Curtis K Harder1, John J Hawboldt. 1. , PharmD, is with the Pharmacy, Vancouver Island Health Authority, Victoria, British Columbia.
Abstract
BACKGROUND: In 2007, because of a potential interaction between ceftriaxone and calcium-containing IV solutions, Roche Laboratories (manufacturer of Rocephin [ceftriaxone] in the United States) issued letters to health care professionals advising them of changes to the product monograph. Subsequently, warning letters were also issued by the US Food and Drug Administration (FDA) and Health Canada. The Health Canada recommendations and their implications for clinical practice generated debate in the Canadian hospital pharmacy community. OBJECTIVE: To evaluate the response to the warnings among hospital pharmacists and their respective institutions. METHODS: An anonymous, voluntary 10-question survey was distributed to members of the Pharmacy Specialty Networks of the Canadian Society of Hospital Pharmacists. Requests to participate were solicited via 2 e-mail messages. Responses were analyzed descriptively. RESULTS: A total of 152 pharmacists participated in the survey. Forty-three respondents (28.3%) reported being very concerned and 86 (56.6%) reported being somewhat concerned about the Health Canada Notice to Hospitals. About half (77/152 [50.7%]) of the respondents felt that the Health Canada notice did not need to be strictly heeded. Two-thirds (98/145 [67.6%]) reported that their institutions had addressed the risk of an interaction through a change in policy regarding the administration of ceftriaxone. Eighty-eight (61.5%) of 143 participants indicated that their institution's official position on the notice was that it represented a "relative contraindication" (i.e., the benefit may outweigh the risk). CONCLUSIONS: Warning letters issued by the manufacturer, the FDA, and Health Canada generated concern within the Canadian hospital pharmacy community. However, a large proportion of hospital pharmacy practitioners did not agree with strict adherence to the Health Canada notice.
BACKGROUND: In 2007, because of a potential interaction between ceftriaxone and calcium-containing IV solutions, Roche Laboratories (manufacturer of Rocephin [ceftriaxone] in the United States) issued letters to health care professionals advising them of changes to the product monograph. Subsequently, warning letters were also issued by the US Food and Drug Administration (FDA) and Health Canada. The Health Canada recommendations and their implications for clinical practice generated debate in the Canadian hospital pharmacy community. OBJECTIVE: To evaluate the response to the warnings among hospital pharmacists and their respective institutions. METHODS: An anonymous, voluntary 10-question survey was distributed to members of the Pharmacy Specialty Networks of the Canadian Society of Hospital Pharmacists. Requests to participate were solicited via 2 e-mail messages. Responses were analyzed descriptively. RESULTS: A total of 152 pharmacists participated in the survey. Forty-three respondents (28.3%) reported being very concerned and 86 (56.6%) reported being somewhat concerned about the Health Canada Notice to Hospitals. About half (77/152 [50.7%]) of the respondents felt that the Health Canada notice did not need to be strictly heeded. Two-thirds (98/145 [67.6%]) reported that their institutions had addressed the risk of an interaction through a change in policy regarding the administration of ceftriaxone. Eighty-eight (61.5%) of 143 participants indicated that their institution's official position on the notice was that it represented a "relative contraindication" (i.e., the benefit may outweigh the risk). CONCLUSIONS: Warning letters issued by the manufacturer, the FDA, and Health Canada generated concern within the Canadian hospital pharmacy community. However, a large proportion of hospital pharmacy practitioners did not agree with strict adherence to the Health Canada notice.
Authors: Scott V Monte; William Allan Prescott; Kristin K Johnson; Lori Kuhman; Joseph A Paladino Journal: Expert Opin Drug Saf Date: 2008-09 Impact factor: 4.250