extensively Extremely Drug Resistance - TB |
Section 1
THE NECESSITY FOR A PLAN
PROPOSITION
Since the discovery of penicillin, hundreds of antimicrobials and similar drugs have been invented and put into use. The birth of antimicrobial signaled a new era of medical development in treatment for infections.
Aside from their medical roles in humans, bactericides are also widely used in animal husbandry, aquaculture and crop farming for disease prevention and treatment in animals and productive purposes. The continuous exposure to bactericides results in the high proportion of antimicrobial-resistant bacteria in animal excrements.
Antimicrobials are greatly beneficial in treating humans and even animals when prescriptions and treatments are done properly. However, those drugs have been widely, extensively used and abused, causing bacteria to adapt and become resistant to antimicrobials, reducing or eliminating the drugs' effectiveness. Antimicrobial resistance is a cause of concern not only for clinical doctors in the treatment process, but also the whole society in the community's health.
Antimicrobial resistance (AMR) is the state where microorganisms (such as bacteria, viruses, fungi and parasites) are able to resist antimicrobials which were previously effective on them. The resistant organisms (bacteria, viruses, parasites) can withstand the attack of antimicrobials (such as antibiotics, antivirals, antimalarial medications) leading to specific remedies being ineffective, extended infection (which can lead to death) and can spread to other humans. AMR is the inevitable result of the antimicrobial use in treatment and is on the rise as antimicrobial abuse is becoming more common.
There has been occurrences of bacteria which are resistant to nearly all antimicrobials, also known as extensively drug-resistant bacteria.
In Vietnam, most of medical facilities have to face the quick spread of multidrug-resistant bacteria, with severity and speed increasing at an alarming rate. The burden of antimicrobial resistance is increasing due to increasing costs of treatment, extended treatment period, hence affecting patients' and the community’s health, and the society’s development as a whole. In the future, countries risk having no effective drugs for treatment for communicable diseases if they have no intervention measures.
Currently, antimicrobial resistance is not a new problem, but has become dangerous and pressing, requiring collective effort in order to prevent humanity from returning to the time of no antimicrobials. The World Health Organization (WHO) states that we are living in an antimicrobial-dependent era and requests global responsibility for protecting the precious antimicrobial source for future generations.
On the World Health Day in 2011, WHO’s slogan for prevention of antimicrobial resistance is “no action today, no cure tomorrow” and called on nations to urgently formulate plans to deal with antimicrobial resistance.
Therefore, formulation of a general, comprehensive, long-term plan to combat antimicrobial resistance is a vital necessity for Vietnam at the present time.
I. CURRENT SITUATION
1. The state of antimicrobial resistance
1.1. Global antimicrobial resistance situation
In many countries worldwide, especially developing ones, antimicrobial resistance has become a cause for alarm. The burden of costs of treatment for infections is considerably heavy due to replacement of old antimicrobials by new, more expensive ones.
In 2011, drug-resistant tuberculosis occurred in nearly all countries.
There are 640.000 cases of multidrug-resistant tuberculosis (MDR - TB), with 9% of them being extensively drug-resistant tuberculosis (XDR - TB) [1].
There is also the rise of artemisinin-resistant Falciparum parasites in Southeast Asia. Resistance to antimalarial treatments of the previous generation such as chloroquine and sulfadoxine/pyrimethamine is common in most countries where malaria occurs.
International access to antivrals for treatment for HIV has increased the risk of resistance, which is a threat to humanity. About 15% of patients had to undergo second and third-line regimens. The cost of drugs for those regimens is 100 times more than those for the first-line regimen. The rise of resistance of HIV poses a challenge for maintaining the global access program for low-income nations. Those nations have to enhance health services and improve care quality for HIV patients in order to minimize the spread of resistant viruses.
ANSORP’s surveillance research data from January 2000 to June 2001 in 14 centers of 11 Southeast Asian countries show S. pneumoniae bacteria having high resistance. Out of 685 species of S. pneumoniae isolated from patients, there were 483 (52.4%) no more susceptible to penicillin, 23% neutral and 29.4% resistant to penicillin ((MIC ≥ 2mg/l) . The results from isolated bacteria show that penicillin resistant rate was the highest in Vietnam (71.4%), then South Korea (54.8%), Hong Kong (43.2%) and Taiwan (38.6%). Resistance to erythromycin was also very high, which is 92.1% in Vietnam, 86% in Taiwan, 80.6% in South Korea, 76.8% in Hong Kong and 73.9% in China. The multicenter research trial data clearly show the rate and speed of resistance to S. pneumoniae in many Asian countries where infection rates are among the highest [3].
According to KONSAR research data from 2005 to 2007 in Korean hospitals, the occurrence rate of Methicillin-resistant S. aureus (MRSA) was 64%, K. pneumoniae which are resistant to third-generation cephalosporin was 29%, fluoroquinolone-resistant E.coli is 27%, resistant Acinetobacter spp. was 48%, amikacin-resistant P. aeruginosa was 19%, resistant Acinetobacter spp. was 37%. Occurrence rates of vancomycin-resistant E. faecium and imipenem-resistant Acinetobacter spp. gradually increased. Resistance of E. coli and K. pneumoniae to third-generation cephalosporin and P. aeruginosa to imipenem in testing laboratories was found to be higher than in hospitals [4].
