This blog talks about:
- The definitions of ADR and AE.
- The key differences between these two terms.
- The different types of reactions within these terms.
Table of Contents:
- An Overview of ADR and AE
- Difference between ADR and AE
- Examples
- Key Takeaways
- Assessing AE and ADR
- Conclusion
- References
- FAQ
ADR and AE
These are two words often used daily within pharmacovigilance unit.
But many of us think these two terms are same and don’t aware of the difference between these two terms. There are some debates and discrepancies in defining the two terms.
Similar but distinct
More in similar but distinct. We will learn here those distinctions.
In simple understanding, ADR and AE both have drugs involved in general.
“In this era, our lives intertwine with drugs, knowingly or unknowingly, in diverse forms. Amidst this connection, we must tread carefully, mindful of the potential for both healing and adverse events, striving to ensure a safer and healthier existence for all.”
Difference between ADR and AE
Adverse event: (AE/ADE)
Adverse events encompass:
- Any undesirable
- Any untoward
- Harmful occurrences that happen after drug administration.
Including both expected and unexpected events. This broader term encompasses a wide range of events, which may or may not caused by the drug itself.
Adverse events further classified into:
- Serious adverse event
- SUSAR (Suspected Unexpected Serious adverse reactions)
- Non-serious adverse event
Examples
Some potential adverse events of which you may be unaware:
- Physical occurrences, such as wounds, rashes, mosquito bites or falls.
- Psychological manifestations, like changes in cognition or memory issues.
- Laboratory findings, such as elevated creatinine levels.
- Deterioration/worsening of any pre-existing conditions.
- Treatment failure
- Medication errors
- Pregnancy as an adverse event to assess any potential risks to the baby.
- Occurrences of any abnormal episodes.
- Defects and mistakes, whether intentional or not. It includes manufacturing defects, Dispensing error, Prescription error.
✍️ Note: The events related to patient characteristics, such as alcoholism or smoking, are not classified as traditional adverse events. Instead, they fall under social circumstances.
Adverse reaction: (ADR)
World Health Organization (WHO) deined ADR as:
- Response to the drug
- Noxious
- Unintended
It occurs at doses usually used in man for prophylaxis, diagnosis or therapy of disease or for the modification of a physiological function.
ADRs are among the leading causesof death in many countries.
ADR is most likely linked because of drug administration. We otherwise call as side effects and also suspected in all available cases.
So, adverse drug reactions in specific refer to classified and determined to be caused by the drug.
In many situations, ADRs are the subset of adverse events, where a causal relationship with the administered drug has been established.
These terms are classifies in to two types:
- Type A reactions – sometimes referred to as augmented reactions – which are ‘dose-dependent’ and predictable on the basis of the pharmacology of the drug
- Type B reactions – bizarre reactions – which are idiosyncratic and not predictable on the basis of the pharmacology.
Key takeaways:
Adverse drug reaction(s) is a general term, whereas Adverse event is a unique term. Employed by healthcare professionals, particularly in research and extensively within pharmacovigilance.
Adverse drug reactions are typically pre-recorded and documented, unlike adverse events.
In the context of pharmacovigilance, All ADR’s considered as an AE but all the AE are not actually ADR.
Adverse events encompass all the events with a broader classification that includes ADRs, whereas adverse drug reactions specifically refer to reactions caused by drugs.
AE and ADR result from both appropriate and inappropriate usage of drug (medicines).
Assessing (AE/ADE) and ADR
So here comes the causality assessment an important role,
Thus, causality assessment plays a significant role in pharmacovigilance (PV). It involves evaluating the available evidence to determine the likelihood and strength of the causal relationship between the drug and the reported adverse event.
Can an AE Evolve into an ADR?
Yes, possibly when reconciling reports based on findings. If new events occur in the majority of the population and are properly reported.
It has a unique protocol to follow. Based on solid evidence, these events can then be added to the list of adverse reactions associated with the specific drug(s).
However, it isn’t so straightforward to be listed quickly.
Causality assessment plays a critical role in assessments of all the cases.
By conducting causality assessments, PV professionals can identify and classify ADR and AE. It helps to manage and maintain the safety profile of medications effectively.
Conclusion
We hope our explanations have clarified your understanding and dispelled any long-term confusion. If you have additional points to suggest or further recommendations.
Feel free to share them below. Your input is valuable to us.
Acronyms
- ADR- Adverse Drug Reactions
- AE- Adverse Event
References:
- Bibliography:
Coleman, J.J., Pontefract, S.K., 2016. Adverse drug reactions. Clin Med (Lond) 16, 481–485. https://doi.org/10.7861/clinmedicine.16-5-481 - ncbi
- Pharmacy times
- Eupati
PDF references:
FAQ
What are AE and ADR?
Adverse events encompass any undesirable or harmful occurrences that happen after drug administration, including both expected and unexpected events. This broader term encompasses a wide range of events, which may or may not caused by the drug itself.
2. ADR – Adverse Drug Reaction
It may not the case of ADR it must linked because of drug administration. We can simply call as side effects and also suspected in all available cases.
What is difference between AE and ADR?
What are the types of reactions?
2. Type B reactions – bizarre reactions – which are idiosyncratic and not predictable on the basis of the pharmacology.
What are the types of Adverse Events?
1. Serious Adverse Event
2. Non-Serious Adverse Event
What do side effects entail?
Side effects refer to unexpected or unintended reactions that occur as a result of taking a medication or undergoing a medical treatment. Here ADR and AE and side effects are more over synonymous.
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