Introduction:
The World Health Organization (WHO) defines pharmacovigilance as the science and set of activities related to the detection, assessment, understanding and prevention of adverse or side effects and any other problem related to medicines.
Pharmacovigilance is the study of the safety of a drug after marketing it under realistic conditions for clinical use and in large populations.
Drugs are monitored in pharmacovigilance activities through several methods, including reviewing and evaluating reports of suspected adverse reactions, published literature, epidemiological studies, and results of additional clinical trials.
Oubari Pharmaceutical Industries started its activities of pharmacovigilance by receiving and evaluating the safety data and taking regulatory procedures as necessary.
Pharmacovigilance objectives:
Pharmacovigilance is vital for increasing medical understanding and future research in drug product development. Any improvements in safety or understanding will ultimately improve and enhance the reality of health care, so pharmacovigilance aims to:
- Early detection of new side effects of medications.
- Early detection of high frequency of side effects of medications.
- Detecting risk factors associated with side effects of medications.
- And take the necessary management steps to reduce the above.
Side effect or Adverse effect
What is the side effect?
It is an adverse reaction that is a harmful and unintended response to a medicinal product. So, it is harm result from the use of the drug, whether after overdose, misuse, or accidentally.
Is it possible that side effects may occur that are not mentioned in the medicine’s internal leaflet?
Of course, it is possible, and the reason is that all medicines undergo clinical studies before being marketed to ensure their effectiveness and safety.
However, the number of patients and the duration of the study may often not be sufficient to detect some symptoms, especially rare ones.
This is an important justification for monitoring post-marketing side effects of medications and patients’ use of them.
Reporting side effects:
This service allows individuals, whether consumers of pharmaceutical products or healthcare providers, to report side effects.
A specialized team from the company's Pharmacovigilance Department evaluates and follows up on the cases, and then takes the necessary regulatory measures to ensure the safety of these products.
Reporting side effects is very vital and important to achieve the safe use of the drug, and therefore contact information is necessary in order to follow up on the case and complete the reporting information provided if necessary.
Use the company's website by clicking on the link and filling out the form:
- Clicking opens the form https://docs.google.com/forms/d/e/1FAIpQLScwYjqvpzOz8VctOeWpPdJcwMU-MaLYdo6985r6A09eYONJXA/viewform
- Communicate by e-mail: enter the e-mail address
- By calling the number: 0930200870
- Communicate by WhatsApp on the number: 0930200870
Data confidentiality:
The information contained in the report is treated confidentially and is fully protected by the company; Including the identity of the patient and the report preparer, and it will not be disclosed to any party or under any circumstances.
After clicking on the form link, the following message will appear, followed by the form
Introductory letter:
- Patients or health care providers can voluntarily submit reports of side effects and quality of preparations.
- Filling this form takes some time, but reporting side effects and the quality of the preparations is vital and important for the safe use of the medicine.