Thông tư 23/2011/TT-BYT

CIRCULAR

ON DIRECTIONS FOR USE OF DRUGS IN HEALTH FACILITIES WITH BEDS FOR PATIENTS

Pursuant to the Pharmacy Law No.34/2005/QH11 dated June 14, 2005;

Pursuant to the Decree No.188/2007/ND-CP of December 27, 2007 of the Government regulating functions, duties, powers and organizational structure of the Ministry of Health;

The Ministry of Health guides the use of drugs in the health facilities with beds for patients as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of governing

This Circular guides the use of drugs in health facilities with beds for patients.

Article 2. Responsibility for the designation and direction for use of drugs

1. Persons who are responsible for designing the use of drugs for patients (referred to as physician) include:

a) Doctors;

b) Physicians at the health stations of communes, wards and townships (referred to as commune health stations) and hospitals of districts, towns and cities (hereinafter referred to as district hospitals) where have not got doctors in charge of designing the use of drugs for patients;

c) Physicians of traditional medicine at the commune health stations and district hospitals who are responsible for designing the use of traditional drugs, drugs from medicinal herbs to patients;

d) Midwifes at the commune health stations when having no doctors, physicians for designing the use of emergency drugs in case of midwifery.

2. Direction for use of drugs

a) Pharmacists of Department of Pharmacy are responsible for updating information on drugs and guiding use of drugs for Physicians, pharmacists, nurses and patients.

b) The physicians guide the patients (or relatives of patients) the use of drugs.

c) Nurses, midwives are responsible for patients’ taking medication or guiding the patients to take medication to ensure that drugs are used in a correct manner, on time, sufficient dose by physician order.

d) Patients must comply with treatment, not arbitrarily quit use of drugs or arbitrarily use drugs not in compliance with designation of the physicians. Patients or the patients’ relatives are responsible for all accidents caused by arbitrary use of drugs not in compliance with designation of the physicians.

Chapter II

INSTRUCTION OF USE OF DRUGS

Article 3. Physicians perform the designation of drugs

1. When conducting the medical examination, the physician must exploit history taking drugs, history of allergies, lists of drugs which patients had used before they are hospitalized within 24 hours and record the clinical happening of patients into the medical record (paper or electronically as prescribed by the Ministry of Health) to designate drug use or stop using drugs.

2. Drugs designated for patients should ensure the following requirements:

a) In accordance with diagnosis and happening of disease;

b) In accordance with state of pathology and the natural disposition of patient;

c) In accordance with the age and weight;

d) In accordance with treatment guidelines (if any);

đ) Not to abuse drugs.

3. The way to record drug designation

a) Designation of drug use must fully and clearly be recorded in the prescriptions, medical records, not to abbreviate name of drug, not to write notation. For the correction of any content, it must be signed next to the corrected one.

b) The contents of the designation of drug include drug name, concentration (content), dose, number of times for using drugs within 24 hours, the distance between doses, time of drug use, route of administration and the special attention when taking drug.

c) Recording designation of drug use in the order: injection, oral route, place, and external use and alternative routes.

4. Regulations on numbering on date of taking drugs for some groups of drugs required to be cautious when using.

a) Group of drugs required to be numbered on the date of taking drugs includes:

- The radioactive drugs;

- The addictive drugs;

- The psychotropic drugs;

- The antibiotics;

- The drugs for treatment of tuberculosis;

- The steroids.

b) For chronic patients need to use addictive drugs, psychotropic drugs, tuberculosis treatment drugs, steroids and long-term cancer treatment drugs, then write ordinal number for date of using drugs by batch of treatment, number of days of each treatment batch and it should clearly state the starting and ending dates of drug use.

5. Designation of the time to take drugs

a) In case of emergency patients, physicians designate drug use by the patient's happening.

b) In case patients need to be monitored for drug selection or selection of appropriate doses, physicians designate drug use every day.

c) In case patients have been selected drugs and the appropriate dose, maximum duration for drug designation is not more than 2 days (for working days) and 3 days (for holidays).

