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MINISTRY
OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No.:
1088/QD-BYT
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Hanoi,
04 April, 2013
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DECISION
ON ISSUING INSTRUCTIONS ON MONITORING OF
ADVERSE DRUG REACTION (ADR) AT MEDICAL FACILITIES
MINISTER OF HEALTH
Pursuant to Decree No. 63/ND-CP
dated 31/8/2012 of the Government defining functions, duties, powers and
organizational structure of the Ministry of Health;
At the request of the Director
of Medical Service Administration – Ministry of Health,
DECIDES:
Article 1.
Issued with this Decision the “Instructions on monitoring
of adverse drug reaction (ADR) at medical facilities”.
Article 2.
This Decision takes effect from its signing date.
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PP.
MINISTER
DEPUTY MINISTER
Nguyen Thi Xuyen
INSTRUCTION
MONITORING OF ADVERSE DRUG REACTION (ADR) AT
MEDICAL FACILITIES
(Issued with Decision No.1088/QD-BYT dated 04/04/2013 of the Minister of
Health)
The Pharmaceutical Law 2005 defines
the Adverse Drug Reactions – ADR as the unwanted and harmful effect on health,
which can occur in normal doses.
As defined by the World Health
Organization, ADR is harmful and unintended reactions which may occur in normal
doses in people for purpose of disease prevention, diagnosis, treatment or
change of physiological functions of the body.
ADR is one one the causes to
increase the morbidity and mortality rate, prolong hospital length of hospital stay,
increase the treatment adherence and treatment costs for patients. Therefore,
the monitoring of ADR plays an important role to minimize risks related to
medications during during the patient's medication administration. The
monitoring of ADR includes the detection, addressing, report, assessment and
prevention of ADR.
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- Raising the awareness of safety
in medication administration and encouraging the medical officers to report on
ADR as professional duties in clinical practice and as a part of responsibility
and occupational ethics.
- Early detecting the medication
safety issues, promptly managing and proactively taking preventive measures of
adverse incidents occurring during the use of medication in patients, strengthening
the rational medication administration, reducing the morbidity and mortality
related to medication in practice.
I. ADR monitoring
ADR monitoring is the
responsibility of all medical officers including doctors, pharmacists, nurses,
midwives, technicians and other medical officers at medical facilities.
1. Nurses, midwives, technicians
a) ADR detection
- Monitor and detect the abnormal
clinical and subclinical signs in patient based on the information provided by
patient and the symptoms recorded during patient care and follow-up (See
Appendix 01).
- Immediately inform the treating
doctor and the Pharmacy (if any) of patient’s abnormal condtion.
- Write down information related to
the medication the patient has used (suspected ADR medication and other
concomitant medications) including: name of medication, dosage, route of
administration, manufacturer, batch number, date and time of starting and
finishing the medication administration (if any) and reasons for medication
administration.
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b) ARD management
- Manage ADR as ordered by the
treating doctor.
- Monitor patient and immediately
inform the treating doctor in case of patient’s abnormal development during the
subsequent treatment.
- In case of emergency, stop using
the suspected medication threatening patient’s life before informing doctor.
2. Doctors
a) ADR monitoring
- Check the notable points before
giving prescription (see Annex 6).
-Give instructions to nurses,
midwives and technicians on signs to be monitored for ADR detection during administration
of medication for patients.
(Eg. muscle pain in patients using
lipid-lowering medication of statin and diarrhea while taking antibiotics for
days, ...).
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- Detect and record the abnormal
clinical and subclinical signs in patient in medical record (see Annex 01).
- Check all medications the
patients have used.
- Organoleptically check the
quality of kept medication sample to see if there is any abnormal signs of
medical quality.
- Check some following information:
+ The use of medication is
consistent with the condition or takes consideration of associated diseases and
contraindication in patient?
+ Dose is correct as recommended ?
+ Patient is allergic especially to
medication ?
+ There is a consistency of time of
administration of suspected medication and the time of ADR occurrence?
c) ADR management
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- Reduces dose or discontinuation
of suspected ADR medication if the clinical conditions allow.
- Promptly takes measures for
symptom treatment, support treatment to ensure the vital functions for patient.
- Complies with relevant
professional instructions of the Ministry of Health if the ADR management is
within such instructions.
- In case of necessity, discusses
the way of management with colleagues, holds a professional consultation and
refers to additional information from the pharmacist, the medication
information unit or Drug Information and Adverse Drug Reaction Monitoring Center.
