Circular No. 14/2015/TT-BYT on Methadone drug management

CIRCULAR

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Based on the Medicine Law dated 1June 4, 2005;

Based on Decree No. 96/2012/NĐ-CP dated August 15, 2012 of the Government on treatment for drug addiction using substitute medicines; 11 Based on Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of HIV/AIDS Prevention and Control,1The Minister of Health issues this Circular on the management of Methadone.

1. Forecasting and distribution of Methadone.

2. Transport, delivery, and storage of Methadone. reason 3. Prescribing Methadone.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates:

4. Dispensing Methadone, transferring treatment for drug addiction using Methadone (hereinafter referred to as transfer of treatment) and handling certain special situations.

5. Management of records, ledgers, and reports on Methadone.

Article 2. Principles of Application of Laws

1. The management of Methadone must comply with the provisions of this Circular and other regulatory legal documents concerning the management of addictive drugs, psychotropic substances, and precursor chemicals used as medicines.

2. In cases where regulatory legal documents issued by the Ministry of Health prior to the effective date of this Circular contain different provisions from those of this Circular on the same issue, the provisions of this Circular shall apply.

FORECASTING AND DISTRIBUTION OF METHADONE

Article 3. Authority to Approve Forecasts of Methadone Usage Requirements

1. The Ministry of Health approves forecasts of Methadone usage from sources under the management authority of the Ministry of Health and other Ministries and sectors without primary health management units.

Chapter II

2. Provincial Departments of Health (hereinafter referred to as Provincial Health Departments) approve forecasts of Methadone usage from sources under their management authority.

3. Primary health management agencies of Ministries and sectors (hereinafter referred to as Primary Agencies) approve forecasts of Methadone usage from sources under their own management authority.

Article 4. Procedures for Forecasting, Approval of Forecasts, and Distribution of Methadone Under the Management Authority of the Ministry of Health

1. Before the fifth day of January, April, July, and October each year, or in case of emergency, Methadone drug addiction treatment facilities (hereinafter referred to as Methadone Treatment Facilities) prepare forecasts of Methadone usage requirements according to Model No. 2 of Appendix 1 attached to this Circular, including the usage needs of patients at Methadone dispensing facilities under the management authority of the Methadone Treatment Facility, and send them to the Provincial Centers for HIV/AIDS Prevention and Control (hereinafter referred to as Provincial HIV/AIDS Prevention Centers).

2. Before the tenth day of the month when the forecast is prepared, the Provincial HIV/AIDS Prevention Center must complete the consolidation and send to the Provincial Health Department a consolidated table of Methadone usage requirements as stipulated in Clause 1 of this Article according to Model No. 3 of Appendix 1 attached to this Circular.

3. Before the fifteenth day of the month when the forecast is prepared, the Provincial Health Department must complete: the "d) The original or a certified copy of the discharge summary or a summary of the medical record as prescribed in Appendix 3 and Appendix 4 issued together with this Circular. If the worker has not been hospitalized or treated as an outpatient, they must have documents related to the examination and treatment of occupational injuries or diseases corresponding to the time of the accident and the injury for which assessment is requested.

a) Approval of forecasts of Methadone usage requirements of Methadone Treatment Facilities for sources under the management authority of the Provincial Health Department according to Model No. 3 of Appendix 1 attached to this Circular. The approval is made in three copies and sent as follows: one copy sent to the distribution unit, one copy sent to the Provincial HIV/AIDS Prevention Center, and one copy retained at the Provincial Health Department;

b) Consolidation of Methadone usage requirements of Methadone Treatment Facilities for sources under the management authority of the Ministry of Health according to Model No. 3 of Appendix 1 attached to this Circular and send to the Ministry of Health (Department of HIV/AIDS Prevention and Control) for approval of the forecast. The consolidated forecast is sent as follows: one copy sent to the Ministry of Health (Department of HIV/AIDS Prevention and Control), one copy sent to the Provincial HIV/AIDS Prevention Center, and one copy retained at the Provincial Health Department.

