The first query is pertaining to use of Neofax and British formulary for
checking dosage of various drugs used in newborn. There was no separate
neonatal drug formulary available by Indian regulatory body like DCGI at
the time when this study was conducted. So, we had to use Neofax and
British neonatal drug formulary for bedside consultation of drug dose,
route, frequency and duration, and USFDA drug list of approval for
neonatal use for the particular indication. Data were cross checked
randomly by an independent specialist, who was not the part of this
study. Most of the units in India confirm the drug dose, route,
frequency and duration from latest Neofax edition or standard text
books.
Second query is regarding source/document relied upon
to classify the drug as off-label. Definition of off-label used in this
study was as per the definition used by Turner, et al. [1].
We deliberately did not include inotropes in the list
of off-label drugs. Inotropes are used for clinical shock without
functional echocardiography and without intra-arterial blood pressure
monitoring. This was prospective chart audit, without interfering with
practice; so we decided to use only common drugs in this audit.
The concern regarding informing parents before using
off-label drug is quite right. Various neonatal intensive care units
inform parents before using postnatal corticosteroids.