Nghị định 131/2020/ND-CP

DECREE

PROVIDING FOR CLINICAL PHARMACOLOGY ORGANIZATION AND ACTIVITIES IN HEALTHCARE ESTABLISHMENTS

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Law on Pharmacy dated April 06, 2016;

At the request of the Minister of Health;

The Government hereby promulgates a Decree providing for clinical pharmacology organization and activities in healthcare establishments.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for clinical pharmacology organization; clinical pharmacology activities and responsibility for clinical pharmacology activities of healthcare establishments administering drugs according to regulations of law on medical examination and treatment.

Article 2. Regulated entities

This Decree is applicable to healthcare establishments administering drugs according to regulations of law on medical examination and treatment, including healthcare establishments of the people's armed force; and Vietnamese and foreign organizations and individuals involved in clinical pharmacology organization and activities in Vietnam.

Chapter II

CLINICAL PHARMACOLOGY ORGANIZATION

Article 3. Clinical pharmacology unit and number of persons in charge of clinical pharmacology

1. Clinical pharmacology unit:

a) The clinical pharmacology unit, which is affiliated to the pharmacy department of each healthcare establishment, shall carry out clinical pharmacology activities at the establishment to serve outpatients having health insurance and inpatients;

b) Healthcare establishments that do not have a pharmacy department in accordance with regulations of law on medical examination and treatment (hereinafter referred to as “healthcare establishments without a pharmacy department”) must have a clinical pharmacology unit to carry out clinical pharmacology activities serving outpatients having health insurance and inpatients;

c) For healthcare establishments operating a pharmacy, pharmacies on the premises of these healthcare establishments shall carry out clinical pharmacology activities in the pharmacies to serve drug buyers.

2. Number of clinical pharmacology supervisors and clinical pharmacologists:

a) Healthcare establishments with at least 200 hospital beds shall have 01 clinical pharmacology supervisor, at least 01 clinical pharmacologist for every 200 inpatient beds and at least 01 clinical pharmacologist for every 1.000 prescriptions given to outpatients having health insurance in a day;

b) Healthcare establishments with fewer than 200 hospital beds or healthcare establishments without a pharmacy department shall have at least 01 clinical pharmacology supervisor cum clinical pharmacologist serving inpatients (if any) and at least 01 clinical pharmacologist for every 1.000 prescriptions given to outpatients having health insurance in a day;

c) A pharmacy on the premises of a healthcare establishment must have at least 01 clinical pharmacologist for every business location of the pharmacy. The chief pharmacist of the pharmacy may also be in charge of clinical pharmacology therein.

3. Roadmap to increase of number of clinical pharmacologists in healthcare establishments:

a) By January 01, 2026 at the latest, hospitals of class II and higher must ensure sufficient number of clinical pharmacologists with at least 01 clinical pharmacologist for every 150 inpatient beds and at least 1,5 clinical pharmacologists for every 1.000 prescriptions given to outpatients having health insurance in a day;

b) By January 01, 2031 at the latest, healthcare establishments must ensure sufficient number of clinical pharmacologists with at least 01 clinical pharmacologist for every 100 inpatient beds and at least 02 clinical pharmacologists for every 1.000 prescriptions given to outpatients having health insurance in a day.

Article 4. Requirements for clinical pharmacologists

1. Clinical pharmacologists working at healthcare establishments shall hold a bachelor’s degree in pharmacy or higher (conferred upon or recognized in Vietnam), unless otherwise provided for by Clause 2 herein.

2. Clinical pharmacologists working at traditional medicine establishments must hold one of the following degrees (conferred upon or recognized in Vietnam):

a) A degree meeting the requirement stated in Clause 1 herein and one of the degrees/certificates in traditional medicine provided for in Points i and l Clause 1 Article 13 of the Law on Pharmacy;

b) A bachelor’s degree in traditional pharmacy or higher;

c) A bachelor’s degree in traditional medicine or higher.

3. Clinical pharmacologists working in pharmacies on the premises of a healthcare establishment must meet the requirement stated in Clause 1 herein. Chief pharmacists who are also in charge of clinical pharmacology shall meet the requirements provided for in Clause 1 Article 18 of the Law on Pharmacy.

Article 5. Clinical pharmacology supervisors

1. Clinical pharmacology supervisors working at healthcare establishments must meet the requirements stated in Article 21 of the Law on Pharmacy and hold a pharmacy practice certificate according to regulations in Clause 3 Article 11 of the Law on Pharmacy.

2. Content of apprenticeship served by clinical pharmacology supervisors:

a) Clinical pharmacology supervisors working at healthcare establishments must complete an apprenticeship in bioequivalence testing; clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center;

b) Clinical pharmacology supervisors working at traditional medicine establishments must complete an apprenticeship in clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center for traditional drugs;

3. Clinical pharmacology supervisors shall serve an apprenceticeship of at least 2 years. Persons holding a doctoral degree or second level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 6 months. Persons holding a master’s degree or first level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 12 months.

