PHỤ LỤC 8 Thông tư 21/2013/TT-BYT: DANH SÁCH MỘT SỐ ĐỐI TƯỢNG NGƯỜI BỆNH VÀ THUỐC CÓ NGUY CƠ CAO XUẤT HIỆN ADR

CIRCULAR

PRESCRIBING ORGANIZATION AND OPERATION OF THE DRUG AND TREATMENT COUNCIL IN HOSPITALS

Pursuant to the Government’s Decree No. 63/2012/ND-CP, dated August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Director of the Medical examination and treatment Management Department;

The Minister of Health promulgates the Circular prescribing organization and operation of the drug and treatment council in hospitals.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular prescribes organization and operation of the drug and treatment Council in hospitals (hereinafter referred to as the Council).

Article 2. Interpretation of terms

1. ABC analyzing is method of correlation analyzing between quantity of drugs consumed every year and cost with the aim to define drugs occupying big proportion in drug budget of hospital.

2. VEN analyzing means method to define priority for drug procurement and storage in hospital when funding is not enough for purchase of entire drugs of all kinds as wishes. In VEN analyzing, drugs are divided into 3 items specifying as follows:

a) V drugs (Vital drugs) – means drugs used in cases of first-aid or important drugs which necessarily must have to serve the medical examination and treatment of hospitals.

b) E drugs (Essential drugs) – means drugs used in cases of diseases with importance less than but still be important diseases in disease model of hospitals.

c) N drugs (Non-essential drugs) - means drugs used in cases of mild diseases, diseases which patient may recover natural, may include drug kinds of which  treatment efficiencies have not  yet been affirmed clearly or high prices not correspond to clinical benefit of drugs.

3. Defined dose daily means average dose maintained daily with main indications of a drug.

4. Rational drug use means drug use satisfying clinical requirement of patient at appropriate dose on each patient individual (right dose, right duration of giving drug and time of drug use), meeting requirements on quality, ability of provision and appropriate prices aiming to reduce the lowest expense level for patients and community.

Chapter 2

FUNCTION AND TASKS OF COUNCIL

Article 3. Function

The Council has function of consulting director of hospital about matters involving drugs and treatment by drugs of hospitals, good implementation of national policy on drugs in hospital.  

Article 4. Elaboration of provisions on drug management and use in hospital

The Council elaborate specific provisions about:

1. Criteria to select drugs for elaborating list of hospital drugs

2. Selection of guides on treatment (treatment regimens) to serve as basis for elaboration of list of drugs;

3. Process and criteria to supplement or remove drugs from list of hospital drugs;

4. Criteria to select drugs in bidding for drug purchase;

5. Process of drug allocation from the Pharmacy Division to the patients aiming to ensure that drugs are used properly and safely;

6. Selection of some drugs not stated in list of hospital drugs in case of arising these drugs due to demand of treatment;

7. Limitation of use of some drugs with big value or drugs with serious-adverse reactions, drugs belonging to doubts on treatment efficiency or safety; 

8. Use of proprietary medicines and alternative drugs in treatment;

9. Process of supervising use of drugs at clinical departments;

10. Management and supervision of activities of drug information provision of medical representatives, pharmacy companies and documents of drug advertisement.

Article 5. Elaboration of list of drugs used in hospital

1. Principles of elaborating the list:

a) To ensure conformity with model of diseases and cost of drugs used for treatment in hospital;

b) Conformity of classifying the technical specialized levels;

c) Base on guides or treatment regimens already elaborated and applied at hospitals or the medical examination and treatment establishments;

d) Satisfying the new methods, new techniques in treatment;

dd) Conformity with the specialized scope of hospital;

e) Unifying with the list of essential drugs and list of key drugs promulgated by the Ministry of Health;

g) Prioritizing the drugs produced domestically.

2. Criteria of selecting drugs:

a) Drugs have full reliable evidences on treatment efficiency, safety through result of clinical test.  The reliability of evidence is presented at Annex 1 issued together with this Circular;

b) Drugs are available in the appropriate dosage forms and ensure bioavailability, stability on quality in conditions of preservation and use in accordance with regulation;

c) When there are two or more drugs equivalent to each other about two criteria specified in Point a and Point b Clause 2 of this Article, it is required to select on the basis of assessing carefully elements of the treatment efficiency, safety, quality, price and provision ability;

d) For drugs with same treatment efficiency but various dosage form and mechanism of effect, when select, it is required to analyze  cost – efficiency among drugs with each other, compare total cost related to the course of treatment, not compare cost calculated under unit of each drug;

dd) Prioritize to select drugs in form of single substances. For drugs in forms of compound with many elements, it is required to have full documents proving dosage of each active ingredient meeting requirement of treatment on a population of objects of patients specially and have outstanding advantages about safety or convenient use in comparison with drugs in form of  single substances;

e) Prioritize to select generic drugs or drugs bearing international common name, limit proprietary names or specific producers.

g) In some cases, it may base on some various elements such as pharmacokinetic characteristics or element of preservation equipment, system of warehouses or producers, suppliers;

3. Steps of elaborating the drug list:

a) Collecting, analyzing situation of medicine use in last year about quantity and use value, ABC - VEN analysis, drugs with bad quality, decayed drugs, adverse drug reactions, mistakes in treatment based on reliable information sources;

b) Assessing the drugs proposed for supplementation or removal from clinical department in an objective manner;

c) Elaborate the list of drugs and classify drugs in the list according to the treatment groups and according to VEN classification;

d) Elaborate contents guiding use of the list (example as: drugs limited in usage, drugs required for medical consultation, addicted drugs, psychotropic drugs …).

