Circular 14/2015/tt-Byt: Methadone Medication Management

Original Language Title: Thông tư 14/2015/TT-BYT: Quản lý thuốc Methadone

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MINISTRY OF HEALTH
Number: 14 /2015/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, June 25, 2015

IT ' S SMART

Manage medications M Ethadon e

__________

The Law School. 1 June 4, 2005;

Base of Protocol 96 /2012/NĐ-CP 15 11 2012 Government of the Government rules on the treatment of opiates of opiates with alternative medicine;

Base of Protocol 63 /2012/NĐ-CP August 31, 20 1 2 of the Government rules the functions of duty, jurisdiction and organizational structure of the Ministry of Health;

On the recommendation of the Bureau of Defense, anti-HIV/AIDS,

Minister of Health, Department of Health. Why? Methadone.

Chapter I

COMMON RULES

What? 1. The adjustment range

This message rules:

1. Preparation and distribution of Methadone.

2. Transport, delivery and maintenance of Methadone.

3. Methadone prescription.

4. Metabolism Methadone, relax treatment for drug-addicted opiates with Methadone (which later calls for treatment transfer) and handles some special situations.

5. Case management, book book, Methadone drug reports.

What? 2. Principles of Law application

1. The management of Methadone has to comply with the regulations at this level and the regulation of other laws of law in terms of drug management, mental medication, and drug prescriptions.

2. The case of legal law enforcement issued by the Ministry of Health prior to this time of passage is valid for the implementation of these rules on the same issue that applies the provisions of this message.

Chapter II

PROJECT AND DISTRIBUTION OF METHADONE

What? 3. The approval authority intends to use Methadone drug

1. The Department of Health approved the use of methadone from the medical source of the Department of Health and ministries, the non-unit sector of the health care unit.

2. Provincial Health Department, central city (later called the Department of Health) browse for the use of methadone from the medical department's source of medicine.

3. The head of health care management of the ministries, the industry (later known as the Base Agency) browse the category of Methadone drug use from the source of the Department's management, industry.

What? 4. Preparation planning, planning and distribution of Methadone drugs under the management jurisdiction of the Ministry of Health and Department Medical

1. Before the 5th of January, 4, 7 and October every year or in the case of a sudden, the treatment facility for drug addiction to methadone (later called Methadone treatment facility) set up a demand for Methadone drugs. According to the number two Annex 1 issued by this privacy, including the need to use the drug of the sick at the methadone drug facility in the jurisdiction of the treatment facility Methadone and sent back to the Center, against HIV/AIDS, the city. It is the Central Committee of the Central Committee (later called the Centre for Prevention of HIV/AIDS).

2. Before the 10th of the month of the scheduled month, the Centre for Prevention, the anti-HIV/AIDS department had to complete the synthesis and send the Department of Health to the need for the use of the methadone to use the prescribed Methadone. Hey.

3. Before the 15th of the scheduled month, the Health Department must complete:

a) Browse for the need to use the methadone of the methadone treatment facility on the medical source administered by the Department of Health by the number 3 Annex 1 issued this message. The plan was to be built in 3 copies and sent as follows: 1 distribution unit, 01 to the Central Office, anti-HIV/AIDS and 01-copy of the Department of Health;

b) The need for the use of methadone of the methadone treatment facilities on the medical source administered by the Department of Health under pattern 3 Annex 1 issued by this message and sent the Department of Health (Department of Defense, Anti-HIV/AIDS) to recommend the review. Yeah. The planned synthesis was sent as follows: 01 to the Department of Health (Bureau of Defense, Anti-HIV/AIDS), 01 sent to the Centers for Prevention, anti-HIV/AIDS department, and 01 copies at the Department of Health.

4. Before the 20th of the scheduled month, the Ministry of Health (Bureau of Defense, Anti-HIV/AIDS) reviewed, approved the need for the need to use Methadone drugs of the provinces to the Department of Health ' s management of the Department of Health under pattern 3 Annex 1 issued by Ly. Hey. The plan is to be established in 4 units: 1 distribution unit, 01 to the Department of Health, 01 of the Centers for Prevention, Anti-HIV/AIDS Prefated, and 01 copies at the Department of Health (Bureau of Defense, Anti-HIV/AIDS).