Antimicrobials which were previously effective in treatment for dysentery caused by Shigella is now resisted by those bacteria, hence, nowadays, WHO recommends ciprofloxacin for such treatment. However, the rapid rise of resistance to ciprofloxacin has reduced both effectiveness and safety of treatment, especially in the case of children
AMR has become a major problem in treatment for gonorrhea (caused by N. gonorrhoeae), even affecting oral cephalosporin, the drug of last resort and is on the rise worldwide. Failure to treat infections caused by N. gonorrhoeae with lead to increase in disease and death rates, hence reversing all achievements in control of sexually-transmitted diseases. Control of those diseases has been negatively affected by development and spread of antimicrobial resistance.
New mechanisms of resistance, such as a beta-lactamase named NDM-1, have occured in a number of Gram-negative bacilli. This can destroy the effectiveness of strong antibiotics, which usually are drugs of last resort for treatment for multidrug-resistant bacteria species.
1.2. Antimicrobial use and resistance situation in Vietnam
1.2.1. Antimicrobial use in the community
According to a survey on antimicrobial sale in both rural and urban drugstores in Northern provinces, the drug seller and people’s awareness of antimicrobials and antimicrobial resistance is still low, especially in the rural area. Out of 2953 drugstores surveyed, 499/2083 urban drugstores (24%) and 257/870 rural drugstores (29.5%) sell prescription antimicrobial drugs. Antimicrobials make up 13.4% and 18.7% total revenues of urban and rural drugstores respectively. Most antimicrobials have been sold without prescriptions (88% for urban, 91% for rural). 31.6% of antimicrobials have been bought in urban areas for treating coughs, and 21.7% of antimicrobials have been bought in rural areas for treating fevers. Three antimicrobials with highest sales are ampicillin/amoxicillin (29.1%), cephalexin (12.2%) and azithromycin (7.3%). 49.7% of urban buyers and 28.2% of rural buyers request antimicrobial sale without prescriptions [5].
1.2.2. Antimicrobial use and resistance in hospitals
The results of a report on effectiveness of antimicrobials in the 2003-2006 period show the resistance of Klebsiella spp. to third-generation and fourth-generation cephalosporin, fluoroquinolone and aminoglycoside sharply increased from >30% in 2003 to >40% in 2006; from >40% in 2004 to >50% in 2006 for Pseudomonas spp. and from >50% in 2004 to >60% in 2006 for Acinetobacter spp. Imipenem/cilastatin and carbapenem, which were only introduced into the Vietnamese market less than 10 years prior, were also reduced in effectiveness towards gram-negative bacilli which do not produce enzymes.
Resistance of Pseudomonas spp. to imipenem/cilastatin gradually increased from 12.5% in 2003 to 15.5% in 2005, and then 18.4% in 2006 [5].
According to data on antimicrobial use and resistance in 15 Ministry-affiliated hospitals and provincial general hospitals in Hanoi, Haiphong, Hue, Da Nang, Ho Chi Minh City, etc. from 2008 to 2009, in 2009, 30 to 70% of Gram-negative bacteria were resistant to third and fourth-generation cephalosporin, nearly 40 to 60% were resistant aminoglycoside and fluoroquinolone. Nearly 40% of Acinetobacter species became less susceptible to imipenem.
The average antimicrobial usage was 274.7/100 days per bed, which is considerably higher than the Netherlands, which reported 58.1 DDD/100 days per bed for the same period, and 139 hospitals of 30 European countries, which reported 49.6 DDD/100 days per bed. The correlation between antimicrobial use and resistance is clearly shown by the fact that the resistance of Gram-negative bacteria to fourth-generation cephalosporin is high in places with high antimicrobial consumption [6].
The results of “Study on the role of antimicrobial use in hospital-acquired infection in some medical facilities’ intensive care units” show that the four isolated bacteria with the most quantities are Acinetobacter spp, Pseudomonas spp, E.coli and Klebsiella spp. Infections caused by either Acinetobacter spp. or Pseudomonas spp. make up most (>50%) of hospital-acquired pneumonia cases (with or without mechanical ventilation). All 4 aforementioned species are multidrug-resistant. Resistance is especially high to third and fourth-generation cephalosporin (about 66-83%), followed by aminoglycoside and fluoroquinolone at more than 60%.
High antimicrobial resistance is also indicated by the rate of antimicrobial usage based on initial experience not fitting antibiograms being 74% [7].
1.2.3. Anti-tuberculosis drug use and drug-resistant tuberculosis
WHO’s 2012 report estimated that Vietnam ranks 12th among 22 countries with heaviest tuberculosis (TB) burden, and 14th among 27 countries with multidrug-resistant tuberculosis (MDR-TB) burden.
The rate of MDR-TB occurrence is 2.7% among newly infected patients (about 4800) and 19% among patients who undergo further treatment (about 3400).
WHO estimated that there were about 3500 MDR-TB patients (with 95% confidence level ranging from 2600 to 4700) among the patients who were found to be suffering from pulmonary TB [8].
However, in recent years, TB's situation has become more complicated due to influences of the HIV/AIDS pandemic and antimicrobial resistance.
