We are grateful to Dr. R.N. Srivastava for his interest in our article on the newly launched National Pharmacovigilance Program(1). He has raised a doubt regarding wisdom of permitting nurses and pharmacists to "independently" report an Adverse Event (AE). We believe that nurses and pharmacists play an important role in pharmacovigilance and that they should be encouraged to report AEs independently. Given their unique position in drug administration and recording observations on in-patients, nurses who form a large proportion of health-care staff in our vast country will contribute significantly to the spontaneous reporting of adverse events and adverse drug reactions. Since October 2002, nurses in the UK have been permitted to report AEs. On analyzing their inputs, it has been noted that their reports are valuable, both in number and in quality, and as complete as those from general practitioners and hospital doctors(2,3). Pharmacists too would play a major role in pharmacovigilance by reporting AEs to drugs prescribed in outpatient practice as they often receive valuable feedback from their clients, information which may not reach the prescribing doctors. We would like to mention that up to 68 countries have already authorized pharmacists to report AEs and this has led to a substantial improvement of the international adverse drug reactions reporting system(4).

We fully endorse Dr. R.N. Srivastava’s suggestion that the Clinical Pharmacology Cell of the Indian Academy of Pediatrics should liaison with the National Pharmacovigilance Program to improve the current unsatisfactory state of pediatric pharmacovigilance in our country. We reiterate our earlier demand that an expert pediatrician nominated by the Indian Academy of Pediatrics should be a member of the National Pharmacovigilance Advisory Committee. This would help in fostering the much-needed collaboration between the Indian Academy of Pediatrics and the National Pharmacovigilance Program and eventually improve awareness about the national program amongst its 16,000 members. Only collaborative efforts will ensure that a significant number of AEs get reported. This will lead to early identification of rare and life-threatening adverse drug reactions and help ensure that children in our country receive safe drugs.

Lastly, we wish to inform Dr. R.N. Srivastava and readers that detailed information about the national program, viz., the AE reporting form, the protocol, list of centers, members of the National Pharmacovigilance Advisory Committee, etc. is available at the Central Drugs Standard Control Organization (CDSCO) website: http://cdsco.nic.in/html/pharmaco.html

Sandeep B. Bavdekar,
*Sunil Karande,
Seth GS Medical College and KEM Hospital,
Parel, Mumbai, and
*Lokmanya Tilak Municipal Medical College and General Hospital,
Sion, Mumbai, India.

1. Bavdekar SB, Karande S. National pharmaco-vigilance program. Indian Pediatr 2006; 43: 27-32.

2. Morrison-Griffiths S, Walley TJ, Park BK, Breckenridge AM, Pirmohamed M. Reporting of adverse drug reactions by nurses. Lancet 2003; 361: 1347-1348.

3. Ranganathan SS, Houghton JE, Davies DP, Routledge PA. The involvement of nurses in reporting suspected adverse drug reactions: experience with the meningococcal vaccination scheme. Br J Clin Pharmacol 2003; 56: 658-663.

4. van Grootheest K, Olsson S, Couper M, de Jongvan den Berg L. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004; 13: 457-464.