What is the difference between an adverse event AE and adverse drug reaction ADR?

ADR which is called the adverse drug reactions is any retaliation to a drug that is harmful, toxic, and unplanned that occurs at doses and used in human’s diagnosis or therapy for a disease excluding failure to achieve the intended purpose. ADR is a conceptual and practically orthodox drug.

ADE which is called the adverse drug event is an unfavourable drug event that tells the injuries resulting from the use of the drug. It includes the harm caused by drug and harmful reactions from the use of the drug. A causal association is not found between the drug and the event.

ADR vs ADE

The main difference between ADR and ADE is that ADE includes all medical errors (name confusion of drugs, mis-administration, miscalculations, etc) but ADR doesn’t include any medical errors.

Parameter of ComparisonADRADE
ConceptAny toxic and harmful change which is suspected to be due to a drug normally used in man and occurs at doses.Any medical occurrence which is not expected, but present during treatment with a pharmaceutical product.
Causal RelationshipA causal connection between the drug and the event is suspected.No need to have a Causal relationship.
What it depictsDepicts allergies and side effects.Depicts harm caused by a drug and harm from its uses.
Medical ErrorsMedical errors are not included in the definition.Medical errors are included in the definition.
Common ExampleAn allergic reaction from medication.Aspiration pneumonia after over-sedation secondary to morphine overdose.

ADR is a reaction that is stated for a particular drug in the instruction description given by drug manufacturer. ADR is more dangerous from side effects and the risk of hospitalization is also higher in patients due to ADR.

Here, we have a causal between the medicinal product and the adverse event. If compared to side effects, Adverse Drug Reaction has less constancy than it. It is the contusion developing because of the use of the drug.

What are the most common ADRs?

  1. Nausea
  2. Vomiting
  3. Fatigue
  4. Constipation
  5. Diarrhoea
  6. Skin reactions
  7. Drowsiness
  8. Anorexia

What are the 2 major types of ADR?

  1. Augmented/Predicted ADR– Based on the pharmacological properties of a drug. It is a more common type of ADR. This type of ADR is mostly preventable and reversible. 
  2. Bizarre/Unpredictable ADR- Based on the peculiarities of a patient. It is a less common type of ADR. This type of ADR is more serious and requires drug withdrawal. It includes hypersensitivity/allergy, Idiosyncrasy.

It is an injury resulting from medical involvement related to a drug. The appearance of an ADE does not usually depict any delusion or care and protection of an inferior level.

ADE which is a curable result from an error of an inappropriate medication that outstretches the patient and causes them very much harm.

It is roughly calculated that approximately 50% of ADEs are preventable. Here, we do not have a causal association between a drug and an adverse event. ADE is one of the most familiar intense events which are preventable in all position of supervision and protection.

What are the Prevention Methods for ADE?

  1. Avoid redundant use of medicines by sticking to the orthodox authorized concept.
  2. Medication settlement when there is a need for adjustment in care and supervision.
  3. Reduce intrusion to enable and give permission to the nurses to administer medications safely.

What are the 2 major types of ADEs?

  1. Potential ADE- These are the curable and protected adverse drug events that result from a delusion in the wrong medication that goes to the patient and causes them a lot of harm. Half of the total ADE cases are preventable.
  2. Ameliorable ADE- These are the nonpreventable adverse drug events. It is the kind of ADE in which a patient undergoes harm from a medication that will not be completely preventable. These are popularly known as side effects.

  1. When the relation between regulated drug and occurrence of reaction is identified, then it is called adverse drug reaction whereas when the relation between regulated drug and occurrence of an event is not identified, then it is called adverse drug event. 
  2. Medical errors containing miscalculations, name confusion of drugs, mis-administration, etc are included in ADE whereas these all are not included in ADR.
  3. The persistence of ADR is less as compared to ADE.
  4. In ADR, the harm is directly caused to a person whereas, in the case of ADE, harm does not need to be directly caused to the person.
  5. ADR represents allergies and some minor side effects whereas ADE represents harm caused by a drug and hazardous effects from its uses.
  6. ADR has more exposure to risk if compared with ADE as ADR has many dangerous results.
  7. ADR is always related to the administered medicinal product and ADE is not always (may or may not) related to the administered medicinal product.

In simple words, ADR is an injury caused due to intake of medication. ADRs may occur due to the merging of two or more drugs together. An ADE means an injury that occurs at the time when a drug is used. ADR is the only kind in which there is harm related to the medication.

The U.S. Food and Drug Administration established intense ADE as one when the patient outcome is one of the following including Death, Hospitalization, life-threatening, Congenital abnormality, etc.

ADE may be local which means that it is limited to a definite location, or systemic, where medication has caused insane effects throughout the organized communication. There is a total of 150 Adverse Drug Reactions Monitoring Centres (AMCs) overall throughout India.

References

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To many people, adverse events and side effects mean the same thing and are used interchangeably, which is incorrect.

Adverse events are unintended pharmacologic effects that occur when a medication is administered correctly while a side effect is a secondary unwanted effect that occurs due to drug therapy.

It is a common misconception that adverse events and side effects are the same thing. In fact I have seen these 2 words used interchangeably although they have different meanings, which many healthcare professionals may not be aware of. Below I will discuss each in order to help healthcare professionals as well as patients differentiate between an adverse event and a side effect.

Adverse Events

An adverse event is an undesired occurrence that results from taking a medication correctly. The event can either be a type A reaction or a type B reaction. Type A reactions are predictable adverse events which are commonly dose dependent and can be mild, moderate, or severe. Type B reactions are completely unpredictable and have nothing to do with doses. They occur less often and are influenced by patient-specific susceptibility factors such as drug allergies and intolerances. A patient may experience an adverse event due to the healthcare provider’s lack of knowledge of the drug and the medications complete mechanism. The event is not expected by either the doctor or the patient and the effects can be reduced by lowering the dose or just stopping the medication all together.

Side Effects

A side effect is an undesired effect that occurs when the medication is administered regardless of the dose. Unlike adverse events, side effects are mostly foreseen by the physician and the patient is told to be aware of the effects that could happen while on the therapy. Side effects differ from adverse events and later resolve on their own with time after taking the medication for several weeks. Some medications are even utilized due to their side effects, one example being mirtazapine used in anorexic patients due to the medications potential to cause weight gain. Side effects are tracked and investigated extensively during clinical trials before entering the market.

Conclusion

Adverse events are different from side effects and are never desired. Adverse events require interventions whereas most side effects spontaneously resolve with time. The 2 words are incorrectly used interchangeably yet mean 2 separate things. Although this may seem like common sense to some, the incorrect use of these 2 words appears to be a common mistake within the healthcare field.

Knowing the correct information is essential, not only to store in your general knowledge but it is also helpful to explain the difference to your patients when counseling them. This allows them to recognize that a little stomach upset with a medication is a just a side effect and will go away with time, it is normal and the patient shouldn’t be too concerned with the matter vs. if the patient takes a medication and their throat starts to close. Most likely the patient would then be experiencing an adverse event such as anaphylaxis and should be prompted to seek medical attention immediately. That is just one example of why it is important for not only the healthcare provider, but for the patient to be able to recognize the differences between the two terms, as the expressions are commonly used wrongly.

Reference

Food and Drug Administration Med-Watch program //www.fda.gov/Safety/Medwatch. Accessed February 20.

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