According to WHO, drug-resistant TB is currently a very pressing matter. Treatment for drug-resistant TB usually does not achieve positive results, especially in the case of MDR-TB patients. The cost of treatment for MDR-TB is hundred times more than for TB with no drug resistance, and MDR-TB can be even untreatable in some cases. Currently, the ocurrence rate of MDR-TB among TB patients in Vietnam is still below 3%, but the number of newly infected AFB (+) TB patients in Vietnam per year is still high, which means that the number of MDR-TB patients is not small. Furthermore, there are 350 patients who suffer from chronic pulmonary TB, and most of those cases are MDR-TB, which exacerbates the current state of antimicrobial resistance.
Drug-resistant TB may be caused by the bacteria adapting themselves for survival; patients not following their treatment regimens, reducing their doses or stop taking medications entirely on their own; environmental pollution, spitting and littering in public places, etc.
Those are the reasons for Vietnam having a large number of TB patients with high drug resistance.
1.2.4. Use of HIV medications and resistance of HIV
Since the discovery of the first patient in 1990, until March 31, 2012, there had been 199,744 living HIV patients with 49,369 out of them had AIDS, alongside 52.681 deaths caused by AIDS. The pandemic is still spreading but has had signs of slowing down in recent years, thanks to implementation of intervention programs.
In Vietnam, from the mid-1990s, ARV drugs has been used, albeit limitedly, in a number of large cities and provinces, especially Hanoi and Ho Chi Minh City, under treatment regimens using one or a combination of two ARV drugs.
Since 2005, the three-drug combination treatment regimen based on highly active antiretroviral therapy (HAART) has been mentioned in the Ministry of Health’s national guidelines for diagnosis and treatment for HIV/AIDS, in which adherence to ARV treatment is considered to be one of the prerequisites for the treatment’s success.
The use of ARV also gives rise to ARV-resistant HIV species and the risk of them being spread in the community. In countries which have adopted ARV for many years, 5 to 27% of newly infected HIV patients have HIV-1 species which can resist one type of ARV or more.
According a research on drug resistance carried out in Ho Chi Minh City, the occurrence of drug-resistant HIV in drug addicts, prostitutes and those suffering from sexually transmitted diseases having no prior access to ARV is 6.5%. Research results from the Pasteur Institute in Ho Chi Minh City on pregnant women who had no prior access to ARV and newly infected HIV patients (who are under 30, have more the 500 lympho T CD4 cells per mm3 and no prior access to ARV) show that all had occurrence of drug-resistant HIV less than 5%. Another research in Ho Chi Minh City shows that the occurrence of drug-resistant HIV in pregnant women participating in the Prevention of Mother-to-Child Transmission (PMTCT) program before taking medications is fairly low, at 0.6%. 17.53% of women were found with drug-resistant HIV two weeks after birth, while the figure is only 3.06% two months after birth. 3TC-resistant mutations tend to be found in pregnant women undergoing treatment regimens using AZT+3TC combination and NVP-resistant mutations are found in pregnant women using single-dose NVP. 3TC-resistant mutations tend to be found in pregnant women undergoing treatment regimens using AZT+3TC combination and NVP-resistant mutations are found in pregnant women using single-dose NVP. Even though the occurrence of drug-resistant virus decreases over time after taking preventive drugs, drug-resistant species can still exist under the detectable threshold and can reemerge when the mother undergoes treatment regimens using resisted drugs.
In 2008, the Ministry of Health formulated the national plan on for prevention and surveillance of drug-resistant HIV upon WHO's recommendations. The national plan consists of the following tasks: (1) collection of drug-resistant HIV early warning indices; (2) surveillance of drug-resistant HIV's occurrence in patients undergoing first-line ARV treatment regimen; and (3) investigation of the occurrence of drug-resistant HIV in patients who have not yet undergone ARV treatment.
Since 2008, Vietnam has annually collected data related to ARV treatment results and drug-resistant HIV early warning indices in ARV treatment facilities nationwide.
Surveillance, carried out by some units, of drug-resistant HIV in newly infected patients who had not undergone ARV treatment shows the occurrence of drug-resistant HIV being below 5%.
1.2.5. Antimicrobial use and resistance in crop farming and animal husbandry
In animal husbandry, in order to lower the risk of epidemics, animal farmers tend to employ many types of antimicrobials and stimulants, including veterinary drugs and compounds that are prohibited from circulation, for growth stimulation or disease prevention and treatment in the livestock. Without proper control, such use of veterinary drugs and compounds in animal husbandry can cause a huge risk to the environment and human health, such as antimicrobial resistance in humans, due to antimicrobial residue in feces and urine being transmitted to crops and through water sources to humans, etc. In intensive animal farming, there is abuse of multiple synthetic antimicrobials, and households which use 3 to 6 antimicrobial compounds make up 27% of adult pig farms, 24% of piglet farms and 10% of adult chicken farms (Vu Dinh Ton et al, 2010). Veterinary antimicrobial and chemical use is primarily based on experience, resulting in the farmers increasing the dosage and treatment period on their own. Antimicrobial use based on disease symptoms is 44%, as prescribed by veterinarians is 33%, in compliance with manufacturers’ recommendations is 17%, and only 6% of farms use antimicrobials in accordance with antibiograms (Nguyen Quoc An, 2009) [5].
