Applying new regulations on the organization and activities of clinical pharmacology in healthcare establishments from January 1, 2021

28/11/2020 10:10 AM


The Government has just issued Decree 131/2020/ND-CP providing for clinical pharmacology organization and activities in healthcare establishments. Accordingly, healthcare establishments without a pharmacy department still have to organize a clinical pharmacy division to carry out activities for outpatients with health insurance cards and inpatients.

The clinical pharmacy division organizes clinical pharmacy activities at the establishment to serve outpatients with health insurance cards and inpatients

This Decree applies to healthcare establishments engaged in medicine use in accordance with the law on medical examination and treatment, including healthcare establishments of the armed forces; domestic and foreign organizations and individuals related to clinical pharmacy organizations and activities in Vietnam.

The Decree clearly states: The clinical pharmacy division of the pharmacy department of the health establishments will organize the implementation of clinical pharmacy activities at the establishments to serve outpatients with health insurance cards and inpatients.

Healthcare establishments without a pharmacy department still have to organize a clinical pharmacy division to carry out activities for outpatients with health insurance cards and inpatients.

Drugstores on the premises of healthcare establishments carry out clinical pharmacy activities at pharmacies to serve people in case the establishments have pharmacies.

According to the Decree, the pharmacy devision of healthcare establishments shall carry out clinical pharmacy activities according to the provisions of Article 80 of the Law on Pharmacy and specifically defined as follows:

1. Providing consultancy during the compilation of List of drugs at health facilities to ensure reasonable, safe, and effective use of drugs.

2. Providing consultancy and supervising the prescription and use of drugs.

3. Providing information and instructions on how to use drugs for medical practitioners, drug users, and the public.

4. Participate in development of procedures and guidelines for use of drugs and supervise the adherence to such procedures.

5. Analyzing, assessing efficacy of drugs at health facilities.

6. Participating in monitoring and supervising of adverse effects of drugs.

7. Participating in scientific research related to reasonable, safe, and effective use of drugs.

The Decree also specifies the roadmap for implementation, from January 1, 2021, the following healthcare establishments must organize clinical pharmacy activities: Hospitals, Hospitals with hospital beds (referred to as ‘hospitals’ for short) including general hospitals and specialized hospitals of class I or higher affiliated to the Ministry of Health, Health Departments of centrally-run provinces and cities or of the Ministry of National Defense, the Ministry of Public Security and other ministries and branches assigned by the Health Ministry to be the backline of technical expertise; Private healthcare establishments ranked equivalent to those of class I hospitals.

No later than January 1, 2024, healthcare establishments that are class II hospitals affiliated to the Ministry of Health, Health Departments or private or affiliated to the Ministry of National Defense, the Ministry of Public Security and other ministries and branches must organize clinical pharmacy activities.

No later than January 1, 2027, healthcare establishments that are class III or IV hospitals, and unclassified hospitals directly under the district, town or provincial cities, or private, or under the management of the Ministry of National Defense, the Ministry of Public Security and other ministries and branches, must organize clinical pharmacy activities.

No later than January 1, 2030, healthcare establishments engaged in drug use in accordance with the law on medical examination and treatment must organize clinical pharmacy activities.

The Minister of Health is responsible for providing professional and technical guidance to clinical pharmacy activities specified in this Decree.

The Minister of National Defense, the Minister of Public Security and Ministers of ministries and branches are responsible for providing professional and technical guidance to carry out clinical pharmacy activities for healthcare establishments under management authority.

This Decree takes effect on January 1, 2021. Circular No. 31/2012/TT-BYT dated December 20, 2012 of the Minister of Health guiding clinical pharmacy activities in hospitals is abolished./.

VSS