- Closely monitors in case of
required re-continuation of ADR suspected medication when there is no
alternative medications or their benefits outweigh the risks.
d) ADR evaluable
- Look up to see if ADR is
specified in the medication administration instruction or medical literature materials
of medication.
- Depending on professional
conditions, it is possible to evaluate the relation between the suspected
medication and ADR occurring in patient based on the classification scale of
WHO or Naranjo scale (see Annex 4).
3. Pharmacists
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b) Discuss with treating doctor if
detecting ADR upon performance of clinical pharmaceutical activities at
departments to have appropriate management measures.
c) Provide information about
medication during ADR identification and management as required by the medical
officers.
d) Guide and help doctors and
nurses in full and and correct completion of necessary information in the
reporting form of ADR of medication.
e) Pharmacists may collect
information directly and write ADR report.
II. Instructions
on ADR report
1. Subjects writing report
a) The persons write ADR report
directly are doctors, pharmacists, nurses, midwives, technicians and other
medical officers; encouraging many people to write and complete reports.
b) Information about reporter,
patient and reporting unit specified in the ADR reporting form of medication is
kept confidential under current regulation by the Drug Information and Adverse Drug Reaction Monitoring Centers.
2. Required cases of report
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- Medications, vaccines and medical
biologicals
- Oriental medicine, medicine from
pharmaceutical materials, pharmaceutical materials and traditional medicine.
b) Pay special attention to report:
- Serious ADR (which leads to one
of the following consequences: death; life threatening; required
hospitalization for treatment or prolonged length of hospitalization; heavy or
permanent sequelae for patient; innate birth defects in the fetus or any ADR
identified as clinically serious consequence).
- All ADRs of medications newly
introduced for administration in treatment at hospitals.
- New ADR of medication which has
ever been known (not described in medication administration instruction, Vietnamese national drug formulary, MIMS, Vidal or other medication
information reference materials).
- ADR occurs continuously with a
type of medication or a batch of medication during a short time at the medical
facility.
c) The medical officers are
encouraged to report on issues related to medication quality and error in medication
administration.
3. Time to send report
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b) Report should be made while
patient has not been discharged to have adequate information and perform the
necessary tests to identify the causes of ADR.
c) The report to the Drug
Information and Adverse Drug Reaction Monitoring Centers must be sent on
schedule:
- The report on serious ADR causing
patient’s death or life threatening must be sent as soon as possible but within
07 working days from the time of reaction occurrence.
- The remaining reports on serious
ADR shall be sent as soon as possible but within 15 working days from the time
of reaction occurrence.
- The reports on unserious ADR can
be gathered and sent annually before the 5th date of the following
month.
4. Instruction on filling out
the form of ADR of medication
a) General principles:
- Completion of reporting form with
complete information obtained from the medical record.
- Use of one of separate report for
each patient.
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- Clear and correct handwriting of
medication name, restricted abbreviation.
- Information must be filled out
correctly, consistently without inconsistency of information in report.
b) ADR reporting form (see Annex
5).
c) Minimum information to be filled
out in the ADR reporting form
- Patient’s information: full name,
age and sex.
- Information about ADR: detailed
description of ADR, date of reaction occurrence, ADR development after
management (including the development after discontinuation or dose reduction
or re-continuation of suspected medication).
- Information about suspected
medication: name, dosage, route of administration, reasons for administration,
date and time of starting
the medication.
- Information about the reporter
and reporting unit: name of reporting unit, full name of reporter, position,
contact telephone or email (if any).
- With the remaining information in
the reporting form, the medical officers are encouraged to collect and add a
maximum of information.
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- Administrative information
+ Reporting place: write the name
of treating department, name of medical facility or reaction detection place
and name of province/city.
+ Reporting code of unit: defined
by the medical facility itself for convenient monitor and management of ADR
report. The unit may also use the patient’s code of medical record to replace
such reporting code.
+ Reporting code (managed by the
National Drug Information and Adverse Drug Reaction Monitoring Center): this part is filled out by the National Center or local Center after the receipt of
report).
- Information about patient
+ Item 1: Patient’s full name.
+ Item 2: Patient’s age is filled
by one of the two ways:
Way 1: Date of birth: fill out the
patient’s date/month/year of birth or only “year of birth” if the date and
month are unknown.
Way 2: Age: fill out the age of
patient by the time of ADR occurrence.
