C Explanatory memorandum
by Mr Joseph O’Reilly, rapporteur
1 Introduction
1. Addiction to prescribed medicines
is a worldwide problem, which has dramatic consequences for the well-being
of the people concerned (and that of their families), and a high
social and economic cost for society. It has reached epidemic proportions
in the United States, where in pre-pandemic 2017 an estimated 18
million people had misused prescription medications at least once
Note and on average, 130 people died of
opioid overdoses each day – more than doubling during the pandemic,
to more than 270 a day.
Note The problem is extending rapidly
in other parts of the world,
Note including Europe, where it is evidenced,
for example, by the growing number of people entering treatment
services for non-medical use of pharmaceutical opioids.
Note However, while such
addiction was among the leading public health issues in the United
States before 2020, it remains largely under-researched and under-reported
in Europe. The Covid-19 pandemic seems to have further exacerbated
the problem worldwide,
Note disrupting treatment services, multiplying
and worsening mental health problems, and bumping the topic further
down on public health priority lists.
2. Finding the right terminology to use in this report has not
been easy. The motion for a recommendation which started off the
work of our committee on this topic was entitled “Involuntary addiction
to prescription medicines.” The term “involuntary addiction” was
originally used to stress the lack of choice/control on the part of
the person addicted to prescription medicines, in contrast to persons
“choosing” to engage in “recreational” drug use or self-medicating.
Fundamentally, however, no-one chooses to become an addict: all
addiction is involuntary. According to the European Monitoring Centre
for Drugs and Drug Addiction, addiction is “a repeated powerful
motivation to engage in a purposeful behaviour that has no survival
value, acquired as a result of engaging in that behaviour, with
significant potential for unintended harm”. In the case of addiction
to prescription medicines, it is usually the result of an insidious
and gradual process of giving up control of one’s own life for the
sake of relief provided by the medicine, typically to counter physical
or psychological pain.
3. I have decided to use the term “prescribed medicines” rather
than “prescription medicines” in this report,
Note in order to
focus on the prevention, identification, management and treatment
of addiction to prescribed medicines. Dealing with addiction to
prescription medicines in general, many of which are acquired illegally and/or
on the black market, and thus are also often falsified, would require
a slightly different focus.
Note I
have also used the term “addiction to” rather than “dependence on”
throughout the report;
NoteNoteNote this has been criticised as
stigmatising,
Note in
particular for patients (physiologically) dependent on prescribed
antidepressants. My aim has not been to stigmatise anyone, but the
submissions have come too late for me to re-write my whole report, though
I am preparing an amendment to paragraph 2.2. of the draft recommendation.
4. Addressing addiction to prescribed medicines is essential
for human rights protection and sustainable development. According
to the World Health Organization (WHO), “the enjoyment of the highest
attainable standard of health is one of the fundamental rights of
every human being”.
Note Such enjoyment is clearly undermined
by any kind of addiction. Target 3.5 of the United Nations 2030
Agenda for Sustainable Development which is devoted to strengthening
the prevention and treatment of substance abuse, needs to be used
as a global framework and impetus for stronger action in this area
– now, at the (hopefully) tail-end of a global pandemic, more than
ever before.
5. Effective access to prescribed medicines is also an integral
part of the right to health. Indeed, the Single Convention on Narcotic
Drugs of 1961 recognises that the medical use of narcotic drugs
is indispensable for the relief of pain and suffering and requires
that the availability of such medicines is assured and not unduly restricted.
Thus, regulations should not limit distribution of prescribed medicines
for those in need, so that patients do not become hostage to restrictive
national regulations (which can be the case for patients in end-of-life
situations who need access to strong narcotic painkillers as part
of cancer or palliative care, for example, or for patients prescribed
similar medicines as part of the treatment of substance-abuse disorders).
Note
6. In short, dealing with addiction to prescribed medicines is
all about balancing the competing needs of ensuring effective access
to prescribed medicines as an integral part of the right to health,
and preventing nefarious addiction to prescribed medicines as an
integral part of the same right to health, free of dependency or
addiction. My aim in drafting this report has been to explore the
current situation in Europe with respect to addiction to prescribed
medicines, examine examples of good practice – in particular thanks
to a fact-finding visit to Denmark – and make recommendations on
how to ensure that patients who need the medicines get them; unnecessary
or inappropriate use is prevented; alternative treatments are used
as much as possible; risks are minimised; and relevant support is
provided to the victims of addiction.
