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SHANDS June 2002 at the University of Florida Drugs & Therapy B ◆ U ◆ L ◆ L ◆ E ◆ T ◆ I ◆ N

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SHANDS June 2002 at the University of Florida Drugs & Therapy B ◆ U ◆ L ◆ L ◆ E ◆ T ◆ I ◆ N Volume 16, Number 6 SHANDS June 2002 at the University of Florida Drugs & Therapy B ◆ U ◆ L ◆ L ◆ E ◆ T ◆ I ◆ N PAIN MANAGEMENT FORMULARY UPDATE The Pharmacy and Therapeutics Ode to the Sphincter: The Committee met May 21, 2002. 2 drugs were added in the Formu- comparative effects of lary and 2 drugs were deleted. 1 drug was evaluated, but not added: it was designated nonformulary morphine and meperidine and not available. In total, 5 drugs 1 were designated not available. cute pancreatitis is a clinical out the facts. A syndrome characterized by severe In 1 study identified in this review, acute abdominal pain, vomiting, and Coelho and colleagues evaluated the elevations in serum amylase and effects of morphine, meperidine, and ◆ ADDED lipase concentrations. It is most other narcotic analgesics on the biliary Arsenic trioxide commonly associated with alcohol pressure of opossums (the chosen (Trisenox® by Cell Therapeutics) ingestion and gallstones. Medical animal model for biliary studies).2 teaching has been that morphine Although biliary pressure was higher Dimercaprol in animals that had undergone chole- (BAL in Oil by Akorn) ◆ cystectomy, the difference between ◆ DELETED Studies of narcotic effects morphine and meperidine was not Ergonovine injection on the sphincter of Oddi significant. Furthermore, in animals (generic by Bedford Labs) with a gallbladder, the increase in and bile duct pressures biliary pressure was not significant, Tolazoline (Priscoline® by Ciba) indicate that there is no regardless of whether morphine or meperidine was administered. ◆ EVALUATED, BUT NOT ADDED difference between In a human trial by Economou and Dexmedetomidine* morphine and meperidine Ward-Mcquaid, 31 patients were given (Precedex® by Abbott) morphine, meperidine, or another nar- for acute pain relief in cotic agonist after cholecystectomy.3 *Nonformulary and not available patients with pancreatitis. Although biliary pressures were in- creased significantly from baseline in ◆ NONFORMULARY, both the morphine and meperidine NOT AVAILABLE should not be used for treatment of groups, there was no difference Desloratadine pain associated with pancreatitis between the agents. (Clarinex® by Schering) because of the potential for inducing Pitfalls of early trials include the spasms in the sphincter of Oddi. method by which biliary pressures Fentanyl PCA Cartridges Meperidine was purported not to were measured. Early studies used (generic)† induce these spasms; therefore, it was a T-tube, which is considered an the the preferred opioid in this patient indirect measurement that is more Meperidine Oral & PCA population. This was an irrational prone to error than modern methods (generic) justification for the continued use of of bile duct pressure measurement via meperidine as a pain medication. ERCP. In a 1990 study by Thune and Octreotide Depot There is no head-to-head study ® colleagues, morphine was compared (Sandostatin LAR Depot by comparing morphine and meperidine Novartis) to meperidine via direct manometry of that shows any difference in pain- continued on page 4 relief. Studies of the narcotic effects on †50 mcg/mL the only strength still the sphincter of Oddi and bile duct available also suggest there is no difference ◆ between these agents. Several investigators have examined INSIDE THIS ISSUE Arsenic trioxide is an inorganic the issue of narcotic analgesic effects metal used for the treatment of in patients with acute pancreatitis. ◆ Tessalon® Pearl leukemia. The labeled indication for A review of clinical trials comparing ◆ Dietery supplement safety continued on page 2 various narcotic analgesics and their effects on biliary pressure helps sort Formulary update, from page 1 larly—never intravenously. The ‘oil” One abstract showed a significantly arsenic trioxide is for the induction vehicle for dimercaprol is peanut oil, shorter time to extubation, but the of remission and consolidation of which should be considered in quality of these data could not be acute promyelocytic leukemia (APL) patients allergic to peanuts. assessed. in patients who are refractory to or Dimercaprol must be available when Hypotension is the main adverse have relapsed from retinoid and arsenic trioxide is given. It is also used effect associated with the use of anthracycline chemotherapy and for rare, but serious, environmental dexmedetomidine. Other adverse whose APL is characterized by the toxicological exposures. Therefore, it events include hypertension and presence of the t(15;17) transloca- has been stocked in the Pharmacy, nausea. In a study that assessed tion of the PML/RAR-alpha gene although not officially listed in