1.2.6. Hospital-acquired infection and infection control in hospitals
Hospital-acquired infection (HAI) is one of the top challenges and concerns both in Vietnam and worldwide. Many researches show that HAI heightens death rate, prolongs hospital stay and antimicrobial use, increase antimicrobial resistance and treatment costs.
American statistics show that: the cost of treating a patient with HAI tends to be 2 to 4 times more than treating one without HAI. Specifically, the cost incurred due to blood infection related to intravenous tools is from USD 34,508 to USD 56,000, and the cost incurred due to pneumonia in patients using mechanical ventilators is from USD 5,800 to USD 40,000. There are 2 million patients suffers from HAI per year in the US, causing 90,000 deaths and incurring USD 4.5 billion extra in hospital fees.
HAI in Vietnam has not been fully identified. There are few published documents and surveillance results on HAI. The damage HAI have caused to human and financial resources nationwide has also not yet been identified. There are three national-level investigations that have been conducted. One investigation in 1998 on 901 patients in 12 hospitals nationwide shows that the HAI rate was 11.5%, and surgical infections make up 51% of HAI cases. In 2001, the HAI rate measured from 11 hospitals was 6.8%, with hospital-acquired pneumonia being the most common cause (41.8%). An investigation in 2005 shows that the HAI rate measured from 19 hospitals nationwide was 5.7%, with hospital-acquired pneumonia still being the most common cause (55.4%). There has been no research on the costs incurred by HAI.
Diseases caused by HAI have much higher antimicrobial resistance than those caused by infections in the community. HAI caused by highly resistant bacteria such as methicillin-resistant S. aureus, vancomycin-resistant Enterococci, multidrug-resistant A. baumanni and P. aeruginosa make up a considerable proportion.
The current state of HAI control: The infection control system has not met the requirements; the infection control staff is lacking in both numbers and competence, also mostly untrained; the infrastructure and necessary tools for infection control are insufficient, especially in district hospitals; many professional tasks in infection control has not been carried out; no database system of HAI, epidemics, antimicrobial-resistant microorganisms, etc.
2. Causes of antimicrobial resistance
2.1. Inappropriate use of antimicrobials
Antimicrobial overdose, underdose or abuse results in antimicrobial resistance, enabling drug-resistant microorganisms to appear, transform and spread. In fact, many patients buy antimicrobials for self-treatment without doctors’ prescriptions, use antimicrobials to treat conditions which are not infections, use antimicrobials which are inappropriate for the bacteria, viruses and parasites that need to be treated, or inappropriate dosage, content, usage time, etc.
2.2. Limited tests and inspections
The quality inspection system has not satisfied the current demands due to lack of capacity for testing many compounds; inability to ensure quality control of all individual batches of each type of product available on the market.
2.3. Ineffective prevention and control of communicable diseases
Ineffective prevention and control of communicable diseases accelerates the spread of drug-resistant bacteria. Hospitalized patients are a primary transmission method of resistant microorganisms from person to another.
2.4. The surveillance system for antimicrobial resistance has not yet been established
Vietnam currently has no national surveillance network for antimicrobial resistance.
Surveillance of antimicrobial resistance has only been established and implemented in a few units, such as National Hospital of Tropical Diseases, Bach Mai Hospital, 1st Children’s Hospital, etc.
However, those surveillance activities have not been carried out on a regular basis. The lack of test facilities which have sufficient capacity for accurate determination of drug-resistant microorganisms causes difficulties in detection of recently discovered drug-resistant microorganisms, therefore no quick response can be made to contain this state of antimicrobial resistance.
2.5. Inappropriate control of antimicrobial use in animal husbandry
Antimicrobials has become increasingly commonly used in animal husbandry to stimulate growth and prevent diseases. This can give rise to resistant microorganisms and cause antimicrobial resistance in humans.
2.6. Regulations on medical services have not been frequently and constantly updated
Many communicable diseases have insufficient or outdated guidelines for diagnosis and treatment. Besides, regulations on antimicrobial use, antibiograms, microbiological tests have not been comprehensive and perfected; inspection and surveillance during implementation by the local authorities have not been carried out on a regular basis.
Limited awareness of antimicrobial resistance among the public and health staff
The people’s habit of self-treatment and imitating other prescriptions give rise to arbitrary antimicrobial use, contributing to the rise of antimicrobial resistance. Besides, there is a lack of health staff's professional capacity and equipment, means and capacity to make antibiograms in some health facilities, especially those at lower levels, or in remote regions, resulting in patients not being able to use antimicrobials appropriately.
3. Consequences and burdens of antimicrobial resistance
Antimicrobial resistance is not a new phenomenon, but has become more severe over time, and its acceleration greatly affects the community’s health. Hence, nearly 70 years since the introduction of antimicrobials, we are facing the prospect of some infections having no effective antimicrobial treatment, especially infections related to surgery, chemotherapy, tissue and organ transplant.
Besides, antimicrobial resistance causes scarcity and shortage of new antimicrobials, especially those who are suffering from MDR infections.
The social and financial costs of treatment for antimicrobial-resistant infections place considerable burdens on individuals, families and the society due to prolonged treatment period, negative prognoses and waste caused by spending on inappropriate drugs.