2 Aim and scope of the report
7. A prescription medicine is
a pharmaceutical product that legally requires a medical prescription
to be dispensed. In contrast, over-the-counter medicine can be obtained
without a prescription. The aim of this limitation is to ensure
that the medicine is used by the patient concerned for a specific
purpose and in accordance with the instructions (for example duration,
dosage) of a qualified health professional.
8. The following types of medicines are most susceptible to creating
addiction: 1) stimulants, which are prescribed to control impulse
control disorders, for example attention deficit hyperactivity disorder;
2) opioids, which are prescribed mostly against pain and 3) tranquilisers
/ sedatives and anti-depressants, which are prescribed to treat
anxiety, depression, sleep disorders, etc.
Note
9. There are many cases when the addiction to prescription medicines
has its origin in the intake of such medicines as part of a treatment
prescribed by a health professional.
Note Different pathways towards
and out of addiction have been identified for different groups of
the population (young people, women, older generation, children).
In Denmark, for example, some patients’ pharmacological dependence
on prescribed medicines is treated via a tapering-off regimen with
their general practitioner, while other patients present more complicated addiction
quandaries (including psychological dependence, multi-co-dependencies,
or other problems) and are treated in specialised pain or withdrawal
centres.
10. Addiction to prescription medicines has skyrocketed in the
recent decades,
Note due
to the availability and marketing of new forms of medicines, such
as opioids (for example OxyContin, or tramadol). In 2018, globally, the
production of opium and manufacture of cocaine was at the highest
levels ever recorded.
Note At
the same time, global opium production in 2020 has stabilised.
Note While increasing use
of their derivatives by pharmaceutical industries helps immensely
to reduce the suffering of many people across the world, it also raises
some serious concerns.
11. The pharmaceutical industry has a vested interest in generating
sales to cover ever growing expenditures on research and development
and marketing.
Note The
Assembly raised the issue of the compatibility of public health
and the interests of the pharmaceutical industry in its
Resolution 2071 (2015) “Public health and the interests of the pharmaceutical
industry: how to guarantee the primacy of public health interests?”.
This is without doubt an important area to consider in the present
report as well, in particular in view of the conviction of Insys
Therapeutics – a pharmaceutical company in the US – found guilty
of racketeering charges in a rare criminal prosecution,
Note and the US$270 million settlement by Purdue
Pharma over its powerful narcotic prescription painkiller, OxyContin.
Note Many more cases against the companies alleged
to have fuelled the opioid epidemic in America are still being litigated.
On 26 August 2019, a judge in Oklahoma ruled that Johnson &
Johnson had intentionally played down the dangers and oversold the
benefits of opioids and ordered it to pay the State US$572 million;
however, the ruling was overturned by the Oklahoma supreme court
in November 2021.
NoteNoteIn any case, lack of regulation in the field,
leads to a low level of accountability, thousands of lives lost,
and long-term losses for the pharmaceutical industry, as the case
of the Purdue Pharma bankruptcy in 2021 illustrates.
Note The US Congress is currently investigating
the role of the global consulting company McKinsey & Company
over its role in the opioid crisis, related to its business practices,
conflicts of interest and management standards.
Note
12. Furthermore, such medicines are sometimes prescribed too easily
and for longer than necessary. In fact, it is not always possible
for doctors to assess the level of distress of the patient and to
recognise a possible addiction. Relevant training, guidelines or
standards are not always consistent or sufficient. Also, “shared decision
making” is part of the culture in some countries, and patients can
ask for a specific medicine that has worked well for them in the
past.
13. Once addiction has set in, when medicines are not available
from doctors, they are often procured from friends, family, or through
“pharmacy hopping” or “pharmacy tourism”. The Internet is becoming
a new additional source of medicines which is easily accessible
and difficult to control. Addiction to prescription medicines is
thus often likely to result in the subsequent use of falsified medicines
and/or illegal drugs.
