How pharmacovigilance can be defined?
According to the World Health Organization, pharmacovigilance is defined as:
“The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.”
In simple terms, pharmacovigilance focuses on monitoring the safety of medicines and ensuring that any risks associated with their use are identified, evaluated, and minimized to protect patients.
How Adverse event can be defined?
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E2A guideline), an adverse event (AE) is defined as:
“Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.”
In simpler terms, an adverse event is any unfavorable or unintended sign, symptom, or disease that occurs after using a medicine, whether or not it is related to the drug.
How Adverse drug reaction can be defined?
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E2A guideline), an adverse drug reaction (ADR) is defined as:
“In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.”
“For marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease, or for modification of physiological function.”
In simpler terms, an ADR is a harmful and unintended response to a medicine where a causal relationship is at least a reasonable possibility.
Do drugs cause adverse drug reactions (ADRs)?
On the hypothetical side, all medications may cause some ADRs, but many people use drugs without causing them any ADRs The benefit of taking a drug has generally outweigh the risk that may occur.
Why adverse event (AE) and adverse drug reaction (ADR) needs to be reported and pharmacovigilance is needed?
Reporting adverse events (AEs) and adverse drug reactions (ADRs) is a core part of pharmacovigilance, and it serves several critical purposes:
1. Patient safety
The primary goal is to protect patients. Reporting helps identify new or rare side effects, serious risks, or changes in the frequency/severity of known reactions so action can be taken early.
2. Detection of new safety signals Individual reports, when combined, can reveal patterns (signals) that were not seen during clinical trials—especially rare or long-term effects.
3. Continuous benefit–risk evaluation Health authorities and pharma companies use AE/ADR data to reassess whether a medicine’s benefits still outweigh its risks throughout its lifecycle.
4. Regulatory decision-making Data from reports can lead to important actions such as: • Updating prescribing information (SmPC/PIL) • Adding warnings or precautions • Restricting use • Product recalls or withdrawal in extreme cases
5. Improving safe use of medicines Reporting helps identify: • Medication errors • Off-label use issues • Drug interactions • Special population risks (e.g., elderly, children, pregnancy)
6. Legal and compliance requirements Regulatory authorities and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use require timely reporting of AEs/ADRs to ensure global drug safety standards are maintained.
7. Public health protection At a broader level, AE/ADR reporting contributes to safer healthcare systems and informed decision-making for clinicians, patients, and regulators. In short, even a single report can contribute to identifying a serious risk—so consistent reporting is essential. The Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for implementing appropriate actions and measures to minimize the recurrence of adverse drug reactions (ADRs) in patients. Timely reporting of drug safety information to us helps fulfill our regulatory obligation to report ADRs to the competent authorities. This, in turn, contributes to improving the quality of healthcare services provided to the public and the community.
2. Detection of new safety signals Individual reports, when combined, can reveal patterns (signals) that were not seen during clinical trials—especially rare or long-term effects.
3. Continuous benefit–risk evaluation Health authorities and pharma companies use AE/ADR data to reassess whether a medicine’s benefits still outweigh its risks throughout its lifecycle.
4. Regulatory decision-making Data from reports can lead to important actions such as: • Updating prescribing information (SmPC/PIL) • Adding warnings or precautions • Restricting use • Product recalls or withdrawal in extreme cases
5. Improving safe use of medicines Reporting helps identify: • Medication errors • Off-label use issues • Drug interactions • Special population risks (e.g., elderly, children, pregnancy)
6. Legal and compliance requirements Regulatory authorities and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use require timely reporting of AEs/ADRs to ensure global drug safety standards are maintained.
7. Public health protection At a broader level, AE/ADR reporting contributes to safer healthcare systems and informed decision-making for clinicians, patients, and regulators. In short, even a single report can contribute to identifying a serious risk—so consistent reporting is essential. The Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for implementing appropriate actions and measures to minimize the recurrence of adverse drug reactions (ADRs) in patients. Timely reporting of drug safety information to us helps fulfill our regulatory obligation to report ADRs to the competent authorities. This, in turn, contributes to improving the quality of healthcare services provided to the public and the community.
Who is responsible to report adverse drug reaction or event to the MAH?
Healthcare professionals, patients, caregivers, or any person in close contact with the patient may report suspected adverse drug reactions (ADRs) and adverse events (AEs) to the Marketing Authorization Holder (MAH).
Who is responsible to report adverse drug reaction or event to the MAH?
Healthcare professionals, patients, caregivers, or any person in close contact with the patient may report suspected adverse drug reactions (ADRs) and adverse events (AEs) to the Marketing Authorization Holder (MAH).
We are reachable on the below communication details NPI and Elixir KSA.
- Elixir Pharmaceutical Company LLC
King Saud Road, Al-Washim District, 1st Floor Office No. 105, P.O.Box: 12735,
Riyadh, Kingdom of Saudi Arabia Tel Phone: 00966112780890 Ext. 101-103
Phone: (+966) 503107030/ (+966) 559935909
Email: m.almusaitir@elixirpharma.sa and SOM.KSA@npioman.com
We are reachable on the below communication details NPI and Elixir UAE.
- Dubai Science Park, Warehouse complex, Block B 11.
Dubai
United Arab Emirates
Phone: +971505169571
Email: kahlid@npioman.om
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