|
Sign In to gain access to subscriptions and/or personal tools.
|
American Journal of Hospice and Palliative Medicine®, Vol. 23, No. 2,
135-149 (2006)
DOI: 10.1177/104990910602300211
Are newer, more expensive pharmacotherapy options associated with superior symptom control compared to less costly agents used in a collaborative practice setting?
Douglas J. Weschules, PharmD, BCPS
Terni Maxwell, MSN, APRN, BC-PCM
JoAnne Reifsnyder, PhD, APRN, BC-PCM
Calvin H. Knowlton, PhD, MDiv, RPh
excelleRx, Inc., An Omnicare company, Philadelphia, Pennsylvania
Innovative approaches to care may be necessary to provide the most effective symptom management to hospice patients. One approach is prescribing newer pharmacotherapy options with the potential to improve symptom management in hospice. Such therapies are sometimes prescribed outside of Food and Drug Administration indications and are typically more costly than older agents usedfor the same symptoms. Another approach is the collaborative practice (CP) care model, whereby clinical pharmacists are given prescriptive authority according to evidence-based protocols and algorithms within boundaries approved by a physician. The agents typically included in CPprotocols are those with wide therapeutic indices and with substantial evidence to support their use. The purpose of this study was to examine both approaches to management ofpain, insomnia, and nausea, comparing symptom scores for those patients who received noncollaborative drug therapies (transdermal fentanyl, zolpidem, and ondansetron) to those who received agents under CP (oral sustained-release opioids, temazepam, andprochlorperazine). The object of the study was to investigate outcomes associated with newer drug therapy options as compared to older agents for the management of pain, insomnia, and nausea. A secondary goal is to compare symptom outcomes for patients receiving pharmaceutical care under CP and non-CP models. The study design was retrospective with a cohort. A total of 50 patients were randomly selected for each cohort of the pain and insomnia study arms. Only 45 patients prescribed oral ondansetron met inclusion criteriafor the nausea group; 45 patients prescribed prochlorperazine were randomly selected as the comparator group. Patients were compared on their degree of response to the prescribed therapy. Response was classified as complete, partial, no improvement from baseline, worsened, or unknown. A complete response was defined as the symptom score improving to a 0 of 10, regardless of the previous value documented. A partial response was defined as any improvement in score that did not result in a 0 of 10. No improvement from baseline reflected a lack of overall change in score throughout the series of data points collected. A worsened response was any score found to be higher than the score documented at the time of dispense. The unknown category reflects any set of scores that had an "NIA" documented at the time of medication dispense or when documented for both attempts subsequent to dispensing the medication. A complete response was present in 14 of 50 (24 percent) of the patients prescribed fentanyl as compared with 12 of 50 (28 percent) of those prescribed oral therapy (p = .82). Responses defined as partial, no improvement over baseline, worsened, and unknown were also comparable between the two cohorts. A complete response was seen in 26 patients prescribed temazepam (52 percent), whereas only 11 (22 percent) of patients initially prescribed zolpidem achieved the same response (p = .003 7). Both groups had a similar distribution of partial, no improvement over baseline, and worsened responses. For the nausea arm of the study, a difference was found in the number of complete responses, favoring prochlorperazine (22 of 45, 48.9 percent for prochlorperazine, 12 of 45, 26.7 percent for ondansetron, p =. 0504), as well as an increased number of worse responses seen with ondansetron patients (p = .0513); however, neither difference was statistically significant. Newer pharmacotherapy options for the management of pain, insomnia, and nausea were not found to be superior when compared to older agents prescribed under CR
Key Words: collaborative practice hospice pharmaceutical care prescribing symptom management
References
- 1. Resource Kit on Collaborative Practice. Compiled by the 2002 Publications Committee ofACCP, Kansas City: ACCP, 2003.
- 2. Miaskowski C, Cleary J, Burney R, et al.: Guideline for the Management of Cancer Pain in Adults and Children. APS Clinical Practice Guidelines Series, No. 3. Glenview, IL: American Pain Society, 2005.
