ADVERSE DRUG REACTION REPORT
Business hours - phone.: +371 67013724
24 h - mob phone.: +371 26137761
Phone& Fax: +371 67013777
E – mail: adr@olainfarm.lv
www.olainfarm.lv
I.
INITIALS
ON PATIENT INFORMATION
ETHNICITY
DATE OF BIRTH
Day
Month
Year
AGE
SEX
Female
Main Diagnosis
II.
WEIGHT
Please, indicate information :
hypersensibility to drugs
allergies
abuse of alcochol
HRT, contraceptive therapy
Pregnancy
Male
Concomitant disease/diseases; please indicate a hospital if appropriate
ADVERSE DRUG REACTION
ONSET
ADEVESRE DRUG REACTION (ADR) DESCTRIPTION (symptoms, results of the analysis, changes in laboratory data range,
drugs used for the ADR treatment)
Day
Month
Year
TIME: _ _/_ _
END
Month
Day
Year
DURATION:
(if continued less than 24 hours,
specify hours)
Was the use of drug terminated
when adverse reaction appeared ?
Y
N
Unknown
Adverse Drug Reaction caused:
Patient’s death (data) _ _/_ _/_ _
Hospitalisation or prolongation of existing hospitalisation
Results in persistent or significant disability or incapacity (underline appropriate)
Life-threatening
Congenital anomaly/birth defect
Other medically important case : please specify___________________
Other – please, specify _____________________
Outcome of the Adverse Drug Reaction:
Complete recovery
Not resolved, without sequel,
Not resolved, with sequel - please, specify _________________________
Ongoing
Not known
III.
Did reaction reappear :
After renewing the drug intake?
Y
N
Unknown
After increasing the dose?
Y
N
Unknown
SUSPECTED DRUG WHICH MIGHT CAUSE ADVERSE DRUG REACTION
Trade name, drug
form, active
substance and
manufacturer
IV.
Did reaction dissappear:
After withdrawing the drug?
Y
N
Unknown
After reducing the dosage?
Y
N
Unknown
Indications for use
Route of
administration
Dose, units,
frequency
Start date
End date
Batch/
Series
No.
Are the
drugs taken
for the first
time in life?
If drugs
were
applied
earlier,
were the
reactions
similar?
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
CONCOMITANT DRUGS USED IN LAST 3 MONTHS (INCLUDING SELF-TREATMENT)
Trade name, drug form,
active substance and
manufacturer
Indications for use
Route of
administration
CONTINUATION FROM PREVIOUS PAGE
Monitoring of Adverese Drug Reactions JSC Olainfarm
1 from 2
Dose, units,
frequency
Start date
End date
Batch/Series
No.
PATIENT’S
INITIALS
For JSC Olainfarm personnel only
DATE RECEIVED AT JSC
OLAINFARM
____________________________________
_
Business hours - phone.: +371 67013724
24 h - mob phone.: +371 26137761
Phone& Fax: +371 67013777
E – mail: adr@olainfarm.lv
www.olainfarm.lv
V.
REPORTER (doctor or pharmacist)
NAME, SURNAME
PHONE
E - MAIL
OFFICE ADRESS
SPECIALITY/QUALIFICATION
(physician, pharmacist, other health professional : please – specify)
SIGNATURE
DATE OF REPORT
I understand that by signing and/or sending the report I give the permission to the staff of JSC Olainfarm to contact me in order to clarify the information referred to into
the report and ask the necessary questions.
VI.
ADDITIONAL INFORMATION
(e.g.: on serious concomitant disease, allergic reactions, increased drug sensitivity, pregnancy, significant laboratory test results)
Adverse Drug Reaction is a response to a medicinal product which is noxious and unintended. Adverse reactions may arise from use of the product
within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation
include off-label use, overdose, misuse, abuse and medication errors.
Call for physicians and pharmacists to report about all observed Adverse Drugs Reactionss, which could be related with JSC Olainfarm
produced drugs usage - with aim to know as much as possible about our drug safety and maintain their safety profiles we are calling to report
on each and every adverse reaction which has been brought to your attention!
In this report blank we ask to describe in detail the process of the observed adverse drug reaction and provide with information regarding the patient and
his/her relevant medical history. In description of drugs used by patient please indicate the active substance and in particular the drugs forms (e.g.
prolonged forms of drugs). Please note - only correct and detailed information allows us to analyze and identify adverse drug reaction and the possible
causal relationship with other medications used simultaneously. We will be thankful, if you could attach additional documentation from hospital or
patient’s ambulatory card without any patient’s personal information (indicate initials only!).
Please be informed that according legislation we are obliged to inform European Medicines Agency on each and every serious adverse reaction in fifteen
days from the day of the receipt of information. About all non-serious reactions which occured in EU member states we should inform in 90 days.
Serious Adverse Reaction – an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of
existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect or is medically important
(significant).
We will be thankful if in cases of serious advers reactions or when suspecting them you will report to us immediately by phone and by sending us report
form by fax or e –mail (please, see details on the top right corner). Also you can send the information by post: JSC Olainfarm, Pharmacovigilance Group,
Rupnicu street 5, Olaine, Latvia, LV – 2114
In other cases Adverse Drug Event Report will be sent to JSC Olainfarm ASAP.
Also you can download our report forms from our website: http://olainfarm.lv/en/products-and-services
If there is lack of space for information placing, please feel free to use new blank page and attach it to the report form.
Monitoring of Adverese Drug Reactions JSC Olainfarm
2from 2
For JSC Olainfarm personnel only
DATE RECEIVED AT JSC
OLAINFARM
____________________________________
________________________________