Circular No. 05/2016/TT-BYT on prescribing medication for out-patient treatment

CIRCULAR

Provisions on prescribing medications for outpatient treatment

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Based on Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."hereinafter referred to as the DecreeDeputy ministers of ministerial-level agencies, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Healthpolicies;

1. Accounting accounts reflect regularly, continuously, systematically the situation of assets, receipt and use of funds at the unit; monitor revenue, expenses, results of operations, and other items at the unit.n lArticle 2. This Circular applies to patients who have been prescribed daytime radiotherapy, chemotherapy, or combined chemoradiotherapy and healthcare facilities that have been approved by competent authorities to perform chemotherapy, radiotherapy techniques (or treatment with radioactive isotopes).

The Minister of Health issues this Circular to provide provisions on prescribing medications for outpatient treatment.

Article 1. Scope of Regulation

Article 1. This Circular provides provisions on prescribing medications for outpatient treatment applicable to state and private healthcare facilities.

2. This Circular does not apply to the following cases:

a) Prescribing traditional medicine prescriptions, combined prescriptions of traditional medicine with modern drugs;

b) Prescribing medication for opiate addiction treatment using substitute drugs.

Article 2. Applicability

Article 2. Prescribers shall be doctors and medical practitioners holding a practice certificate for diagnosis and treatment (hereinafter referred to as doctors and medical practitioners).

2. Healthcare facilities must have a permit for diagnosis and treatment (hereinafter referred to as healthcare facilities) and retail pharmacies must have a certificate of qualification for pharmaceutical business operations (hereinafter referred to as retail pharmacies).

3. Patients and their family members with outpatient treatment prescriptions.

Article 3. Provisions for prescribers

1. Doctors.

2. Medical practitioners may prescribe medications when they meet all of the following conditions:

a) Hold a practice certificate for diagnosis and treatment and work at a district-level state healthcare facility or commune health station, ward, town, workplace, or school health center (hereinafter referred to as commune health station);

b) Must have a written assignment from the head of the district-level healthcare facility assigning them to diagnose and treat patients according to the local health management hierarchy.

3. Doctors and medical practitioners at commune health stations are permitted to prescribe medications for diseases within the scope of general medical diagnosis and treatment as determined within the scope of the commune health station and the qualifications of the doctor or medical practitioner.

4. In emergency situations where the patient has not yet been admitted to the hospital, any prescriber from any specialty (including traditional medicine) may prescribe medications appropriate to the emergency situation.

Article 4. Principles for Issuing Prescriptions

1. Prescriptions may only be issued after obtaining examination results and making a diagnosis.

2. Prescriptions must be appropriate to the diagnosis and severity of the disease.

Article 3. The quantity of prescribed medications shall be carried out in accordance with the Diagnosis and Treatment Guidelines of the Ministry of Health or sufficient for up to thirty days maximum, except in cases provided for in Articles 7, 8, and 9 of this Circular.

Article 4. Medical practitioners are not allowed to prescribe finished combination products containing addictive substances, finished combination products containing psychotropic substances, and finished combination products containing precursors that do not belong to the list of non-prescription drugs issued by the Minister of Health.

Article 5. The following items shall not be included in the prescription:

a) Medications or substances not intended for disease prevention or treatment;

b) Medications not legally permitted to circulate in Vietnam.

c) Nutritional supplements;

d) Cosmetics.

Article 5. Form of Prescription

1. Prescription for patients seeking medical examination at healthcare facilities:

Prescribers shall issue prescriptions for patients on Prescription Forms according to Model 01 or Outpatient Medical Records according to Model 02 attached to this Circular and record the drug name, dosage, quantity, and number of days of use in the Outpatient Medical Record of the healthcare facility.

Article 2. Prescription for patients undergoing outpatient treatment:

Prescribers shall make treatment decisions by prescribing medications into the outpatient treatment medical records of the patient while simultaneously issuing prescriptions (copying treatment decisions) into the patient's Outpatient Medical Record according to Model 02 or Long-term Disease Treatment Records according to Model 03 attached to this Circular.