- 3. Coyle N, Adelhardt J, Foley KM, et al.: Character of terminal illness in the advanced cancer patient: Pain and other symptoms during the last four weeks of life. J Pain Symptom Manage. 1990; 5(2): 83-93.[CrossRef][Medline]
[Order article via Infotrieve]
- 4. Gomez-Batiste X, Madrid F, Moreno F, et al.: Breakthrough cancer pain: Prevalence and characteristics in patients in Catalonia, Spain. J Pain Symptom Manage. 2002; 24(1): 45-52.[CrossRef][Medline]
[Order article via Infotrieve]
- 5. Gosney M: Cancer in the elderly. In: Sykes N, Fallon M, Patt R (eds): Clinical Pain Management: Cancer Pain. New York: Oxford University Press, 2003.
- 6. Higgenson IJ, Hearn J, Addington-Hall J: Epidemiology of cancer pain. In: Sykes N, Fallon M, Patt R (eds): Clinical Pain Management: Cancer Pain. New York:Oxford University Press, 2003.
- 7. Mercadante S, Armata M, Salvaggio L: Pain characteristics of advanced lung cancer patients referred to a palliative care service. Pain. 1994; 59(1): 141-145.[CrossRef][Medline]
[Order article via Infotrieve]
- 8. Regan J, Peng P: Neurophysiology of cancer pain. Cancer Control. 2000; 7(2): 111-119.[Medline]
[Order article via Infotrieve]
- 9. Zeppetella G. Riberio MD: Episodic pain in patients with advanced cancer. Am .JHosp Palliat Care. 2002; 19(4): 267-276.
- 10. Du Pen SL, Du Pen AR, Polissar N, et al.: Implementing guidelines for cancer pain management: Results of a randomized controlled clinical trial. J Clin Oncol. 1999; 17(1): 361-370.[Abstract/Free Full Text]
- 11. Ersek M, Kraybill BM, Du Pen S: Factors hindering patients' use of medications for cancer pain. Cancer Pract. 1999; 7(5): 226-232.[CrossRef][Medline]
[Order article via Infotrieve]
- 12. Ferrell BR, Juarez G, Borneman T: Use of routine and breakthrough analgesia in homecare. Oncol Nurs Forum. 1999; 26(10): 1655-1661.[Medline]
[Order article via Infotrieve]
- 13. Miaskowski C, Dodd MJ, West C, et al.: Lack of adherence with the analgesic regimen: A significant barrier to effective cancer pain management. J Clin Oncol. 2001; 19(23): 4273-4274.[Free Full Text]
- 14. Muijsers RBR, Wagstaff AJ: Transdermal fentanyl: An updated review of its pharmacological properties and therapeutic efficacy in chronic cancer pain control. Drugs. 2001; 61(15): 2289-2307.[CrossRef][Medline]
[Order article via Infotrieve]
- 15. Ahmedzai S, Brooks D: Transdermal fentanyl versus sustained-release oral morphine in cancer pain: Preference, efficacy, and quality of life. TTS-Fentanyl Comparative Trial Group. J Pain Symptom Manage. 1997 May; 13(5): 254-261.[CrossRef][Medline]
[Order article via Infotrieve]
- 16. Wong J-O, Chiu G-L, Tsao C-J, et al.: Comparison of oral controlled-release morphine with transdermal fentanyl in terminal cancer pain. Acta Anaesthesiol Sin. 1997; 35(1): 25-32.[Medline]
[Order article via Infotrieve]
- 17. Hunt R, Fazekas B, Thorne D, et al.: A Comparison of subcutaneous morphine and fentanyl in hospice cancer patients. JPain Symptom Manage. 1999; 18(2): 111-119.
- 18. Rischitelli DG, Karbowicz SH: Safety and efficacy of controlled-release oxycodone: A systematic literature review. Pharmacotherapy. 2002; 22(7): 898-904.[CrossRef][Medline]
[Order article via Infotrieve]
- 19. van Seventer R, Smit JM, Schipper RM, et al.: Comparison of TTS-fentanyl with sustained-release oral morphine in the treatment of patients not using opioids for mild-to-moderate pain. Curr Med Res Opin. 2003; 19(6): 457-469.[CrossRef][Medline]
[Order article via Infotrieve]
- 20. Weschules DJ, Bain KT, Reifsnyder J, et al.: Toward evidence-based prescribing at end-of-life: A comparative analysis of sustained-release morphine, oxycodone, and transdermal fentanyl and clinical outcome markers in the hospice patient. Pain Med. 2005 (in press).