4. Before the twentieth day of the month when the forecast is prepared, the Ministry of Health (Department of HIV/AIDS Prevention and Control) reviews and approves forecasts of Methadone usage requirements of provinces for sources under the management authority of the Ministry of Health according to Model No. 3 of Appendix 1 attached to this Circular. The approval is made in four copies: one copy sent to the distribution unit, one copy sent to the Provincial Health Department, one copy sent to the Provincial HIV/AIDS Prevention Center, and one copy retained at the Ministry of Health (Department of HIV/AIDS Prevention and Control).

5. Based on the approved forecast of Methadone usage requirements by the competent authority, the distribution unit is responsible for:

a) Agreeing with the Methadone Treatment Facility on the quantity and time of specific drug deliveries. The drug delivery must be completed before the thirtieth day of the month when the forecast is prepared;

b) Reporting to the competent authority approving the forecast of Methadone usage requirements about the specific quantity and time of drug delivery.

5. Based on the approved forecast of Methadone usage needs, the distribution unit shall be responsible for:

a) Agreeing with the Methadone treatment facility on the quantity and specific delivery time of the drug. The drug delivery must be completed before the 30th day of the month when the forecast is established;

b) Reporting to the authority that approved the forecast of Methadone usage needs regarding the specific quantity and delivery time of the drug.

Article 5. Procedure for Estimating, Approving Estimates, and Distributing Methadone within the Management Authority of the Lead Agency l1. Before the fifth day of January, April, July, and October each year, or in case of emergency, the Methadone treatment facility shall prepare an estimate of the drug usage needs according to Model No. 2 of Appendix 1 issued together with this Circular, including the drug requirements of patients at Methadone dispensing facilities under the management authority of the treatment facility, and submit it to the Lead Agency before the fifth day of the month in which the estimate is prepared.

2. Before the tenth day of the month in which the estimate is prepared, the Lead Agency shall approve the estimates of Methadone usage needs of Methadone treatment facilities and Methadone dispensing facilities under the management authority of relevant ministries and sectors according to Model No. 3 of Appendix 1 issued together with this Circular. The estimate shall be made in three copies: one copy sent to the distribution unit, one copy sent to the Methadone treatment facility, and one copy retained by the Lead Agency for approving the estimate.

3. Based on the approved estimate of Methadone usage needs, the distribution unit shall be responsible for:

b) Reporting to the Lead Agency on the quantity and time of drug delivery.

a) Agreeing with the Methadone treatment facility on the quantity and specific delivery time of the drug. The drug delivery must be completed before the 30th day of the month when the forecast is established;

Article 6. Procedure for Establishing Usage Plans and Distributing Methadone to Dispensing Facilities

1. Before the twenty-fifth day of each month, or in case of emergency, the Methadone dispensing facility shall prepare a report on drug usage and an estimate of Methadone according to Model No. 1 of Appendix 1 issued together with this Circular and send it to the Methadone treatment facility. 2. Based on the proposal from the Methadone dispensing facility and the actual approved supply of Methadone, the Methadone treatment facility shall compile and approve the usage plan of Methadone for Methadone dispensing facilities under its management authority according to Model No. 2 of Appendix 1 issued together with this Circular. The estimate shall be made in two copies: one copy sent to the Methadone dispensing facility and one copy retained by the Methadone treatment facility. subject, organization, unit under the People's Committee of the commune level 3. The Methadone treatment facility shall transfer Methadone to Methadone dispensing facilities with specific quantities and delivery times. Drug delivery must be completed before the thirtieth day of each month.

Article 7. Enterprises Distributing Methadone

1. Enterprises specified in Clause 1, Article 5 of Circular No. 19/2014/TT-BYT dated June 2, 2014, issued by the Minister of Health, concerning the management of addictive drugs, psychotropic drugs, and precursor chemicals used as drugs (hereinafter referred to as Circular No. 19/2014/TT-BYT).