5. Based on the planned review of the need for methadone to be approved by the authorities, the distribution unit is responsible:

a) Unity with the basis of Methadone treatment in terms of quantity and time of specific delivery. The delivery must be done before the 30th of the month of setting;

b) The authoritative agency report approved the need for the use of Methadone drugs in terms of the number and time of specific delivery.

What? 5. Process l Planning, planning, and distribution of Methadone, the agency's management authority.

1. Before the 05 of January, 4, 7 and October of every year or in the case of a sudden, Methadone treatment set up a need for the need to use Methadone drug on the number 2 Annex 1 issued this message, including the need for human medicine. The disease at the Methadone drug grant facility is administered by the treatment facility Methadone and sent to the First Agency on the 5th of the Month of the Preparation Month.

2. Prior to the 10th of the month of planning, the Agency for Appropriation planned to use Methadone drugs of the methadone treatment facilities and the local Methadone drug-issued facility, the management industry under the No. 3 Appendix 1 grant issued by this Information. The category is set up 3 copies: 1 distribution unit, 01 to the treatment of Methadone and 01 at the Preparation Browser Headquarters.

3. Based on the planned release of the need for methadone to be approved, the distribution unit is responsible:

a) Unity with the basis of Methadone treatment in terms of quantity and time of specific delivery. The delivery must be done before the 30th of the month of setting;

b) The initial agency report on the number and time of the specific delivery.

What? 6. The planning process uses and distributs the drug Methadone to the the muscle Methadone drug.

1. Before 25 per month or in the case of a break-up, the methadone drug facility set up a report using and envisaged Methadone drug prescriptions on the number 1 Annex 1 issued by this message sent back to the Methadone treatment facility.

2. The proposed base of the methadone drug grant facility and the fact that Methadone drugs are issued with approval, the treatment facility Methadone aggregate and browse the plan to use the methadone drug of Methadone drug grant facilities under management jurisdiction. According to the number 2 Annex 1 issued this message. The project is set up to 2 copies: 1 copies of the Methadone and 01 drug-based storage facilities at the Methadone treatment facility.

3. Methadone treatment of Methadone drug delivery for Methadone drug delivery facilities with a specific amount of medication and time of delivery. The delivery must be done before 30 months.

What? 7. Methadone drug distribution business

1. Businesses are regulated at Clause 1 Article 5 Digital 19 /2014/TT-BYT June 02, 2014, by the Secretary of Health for the regulation of drug management, mental health and drug-making prescriptions (the following calls are Digital). 19 /2014/TT-BYT).

2. The businesses are authorized by the Minister of Health to produce methadone drug in the country and meet the good practice of distributing drugs by regulation at Digital Notice. 48 /2011/TT-BYT December 21, 2011 by the Minister of Health enacted the principle of "Good Practice of Distribution".

Chapter III

SHIPPING, DELIVERY AND PRESERVATION OF METHADONE

What? 8. Methadone drug transport

The transport of Methadone to the treatment facilities of Methadone, the methadone drug-delivery facility performs by regulation at Article 13 Digital. 19 /2014/TT-BYT.

What? 9. Methadone drug delivery

In addition to adhering to regulations on the prescribed drug delivery at Article 12 Digital 19 /2014/TT-BYT, Methadone has to comply with the following regulations:

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

a) The drug delivery personnel of the distribution unit and drug management staff at the treatment facility Methadone performs the delivery, receiving the medication Methadone and the receipt of Methadone drug delivery by the prescribed form at Annex 2 issued by Ly. Hey. The protocol is set up to 05 copies: 01 copies at the treatment facility Methadone, 01 to the Center for Prevention, Anti-HIV/AIDS Prefectures, 01 copies at the distribution unit, 1 unit submitted units responsible for the determination of Methadone, and 01 to the agency. The authority to approve the order of methadone;

b) The administrator of the drug store at the basis of Methadone's treatment of methadone drug information is delivered:

-The unit's general drug management system for the MMethadone treatment facility in the unit has a common drug store;

Methadone's methadone drug store monitor is set up by a 3-issued Annex 3 issued by this Privacy for the independent Methadone treatment facility and has its own Methadone pharmacy.

