What is the meaning of "Pharmacovigilance"?
The World Health Organization (WHO) defines pharmacovigilance (PhV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
What is the meaning of "Adverse Drug Event" (ADE)?
Any untoward medical occurrence that may present during treatment with a medicine, but which doesn’t necessarily have a causal relationship with this treatment.
What is the meaning of "Adverse Drug Reaction" (ADR)?
Any unintended effect of the drug (Harmful Only) occurring at normal doses, which is related to the pharmacological properties of the drug.
Which Events should you report?
If there is a suspicion only (even without confirming whether the drug is the cause) that the patient has been subjected to a reaction to the drug, it must be reported immediately
It is also not required to report adverse reactions resulting from Prescription Only Medicine (POM), but also over-the-counter (OTC) drugs ................... Please report all suspected reactions, including minor reactions, and that in the following cases:
All suspected ADE associated with: -
Any of UTOPIA Pharmaceutical Products.
Drug-Drug or Drug-Food or Drug-Food supplements interactions.
Medication Error or Overdose or Abuse or Misuse or Off label use.
Product use during pregnancy, lactation or with children under 18 years of age.
Any problem related to the Quality of any UTOPIA Pharmaceutical Products. (For example: a problem in Packaging, Physical, suspected counterfeit product and Leaflet problem
Who can report an ADR or any drug related problems?
For example physicians, Pharmacists, dentists, Nurses, family practitioners and medical specialists.
Patients & their relatives
in this case seek the patient permission to contact their healthcare professionals for additional information and data verification.
What are the minimum criteria for a Valid Report?
A Suspect Drug (s).
An Adverse Event (s).
The information collected during the clinical phases (pre-marketing) is incomplete regarding adverse drug reactions (ADRs) and this is mainly due to:
The number of patients undergoing clinical trials is very limited and does not represent the rest of the patients in general. There are also special groups who do not undergo clinical trials (such as children, the elderly, or pregnant women) and therefore their information is almost unknown.
Information about rare or serious adverse reactions or drug-drug interactions is often incomplete during the clinical trial stages.
Consequently, the importance of pharmacovigilance with regard to permanent monitoring of the drug appears after a very important marketing to allow the discovery of everything new about the drug with regard to the pros or cons as well as preventing adverse effects or any other problem related to the drug.
That is why all medical service providers all over the world (from the Ministry of Health, Pharmaceutical companies, Physicians, Pharmacists, Nursing staff to the Patient) all over the world collaborate to report rapidly, as it can save the lives of their patients and others.
That is to improve overall health and safety regarding the use of Medications and reduce drug related problems that inevitably lead to better treatment outcomes.