Skip to main content
Top
Published in: Supportive Care in Cancer 5/2006

01-05-2006 | Supportive Care International

Is the use of transdermal fentanyl inappropriate according to the WHO guidelines and the EAPC recommendations? A study of cancer patients in Italy

Authors: Carla Ripamonti, Elena Fagnoni, Tiziana Campa, Cinzia Brunelli, Franco De Conno

Published in: Supportive Care in Cancer | Issue 5/2006

Login to get access

Abstract

Background

World Health Organization (WHO) guidelines, Agency for Health Care Policy and Research (AHCPR) clinical practice guidelines, and EAPC recommendations indicate oral route of opioid administration as the preferred route. Transdermal administration of opioids is considered an alternative when patients cannot take medications orally. Moreover, WHO and EAPC indicate orally administered morphine as the first-choice drug for the treatment of moderate to severe cancer-related pain. However, we can see that in Italy there is an increasing use of transdermal fentanyl (TF) as first-choice strong opioid (and route) even when oral administration of opioids is possible.

Aims

The aims of this study are to describe the modality in the use of TF administration in two settings of care, taking into consideration (1) the drugs previously taken by the patients, (2) the reasons for switching from any drug to TF, (3) the conversion ratio used, and (4) the frequency of “inappropriate use of transdermal fentanyl according to the WHO guidelines and the EAPC recommendations”, i.e., switching to fentanyl patch from any drug, even if there were no contraindications in using oral morphine. The settings of care considered were the out-patient palliative care unit (OP-PCU) and the oncological wards (OWs) of the National Cancer Institute (NCI) of Milan.

Patients and methods

The clinical charts of 98 patients prescribed with and given fentanyl patch for the first time at the NCI of Milan in 2002 were reviewed and the data gathered were grouped according to the administration of fentanyl at the OP-PCU (63 out-patients) or at the OWs (35 in-patients). Summary descriptive statistics and bar and box plots have been used. Fisher two-tailed exact text was applied to test the differences between in- and out-patients.

Results

Before switching to TF, (1) in-patients were more frequently treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and weak opioids (mostly tramadol) in respect to the out-patients (44.1 vs 25.8%) who were mostly treated with oral morphine (48.4 vs 20.6%) (p=0.045), and (2) 88.7% of the out-patients were treated with oral opioids and only 1.6% with parenteral opioids in respect to OWs where 69.7% were on oral opioids and 18.2% on parenteral opioids (p=0.006). In 29% of out-patients and in 53% of in-patients, changing to fentanyl patch was considered as “inappropriate” (p=0.028) according to the WHO guidelines and the EAPC recommendations. No statistically significant differences between the two settings were observed regarding the reasons for switching and the conversion ratio used.

