Business hours - phone.: +371 67013724
PATIENT REPORT ON ADVERSE DRUG REACTION 24 h
I.
- mob phone.: +371 26137761
Phone& Fax: +371 67013777
E – mail: adr@olainfarm.lv
www.olainfarm.lv
INFORMATION ON THE PERSON WHO SUBMITTED REPORT
To clarify (if necessary) the information referred to in the report, please indicate the contact details below
Name
Surname
e-mail
II.
Contact phone
INFORMATION ON THE PATIENT
It is reported on the :
Own person who submitted reoprt
Other person
Other person - a person whose legal or authorised
representative is rapporteur, - the minor child of the person,
the person who has been declared legally incompetent,
incapacitated
Impact on fetus during pregnancy
Ompact on child during breast feeding
PATIENT’s NAME, SURNAME
(if allowed to contact a physician/health care
specialist as specified in section VII;
if do not allowed - specify initials)
ETHNICITY
AGE
SEX
F.
If known :
Person’s main disease (diagnosis)
II.
WEIGHT
M.
If known :
Person’s concomitant disease/es (diagnose/es); if hospitalised – indicate
the hospital
Indicate information known on
person:
hypersensibility to drugs
allergies
abuse of alcochol
hormone replacement therapy
and/or contraceptive therapy
pregnancy
DESCRIPTION OF THE ADVERSE DRUG REACTION AND OTHER IMPORTANT INFORMATION AT YOUR
DISPOSAL
Please describe Adverse Drug Reaction/s, providing the most useful information (symptoms, results of the analysis, changes in
laboratory data range, drugs used for the Adverse Drug Reaction treatment); also please indicate any medically related
information which is at your disposal.
REACTION ONSET YOU
KNOWN
Day
Month
Year
TIME: _ _/_ _
END of the REACTION
Day
Month
Year
DURATION:
(if continued less than 24 hours,
specify hours)
INFORMATION YOU KNOWN:
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
IV.
Did reaction dissappear:
After withdrawing the drug?
Y
N
Unknown
After reducing the dosage?
Y
N
Unknown
Did reaction reappear :
After renewing the drug intake?
Y
N
Unknown
After increasing the dose?
Y
N
Unknown
THE SUSPECTED DRUG WHICH MIGHT HAVE CAUSED ADVERSE DRUG REACTION
Monitoring of Adverese Drug Reactions JSC „Olainfarm”
1 from 2
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
Trade name;
Marketing Aathorization
Holder/parallel importer
(see on package)
V.
What is the
purpose of
drug use?
(for
treatment of
which
symptoms or
disease?)
How often
drugs used?
(e.g. twice a
day, other specify)
End date
(if not stopped,
plaese indicate)
Start date
Batch/Series
Nr.
(see on
package)
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
DRUGS OBTAINED FROM
Pharmacy
VI.
Dosage
used at one
intake
(e.g.
2 tablets, 1
injection,
other specify)
Internet (if possible – indicate
web adress)
Hosptial
From other country ( if
possible – indicate country)
Other (if possible – indicate)
CONCOMITANT DRUGS USED IN LAST 3 MONTHS (INCLUDING SELF-TREATMENT)
Trade name
What is the
purpose of drug
use?
(for treatment of
which symptoms or
disease?)
Dosage used at
one intake
(e.g. 2 tablets,
1 injection, other specify)
How often
drugs used?
(e.g. twice a
day, other specify)
Start date
End date
(if not stopped,
plaese indicate)
Batch/Series Nr.
(see on package)
VII. INFORMATION ON PATIENT’S DOCTOR
I GIVE THE PERMISSION to the JSC Olainfarm employees to contact the physician (general practioner) or other health
care professional (including doctor to whom the information on Adverse Drug Reaction was submitted) in order to concretize
information mentioned in the report, as well as information on patient’s health condition (if necessary)
Yes, my physician(general practitioner)
Yes, other health care professional
Yes, other
I have no/I do not know my physician(general practitioner)
or other health care professional
NOT ALLOWED
Name, surname of physician(general practitioner)/other
health care professional
Contact information of physician(general practitioner)/other
health care professional
Sender’s signature ________________________
Date _ _/_ _/_ _ _ _
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.
If there is lack of space for information placing, please feel free to use new blank page and attach it to the report form.
JSC Olainfarm guarantees the confidentiality of personal data.
Monitoring of Adverese Drug Reactions JSC „Olainfarm”
2 from 2
For JSC Olainfarm personnel only
DATE RECEIVED AT JSC „OLAINFARM”
________________________________