the patient satisfaction, patients com- expression. APL is a subset of acute Formulary. Dimercaprol was listed in plained that they were undersedated myelocytic leukemia with this the Formulary for these potentially on dexmedetomidine, despite specific chromosomal abnormality. life-threatening toxicities. appearing comfortable. Patients Although the exact mechanism of Ergonovine injection was a may also exhibit signs of withdrawal arsenic trioxide is not known, it parenteral ergot alkaloid that was (nervousness, agitation, headaches, appears to target the specific primarily used by cardiologists to and increased blood pressure) if dex- chromosomal abnormality present induce vasospasm and diagnose medetomidine is stopped abruptly. in APL cells. angina (ie, the ergonovine provocation Based on the pharmacology of Current therapy for newly diag- test). This has fallen out of favor and dexmedetomidine, there is interest nosed APL includes all-trans retinoic the manufacturer of injectable ergono- in its use as a sedating agent in non- acid (ATRA) in combination with vine has stopped making this drug. intubated, neurologically impaired anthracyclines for consolidation, then Tolazoline was a parenteral direct patients who need to lie still for a ATRA for maintenance. Although peripheral vasodilator with moderate procedure (eg, MRI). In this situation, most patients respond to standard ◆ it would provide sedative effects, but therapy, about a third of patients would not decrease respiratory that achieve remission will relapse. Treatment with arsenic function. However, dexmedetomidine Patients with APL who relapse trioxide is associated with does decrease blood pressure in are treated with stem cell transplan- about a third of patients. Also, tation (SCT), when an HLA-compat- serious adverse effects. dexmedetomidine could be used in ible donor is available. Arsenic tri- There is a black-box the operating room (OR) for intrave- oxide offers an alternative to SCT. nous anesthesia and provide mor- The response rate depends on the warning about APL phine-sparing effects, yet have no patient’s previous treatment status, differentiation syndrome effect on respiration. but more than half of the previously and QT prolongation. A particularly interesting niche treated patients responded in for dexmedetomidine could be the clinical trials. facilitation of extubation. Other Treatment with arsenic trioxide alpha-adrenergic blocking activity. sedatives can cause respiratory is associated with serious adverse It was recently discontinued by the depression, which can make extuba- effects. There is a black-box warn- manufacturer and is now unavailable. tion more difficult. Unfortunately, ing about APL differentiation syn- It was used by radiologists for special there are no published data to support drome and QT prolongation. APL procedures. Nitroglycerin has replaced the use of dexmedetomidine for off- differentiation syndrome is charac- the use of tolazoline. labeled indications. Further, there terized by fever, dyspnea, weight Dexmedetomidine is a relatively are no published data that showed gain, pulmonary infiltrates, and selective alpha-2-adrenergic receptor more rapid extubation, shorter ICU pleural or pericardial effusions. This agonist with centrally mediated seda- stays, or lower costs in the ICU when syndrome can be fatal. Arsenic tri- tive effects. The sedative, analgesic, dexmedetomidine is used. Although oxide can also cause QT interval and anxiolytic properties of dexmede- there are theoretical pharmacologic prolongation and complete atrioven- tomidine are attributed to decreased advantages of dex-medetomidine, tricular (AV) block. QT prolongation central noradrenergic activity. It has a there is insufficient evidence that can result in torsade de pointes. labeled indication for short-term (ie, these pharmacologic differences Therefore, factors that increase the <24 hours) sedation of initially intubated result in better patient outcomes. risk of QT prolongation (eg, hypo- and mechanically ventilated patients Dexmedetomidine costs about kalemia and hypomagnesemia) during treatment in an intensive care $275 per day, which is nearly twice must be considered and increased setting. There are no published data to the cost of propofol and 7 times the monitoring is required. support the use of dexmedetomidine cost of midazolam. There are no A typical induction and consoli- for other indications. proven offsetting cost benefits. dation course of therapy will cost There are few published data on Dexmedetomidine was not added nearly $36,000 and each additional dexmedetomidine for the labeled in the Formulary and was designated consolidation course will cost indication. Of the 3 major evaluations nonformulary and not available. $11,000. Arsenic trioxide usually used for FDA approval, only 1 has Should additional data be published will be administered
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