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Adverse reactions

An adverse reaction is any unfavorable and unexpected reaction of the body which occurred during or following treatment with a Polpharma product. The company also collects information about the product, such as: drug use in pregnancy, drug inefficacy, dosing error, drug use without medical indication, or drug off-label use.

REPORT AN ADVERSE REACTION OF A POLPHARMA PRODUCT

How to report an adverse reaction

  • By electronic means using the online form at www.polpharma.pl 
  • By phone at: +48 22 364 61 00
  • By email to the address: phv@polpharma.com
  • By letter to the address:

POLPHARMA Biuro Handlowe,

ul. Bobrowiecka 6, 00-728 Warszawa,

Dział Nadzoru Nad Bezpieczeństwem Farmakoterapii (Pharmacovigilance & Medical Information Department)

  • By fax:+48 22 364 61 66

What the report should contain

  

Details of the person experiencing the adverse reaction

Specify patient’s identifiers, e.g. initials, gender or age. Also, information on height and body mass are helpful – in particular for children and adults with atypical height or body mass.

   

Product details

Specify the name of the drug, cosmetic or medical device suspected of causing the adverse reaction. A situation may arise where the patient is taking more than one product. In such a situation, specify the names of all used products. Information on the product dose is important, e.g. 200 mg tablet or 5 mg/ml syrup, and the manner of drug use – how many times a day and in what doses. Some products are used chronically. It is worth mentioning this. It is important because if the patient has been taking the relevant product for years without experiencing any adverse reactions, and if such adverse reactions occur with the start of use of another product, it may be suspected that the adverse reaction is caused by the new product or that the reaction has been caused e.g. by interaction between the products.

 

Description of the adverse reaction

Describe the reaction in as much detail as possible, including its severity, duration – and, if it subsided, describe whether the reaction subsided on its own or as a result of the administered treatment. It is important to provide the reason for drug use, e.g. toothache, stomach ailments, hypertension, etc. If the reaction did not subside, specify whether it is receding or intensifying, whether any treatment is being administered, whether the product has caused any lasting effects in the patient.

  

Reporting person’s details

Specify the details, including forename, surname, full address or telephone number or email.

 

Additional information

If such details are available, specify whether the product which caused the adverse reaction had already been used in the past and whether also then it caused a similar reaction. Information on patient’s allergies is important as well. If the report concerns an adverse reaction in a newborn, specify the names of the products taken by the child’s mother during pregnancy. Not always all the details are available at the time of submitting the case report. In such a case, any additional information should be provided once it becomes available. It is recommended to specify whether this information is supplementary to any case report that has already been submitted.

  

source: website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Where to report an adverse reaction

 

Patients or their caregivers may report adverse reactions to:

  • a physician, pharmacist, nurse or other healthcare professionals
  • the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)
  • a pharmaceutical company responsible for the drug

  

Healthcare professionals (a physician, pharmacist, nurse) are required to report adverse reactions to:

  • the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (www.urpl.gov.pl)
  • a pharmaceutical company responsible for the drug.

Educational materials and safety communications

Educational materials supplement the information included in product information (Summary of Product Characteristics, patient leaflet) and improve the conditions of use of medicinal products by having a favorable influence on the activities of healthcare professionals (physicians, pharmacists, nurses), patients or their caregivers. They focus on achievable goals and provide clear and concise information describing the activities to be taken in order to prevent and minimize any substantial risks and to optimize the risk to benefit ratio.

Educational materials for the patient

They increase awareness of the early symptoms of specific adverse reactions and how best to proceed in case of their occurrence. They may also provide information on proper administration of the product or remind of an important activity.