- 21. Clark AJ, Ahmedzai SH, Allan LG, et al.: Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic noncancer pain. Curr Med Res Opin. 2004; 20(9): 1419-1428.[CrossRef][Medline]
[Order article via Infotrieve]
- 22. Hospice Facts and Figures from the National Hospice and Palliative Care Organization, 2003 data. Available at: www.nhpco.org.
- 23. Kalso E, Vainio A: Morphine and oxycodone hydrochloride in the management of cancer pain. Clin Pharmacol Ther 1990; 47: 639-646.[Medline]
[Order article via Infotrieve]
- 24. Mucci-LoRusso P, Berman BS, Silberstein PT, et al.: Controlled-release oxycodone compared with controlledrelease morphine in the treatment of cancer pain: A randomized, double-blind, parallel-group study. Eur JPain. 1998; 2: 239-249.
- 25. Bruera E, Belzile M, Pituskin E, et al.: Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain. J Clin Oncol. 1998; 16: 3222-3229.[Abstract]
- 26. Curtis GB, Johnson GH, Clark P, et al.: Relative potency of controlled-release oxycodone and controlled-release morphine in a postoperative pain model. Eur J Clin Pharmacol. 1999; 55: 435-439.
- 27. Heiskanen T, Kalso E: Controlledrelease oxycodone and morphine in cancer-related pain. Pain. 1997; 73: 37-45.[CrossRef][Medline]
[Order article via Infotrieve]
- 28. Allan L, Hays H, Jensen N-H, et al.: Randomized crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic noncancer pain. BMJ; 2001; 322: 1154-1158.[Abstract/Free Full Text]
- 29. Guest JF, Ruiz FJ, Russ J, et al.: A comparison of the resources used in advanced cancer care between two different strong opioids: An analysis of naturalistic practice in the UK. Curr Med Res Opin. 2005; 21(2): 271-280.[CrossRef][Medline]
[Order article via Infotrieve]
- 30. BergerA, Smith M, Lidsky L, et al.: Opioid use and healthcare charges at the end of life in patients with metastatic cancer. Managing Care Interface. 2004; 17(4): 28-34.
- 31. Roth T: New developments for treating sleep disorders. J Clin Psych. 2001; 62S (10): 3-4.
- 32. Foley DJ, Monjan AA, Brown SL, et al.: Sleep complaints among elderly persons: An epidemiologic study of three communities. Sleep. 1995; 18: 425-432.[Medline]
[Order article via Infotrieve]
- 33. Savard J, Morin CM: Insomnia in the context of cancer: A review of a neglected problem. J Clin Oncol. 2001; 19: 895-908.[Abstract/Free Full Text]
- 34. Couzi RJ, Helzlsouer KJ, Fetting JH: Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995; 13: 2737-2744.[Abstract]
- 35. Harrison LB, Zelefsky MJ, Pfister DQ, et al.: Detailed quality of life assessment in patients treated with primary radiotherapy for squamous cell cancer of the base of the tongue. Head Neck. 1997; 19: 169-175.[CrossRef][Medline]
[Order article via Infotrieve]
- 36. Lindley C, Vasa S, Sawyer WT, et al.: Quality of life and preferences for treatment following systemic adjuvant therapy for early-stage breast cancer. J Clin Oncol. 1998; 16: 1380-1387.[Abstract/Free Full Text]
- 37. Holm KJ, Goa KL: Zolpidem: Anupdate of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia. Drugs. 2000; 59(4): 865-889.[CrossRef][Medline]
[Order article via Infotrieve]
- 38. Nowell PD, Mazumdar S, Buysse DJ, et al.: Benzodiazepines and zolpidem for chronic insomnia: A meta-analysis of treatment efficacy. JAMA. 1997; 278(24): 2170-2177.[Abstract]
- 39. Vermeeren A, O'Hanlon JF, Declerck AC: Acute effects of zolpidem and flunitrazepam on sleep, memory and driving performance, compared to those of partial sleep deprivation and placebo. Acta Ther. 1995; 21(1): 47-64.
