Pharmacovigilance
WE CARE ABOUT THE SAFETY OF POLFARMEX PRODUCTS
The quality and safety of Polfarmex medications are our top priorities. Our responsibility does not end when a medicine leaves the factory. We carefully monitor our drugs throughout their entire life cycle, also conducting pharmacovigilance.
What is pharmacovigilance?
Pharmacovigilance involves all activities related to collecting information, and detecting and preventing adverse drug reactions in humans. The primary goal of pharmacovigilance is to improve the safety profile of medication use.
What are the goals of pharmacovigilance?
The primary goal of pharmacovigilance is to detect adverse drug reactions and estimate their frequency. Pharmacovigilance also helps identify interactions between different medications, as well as between medications and food. Additionally, systematically gathering data over many years allows us to observe long-term effects of therapy, especially in the case of chronic diseases. It also helps quickly detect changes in the benefit-risk balance of a drug.
What are adverse drug reactions?
An adverse drug reaction is any undesirable and unintended response by the body that occurs during or after drug therapy.
How and to whom can I report an adverse drug reaction?
Patients, actual caregivers, legal representatives
- To healthcare professionals: doctors, dentists, pharmacists, pharmacy technicians, laboratory diagnosticians, paramedics, nurses, midwives
- To the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (https://smz2.ezdrowie.gov.pl)
- To the pharmaceutical company responsible for the drug
Healthcare professionals
- To the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (https://smz2.ezdrowie.gov.pl)
- To the pharmaceutical company responsible for the drug.
What should a report include?
Patient information.
It is necessary to provide at least one element that makes it possible to identify the patient, such as: initials, sex, age. Information about the patient’s age, weight and height is also helpful.
Description of the adverse reaction
Describe when the adverse reaction occurred, how long it lasted and when it ended. It is important to detail the symptoms of the adverse reaction as thoroughly as possible.
Name of the medication or active ingredient
Provide the name of the drug suspected of causing the adverse reaction. Specify the dose of the medication you are taking (e.g., 20 mg) and the frequency of administration (e.g., twice daily). Indicate the method of drug administration (e.g., orally), the estimated start date and end date of taking the medication, and the reason for its use (e.g., hypertension). If you are taking more than one medication, list all of them.
Information about the person reporting
Provide your first and last name, phone number, home address or email address.
If you are a healthcare professional, specify your specialty and work address.
Additional information
Indicate if you have had reactions to the drug in the past. Also indicate whether you experience allergic reactions and other diagnosed illnesses or if you have been instructed to undergo additional diagnostic tests.
Why is reporting adverse drug reactions important?
Every piece of information provided by a patient enhances our understanding of a drug. The knowledge that is continuously updated, acquired and accumulated through reports of adverse drug reactions is returned to healthcare providers and patients in the form of new information about medications, including guidelines for their use that ensure the greatest possible safety.
YOUR REPORT MATTERS
REPORT AN ADVERSE REACTION
If you want to report an adverse reaction to a Polfarmex medication, you can use the following options:
- Fill out the online form
- Contact us at +48 (24) 357 42 30
- Send the completed adverse reaction report form via email to: ndl@polfarmex.pl
Downloadable files:
Adverse Reaction Reporting Form (docx, pdf)