Debate over the risks of long-term opioid therapy: “Don’t throw the
baby out with the bathwater”
New EFIC recommendations
EFIC President elect Prof Bart Morlion pleaded for the rational use of opioids. At the Congress of the
European Pain Federation EFIC he argued that the situation in Europe and North America with
respect to potential opioid risks were not comparable and advocated careful scrutiny of indications to
prescribe opioids as well as regular evaluation of patients. In autumn the European Pain Federation
EFIC plans to publish guidance for the appropriate use of opioids in Europe.
Vienna, 3 September 2015 – At the EFIC Congress taking place in Vienna, Prof Bart Morlion,
President elect of the European Pain Federation EFIC, warned that in view of recent debates on longterm therapy with opioid analgesics, “we don’t want to throw the baby out with the bathwater by being
overcautious. Chronic pain destroys lives and we have few tools at our disposal. Opioids provide
important therapeutic options in bringing relief from acute and chronic pain. We should not restigmatise these analgesics, but instead clarify how than can be used safely and effectively.” More
than 4,000 experts from across the globe have gathered in the Austrian capital to discuss the latest
trends and developments in all areas of pain medicine.
The Belgian pain expert’s appeal in respect of opioid therapy comes in the light of the fact that opioids
are prescribed 7.5 times more frequently today than they were in 1990. “From the point of view of pain
medicine, it is a positive development that the stigmatisation of opioids is retreating, at least in some
parts of the world,” Prof Morlion argued. Nevertheless, recent debate on the use of opioids has
highlighted the problem of addiction and other risks, especially on the basis of publications from the
USA, Canada and Australia. The US Food and Drug Administration (FDA) has refined the indications
for opioid prescription and called upon manufacturers to conduct more studies on the risks of misuse,
addiction, hypersensitivity to pain, overdose and death. And the European Council has initiated a
discussion on the topic of medication misuse and addiction, with a particular focus on opioid
analgesics.
US data do not reflect the European situation
Sales of opioid analgesics quadrupled in the USA between 1999 and 2010. “This was in part due to
the fact that pain had often gone untreated. But, for example, a disproportionate increase was seen in
prescriptions for chronic musculoskeletal pain, and this should definitely be looked into,” Prof Morlion
commented. Developments in North America have even been described as an “opioid epidemic.”
More than 100,000 people have died directly or indirectly as a result of taking prescribed opioids in the
USA over the last twenty years, with over 16,000 deaths recorded in 2010.
However, Prof Morlion argued against generalising data from the USA and applying them to Europe.
“The problem of misuse is more serious in North America, partly also in Australia, because the
prescription of opioids is less strictly regulated than in Europe, where access is closely controlled by
the use of special prescription forms and drug abuse registers,” he explained.
In 2010 per capita use of strong opioids was 693 morphine equivalents in the USA – significantly
higher than in other high income countries where there are greater controls on prescribing the drugs:
in Denmark the figure was 470 morphine equivalents per capita, in Germany 276, in the UK 335, in
Norway 266, in France 220, in the Netherlands 205, in Italy 144 and in Japan 26. “Reports on
increasing problems with opioids, particularly from North America, are mostly related to long-term
prescription with a lack of careful patient selection and patient reassessment,” Prof. Morlion
commented. In some US states, so-called pill mills – clinical facilities that prescribe controlled
substances such as opioids without careful consideration of guidelines and indications – may have led
to many opioid-related deaths.
Randomised control trials have shown opioids to be highly effective not only in treating cancer-related
pain, but also in therapy for non-cancer pain. Long-term follow-up studies have demonstrated that this
effectiveness can be maintained for extended periods. Nevertheless, adverse effects cannot be
disregarded. Side effects can include constipation, nausea, vomiting and dizziness. Long-term
consequences have included inhibition of endogenous sex hormone production and infertility.
Immunosuppression, sleep-disordered breathing and increased sensitivity to pain are other possible
consequences. Death from unintentional overdosing can also occur.
European recommendations to be published in autumn
Prescription practices in Europe still vary between different countries. For this reason, the European
Pain Federation EFIC has created a working group to develop Europe-wide guidance on appropriate
and responsible use of opioids, especially in long-term treatment of chronic pain. The EFIC
recommendations are expected later in autumn. “The guidelines should provide doctors throughout
Europe with support and advice for optimal use of opioid analgesics that is easy to put into practice,”
explained Prof. Morlion. “The key aims of optimised treatment with opioids are effective pain relief, a
high level of safety, the avoidance of substance abuse and ensuring social participation in patients.”
Strategies for safe opioid therapy
“There are certainly many good reasons for the increase in prescription rates. However, in future more
care needs to be taken to ensure that opioids are the right choice for the individual patient,” Prof
Morlion emphasised. The value of opioid therapy must be assessed for each patient through
differential diagnosis, and by weighing up the risk of concomitant disorders as well as the potential for
opioid-related adverse effects and substance abuse. For patients who do not respond to opioid
treatment, opioid rotation – switching to a different opioid – should be considered before simply
discontinuing therapy. But exit strategies should be in place from the beginning of treatment. Because
chronic opioid therapy is known to be associated with dose-dependent adverse effects on several
organ systems, various practice guidelines recommend that for a morphine equivalent dose (MED) of
80-120mg per day or above, providers should seek consultation from a pain specialist before
proceeding. “Regular monitoring and reassessment are essential in cases of long-term opioid
prescription. Patient care by doctors must not be limited to just prescribing ‘refills’,” Prof. Morlion
underlined. Clinicians prescribing opioids need to be familiar with monitoring patients. Moreover,
pharmacotherapy with opioids should always be placed within the framework of a multimodal,
interdisciplinary treatment strategy.
“We need to look at the increasing use of opioids from a number of different angles. Opioids are not
without side effects, and for this reason they should only be prescribed in cases where there is a good
balance between pain relief and side effects, where there are long-term benefits, and where other
methods of treatment have failed,” Prof Morlion concluded. “As a specialist European organisation, we
are dedicated to making the case for a sensible balance between underprescription, and
overprescription and the problems of substance abuse. We can’t allow misuse in some parts of the
world to result in calls for global restrictions that would create insurmountable barriers to patients
receiving opioids when they are urgently needed to manage pain.”
EFIC Press Office
B&K - Bettschart&Kofler Kommunikationsberatung
Dr Birgit Kofler
Ph.: +43 1 3194378; +43 676 6368930; +49 172 7949286
E-mail kofler@bkkommunikation.com