2. Protocol Methadone between Methadone treatment facility and Methadone drug delivery facility:

a) The transport staff of the treatment facility Methadone and the drug management staff at the Methadone drug-delivery facility conduct the exchange, the tracking sign, the daily Methadone treatment of the methadone treatment facility set up by the prescribed form at Annex. The four of them were attached to this level.

b) The drug management staff at the Methadone drug-issued facility joins the data on the Methadone drug store monitor as prescribed at the point b 1 This Article.

3. The case of detection of abnormal signs of Methadone drug, abnormal processing is carried out by regulation at Clause 1 Article 16 of this.

What? 10. Export, enter Methadone every day

1. The daily injection of Methadone at the basis of Methadone treatment is as follows:

a) Drug store management personnel prepare the number of Methadone drugs suitable for export to the drug department;

b) The export of Methadone from the repository to the daily prescriptions department must meet the following requirements:

-Copy that.-Copy that.-Copy that.

-There's enough signatures from the two of you to keep the keys to the methadone.

-There is confirmation by the drug department of the treatment facility Methadone or the head of the methadone treatment facility to perform the identification of Methadone from the repository for the department of drug delivery. The mandate must be made in writing. The authorized person is not delegated to others.

2. The export of Methadone at the Methadone drug level facility performs as follows:

a) Drug management personnel preparing the number of Methadone drugs suitable to export to the drug-grade worker;

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

-Copy that.-Copy that.-Copy that.

-There's enough signatures from the two of you to keep the keys to the methadone.

-There is a confirmation of the person responsible for the technical expertise of the drug-delivery facility Methadone or the head of the methadone drug-issued facility that performs the identification of Methadone from the repository for the department of drug delivery. The mandate must be made in writing. The authorized person is not delegated to others.

3. Enter the daily Methadone drug from the emergency room into the repository: The drug-grade worker checks the amount of unusable Methadone drugs during the day and handed over to the agent of the drug store to log on to the Department of Tracking, Drug-importing Methadone daily rules at point b 1 and point b 2 This.

What? 11.

1. The preservation of methadone at the treatment facility Methadone performs as stipulated at paragraph 1 Article 3, Clause 1 Article 4, Clause 2 Articles 5 Digital 12 /2015/TT-BYT May 28, 2015, of the Minister of Health on detailed instructions to enforce some of the provisions of the Fifth Protocol. 96 /2012/NĐ-CP November 15, 2012 of the Government Regulation on the treatment of opiates of opiates in substitution drugs (the following is called Digital Digital). 12 /2015/TT-BYT).

2. The preservation of methadone at the basis of the methadone drug grant implementation prescribed at Article 6, Article 7, Article 8 Digital News 12 /2015/TT-BYT.

Chapter III

METHADONE.

What? 12. Conditions for the prescription drug Methadone

Methadone prescrip must meet the following conditions:

1. The doctor has time to do the autopsy, cure the disease from 18 months or more.

2. There is a certificate that has been trained in the treatment of opiates of drugs in methadone drugs issued by training facilities assigned to the Ministry of Health.

What? 13.

1. The doctor is only prescribed Methadone after a direct examination, assessment of the disease; prescribation on the disease and the Methadone prescription. A sample of the drug made by the prescribed pattern at Annex 2 issued by Decision No. 04 /2008/QĐ-BYT February 01, 2008, of the Minister of Health on the enacumment of the Drug Prescribed Procedure in outpatient treatment (the following call is Decision No. 04 /2008/QĐ-BYT).