Article 3. Prescription for patients who need to continue outpatient treatment immediately after completing inpatient treatment:

a) In cases where the prescriber forecasts that the patient only needs to continue using medication for one to seven days, the prescription should be continued in the inpatient treatment medical record while simultaneously issuing prescriptions (copying treatment decisions) into the Outpatient Medical Record or Long-term Disease Treatment Records of the patient.

b) In cases where the prescriber forecasts that the patient needs to continue treatment for more than seven days, they must switch to outpatient treatment (creating an outpatient treatment medical record) immediately after the end of inpatient treatment, and the prescription shall be carried out according to the provisions of Clause 2 of this Article.

Article 4. Prescription for addictive drugs, psychotropic drugs, and precursors shall be carried out according to the provisions of Articles 7, 8, and 9 of this Circular.

Article 6. General Requirements for Prescription Content

Article 1. All fields printed in the Prescription Form or in the Outpatient Medical Record or Long-term Disease Treatment Records of the patient must be filled in completely, clearly, and accurately.

Article 2. Accurately record the address where the patient resides permanently or temporarily: house number, street, residential group, village, hamlet, commune, ward, town.

Article 3. For children under 72 months old, the age in months must be recorded, along with the name of the father or mother of the child.

Article 4. Write the drug name according to the international non-proprietary name (INN, generic), except for drugs with multiple active ingredients. If the trade name is also recorded, it must be placed in parentheses after the international non-proprietary name.

Example: For Paracetamol

- Write the drug name according to the international non-proprietary name: Paracetamol 500mg.

- If the trade name is also recorded: Paracetamol 500mg (Hapacol or Biragan or Efferalgan or Panadol,...)

Article 5. Record the drug name, concentration/dosage, quantity, dose, route of administration, and time of administration for each type of drug.

6. The quantity of addictive drugs must be written in words, with the first letter capitalized.

Article 7. Quantity of drugs: Add a zero before single-digit numbers (less than ten).

Article 8. In case of corrections to the prescription, the prescriber must sign next to the corrected content.

Article 9. Cross out any blank space remaining below the prescription content to above the prescriber's signature; sign, write (or stamp) the prescriber's full name.

Article 7. Prescription for Addictive Drugs

Article 1. Prescribe on Prescription Form "N" according to Model 04 attached to this Circular and make three copies: 1 copy of Prescription Form "N" retained by the healthcare facility; 1 copy of Prescription Form "N" retained in the Outpatient Medical Record or Long-term Disease Treatment Records of the patient; 1 copy of Prescription Form "N" retained at the pharmacy dispensing or selling the drugs with the seal of the healthcare facility. In cases where the pharmacy dispensing or selling the drugs is the same healthcare facility that issued the prescription, the seal of the healthcare facility is not required.

Article 2. Prescription for acute illness treatment shall not exceed a quantity sufficient for seven days use.

3. In the case of prescribing narcotic drugs, the prescriber shall guide the patient or the patient's family member (in cases where the patient cannot visit the medical facility or the patient does not have full civil capacity) to write a commitment on the use of narcotic drugs. The commitment is made according to the model specified in Appendix No. 05 issued together with this Circular, and is made in two identical copies, of which: one copy is kept at the medical facility, and one copy is handed over to the patient or the patient's family member.

4. Healthcare facilities must establish a list of sample signatures of prescribers of addictive drugs from their own facility and send it to relevant departments within the healthcare facility for their knowledge.

Article 8. Prescription for narcotic drugs to relieve pain for cancer patients or AIDS patients

1. When diagnosing a cancer patient or an AIDS patient, the medical facility shall make an Outpatient Treatment Medical Record for the patient and issue a Long-Term Disease Treatment Booklet for the patient. The prescriber shall guide the patient or the patient's family member to commit to using narcotic drugs for the patient in the commitment section on page 2 of the Long-Term Disease Treatment Booklet (the content of the commitment is specified in Appendix No. 05 issued together with this Circular).

2. The dose of narcotic drugs prescribed for pain relief shall be based on the patient's pain relief needs, with each prescription valid for a maximum of 30 (thirty) days, but at the same time, three prescriptions for three consecutive treatment periods must be recorded, each prescription for one treatment period not exceeding 10 (ten) days (clearly stating the start and end dates of the treatment period).