II. LEGAL BASIS
1. Law on Medical Examination and Treatement No. 40/2009/QH12, dated November 23, 2009.
2. Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005.
3. Law on Prevention of Infectious Diseases No. 03/2007/QH12 dated November 21, 2007.
4. Law on HIV/AIDS Prevention and Control No. 64/2006/QH11 dated June 29, 2006.
5. Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health.
6. Prime Minister’s Decision No. 1208/QD-TTg dated September 4, 2012 approving the National Health Target Program for the 2012-2015 period.
Section 2
THE PLAN’S SPECIFICS
I. OBJECTIVES
1. Common objectives:
Step up antimicrobial resistance prevention activities, contributing to improving quality and effectiveness of epidemic prevention, medical examination and treatment for the purpose of protection, care and improvement of people's health.
2. Specific objectives:
2.1. Raise awareness of antimicrobial resistance among the public and health staff
2.2. Enhance and perfect the national surveillance system for antimicrobial use and resistance.
2.3. Ensure adequate supply of drugs with good quality, satisfying the demand for care of people’s health.
2.4. Step up safe and appropriate drug use
2.5. Step up infection control
2.6. Step up appropriate and safe use of antimicrobials in crop farming, animal husbandry and aquaculture
II. ACTIVITIES TO BE UNDERTAKEN
1. Raise awareness of antimicrobial resistance among the public and health staff
1.1. Activities
a) Produce continuous training documents and develop communication materials.
b) Organize communication activities, including direct communication (talks, seminars, consultations, etc.) and indirect communication through the mass media (TV spot, radio spot, knowledge dissemination, newspaper articles, etc.)
1.2. Time and roadmap
Phase 1 (From 2013 to 2016):
a) Create communication materials such as leaflets, billboards, posters, booklets, video spots, TV spots on propagation and dissemination of causes, consequences of antimicrobial resistance and methods of antimicrobial resistance prevention.
b) Create materials providing guidelines for prevention of antimicrobial resistance for health staff and the community.
c) Organize seminars, talk and consultation sessions to answer queries concerning prevention of antimicrobial resistance through the mass media.
d) Organize communication activities for health education on prevention of antimicrobial resistance through the mass media, from central to local level.
e) Organize antimicrobial resistance prevention months nationwide.
f) Organize conferences for drills, dissemination and education about laws on prevention of antimicrobial resistance.
g) Organize continuous training courses and drills in communication skills, surveillance and evaluation of antimicrobial resistance prevention.
Phase 2 (From 2016 to 2020):
Continue maintaining communication activities alongside surveying and evaluating the community’s knowledge about antimicrobial resistance.
2. Enhance, improve and perfect the national surveillance capacity for antimicrobial use and resistance
2.1. Activities
a) Create and perfect documents regulating clinical microbiological tests, the standard testing process, building standard microbiological laboratories and reference laboratories;
b) Establish a surveillance system for antimicrobial resistance;
c) Participate in creating curriculums and syllabuses for microbiology and antimicrobial in medical-pharmaceutical universities and vocational schools;
d) Conduct continuous training courses and drills in order to improve the staff’s capacity for carrying out clinical microbiological tests and research on antimicrobial resistance;
e) Formulate collaborative continuous training programs on antimicrobial resistance prevention between medical and pharmaceutical schools, both domestic and overseas.
f) Create a database of antimicrobial use and resistance.
2.2. Time and roadmap
2.2.1. Phase 1
a) Create and perfect standard testing processes and guidelines for clinical microbiological test.
b) Establish the National Center for Clinical Microbiological Test.
c) Conduct drills and continuous training courses in clinical microbiological technical expertise for the staff of the National Center and 30 testing laboratories nationwide.
d) Form functions, tasks, organizational structure, manpower and equipment for the clinical microbiological laboratories.
e) Organize overseas training courses in surveillance of antimicrobial resistance.
f) Establish a surveillance network for antimicrobial use and resistance in 30 testing laboratories nationwide.
g) Create new templates and softwares for surveillance of and report on antimicrobial use and resistance.
h) Conduct scientific research projects on antimicrobial resistance.
i) Participate in scientific conferences on antimicrobial resistance, both domestic and worldwide.
2.2.2. Phase 2
a) Complete a database of antimicrobial use and resistance.
b) Create a set of evaluation indices, establish an information gathering and processing system, create a website about monitoring, surveillance and evaluation of antimicrobial resistance.
c) Organizes scientific conferences on prevention of antimicrobial resistance.
3. Ensure adequate supply of essential drugs with good quality
3.1. Activities
a) Perfect and update the system of documents regulating the lists of essential drugs and drugs primarily used in medical facilities;
b) Invest in production of drugs with good quality and reasonable prices for the market;
c) Comprehensive drug quality control in production, import, export, circulation and use.
3.2. Time and roadmap
3.2.1. Phase 1
a) Update the list of essential and primary drugs to fit the disease circumstances and socioeconomic conditions of Vietnam, to be suitable for scientific and technological progress in each particular phase and technical expertise in each level.
b) Carry out monitoring and surveillance of counterfeit drugs circulating in the market.
c) Continue stepping up implementation of the “Vietnamese people prioritizes Vietnamese drug” project.
d) Formulate, propose mechanisms and solutions for domestic pharmaceutical enterprises to prioritize production of generic drugs.
e) Invest in production of drugs with good quality and reasonable prices for the market.
