Quyết định 772/QĐ-BYT 2016 về Hướng dẫn thực hiện quản lý sử dụng kháng sinh trong bệnh viện

THE MINISTRY OF HEALTH

Decision No. 772/QD-BYT dated March 04, 2016 of the Ministry of Health on issuing the “Instructions on management of the antibiotic use in hospitals”

Pursuant to the Law 2009 on medical examination and treatment;

Pursuant to the Government s Decree No. 63/2012/ND-CP dated 31 August 2012 on the functions, missions, authority and organizational structure of the Ministry of Health;

Pursuant to the Decision No. 2174/QD-BYT dated 21 June 2013 on the approval of the National action plan for combating antibiotic resistance from 2013 to 2020;

At the request of the Head of the Agency of Health examination and treatment,

DECIDES:

Article 1.This Decision is enclosed with the “Instruction on management of the antibiotic use in hospitals”.

Article 2.The “Instruction on management of the antibiotic use in hospitals” issued with this Decision shall apply to hospitals.

The Director of each hospital shall have the Instruction applied accordingly.

Article 3.This Decision takes effect on the signing date.

Article 4.Chief of the Ministry s Office, Chief of the Ministry s Inspectorate, Head of the Agency of Health examination and treatment, Heads of Faculties of the Ministry of Health, Directors of hospitals and institutes with medical beds under the Ministry of Health, Directors of Faculties of Health of provinces and centrally affiliated cities, Medical heads of sectors and Heads of relevant units are held responsible for enforcing this Decision./.

For the Minister

The Deputy Minister

Nguyen Thi Xuyen

INSTRUCTIONS

ON MANAGEMENT OF THE USE OF ANTIBIOTICS IN HOSPITALS
(Issued with the Decision772/QD-BYT dated 04 March 2016)

I. OBJECTIVES

1. Uphold the rational use of antibiotics

2. Alleviate undesirable effects of antibiotics

3. Augment the quality of medical attention

4. Preclude antibiotic-resistant bacteria

5. Reduce medical expenses

II. REQUIREMENTS (For implementers)

1. The use of antibiotics shall be managed by a body whose members’ roles, functions and missions must be determined. The core of the body shall be the hospital’s Medicine and Treatment Council s subcommittee for supervision of antibiotic use and surveillance of antibiotic resistance in common pathogenic bacteria.

2. Establish annual plans and carry out activities to manage the use of antibiotics in the hospital.

3. Inspect and supervise activities and implement interventions.

4. Evaluate and report, via the regulated form, the use of antibiotics and level of antibiotic resistance in pathogenic bacteria in the hospital.

III. IMPLEMENTATION

A. The establishment of the body for management of the use of antibiotics

1. Medicine and Treatment Council provides counsels to the hospital s leadership to make decisions on the establishment of the body for management of the use of antibiotics (referred to as the antibiotic management body) in the hospital and on the missions assigned to each of its members, whose roles and mutual supports must be defined.

2. The constituents of the antibiotic management body:

a) Main members: Bacterial disease/clinical doctors, clinical pharmacists, microbiologists, bacterial contamination control specialists, representatives of General planning faculty and Quality control faculty.

b) Other members: nurses, information technology specialists and personnel of the patient safety committee (if any).

3. The procedure of the antibiotic management body’s activities is summarized in the flow chart in Appendix 1.

B. The duties of the antibiotic management body to support the Director of the hospital:

1. Contributions to the establishment of regulations on the management of the use of antibiotics in the hospital

a) Participate in the establishment of guidelines for the use of antibiotics according to:

- Pathogenic model of hospital-acquired bacterial diseases.

- Ministry of Health’s guidelines for the use of antibiotics.

- Medical evidence and level of antibiotic resistance in bacteria in the hospital.

- Guidelines for treatments and international reference documents: Infectious Diseases Society of America (IDSA), Agency for Healthcare Research & Quality (AHRQ), U.S. National Library of Medicine (MEDLINE), National Institute for Health and Care Excellence of the United Kingdom (NICE-UK), Cochrane Library, Canadian Medical Association (CMA), etc.

Essential details for the production of documents:

- Guidelines for choice of antibiotics:

+ The choice of antibiotics is subject to the characteristics of the pathogen and patient, positions of bacterial infections, pharmacokinetics, pharmacodynamics and drug resistance model.