14. I am convinced that the “war on drugs”-approach is not appropriate
to address this issue. I also feel that addiction to prescribed
medicines is highly complex, and a systemic social problem that
requires a holistic and multidisciplinary approach. In this report,
I will 1) highlight the main challenges, including the impact of
the Covid-19 pandemic; 2) explore the current policies and strategies
in this area; 3) examine to what extent they consider the specific
needs of various groups of people and whether they address the root
causes of addiction to prescription drugs. I will then propose policy
recommendations on how a public health model could be developed
and strengthened, to prevent and address addiction to prescribed
medicines. I also hope that this report will allow to promote public
debate and raise awareness of the scale and gravity of this problem
in Europe.
15. I have analysed the available research, including reports
of the United Nations Drug Control Programme, the World Health Organization,
the European Monitoring Centre for Drugs and Drug Addiction and
the Council of Europe’s Co-operation Group to Combat Drug Abuse
and Illicit Trafficking in Drugs (Pompidou Group). I have also based
my report on the Assembly’s work on “Drug policy and human rights
in Europe: a baseline study,”
Note in
which I was involved as rapporteur for opinion and have updated
it on the basis of recent media reports. Finally, I visited Denmark,
a country with well-developed policy in this area, on 11-12 October
2021, to explore the perspectives of public health officials, academics,
and organisations representing patients’ interests, as well as the
existing channels for policy dialogue and possible ways to improve
them.
3 The
main challenges
3.1 Understanding
the addictive potential of prescription medicines
16. The act of prescription of
a medicine as such has several reasons. In some cases, the intention
is to entitle a patient to either free or subsidised drugs;
Note in other cases, the reason is to control
the consumption of medicines that lose effect if consumed in an
uncontrolled manner, as in the case of antibiotics and the related antimicrobial
resistance issue;
Note while
in some cases prescription is a matter of care for the patient’s
health in order to avoid a “prescription” overdose.
Note
17. Another aspect to pay attention to in this context is withdrawal
syndrome. Such an iatrogenic syndrome often appears as a consequence
of withdrawal of opioid and benzodiazepine medicines.
Note For example,
opioid withdrawal syndrome may be defined as the occurrence of dysphoric
mood, nausea, vomiting, diarrhea, or fever up to several days after
cessation of opioid therapy.
Note While short courses
of certain medicines are not generally associated with withdrawal
syndrome,
NoteNote it has been known for
decades that long courses do. A natural outcome of lasting withdrawal
syndrome, be it physical or psychological, is dependence.
Note
18. Even though the above-mentioned medication classes are highly
valued for their therapeutic effect, their misuse may cause dependence
or even addiction.
Note Addiction
arises when the organism’s endogenous receptor system that these
drugs target, cannot function properly anymore without external
stimulation by certain medicines.
Note
19. Moreover, while antidepressants play an important role in
treating depression and anxiety, it is essential to address how
people will ultimately stop treatment. People may suffer withdrawal
reactions after stopping antidepressants, as well. Discontinuation
problems vary according to dose, treatment duration, and the individual
antidepressant. They may be mild or non-existing, but also disturbing
and unpleasant or even severe, including dizziness, nausea, anxiety,
panic, mood changes, sweating, agitation, insomnia, nightmares,
and electric shock sensations as common symptoms. The dose of antidepressant
needs to be lowered very gradually, usually over several months
or longer, with the final stages of withdrawal requiring particularly
small reductions.
Note Steroids also need to be
tapered off gradually.
20. Prescribers and retailers, in general, must increase their
vigilance when prescribing or supplying medicines
Note in order
to prevent and control drug diversion behaviours, and thereby reduce
the negative impacts of their misuse. They must give clear information
about the effects that medications may have and provide advice about
any possible drug interactions. They can create drug records in
order to prevent consultations with multiple doctors and subsequent
duplicate prescriptions (so-called “doctor shopping”) for a drug
with misuse potential. Patients should be informed on how to stop
their treatment.
3.2 The
impact of the Covid-19 pandemic
21. Since the start of 2020, the
world has been confronted with an unprecedented public health threat
with the emergence of the Covid-19 pandemic. In response to the
outbreak of this disease, a range of containment measures has been
implemented in order to reduce the spread of the virus. One of the
impacts of these measures has been a widespread worsening of mental
health, including anxiety, depression, stress, self-harm, suicide
attempts, and suicides.
Note Lingering
symptoms after infection with the virus, often called “long Covid”, can
also include pain, fatigue, anxiety, depression and “brain fog”.