2. Enterprises permitted by the Minister of Health to produce Methadone domestically and meeting the conditions for good distribution practices as stipulated in Circular No. 48/2011/TT-BYT dated December 21, 2011, issued by the Minister of Health, regarding the "Good Distribution Practices" principles.

TRANSPORTATION, HANDOVER, AND STORAGE OF METHADONE

Article 8. Transportation of Methadone

The transportation of Methadone to Methadone treatment facilities and Methadone dispensing facilities shall be carried out in accordance with Article 13 of Circular No. 19/2014/TT-BYT.

Chapter III

Article 9. Handover of Methadone

In addition to complying with the regulations on handover of drugs stipulated in Article 12 of Circular No. 19/2014/TT-BYT, the handover of Methadone must also comply with the following additional regulations:

1. Handover between the distribution unit and the Methadone treatment facility:

a) Staff transporting drugs from the distribution unit and staff managing the drug warehouse at the Methadone treatment facility shall carry out the handover of Methadone and prepare a handover record for Methadone according to the model prescribed in Appendix 2 issued together with this Circular. The handover record shall be made in five copies: one copy retained by the Methadone treatment facility, one copy sent to the Provincial AIDS Prevention and Control Center, one copy retained by the distribution unit, one copy sent to the unit responsible for finalizing the Methadone drug account, and one copy sent to the agency authorized to approve the Methadone drug estimate;

b) Staff managing the drug warehouse at the Methadone treatment facility shall enter information about the handed-over Methadone into:

- The common addictive drug management ledger of the unit if the Methadone treatment facility belongs to a unit with a common drug warehouse;

- The Methadone drug warehouse tracking ledger of the Methadone treatment facility established according to the model prescribed in Appendix 3 issued together with this Circular if the Methadone treatment facility is independent and has a separate Methadone drug warehouse.

2. Handover between the Methadone treatment facility and the Methadone dispensing facility:

a) Staff transporting from the Methadone treatment facility and staff managing drugs at the Methadone dispensing facility shall proceed with the handover and sign the daily Methadone drug issuance and receipt tracking ledger of the Methadone treatment facility established according to the model prescribed in Appendix 4 issued together with this Circular;

b) Staff managing drugs at the Methadone dispensing facility shall input data into the Methadone drug warehouse tracking ledger according to Point b, Clause 1 of this Article.

3. In cases where abnormal signs of Methadone are detected, the handling of such abnormalities shall be carried out in accordance with Clause 1, Article 16 of this Circular.

a) The transport staff of the Methadone treatment facility and the drug management staff at the Methadone dispensing facility shall carry out the handover and sign the Methadone Inbound and Outbound Tracking Book daily, which is established according to the model prescribed in Appendix 4 issued together with this Circular;

b) The drug management staff at the Methadone dispensing facility shall enter data into the Methadone Drug Inventory Tracking Book in accordance with Point b Clause 1 of this Article.

3. In case of detecting any abnormal signs of Methadone, the handling of such abnormalities shall be carried out in accordance with the provisions of Clause 1 Article 16 of this Circular.

Article 10. Daily Export and Import of Methadone

1. The daily export of Methadone from Methadone treatment facilities shall be carried out as follows:

a) Staff managing the drug warehouse prepares the appropriate quantity of Methadone for export to the dispensing department;

b) The export of Methadone from the storage room to the daily dispensing department must meet the following requirements:

- Recording complete information in the Daily Export and Import Drug Methadone Logbook;

- Having signatures of two key holders of the Methadone drug storage cabinet;

- Confirmation by the person in charge of the pharmacy department at the Methadone treatment facility or a person authorized by the head of the Methadone treatment facility to confirm the transfer of Methadone from the storage room to the dispensing department. Such authorization must be in writing. The authorized person may not redelegate this authority to another person.

