Pharmacovigilance
About Pharmacovigilance
Pharmacovigilance
About Pharmacovigilance
ABOUT PHARMACOVIGILANCE
ABOUT PHARMACOVIGILANCE
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected.
Before a medicine is authorized for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine’s authorization, it has been tested in a relatively small number of selected patients for a limited length of time.
After authorization the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain of adverse drug reactions may emerge in such circumstances.
It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.
What does pharmacovigilance do?
The role of pharmacovigilance is to assess the benefits and risks of a drug and to ensure that the benefits are always outweighed, and it does not stop after the drug is approved.
Aims of Pharmacovigilance:
1. To improve public health and safety in relation to the use of medicines
2. To detect problems related to the use of medicines and communicate the findings in a timely manner
3. To contribute to the assessment of medicines, encouraging their safe, rational and more effective use
4. To ensure effective safety communication to healthcare professionals and the public.
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About us :
Pharmacovigilance Department in MUP was established with the entry of pharmacovigilance in Egypt to monitor the safety and efficacy of all our products throughout their life cycle and to increase awareness regarding proper medicine use to all our company staff, healthcare professional and to the public.
Our mission :
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- Monitoring the risk-benefit balance of all our products.
- Providing continuous awareness to health care professional about the safe use of our products.
- Implementing safety measures to reduce risks and prevent adverse
Responsibilities of PV Department:
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- Implementing an efficient Pharmacovigilance System in accordance with international guidelines and Regulatory Authorities.
- Implementing a pro-active Risk Management Plan for our products.
- Creating and submitting Periodic Benefit Risk Evaluation Report for our products according to the European Union reference dates.
- Collecting, validating, assessing and Submitting Individualized Case Safety Reports for our products.
- Performing routine trainings and awareness sessions for our medical and sales staff.
- Performing audits on our business partners.
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Reporting to Pharmacovigilance Department :
Spontaneous adverse reaction reporting is the backbone of pharmacovigilance and is required to create hypotheses about potential harms of medicines that need further evaluation.
The main Purpose of Pharmacovigilance is to ensure the safety and efficacy of our medicinal products, this can only be achieved by your contribution, as a patient, a healthcare professional, a friend, or a family member. it is your duty and responsibility to report any adverse effect associated with medicine use.
Please note that your information is private and only shared with the expert pharmacovigilance team in order to validate and asses the case properly ensuring maximum benefit to you.
Please remember if you are exposed to an adverse event and not sure if it is expected or not, serious or not it is always better to report.
Why should you report adverse effects?
To protect patients from unnecessary harm because many ADRs are preventable.
To know of something that is harmful to another person, who does not know, and not telling, is unethical .
What to write in the report?
• The name of the medicinal product you suspect and any other medicines you took at the same time.
• Describe The exact adverse event that happened
• The patient’s information ( gender, weight, age)
• Patients or reporter contact information.
When should you report?
Please report to our pharmacovigilance department the following cases:
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- Adverse effect that could be associated with taking a medicinal product.
- Lack of efficacy of a medicinal product.
- Drug interactions, Overdose .
- Medication errors, Misuse of a drug .
- Any other drug related problems .
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Or Email PV department: pv@mupeg.com. Or Call PV Head office: +022712451.