Nội dung toàn văn Decision No. 1088/QD-BYT instructions on monitoring of adverse drug reaction ADR at medical facilities
MINISTRY OF HEALTH -------- | SOCIALIST REPUBLIC OF VIETNAM |
No.: 1088/QD-BYT | Hanoi, 04 April, 2013 |
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.
Article 3. Chief of ministerial Office, Head of Medical Service Administration, ministerial Chief Inspector, Directors General, Directors of Ministry of Health; Director of National Drug Information and Adverse Drug Reaction Monitoring Center of HCM City; Director of hospitals and Institute with patient beds directly under the Ministry of Health, Director of Department of Health of provinces and centrally-run cities, Head of medical sectors and Head of relevant units are liable to execute this Decision./.
| PP. MINISTER |
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.
The Ministry of Health issues this instruction with the objectives:
- 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.
- Keep the packaging and blister pack used by patient for reference in case of need of more information.
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, ...).
b) ADR detection
- 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
- Evaluates the seriousness of ADR to decide the appropriate clinical management.
- 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
a) During the performance of professional activities, review of medical records or medication approval at Pharmacy, the pharmacist can detect ADR based on the medications used to manage their ADR, the abnormal clinical signs or paraclinical test result (see Annex 3); give priority to review the medical record of special patients using medications prone to ADR (see Annex 2).
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
a) Report all adverse incidents during treatment with suspected causes such as:
- 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
a) The report must be sent as soon as possible after the occurrence of reaction, even when the information obtained is incomplete (initial report). In this case, additional report may be sent if collecting more information (additional report).
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.
- In case of use of medication for treatment of ADR but causing another ADR for patient, a separate report should be made.
- 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.
d) Detailed instruction on information to be filled out in the ADR report.
- 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.
In case the child patient is under 01 year old: specify month or day of age.
+ 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.
+ Item 10: fill out information about measures taken to manage the reaction including: management measures, medication for symptom treatment and supported treatment and other measures to ensure the vital functions for patient.
+ 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.
Ö In case of no information about ADR development after discontinuation or dose reduction of suspected medication, put (√) in the box “No information”.
+ 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.
- Information about the reporter:
+ 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
- Way 2: Sent by email.
- 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
Tel: 043 933 5618
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
1. When receiving ADR report, the National Drug Information and Adverse Drug Reaction Monitoring Center or the local Centers shall send the confirmation and thank letter to the unit/individual sending the report.
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.
d) Check the medication interaction and contraindication in prescription for the medication provsion procedure at the Pharmacy.
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.
d) Makes periodical summary of ADR report activities in hospital; uses information about safety to update, modify and add the list of medications of hospital, treatment instructions and professional procedure in hospital.
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
- Rapid weight gain
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
- Bacterial infection, fungal infection
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
- Increased lymphocyte
- 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
- Gums disorder
- Xerostomia
- Mouth ulcer
- Esophageal ulcer
- Epigastric pain
- Gallstone
- Pancreatitis
- Constipation
- Diarrhea and pseudomembranous colitis
- Gastrointestinal bleeding
8. Respiratory disorder
- Dyspnea
- Bronchospasm
- Interstitial pneumonia
9. Abnormal blood glucose value
- Hyperglycaemia
- Hypoglycemia
10. Endocrine disorder
- Hypothyroidism
- Hyperthyroidism
- Increased prolactin in blood
- Drug-induced lupus erythematosus
11. Neurological and muscular disorder
- Peripheral neuropathy
- Dizziness
- Seizure
- Myotonic disorder
- Extrapyramidal disorder
- Increased intracranial pressure
- Abnormal movements
- Myalgia
- Rhabdomyolysis
- Osteoporosis
- Osteonecrosis
12. Abnormal blood pressure
- Hypotension
- Orthostatic hypotension
- Hypertension
13. Cardiac disorder
- Arrhythmia or abnormal ECG
- Pericarditis
- Slow heartbeat
- Thrombosis / stroke
- Cardiomyopathy
- Heart valve disease
- Heart failure
14. Psychosis
- Confusional state due to drug
- Agitation
- Mental inhibition
- Mood swing: depression, mania
- 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
LIST OF PATIENTS AND MEDICATIONS WITH HIGH RISK OF ADR
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
- Patients with history of allergy, drug allergy, food allergy or unexplained allergy.