2. The Methadone prescription must comply with specialized guidelines stipulated at Decision No. 3140 /QĐ-BYT on 30 August 2010 by the Minister of Health on the issuing of the management of the treatment of drug addiction to drug methadone (later called). It is a 3140 /QD-BYT decision, and the following regulations:

a) To the sick in the time of the dose: Dr. Methadone daily;

b) For the pathology of the treatment phase: Doctor prescribbled after 3 to 05 days of treatment according to the condition of the disease and must be noted the date of the start, the end date of the dose correction;

c) For the pathology of the duration of the treatment: The duration of the medication Methadone does not exceed one (01) months and must specify the start date, the end date of the treatment;

d) For patients in the period of reduced dose to stop treatment: Time per order Methadone is two (02) weeks and must specify the start date, the end date of the treatment;

For patients during the sustained period of treatment, treatment must be found at the facility, treating the disease not to provide Methadone treatment services, or at home, unable to get to Methadone treatment facility or Methadone drug delivery facility. Daily drinking: The duration of the treatment of Methadone does not exceed seven (7) days and must specify the date of the beginning, the end date of the treatment.

Chapter V.

LEVEL OF METHADONE DRUG, RELAY TREATMENT AND PROCESS SOME SPECIAL SITUATIONS.

What? 14. Methadone drug.

1. When the drug is issued at the treatment facility Methadone or the drug-issued facility Methadone, the drug-issued MeMethadone worker is responsible:

a) Level the correct dose for the patient according to the doctor ' s instructions in the prescription. In cases where the disease is in the phase of an overdose, the drug-grade worker coordinates with the doctor and the administrative officer who follows the person in the ring from three (03) hours to four (04) hours after taking the first dose of Methadone.

b) observing the sick while taking the medication to ensure the ill drinker of Methadone before coming out of the facility;

c) Records the use of Methadone drug of patients on a daily Methadone drug tracking book set up by a prescribed pattern at Annex 5 issued by this Information and Trace Surveillance of Medication Methadone created by the sample. regulation at Annex 6 issued by this message (the following this is called Methadone treatment);

d) comply with the principle of information security of the sick person.

2. When taking Methadone on the basis of Methadone treatment or Methadone drug injection facility, the sick person is responsible:

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

b) The sign has taken the pill to monitor the treatment of Methadone;

c) Compliance with the guidance of the medical staff.

What? 15. Transfer of treatment

1. The transition of implementation treatment pursues to Article 19 Digital Digital. 12 /2015/TT-BYT.

2. The case of a sick person must be in the patient ' s treatment at the clinic, treating the disease not to provide the treatment of Methadone but the same on the site with the Methadone treatment facility that the sick person is treating:

a) The sick person who makes the offer to take the medication Methadone at the clinic, cure the disease according to the number 1 Annex 7, which is accompanied by this information and sends the treatment of Methadone;

b) Physician at the facility of the disease, it is responsible for confirming the application of the pathology of Methadone, which confirms that the patient is not resistant to the use of methadone. For special pathology cases, the assembly is prescribed by Article 56 of the medical examination, the treatment of the disease.

c) The application base is to be taken with Methadone and confirm that there is no anti-doctor ' s use of methadone at the clinic, treating the disease, the doctor of the treatment facility Methadone prescrip Methadone prescription for the pathologist at the Point. This is two Article 13 of this.

d) The physician's prescription base, the drug-grade agent of the treatment facility Methadone, is responsible:

-Delivery of the number of Methadone drugs used in one (01) days and Votes follow the treatment of Methadone treatment for medical workers who are headed by the head of the methadone treatment facility (later called methadone delivery) To transfer methadone to the clinic, cure the disease.

-Record the use of the patient's drug on the daily prescription of methadone.

Methadone has the responsibility to bring the papers after the delivery of Methadone to the sick:

-Introduction of the methadone treatment facility or Methadone drug-issued facility;

-Methadone.

-The patient's methadone treatment.

e) The person who delivered the drug directly followed the drinking of Methadone of the sick and signed on to the treatment of Methadone with the sick;

g) After the disease end of the treatment at the clinic, the treatment, the treatment facility Methadone continues to treat the sick person according to the current regulation.

