PV 1 Flashcards
What is the origin of the term ‘Pharmacon’?
Greek for medical substance/drug
What does ‘Vigila’ mean in Latin?
To keep watch
Define Pharmacovigilance.
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
What is an Adverse Event/Adverse Experience?
Any untoward medical occurrence during treatment with a pharmaceutical product that does not necessarily have a causal relationship with the treatment.
Define Adverse Reaction.
A noxious and unintended response to a drug occurring at doses normally used in humans.
What is an Active surveillance system?
The collection of case safety information as a continuous pre-organized process.
What are Biologicals?
Medical products prepared from biologic material of human, animal or microbiologic origin.
What does ‘Benefit’ refer to in pharmacovigilance?
An estimated gain for an individual or a population.
Explain the term ‘Benefit/harm’.
Positive and negative subjective qualitative experiences of individual patients.
What was Thalidomide originally marketed as?
A nonaddictive, nonbarbiturate sedative.
What serious issue arose from Thalidomide use?
Deformed infants (phocomelia) with more than 20,000 cases reported.
List some medical conditions today that Thalidomide is used to treat.
- Leprosy
- Multiple myeloma
- Cancers
- Crohn’s disease
- HIV
What did the Thalidomide disaster lead to in the USA?
Amendment of the Federal Food, Drug & Cosmetic Act to require both safety and efficacy data.
What is the role of the Uppsala Monitoring Centre?
To manage the international database of ADR reports received from National Centres.
What are the factors that determine the effectiveness of the reporting system?
- Size of the database
- Quality of the reports
- Timeliness of reporting
- Active reporting culture
True or False: Safety of a new drug is absolute.
False
Before new medicine approval, what must be shown about the drug?
- Good quality
- Effective
- Safe for its proposed purposes
What are some recently included concerns in pharmacovigilance?
- Herbals
- Traditional and complementary medicines
- Blood products
- Biologicals
- Medical devices
- Vaccines
What are the specific aims of pharmacovigilance?
- Improve patient care and safety
- Improve public health and safety
- Assess benefit, harm, effectiveness, and risk
- Promote understanding and education
Fill in the blank: Pharmacovigilance aims to promote _______ in medication use.
[safe, rational and effective use]
What is one potential risk that may not be detected during pre-registration development of a drug?
Rare yet serious adverse events
What does the term ‘substandard medicines’ refer to?
Medicines that do not meet quality standards.
List some issues relevant to pharmacovigilance.
- Medication errors
- Lack of efficacy reports
- Use of medicines for unapproved indications
- Acute and chronic poisoning cases
- Drug-related mortality
- Abuse and misuse of medicines
- Adverse interactions
