|
Indian Pediatr 2016;53: 1031-1032 |
|
The Academy Should take-up the Issue of
Off-label Prescriptions
|
Sandeep B Bavdekar
Department of Pediatrics, TN Medical College and BYL
Nair Charitable Hospital, Mumbai, India.
Email:
[email protected]
|
The recent event involving the off-label use of avastin (bivacizumab
injection, 100 mg/4mL) should serve as an eye-opener to pediatricians.
In an unfortunate incident, a few patients lost vision after an
ophthalmological procedure [1]. The regulator, Central Drugs Standard
Control Organization (CDSCO) chose to issue a warning pointing out that
avastin used in these patients is not approved for use in ophthalmology,
and directed that such use be desisted from [1]. The warning was later
withdrawn [2], once it was noted that although off-label, its use as an
anti-vascular endothelial growth factor (VEGF) for the treatment of
age-related macular degeneration (AMD) is endorsed by the WHO [3],
International Council of Ophthalmology, National Institutes of Health,
and regulatory agencies of France and Italy [2]. However, the event
brought the issue of off-label drugs into a sharp focus.
Off-label drug-use is a reality and needs to be
resorted to, as the discoveries made after market authorization compel
medical practitioners to use the drug for new indications, in new
populations using better dosage regimens. As children are usually not
enrolled in clinical trials, many drugs continue to be marketed without
appropriate pediatric labeling. Pediatricians prescribe drugs on the
basis of available evidence (as they should), textbook-material,
guidelines or consensus statements. This ensures that children are
treated with better therapies as per new evidence. But, if it is used
for indications not listed in the license or is administered in a manner
(dose, dose regimen, route of administration, etc.) not described
in the license; the use constitutes off-label drug use. Off-label drug
use is highly prevalent in neonates and children [4,5], and while
prescribing these drugs, the treating pediatricians have a greater
responsibility. If any controversy arises, they are required to prove
that they acted in good faith and that their actions are supported by
available evidence.
As the parents and media may misconstrue off-label
use as experimental or unapproved use, the pediatrician can face rough
weather. In addition, the accelerated reaction of the regulator might
put an additional stress. It is imperative that the Indian Academy of
Pediatrics (IAP) comes out with a guidance statement for its members
regarding off-label use of drugs, detailing the legal position, role of
the regulator, therapeutic decision- making process and prescriber
responsibilities. As off-label use is highly prevalent among pregnant
women, cancer patients and psychiatric patients as well; the Academy
should collaborate with professional organizations of these specialties
to plead with the regulator and policy makers for facilitating change in
labels in case of older drugs, where a considerable body of evidence is
available. This will help assure parents, media and the society at large
that the drug therapy is safe and efficacious. IAP should also come out
with evidence-based updated guidelines for management of pediatric
conditions. This will act as support and a ready-reference when a
pediatrician is required to employ off-label drug.
References
1. Directorate General of Health Services. Office of
the Drugs Controller General of India (DCGI). Notice. F No.
12-52/2004-DC (Part I). Available from:
http://www.dfda.goa.gov.in/images/uploads/ale_not.pdf. Accessed May
16, 2016.
2. Directorate General of Health Services. Office of
the Drugs Controller General of India (DCGI). Notice. F No.
12-52/2004-DC (Part I). Available from:
http://www.cdsco.nic.in/writereaddata/ AVASTIN.pdf. Accessed May 15,
2016.
3. World Health Organization. WHO Model List of
Essential Medicines. 19th list (April 2015) (Amended June 2015).
Available from:
http://www.who.int/selection_medicines/committees/expert/20/EML_2015_FINAL_amended_
JUN2015.pdf?ua=1. Accessed May 15, 2016.
4. 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.
5. Jobanputra N, Save SU, Bavdekar SB. Off-label and
unlicensed drug use in children admitted to Pediatric Intensive Care
Units (PICU). Int J Risk Saf Med. 2015;27:113-21.
|
|
|
|