- 40. Fleming J, Moldofsky H, Walsh JK: Comparison of the residual effects and efficacy of short term zolpidem, flurazepam and placebo in patients with chronic insomnia. Clin Drug Invest. 1995; 9(6): 303-313.
- 41. Rosenberg J, Ahlstrom F: Randomized, double blind trial of zolpidem 10 mg versus triazolam 0.25 mg for treatment of insomnia in general practice. Scand J Prim Healthcare. 1994; 12(2): 88-92.
- 42. Silvestri R, Ferrillo F, Murri L: Rebound insomnia after abrupt discontinuation of hypnotic treatment: Double-blind randomized comparison of zolpidem versus triazolam. Hum Psychopharm. 1996; 11: 225-233.[CrossRef]
- 43. Bain KT, Weschules DJ, Knowlton CH, et al.: Toward evidence-based prescribing at end of life: A comparative review of temazepam and zolpidem for the treatment of insomnia. Am J Hospice Palliat Care. 2003; 20(5): 382-388.
- 44. Dtindar Y, Dodd S, Strobl J, et al.: Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: A systematic review and metaanalysis. Hum Psychopharmacol. 2004; 19: 305-322.[CrossRef][Medline]
[Order article via Infotrieve]
- 45. Oude Voshaar RC, van Balkom AJLM, Zitman FG: Zolpidem is not superior to temazepam with respect to rebound insomnia: A controlled study. Eur Neuropsychopharmacol. 2004; 14: 301-306.[CrossRef][Medline]
[Order article via Infotrieve]
- 46. Vermeeren A: Residual effects of hypnotics. Epidemiology and clinical implications. CNS Drugs. 2004; 18(5): 297-328.[CrossRef][Medline]
[Order article via Infotrieve]
- 47. McMillan SC, Small BJ: Symptom distress and quality of life in patients with cancer newly admitted to hospice homecare. Onc Nurs Forum. 2002; 29(10): 1421-1428.
- 48. Weitzner MA, Moody LN, McMillan SC: Symptom management issues in hospice care. AmJHosp Palliat Care. 1997; 14:190-195.
- 49. Muir JC, von Gunten CF: Abdominal cancer, nausea, and vomiting. JPalliat Med. 2001; 4(3): 391-394.
- 50. Gralla RJ, Osoba D, Kris MG, et al.: Recommendations for the use of antiemetics: Evidence-based clinical practice guidelines. JClin Oncol. 1999; 17(9): 2971-2994.[Free Full Text]
- 51. Roberts JT, Priestman TJ: A review of ondansetron in the management of radio-therapy-induced emesis. Oncology. 1993; 50: 173-179.[Medline]
[Order article via Infotrieve]
- 52. Chen JJ, Frame DG, White TJ: Efficacy of ondansetron and prochlorperazine for the prevention of postoperative nausea and vomiting after total hip replacement or total knee replacement procedures. A randomized, double-blind, comparative trial. Arch Intern Med. 1998; 158: 2124-2128.[Abstract/Free Full Text]
- 53. Chang P, Okamoto M, Chen J, et al.: Cost-effectiveness analysis of ondansetron and prochlorperazine for the prevention of postoperative nausea and vomiting. JManag Care Pharm. 2005; 11(4): 317-321.
- 54. Dresner M, Dean S, Lumb A, et al.: High-dose ondapsetron regimen vs. droperidol for morphine patient-controlled analgesia. Br JAnaesth. 1998; 81: 384-386.
- 55. Mercadante S, Sapio M, Serretta R: Ondansetron in nausea and vomiting induced by spinal morphine. JPain Sympt Manage. 1998; 16(4): 259-262.[CrossRef]
- 56. Vivian EM: Improving blood pressure control in a pharmacist-managed hypertension clinic. Pharmacotherapy. 2002; 22(12): 1533-1540.[CrossRef][Medline]
[Order article via Infotrieve]
- 57. Borenstein JE, Graber QSaltiel E, et al.: Physician-pharmacist comanagement of hypertension: A randomized, comparative trial. Pharmacotherapy. 2002; 23(2): 209-216.
