MedDRA is a rich and highly specific standardized medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. Here is some practice Q & A for your reference
2. Description: Physician administered paliperidone palmitate
injection in the gluteus instead of the deltoid during the
initiation phase of the drug. The drug is supposed to be
given in the deltoid for the first two (2) injections (Day One
and Day Eight) then can be given either in gluteus or deltoid
thereafter.
Reported Terms: Drug administered at inappropriate site and Off label
use
2
3. Description: A medication patch was applied by the
patient to her leg even though the the
package insert instructed that the patch be applied to
the upper arm.
Reported Term: Drug administered at inappropriate site
3
4. Description: Five days ago, I started taking
LEVAQUIN for pneumonia. I am
breastfeeding my infant. He seems OK. Are
there any side effects?
4
# of ICSRs: One (1) (baby).
Reported Term for baby ICSR: Drug exposure via breast
milk. .
5. Description: I was using MICRONOR for two
(2) months. The amount of breast milk I
have been producing has gone down and
my baby lost two pounds.
5
# of ICSRs: Two (2) (mother and baby).
Reported Term for maternal ICSR: Decreased quantity of
breast milk.
Reported Term for baby ICSR: Weight loss and Drug
exposure via breast milk. .
6. Description: The patient always put on
three (3) patches of DURAGESIC instead of
the one (1) prescribed because it helped to
improve his mood. His doctor now refuses
to prescribe DURAGESIC, because he thinks
the patient is abusing it.
6
Reported Term: Drug abuse