International Journal of Risk & Safety in Medicine 18 (2006) 115–119 115 IOS Press Designing a spontaneous adverse drug reaction reporting form: An exercise for medical students P.R. Shankar * and P. Subish Department of Pharmacology, Manipal College of Medical Sciences, Pokhara, Nepal 1. Introduction Spontaneous adverse drug reaction (ADR) reporting schemes have been a major source of information in pharmacovigilance [6]. Spontaneous reporting can prevent new medicine tragedies from developing and can improve the labeling of many effective pharmaceutical products [2,9]. However, spontaneous reporting schemes are associated with relatively low levels of reporting. It is likely that less than 10% of serious reactions are notified. Problems of motivating reporters, commitment, lack of clarity about what should be reported and fear of recrimination for errors may be some of the factors responsible. The scheme operates on the basis of reporting all ADRs despite uncertainty about a causal relationship [5]. A review of National spontaneous reporting schemes shows that reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. The types of reactions for which reports are requested, and the products covered were different. A study from the year 2002 in 18 countries showed that the number of reports received by different national spontaneous reporting schemes for adverse drug reactions varies considerably from a few hundred each year in South Africa to over 20,000 in the US [4]. Current statistics on reports submitted via “Vigibase Online” (VOL) to Vigibase, the WHO international ADR database, have been less than 25 from Congo, Cyprus, Ethiopia, Nepal and Uzbekistan [8]. One of the problems with national spontaneous reporting programs is the lack of user friendliness of the reporting forms. These issues make the design and content of an ADR reporting form critical in encouraging participation and presenting an attractive face to the pharmacovigilance program. Medical doctors along with other healthcare professionals should be aware of the importance of report- ing and should report ADRs as part of their professional responsibility. Doctors should be knowledgeable about the ADR reporting systems in their region and country. Developed countries have incorporated the teaching of pharmacovigilance into medical and pharmacy curricula [1,10]. However, in developing countries most medical colleges do not teach pharmacovigilance. ADRs are only covered as a topic in the theory course. * Corresponding author: Dr. P. Ravi Shankar, Manipal College of Medical Sciences, PO Box 155, Deep Heights, Pokhara, Nepal. Tel.: +977 61 523600; Fax: +977 61 522160; E-mail: pathiyilravi@hotmail.com. 0924-6479/06/$17.00  2006 – IOS Press and the authors. All rights reserved