Note
22. Having a substance use disorder has been shown to increase
the risk of becoming infected by Covid-19, of more adverse Covid-19
outcomes, and of death from Covid-19.
Note Indeed,
both stimulants and opioids negatively impact immune functions:
white blood cells do not function properly. The use of opioids can
impact breathing by slowing it or making it ineffective. This can
lead to decreased oxygen in the blood, brain damage, or death. The
use of stimulants can cause acute health problems such as stroke,
heart attacks, abnormal heart rhythm, and seizures, as well as more
chronic conditions such as heart or lung damage. In general, it
is acknowledged that individuals with substance use disorder may
be especially susceptible to Covid-19.
Note The vaccines
against Covid-19 do not interfere with the treatment of substance
use disorder. On the contrary, people with substance use disorder
should get vaccinated. It is thus important to have the community
actively engage in order to build trust in vaccination.
Note
23. The effects and implications of the pandemic are concerning.
Studies have already revealed the impact of the Covid-19 pandemic
on drug markets, use, harms, and services.
Note There
were supply shortages of numerous street drugs, such as opioids,
price increases for consumers on the black market, and reductions
in purity. These issues, in combination with general economic stress,
may have encouraged shifts to different, and sometimes riskier,
drug-using behaviours.
24. Indeed, whether it is tobacco, alcohol, cannabis or psychotropic
drugs, consumption since the beginning of the pandemic has increased.
Psychotropic drugs, such as anxiolytics, antidepressants, and hypnotics (sleeping
pills), have been massively prescribed. These increases likely reflect
the significant psychological impact of the Covid-19 outbreak –
with emotional changes such as increasing worry, sadness, fear,
and loneliness –, its social, professional, and economic consequences,
and the restricted availability of talking therapies during lockdowns.
25. Since early 2020, Europe’s drug-related challenges, including
drug supply, consumption, and related harms, have been heavily impacted
by the Covid-19 pandemic. Today, some assessments have shown the impact
of Covid-19 on prescription drug use in the short term, but also
highlighted the limitation of data, notably regarding the long-term
impact of the pandemic. It is necessary to pay attention to the
psychological and socioeconomic impacts of the pandemic, as well
as to possible changes in drug consumption patterns and related
harms. Nonetheless, studies provide a valuable first glimpse into
the new developments emerging from the pandemic. For instance, the
shift to the greater use of online platforms for drug supply and
clinical management of drug problems may persist beyond the Covid-19
pandemic and may likely lead to innovations in monitoring and research
methods in the drugs field to capture the “online dimension” of
the European drug situation.
Note
26. This is because one of the early effects of the pandemic outbreak
was the disruption in access to medication and other support services,
due to physical distancing, lockdowns, quarantines, and other public health
measures. In response, States have taken steps to expand access
to needed medications during the pandemic. Policy changes facilitating
“telehealth” or “telemedicine” were carried out.
Note
27. Since the first lockdowns, there was an increase in the use
of remote counselling by treatment and harm reduction services.
Telemedicine, by phone or video, has made it possible to expand
access to medications during lockdowns: this significantly improved
the ability of providers to give treatment for opioid use disorder and
also helped retain patients in treatment.
Note People with opioid
use disorders were able to begin treatment with buprenorphine without
an initial in-person doctor visit, which used to be the rule. Methadone
treatment previously required daily supervised dosing with tightly
controlled take-home options, but patients deemed stable were able
to obtain 28 days of take-home doses. In terms of the criminal justice
system, many prisons and jails have been proactive and implemented
policy changes because of the pandemic.
Note
28. Telemedicine has brought a more equitable way to access to
treatments into the communities.
Note It proved
beneficial in reaching individuals and new patients that needed
treatment by extending service coverage, especially to remote areas
where physical services were limited. It was also reported as an
efficient way to connect with other professionals and relevant health
and social services, thereby improving client referral.
29. However, many challenges were highlighted. Not everybody has
access to the Internet. Some groups have difficulties using the
technology, such as older drug users, clients referred by the criminal
justice system or clients with severe mental health issues and complex
comorbidities. In addition, there are inequalities in accessing
the Internet between urban and rural areas. For these reasons, not
everyone can access telehealth adequately or at all. Some of these
challenges have resulted in a yet unknown number of clients having
to gradually drop out from treatment. While the benefits of the
use of remote interventions are evident, the cost of risking losing
or neglecting certain patient groups should not be underestimated.
