Pharmacovigilance
«Euro Lifecare» creates, provides and guarantees the functioning of the pharmacovigilance system in Ukraine, which is a prerequisite for finding medicinal products in circulation in Ukraine in accordance with the Order of the Ministry of Health of Ukraine dated December 27, 2006 No. 898, which entered into force on January 6, 2017 p. (link http://zakon3.rada.gov.ua/laws/show/z0073-07 )
Pharmacovigilance system of our company sets the following tasks:
- to monitor the safety of drugs;
- to investigate the adverse reactions of patients to drugs;
- to analyze the effectiveness of medicines;
- to identify any changes in the ratio of risk / benefit, analyze the identified changes;
- to ensure that in the event of the detection of previously unknown hazardous properties of the medicinal product, which has or could lead to grave health and life effects or a change in the assessment of the risk-benefit / risk-benefit ratio that became known as a result of the analysis will be taken necessary measures, and guarantees of making appropriate changes and additions to the safety information of the medicinal product, reflected in its general characteristic.
Dear patients and colleagues!
If you have any information about the adverse reaction or detection of the dangerous properties of the drug of Euro Lifecare, please fill out the form below.
We emphasize that any information provided by you is important to us! We take care of your health!
Authorized person responsible for Pharmacovision of Euro Lifecare Company – Belikova Svetlana
REQUIREMENTS FOR COMPLETING THE MESSAGE CARD
І. Patient Information
FULL NAME. patient (last name, first name and patronymic of the patient are indicated in the first letters. If the message concerns a medicinal product or vaccine that a pregnant woman took, and an adverse reaction occurred in the fetus, all data (except for the adverse reaction) is provided about the mother).
Medical history/outpatient card number (indicate the number of the patient’s medical history or outpatient card).
Date of birth/age (the day, month and year of birth of the patient are indicated. For patients aged 3 years and older, years are indicated (for example, 4 years) for patients under 3 years – months (for example, 24 months) for patients under the age of one month – days (for example, 5 days)).
Gender (indicated either F or M. If the message concerns a medicinal product or vaccine that a pregnant woman took, and an adverse reaction occurred in the fetus, all data (except for the adverse reaction) is provided about the mother, indicating the trimester of pregnancy).
Weight (indicate the patient’s weight in kg).
Height (patient’s height in cm is noted).
II. Suspects PR / OE / NSPI
Suspected ADR / NSPI (describes each clinical manifestation of an ADR / AEFI, indicating the dates and times of onset, end and consequences) / Indication of OE (describes each AE / NSPI, indicating the dates and times of the beginning and end and consequences of an ADR / AE / NSPI. In the message for congenital anomalies of the fetus, the date of birth of the child or gestational age is indicated).
Investigation PR / OE / NSPI (the corresponding positions are indicated).
Correction of PR / OE / NSPI (the corresponding positions are indicated).
What are considered the manifestations of ADR / NSPI (applies to the case of ADR / NSPI in general) (the corresponding positions are indicated. In the case of a group NSPI, message cards are filled out for each patient for whom NSPI is registered and who has undergone immunization / tuberculin diagnostics).
III. Information about the suspected drug, vaccine, tuberculin
Suspected drug, vaccine, tuberculin (trade name, release form, manufacturer) (indicate the trade name of the drug, vaccine, tuberculin suspected of being involved in the occurrence of ADR / OE / NSPI, dosage form, manufacturer).
Batch number (indicate the batch number of the suspected drug, vaccine, tuberculin).
Indications (indications for prescribing the suspected drug, vaccine, tuberculin are indicated (if possible according to ICD-10)).
Strength of action (indicates the content of the active substance(s) in quantitative terms per dose unit or volume unit, or mass unit in accordance with the dosage form of the suspected drug, vaccine, tuberculin).
Single dose (indicates a single dose of the suspected drug, vaccine, tuberculin).
Frequency of administration (indicate the frequency of administration of the suspected drug, vaccine, tuberculin).
Method of administration (indicates the method of administration of the suspected drug, vaccine, tuberculin).
Date and time of initiation of therapy (indicate the day, month, year and purpose of the suspected drug, vaccine, tuberculin).
Date and time of end of therapy (indicate the day, month, year and time of end of use of the suspected drug, vaccine, tuberculin).
Measures were taken in relation to the suspected drug, vaccine, tuberculin for the correction of PR / OE / NSPI (the corresponding positions are indicated).
ІІІа. Additional information on the incidence of AEFI on vaccines or tuberculin
Category of immunization or tuberculin diagnostics (a mark in the corresponding cell indicates the category of immunization or tuberculin diagnostics).
NSPI category (a mark in the corresponding cell indicates the NSPI category).
Dose number (for vaccine) (a mark in the corresponding cell indicates the dose number of the vaccine complex).
Vaccine/tuberculin injection site (a mark in the appropriate box indicates the site of vaccine/tuberculin administration).
Method of administration of the vaccine/tuberculin (a check mark in the appropriate box indicates the method of administration of the vaccine/tuberculin).
Data from the life history of the person who was vaccinated / tuberculin diagnostics (history of vaccinations, the presence of reactions to previous administrations of vaccines, tuberculin, the presence of an acute or exacerbation of a chronic disease within 1-1.5 months before immunization / tuberculin diagnostics, the use of immunosuppressive therapy for 1 months and blood products for 3 months before immunization, etc.) (indicate information about vaccination history, the presence of a reaction to previous administrations of vaccines, tuberculin, the presence of an acute or exacerbation of a chronic disease within 1-1.5 months before immunization / tuberculin diagnostics, use of immunosuppressive therapy for 1 month and blood products for 3 months before immunization / tuberculin diagnostics, etc.).
IV. Information about concomitant medications (except for drugs that were used to correct the consequences of ADR / NSAIDs / AE)
Related medicines, vaccine, tuberculin (trade name, dosage form, manufacturer, batch number) (indicate the trade names of the accompanying medicines that were intended, their release form, manufacturer, batch number).
Indications (indications for prescribing concomitant medications, vaccines, tuberculin are indicated (if possible according to ICD-10)).
Strength of action (indicates the content of the active substance(s) in quantitative terms per dose unit or volume unit, or mass unit in accordance with the dosage form of concomitant medications, vaccines, tuberculin).
Single dose (indicates a single dose of suspected drugs, vaccines, tuberculin).
Frequency of administration (indicate the frequency of administration of suspected drugs, vaccines, tuberculin).
Method of administration (indicates the method of administration of concomitant medications, vaccines, tuberculin).
Date of initiation of therapy (indicate the day, month and year of prescription of concomitant medications, vaccines, tuberculin).
End date of therapy (indicate the day, month and year of the end of the use of concomitant medications, vaccines, tuberculin).
Other important information (concomitant diagnoses, data from laboratory and instrumental studies, allergic anamnesis, pregnancy indicating the duration of pregnancy, method of conception, outcome of pregnancy (if the pregnancy is completed, the date of birth, type of birth, etc.) are indicated) (data that may influence the manifestation of an adverse reaction / lack of effectiveness, but are not directly related to it).
V. Information about the speaker
The surname, first name, patronymic of the notifier, specialty, organization (health care institution), postal address of the organization, telephone number, and date of completion are indicated.
VI. Information about the medical / pharmaceutical specialist (if not the notifier)
The surname, first name, patronymic of the medical/pharmaceutical specialist, specialty, healthcare institution, location, address, telephone number, and date of completion are indicated.