2. The daily export of Methadone from Methadone dispensing facilities shall be carried out as follows:

a) Staff managing the drugs prepares the appropriate quantity of Methadone for export to the dispensing staff;

b) The export of Methadone must meet the following requirements:

- Recording complete information in the Daily Export and Import Drug Methadone Logbook;

- Having signatures of two key holders of the Methadone drug storage cabinet;

- Confirmation by the person responsible for technical expertise at the Methadone dispensing facility or a person authorized by the head of the Methadone dispensing facility to confirm the transfer of Methadone from the storage room to the dispensing department. Such authorization must be in writing. The authorized person may not redelegate this authority to another person.

3. Re-importing daily unused Methadone from the dispensing room back into the storage room: Dispensing staff checks the remaining quantity of unused Methadone for the day and hands it over to the drug warehouse manager to record in the Daily Export and Import Drug Methadone Logbook as stipulated in Point b Clause 1 and Point b Clause 2 of this Article.

Article 11. Storage of Methadone

1. The storage of Methadone at Methadone treatment facilities shall be carried out in accordance with the provisions of Clause 1 Article 3, Clause 1 Article 4, and Clause 2 Article 5 of Circular No. 12/2015/TT-BYT dated May 28, 2015 issued by the Minister of Health on detailed guidance for implementation of certain provisions of Government Decree No. 96/2012/NĐ-CP dated November 15, 2012 regarding methadone substitution therapy for opiate addiction (hereinafter referred to as Circular No. 12/2015/TT-BYT).

2. The storage of Methadone at Methadone dispensing facilities shall be carried out in accordance with the provisions of Articles 6, 7, and 8 of Circular No. 12/2015/TT-BYT.

Chapter III

METHADONE PRESCRIPTION FORM

Article 12. Conditions for Methadone Prescribers

Methadone prescribers must meet the following conditions:

1. They must be doctors who have worked in medical examination and treatment for at least eighteen months.

2. They must hold a certificate of training in methadone substitution therapy for opiate addiction issued by training institutions assigned tasks by the Ministry of Health.

Article 13. Methadone Prescription

1. Doctors can only prescribe Methadone after directly examining and assessing patients; prescribing the drug in the patient's medical record and the Methadone Prescription Form. The prescription form shall follow the model prescribed in Appendix 2 attached to Decision No. 04/2008/QĐ-BYT dated February 1, 2008 issued by the Minister of Health on the regulation of drug prescriptions in outpatient treatment (hereinafter referred to as Decision No. 04/2008/QĐ-BYT).

2. Methadone prescriptions must comply with the professional guidelines set forth in Decision No. 3140/QĐ-BYT dated August 30, 2010 issued by the Minister of Health on the guidance for methadone substitution therapy for opiate addiction (hereinafter referred to as Decision No. 3140/QĐ-BYT) and the following regulations:

a) For patients in the dose-finding phase: Doctors prescribe daily Methadone;

b) For patients in the dose-adjustment phase: Doctors prescribe Methadone every three to five days based on the patient's condition and must clearly indicate the start and end dates of the dose adjustment period;

c) For patients in the maintenance treatment phase: Each prescription for Methadone shall not exceed one month and must clearly indicate the start and end dates of the treatment period;

d) For patients in the dose-reduction phase leading to cessation of treatment: Each prescription for Methadone shall be for two weeks and must clearly indicate the start and end dates of the treatment period;

đ) For patients in the maintenance treatment phase but must be hospitalized in a healthcare facility that does not provide methadone treatment services or must stay at home and cannot reach the methadone treatment facility or dispensing facility to take the medication daily: Each prescription for Methadone shall not exceed seven days and must clearly indicate the start and end dates of the treatment period.