3.2.2. Phase 2
Continue the pre-2015 phase’s activities alongside organizing themed scientific conferences and facilitating patients’ access to essential drugs.
4. Step up safe and appropriate drug use
4.1. Activities
a) Create, complete and update documents regulating and providing guidelines for appropriate drug use; guidelines for antimicrobial use; guidelines for treatment;
b) Organize seminars, conferences, drills and continuous training courses in prescription and clinical pharmaceutical practice.
c) Improve the work capacity of the Drug and Treatment Council;
d) Organize seminars and conferences on safe and appropriate drug use, evaluate the Drug and Treatment Council’s activities.
e) Carry out monitoring, inspection and surveillance of safe and appropriate drug use in medical facilities.
e) Create and complete training and continuous training programs for clinical pharmaceutical practice.
4.2. Time and roadmap
4.2.1. Phase 1
a) Create, update and promulgate Guidelines for treatment.
b) Create Guidelines for antimicrobial use materials for health staff and the community.
c) Conduct drills and continuous training courses in prescription and clinical pharmaceutical practice.
d) Create regulations on the Drug and Treatment Council’s activities.
e) Conduct drills and continuous training courses in Guidelines for treatment to health staff.
f) Evaluate compliance with Guidelines for treatment in medical facilities.
g) Create documents regulating drug use assessment.
h) Create a set of indices for drug use assessment in hospitals and the community.
i) Carry out surveillance and assessment of drug use, surveillance of compliance with treatments, step up the Drug and Treatment Council’s activities in medical facilities.
j) Organize conferences on drug use assessment and the Drug and Treatment Council’s activities in health facilities.
4.2.2. Phase 2
a) Collaborate in researching drug use, especially antimicrobials.
b) Conduct drills and continuous training courses, both domestic and overseas, in drug information, drug use, and clinical pharmaceutical practice.
c) Manage and gather information, assess drug use indices
d) Organize scientific conferences on antimicrobial use and resistance.
5. Step up infection control
5.1. Activities
a) Perfect and update documents regulating infection control;
b) Conduct drills, continuous training courses, inspections, surveillance and evaluation of infection control to health staff.
c) Accelerate establishment of a surveillance network and data report system in order to form an infection control database.
5.2. Time and roadmap
5.2.1. Phase 1
a) Amend, update and promulgate legislative documents, policies, national technical regulations and documents providing guidelines for hospital-acquired infection control.
b) Perfect the organization of infection control pursuant to Circular No. 18/2009/TT-BYT dated October 14, 2009 providing guidelines for organizing the implementation of infection control in medical facilities.
c) Conduct drills and continuous training courses for improving knowledge and practical skills of infection control to health staff and infection control staff in health facilities.
d) Create infection control surveillance indices.
e) Establish a surveillance and data report system for hospital-acquired infection in hospitals affiliated with the Ministry of Health and provincial general hospitals.
5.2.2. Phase 2
a) Step up scientific research in the field of infection control.
b) Organize National Scientific Conferences biennially and International Scientific Conferences on Infection Control once every 5 years.
6. Step up appropriate and safe use of antimicrobials in crop farming, animal husbandry and aquaculture
6.1. Activities
a) Create documents regulating and providing guidelines for use of antimicrobials and growth stimulants in crop farming, animal husbandry and aquaculture.
b) Create a list of allowed antimicrobials and regulations on antimicrobial residue limits in crop farming, animal husbandry and aquaculture.
c) Create a surveillance system for appropriate and safe use of antimicrobials in crop farming, animal husbandry and aquaculture.
6.2. Time and roadmap
6.2.1. Phase 1
a) Create documents regulating antimicrobial use in crop farming, animal husbandry and aquaculture.
b) Create regulations on allowed antimicrobials and antimicrobial residue limits in crop farming, animal husbandry and aquaculture.
c) Create a surveillance system for antimicrobial use in crop farming, animal husbandry and aquaculture.
6.2.2. Phase 2
a) Collaborate in researching and assessing antimicrobial use and resistance in crop farming, animal husbandry and aquaculture.
b) Assess antimicrobial use and resistance in crop farming, animal husbandry and aquaculture.
c) Continue carrying out antimicrobial resistance prevention activities.
Section 3:
SOLUTIONS
I. MECHANISMS, POLICIES AND MANAGEMENT
1. Gradually perfect the legislative document system and create technical guidelines for control of communicable diseases and infection, surveillance of antimicrobial resistance, step up appropriate drug use.
2. Perfect the legislative document system for antimicrobial use in crop farming, animal husbandry and aquaculture.
3. Step up inspection and surveillance of implementation of professional regulations related to guidelines for treatment, drug use, hospital drugstores and infection prevention in health facilities.
4. Step up assessment of TB epidemic, drugs, equipment, TB in HIV/AIDS patients and drug resistance of TB bacteria.
5. Increase surveillance of drug quality, prevent circulation of low-quality and counterfeit drugs.
6. Increase the management capacity for the following programs: prevention of TB, HIV/AIDS and antimicrobial resistance, alongside infection control.