- 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).
- Solution paralyzing heart muscle.
- 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).
- Opioid used in anesthesia or sedation, intravenously administered, transdermal therapeutic system or orally.
- 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
- Magnesium sulfate by injection.
- 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
ADR
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 | Overdose of sedative of benzodiazepine class |
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 | |
Prothrombin time (PT)> 100 seconds | Overdose of heparin anticoagulant |
INR value > 6 | Overdose of vitamin K antagonist anticoagulant |
White blood cell < 3000="">3 | Reduced neutrophil due to medication of disease |
Platelet count < 50="" 000="">3 | Adverse reactions related to drug |
Blood glucose < 2,78=""> | Hypoglycemia related to insulin and diabetes medications |
Increased serum creatinine | 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 | |
Unplanned discontinuation without known cause during treatment | 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.
1. Classification scale of WHO
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. · The reaction is the known typical side effect of suspected medication (with clear pharmacological mechanisms) · 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 · There is insufficient information on development of reaction upon discontinuation of suspected medication or unclear information on discontinuation of medication. |
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.
Table 2: ADR assessment scale of Naranjo
Suspected medication:……………………………
ADR signs:…………………………………………………………………
No. | Assessment questions | Scoring | Score | ||
Yes | No | No information | |||
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 | -1 | 0 |
|
3 | Has the reaction been improved after discontinuation of medication or administration of antagonist? | 1 | 0 | 0 |
|
4 |
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 | 0 |
|
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? | 1 | 0 | 0 |
|
8 | Does the reaction become more serious upon increase of dosage or less serious upon decrease of dosage? | 1 | 0 | 0 |
|
9 | 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 | 0 |
|
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)
4. Doubtful (<1 or="" 0="">
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): |
Please make report even when you are not sure about the product causing reactions and/or have insufficient information.
A. INFORMATION ABOUT PATIENT |
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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 | |||||||||||||||||||||||||
12. Result after management of reaction □ 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 | Number of administration per day/week/month. | Route of administration | Treatment date (date/month/year) | Reasons for administration |
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Starting | Kết thúc |
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ii |
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iii |
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No. (corresponding to 13 | 14. After discontinuation/dosage reduction of suspected medication, the reaction has been improved? | 15. Has the reaction occurred upon re-continuation of suspected medication? |
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Yes | No | No discontinuation/dosage reduction | No information | Yes | No | No re-continuation | No information |
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I | □ | □ | □ | □ | □ | □ | □ | □ |
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Ii | □ | □ | □ | □ | □ | □ | □ | □ |
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Iii | □ | □ | □ | □ | □ | □ | □ | □ |
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Iv | □ | □ | □ | □ | □ | □ | □ | □ |
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16. Concomitantly administered medications (except for medications administered for treatment/remedy of ADR consequences |
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Name of medication | Dosage form, content | Treatment date (date/month/year) | Name of medication | Dosage form, content | Treatment date (date/month/year) |
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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? WHO scale Naranjo scale Other: ………………………………………… |
19. Comments of medical officer (if any)
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E. INFORMATION ABOUT REPORTER
20. Full name:.......................................................................................... Occupation/position: ………………………………. Contact Tel: ............................................................................ Email: ............................................................................ | |||
21. Signature | 22. Form of report: | First time/ Additional | 23. Reporting date:…./……./………. |
Thank you!
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 · Errors during medication administration 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 · Nurse/midwife · 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:
Hanoi University of Pharmacy, 13-15 Le Thanh Tong, Hoan Kiem district, Hanoi
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 |
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2. Reaction classification · New medication Old medication · Serious Unserious |
| 4. Enter data in the national database system |
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5. Enter data in Vigiflovv software |
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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 |
| Sending date ……../………../………… | 8. Send report to UMC |
| Sending date ……../………../………… | |||||
9. Appraisal result Definite Doubtful Other: ......................................... Probable Unclassified ......................................... Possible Unclassifiable ......................................... | ||||||||||
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?
+ The relevant paraclinical tests have been done and the result of such tests have been assessed?
+ 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.
- Be careful to give prescription to child patients, elderly patients, pregnant or breastfeeding women, seriously ill patients, patients with renal or hepatic impairment. Closely monitor such patients during the medication administration.
- 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.
