Page 18 - Risk Management Bulletin February 2024

RMAI BULLETIN FEBRUARY 2024

in the number of kids born with severe birth abnor- Y Limited understanding of foetal development: At
malities, such as missing or deformed limbs, facial the time, there was little understanding of how
deformities, and other critical disorders, in the early medications could affect foetal development. The
1960s.It was soon established that thalidomide, which safety testing on thalidomide was done on ani-
had been taken by many pregnant women in the early mals, which did not correctly reflect the possible
stages of pregnancy, was the cause of severe birth risks to human foetuses.
abnormalities.
Y Poor communication between regulators and
healthcare providers: There was a dearth of com-
The thalidomide disaster was linked back to poor drug munication regarding the possible risks of thalido-
testing and regulation. The medicine was licensed in
mide among regulatory agencies and healthcare
various countries, including Germany, without proper professionals, allowing the medicine to be widely
safety testing. In other countries, such as the United prescribed without adequate knowledge of its ef-
Kingdom, the medicine was approved based on animal
fects.
safety data that did not adequately reflect the hazards
to human foetuses.
Lessons:
Y The need of rigorous safety testing of drugs be-
The thalidomide disaster had a significant impact on
fore they are allowed for usage was underlined by
the pharmaceutical business, as well as how pharma-
the thalidomide disaster. New regulations were
ceuticals are tested and regulated. Governments all
throughout the world tightened medication approval enacted to demand more extensive drug testing,
particularly in sensitive populations such as preg-
standards, requiring more stringent safety testing be-
nant women and fetuses.
fore new drugs could be marketed to the public. The
significance of testing medications on pregnant women Y Better communication: The incident also high-
and their foetuses before to approval was also lighted the significance of clear communication
recognised, and new laws were enacted to ensure that about the potential hazards and benefits of drugs
this occurred. among regulators, healthcare practitioners, and
patients. Clearer communication could aid in the
Thalidomide survivors and their families continue to prevention of future disasters and ensuring that
campaign for government and pharmaceutical sector patients are aware of the potential risks of any
support and help. Many of the affected children re- medications supplied to them.
quire specialised medical treatment as well as aid with Y Patient safety should be prioritized: The thalido-
daily activities, and a number of organisations have mide disaster served as a reminder of the signifi-
been formed to provide support and advocacy for tha- cance of putting patient safety first in drug devel-
lidomide survivors. In addition, novel treatments, such opment and regulation. Patient safety should be
as prosthetic limbs and other assistive equipment, the number one priority. Patient safety should be
were created to help control the symptoms of thali- the first priority in all aspects of healthcare, includ-
domide-related illnesses. ing drug development, testing, and approval.

Overall, the thalidomide disaster serves as a sharp Remedies:
reminder of the need of testing for safety and efficacy Y Following the thalidomide disaster, drug testing
in the development of new pharmaceuticals, as well and approval requirements were dramatically
as protecting vulnerable people from harm. strengthened to require more extensive safety
testing, particularly in sensitive groups such as
Causes: pregnant women and foetuses.
Y Thalidomide was approved in various countries Y Support for afflicted patients: Several organiza-
without proper safety testing, allowing the drug to tions have been founded to provide thalidomide
be marketed to pregnant women without knowl- survivors with support and advocacy, including
edge of the drug's potential hazards to foetuses. medical care and assistance with daily activities.

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