P A Chyka1, S W McCommon. 1. University of Tennessee, Department of Pharmacy Practice and Pharmacoeconomics and Southern Poison Center, Memphis, USA. pchyka@utmem.edu
Abstract
BACKGROUND: Although US poison control centres manage approximately 30,000 adverse drug reactions each year, the extent of voluntary reporting of these events to the US Food and Drug Administration (FDA) MedWatch spontaneous surveillance programme is unknown. METHODS: A survey was mailed to directors of all 72 US poison control centres during April 1999 to determine their practices and opinions on reporting adverse drug reactions. The survey requested information on the poison control centre staff's practices in reporting adverse drug reactions to the FDA MedWatch programme during 1998. RESULTS: A total of 56 fully completed surveys were returned. Of the respondents, 30 had not directly submitted adverse drug reaction reports to the FDA, 22 had submitted 10 or less, and 4 had submitted a total of 47 during 1998. Reasons given for not routinely reporting adverse drug reactions included adverse drug reactions reporting is not part of the regular routine (20%), lack of time to complete forms (15%), inability to determine causality (13%), most reactions are already reported and not unique (10%), reporting to the FDA is too much work (9%), and responsibility rests with the attending physician (7%). Direct reporting to MedWatch of any cases of adverse drug reactions was more likely when the poison control centre was certified by the American Association of Poison Control Centers (p < 0.05; odds ratio = 5.1; 95% confidence interval 1.1 to 23.5); however, this practice was not associated with documenting deaths associated with adverse drug reactions, having more than 75% of the staff of the Poison Information Specialists composed of pharmacists or nurses, or managing greater than 20,000 or 34,000 human exposure cases during 1998. Approximately half of the poison control centres directly or indirectly reported some adverse drug reactions to the FDA by virtue of contacting the manufacturer or cooperating with postmarketing surveillance. CONCLUSION: Poison control centres represent an underutilised source of reporting to MedWatch, but several internal and external obstacles limit the direct reporting of adverse drug reactions routinely.
BACKGROUND: Although US poison control centres manage approximately 30,000 adverse drug reactions each year, the extent of voluntary reporting of these events to the US Food and Drug Administration (FDA) MedWatch spontaneous surveillance programme is unknown. METHODS: A survey was mailed to directors of all 72 US poison control centres during April 1999 to determine their practices and opinions on reporting adverse drug reactions. The survey requested information on the poison control centre staff's practices in reporting adverse drug reactions to the FDA MedWatch programme during 1998. RESULTS: A total of 56 fully completed surveys were returned. Of the respondents, 30 had not directly submitted adverse drug reaction reports to the FDA, 22 had submitted 10 or less, and 4 had submitted a total of 47 during 1998. Reasons given for not routinely reporting adverse drug reactions included adverse drug reactions reporting is not part of the regular routine (20%), lack of time to complete forms (15%), inability to determine causality (13%), most reactions are already reported and not unique (10%), reporting to the FDA is too much work (9%), and responsibility rests with the attending physician (7%). Direct reporting to MedWatch of any cases of adverse drug reactions was more likely when the poison control centre was certified by the American Association of Poison Control Centers (p < 0.05; odds ratio = 5.1; 95% confidence interval 1.1 to 23.5); however, this practice was not associated with documenting deaths associated with adverse drug reactions, having more than 75% of the staff of the Poison Information Specialists composed of pharmacists or nurses, or managing greater than 20,000 or 34,000 human exposure cases during 1998. Approximately half of the poison control centres directly or indirectly reported some adverse drug reactions to the FDA by virtue of contacting the manufacturer or cooperating with postmarketing surveillance. CONCLUSION: Poison control centres represent an underutilised source of reporting to MedWatch, but several internal and external obstacles limit the direct reporting of adverse drug reactions routinely.
Authors: A Bate; M Lindquist; I R Edwards; S Olsson; R Orre; A Lansner; R M De Freitas Journal: Eur J Clin Pharmacol Date: 1998-06 Impact factor: 2.953