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+ Item 3: put the stick (√) in one
of 02 boxes to choose Male or Female.
+ Item 4: fill out the patient’s
weight (if having information).
- Information about ADR
+ Item 5: fill out information
about the time of starting ADR in patient by date/month/year.
+ Item 6: fill out the period of
time from the last administration of ADR suspected medication to the time of
ADR occurrence.
+ Section 7: describe ADR
expressions especially the abnormal signs and symptoms occurring in patient and
clinical development of such symptoms, especially upon reduction/stop of
administration or re-continuation of ADR suspected medication. Do not write generally as:
infusion reaction, allergy ...
+ Item 8: fill out the result of
paraclinical tests related to the reaction and development of such results
during the management of ADR, especially paying attention to the abnormal
result of test (Eg. Increased ASAT, ALAT, serum creatinine;
reduction in number of red blood cells, white blood
cells, hemoglobin, ...).
Note: For ttem 7 and 8, the doctor
should let patient fill out or check information if it is filled out by another
medical officer.
+ Item 9: fill out the information
about the patient’s medical history (if collecting information) including: ADR
history (patient has encountered the similar ADR before with the ADR suspected
medication or medications of the same group?) allergy history, pregnancy
condition, tobacco and alcohol addiction, liver or kidney condition (if any) of
patient.
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+ Item 11: put the stick (√) in one
or boxes to show the seriousness of ADR (as
identified by the reporter) including:
death, life threatening, hospitalization/prolonged length of hospital stay,
permanent / heavy disability, birth defect. If the reporter judges
that the reaction is mild, put the stick in the box “Unserious”.
+ Item 12: put stick (√) in the
corresponding boxes to show the result after DR management including: died due
to ADR or unrelated to medication, not recovered, recovering, recovered with
and without sequelae.
- Information about ADR
suspected medication
+ Item 13: Information about ADR
suspected medication
Ö
Clearly and completely write the required items including: name of medication,
dosage, route of administration, reasons for medication administration, date
and time of starting and finishing the medication administration, manufacturer,
batch number. Note: do not confuse between the “reasons for medication
administration” and “ADR expression”.
Ö
The reporting form should have a space to write a maximum of 04 suspected ADR
medications. If the number of suspected medication is greater, the reporter may
send an additional note. The name of medication should be written with its
brand name and International Nonproprietary Name (INN).
+ Item 14: ADR development after
discontinuation or reduction in dose of suspected medication (put the (√) in
each line in the order corresponding to the suspected medication listed in item
13).
Ö
In case of remaining administration of suspected medication: put (√) in the box
“continuation/no dose reduction”.
Ö
In case of discontinuation or dose reduction: put (√) in one of two options “
Yes/ No” to determine ADR has improved after discontinuation or dose
reduction or not.
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+ Section 15: ADR development after
re-continuation of suspected medication (put (√) in each line in the order
corresponding to the suspected medication listed in item 13).
Ö
In case of no re-continuation of suspected medication (put (√) in the box “No
re-continuation”.
Ö
In case of re-continuation of suspected medication (put (√) in one of the two
options “ Yes/ No” to determine ADR has re-occurred after re-continuation
of medication.
Ö
In case of no information about ADR development after re-continuation of
suspected medication, put (√) in the box “No information”.
Note: Be careful upon
re-continuation of suspected medication; only re-continue the ADR suspected
medication when there is no alternative treatment medication or when the
benefits of such medication outweigh the risks while ensuring necessary
measures to manage ADR.
+ Item 16: List the medications
used concomitantly with the suspected medications (no indicating medications
used for treatment of ADR in this item) according to the required items: name
of medication, time of starting and finishing administration of such
medication. Specify the route of administration and dosage of such medications.
- ADR assessment of unit
+ Item 17 and 18: the assessment of
relation between the medication and ADR is not required and is done depending
on the professional conditions of each hospital. It may be done based on the
classification scale of WHO or Naranjo scale (see Annex 4).
+ Section 19: the reporter may
express his/her professional opinions related to ADR and patient in the report
based on the recorded clinical reality, assessment and management of ADR.
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+ Item 20: fill out all personal
information including: Full name, title/position, contact telephone or address,
email (if any). The information about the reporter shall be kept confidential.
Such information helps the Drug Information and Adverse Drug Reaction
Monitoring Center make contact in case of necessity and provide feeback on
appraisal information to the reporter.
