Latest regulations on mumber of clinical pharmacologists in Vietnam

Latest regulations on mumber of clinical pharmacologists in Vietnam (Internet image)

1. Regulations on the clinical pharmacology unit in Vietnam

Regulations on the clinical pharmacology unit according to Clause 1, Article 3 of Decree 131/2020/ND-CP are as follows:

- The clinical pharmacology unit under the pharmacy department of healthcare facilities organizes clinical pharmacy activities at the facility to serve outpatients with health insurance cards and inpatients;

- Healthcare facilities that do not organize a pharmacy department according to the law provisions on medical examination and treatment must still organize a clinical pharmacology unit to carry out clinical pharmacy activities serving outpatients with health insurance cards and inpatients;

- Pharmacies within the premises of healthcare facilities organize clinical pharmacy activities at the pharmacy to serve customers buying medicines in case the healthcare facility has an organized pharmacy.

2. Latest regulations on mumber of clinical pharmacologists in Vietnam

According to Clause 2, Article 3 of Decree 131/2020/ND-CP, the number of clinical pharmacology supervisors and clinical pharmacologists in Vietnam is as follows:

- Healthcare facilities with 200 or more beds must assign one clinical pharmacology supervisors and have a ratio of at least one clinical pharmacist for every 200 inpatient beds and at least one clinical pharmacist for every 1,000 prescriptions issued to outpatients with health insurance cards in one day;

- Healthcare facilities with fewer than 200 beds or facilities that do not organize a pharmacy department according to the law provisions on medical examination and treatment must have at least one clinical pharmacology supervisors who concurrently performs clinical pharmacy duties serving inpatients (if any) and must have a ratio of at least one clinical pharmacist for every 1,000 prescriptions issued to outpatients with health insurance cards in one day;

- Pharmacies within the premises of healthcare facilities must have at least one clinical pharmacist for each business location of the pharmacy. The person responsible for the professional aspects of the pharmacy can simultaneously perform clinical pharmacy duties at the pharmacy.

3. Regulations on the clinical pharmacology supervisors in Vietnam

Regulations on the clinical pharmacology supervisors in Vietnam according to Article 5 of Decree 131/2020/ND-CP are as follows:

- The clinical pharmacology supervisors at the healthcare facility must meet the conditions prescribed in Article 21 of the Pharmacy Law 2016 and have a practicing certificate in pharmacy as prescribed in Clause 3, Article 11 of the Pharmacy Law 2016.

- Areas of professional practice for the clinical pharmacology supervisors:

+ The clinical pharmacology supervisors at the healthcare facility must practice in one of the following professional areas: Bioequivalence testing of drugs; clinical trials of drugs; pharmacological, clinical pharmaceutical research; pharmacovigilance at drug information centers and monitoring adverse drug reactions;

+ The clinical pharmacology supervisors at a traditional medicine healthcare facility must practice in one of the following professional areas: Clinical trials of traditional medicines; pharmacological, clinical pharmaceutical research; pharmacovigilance at drug information centers and monitoring adverse reactions of traditional medicines.

- The duration of professional practice for the clinical pharmacology supervisors is at least 2 years. For individuals with a doctoral degree or specialized level II in related fields, the required professional practice duration is at least 6 months. For individuals with a master's degree or specialized level I in related fields, the required practice duration is at least 12 months.

- The clinical pharmacology supervisors at a healthcare facility, except as stipulated in Clause 5, Article 5 of Decree 131/2020/ND-CP, must professionally practice at one of the following facilities:

+ Facilities providing clinical trial services or conducting bioequivalence studies of drugs; facilities conducting clinical trials or bioequivalence studies not for commercial purposes;

+ Centers or departments of pharmacological, clinical pharmaceutical research in tertiary medical, pharmaceutical training institutions;

+ National or regional drug information centers and monitoring adverse drug reactions;

+ Healthcare facilities that organize and conduct clinical pharmacy activities as prescribed in this Decree or those that had organized and conducted clinical pharmacy activities according to law provisions before Decree 131/2020/ND-CP was effective.

- Persons responsible for clinical pharmacy work at traditional medicine healthcare facilities practice professionally at hospitals, institutes with beds that conduct traditional medicine activities and organize, operate clinical pharmacy as prescribed in Decree 131/2020/ND-CP or had organized, operated clinical pharmacy according to law provisions before Decree 131/2020/ND-CP was effective.

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