Clear indications of bacteria and results of antibiotic susceptibility tests facilitate the choice of the best effective and least virulent antibiotic that has the narrowest spectrum in correlation with the pathogens identified.

+ De-escalate antibiotic treatment according to antibiotic susceptibility tests.

+ Prioritize 01 type of antibiotics according to antibiotic susceptibility tests.

+ Combine antibiotics only to intensify the destruction of bacteria, decrease the possibility of resistant species appearing and treat infections caused by various types of bacteria.

- Guidelines for optimization of dosage:

+ Dosage of antibiotics is subject to the intensity of the illness, patient s age and weight, liver and kidney functions.

+ Optimize dosage according to the pharmacokinetics/pharmacodynamics of the medicine.

+ The level of drug in the blood must be maintained as per recommendations to avert toxicity if medicine concentration in the blood, highly virulent bacteria and narrow-spectrum traits (e.g. aminoglycoside, polypeptide) can be monitored.

- Guidelines for switching antibiotics from intravenous to oral administration when permissible

+ Appendix 2 regulates criteria to determine a patient s eligibility to switch from intravenous to oral administration of antibiotics. Appendix 3 stipulates the list of antibiotics switched from intravenous to oral administration.

- Guidelines for the use of antibiotic prophylaxis according to specific conditions of each faculty of the hospital.

b) Participate in the making of the list of antibiotics requiring medical consultation before prescription

- The list of antibiotics requiring medical consultation before prescription shall base on the list of antibiotics marked with an asterisk as per the Ministry of Health’s regulations.

c) Participate in the establishment of the list of antibiotics ratified before use, prescription request form and procedures for the ratification of such antibiotics.

- The list of antibiotics ratified before use comprises strong and highly virulent antibiotics with narrow spectrum, which are active against infections caused by multidrug-resistant bacteria or for rare indications. This list of antibiotics must adhere to specific conditions of each hospital and the list of antibiotics requiring ratification in Appendix 4.

- The procedures for prescription of antibiotics ratified before use, as per Appendix 5, must adhere to actual conditions of the hospital.

- The antibiotics request form, as per Appendix 6, must be approved before use.

d) Participate in the development of guidelines for treatments against bacterial diseases commonly found in a hospital For example:

- Septicemia.

- Upper respiratory tract infection.

- Lower respiratory tract infection.

- Urinary tract infection.

- Soft tissue infections.

dd) Participate in the preparation of documents and guidelines for clinical microbiology

- Contribute to the establishment of procedures and guidelines for proper extraction, storage, transport and acquisition of clinical specimens by the clinical faculty and microbial faculty.

- Contribute to the establishment of standard test procedures for accuracy and reliability.

e) Participate in the establishment of procedures and rules for basic bacterial infection control, such as:

- Procedures:

+ Hand sanitization.

+ Sterilization of surgical instruments.

+ Sterilization of surgical rooms.

+ Instrument steaming and handling process.

+ Clinical specimen processing process.

+ Autoclave sterilization process.

- Rules:

+ Use of personal protection apparatus during the processing of clinical specimens.

+ Environmental cleaning for healthcare.

+ Management of garments for prevention of contagion.

+ Quarantine of patients infected by multidrug-resistant bacteria.

2. Norms for evaluation

a) Norms of antibiotic use:

- Quantity, percentage of patients prescribed with antibiotics.

- Quantity, percentage of antibiotics prescribed according to the guidelines.

- Quantity, percentage of surgical operations prescribed with antibiotic prophylaxis.

- Quantity, percentage of patients prescribed with one antibiotic.

- Quantity, percentage of patients prescribed with a combination of antibiotics.

- Quantity, percentage of patients prescribed with intravenous antibiotics.

- Average days of therapy.

- Defined daily dosage of each antibiotic.

- Quantity, percentage of patients who cease using antibiotics or administer antibiotics orally in lieu of injection in specific circumstances.

b) Norms of hospital-acquired bacterial infection

- Percentage of patients out of total inpatients, who succumb to hospital-acquired infections.

- Percentage of surgical operations out of total operations, which result in post-operative infections.

