EDITORIAL For reprint orders, please contact: [email protected]
What to do about opioids for chronic noncancer pain? A perspective from Australia “…unlike other disease areas where the issues are purely medical and hence in principle addressable by guidelines, the issues around appropriate opioid use and misuse go beyond the strictly medical and include the psychological, sociological, legal and regulatory.” Paul Rolan† Many countries in the developed world are awash with opioid overuse, misuse and opioid-related deaths, which have paralleled the increasing medical use of opioids for chronic noncancer pain [1] . This is despite growing concern over the efficacy of these drugs in long-term management. To attempt to reduce the harm associated with opioids but to ensure the continued availability for patient benefit, multiple attempts to develop guidelines, improve regulation and training have recently been attempted or are in progress [2,101,102] . However, unlike other disease areas where the issues are purely medical and hence in principle addressable by guidelines, the issues around appropriate opioid use and misuse go beyond the strictly medical and include the psychological, sociological, legal and regulatory. Hence strategies extending beyond guideline development are likely to be necessary. Given these multiple overlapping areas, it is likely that any solution will not be directly translatable into another healthcare environment although some individual points may be common across jurisdictions. In Australia, our healthcare environment has many similarities with those in western Europe and in Canada being largely based
on the public sector with universal insurance and medication reimbursement to some degree. However there are some initiatives and systems unique to Australia, which may put us in a stronger position to find the right balance and methods to achieve Quality Use of Medicines for this difficult class of treatments. Australia is unique in having a National Medicines Policy [103] . This was initially launched in 1999 with the objective to improve positive health outcomes for all Australians through their access to and wise use of medicines. The chair of the eightmember committee, which is responsible for policy development, sits on an executive group which reports directly to the Federal Health Minister. This gives a remarkably short path for an advisory group to access the highest levels of government so that policy recommendations can be actioned. The National Medicines Policy is currently developing a policy on opioid use for chronic noncancer pain. It is reasonable to anticipate that recommendations made will be translated into action. The second unique structural component to our healthcare system is NPS, formerly known as the National Prescribing
“Many countries in the developed world are awash with opioid overuse, misuse and opioid-related deaths, which have paralleled the increasing medical use of opioids for chronic noncancer pain.”
Medical School, University of Adelaide, Adelaide, Australia; Tel.: +61 883 034 102; Fax: +61 883 224 0685; [email protected] †
10.2217/PMT.11.59 © 2011 Future Medicine Ltd
Pain Manage. (2011) 1(6), 495–497
ISSN 1758-1869
495
Editorial Rolan
“Australia has a good track record of research of the clinical pharmacology of the opioids and we expect to contribute to the global evidence base on which to make informed policies.”
Service [104] . NPS is an independent group, established in 1998, funded by the federal government, with objectives of helping health professionals and consumers access up-to-date, unbiased comparative information on medicines and other healthcare technologies. In addition to providing information, NPS has developed training modules for healthcare practitioners in the areas of pain management and opioid use. Recently, NPS has received federal funding for a medicines monitoring project in which the prescribing at over 500 general practitioner (family physician) practices will be analyzed: records will be for over 1% of the population [104] . This will provide excellent information of how opioids, among other drugs for pain, are being used in clinical practice in a wide variety of demographic groups so that it can be compared with best practice. Another world first for Australia is a National Pain Strategy, lead by Professor Michael Cousins and released in 2009 [105] . This brought together pain and mental health practitioners, consumer groups and researchers to facilitate the recognition that chronic pain is a disease in its own right with high societal impact. It followed on from the development of a specialist medical college, the Faculty of Pain Medicine, with the collaboration of five medical colleges. More recently, the Institute of Medicine in the USA has released a similar report, highlighting the similar problem that pain research accounts for a grossly disproportionately low proportion of national research funding (only about 1%) compared with the level of disease impact [106] . It is hoped that such activities will foster an environment more conducible to research funding. Another important program with regards to opioids is the development of a National Prescription Drug Misuse Strategy. This is currently in development with the aim of recommending actions to ensure that drugs such as opioids and benzodiazepines are only prescribed appropriately and that misuse is promptly detected and managed. The strategy is likely to become part of the National Medicines Policy. It is premature to speculate on the likely outcomes of all these activities. However it would be surprising if some of the following were not considered: Specific training of prescribers with regard to
opioid prescribing, including pretreatment counseling; development of agreed management
496
Pain Manage. (2011) 1(6)
plans with the patients; when to stop; how to monitor and deal with a demanding patient; perhaps specific credentialing; Public education to improve health literacy in
the appropriate role of medication in pain management; Adequate access to nonopioid alternatives
including non-drug therapies; New technologies for monitoring, reconciling
prescribing with use; Differential reimbursement of medication
based on abuse potential; Priority research funding to address important
gaps in the evidence base. The main technique used to develop such a policy is likely to be by consensus among the relevant parties – medical, allied health, regulatory and government. The ideal method would be in response to a sound evidence base on the best actions and policies. Unfortunately, there is a glaring absence of data on which to base policy. Indeed, a recent publication from the American Academy of Pain Medicine regarding research gaps on use of opioids for chronic noncancer pain [3] could have its title paraphrased as ‘Thirty seven things we need to know about opioids but don’t’. This is particularly embarrassing for a class of drugs used in medical practice for several thousand years. Long held consensus views may need to be challenged. For example, the dogma that controlled release formulations are superior to instant release formulation has recently come into question [4,5] . Additionally, the potentially reduced abuse potential of formulations which contain low doses of opioid antagonists with poor oral bioavailability, intended to reduce constipation or to increase efficacy, does not appear to have been systematically studied. Australia has a good track record of research of the clinical pharmacology of the opioids and we expect to contribute to the global evidence base on which to make informed policies. Financial & competing interests disclosure The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
future science group
What to do about opioids for chronic noncancer pain? A perspective from Australia Bibliography 1
Okie S. A flood of opioids, a rising tide of deaths. N. Engl. J. Med. 363(21), 1981–1985 (2010).