Note
30. In this respect, it is necessary to provide access to the
web for everybody. Without proper internet access, health disparities
will remain and continue to grow. Everybody should benefit from
the advantages that come through the internet, which includes telehealth,
but also education and information.
31. Since the question of access to the internet is out of the
scope of the mandate of the Committee on Social Affairs, Health
and Sustainable Development, I would urge the competent Assembly
and intergovernmental committees to join forces to further develop
recommendations on electronic health (eHealth) and mobile health (mHealth)
based on evidence and good practice. Development of a framework
for pan-European implementation of eHealth and mHealth is one of
the paths to take. The World Health Organization has developed a
set of Digital Health Country Vignettes illustrating the continued
importance of digital health across WHO’s European Region during
the Covid-19 pandemic.
Note Europe has boosted its
eHealth and mHealth usage, while the Covid-19 pandemic became a
trigger for even greater uptake of mHealth. These case studies showcase
innovative digital health tools, technologies, and actions that
countries in WHO’s European Region have implemented to strengthen
the health system response to Covid-19.
32. Nevertheless, there is still work to be done. With the lessons
learnt from different member States, the Council of Europe may replicate
good practices by incorporating these into recommendations. The
focus of such recommendations should be on both, the availability
of digital infrastructure, and accessibility and acceptability of
that infrastructure by end-users, be it patients or healthcare practitioners.
Such actions are also in line with the
Global
strategy on digital health 2020-2025, where member States, individually or in co-operation,
propose actions to assess and promote digital health solutions that
are aligned with country-defined needs and health related to the
United Nations’ Sustainable Development Goals.
Note Granting access to the Internet
is vital for sustainability and the up-scaling of the above-mentioned
strategies.
33. The application of Electronic Healthcare Records ensures that
those in need of prescribed medicines do receive them, while those
who are already receiving medication, consume these in a technology-enhanced supervised
manner: this way, over-prescription is minimised and the same prescription
cannot be used twice, thus minimising also the pharmacy-hopping
possibility. Telemedicine, especially by means of mobile apps (mHealth)
allows individuals to control their intake of medicines, consult
healthcare professionals at distance regarding the preferred mode
of medicines consumption, as well as to seek help in overcoming
withdrawal syndrome and dependency issues.
3.3 Lessons
from the experience of Denmark
34. I would like to thank wholeheartedly
the Danish delegation to the Assembly, in particular its Secretariat, for
organising such a productive fact-finding visit to Copenhagen for
me in October 2021. My thanks also go to all the interlocutors who
took the time to meet me, from the Ministry of Health, the Health
Authorities, the Medicines Agency, the Health Committee of the Danish
Parliament, academia, and the Danish Rheumatism Association. The
visit to the Interdisciplinary Pain Center at Gentofte Hospital
was especially insightful.
35. The Danish health system serves 5.7 million inhabitants. It
is financed by general taxes and characterised by universal coverage,
free and equal access, and a high degree of decentralisation. General practitioners
act as a gateway for access to hospital and specialised treatment.
In Denmark, the Medicines Agency approves new medicines, the Health
Authority assesses whether medicines should be recommended in daily
use in the primary sector, and medical doctors have a free right
of prescription and may prescribe off label, as well. The Danish
Medicines Council assesses whether medicines should be recommended
in the secondary sector. In 2020, funding from the Danish Ministry
of Health was made available for three specific initiatives addressing
addiction to prescription medicines
Note.
36. Denmark realised in the mid-2010s that the consumption of
prescribed opioids (including tramadol
Note) was high, especially compared to
the other Nordic countries
Note. Waiting times for consultation
when referred to the highly specialised pain management units for
other than pharmacological treatment with opioids was long, as was
the waiting time for consultation when referred to a psychiatric
specialist, leading to longer treatment with antipsychotics with
an addictive potential. Documentaries on addiction to prescription
medicines aired on Danish TV in 2017 raised the awareness of the
general public and led to a higher sense of urgency. Doctors, hospitals,
NGOs and health authorities worked together to address the problem,
for example by making it mandatory to report all suspected adverse
reactions to tramadol from September 2017 to September 2018.