II. INFORMATION, COMMUNICATION, EDUCATION
1. Step up dissemination, propagation and education about laws on safe and appropriate drug use.
2. Raise awareness of antimicrobials and antimicrobial resistance among the community, health staff, crop farmers, animal farmers and aquaculturists.
3. Carry out antimicrobial resistance prevention month programs.
4. Step up educational communication among the people, gradually increase private sector participation in TB prevention: mobilize, request and make use of members of the society, patients’ family members to participate in TB prevention in all levels and forms.
III. TECHNICAL EXPERTISE AND TRAINING
1. Perfect professional guidelines, technical processes of diagnosis, treatment, microbiological test and surveillance of antimicrobial resistance for the implementing units to follow.
2. Step up training and improving health staff’s professional capacity, diversify training types; provide continuous, supplementary, domestic and overseas training in diagnosis and treatment, especially for communicable diseases; microbiological test; infection control, surveillance of antimicrobial resistance in health facilities.
3. Perfect curriculums and syllabuses for microbiology and antimicrobial in medical universities and vocational schools;
4. Increase investment in infrastructure; provide vehicles and equipment in order to meet the demand for infection control, microbiological test, surveillance of antimicrobial resistance, drug quality test.
5. Upgrade microbiological testing laboratories and research centers in central hospitals and domestic medical universities.
6. Continue improving drug quality and carry out bioequivalence assessment.
7. Ensure adequate supply of drugs specified in the essential list in medical facilities.
8. Perfect the data collection and statistics report system, gradually modernize and integrate information technology in order to manage data online and nationwide.
9. Combine national anti-TB activities with other national health programs at district and commune levels.
IV. FINANCE
Draw investment from state budget, official development assistance (ODA) funds and other legal funding sources in order to carry out the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020:
1. Domestic: The units ensure funding sources to carry out activities within their assigned scopes and state budget being provided in accordance with annual and 5-year plans.
2. Mobilize funding sources from international and non-governmental organizations: WHO, FAO, GARP – Vietnam, UNAIDS, the World Bank, etc.
V. SCIENTIFIC RESEARCH AND INTERNATIONAL COOPERATION
1. Step up research on and transfer of new techniques in diagnosis and treatment for communicable diseases, microbiological test, verification of microbiological test quality.
2. Increase research capacity for drug use assessment, antimicrobial resistance, especially extensively drug-resistant bacteria.
3. Step up research on hospital-acquired infection.
4. Cooperate with related units in stepping up research on antibiotic, antiviral, antiparasitic use assessment, antimicrobial resistance, especially extensively drug-resistant bacteria.
5. Enhance international cooperation, exchange and share of experience, participate in specialized scientific seminars, conferences, forums on prevention and control of communicable diseases, appropriate drug use, hospital-acquired infection, verification of microbiological test quality, antimicrobial resistance.
6. Carry out international cooperation in continuous training, researching on drug use, clinical pharmaceutical practice.
Section 4:
IMPLEMENTATION
I. Establishment of Steering Committee
1. Head of Committee: Minister of Health
2. Vice heads of committee: Vice Ministers of Health and Agriculture and Development
3. Members: Director Generals and Deputy Director Generals of the following administrations: Medical Services, Food Safety, Preventive Healthcare, HIV/AIDS Control, Drug, Health Environment Management, Science, Technology and Training; Director Generals and Deputy Director Generals of the following Departments: Planning and Finance, Medical Equipment and Works, Medical Insurance;
Ministry of Health’s inspector; relevant Administrations and Departments of the Ministry of Agriculture and Rural Development.
4. Secretaries: Representatives of relevant Administrations and Departments of the Ministry of Health and the Ministry of Agriculture and Rural Development.
5. Specialized subcommittees:
a) Infection control subcommittee
b) Treatment subcommittee (communicable disease, intensive care, HIV/AIDS, TB)
c) Surveillance and inspection of antimicrobial use committee
- Prevention, diagnosis and treatment in health facilities and the community
- Crop farming, animal husbandry and aquaculture
d) Logistics subcommittee
e) Communication and education subcommittee
6. Permanent division: Medical Services Administration
II. ALLOCATION OF IMPLEMENTATION RESPONSIBILITIES
1. Units affiliated with the Ministry of Health
1.1. Medical Services Administration
a) Act as the cooperative link to related units to direct and provide instructions on implementation; consolidate the Plan's action results to report to the Minister and Deputy Ministers of Health.
b) Create technical guidelines for control of communicable diseases, treatment regimens, surveillance of antimicrobial resistance, drug use;
Organize inspection and surveillance of implementation of professional regulations related to guidelines for treatment, drug use and infection control in health facilities.
d) Establish the national surveillance system for antimicrobial resistance; carry out monitoring, management, surveillance and issue warnings about antimicrobial resistance and its danger; create a database of antimicrobial use and resistance; conduct drills and continuous training courses in clinical microbiology for the staff of the National Center and 30 testing laboratories nationwide;
e) Establish a surveillance and data report system for hospital-acquired infection in hospitals affiliated with the Ministry of Health and provincial general hospitals.
f) Carry out surveillance and assessment of drug use, surveillance of compliance with treatments, step up the Drug and Treatment Council’s activities in medical facilities.
g) Organize assessment of TB epidemic, drugs, equipment, TB in HIV/AIDS patients and drug resistance of TB bacteria.