- Percentage of patients out of total patients on breathing machines, who acquire ventilator-associated pneumonia.

- Percentage of patients out of total patients with central venous catheter, who incur catheter-related sepsis.

- Percentage of patients out of total patients with urinary catheter, who obtain urinary tract infections.

- Ratio of hand sanitizers used to total medical beds.

- Percentage of quarantined cases with infections caused by multidrug-resistant bacteria (including carbapenem).

c) Norms of drug resistance level (in conformity to EUCAST or CLSI):

- Quantity and percentage of bacteria resistant to each antibiotic in each specimen per faculty or in the clinical sector;

- Quantity and percentage of bacteria producing extended spectrum beta-lactamase (ESBL);

- Quantity and percentage of methicillin-resistant staphylococcus aureus (MRSA);

- Quantity and percentage of intermediate-level vancomycin-resistant staphylococcus aureus (MRSA);

- Quantity and percentage of vancomycin-resistant enterococci (VRE);

- Quantity and percentage of carbapenem-resistant bacteria;

- Quantity and percentage of colistin-resistant bacteria;

- Quantity and percentage of antibiotic-resistant clostridium difficile;

d) Other norms:

- Quantity and percentage of medical officials who adhere to guidelines (treatment, antibiotic use, microorganism, bacterial infection control).

3. Determination of interventions via surveys of antibiotic use and drug resistance level

a) Antibiotic use survey:

- The tendencies of antibiotic therapy in each faculty or the entire hospital shall be summated and analyzed (according to DDD, ABC, etc.)

- Chronological change of antibiotic use shall be recorded.

- Faculties/department that use plenteous or zero amount of antibiotics shall be identified according to the rules on the use of antibiotics

- The use of antibiotics shall be evaluated according to the norms established.

- Rational prescription of antibiotics refers to antibiotic choice, route, duration, de-escalation or discontinuation of therapy according to the results of antibiotic sensitivity tests that identify pathogenic bacteria.

b) Antibiotic resistance level survey

Data on antibiotic-resistant bacteria, which, in particular, cause common hospital-acquired infections, shall be compiled and analyzed according to the norms of drug resistance level and the hospital’s drug resistance model.

4. Interventions

Physicians, pharmacists and nurses shall undergo regular training and drills on the antibiotic stewardship program including the compliance to guidelines, rules and working methods to enhance the efficiency of the management of antibiotic use in the hospital.

a) Guidelines for diagnosis, therapy and antibiotic use shall be updated.

b) Training and drills on diagnosis and treatment of bacterial diseases and rational prescription of antibiotics shall be carried out.

c) Training and drills for microbial and medical officials on techniques of sampling, culture, isolation and identification of bacteria, antibiotic susceptibility test.

d) Medical personnel shall be trained and drilled in methods for bacterial infection control, handling of specimens and medical instruments for surgery, etc.

5. Post-intervention assessment and feedback

a) Analyze post-intervention tendencies of antibiotic use, drug resistance level and conditions of bacterial infection in comparison to those before interventions.

b) Provide feedbacks to the hospital’s leadership via monthly/quarterly/yearly analysis reports.

c) Provide feedbacks to physicians directly or via documents retained in the clinical faculty. Provide information to faculty heads and prescribers, publish information on bulletins and present data in pre-shift meetings and seminars in the hospital, and make reports to the Council of medicine and treatment.

d) Conduct assessments and provide feedbacks to the hospital’s leaderships and physicians in regular manner until the rational use of antibiotics.  Transcribe results of the assessments and changes in the use of antibiotics after interventions.

e) Assess the performance of the hospital’s antibiotic management body according to Appendix 7.

6. Information and report

a) Provide information of the hospital’s bacterial disease model.

b) Monitor and report the use of antibiotics via the regulated form and at the requests for antibiotic type/group, faculty/department, and the entire hospital.

c) Report the percentage of hospital-acquired infections according to Appendix 8.

d) Give data reports on the antibiotic resistance in common pathogenic bacteria through WHONET.