4. Unless otherwise provided for in Clause 5 herein, clinical pharmacology supervisors working at healthcare establishments shall serve their apprenticeships at one of the following facilities:

a) Providers of clinical trial services or bioequivalence study services; non-commercial bioequivalence testing facilities or clinical trial institutions;

b) Pharmacology or clinical pharmacology departments or centers of schools providing undergraduate medicine/pharmacy programs;

c) National or regional drug information and adverse drug reactions monitoring centers;

d) Healthcare establishments the clinical pharmacology units and activities of which are in compliance with regulations in this Decree or regulations of law taking effect prior to the entry into force of this Decree.

5. Clinical pharmacology supervisors working at traditional medicine establishments shall serve their apprenticeships at hospitals and institutes having hospital beds, practicing traditional medicine and having clinical pharmacology units and activities in compliance with regulations in this Decree or regulations of law taking effect prior to the entry into force of this Decree.

Chapter III

CLINICAL PHARMACOLOGY ACTIVITIES

Article 6. Clinical pharmacology activities in pharmacy departments

Pharmacy departments of healthcare establishments shall carry out clinical pharmacology activities according to regulations in Article 80 of the Law on Pharmacy and the following regulations:

1. Give advice on drug list formulation at healthcare establishments for proper, safe and effective drug use:

a) Develop drug selection criteria to provide advice for drug and treatment councils of healthcare establishments;

b) Receive and handle information on the safety and effectiveness of drugs included in drug lists of healthcare establishments to propose revisions to drug lists to ensure proper, safe and effective drug use;

c) Analyze and assess safety and effectiveness of drug use by healthcare establishments based on cost - effectiveness, cost - benefit and risks - benefit evidence to provide advice and information on formulation of drug lists of healthcare establishments and ensure proper, safe and effective drug use;

2. Give advice on and supervise prescription and drug use:

a) Give advice on drug use to assist persons making out prescriptions (hereinafter referred to as “prescription makers”) with selecting drugs. Inspect and control the prescription process and appraise physician orders to detect and prevent possible mistakes. Consolidate and analyze the cause of such mistakes to propose solutions and improve prescription quality;

b) Participate in drug use analysis (clinical case discussion) for drug-resistant infections and patients with complex polypharmacy or at the request of heads of healthcare establishments;

c) Participate in medical consultations or councils for professional diagnosis related to drug selection.

3. Provide drug use information and instructions for healthcare practitioners, drug users and the community:

a) Provide healthcare practitioners with information on new drugs, including drug name, ingredients, pharmacological effects, indications, contraindications, interactions, dosage, directions for use, use on patients requiring special attention, information related to warnings, drug safety and other necessary information;

b) Provide drug users and the community with information on drugs, including drug name, ingredients, concentration, content, dosage form, indications, contraindications, dosage, directions for use and warnings;

c) Provide the information required per Points a and b herein directly, in writing or by posting on bulletin boards and websites of healthcare establishments.

4. Participate in formulation of instructions and procedures for drug use and supervision of compliance with such procedures:

a) Develop procedures for drug use and instructions on use of drug lists of healthcare establishments;

b) Cooperate with drug and treatment councils of healthcare establishments in formulating supervision procedures for use of narrow therapeutic index drugs, drugs with multiple serious side effects and drugs requiring dilution for intravenous administration, drug use on patients requiring monitoring or use of drugs with special storage conditions according to treatment requirements;

c) Directly participate in treatment and supervision of compliance with drug use procedures approved by drug and treatment councils of healthcare establishments or heads of healthcare establishments.

5. Analyze and assess drug use effectiveness at healthcare establishments:

a) Develop plans for biannual and annual analysis and assessment of drug use effectiveness, and trends and plans for drug use at healthcare establishments for the following year;

b) Analyze and assess drug use effectiveness by assessing how clinical guidelines and drug lists of healthcare establishments match with indications of drugs provided for their clinical departments.

6. Participate in drug adverse reactions monitoring:

a) Provide healthcare practitioners, nurses, technicians and midwives with information on drug adverse reactions, other information on drug safety, methods and guidelines for detection and handling of drug adverse reactions;

b) Monitor drug adverse reactions and receive information to prepare consolidated reports on drug adverse reactions at healthcare establishments according to guidelines from the Ministry of Health;

c) Submit ad hoc reports on risk to patient’s health related to drug use or improper drug uses at healthcare establishments to heads of healthcare establishments.

7. Participate in clinical trials and bioequivalence tests at healthcare establishments and other scientific researches on proper, safe and effective drug use.

