FAQs on Pharmacovigilance
Pharmacovigilance: Background information (FAQs)
What is pharmacovigilance?
The word pharmacovigilance is derived from the Greek ‘Pharmaco’ (medicine) and the Latin ‘Vigilantia’ (vigilance, watchfulness). It is the process of monitoring, evaluating and improving the safety of medicines in use. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Healthcare professionals (e.g. Doctors and Pharmacists) have a role too, in reporting suspected side effects of medicines to government agencies or pharmaceutical companies
What is a side effect?
This is an unwanted response to a medicine. It may manifest as symptoms (e.g. headache, nausea) or as an illness (liver or kidney problems). Doctors and pharmacists call these ‘adverse drug reactions’ or ‘adverse reactions’.
How common are side effects?
Adverse reactions can occur with any medicine. Adverse Reactions related to the administration of the medicine are clearly listed in the information to prescribers (the Summary of Product Characteristics (SPC)) and in the package leaflet available to the patient.If side effects become troublesome, however, you must promptly inform the doctor or pharmacist who looks after your medical care.
What is a serious adverse reaction?
One that results in death or is life threatening, when a reaction leads to hospital admission or when it is disabling (e.g. blindness, deafness). Adverse reactions linked to a birth defect are also considered serious irrespective of the severity of the birth problem.
Can patients report directly?
There is nothing to stop a patient reporting via their doctor or pharmacist. These health care professionals can help put the information into the right medical context for further evaluation by the authorities, particularly if they suspect a serious or severe reaction.
What regulatory action can be taken?
Warnings are issued.In extreme cases drugs have been removed from the market.
What is pharmacovigilance?
The word pharmacovigilance is derived from the Greek ‘Pharmaco’ (medicine) and the Latin ‘Vigilantia’ (vigilance, watchfulness). It is the process of monitoring, evaluating and improving the safety of medicines in use. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Healthcare professionals (e.g. Doctors and Pharmacists) have a role too, in reporting suspected side effects of medicines to government agencies or pharmaceutical companies
What is a side effect?
This is an unwanted response to a medicine. It may manifest as symptoms (e.g. headache, nausea) or as an illness (liver or kidney problems). Doctors and pharmacists call these ‘adverse drug reactions’ or ‘adverse reactions’.
How common are side effects?
Adverse reactions can occur with any medicine. Adverse Reactions related to the administration of the medicine are clearly listed in the information to prescribers (the Summary of Product Characteristics (SPC)) and in the package leaflet available to the patient.If side effects become troublesome, however, you must promptly inform the doctor or pharmacist who looks after your medical care.
What is a serious adverse reaction?
One that results in death or is life threatening, when a reaction leads to hospital admission or when it is disabling (e.g. blindness, deafness). Adverse reactions linked to a birth defect are also considered serious irrespective of the severity of the birth problem.
Can patients report directly?
There is nothing to stop a patient reporting via their doctor or pharmacist. These health care professionals can help put the information into the right medical context for further evaluation by the authorities, particularly if they suspect a serious or severe reaction.
What regulatory action can be taken?
Warnings are issued.In extreme cases drugs have been removed from the market.
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