Non availability of Cloxacillin, A Deterrent for Rational Antimicrobial Practice.

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 decisionmaking process and prescriber responsibilities. As offlabel 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 evidencebased 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. SANDEEP B BAVDEKAR Department of Pediatrics TN Medical College and BYL Nair Charitable Hospital, Mumbai, India. [email protected] REFERENCES