6. Selection of route of administration for patients

a) Based on the patient status and severity of disease, the use route of drugs to make physician order for the appropriate route of administration.

b) Only using injection route when the patients cannot take drugs by oral route or when using drugs by oral route does not meet requirements on treatment or with drugs only for injection route.

7. Physicians must inform the unwanted effects of drugs for nurse caring and monitoring patients (or relatives of patients). Tracking the response of patients as taking the drugs and timely handling drug use-related complications. Reporting adverse reactions of drugs to the Department of Pharmacy right after the reaction occurs (in Form of Appendix 5).

Article 4. Synthesis of drugs in the clinical Department

1. Nurses synthesize drugs and chemicals from case history into book of daily drugs synthesis (in Form of Appendix 10), then synthesize drugs of the Department into the Slip of receiving drugs (in form of Appendix 1) particularly, Slip of receiving chemicals, Slip of receiving consumed medical supplies (in form of Appendix 2, 3) shall be synthesized weekly.

2. Addictive drugs, psychotropic drugs, radioactive drugs are required to have separate Slip of receiving drugs under current regulations.

3. Slip of receiving drugs must be approved by head of department or the physicians authorized in writing by head of department. Slip of receiving drugs on the holidays and for the cases requesting for irregular supply of drugs, doctors, physicians who are on duty are allowed to sign on them.

4. Synthesis book and the Slip of receiving drugs must be recorded clearly, full content, accurately, not being abbreviated; in case of correction, it must be signed for certification next to the corrected one.

Article 5. Assurance of the quality and instruction of drug use of department of pharmacy organizing the supply and delivery of drugs

1. Inspecting the prescriptions; Slip of receiving drugs daily before delivering drugs.

2. Organizing the daily delivery of drugs and additional drugs in accordance with physician order; delivering drugs promptly to ensure patients’ taking the correct-time drugs.

3. Drugs distributed in retail no longer in packaging must be packed in airtight packaging and with label recorded drug name, concentration (content) and expiry date. The retail separation of drugs is required to ensure the clean environment and hygienic operation.

4. Depending on conditions, the hospital specialist, Department of Pharmacy prepares drugs by physician order and delivers under availably-prepared form of for use.

5. Department of Pharmacy shall refuse to supply and deliver drugs in case the Sip of receiving drugs or prescriptions are error. Sip of receiving drugs or prescriptions with drugs replacement after consulting the pharmacist of Department of Pharmacy must be signed for certification next to the replaced one by signer in Sip of receiving drugs (or prescriptions).

6. Notice of information on drugs: drug name, composition, pharmacological effects, unwanted effects, dosage, and application of treatment, cost, quantity of inventory.

7. Pharmacy Department to act as the contact agency to submit leader of hospital the report of adverse drug reactions (in Form of Appendix 5) and send to the National Center on drug information and monitor adverse drug reactions immediately after the handling.

Article 6. Responsibilities of clinical department for designating patients to use drugs

1. Before patients take drugs

a) To disclose drug used every day for each patient by informing them prior to administration, and require patient or his/her relative to sign in the Slip of drug publication (in form of Appendix 7). The Slip of drug publication is placed at top or bottom of patient’s bed.

b) To guide, explain for patient to observe the treatment.

c) To check the drugs (drug name, concentration, content, once dose, number of times of drug use within 24 hours, the distance between dosages, time of drug use and route of administration) compared with physician order, check the expiry date and organoleptic quality of the drugs. When detecting abnormalities in the physician order such as designation of prescribed overdose use, the irrational route of administration or use of many drugs at the same time causing interactions, nurses must report to the treating physician or physician on duty.

d) Preparation of facilities and drugs:

- To prepare the facilities for patients to use drugs: drug trays, sanitary drinking water in case of patients taking the drug by oral route, drug bottles per hour for each patient;

- Means of transport of drugs required to ensure clean, tidy, easy to find;

- To prepare availably first aid box and anti-shock therapy for drugs required to use injection route;

- Preparation of solution of injection for patients is required to properly mix solvent, sufficient volume and in accordance with provisions of the manufacturer.