Article 7. Clinical pharmacology activities in clinical departments and outpatient departments

Clinical pharmacologists shall analyze and monitor drug use by patients undergoing medical examination and treatment at healthcare establishments. Clinical pharmacologists shall perform the following tasks for each patient:

1. Obtain the following information on the patient from their medical record and face-to-face interviews:

a) Drug history;

b) Summary of available paraclinical test results and clinical information.

2. Review the drugs prescribed for the patient during check-in rounds or review physician orders in the medical record and prescriptions, including:

a) Indications;

b) Contraindications;

c) Drug selection;

d) Drug administration: dosage, dosage interval, administration time, administration route, drug use on special patient populations and duration;

dd) Important drug interactions;

e) Drug adverse reactions.

3. Provide nurses and midwives with directions for use.

4. Cooperate with healthcare practitioners in giving advice on what to do when using a drug to the patient.

Article 8. Clinical pharmacology activities in clinical pharmacology units of healthcare establishments without a pharmacy department

Clinical pharmacology units of healthcare establishments without a pharmacy department must carry out the clinical pharmacology activities provided for in Point a Clause 2, Clause 3, Point a Clause 4, Clause 6 Article 6 and Article 7 herein.

Article 9. Clinical pharmacology activities in pharmacies on the premises of healthcare establishments

Clinical pharmacology supervisors or clinical pharmacologists of pharmacies on the premises of healthcare establishments shall carry out clinical pharmacology activities according to regulations in Clauses 2, 3 and 6 Article 80 of the Law on Pharmacy and the following regulations:

1. Give advice and information of drugs to drug buyers and users:

a) Provide drug use advice, instructions, explanations, information and recommendations for drug buyers or patients; give instructions on how to use drugs and follow prescriptions to drug buyers;

b) Advise patients to visit a doctor specializing in a suitable field for diseases the medications for which require doctor’s diagnosis;

c) Replace a prescribed drug with another drug that has the same active ingredient(s), administration route and dosage with the buyer’s consent and take responsibility for such replacement.

2. Advise and discuss with persons prescribing medications in case of an unsuitable prescription:

a) If detecting a prescription with unclear drug name, concentration, content or quantity or a legal or technical wrong or a potential risk to a patient’s health, notify the prescription maker;

b) Give advice and explanations to drug buyers, and hold the right to refuse selling prescription drugs in case of invalid, erroneous or questionable prescriptions or prescriptions collected for non-treatment purpose and notify the prescription makers.

3. Participate in drug adverse reactions monitoring:

a) Provide drug buyers and drug users with adequate and accurate information related to known adverse reactions and side effects of purchased drugs;

b) Give instructions on how to handle drug overdose, side effects and adverse reactions to drug buyers and drug users;

c) Monitor and receive information on drug side effects and adverse reactions to submit consolidated reports to the pharmacy department.

Chapter IV

RESPONSIBILITY FOR CLINICAL PHARMACOLOGY ACTIVITIES

Article 10. Responsibilities of heads of healthcare establishments

Heads of healthcare establishments shall organize clinical pharmacology activities and take responsibility for results of clinical pharmacology activities of their healthcare establishments in compliance with the following regulations:

1. Assign sufficient clinical pharmacologists according to regulations in Clause 2 or Clause 3 Article 3 herein and organize clinical pharmacology activities at their healthcare establishments.

2. Ensure that clinical pharmacology supervisors and clinical pharmacologists participate in training and refresher courses in clinical pharmacology in a continuous manner.

3. Ensure that there are sufficient facilities and equipment for the clinical pharmacology activities provided for in Articles 6, 7, 8 and 9 herein.

Article 11. Responsibilities of pharmacy department head and heads of clinical pharmacology units of healthcare establishments without a pharmacy department

1. Responsibilities of pharmacy department head:

a) Directly organize clinical pharmacology activities at their healthcare establishment in compliance with regulations in this Decree;

b) Take responsibility for the technical aspect of clinical pharmacology activities at their healthcare establishment;

c) Formulate and propose procedures for clinical pharmacology activities at their healthcare establishment to the establishment head for promulgation;

d) Cooperate with clinical departments, paraclinical departments and other relevant departments in clinical pharmacology.

2. Heads of clinical pharmacology units at healthcare establishments without a pharmacy department also have the responsibilities stated in Clause 1 herein.

Article 12. Responsibilities of clinical department heads and outpatient department head

1. Direct doctors, nurses, technicians and midwives of their departments to cooperate with clinical pharmacologists in the clinical pharmacology activities provided for in Articles 6, 7, 8 and 9 herein.

2. Clinical department heads shall announce plans for medical consultations or diagnosis councils related to drug selection in writing so that clinical pharmacology supervisors and clinical pharmacologists can participate according to regulations in Point c Clause 2 Article 6 of this Decree.

