Ministry of Health proposes new regulations on drug prescription

The Ministry of Health is drafting a Circular regulating prescriptions and the prescription of pharmaceutical and biological drugs in outpatient treatment.

This Circular aims to ensure that drug prescriptions are appropriate to the diagnosis and severity of the disease, while achieving the goal of safety and rationality in drug use.

By January 1, 2027, other medical examination and treatment facilities will have to implement electronic prescriptions.

According to the draft, drug prescription must be based on one of the following documents: Diagnosis and treatment guidelines issued or recognized by the Ministry of Health, Diagnosis and treatment guidelines of medical examination and treatment facilities developed according to the provisions of Article 6 of Circular No. 21/2013/TT-BYT, Instructions for use of drugs attached to drug registration dossiers licensed by the Ministry of Health, and current Vietnamese National Pharmacopoeia.

In particular, the quantity of prescribed drugs will be based on treatment guidelines, but must not exceed 30 days, except in cases of prescribing addictive drugs, painkillers for cancer or AIDS patients, psychotropic drugs, and precursor drugs.

The draft also specifies drugs that are not allowed in prescriptions, including drugs not intended for disease prevention or treatment, drugs not licensed for circulation in Vietnam, functional foods and cosmetics.

To ensure clarity and accuracy, the prescription must include full patient information such as personal identification number or citizen identification number (if any), and the patient's permanent or temporary residence address.

For children under 72 months of age, the number of months of age, weight, and name of the father or mother must be added. The prescription must clearly state the day, month, and year of validity, and must not be earlier than the prescription date, except in the case of prescriptions for narcotic drugs or psychotropic drugs.

According to the draft regulations, prescriptions must follow the following guidelines: For drugs with one active ingredient, write the international non-proprietary name (INN, generic), for example: Paracetamol 500mg. For drugs with multiple active ingredients or biological products, write the trade name.

If prescribing a toxic drug, the toxic drug must be listed before any other drugs. An electronic prescription will have the same legal value as a paper prescription.

Medical examination and treatment facilities will use software to create, digitally sign, share and store prescriptions.

In particular, for specially controlled drugs such as narcotic drugs, psychotropic drugs, and precursor drugs, medical facilities need to print prescriptions and store them on site.

According to the draft, medical examination and treatment facilities will implement electronic prescriptions according to the roadmap: From the effective date of the Circular, specialized hospitals must implement electronic prescriptions. By January 1, 2026, basic hospitals must also implement electronic prescriptions.

By January 1, 2027, other medical examination and treatment facilities will have to implement electronic prescriptions.

It is known that after the revised Pharmacy Law allowed the online sale of non-prescription drugs, according to users, buying and selling drugs has become much more convenient than before.

The online drug market in Vietnam began to grow strongly from 2017 - 2018 and currently accounts for about 5-8% of the drug market share, with more than 1,000 online pharmaceutical businesses.

According to Mr. Nguyen Tuan Cuong, Director of the Drug Administration of Vietnam, Ministry of Health, the number of consumers connected to the Internet in Vietnam has increased sharply and is expected to reach 40 million people by 2025. However, selling drugs online also faces many challenges.

Online drug stores are only allowed to sell non-prescription drugs and are not controlled drugs. Online drug stores must comply with inspection and licensing regulations before selling drugs through electronic platforms.

The Drug Administration recommends that online drug stores must comply with strict regulations on drug sales.

Specifically, establishments must be granted a Certificate of Eligibility for Pharmaceutical Business, provide information about drugs and advise consumers on drug use. The inspection and supervision of drug sales via e-commerce will be strictly implemented to ensure that consumers use drugs safely and effectively.

Legalizing online drug sales not only helps people easily access drugs but also contributes to promoting digital transformation in the pharmaceutical industry. Online pharmacies will have the opportunity to improve the efficiency of warehouse management, operations and help pharmaceutical products reach consumers in all regions.

Currently, FPT Long Chau, a company in the pharmaceutical industry, has deployed an online drug sales platform via VNIed, helping people in remote areas easily access genuine, quality drugs and minimize the risk of buying fake drugs.

This system also helps warehouse management and drug distribution become smarter, improving service quality and consumer satisfaction. Legalizing online drug sales is the right step, helping to significantly improve drug supply and drug quality management throughout the entire supply chain, from production to consumers.

Source: https://baodautu.vn/bo-y-te-de-xuat-quy-dinh-moi-ve-ke-don-thuoc-d250101.html