3. In the case of prescribing narcotic drugs for pain relief for terminal cancer patients or AIDS patients who are bedridden at home (patients who cannot visit the medical facility): The patient must have a Confirmation Letter from the head of the commune health station where the patient resides confirming that the patient requires continued pain treatment with narcotic drugs according to the model specified in Appendix No. 06 issued together with this Circular as the basis for the doctor at the medical facility to prescribe the drug. Each prescription, the quantity of drugs used shall not exceed 10 (ten) days.

Article 9. Prescribing Psychotropic Drugs and Precursors

1. Prescribe on Prescription Form "H" according to the model specified in Appendix No. 07 issued together with this Circular, and make three copies, of which: one Prescription Form "H" is kept at the medical facility; one Prescription Form "H" is kept in the Patient's Medical Record or Long-Term Disease Treatment Booklet; one Prescription Form "H" is kept at the pharmacy supplying the drug with the stamp of the medical facility. In cases where the drug is supplied by the medical facility itself, there is no need for the stamp of the medical facility.

2. For acute diseases: Prescribe a quantity of drugs not exceeding ten (10) days of usage.

3. For long-term diseases (chronic diseases): Prescribe drugs according to the diagnosis and treatment guidelines of the Ministry of Health or prescribe with a maximum drug usage period of 30 (thirty) days.

4. For mental illness patients and epilepsy patients:

a) Prescribe drugs according to the diagnostic and treatment guidelines of the specialty.

b) The patient's family member or staff of the commune health station where the patient resides shall be responsible for distributing and collecting the drugs and signing their full name in the commune health station's drug distribution book (model book according to the specialty's guidance).

c) Whether a mentally ill patient can collect their own medication is decided by the prescriber on a case-by-case basis.

Article 10. Prescription of Medications by Medical Facilities Applying Information Technology in Prescription

1. The prescription printed once on a computer, then printed out and signed by the prescriber, and given one copy to the patient to keep in the Patient's Medical Record or Long-Term Disease Treatment Booklet.

2. Prescription Form "N" shall be implemented according to Clause 1, Article 7 of this Circular, and Prescription Form "H" shall be implemented according to Clause 1, Article 9 of this Circular: The prescription is printed in three copies corresponding to the retention of the prescription.

3. Prescription Form "N" as stipulated in Clause 2, Article 8 of this Circular: The prescription is printed in six copies corresponding to three treatment periods for one medical consultation, of which: three copies corresponding to three treatment periods are kept in the Outpatient Treatment Medical Record of the patient; three copies corresponding to three treatment periods are handed over to the patient or the patient's family member.

4. Medical facilities applying information technology must ensure the retention of prescriptions to extract data when necessary.

Article 11. Validity period of prescriptions for purchasing and collecting drugs

1. A prescription is valid for purchasing or collecting drugs within a maximum of five (5) days from the date of issuance.

2. Prescriptions can be purchased from legitimate retail pharmacies nationwide.

3. The time for purchasing or collecting narcotic drugs shall be consistent with the date of the treatment period recorded in the prescription. Purchase or collection of the second or third batch of narcotic drugs for cancer patients and AIDS patients should be done one (one) to three (three) days before each treatment period (if it falls on a public holiday, Saturday, or Sunday, purchase or collection should be done on the nearest working day before or after the holiday).

Article 12. Returning Narcotic Drugs, Psychotropic Substances, and Precursors Due to Non-use or Incomplete Use

1. The patient or the patient's family must return Narcotic Drugs, Psychotropic Substances, and Precursors that have not been used or have not been fully used to the entity that issued or sold the drugs.

2. The entity issuing or selling the drugs shall prepare a record of receiving returned Narcotic Drugs, Psychotropic Substances, and Precursors from the patient or the patient's family according to the model specified in Appendix No. 08 attached hereto. The record shall be made in two copies (one copy retained at the issuing or selling entity, one copy handed over to the person returning the drug).

3. Returned Narcotic Drugs, Psychotropic Substances, and Precursors shall be kept separately and processed in accordance with the relevant laws on pharmaceuticals.

