07 Clinical pharmacology activities in pharmacy departments under Vietnamese law

07 Clinical pharmacology activities in pharmacy departments under Vietnamese law (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. What is clinical pharmacology?

According to Clause 40, Article 2 of the Law on Pharmacy 2016, clinical pharmacology means scientific research and pharmacy practice related to consultancy on reasonable, safe, and effective use of drugs for optimizing the use of drugs.

2. Clinical pharmacology activities in pharmacy departments under Vietnamese law

Specifically, in Article 6 of Decree 131/2020/ND-CP, pharmacy departments of healthcare establishments shall carry out clinical pharmacology activities in Vietnam according to regulations in Article 80 of the Law on Pharmacy 2016 and the following regulations:

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

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

- 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;

- 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:

- 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;

- 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;

- 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:

- 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;

- 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;

- 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:

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

- 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;

- 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:

- 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;

- 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:

- 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;

- 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 of Vietnam;

- 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.

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