Chương III Nghị định 131/2020/NĐ-CP: Hoạt động dược lâm sàng

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.