4. Train and guide for medical officers in using the medicine list.

5. Annually, assess, revise the medicine list.

Article 6. Elaboration and implementation of treatment guides

Depend on scale and ability of each hospital, the Council may self-elaborate the treatment guide or make reference from available documents from sources at Annex 1 issued together with this Circular to elaborate the treatment guide to use in its hospital.

1. Principles in elaborating the treatment guide:

a) Conformity with the treatment guide and guide of the national objective programs promulgated by the Ministry of Health.

b) Conformity with the specialized qualification, available human resource and equipment of unit. 

c) Reflect the present practice rules.

d) Be simple, easy to understand and easy to update.

2. Steps to elaborate the treatment guides:

a) Defining expert groups to elaborate or adjust the available treatment guides;

b) Elaborating the master plan for elaboration and implementation of treatment guide;

c) Defining diseases which need treatment guide in hospital;

d) Select and elaborate the appropriate treatment guides;

dd) Define the information types mentioned in the treatment guide;

e) Consult opinions and test the application of treatment guide;

g) Popularize guide and implement the treatment guides;

3. Carrying out execution

a) Supply full treatment guide to physicians;

b) Train use for all physicians;

c) Carry out following up, supervision of compliance with the treatment guide;

d) Periodically review and update contents of the elaborated guide.

Article 7. Defining and analyzing matters related to the medicine use

1. Defining matters related to the medicine use during storage, preservation to prescription, issuance and use include:

a) Storage of drugs: Situation of empty warehouse due to lack of fund, inventory due to a weak provision system;

b) Preservation of drugs: Drugs not ensure quality because conditions of preservation are not right and insufficient;

c) Prescription: The prescriptions are not appropriate with disease status of patients; the physicians fail to comply with the medicine list, fail to comply with treatment regimens and guides, and fail to pay attention to the interaction of drugs in prescription;

d) Allocation of drugs: It may be mistake, fail to perform full 5 right things (right drugs, application to right patients, right dose use, right time, and right way);

e) Use of drugs: improper way, improper dosage, improper time of medicine use, duration of medicine use times, preparation of drugs, drug interactions; adverse drug reactions; interactions among drugs, between drugs and food; inoperative medicine.

2. The analyzing methods applied for detecting problems involving medicine use:

The council needs apply at least one of following methods to analyze the medicine drug in unit:

a) ABC analysis: Steps of analysis are performed according to guide in Annex 2 issued together with this Circular;

b) Analysis of treatment group: Steps of analysis are performed according to guide in Annex 3 issued together with this Circular;

c) VEN analysis: Steps of analysis are performed according to guide in Annex 4 issued together with this Circular;

d) Analysis according to the defined daily dose - DDD: Steps of analysis are performed according to guide in Annex 5 issued together with this Circular;

e) Supervision of indicators of drug use made according to guide in Annex 6 issued together with this Circular.

3. The Council needs define problems, reasons involving the medicine use and select solutions to intervene suitably according to guide in Annex 7 issued together with this Circular. 

Article 8. Supervision of adverse drug reactions (ADR) and mistakes in treatment

1. Elaborate the process of detecting, assessing, settling, ADR provision and mistakes in cycle of medicine use at hospital from stage of diagnosis, prescription by physicians, preparation and allocation of drugs by pharmacists, implementation of medical commands and the use guide of nursing officers, compliance in treatment of patients with the aim to ensure safety for patients during medical treatment.

2. Organizing the ADR supervision, recording and learning experiences from mistakes in treatment.

a) Elaborate the process of medicine use, strict supervision of using drugs with high risk of appearing ADR and use of drugs on patient objects with high risk of happening ADR according to guide in Annex 8 issued together with this Circular;

b) Organize the medical consultation, discussions, and assessment to result ways to settle and propose standby measures in cases where happen serious adverse reactions, mistakes in treatment in hospital;

c) Make annual reports on ADR and mistakes in treatment at hospital, submit them to Director of hospital for approval and sending them to the Ministry of Health, the provincial Department of Health, the National Center of Drug information and Monitoring the adverse drug reactions. 