Chapter V

METHADONE DISPENSING, TRANSFER OF TREATMENT, AND HANDLING OF CERTAIN SPECIAL CASES

Article 14. Distribution of Methadone Medication

1. When distributing medication at a Methadone treatment facility or a Methadone distribution facility, the Methadone distribution staff shall be responsible for:

a) Distributing the correct dosage to patients according to the physician's prescription. In cases where patients are in the dose-finding phase, the distribution staff shall cooperate with physicians and administrative personnel to monitor the patient for a period of three (03) to four (04) hours following the first dose of Methadone;

b) Observing patients while they take their medication to ensure that they consume all of the Methadone before leaving the facility;

c) Recording the use of Methadone by patients in the daily Methadone distribution monitoring log established according to Model 5 attached to this Circular and the Patient Monitoring Form for Methadone Treatment established according to Model 6 attached to this Circular (hereinafter referred to as the Patient Monitoring Form for Methadone Treatment);

d) Adhering to the principle of patient information confidentiality.

2. When receiving Methadone medication at a Methadone treatment facility or a Methadone distribution facility, patients shall be responsible for:

a) Consuming all of the Methadone in the presence of medical staff;

b) Signing the Patient Monitoring Form for Methadone Treatment to confirm consumption of the medication;

c) Following the instructions of medical staff.

Article 15. Transfer of Treatment

1. The transfer of treatment shall be carried out in accordance with the provisions of Article 19 of Circular No. 12/2015/TT-BYT.

2. In cases where patients must undergo inpatient treatment at a healthcare facility that does not provide Methadone treatment services but is located within the same administrative area as the Methadone treatment facility where the patient is currently being treated:

a) Patients shall submit a request form to consume Methadone at the healthcare facility according to Model 1 of Appendix 7 attached to this Circular and send it to the Methadone treatment facility;

b) Physicians at the healthcare facility shall be responsible for confirming the request form for consuming Methadone from the patient, including confirming that the patient has no contraindications to using Methadone. For special cases requiring consultation, organize consultations in accordance with the provisions of Article 56 of the Law on Medical Examination and Treatment;

c) Based on the request form for consuming Methadone and the confirmation that there are no contraindications to using Methadone from the physician at the healthcare facility, the physician at the Methadone treatment facility shall prescribe Methadone for the patient in accordance with Point d Clause 2 of Article 13 of this Circular;

d) Based on the prescription from the treating physician, the Methadone distribution staff at the Methadone treatment facility shall be responsible for:

- Delivering the required amount of Methadone for one (01) day and the Patient Monitoring Form for Methadone Treatment to the medical staff assigned by the head of the Methadone treatment facility to transfer the medication (hereinafter referred to as the Methadone delivery person) to deliver the Methadone to the healthcare facility for the patient;

- Recording the use of medication by the patient in the daily Methadone distribution monitoring log;

đ) The Methadone delivery person shall be responsible for carrying the following documents when transferring Methadone to the patient:

- An introduction letter from the Methadone treatment facility or the Methadone distribution facility;

- The Methadone prescription;

- The Patient Monitoring Form for Methadone Treatment of the patient.

e) The Methadone delivery person shall directly monitor the patient's consumption of Methadone and sign the Patient Monitoring Form for Methadone Treatment together with the patient;

g) After the patient completes the treatment process at the healthcare facility, the Methadone treatment facility shall continue to treat the patient in accordance with current regulations.

3. In cases where patients must undergo inpatient treatment at healthcare facilities that do not provide Methadone treatment services and are not located in the same administrative area as the Methadone treatment facility where the patient is currently being treated:

a) Patients shall submit a request form to consume Methadone at the healthcare facility according to Point a Clause 2 of this Article;

b) The Methadone treatment facility where the patient is currently being treated shall proceed with the procedures for transferring the patient according to Article 19 of Circular No. 12/2015/TT-BYT to a nearby Methadone treatment facility near the healthcare facility;

c) The Methadone treatment facility where the patient is transferred shall carry out the distribution of Methadone to the patient at the healthcare facility according to the provisions of Points b, c, d, đ, and Point e Clause 2 of this Article;

d) After the patient completes the treatment process at the healthcare facility, the Methadone treatment facility where the patient was treated prior to entering the healthcare facility shall continue to treat the patient in accordance with current regulations.