+ Item 21: signature of reporter
+ Item 22: when there is additional
information for a report of ADR case sent before, the reporter should fill out
in a new ADR report and make note by put the (√) in the content of No.22
(Reporting form: First/Additional) in the reporting form. The reporter may make
additional note in the additional report or notify by telephone, fax or email
to the Center of the reporting date or code of first report.
+ Item 23: fill out date/month/year
of report preparation.
5. Way of ADR report sending
a) At the medical facilities with
the Pharmacy: the medical officer shall send the ADR report to the Pharmacy as
a central place for gathering of reports in hospital. In case of emergency,
send report directly to the National Drug Information and Adverse Drug Reaction
Monitoring Center or the local Centers and then notify the Pharmacy.
b) At the medical facilities
without the Pharmacy: the medical officer shall send the ADR report to the
National Drug Information and Adverse Drug Reaction Monitoring Center or the
local Centers.
c) The ADR report is filled in the
reporting form under regulations and sent to the National Drug Information and Adverse Drug Reaction Monitoring Center or the local Centers by one of the 5 forms as
follows:
- Way 1: Sent by post
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- Way 3: Online ADR report
+ Visit the website:
http://baocaoadr.vn
+ Read and follow instructions on
this website.
- Way 4: Sent by fax.
- Way 5: Make a phone call to
report directly to the Center in case of emergency. The information is then
filled in the reporting form and sent to the Center by one of the 04 way
mentioned above.
6. Place of report receipt
The report may be sent to the one
of two addresses as follows::
a) National Drug Information and
Adverse Drug Reaction Monitoring Center (receives all reports from
provinces/cities nationwide)
Address: Hanoi University of
Pharmacy, 13-15 Le Thanh Tong, Hoan Kiem district, Hanoi
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Fax: 043 933 5642
E-mail:
[email protected]
Website:
http://canhgiacduoc.org.vn
b) Area Drug
Information and Adverse Drug Reaction Monitoring Center of HCM City (receives
reports from Danang back).
Address: Cho Ray
hospital, 201B Nguyen Chi Thanh, ward 12, district 11, HCM City
Tel :
08.3.8563537
Fax: 08.3.855726
E-mail:
[email protected]
III.
Feeback on report from the National Drug Information and Adverse Drug Reaction
Monitoring Center or the local Centers
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2. The reports shall
be appraised by the National Center or local Centers according to the Procedure
for processing of ADR reports of the Center.
3. Annually, the
National Center shall summarize and classify the ADR reports and send the
summary report on ADR to the Ministry of Health, Departments of Health and
medical facilities.
4. In case of
necessity of quick feedback, especially to the serious ADR cases, the National
Center or local Centers shall quickly collect information and appraise it to
send the feedback to the medical officers of the medical facilities sending
reports.
IV. ADR
prevention
Many adverse drug reactions can be
prevented by the preventive measures during the administration for patient.
1. Medical officers
a) Comply with indication,
contraindication, precaution and dosage of medication, pay attention to
medication interaction in prescription and fully monitor patients during
treatment to ensure rational medication prescription (see Annex 6).
b) Comply with caution upon
prescription of hight risk medications or prescription in special patients (see
Annex 2).
c) Comply with the procedure for
preservation and admistration for patients.
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2. Pharmacy and medication
information unit of hospital
a) Update information about
medication administration, new medications and medication safety and send it to
the medical officers and patients at the medical facilities in various forms:
direct consultation scientific activities, professional activities, provision
of newsletters and leaflets about medication iin hospitals.
b) Monitor quality before
medication provision to departments.
c) Give instructions and support to
the medical officers in ADR report.
d) Keep feedback letter on receipt
of report and feedback report of the Drug Information and Adverse Drug Reaction
Monitoring Center.
3. Treatment and medication
Council
a) Develops the procedure for
detection, assessment, management and ADR report in hospital.
b) Identifies list of high-risk
medications to be monitored and develops the procedure for instructions on
administration of such medications in hospital.
c) Holds consultation, discussion
and assessment to come to conclusion on management and recommend the preventive
measures in case of occurrence of serious adverse reactions in hospital.
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e) Provides periodical training for
medical officers of medical facilities about skills of detection and management
of ADR, proper and complete filling of ADR report.
ANNEX 1
A NUMBER OF ABNORMAL CLINICAL AND PARACLINICAL SIGNS
POSSIBLY RELATED TO ADR
1. A number of general signs
- Fever
- Headache
- Drowsiness
- Unconsciousness
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2. Skin reactions
- Hives
- Angioedema
- Erythema
- Henoch Schonlein
- Polymorphic light eruption
- Lulious
eruption: erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis, fixed drug eruption.