Conclusions

There is a trend to use fentanyl patch as first-choice strong opioid in cancer patients in situations such as titration phase, in the presence of instable pain, and in the absence of dysphagia or gastrointestinal symptoms where the use of oral morphine is, however, not contraindicated.
Literature
1.
go back to reference World Health Organization (1986) Cancer pain relief. World Health Organization, Geneva, Switzerland World Health Organization (1986) Cancer pain relief. World Health Organization, Geneva, Switzerland
2.
go back to reference World Health Organization (1996) Cancer pain relief, 2nd edn. World Health Organization, Geneva, Switzerland World Health Organization (1996) Cancer pain relief, 2nd edn. World Health Organization, Geneva, Switzerland
4.
go back to reference Hanks GW, De Conno F, Ripamonti C et al (Expert Working Group of the European Association for Palliative Care) (1996) Morphine in cancer pain: modes of administration. BMJ 312:823–826 Hanks GW, De Conno F, Ripamonti C et al (Expert Working Group of the European Association for Palliative Care) (1996) Morphine in cancer pain: modes of administration. BMJ 312:823–826
5.
go back to reference Hanks GW, De Conno F, Cherny N et al (Expert Working Group of the Research Network of the European Association for Palliative Care) (2001) Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 84(5):587–593PubMedCrossRef Hanks GW, De Conno F, Cherny N et al (Expert Working Group of the Research Network of the European Association for Palliative Care) (2001) Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 84(5):587–593PubMedCrossRef
6.
go back to reference Jacox A, Carr DB, Payne R et al (Agency for Health Care Policy and Research (AHCPR) Pharmacological Management) (1994) Recommendations. In: Management of cancer pain. Clinical Practice Guideline No 9. U.S. Department of Health and Human Services, Public Health Service, AHCPR Publication No 94-0592, March, Rockville Jacox A, Carr DB, Payne R et al (Agency for Health Care Policy and Research (AHCPR) Pharmacological Management) (1994) Recommendations. In: Management of cancer pain. Clinical Practice Guideline No 9. U.S. Department of Health and Human Services, Public Health Service, AHCPR Publication No 94-0592, March, Rockville
7.
8.
go back to reference Chinellato A, Terrazzani G, Walley T, Giusti P (2003) Opioids in Italy: is marketing more powerful than the law? Lancet 362:78PubMedCrossRef Chinellato A, Terrazzani G, Walley T, Giusti P (2003) Opioids in Italy: is marketing more powerful than the law? Lancet 362:78PubMedCrossRef
9.
go back to reference De Conno F, Ripamonti C, Brunelli C (2005) Opioid purchases and expenditure in nine western European countries. “Are we killing off morphine?” Palliat Med 19:179–184PubMedCrossRef De Conno F, Ripamonti C, Brunelli C (2005) Opioid purchases and expenditure in nine western European countries. “Are we killing off morphine?” Palliat Med 19:179–184PubMedCrossRef
10.
go back to reference Radbruch L, Nauck F, Sabatowski R (2002) Germany: Cancer pain and palliative care—current situation. J Pain Symptom Manage 24(2):183–187PubMedCrossRef Radbruch L, Nauck F, Sabatowski R (2002) Germany: Cancer pain and palliative care—current situation. J Pain Symptom Manage 24(2):183–187PubMedCrossRef
11.
go back to reference Kornik CA, Santiago-Palma J, Moryl N, Payne R (2003) Benefit–risk assessment of transdermal fentanyl for the treatment of chronic pain. Drug Saf 26(13):951–973CrossRef Kornik CA, Santiago-Palma J, Moryl N, Payne R (2003) Benefit–risk assessment of transdermal fentanyl for the treatment of chronic pain. Drug Saf 26(13):951–973CrossRef
12.
go back to reference Skaer TL (2004) Practice guidelines for transdermal opioids in malignant pain. Drugs 64(23):2629–2638PubMedCrossRef Skaer TL (2004) Practice guidelines for transdermal opioids in malignant pain. Drugs 64(23):2629–2638PubMedCrossRef
13.
go back to reference Scottish Intercollegiate Guidelines Network (SIGN) (2000) Cancer pain guidelines. SIGN, Edinburgh Scottish Intercollegiate Guidelines Network (SIGN) (2000) Cancer pain guidelines. SIGN, Edinburgh
14.
go back to reference Gourlay GK, Kowalski SR, Plummer JL et al (1989) The transdermal administration of fentanyl in the treatment of postoperative pain: pharmacokinetics and pharmacodynamic effects. Pain 37:193–202PubMedCrossRef Gourlay GK, Kowalski SR, Plummer JL et al (1989) The transdermal administration of fentanyl in the treatment of postoperative pain: pharmacokinetics and pharmacodynamic effects. Pain 37:193–202PubMedCrossRef
15.
go back to reference Korke W, de Stoutz N, Morant R (1996) Day-to-day titration to initiate transdermal fentanyl in patients with cancer pain: short- and long-term experiences in a prospective study of 39 patients. J Pain Symptom Manage 11:139–146CrossRef Korke W, de Stoutz N, Morant R (1996) Day-to-day titration to initiate transdermal fentanyl in patients with cancer pain: short- and long-term experiences in a prospective study of 39 patients. J Pain Symptom Manage 11:139–146CrossRef
16.
go back to reference Portenoy RK, Southam MA, Gupta SK et al (1993) Transdermal fentanyl for cancer pain: repeated dose pharmacokinetics. Anesthesiology 78:36–43PubMedCrossRef Portenoy RK, Southam MA, Gupta SK et al (1993) Transdermal fentanyl for cancer pain: repeated dose pharmacokinetics. Anesthesiology 78:36–43PubMedCrossRef
17.
go back to reference Varvel JR, Shaker SL, Hwang SS et al (1989) Absorption characteristics of transdermally administered fentanyl. Anesthesiology 70:928–934PubMedCrossRef Varvel JR, Shaker SL, Hwang SS et al (1989) Absorption characteristics of transdermally administered fentanyl. Anesthesiology 70:928–934PubMedCrossRef
18.