3. The case of the sick must be in the patient ' s treatment at the clinics, the treatment does not provide the treatment of Methadone and not on the same site as the Methadone treatment facility that the sick person is treating:

a) The patient who applied the offer was taken to cure Methadone at the clinic, treating the disease prescribed at the point a paragraph 2;

b) The Methadone treatment facility where the sick person is treating the procedure of transferring the sick to the patient by regulation at Article 19 Digital News 12 /2015/TT-BYT to the facility of Methadone near the facility of disease, healing;

c) The methadone treatment facility where the person is transferred does deliver methadone drug grant to the sick person at the clinic, treating the disease according to the regulations at Point b, c, d, e, and Point 2 This Article;

d) After the disease ended the treatment at the clinic, the treatment, the treatment facility Methadone where the sick person was treated before entering the clinic, the treatment continued treatment for the disease according to the current regulation.

4. The case of people who are sick at home, ca n' t go to Methadone treatment facility to take Methadone drugs daily:

a) The sick person who makes a proposal to be granted methadone at home according to the number 2 Annex 7 issued by this message and sends the basis of treatment of Methadone;

b) The treatment of Methadone treatment has enough people to do methadone drug transfer to the sick, to verify the health status of the sick to determine the granting of methadone for the pathology at home;

c) The case of the non-prescribed illness, Dr. Methadone prescriptions to the pathologist at the expense of Article 2 of this Article 13;

d) The physician's prescription base, the drug-issued agent of the methadone treatment facility, is responsible for making the regulation at the point of 2 This Article;

Methadone has the responsibility to carry the prescribed documents at the point of Article 2 This time when transferring Methadone to the sick;

e) The person who delivered the drug directly transferred Methadone and monitored the drinking of Methadone of the disease, signing on the treatment of Methadone with the disease.

g) After the disease ends the course of treatment at home, the Methadone treatment facility continues to treat the sick person according to the current regulation.

What? 16. Drug treatment of methane spilled, broken, broken, unsecured quality in the process of receiving, preserving and distributing

1. The case of the discovery of the drug is wet, the drug is lost, the drug is missing, the drug is mislabeled, the drug is torn, the drugs, the drugs, the drugs are broken, the pill is cracked, the pill is not qualified when the treatment facility Methadone receives. drug from the distribution unit, when the delivery facility Methadone receives the drug from the treatment facility Methadone, the abnormal processing is done as follows:

a) Hold the status quo of the drug;

b) Set the confirmation of the abnormal status by the prescribed pattern at Annex 8 issued by this message. The receipt has the signature signature of the delivery man, the recipient of the drug, the unit leader receiving the drug and stamped it. The map is set up to 2 copies: 1 filed in the unit of the drug and 1 units of the drug delivery unit;

c) Pay for the stock of the delivery unit. The warehouse ' s treasurer combined with the associated cadres of numbers, sealing the goods before entering the warehouse, while at the same time up-to-date on the low-quality drug card, preserved in the drug-induced drug store and conducting poor drug treatment. According to the current regulations on drug management, mental health, and prescriptions for drugs.

2. The case of the discovery of the drug was wet, the drug was lost, the drug was missing, the drug was mislabeled, the drug was torn, the drug, the drug, the damaged drug, the broken pill, the broken pill, the unqualified medicine bottle at the treatment facility of Methadone. the warehouse of the methadone drug emergency facility, the abnormal processing is done as follows:

a) Define the cause;

b) Set the confirmation of the abnormal status by the prescribed pattern at Annex 8 issued by this message. The receipt has a confirmed signature of 2 drug-issued employees, the head of the Methadone treatment facility or the head of the Methadone drug grant facility and stamped. The margin is set up to 02 copies, 01 copies at the Methadone treatment facility or Methadone drug delivery facility and 01 to the distribution unit;

c) Return the repository of the distribution unit during the subsequent Methadone drug distribution. The warehouse combined with the relevant cadres that inventory the number, sealing of the goods before entering the warehouse, simultaneously updated the low-quality store card, preserved in the drug-induced drug store and conducted the treatment of poor medicines in accordance with rules. The current definition of drug management, mental health, and prescriptions for drugs.