- 58. Coast-Senior EA, Kroner BA, Kelley CL, et al.: Management of patients with Type 2 diabetes by pharmacists in primary care clinics. Ann Pharmacother. 1998; 32: 636-641.[Abstract]
- 59. Gattis WA, Hallelblad V, Whellan DJ, et al.: Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team. Results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) study. Arch Int Med. 1999; 159: 1939-1945.[Abstract/Free Full Text]
- 60. Bogden PE, Koontz LM, Williamson P, et al.: The physician and pharmacist team: An effective approach to cholesterol reduction. J Gen Intern Med. 1997; 12: 158-164.[CrossRef][Medline]
[Order article via Infotrieve]
- 61. Finley PR, Rens HR, Pont JT, et al.: Impact of a collaborative pharmacy practice model on the treatment of depression in primary care. Am JHealth-Syst Pharm. 2002; 59: 1518-1526.
- 62. Cannon JP, Silverman RM: A pharmacist-driven antimicrobial approval program at a Veterans Affairs hospital. Am J Health-Syst Pharm. 2003; 60: 1358-1362.[Free Full Text]
- 63. Gammaitoni AR, Gallagher RM, Welz M, et al.: Palliative pharmaceutical care: A randomized, prospective study of telephone-based prescription and medication counseling services for treating chronic pain. Pain Med 2000; 1(4): 317-331.[CrossRef][Medline]
[Order article via Infotrieve]
- 64. Rapoport A, Akbik H: Pharmacist-managed pain clinic at a Veterans Affairs medical center. Am J Health Syst Pharm. 2004; 61(1): 1341-1343.[Free Full Text]
- 65. Gilbert AL, Roughead EE, Beilby J, et al.: Collaborative medication management services: Improving patient care. Med J Aust. 2002; 177: 189-192.[Medline]
[Order article via Infotrieve]
- 66. Lee AJ, Boro MS, Knapp KK, et al.: Clinical and economic outcomes of pharmacist recommendations in a Veterans Affairs medical center. Am J Health-Syst Pharm. 2002; 59: 2070-2077.[Abstract/Free Full Text]
- 67. Leape L, Cullen DJ, Clapp MD, et al.: Pharmacist participation on physician rounds and adverse drug events in the Intensive Care Unit. JAMA. 1999; 282(3): 267-270.[Abstract/Free Full Text]
- 68. Schumock GT, Butler MG, Meek PD, et al.: Evidence of the economic benefit of clinical pharmacy services: 1996-2000. Pharmacotherapy. 2003: 23(1): 113-132.[CrossRef][Medline]
[Order article via Infotrieve]
- 69. Isetts BJ, Brown LM, Schondelmeyer SW, et al.: Quality assessment of a collaborative approach for decreasing drug-related morbidity and achieving therapeutic goals. Arch Int Med. 2003; 163: 1813-1820.[Abstract/Free Full Text]
- 70. Hardy J, Daly S, McQuade B, et al.: A double-blind, randomised, parallel group, multinational, multicentre study comparing a single dose of ondansetron 24 mg po with placebo and metoclopramide 10 mg tds po in the treatment of opioid-induced nausea and emesis in cancer patients. Support Care Cancer. 2002; 10: 231-236.[CrossRef][Medline]
[Order article via Infotrieve]
- 71. Lindley C, Goodin S, McCune J, et al.: Prevention of delayed chemotherapyinduced nausea and vomiting after moderately high to highly emetogenic chemotherapy: Comparison of ondansetron, prochlorperazine, and dexamethasone. Am J Clin Oncol. 2005; 28: 270-276.[CrossRef][Medline]
[Order article via Infotrieve]
- 72. Currow DC. Coughlan M, Fardell B, et al.: Use of ondansetron in palliative medicine. JPain Sympt Manage. 1997; 13(5): 302-307.[CrossRef]

CiteULike Connotea Del.icio.us Digg Reddit Technorati What's this?
This article has been cited by other articles:

|
 |

|
 |
 
G. J. Wood, J. W. Shega, B. Lynch, and J. H. Von Roenn
Management of Intractable Nausea and Vomiting in Patients at the End of Life: "I Was Feeling Nauseous All of the Time . . . Nothing Was Working"
JAMA,
September 12, 2007;
298(10):
1196 - 1207.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|