4. In cases where patients are at home and cannot come to the Methadone treatment facility to consume Methadone daily:

a) Patients shall submit a Request Form to receive Methadone at home according to Model 2 of Appendix 7 attached to this Circular and send it to the Methadone treatment facility;

b) If the Methadone treatment facility has sufficient personnel to deliver Methadone to the patient, they shall verify the patient's health status to decide on the distribution of Methadone to the patient at home;

c) If the patient has no contraindications, the treating physician shall prescribe Methadone for the patient in accordance with Point đ Clause 2 of Article 13 of this Circular;

d) Based on the prescription from the treating physician, the Methadone distribution staff at the Methadone treatment facility shall be responsible for implementing the provisions of Point d Clause 2 of this Article;

đ) The Methadone delivery person shall be responsible for carrying the documents specified in Point đ Clause 2 of this Article when delivering Methadone to the patient;

e) The Methadone delivery person shall directly deliver Methadone to the patient and monitor the patient's consumption of Methadone, signing the Patient Monitoring Form for Methadone Treatment together with the patient;

g) After the patient completes the treatment process at home, the Methadone treatment facility shall continue to treat the patient in accordance with current regulations.

Article 16. Handling of Methadone Medication that is Damaged, Broken, or Does Not Meet Quality Standards During Reception, Storage, and Distribution

1. In cases where wet medication, medication with missing seals, missing labels, incorrect labels, torn packaging, excess medication, insufficient medication, damaged medication, cracked or broken bottles, or bottles not meeting volume requirements are discovered when a Methadone treatment facility receives medication from a distribution unit, or when a Methadone dispensing facility receives medication from a Methadone treatment facility, the following extraordinary handling procedures shall be implemented:

a) Maintain the current condition of the medication;

b) Prepare a record confirming the abnormal condition according to the model prescribed in Appendix 8 issued together with this Circular. The record must have signatures confirming the condition from the person delivering the medication, the person receiving the medication, the leader of the receiving unit, and a stamp. The record is prepared in two copies: one copy retained at the receiving unit and one copy sent to the delivering unit;

c) Return the medication to the warehouse of the delivering unit. The warehouse manager of the delivering unit will cooperate with relevant staff to inventory the quantity and sealing of the goods before entering the warehouse, while updating the warehouse card for substandard medication, storing it in the narcotic drug warehouse, and proceeding with the handling of substandard medication according to current regulations on managing narcotic drugs, psychotropic drugs, and precursor chemicals used in medications.

2. In cases where wet medication, medication with missing seals, missing labels, incorrect labels, torn labels, excess medication, insufficient medication, damaged medication, cracked or broken bottles, or bottles not meeting volume requirements are discovered in the warehouse of a Methadone treatment facility or a Methadone dispensing facility, the following extraordinary handling procedures shall be implemented:

a) Determine the cause;

b) Prepare a record confirming the abnormal condition according to the model prescribed in Appendix 8 issued together with this Circular. The record must have signatures confirming the condition from two dispensing staff members, the head of the Methadone treatment facility or the head of the Methadone dispensing facility, and a stamp. The record is prepared in two copies, one copy retained at the Methadone treatment facility or Methadone dispensing facility and one copy sent to the distribution unit;

c) Return the medication to the warehouse of the distribution unit during the next Methadone medication distribution period. The warehouse manager will cooperate with relevant staff to inventory the quantity and sealing of the goods before entering the warehouse, while updating the warehouse card for substandard medication, storing it in the narcotic drug warehouse, and proceeding with the handling of substandard medication according to current regulations on managing narcotic drugs, psychotropic drugs, and precursor chemicals used in medications.