- Acne
- Hair loss
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3. Liver dysfunction
- Jaundice, yellow eyes, edema.
- Result of abnormal liver function
test (AST, ALT, alkaline phosphatase, bilirubin in blood).
4. Result of abnormal
haematological test
- Decreased red blood count
- Decreased leukocytes
and
polymorphonuclear leukocytes
- Decreased thrombocytopenia
- Increased eosinophilia
- Haemolytic anemia
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- Positive Coombs reaction
- Decreased prothrombin
5. Anaphylactic reactions and
anaphylactic shock
6. Acute renal failure
- Increased blood creatinine
7. Digestive disorder
- Vomiting, nausea
- Dysphagia
- Dysgeusia
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- Xerostomia
- Mouth ulcer
- Esophageal ulcer
- Epigastric pain
- Gallstone
- Pancreatitis
- Constipation
- Diarrhea and pseudomembranous
colitis
- Gastrointestinal bleeding
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- Dyspnea
- Bronchospasm
- Interstitial pneumonia
9. Abnormal blood glucose value
- Hyperglycaemia
- Hypoglycemia
10. Endocrine disorder
- Hypothyroidism
- Hyperthyroidism
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- Drug-induced lupus erythematosus
11. Neurological and muscular
disorder
- Peripheral neuropathy
- Dizziness
- Seizure
- Myotonic disorder
- Extrapyramidal disorder
- Increased intracranial pressure
- Abnormal movements
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- Rhabdomyolysis
- Osteoporosis
- Osteonecrosis
12. Abnormal blood pressure
- Hypotension
- Orthostatic hypotension
- Hypertension
13. Cardiac disorder
- Arrhythmia or abnormal ECG
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- Slow heartbeat
- Thrombosis / stroke
- Cardiomyopathy
- Heart valve disease
- Heart failure
14. Psychosis
- Confusional state due to drug
- Agitation
- Mental inhibition
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- Sleep disorder
- Eating behavior disorder
- Memory disorder
- Perceptive change
- Psychosis
- Drug abstinence syndrome
15. Other patient’s abnormal
signs recorded during treatment after administration of suspected medications.
ANNEX 2
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1. Persons at high risk of ADR
- Persons with concomitant
diseases.
- Patients use multiple medications
- Patients with prolonged medication
use.
- Elderly and child patients
- Patients treated with medications
with high risk of ADR.
- Patients treated with the drug
have narrow therapeutic range or potential medication interactions.
- Patients with liver and kidney
dysfunction.
- Patients with predisposition
factor of immunodeficiency or autoimmune diseases
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- Alcohol addicts
- Pregnant and breastfeeding women.
2. Some medications with high
risk of ADR
a. Group of medications
- Adrenergic agonists for
intravenous administration (eg. adrenalin, phenylephrin, noradrenalin, dopamin,
dobutamin).
- Β-adrenergic blockers for
intravenous administration (eg. propanolol, metoprolol, labetalol).
- Inhaled or
intravenous anesthetic agents (eg. propofol, ketamin).
- Antiarrhythmic drugs for
intravenous administration (eg. lidocain, amiodaron).
- Vitamin K antagonist
anticoagulants, low molecular weight heparin, unfractionated heparin for
intravenous administration, Xa factor inhibitors (fondaparinux), direct
thrombin inhibitors (eg. argatroban, lepiridin, bivalirudin), antifibrinolytic
drugs (eg. alteplase, reteplase, tenecteplase) and platelet
aggregation inhibitors and receptor blocker glycoprotein IIb/IIIa (eg: eptifibatid).
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- Chemotherapy used in cancer
treatment, by injection or orally.
- Dextrose, hypertonic solution
(concentration ≥ 20%).
- Dialysis solution in peritoneal
dialysis or hemodialysis.
- Epidural anesthetics (eg,
bupivacaine).
- Medication for diabetes orally
administered (eg, metformin).
- Medication for myocardial
contractility, intravenously administered (eg, digoxin, milrinon).
- Medication formulated as
liposomal and respective conventional dosage forms, (eg amphotericin B
liposomes form).
- Sedatives intravenously
administered (eg midazolam).
- Sedatives orally administered for
children (eg. cloral hyrat).
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- Blockers of muscular and
neurotransmitter (eg. succinylcholin, rocuronium, vecuronium).
