Chương 2 Thông tư 21/2013/TT-BYT: Chức năng, nhiệm vụ của hội đồng

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.