2
Chou R, Fanciullo GJ, Fine PG et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J. Pain 10(2), 113–130 (2009).
3
4
Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J. Pain 10(2), 147–159 (2009). Ballantyne J. Opioids around the clock? Pain 152(6), 1221–1222 (2011).
future science group
5
Von Korff M, Merrill JO, Rutter CM et al. Time-scheduled versus pain-contingent opioid dosing in chronic opioid therapy. Pain 152(6), 1256–1262 (2011).
Websites
Editorial
103 Department of Health and Ageing – National
medicines policy www.health.gov.au/internet/main/publishing. nsf/content/National+Medicines+Policy-1 (Accessed 31 August 2011) 104 National Prescribing Service, an independent
101 Canadian guideline for safe and effective use
of opioids for chronic non-cancer pain http://nationalpaincentre.mcmaster.ca/opioid (Accessed 31 August 2011) 102 Prescription Opioid Policy: Improving
mangement of chronic non-malignant pain and prevention of problems associated with prescription opioid use www.racp.edu.au/page/policy-and-advocacy/ public-health-and-social-policy (Accessed 31 August 2011)
provider of medical information in Australia www.nps.org.au (Accessed 31 August 2011) 105 Pain Australia, National Pain Strategy
www.painaustralia.org.au/strategy (Accessed 31 August 2011) 106 Institute of Medicine. Relieving pain in
America: a blueprint for transforming prevention, care, education and research www.iom.edu/Reports/2011/Relieving-Painin-America-A-Blueprint-for-TransformingPrevention-Care-Education-Research.aspx (Accessed 31 August 2011)
www.futuremedicine.com
497
What to do about opioids for chronic noncancer pain? A perspective from Australia “…unlike other disease areas where the issues are purely medical and hence in principle addressable by guidelines, the issues around appropriate opioid use and misuse go beyond the strictly medical and include the psychological, sociological, legal and regulatory.” Paul Rolan† Many countries in the developed world are awash with opioid overuse, misuse and opioid-related deaths, which have paralleled the increasing medical use of opioids for chronic noncancer pain [1] . This is despite growing concern over the efficacy of these drugs in long-term management. To attempt to reduce the harm associated with opioids but to ensure the continued availability for patient benefit, multiple attempts to develop guidelines, improve regulation and training have recently been attempted or are in progress [2,101,102] . However, unlike other disease areas where the issues are purely medical and hence in principle addressable by guidelines, the issues around appropriate opioid use and misuse go beyond the strictly medical and include the psychological, sociological, legal and regulatory. Hence strategies extending beyond guideline development are likely to be necessary. Given these multiple overlapping areas, it is likely that any solution will not be directly translatable into another healthcare environment although some individual points may be common across jurisdictions. In Australia, our healthcare environment has many similarities with those in western Europe and in Canada being largely based
on the public sector with universal insurance and medication reimbursement to some degree. However there are some initiatives and systems unique to Australia, which may put us in a stronger position to find the right balance and methods to achieve Quality Use of Medicines for this difficult class of treatments. Australia is unique in having a National Medicines Policy [103] . This was initially launched in 1999 with the objective to improve positive health outcomes for all Australians through their access to and wise use of medicines. The chair of the eightmember committee, which is responsible for policy development, sits on an executive group which reports directly to the Federal Health Minister. This gives a remarkably short path for an advisory group to access the highest levels of government so that policy recommendations can be actioned. The National Medicines Policy is currently developing a policy on opioid use for chronic noncancer pain. It is reasonable to anticipate that recommendations made will be translated into action. The second unique structural component to our healthcare system is NPS, formerly known as the National Prescribing
“Many countries in the developed world are awash with opioid overuse, misuse and opioid-related deaths, which have paralleled the increasing medical use of opioids for chronic noncancer pain.”
Medical School, University of Adelaide, Adelaide, Australia; Tel.: +61 883 034 102; Fax: +61 883 224 0685; [email protected] †
10.2217/PMT.11.59 © 2011 Future Medicine Ltd
Pain Manage. (2011) 1(6), 495–497
ISSN 1758-1869
495
Editorial Rolan
“Australia has a good track record of research of the clinical pharmacology of the opioids and we expect to contribute to the global evidence base on which to make informed policies.”
