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Indian Pediatr 2015;52: 167 |
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Off-label Drug Use in Neonatal Intensive Care
Unit
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Sandeep B Bavdekar
9, A2 Worli Seaside CHS, KAG Khan road, Worli, Mumbai,
India.
Email:
[email protected]
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The research article on off-label use of drugs in neonates [1] brings an
important issue of drug safety in neonates into a sharp focus. I request
the authors to clarify certain methodological issues.
The authors have stated that the accuracy of dose was
checked from standard neonatal formularies, viz. British National
Formulary 2005 and Neofax 2008, and stated that 75% of medications were
not approved by FDA for neonatal use. They have not mentioned the
document or the source that they relied upon to classify the drug as
off-label or otherwise. It may not be advisable to decide if use of a
particular drug constitutes off-label use or not on the basis of
information included in a Formulary [2]. Considering USFDA licensing
information as a basis to determine off-label status may also not be
appropriate, as such a status should be determined on the basis of
marketing authorization issued by the Indian licensing authority, the
Directorate of Drug Controller General of India (DCGI)/ Central Drug
Standards Control Organization (CDSCO).
Unlike in the USA (where the USFDA website provides
detailed licensing information), labeling information for drugs approved
by DCGI is not easily available. Of late, lay press and judiciary have
started paying attention to the issue of off-label drug use [3-5], and
some parents expect that such drugs be used in their children only with
their knowledge and consent [6]. Under these circumstances, it is
imperative that information about the drug license is available in the
public domain. This would enable the practitioners and parents to take
an informed decision.
Authors ’
exclusion of inotropes from the analysis has led to lower estimates of
off-label use, as dopamine and dobutamine are being used in neonates for
several years as off-label drugs. The practitioners may consider their
use in neonates as safe and effective on the basis of published data and
clinical experience. Nevertheless, such use is considered off-label, as
no efforts are made to get the licensing information updated on the
basis of evidence generated after the drug is marketed. This ‘once
off-label; always off-label’ situation leads to many time-tested drugs
being continued to be classified as off-label. This puts unnecessary
onus on the practitioners, and one can only imagine a situation where
parents voice their reluctance to use these drugs in their newborn
child, because they consider off-label use as experimental or dangerous.
Inclusion of these drugs in the analyses could have helped authors flag
this important issue.
References
1. Jain S, Saini SS, Chawla D, Kumar P, Dhir S.
Off-label use of drugs in neonatal intensive care units. Indian Pediatr.
2014;51:644-6.
2. Preface. Neofax 2011. Montavale, New Jersey,
Thomson Reuters. P v
3. Chand SB. Off-label use of drugs widely prevalent.
Available from: http://timesofindia.indiatimes.com/city/ahmedabad/Off-label-use-of-drugs-widely-prevalent/articleshow/16892931.cms
Accessed September 8, 2014
4. Off-label drug use sparks off an ethical debate.
Available from: http://timesofindia.indiatimes.com/india/Off-label-drug-use-sparks-off-an-ethical-debate/articleshow/1027845.cms
Accessed September 8, 2014.
5. Big Pharma wins a battle on off-label prescribing.
Available from: http://scienceblogs.com/insolence/2012/12/06/big-pharma-wins-a-battle-on-off-label-prescribing/
Accessed September 8, 2014.
6. Bang V, Mallad A, Kannan S, Bavdekar SB, Gogtay
NJ, Thatte UM. Awareness about and views of parents on the off-label
drug use in children. Int J Risk Saf Med. 2014;26:61-70.
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