Hard copies of reports shall be periodically sent to the Ministry of Health (Agency of Health examination and treatment) while soft copies are delivered toquanlysudungkhangsinh@gmail.com

IV. ENFORCEMENT

1. Responsibilities of the Director of the hospital:

a) Direct the Subcommittee for supervision of antibiotic use and surveillance of antibiotic resistance in common pathogenic bacteria under the Council of Medicine and Treatment, Faculty of pharmacy and relevant faculties to develop and execute the Antibiotic stewardship program.

b) Make investments, give supports and encouragement to have the Program executed in effective manner.

c) Direct the tight coordination between the Council of Medicine and Treatment and the Council of bacterial infection control.

2. Responsibilities of heads of clinical faculties:

a) Conform to professional guidelines, procedures and rules in effect.

b) Make proper decisions antibiotic choice, dose, route and duration to optimize antibiotic dosage for each patient, pathogenic bacterium and position of infection.

c) Consult microbial specialists and clinical pharmacists before the use of antibiotics.

d) Monitor the process of therapy and assess the effectiveness of antibiotics used to change and adjust antibiotics for the best clinical achievements and least antibiotic effects undesirable (antibiotic toxicity, rise of resistant bacteria, selective trait of pathogenic bacteria such asClostridium difficile)

dd) Provide guidance and cooperate with others to carry out research to evaluate the efficiency of new antibiotic stewardship methods and of the Antibiotic stewardship program.

3. Responsibilities of the Head of the Faculty of microorganism:

a) Direct the culture and identification of common pathogenic bacteria and fungus in specimens such as blood, pus, excrement, urine, phlegm, fluid, etc, and carry out antibiotic susceptibility tests upon the detection of causes of diseases.

b) Provide data on the results of the culture and susceptibility of bacteria to antibiotics to optimize the use of antibiotics for each patient;

c) Provide high-quality findings of antibiotic susceptibility tests in timely manner.

d) Revise antibiotic susceptibility test techniques on annual basis to maintain accuracy and conformity to each hospital’s use of antibiotics.

dd) Supervise and provide information on the hospital’s antibiotic resistance model.

e) Provide guidance and cooperate with others to carry out research to evaluate the efficiency of new antibiotic stewarship methods and of the Antibiotic stewardship program.

4. Responsibilities of the Head of the Faculty of pharmacy;

a) Propose the list of antibiotics to be limited in the hospital and antibiotics ratified before use, procedures to make requests for prescription of antibiotics that require ratification.

b) Maintain timely and adequate supply of medicines.

c) Provide information on the pharmacodynamics and pharmacokinetics of antibiotics.

d) Provide information, documents and evidences on antibiotic changes.

dd) Assess the use of antibiotics in faculties/departments to make reports and propose changes of antibiotics (change of broad-spectrum antibiotics to narrow-spectrum ones, adjustment of dosage, switching of route of delivery, revision of intervals).

e) Adjust dosage for patients with liver/kidney failure.

g) Provide guidance and cooperate with others to carry out research to evaluate the efficiency of new antibiotic stewarship methods and of the Antibiotic stewardship program.

5. Responsibilities of the Head of the Faculty of bacterial infection control:

a) Establish and enforce rules on the seclusion of patients infected by multidrug-resistant bacteria while guiding and supervising the faculties’ compliance.

b) Regulate details of methods for basic bacterial infection control, such as hand sanitization, use of protective apparatus, sterilization of instruments, equipment and ambiance.

c) Regulate details of sectors/faculties/areas given priority and tighten the supervision and control of bacterial infections in operating theaters, postoperative care rooms, recovery rooms; cleaned hands of surgeons, doctors and nurses; surgical instruments, breathing tube, nasal cannula, endoscopic tools, garments and other items after sterilization, hospital s daily water, distilled water for rinsing tools and in oxygen warming containers, etc.

d) Facilitate the supervision of multidrug-resistant bacteria and coordinate with the Faculty of microorganism to find causes and sources of outbreaks of hospital-acquired infections (through molecular epidemiology).

6. Responsibilities of the Head of Information technology:

Information technology shall be upholded to optimize the management of antibiotic use via the compiling, analysis and integration of information in electronic medical records; doctors’ medical orders, microorganism-related findings; patients’ kidney function, liver function and history for drug allergies; drug interaction, drug costs.

7. Responsibilities of heads of other faculties and medical officials:

Faculties/departments and medical personnel concerned shall be held responsible for performing tasks subject to their functions and missions.