Chương IV Nghị định 131/2020/NĐ-CP: Trách nhiệm thực hiện hoạt động dược lâm sàng

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.