Discussion: The Committee was presented with two separate requests to add dexmedetomidine
to the Formulary. Neither request is within the package labeling of the drug,
which is indicated for sedation for patients during the first 24 hours of mechanical
ventilation in the intensive care setting in the post-operative setting.
The first request was in the area of extubation of patients who have failed a prolonged attempt at extubation. Dexmedetomidine use has been attempted in patients who have demonstrated a hyperdynamic response during weaning of narcotic, benzodiazepine, and/or propofol therapy during extubation attempts. During weaning and extubation, it is necessary to decrease sedation. Stimulation of the sympathetic nervous system causes increases in heart rate and blood pressure. This has not been formally studied and there is currently a proposal in process to evaluate this.
The second request was as an adjuvant to control shivering in stroke patients who have failed meperidine and/or propofol. There is currently no protocol for the use of these agents to control of shivering.
Given the limited data and the lack
of a current protocol, the Committee recommended not adding dexmedetomidine
to the Formulary.
Discussion: The Committee was presented
with a request to add valdecoxib (Bextra) to the Formulary. The request was
submitted by members of the Arthroplasty Service in light of the recent market
withdrawal of rofecoxib. Valdecoxib has been shown to be an efficacious analgesic
at doses of 20 mg twice daily. Valdecoxib has also been shown to provide opioid-sparing
effects in postoperative hip arthroplasty in patients in a placebo-controlled
study. With 20 or 40 mg twice daily (beginning 1 to 3 hours before surgery),
approximately 40% less morphine was required, compared to placebo recipients
during the 48-hour period after the first dose. Amounts of morphine utilized
during the first 24 hours post-surgery (mean) were 32, 21, and 19 mg with placebo,
valdecoxib 20 mg twice daily, and valdecoxib 40 mg twice daily, respectively.
Approximately 96% of patients indicated good or excellent analgesia with either
regimen of valdecoxib, compared to 77% in the placebo group. Higher doses have
not shown to be of any benefit in other studies. The Committee supports package
insert dosing. The Committee addressed concerns in relation to sternal wound
healing and one small study of post CABG patients found an increased risk if
coronary graft thrombosis. Given the current uncertainty about the COX-2 inhibitors,
we will continue to monitor this class closely. The Committee recommends the
warnings under Pharmacy Suggested Dose Instructions in POE ordering system on
COX 2 inhibitors be applied to valdecoxib (Bextra).
The Committee approved the addition of valdecoxib (Bextra) to the Formulary.