3. In cases where the key to the warehouse is lost or there is suspicion about the safety of the medication warehouse at a Methadone treatment facility or a Methadone dispensing facility, the following extraordinary handling procedures shall be implemented:

a) The person discovering the incident reports to the head of the Methadone treatment facility or the Methadone dispensing facility;

b) Prepare a record confirming the abnormal condition according to the model prescribed in Appendix 8 issued together with this Circular. The record must have signatures confirming the condition from the person discovering the incident, one dispensing staff member, the head of the Methadone treatment facility or the head of the Methadone dispensing facility, and a stamp. The record is prepared in one copy and retained at the Methadone treatment facility or Methadone dispensing facility.

4. In cases where Methadone medication is found to be damaged after each day's dispensing to patients, the following extraordinary handling procedures shall be implemented:

a) Dispensing staff report to the head of the Methadone treatment facility or the Methadone dispensing facility;

b) Prepare a record confirming the damage to the Methadone medication according to the model prescribed in Appendix 9 issued together with this Circular. The record must have signatures confirming the condition from two dispensing staff members, the head of the Methadone treatment facility or the head of the Methadone dispensing facility, and a stamp. The record is prepared in one copy and retained at the Methadone treatment facility or Methadone dispensing facility. The Methadone treatment facility or Methadone dispensing facility compiles the monthly quantity of damaged Methadone medication and includes the data in the monthly report on stock and usage of Methadone medication submitted to the Provincial AIDS Prevention and Control Center or the coordinating agency for consolidation.

5. In cases where Methadone medication spills during dispensing to patients, the following extraordinary handling procedures shall be implemented:

a) Determine the cause of the spillage of the Methadone medication;

b) Prepare a record confirming the spilled condition of the Methadone medication according to the model prescribed in Appendix 10 issued together with this Circular. The record must have signatures confirming the condition from two dispensing staff members, the patient, and the head of the Methadone treatment facility or the head of the Methadone dispensing facility, and a stamp. The record is prepared in one copy and retained at the Methadone treatment facility or Methadone dispensing facility;

c) Dispense an additional dose of Methadone to the patient and record information about the additional dose of Methadone dispensed in the daily dispensing log.

Chapter VI

MANAGEMENT OF METHADONE MEDICATION FILES, REGISTERS, AND REPORTS

Article 17. Retention of records and ledgers

1. The retention of prescriptions shall be carried out in accordance with the provisions of Decision No. 04/2008/QĐ-BYT.

2. The retention of records and ledgers related to the management of Methadone shall be implemented in accordance with Clause 1 and Clause 3 of Article 18 of Circular No. 19/2014/TT-BYT.

Article 18. Reporting System

1. Monthly, semi-annual, and annual reports on stock levels and usage at Methadone treatment facilities shall be conducted in accordance with Point a of Clause 2 of Article 19 of Circular No. 19/2014/TT-BYT.

2. Provincial Health Departments shall report annually on the use of Methadone in their respective localities in accordance with Point d of Clause 2 of Article 19 of Circular No. 19/2014/11-BYT.

3. Lead agencies shall report annually on the use of Methadone under their management in accordance with Point d of Clause 2 of Article 19 of Circular No. 19/2014/TT-BYT.

4. Reports on errors, losses, and suspected losses of Methadone shall be made in accordance with Clause 3 of Article 19 of Circular No. 19/2014/TT-BYT.

5. The reports stipulated in Clauses 1, 2, 3, and Clause 4 of this Article shall be submitted simultaneously to the National Center for HIV/AIDS Prevention and Control and the Drug Administration Department under the Ministry of Health.

Chapter VII

IMPLEMENTING PROVISIONS

Article 19. Cross-referencing Provisions

In cases where referenced documents in this Circular are replaced or amended, implementation shall follow the replacement document or the amended document.

Article 20. Implementation Provisions

This Circular takes effect from September 1, 2015.

During implementation, if there are any difficulties, they should be promptly reported to the Ministry of Health (National Center for HIV/AIDS Prevention and Control) for consideration and resolution./.