3. Cooperate with the pharmacy department head or clinical pharmacology supervisors of the healthcare establishment in reviewing consolidated reports on advice on prescription and drug use instructions given by clinical pharmacologists. If the advice is appropriate, the clinical department head/outpatient department head shall inform the prescription maker in writing and report to the drug and treatment council of the healthcare establishment for the conclusion.

Article 13. Responsibilities of clinical pharmacology supervisors

Clinical pharmacology supervisors have the rights and obligations stipulated in Clause 1 Article 82 of the Law on Pharmacy and the following responsibilities:

1. Give advice on and propose the operating model and regulation of operations of the clinical pharmacology unit to heads of the pharmacy department and the healthcare establishment.

2. Assign tasks to clinical pharmacologists and provide clinical pharmacologists with technical direction and guidelines and training in professional operation.

3. Organize and supervise performance of tasks of the clinical pharmacology unit.

4. Report performance of the clinical pharmacology unit to heads of the pharmacy department and the healthcare establishment. Review and inspect drug use advice given to prescription makers by clinical pharmacologists to report it in briefings with clinical departments and the outpatient department, including cases where the prescription maker agrees or disagrees with the advice.

Article 14. Responsibilities of clinical pharmacologists

Clinical pharmacologists have the rights and obligations stipulated in Clause 1 Article 82 of the Law on Pharmacy and the following responsibilities:

1. Carry out the clinical pharmacology activities provided for in Articles 6, 7, 8 and 9 herein.

2. Clinical pharmacologists working in clinical pharmacology units shall work on a full-time or part-time basis in some clinical departments as assigned; directly join treatment teams; and supervise and report on drug use in their healthcare establishments.

3. Participate in scientific research and continuous training courses on clinical pharmacology according to regulations from the Minister of Health.

4. Submit consolidated reports on drug use advice given to prescription makers at least once a week  to the clinical pharmacology supervisor or pharmacy department head or head of the healthcare establishment, including cases where the prescription maker agrees or disagrees with the advice.

Article 15. Cooperation in clinical pharmacology between clinical departments, outpatient department, pharmacy department and clinical pharmacology unit

1. Clinical pharmacologists shall give advice on prescription and drug use at their healthcare establishments in compliance with regulations in this Decree and take responsibility for such advice.

2. If detecting an issue concerning drug use safety, effectiveness or suitability, clinical pharmacologists shall give advice to the prescription maker to optimize drug use and record the advice into the document on drug use analysis using the form provided for by the Minister of Health so that the prescription maker can revise the prescription. If the advice is rejected, the prescription maker shall decide how to give the prescription and use drugs and take responsibility for such decision.

3. Pharmacy department head, general planning department/unit head, outpatient department head, clinical department heads, doctors, technicians, nurses and midwives of healthcare establishments shall cooperate with and enable clinical pharmacologists to complete their duties.

4. Clinical pharmacologists shall comply with assignment and professional direction from the clinical pharmacology supervisor and pharmacy department head.

Chapter V

IMPLEMENTATION CLAUSE

Article 16. Effect

1. This Decree takes effect from January 01, 2021.

2. Circular No. 31/2012/TT-BYT dated December 20, 2012 by the Minister of Health on guidelines for clinical pharmacology in hospitals is annulled.

Article 17. Roadmap to implementation

1. Starting from January 01, 2021, clinical pharmacology organization is required for the following healthcare establishments:

a) Hospitals and institutes with hospital beds (hereinafter collectively referred to as “hospitals”), including general hospitals and specialized hospitals of class I and higher affiliated to the Ministry of Health and Departments of Health or affiliated to the Ministry of National Defense, Ministry of Public Security and other ministries/central authorities and designated as tertiary hospitals by the Ministry of Health;

b) Private healthcare establishments equivalent to class I hospitals.

2. By January 01, 2024 at the latest, class II hospitals that are affiliated to the Ministry of Health and Departments of Health or are private or are affiliated to the Ministry of National Defense, Ministry of Public Security and other ministries/central authorities must organize clinical pharmacology.

3. By January 01, 2027, class III or IV hospitals and hospitals not yet ranked that are at district level or are private or are affiliated to the Ministry of National Defense, Ministry of Public Security and other ministries/central authorities must organize clinical pharmacology.

4. By January 01, 2030 at the latest, other healthcare establishments that administer drugs according to regulations of law on medical examination and treatment must organize clinical pharmacology.

Article 18. Implementing responsibilities

1. The Minister of Health shall provide technical guidelines for the clinical pharmacology activities provided for herein.

2. The Minister of National Defense, Minister of Public Security and heads of other ministries and central authorities shall provide technical guidelines for clinical pharmacology activities at healthcare establishments under their management.

3. The Minister of Education and Training shall cooperate with the Minister of Health in training the workforce for clinical pharmacology.

4. Ministers, heads of ministerial-level agencies, heads of Governmental agencies, and Chairpersons of People’s Committees of provinces and central-affiliated cities shall implement this Decree./.