- Contrast agent by injection.
- Parenteral feeding preparation.
- Sodium chloride, by injection,
hypertonic solution (concentration> 0.9%).
- Sterile water for injection,
transfusion and wound washing (contained in bottle) with volume of 100 mL or
more.
b. Specific medications
- Colchicin by injection.
- Epoprostenol by intravenous
injection
- Insulin by subcutaneous and
intravenous injection
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- Orally administered cancer drugs
used for prescribed non-cancer treatment.
- Oxytocin by intravenous injection.
- Natri nitroprussid by injection.
- Potassium chloride concentrated
solution, by injection.
- Potassium phosphate, by injection.
- Promethazine, by injection
intravenous
- Vasopressin by intravenous
injection or injection in the bone.
ANNEX 3
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LIST OF SOME MEDICATIONS AND TESTS WITH ADR
Dectected
signs
Suggested
causes
Medication
Diphenhydramin (Dimedrol)
Allergic reactions or other
adverse drug reactions
Vitamin K
Overdose of vitamin K antagonist
anticoagulant
Flumazenil
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Antiemetics (haloperidol,
ondansetron, promethazin, metoclopramid)
Nausea / vomiting related to drug
use
Naloxon
Ovedose of opioid analgesics
Diarrhea medication
Diarrhea caused by antibiotics.
Find Clostridium difficile in stool.
Sodium polystyrene (Kayexalate)
Hyperkalemia related or
drug-induced renal failure
Paraclinical test
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Overdose of heparin anticoagulant
INR value > 6
Overdose of vitamin K antagonist
anticoagulant
White blood cell <
3000 / mm3
Reduced neutrophil due to
medication of disease
Platelet count < 50 000 / mm3
Adverse reactions related to drug
Blood glucose < 2,78 mmol/l
Hypoglycemia related to insulin
and diabetes medications
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Renal toxicity related to drug or
medical condition
Positive Clostridium difficile in
stool
Multiple infections involving
antibiotics
Clinical signs
Excessive sedation, coma, fall
Concerning abuse of sedative
Skin rash
ADR
Other signs
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ADR
Transfer to a higher level of
care
ADR
Note: PT (prothrombin time)
INR (international normalized
ratio)
ANNEX 4
ASSESSMENT SCALE OF RELATION BETWEEN MEDICATION AND ADR
An adverse incident occurring
during treatment process may be related to the pathological characteristics or
medication being administered by patient. The identification of ADR causes is a
complex procedure requiring all information about patient, adverse reactions,
suspected medication and concomitantly administered medication. It is also
necessary to take into account the other causes. Depending on professional
conditions, the medical facilities may assess the relation between the
suspected medications and ADR based on the classification scale of WHO or
assessment scale of Naranjo which are used the most for the time being. It is
necessary to note that such assessment is not required upon report on ADR of
medication. The medical officers of medical facilities should send all reports
on drug-induced ADR with no required assessment. Such reports shall be
appraised by the experts of the Naional Centers and local Centers and the feedback
result shall be sent to reporters and medical facilities.
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The relation between the suspected
medication and ADR is divided into 06 levels (table 1).
To classify the relation between
the suspected medication and ADR at which level, it is necessary to meet all
prescribed assessment standards corresponding to such level.
Table
1. Assessment scale of relation between the suspected medication and ADR
Cause
and effect relation
Assessment
standard
Definite
·
Described reaction (abnormal clinical or paraclinical signs) has a close relation
with the time of administration of suspected medication.
·
The reaction which has occurred can not be explained by the patient’s
pathological conditions or other medications concomitantly administered with
the suspected medication.
·
The signs of reaction are improved upon discontinuation of suspected
medication.
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·
The repeated reaction upon re-continuation of suspected medication (in case
of administration of suspected medication)
Probable
·
The reaction described has a rational relation with the time of
administration of suspected medication.
·
The cause of reaction is not sure if there is a relation to the patient’s
condition or other medications concomitantly administered or not.
·
The signs of reactions are improved upon discontinuation of suspected
medications.
·
It is not necessary to have information on re-continuation of medication.
Possible
·
The reaction described has a rational relation with the time of
administration of suspected medication.
·
The reaction can be explained by the patient’s pathological conditions or
other medications concomitantly administered
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Doubtful
·
The reaction is described with unclear relation with the time of drug
administration.
·
The reaction may be explained by the patient’s pathological condition or
other medications concomitantly administered.
