Circular 27/2021/TT-BYT providing regulations on prescribing drugs in electronic form

CIRCULAR

Providing regulations on prescribing drugs in electronic form

___________

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Information Technology Department,

The Minister of Health promulgates the Circular providing regulations on prescribing drugs in electronic form.

Article 1. Scope of regulation

This Circular provides for:

1. Contents and prescribing drugs in electronic form (hereinafter referred to as electronic prescriptions).

2. Legal validity of electronic prescriptions.

Article 2. Contents and prescribing drugs in electronic form

1. For out-patients:

a) In case of prescription of pharmacochemical drugs and biological products in out-patient treatment:

To comply with the Circular No. 52/2017/TT-BYT dated December 29, 2017 of the Minister of Health, providing for prescriptions and prescribing of pharmacochemical drugs and biological products in out-patient treatment, the Circular No. 18/2018/TT-BYT dated August 22, 2018 of the Minister of Health amending and supplementing a number of articles of the Circular No. 52/2017/TT-BYT dated December 29, 2017 of the Minister Health providing for prescriptions and prescribing of pharmacochemical drugs and biological products in out-patient treatment;

b) In case of prescription of traditional drugs, drugs from medicinal materials and combination of traditional drugs, drugs from medicinal materials and pharmacochemical drugs in prescriptions:

To comply with the Circular No. 44/2018/TT-BYT dated December 28, 2018 of the Minister of Health, providing for prescription of traditional drugs, drugs from medicinal materials and combination of traditional drugs, drugs from medicinal materials and pharmacochemical drugs in prescriptions.

2. For in-patients discharged from the hospital:

a) In case of prescription in the notes section of the hospital discharge paper: To comply with Appendix 3 of the Circular No. 56/2017/TT-BYT dated December 29, 2017 of the Minister of Health, detailing the Law on Social Insurance and the Law on Occupational Safety and Health in the health field;

b) In case of prescription according to the out-patient application form: To comply with Clause 1 of this Article.

Article 3. Legal validity of electronic prescriptions

Electronic prescriptions that are made, displayed, digitally signed, shared and stored by electronic method meet the provisions of this Circular have the same legal validity as paper prescriptions.

Article 4. Organization of implementation

1. The Medical Services Administration shall:

a) Assume the prime responsibility for, and coordinate with the Information Technology Department and related units in, formulating a regulation on the management of the National Information System on the management of drug prescriptions and sale of drugs with prescriptions (hereinafter referred to as the National Prescription System); decentralize administration to related units and localities;

b) Manage and operate the National Prescription System;

c) Grant medical examination and treatment establishment identifiers and practitioner codes to subjects under their management through the National Prescription System.

2. The Drug Administration of Vietnam shall:

a) Ensure the connection between the National Pharmacy Database System and the National Prescription System;

b) Direct and guide drug retailers and pharmacy practitioners to implement this Circular.

3. The Information Technology Department shall:

a) Formulate and submit to the Minister for promulgation a technical specification on data structures and guiding for interconnection between the information systems of medical examination and treatment establishments, drug retailers, and the National Prescription System;

b) Guide, technical support and application of information technology solutions to units and localities in the implementation of this Circular;

c) Coordinate with the Medical Services Administration to formulate regulations on management of the National Prescription System.

4. The Departments of Health of provinces and centrally run cities, and health management agencies of ministries and sectors shall:

a) Direct and organize the implementation of this Circular for the units under its management;

b) Grant medical examination and treatment establishment identifiers and practitioner codes to subjects under their management through the National Prescription System;

c) Inspect, evaluate and report the results of the implementation of this Circular to the units under its management to the Ministry of Health.

5. The medical examination and treatment establishment shall:

a) Ensure information technology infrastructure meets technical criteria as prescribed by the Minister of Health;

b) Send electronic prescriptions to the National Prescription System as prescribed by the Minister of Health right after the completion of the medical examination and treatment process for out-patients and before the patient is discharged from the hospital for in-patients;

c) Send electronic prescriptions or electronic prescription codes to the patient or the patient's representative through electronic means under the guidance of the Ministry of Health;

d) Summarize all drugs used by the patient during in-patient treatment and submit it to the National Prescription System before the patient is discharged from the hospital.

dd) Store electronic prescriptions like the storage time of paper prescriptions according to regulations of the Ministry of Health.

6. Drug retailers shall be responsible for receiving electronic prescriptions and sending reports on the supply and sale of drugs according to prescriptions specified in this Circular.

Article 5. Effect

This Circular takes effect on February 15, 2022.

Article 6. Implementation roadmap

Medical examination and treatment establishments must prescribe drugs in the electronic form specified in this Circular according to the specific roadmap as follows:

1. For hospitals of level 3 and higher: complete before June 30, 2022.

2. For other medical examination and treatment establishments: complete before December 01, 2022.

Article 7. Reference provisions

In case the legal documents referred to in this Circular are replaced, amended or supplemented, the replacing, amending or supplementing legal documents shall prevail.

Article 8. Implementation responsibility

Chief of Ministry office; the Chief of Inspectorate of Ministry; Directors and General Directors under the Ministry of Health; Directors of Health Departments of provinces and centrally-run cities; relevant agencies, organizations and individuals shall be responsible for the implementation of this Circular.

Any difficulties arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (via the Information Technology Department) for consideration and handling./.

For the Minister

Deputy Minister

Tran Van Thuan