2. When patients take drugs

a) It is required to ensure hygiene for infection control.

b) It is required to ensure 5 corrections:

- Correct patient;

- Correct medicines;

- Correct dosage;

- Correct route of administration;

- Right time.

c) It is required to directly witness the patients to take drugs and monitor for timely detection of abnormalities of patients when they take drugs.

3. After the patients take drugs

a) To monitor the patients:

- To monitor regularly for timely treatment of abnormalities of the patients. Fully record the clinical happening of patients in the case histories.

- Treating physician is responsible for monitoring drug’s effectiveness and timely handling drug use-related complications, recording the monitoring book of adverse drug reactions (in Form of Appendix 5).

b) To specify the number of drugs for each patient, every time a drug is done, it is required to stick on “Drug was made”.

c) To preserve the remaining drugs (if any) according to manufacturer's requirements.

d) To handle and store equipment related to designation of drug use to patient as prescribed.

Article 7. Management and preservation of drugs in clinical department

1. Drugs in emergency medicine cabinets must be complied with the correct items and the base approved and preserved in accordance with manufacturer's provisions and requirements.

2. Addictive drugs, psychotropic drugs, precursor substance and radioactive drugs need to be managed and preserved according to current regulations.

3. Nurses are assigned to check and compare drug name, concentration/content, quantity, quality, dosage forms of drugs in the Slip of receiving drugs when receiving drugs from the department of pharmacy and when handing drugs over caring nurses.

4. When the nurses detect drugs misuse, drugs loss, drugs damage, they should be reported immediately to the superior manager for taking timely handling measures and clarifying the causes and responsibilities.

5. Excess drugs due to changes in physician order, patients’ department transfer, discharge from hospital, referral or death (hereinafter collectively referred to as discharge) are synthesized (in Form of Appendix 4) with certification of head of clinical department or the person who is authorized in writing by head of clinical department and returned to the department of pharmacy within 24 hours. Addictive drugs, psychotropic drugs, radioactive drugs must be recorded and returned under the current regulations.

6. Synthesis of drugs, chemicals, and consumed medical supplies of each patient shall be made before discharge and send it to department of finance - accounting for payment of hospital fees.

7. Delivery of the actual number of drugs and equipment to the duty team of the next shift is made and record into standing books of drug delivery and standing books of equipment delivery (in Form of Appendix 8, 9).

8. Prohibited the loan, borrowing, change of drugs of individuals.

Article 8. Report

1. Upon the occurrence of special circumstances (accidents, confusion) on the use of drugs, the hospitals should handle immediately and report to upper direct management agency.

2. Report on adverse drug reactions (Form Appendix 5) to the upper direct management agencies and the National Center on drug information and monitoring of adverse drug reactions.

3. Report on the use of addictive drugs, psychotropic drugs, radioactive drugs under the current regulations of the Ministry of Health.

Chapter III

IMPLEMENTATION PROVISIONS

Article 9. Effect

This Circular takes effect from July 25, 2011. This Circular replaces the "Regulation on drug use" in the Regulations of hospitals issued together with Decision No.1895/1997/BYT-QD on 19/09/1997 of the Minister of Health.

Article 10. Responsibility for implementation

Mr. and Mss.: Chief Ministry Office, Director of Department of Medical Examination and Treatment Management, the chief inspector of the Ministry, the General Director, Directors of the Departments under the Ministry of Health, the hospitals’ directors, the Institute with beds for patients under the Ministry of Health, Departments of Health’s Directors of provinces, the centrally-run cities and the medical heads of branches are responsible for the implementation, monitoring and evaluation of the implementation of this Circular.

In the course of implementation should be any difficulties and obstacles, units, localities should promptly report to the Ministry of Health (Department of Medical Examination and Treatment Management) for guidance, review and settlement./.