Unclassified
·
Record the occurrence of reaction but additional information required for
assessment of continuing the collection of additional information for
assessment.
Unclassifiable
·
Record the reaction with suspect of adverse reaction of medication but
failure to assess due to insufficient or inconsistent information and failure
to collect additional information or re-verification.
2. Assessment scale of Naranjo
The relation between the suspected
medication and ADR is divided into 04 levels including: definite, probable,
possible and doubtful. This assessment scale lists 10 questions (based on the
assessment criteria for adverse incident) and makes the scoring based on the
answers (table 2). The total score shall be used to classify the relation
between the suspected medication and ADR.
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Suspected medication:……………………………
ADR signs:…………………………………………………………………
No.
Assessment
questions
Scoring
Score
Yes
No
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1
Has the reaction been described
before in the medical literature?
1
0
0
2
Has the reaction occurred after
treatment with suspected medication?
2
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0
3
Has the reaction been improved
after discontinuation of medication or administration of antagonist?
1
0
0
4
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Has the reaction re-occurred upon
re-contiunation of medication?
2
-1
0
5
Are there other causes (except
for suspected medication) which may cause reaction or not?
-1
2
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6
Has the reaction occurred upon
administration of placebo?
-1
1
0
7
Is the durg concentration in
blood (or other biological fluids) at the toxicity threshold?
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0
0
8
Does the reaction become more
serious upon increase of dosage or less serious upon decrease of dosage?
1
0
0
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Does the patient met the similar
reactions with the suspected medications or previous similar medications?
1
0
0
10
Have the reactions been certified
by the objective evidences like the result of abnormal test or result of
abnormal imaging diagnosis?
1
0
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Total
score
Conclusion
For the conclusion, give the number
corresponding to the following classification levels:
1. Definite (>= 9 points)
2. Probable (5 – 8 points)
3. Possible (1 – 4 points)
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ANNEX
5
REPORT ON ADVERSE DRUG REACTION
Place
of report: ……………………………
INFORMATION ABOUT REPORTER, PATIENT AND REPORTING UNIT IS
KEPT CONFIDENTIAL
Code of
reporting unit……………
Reporting
code (managed by the National Center):
……………………………
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A.
INFORMATION ABOUT PATIENT
1. Full
name:....................................................................
2. Date of
birth:…/……/………
Or age:……………………
3.Sex
□ Male □ Female
4. Weight:
B.
INFORMATION ABOUT ADVERSE DRUG REACTION (ADR)
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5. Date of
reaction occurrence:.. /....... /......................
6. When
did the reaction occur (from the last administration of suspected medication)
:......................................................................
7. Describe
ADR signs
8. Tests
related to reaction
9. Medical history (allergy, pregnancy, tobacco and
alcohol addict, liver, kidney disease...)
10. Way to
manage the reaction
11. Seriousness
of reaction
□ Death □ Hospitalization/Prolonged length of
hospital stay
□ Birth defect
□ Life threatening □ Permanent/serious
disability □ Unserious
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□ Death due to ADR
□ Not recovered
□ Recovered with sequelae
□ Unknown
□ Dealth without relation to medication
□ Recovering
□ Recovered
without sequelae
C. INFORMATION ABOUT SUSPECTED ADR MEDICATION
No.
13. Medication (generic name and brand name)
Dosage form and content
Manufacturer
Batch No.
Dose/1 time
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Route of administration
Treatment date (date/month/year)
Reasons for administration
Starting
Kết thúc
i
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ii
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iii
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14. After discontinuation/dosage reduction of
suspected medication, the reaction has been improved?
15. Has the reaction occurred upon re-continuation
of suspected medication?
Yes
No
No discontinuation/dosage reduction
No information
Yes
No
No re-continuation
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16. Concomitantly administered medications (except
for medications administered for treatment/remedy of ADR consequences
Name
of medication
Dosage
form, content
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Name
of medication
Dosage
form, content
Treatment
date (date/month/year)
Starting
Finishing
Starting
Finishing
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D. UNIT’S ADR APPRAISAL
17. Assessing the relation between medication and ADR
Definite Doubtful
Other :………………………………………………..
Probable
Unclassified
………………………………………………..
Possible
Unclassifiable ………………………………………………..
18. On which scale the unit has made appraisal?
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19. Comments of medical officer (if any)
E. INFORMATION ABOUT REPORTER
20. Full
name:..........................................................................................
