Mock exam questions - WIP Flashcards
When assessing causality from study data, why does is require greater judgement to assess causality from non-randomised studies than randomised studies?
What is “confounding” and how, with bias and chance, is it taken into account when determining causation from study data?
What are the clinical challenges associated with assessing causality?
What methodologies can be used to determine causality and what are their relative advantages and disadvantages?
Briefly discuss the types and limitations of the pre-marketing studies and trials used in drug development and registration
Pre-clinical studies, human volunteer studies and clinical trials are used in the drug development phase to collect safety data about new medications. Briefly describe
these different types of studies, their aims, the type of data and the limitations of data they can produce
Describe the history of Pharmacovigilance
Pharmacovigilance (PV) is defined by the European Commission (EU) as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines”.
In 1938 the US federal food, drug and cosmetic act was established and the public health system was renovated
in 1961a letter was sent to the Lancet journal about the thalidomide tragedy, bringing to light many issues including the reliability of animal testing, and lack of pharmacovigilance
In 1964 the yellow card scheme was structured in the UK
In 1968 the WHO programme for international drug monitoring was instituted
In 1995 the EMA was set up
Describe the thalidomide tragedy
Thalidomide was developed in Germany in the 1950s as a sedative and was tested in several (non-pregnant) animal species and then in humans. The animal results seemed to show that even very high doses were not harmful. In human patients it seemed that the new medicine had remarkably few side effects and was well-tolerated by people taking it. The studies were not rigorous: there was no placebo group and no indication of how long treatment had gone on for. None of the studies were double-blind.
After being on the market for five years as a treatment for morning sickness in pregnant women, it had finally been established that the medicine was responsible for babies being born with underdeveloped arms and legs and other malformations.
only the (S)-enantiomer of thalidomide is teratogenic. However, works have shown that the enantiomers of thalidomide interconvert in vivo
