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MINISTRY
OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.: 23/2011/TT-BYT
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Hanoi, June 10, 2011
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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
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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.
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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;
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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;
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- 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
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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.
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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.
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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;
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- 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”.
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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).
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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
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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./.
FOR MINISTER
DEPUTY MINISTER
Nguyen Thi Xuyen