Occupation/position:
……………………………….
Contact
Tel: ............................................................................ Email: ............................................................................
21. Signature
22. Form of report:
First time/ Additional
23. Reporting date:…./……./……….
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INSTRUCTIONS
ON REPORT PREPARATION
Please make report on
all adverse reactions you are doubtful about, especially when:
· The reactions are related to the new
medications.
· Unexpected or unknown reactions.
· Serious reactions.
· Medication interaction.
· Failure in treatment
· Problems of medication quality
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This form of report is applied to the
reactions caused by:
· Medications and biologicals
· Vaccines
· Traditional medicine or herbal medicine
· Functional food
The reporter may be:
· Doctor
· Pharmacist
· Dentist
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· Other healthcare service providers.
Way to report:
· Fill information in reporting form
· Only fill parts you have information
· You may attach some additional pages (if
the report has not enough space for filling information or relevant tests)
· Please send the report to the National Drug Information and Adverse Drug Reaction
Monitoring Center at the following address:
Mail:
National Drug
Information and Adverse Drug Reaction Monitoring Center
Hanoi University of
Pharmacy, 13-15 Le Thanh Tong, Hoan Kiem district, Hanoi
Fax: 04.3.9335642
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Website:
http://canhqiacduoc.orq.vn Email: [email protected]
You can obtain this
reporting form at the Pharmacy, the General Planning Department of hospital
or download from the website http://canhgiacduoc.org.vn.
For further information, you can contact the National Drug Information and
Adverse Drug Reaction Monitoring Center by the telephone number 043
933 5618 or at email address: [email protected]
Part
for National DI & ADR Center
1. Send
confirmation to the reporting unit
3. Reaction
mentioned in medical literature/SPC/CSDL
2. Reaction
classification
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· Serious
Unserious
4. Enter
data in the national database system
5. Enter
data in Vigiflovv software
6. Seriousness of reaction
Life
threatening/death causing Hospitalization/prolonged
length of hospital stay Causing
deformities / disabilities Related to drug abuse/dependence
7.
Send report to the appraisal Council
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Sending date
……../………../…………
8. Send report to UMC
Sending date
……../………../…………
9. Appraisal result
Definite Doubtful Other: .........................................
Probable Unclassified
.........................................
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10. Report from manager
11. Date:………../…………./………..
12. Signature
The reporting form of ADR is
issued with Circular No. 23/2011/TT-BYT on “ Instruction on medication use in
medical facilities with beds”
ANNEX 6
POINTS TO NOTE DURING DRUG USE TO MINIMIZE ADR
OCCURRENCE
During the prescription and
dispersion of medication or compliance with medical order, the medical officers
need to consider the following factors:
+ The medications are suitable
for the patient’s clinical condition?
+ Dosage, route of
administration and interval between times of medical dispersion are rational?
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+ The patient’s pathological
conditions possibly affect the pharmacokinetics of medications?
+ The patients have allergy to
the medications or other medications in the same pharmacological group?
+ The patients are administered
with other medications (or traditional medicine) which can cause medication
interactions?
+ The medications prescribed are
at high risk of causing ADR? (eg. aminoglycosid, digoxin, vitamin K antagonist
anticoagulants, heparin, chemotherapy for cancer) or medications in need of
monitoring of patients or regular tests for monitoring? (eg. Complete blood
count, electrolyte analysis, serum creatinine, liver function tests, blood
clotting,…).
+ The medications are expired
and preserved as required? (with medications in need of special preservation
conditions).
+ Are there abnormal signs of
quality in case of organoleptic observation (discoloration, fading of drug…)
+ The devices used for injection
and infusion are sterile?
Note:
- Do not prescribed medications if
having no clear reasons for explaining such prescription.
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- Be careful to give prescription
of medications known to be at high risk of causing adverse reactions and
medication interaction (anticoagulants, hypoglycemic agents, medications acting
on the central nervous system); closely monitor the patients with ADR signs
upon medication administration.
- Be careful of interaction between
drug and food, alcohol and other drinks.
- Avoid unnecessary drug
combination.
- Review all medications patients
have used, including the over-the-counter drugs and traditional medicine.
- If the patients have the abnormal
or unknown signs or symptoms related to the pathological conditions, it is
required to consider the possibility of ADR.
- When being doubtful about ADR
occurred in patients, consider the decrease in dosage or discontinuation of
suspected medications as soon as possible, manage, assess and report on ADR of
such medications.