3. Carrying out system of ADR report in hospital:

a) For ADR causing death, threats to life, ADR happened continuously with a drug product or ADR with drugs newly put into use at hospital:

- Report on ADR to Pharmacy Division, for submission to the Standing Council and report to the National or Regional Center of Drug information and monitoring the adverse drug reactions;

- A sub-committee shall supervise ADR and mistakes during treatment, collect information, assess ADR and reflect results to medical officers and the Pharmacy Division, for additional report (if any) to the National or Regional Center of Drug information and monitoring the adverse drug reactions;

b) For other ADR: Encourage medical officers to report, the Pharmacy Division to sum up and send report to the National or Regional Center of Drug information and monitoring the adverse drug reactions;

4. Inform to medical officers of hospital about ADR, mistakes in drug use for timely learning from specialized experiences.

5. Update, revise the list of drugs in hospital, guide the treatment and other specialized processes based on information of ADR and mistakes in the drug use already recorded at hospital.

6. Organize training for medical officers about ADR and mistakes in drug use.

Article 9. Notification, control of drug information

1. The Council of Drug and Treatment has task of transferring information of activities, decisions and proposals to all objects executing its decisions on the basis of ensuring the transparency in decisions to prevent conflicts and disagreements involving rights and benefits

2. Management of the drug information provision in hospital.

a) Direct the unit of drug information provision in hospital to update information of drugs, provide for drug information aiming to ensure the rational and safe drug use in scope of hospital;

b) Use the objective and reliable information sources provided from the Pharmacy Division, unit of drug information provision in elaborating the list of drugs, guiding treatment and other specialized process in conformity with dividing the specialized levels of unit;

c) Consult for director of hospital in elaborating, issuing and carrying out provision on activities of introducing drugs in scope of hospital.

Chapter 3

ORGANIZATION AND OPERATION OF THE COUNCIL

Article 10. Organization of the council

1. The Council must be established at all hospitals, and Director of hospital decides on its establishment; the Council operates under regime of part-time work.  

2. Depend on grade of hospital, the Council has at least 5 members or more, includes the following members:

a) Chairman of Council is Director, or Deputy Chairman of hospital in charge of specialized operation;

b) Deputy Chairman of Council, concurrently being standing member, is chief of the Pharmacy Division of hospital; 

c) Clerk of Council is chief of the Planning and Summing Division, or pharmacist of the Pharmacy Division; or both these members;

d) Members include:

- Chiefs of several key treatment divisions, physician specialized in microbiology and nursing chief of hospitals;

- Grade-II or higher hospitals may have pharmacological member or pharmacist of clinical pharmacy;

- Chief of the Finance and Accounting Division.

Article 11. Organization of the Council

1. The Council shall have meeting on a two-month basis or irregular basis which are convened by the Chairman of Council. The Council may hold irregular meeting to solve problems arising between its periodical meetings. 

2. The Council elaborates the working regulation, action plan and content of periodical meeting in year.

3. Deputy Chairman concurrently being the standing member of Council is responsible for summing up documents related to drugs for meetings of Council.  Documents must be sent in advance to members of Council for study before the meeting.

4. The Council shall discuss, analyze, and propose opinion, make a record and submit it to Director of hospital for approval and organization of implementation after having been approved.

5. The Council shall conduct preliminary and final reviews and make annual and biannual reports according to form specified in Annex 9 issued together with this Circular. 

Article 12. Assigning tasks to members and establishing sub-committees 

Chairmen of Council shall assign specific tasks to members.  Depend on scale of Council, director of hospital may decide on establishment of one of groups (teams) or sub-committee and assign specific tasks to each member of sub-committee:

1. Sub-committee for elaborating the drug list and supervising the drug use in hospital;

2. Sub-committee for supervising the use of antibiotics and monitoring the drug resistance of common pathogenic bacteria;

3. Sub-committee for elaborating the treatment guide:

4. Sub-committee for supervision of adverse drug reactions (ADR) and mistakes in treatment;

5. Sub-committee for supervision of drug information.

Article 13. Relationship between the Drug and Treatment Council with the Council of Science, and the Council of bacterial infection control.

The Council of Drug and Treatment shall propose, direct, and assign members in the Council to elaborate the treatment guide used in hospital. The Council of Science shall appraise and submit to Director of hospital for approval and directing implementation. The Council of Drug and Treatment shall coordinate with the Council of bacterial infection control in elaborating plan on preventing the drug resistance, supervising the drug resistance of common pathogenic bacteria and carrying out these activities in hospital.

Chapter 4

PROVISIONS OF IMPLEMENTATION

Article 14. Effect

This Circular takes effect on September 22, 2013.

To annul the Circular No. 08/BYT-TT dated July 04, 1997, of the Ministry of Health, guiding organization, functions and tasks of the Drug and Treatment Council in hospital to perform the Directive 03/BYT-CT dated February 25, 1997 of the Minister of Health, on correcting the provision, management and use of drugs in hospital and section 9 part III in the hospital’s regulation issued together with the Decision No.  1895/1997/QD-BYT dated September 19, 1997 of the Minister of Health from the effective day of this Circular.

Article 15. Responsibility for implementation

Director of the Medical examination and treatment Management Department shall organize implementation of this Circular.

Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Medical examination and treatment Management Department) for guide, consideration and settlement.

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