1.2. Drug Administration
a) Implement measures for improving drug quality and bioequivalence assessment.
b) Supply drugs specified in the essential list in medical facilities adequately.
c) Carry out monitoring and surveillance of counterfeit drugs circulating in the market.
1.3. HIV/AIDS Control Administration
a) collect data related to ARV treatment results, drug-resistant HIV early warning indices in facilities specializing in treatment for HIV/AIDS nationwide.
b) Carry out monitoring, surveillance and evaluation of drug-resistant HIV in patients undergoing treatment and newly infected patients having no prior ARV treatment.
c) Implement measures for improving capacity of HIV’s drug resistance testing laboratories.
1.4. Preventive Healthcare Administration
Carry out monitoring, surveillance and assessment of antimicrobial use and resistance in the community.
1.5. Food Safety Administration
Carry out monitoring and surveillance of antimicrobial residue in food which directly affects people’s health.
1.6. Ministerial Inspector
Organize inspection of antimicrobial trading without prescriptions.
1.7. Planning and Finance Department
a) Instruct related units to make annual expense forecast based on the assigned tasks of the plan.
b) Draw investment from state budget, ODA funds and other legal funding sources in order to carry out the National Action Plan to Combat Antimicrobial Resistance From 2013 To 2020.
c) allocate regular funds to hospitals for implementation of preventive measures against antimicrobial resistance.
1.8. Medical Insurance Department, Health Environment Management Administration
Cooperate with related units in implementing the Action Plan in accordance with the assigned functions and tasks.
1.9. Science, Technology and Training Administration
a) Propose, support and prioritize research on and transfer of new techniques in diagnosis of communicable diseases and microbiological test.
b) Provide training to improve research capacity for drug use assessment, antimicrobial resistance, especially extensively drug-resistant bacteria and hospital-acquired infection.
c) Step UP continuous training with appropriate forms, both domestic and overseas, in order to increase health staff’s professional capacity.
d) Perfect curriculums and syllabuses for microbiology and antimicrobial in medical and pharmaceutical educational facilities.
1.10. Communication and Reward Department
Preside over and cooperate with related units in dissemination, propagation and education for raising the community and health staff's awareness of antimicrobial resistance prevention, advocate organization of antimicrobial resistance prevention months.
1.11. Provincial Departments of Health
Instruct units within their jurisdictions to formulate and implement plans, allocate resources for implementation of the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020, in ways that are appropriate for each region’s circumstances.
1.12. Hospitals
a) Formulate specific plans which are suitable for each unit’s circumstances in order to implement the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020.
b) Allocate resources for antimicrobial resistance prevention activities: upgrade microbiological laboratories, step up infection control; carry out inspection and surveillance of inappropriate antimicrobial use, etc.
2. Ministry of Agriculture and Rural Development
The Ministry of Agriculture and Rural Development assign units to cooperate with the Ministry of Health in order to direct and provide guidelines for creating regulations on antimicrobial use, list of allowed antimicrobials, antimicrobial residue limits in crop farming, animal husbandry and aquaculture. Carry out inspection and surveillance for antimicrobial use in crop farming, animal husbandry and aquaculture.
REFERENCES
1. WHO, 2012. Global Tuberculosis Control.
2. US and EU, 2011. Transatlantic Taskforce on Antimicrobial Resistance.
3. Song, J-H. and ANSORP members (2004). High Prevalence of Antimicrobial Resistance among Clinical Streptococcus pneumoniae Isolates in Asia (an ANSORP Study). Antimicrobial Agents and Chemotherapy 2004; 48(6): 2101–2107.
4. Lee, K. et al, 2010. Increase of Ceftazidime- and Fluoroquinolone-Resistant Klebsiella pneumoniae and Imipenem-Resistant Acinetobacter spp. in Korea: Analysis of KONSAR Study Data from 2005 and 2007. Yonsei Medical Journal 2010; 51(6): 901-911.
5. GARP, 2010. Situation Analysis on Antibiotic Use and Resistance in Vietnam.
6. Ministry of Health, 2009. First report on antibiotic use and resistance in Vietnam hospitals in 2008-2009.
7. Ly, N.K., Ngo, T.B.H. et al., 2011. Study on the role of antimicrobial use in hospital-acquired infection in some medical facilities’ intensive care units from 2009 to 2010.
File gốc của Decision No. 2174/QD-BYT dated June 21,2013 ratification of the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020 đang được cập nhật.
Decision No. 2174/QD-BYT dated June 21,2013 ratification of the National Action Plan to Combat Antimicrobial Resistance from 2013 to 2020
Tóm tắt
Cơ quan ban hành | Bộ Y tế |
Số hiệu | 2174/QD-BYT |
Loại văn bản | Quyết định |
Người ký | Nguyễn Thị Kim Tiến |
Ngày ban hành | 2013-06-21 |
Ngày hiệu lực | 2013-06-21 |
Lĩnh vực | Thể thao - Y tế |
Tình trạng | Còn hiệu lực |