3. The case of detection of the key loss of the warehouse or suspected of the safety at the drug depot of the Methadone treatment facility or Methadone drug-issued facility, the abnormal processing is performed as follows:

a) The person who found the report for the head of the treatment of Methadone treatment or the basis of the drug Methanone;

b) Set the confirmation of the abnormal status by the prescribed pattern at Annex 8 issued by this message. The receipt has a confirmation signature of the person who discovered the incident, 1 drug-grade worker, head of the methadone treatment facility or Methadone drug-issued facility and stamped. It is set up in 1 copy and is stored at the Methadone treatment facility or Methadone drug-issued facility.

4. The case of the discovery of the drug Loss of Methadone after each day of issuing for the sick, the abnormal processing is performed as follows:

a) Drug-issued staff report to the head of Methadone treatment facility or Methadone drug grant facility;

b) The receipt of the confirmation of Methadone drug damage by the prescribed form at Annex 9 issued by this message. The receipt has a confirmed signature of 2 drug-issued employees, the head of the methadone treatment facility or Methadone drug-issued facility and stamped. It is set up in 1 copy and is stored at the Methadone treatment facility or Methadone drug-issued facility. Methadone treatment facility, Methadone drug-based facility aggregative synthesis of Methadone drugs during the month put the number in the inventory report and using monthly Methadone drugs to the Prevention Center, anti-HIV/AIDS department or the Head Agency to All right.

5. The case of methadone is dumped during the course of the course for the sick, the abnormal processing is done as follows:

a) determine the cause of the drug of Methadone;

b) Set up the identification of the status quo that is dumped by the prescribed form at Annex 10 issued by this message. The receipt has a signed signature of 2 drug-issued employees, who are sick and the head of the Methadone treatment facility or Methadone drug-issued facility and stamped. The border is set up in 01 copies and is stored at the Methadone treatment facility or Methadone drug-issued facility;

c) The dose of Methadone drug supplements complemers with the pathology and records of the dose of Methadone drugs added to the daily Methadone drug tracking book.

Chapter VI

FILE MANAGER, BOOK BOOK, METHADONE DRUG REPORT

What? 17. Save File, Bookbook

1. The storage of the drug execution by the specified number decision 04 /2008/QĐ-BYT.

2. The storage of records, books related to the drug management of Methadone by regulation at Clause 1 and Clause 3 Articles 18 Digital News 19 /2014/TT-BYT.

What? 18. Report Mode

1. Report of the inventory of inventory, monthly usage, 6 months and annually at the Methadone treatment facility made by regulation at Point A 2 Article 19 Digital Information. 19 /2014/TT-BYT.

2. Department of Health Service reports the situation using the local five-monthly Methadone drug at the stipulation at Point 2 Article 19 Notice 19/2014/11-BYT.

3. The agency leads the situation reporting the use of Methadone drug annually due to the ministry, the industry governing by regulation at Point 2 Article 19 Digital News 19 /2014/TT-BYT.

4. Confused report, failure, when there is suspicion of drug failure Methadone made by regulation at paragraph 3 Article 19 Digital News 19 /2014/TT-BYT.

5. Regulation 1, 2, 3 and Clause 4 This is sent simultaneously on the Department of Defense, Anti-HIV/AIDS and the Department of Pharmacology-the Ministry of Health.

Chapter VII.

EXECUTION CLAUSE

What? 19. The reference clause

The case where the text that is shown in this message is replaced or modified, supplemated by an alternate text or text that has been modified, added.

What? 20. Terms of execution

It has been in effect since 1 September 2015.

In the course of execution, if there is an entangrium, the offer reflects in time to the Ministry of Health (Department of Health, Anti-HIV/AIDS) to review, resolve the ./.

KT. MINISTER.
Chief.

(signed)

Nguyen Thanh Long