Article 13. Retaining Prescriptions and Documents for Narcotic Drugs, Psychotropic Substances, and Precursors Used as Medicines, and Prescriptions Containing Antibiotics

1. Medical examination and treatment facilities shall retain prescriptions for one year from the date of issuance.

2. Medical examination and treatment facilities shall retain Prescription "N", Commitment Form for Narcotic Drug Use by Patients, and Prescription "H" for two years from the expiration date of the drug.

3. Entities compounding, issuing, and retailing Narcotic Drugs, Psychotropic Substances, and Precursors shall retain all Prescription "N" and Prescription "H" for two years from the expiration date of the drug.

4. Entities compounding, issuing, and retailing drugs shall retain prescriptions containing antibiotics for one year from the date of issuance. The retention may be carried out in one of the following forms:

a) Retaining the original or a copy of the prescription;

b) Keeping information about the prescription including: name and address of the medical examination and treatment facility, name and address of the prescriber, name of the patient, address of the patient's permanent residence, name of the antibiotic, dosage, quantity.

5. When the retention period for documents concerning Narcotic Drugs, Psychotropic Substances, and Precursors expires, the entity shall establish a Committee to destroy the documents in accordance with Circular No. 19/2014/TT-BYT dated June 2, 2014 on the management of Narcotic Drugs, Psychotropic Substances, and Precursors used as medicines. The destroyed documents include: Prescription "N"; Prescription "H"; Commitment Form for Narcotic Drug Use by Patients; Record of Receiving Narcotic Drugs; Confirmation Letter from the Commune Health Station regarding the need for continued pain relief treatment using Narcotic Drugs (if applicable).

Article 14. Implementation Organization

1. The Department of Medical Examination and Treatment under the Ministry of Health is responsible for guiding, organizing implementation, inspecting, and evaluating the implementation of this Circular.

2. Provincial Departments of Health under the central government, health departments of ministries and sectors shall have the responsibility to:

a) Direct and organize the implementation of this Circular within their jurisdiction and managed units;

b) Inspecting, supervising, and evaluating the implementation results of this Circular within the managed area or unit;

c) Directing the organization of entities selling Narcotic Drugs to outpatients. For districts, counties, towns, cities under provinces without such entities, the pharmacy department of the hospital in the area must supply (at purchase price) Narcotic Drugs to outpatients to ensure sufficient drug supply for patients.

d) Notifying medical examination and treatment facilities and related agencies in the area about the list of entities issuing and selling Narcotic Drugs.

3. Medical examination and treatment facilities and retail drug sellers shall be responsible for:

a) Implementing the provisions of this Circular.

b) Receiving Narcotic Drugs, Psychotropic Substances, and Precursors returned by the patient or the patient's family and proceeding to destroy the drugs in accordance with Circular No. 19/2014/TT-BYT dated June 2, 2014 of the Minister of Health on the management of Narcotic Drugs, Psychotropic Substances, and Precursors used as medicines.

c) For drugs not included in the List of Over-the-Counter Drugs issued together with Circular No. 23/2014/TT-BYT dated June 30, 2014 of the Minister of Health on the List of Over-the-Counter Drugs, retail drug entities may only sell drugs when the buyer has a prescription in accordance with this Circular;

d) Retail drug entities selling Narcotic Drugs must sell Narcotic Drugs to patients based on Prescription "N" prescribed in accordance with Articles 7 and 8 of this Circular.

4. Prescribers shall have the responsibility to:

a) Implement the prescription regulations stipulated in this Circular and bear responsibility for prescriptions issued to patients;

b) Guiding the use of drugs, advising dietary and living habits for patients or their families; guiding patients or their families to immediately inform the prescriber or go to the nearest healthcare facility if there are any unusual signs after taking the drug.

5. Patients and their families are responsible for complying with the provisions of this Circular.

Article 15. Effective Date

1. This Circular takes effect from May 1, 2016.

2. Decision No. 04/2008/QĐ-BYT dated February 1, 2008 of the Minister of Health promulgating the Prescription Regulations for Outpatient Treatment shall cease to be effective from the date this Circular takes effect.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to promptly report to the Ministry of Health (Department of Medical Examination and Treatment) for consideration and resolution./.