Service [104] . NPS is an independent group, established in 1998, funded by the federal government, with objectives of helping health professionals and consumers access up-to-date, unbiased comparative information on medicines and other healthcare technologies. In addition to providing information, NPS has developed training modules for healthcare practitioners in the areas of pain management and opioid use. Recently, NPS has received federal funding for a medicines monitoring project in which the prescribing at over 500 general practitioner (family physician) practices will be analyzed: records will be for over 1% of the population [104] . This will provide excellent information of how opioids, among other drugs for pain, are being used in clinical practice in a wide variety of demographic groups so that it can be compared with best practice. Another world first for Australia is a National Pain Strategy, lead by Professor Michael Cousins and released in 2009 [105] . This brought together pain and mental health practitioners, consumer groups and researchers to facilitate the recognition that chronic pain is a disease in its own right with high societal impact. It followed on from the development of a specialist medical college, the Faculty of Pain Medicine, with the collaboration of five medical colleges. More recently, the Institute of Medicine in the USA has released a similar report, highlighting the similar problem that pain research accounts for a grossly disproportionately low proportion of national research funding (only about 1%) compared with the level of disease impact [106] . It is hoped that such activities will foster an environment more conducible to research funding. Another important program with regards to opioids is the development of a National Prescription Drug Misuse Strategy. This is currently in development with the aim of recommending actions to ensure that drugs such as opioids and benzodiazepines are only prescribed appropriately and that misuse is promptly detected and managed. The strategy is likely to become part of the National Medicines Policy. It is premature to speculate on the likely outcomes of all these activities. However it would be surprising if some of the following were not considered: Specific training of prescribers with regard to
opioid prescribing, including pretreatment counseling; development of agreed management
496
Pain Manage. (2011) 1(6)
plans with the patients; when to stop; how to monitor and deal with a demanding patient; perhaps specific credentialing; Public education to improve health literacy in
the appropriate role of medication in pain management; Adequate access to nonopioid alternatives
including non-drug therapies; New technologies for monitoring, reconciling
prescribing with use; Differential reimbursement of medication
based on abuse potential; Priority research funding to address important
gaps in the evidence base. The main technique used to develop such a policy is likely to be by consensus among the relevant parties – medical, allied health, regulatory and government. The ideal method would be in response to a sound evidence base on the best actions and policies. Unfortunately, there is a glaring absence of data on which to base policy. Indeed, a recent publication from the American Academy of Pain Medicine regarding research gaps on use of opioids for chronic noncancer pain [3] could have its title paraphrased as ‘Thirty seven things we need to know about opioids but don’t’. This is particularly embarrassing for a class of drugs used in medical practice for several thousand years. Long held consensus views may need to be challenged. For example, the dogma that controlled release formulations are superior to instant release formulation has recently come into question [4,5] . Additionally, the potentially reduced abuse potential of formulations which contain low doses of opioid antagonists with poor oral bioavailability, intended to reduce constipation or to increase efficacy, does not appear to have been systematically studied. Australia has a good track record of research of the clinical pharmacology of the opioids and we expect to contribute to the global evidence base on which to make informed policies. Financial & competing interests disclosure The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
future science group
What to do about opioids for chronic noncancer pain? A perspective from Australia Bibliography 1
Okie S. A flood of opioids, a rising tide of deaths. N. Engl. J. Med. 363(21), 1981–1985 (2010).
2
Chou R, Fanciullo GJ, Fine PG et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J. Pain 10(2), 113–130 (2009).
3
4
Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J. Pain 10(2), 147–159 (2009). Ballantyne J. Opioids around the clock? Pain 152(6), 1221–1222 (2011).
future science group
5
Von Korff M, Merrill JO, Rutter CM et al. Time-scheduled versus pain-contingent opioid dosing in chronic opioid therapy. Pain 152(6), 1256–1262 (2011).
Websites
Editorial
103 Department of Health and Ageing – National
medicines policy www.health.gov.au/internet/main/publishing. nsf/content/National+Medicines+Policy-1 (Accessed 31 August 2011) 104 National Prescribing Service, an independent
101 Canadian guideline for safe and effective use
of opioids for chronic non-cancer pain http://nationalpaincentre.mcmaster.ca/opioid (Accessed 31 August 2011) 102 Prescription Opioid Policy: Improving
mangement of chronic non-malignant pain and prevention of problems associated with prescription opioid use www.racp.edu.au/page/policy-and-advocacy/ public-health-and-social-policy (Accessed 31 August 2011)
provider of medical information in Australia www.nps.org.au (Accessed 31 August 2011) 105 Pain Australia, National Pain Strategy
www.painaustralia.org.au/strategy (Accessed 31 August 2011) 106 Institute of Medicine. Relieving pain in
America: a blueprint for transforming prevention, care, education and research www.iom.edu/Reports/2011/Relieving-Painin-America-A-Blueprint-for-TransformingPrevention-Care-Education-Research.aspx (Accessed 31 August 2011)
www.futuremedicine.com
497