go back to reference Holley FO, Van Steennis C (1988) Postoperative analgesia with fentanyl: pharmacokinetics and pharmacodynamics of constant-rate IV and transdermal delivery: Br J Anaesth 60:608–613PubMedCrossRef Holley FO, Van Steennis C (1988) Postoperative analgesia with fentanyl: pharmacokinetics and pharmacodynamics of constant-rate IV and transdermal delivery: Br J Anaesth 60:608–613PubMedCrossRef
19.
go back to reference Gourlay GK, Kowalski SR, Plummer JL et al (1990) The efficacy of transdermal fentanyl in the treatment of postoperative pain: a double-blind comparison of fentanyl and placebo systems. Pain 20:21–28CrossRef Gourlay GK, Kowalski SR, Plummer JL et al (1990) The efficacy of transdermal fentanyl in the treatment of postoperative pain: a double-blind comparison of fentanyl and placebo systems. Pain 20:21–28CrossRef
20.
go back to reference Mystakidou K, Befon S, Kouskouni E, Gerolymatos K, Georgaki S, Tsilika E, Vlahos L (2001) From codeine to transdermal fentanyl for cancer pain control: a safety and efficacy clinical trial. Anticancer Res 21:2225–2230PubMed Mystakidou K, Befon S, Kouskouni E, Gerolymatos K, Georgaki S, Tsilika E, Vlahos L (2001) From codeine to transdermal fentanyl for cancer pain control: a safety and efficacy clinical trial. Anticancer Res 21:2225–2230PubMed
21.
go back to reference Burza M, Ginobbi P, Fusco G, Laurenzi L, Tirelli W, Arcuri E (1998) Transdermal route as an alternative to oral administration of opioids in cancer pain. Clin Ter 149(4):277–280PubMed Burza M, Ginobbi P, Fusco G, Laurenzi L, Tirelli W, Arcuri E (1998) Transdermal route as an alternative to oral administration of opioids in cancer pain. Clin Ter 149(4):277–280PubMed
22.
go back to reference Van Seventer R, Smit JM, Schipper RM, Wicks MA, Zuurmond WWA (2003) 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 19(6):457–469PubMedCrossRef Van Seventer R, Smit JM, Schipper RM, Wicks MA, Zuurmond WWA (2003) 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 19(6):457–469PubMedCrossRef
23.
go back to reference Tawfik MO, Bryuzgin V and Kourteva G (FEN-INT-20 Study Group) (2004) Use of transdermal fentanyl without prior opioid stabilization in patients with cancer pain. Curr Med Res Opin 20(3):259–267PubMedCrossRef Tawfik MO, Bryuzgin V and Kourteva G (FEN-INT-20 Study Group) (2004) Use of transdermal fentanyl without prior opioid stabilization in patients with cancer pain. Curr Med Res Opin 20(3):259–267PubMedCrossRef
24.
go back to reference Vielvoye-Kerkmeer A, Mattern C, Uitendaal MP (2000) Transdermal fentanyl in opioid-naïve cancer patients: an open trial using transdermal fentanyl for the treatment of chronic cancer pain in opioid-naïve patients and a group using codeine. J Pain Symptom Manage 19:185–192PubMedCrossRef Vielvoye-Kerkmeer A, Mattern C, Uitendaal MP (2000) Transdermal fentanyl in opioid-naïve cancer patients: an open trial using transdermal fentanyl for the treatment of chronic cancer pain in opioid-naïve patients and a group using codeine. J Pain Symptom Manage 19:185–192PubMedCrossRef
26.
go back to reference Megens A, Artois K, Vermeire J et al (1998) Comparison of the analgesic and intestinal effects of fentanyl and morphine in rats. J Pain Symptom Manage 15:253–257PubMedCrossRef Megens A, Artois K, Vermeire J et al (1998) Comparison of the analgesic and intestinal effects of fentanyl and morphine in rats. J Pain Symptom Manage 15:253–257PubMedCrossRef
27.
go back to reference Ahmedzai S, Brooks D (1997) Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life—the TTS-fentanyl Comparative Trial Group. J Pain Symptom Manage 13:254–261PubMedCrossRef Ahmedzai S, Brooks D (1997) Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life—the TTS-fentanyl Comparative Trial Group. J Pain Symptom Manage 13:254–261PubMedCrossRef
28.
go back to reference Donner B, Zenz M, Tryba M et al (1996) Direct conversion from oral morphine to transdermal fentanyl: a multicenter study in patients with cancer pain. Pain 64:527–534PubMedCrossRef Donner B, Zenz M, Tryba M et al (1996) Direct conversion from oral morphine to transdermal fentanyl: a multicenter study in patients with cancer pain. Pain 64:527–534PubMedCrossRef
29.
go back to reference Payne R, Mathias SD, Pasta DJ et al (1998) Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol 16:1588–1593PubMed Payne R, Mathias SD, Pasta DJ et al (1998) Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol 16:1588–1593PubMed
30.
go back to reference Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V (Expert Working Group the Research Network of EAPC) (2001) Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol 19:2542–2554PubMed Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V (Expert Working Group the Research Network of EAPC) (2001) Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol 19:2542–2554PubMed
31.
go back to reference Radbruch L, Sabatowski R, Loick G, Kulbe C, Kasper M, Grond S, Lehmann KA (2000) Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine. Palliat Med 14:111–119PubMedCrossRef Radbruch L, Sabatowski R, Loick G, Kulbe C, Kasper M, Grond S, Lehmann KA (2000) Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine. Palliat Med 14:111–119PubMedCrossRef
Metadata
Title
Is the use of transdermal fentanyl inappropriate according to the WHO guidelines and the EAPC recommendations? A study of cancer patients in Italy
Authors
Carla Ripamonti
Elena Fagnoni
Tiziana Campa
Cinzia Brunelli
Franco De Conno
Publication date
01-05-2006
Publisher
Springer-Verlag
Published in
Supportive Care in Cancer / Issue 5/2006
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-005-0918-0

Other articles of this Issue 5/2006

Supportive Care in Cancer 5/2006 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine