What are Special Situation Scenarios in Pharmacovigilance?

Hi All,

You must have come across the term “Special Situation Scenarios in Pharmacovigilance“.

Let’s see what is special situation reporting and their types in brief.


The special situations are non-standard medical conditions that provide valuable information about medicinal product, even when they don’t occur in association with an adverse event or medical condition. Therefore, it should be reported for: 

  1. Complying with regulatory guidelines
  2. Meeting protocol specific requirements
  3. Benefit-risk assessments of medicines
Type of Special Situation Scenarios

  1. Overdose
  2. Off-label use
  3. Drug abuse 
  4. Drug misuse
  5. Medication errors
  6. Lack of Efficacy (LOE)
  7. Pregnancy
  8. Occupational exposure
  9. Product counterfeit
  10. Disease progression
  11. Drug interactions
  12. Drug Addiction
  13. Suspected transmission of infectious agents via a medicinal product (STIAMP)
1. Overdose
Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorised product information.
2. Off-label use
Situations where a medicinal product is intentionally used for a medical purpose not
in accordance with the terms of the marketing authorisation.
Examples include the intentional use of a product in situations other than the ones described in the authorised product information, such as:
  1. Medicine used for disease or medical condition that it is not approved to treat
  2. Medicine administration through different route or method of administration
  3. Medicine used with different dose (posology)
  4. Medicine used in different group of patients (population)
3. Drug Abuse
Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.
4. Drug Misuse
Situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorised product information.
5. Medication errors
A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. A failure in the drug treatment process does not refer to lack of efficacy of the drug, rather to human or process mediated failures.
Medication errors may occur at all stages of the drug treatment process (e.g. prescribing, storage, dispensing, preparation, administration).
6. Lack of Efficacy (LOE)
The lack of expected or desired effect related to a therapy.
Lack of efficacy/effect is an evidence of less than the expected effect of a product
7. Pregnancy and Lactation
Suspected adverse reactions which occur following exposure to a medicinal product during pregnancy and from breast milk should be reported to the regulatory agencies.

8. Occupational exposure
For the purpose of reporting cases of suspected adverse reactions, an exposure to a medicinal product as a result of one’s professional or non-professional occupation.
It does not include the exposure to one of the ingredients during the manufacturing process before the release as finished product.
9. Product counterfeit
Counterfeits of original medicinal products which look like the original may:
  • Contain substances of lower quality or the wrong dose
  • Be deliberately and fraudulently mislabeled with the intention to avoid identifying the source
  • Have counterfeit packaging, wrong ingredients or a lower proportion of the active substance
10. Disease progression
  1. All atypical or accelerated progression* of disease which indicates rather poor efficacy of the company product. e.g. faster progression than expected, or may include other unexpected elements of progression that may be attributed to treatment by the suspected product and / or
  2. The doctor suggests that the progression is causally related to treatment with a company product (rather points to the lack of effectiveness) or the causation was not commented on (then it has to be obtained within the supplementary information).
11. Drug Interaction
Drug interaction is a reaction between two (or more) drugs or between a drug and a food, beverage, or supplement. Taking a drug while having certain medical conditions can also cause a drug interaction.
For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.
12. Drug Addiction
It is a disease that negatively affects a person’s brain and behavior.
  • A person can become obsessed with any legal or illegal drugs. Some people can get addicted to certain medications.
  • This addiction gradually starts developing when the individual continues to consume the drug despite the impairment it causes.
  • Nicotine, marijuana and alcohol are commonly misused drugs in today’s world.
13. Suspected transmission of infectious agents via a medicinal product (STIAMP)
Any organism, virus or infectious particle (e.g. prion proteins of spongiform encephalopathy), pathogenic and nonpathogenic, is considered to be an infectious agent. Transmission of infectious
agents can be derived from clinical symptoms and laboratory findings.
Hope this article finds you helpful. If you have any query, please comment or write to us at pvdrugsafetyinfo@gmail.com

PV & Drug Safety

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