Note
37. On 1 January 2018, new dispensing regulations came into force,
requiring that prescribers, as a general rule, have a face-to-face
consultation with their patient when prescribing the opioids, including
tramadol or codeine
Note in
addition to stronger opioids, and making it impossible to refill
a prescription. National recommendations on the pharmacological
treatment of pain were updated, including guidance on how to taper off
such treatment. National Clinical Guidelines on opioid treatment
of chronic non-malignant pain were published in 2018, on rational
use of medicines for treating attention deficit hyperactivity disorder
in children and young people in 2021, on treatment of anxiety disorders
in adults in 2021, and new Guidelines on sedatives (including low-dose
quetiapine) are planned for 2022. An article on how to prescribe
small quantities of addictive prescription medicines when only large
package sizes are marketed was published in the magazine on rational
pharmacotherapy in August 2020 and distributed to all doctors in
Denmark. A pocket-size pain management guide was created and distributed
to general practitioners (first free, but as demand rose from other
specialties of medicine at 70 cents-cost of printing), and an awareness-raising
campaign on the subject was aired on TV and made available on the
internet.
38. Before the Covid-19 pandemic started, these measures successfully
lowered the consumption of prescribed opioids, in particular – with
the consumption of tramadol alone decreasing by 37% from 2015 to 2019.
The Danish Health Authorities are, however, remaining vigilant,
and continuing their monitoring with a view to responding to changing
consumption patterns of other medicines that may replace the consumption
of opioids and other addictive medicines (for instance, off-label
use of low-dose quetiapine). Our interlocutors at the Health Authorities
stressed the importance of maintaining a holistic approach with
a view to identifying improved options to treat symptoms/conditions
with other interventions than addictive medicines. They also emphasised
the importance of striking the right balance between adequate availability
and necessary restrictions on medicines with an addictive potential.
Thus, the requirement for the doctor to see the patient in person
could pose a problem for people in medically well-indicated long-term
treatment with addictive medicines.
39. What struck me is that even in such a good practice example
as Denmark, there does not seem to be an easy solution to the problematic
use of prescribed medicines, in particular opioids for non-malignant
chronic pain. The fact is that opioids are not a good choice for
such pain conditions, because they lead to addiction and tolerance
(requiring ever higher doses for the same pain-relief effect), thus
also increasing negative side-effects. But it is also a fact that
there is no effective, non-addictive, pharmacological alternative
to opioids. Non-pharmacological pain management should thus be given
a much higher priority. Reducing waiting times to see specialists
or enter alternative residential treatment programmes (such as the
specialised programmes of the Danish Rheumatism Association) is
thus of primary importance. The cost of funding such holistic treatment may
seem high at the outset, but is quickly recouped, including in quality
of life for patients.
40. Another recommendation that the Danish authorities are considering,
and which could be a useful consideration also in other countries,
is how to prescribe and dispense small quantities of addictive medicines, for
example how to prescribe and dispense the medically indicated dose
of 2 tablets when the smallest package of tablets available in retail
is 100 tablets. Indeed, our parliamentary interlocutors also emphasised that
the possible contribution of pharmacists to addressing addiction
to prescribed medicines is not fully used in Denmark, despite the
shortage of doctors in the country – which sometimes leads to general
practitioner secretariats preparing prescriptions in practice, with
the general practitioner only signing off on them, due to shortage
of time and work overload. In this context, the transitions from
hospital to out-patient care seem to be particularly problematic.
41. The academics we met, Mr Anton Pottegård and Ms Anne Mette
Skov Sørensen, provided us with several valuable “take-home” messages.
First, they emphasised that timely registry data on drug use is necessary
to guide interventions (including policy changes). This is particularly
acute during and after the Covid-19 pandemic, which may have affected
prescription drug use. They also, like our parliamentary colleagues
on the Danish Health Committee, raised the alarm on high consumption
of addictive medicines in psychiatry, especially in child and adolescent
psychiatry, and on adult psychiatric and geriatric wards. Second, they
emphasised that if one addictive medicine is phased out, another
one is bound to go up (for example replacing benzodiazepines with
other antidepressants). They considered that the use of gabapentinoids (gabapentin/pregabalin)
would likely constitute an issue in the near future, due to the
crushing down on medical opioid use. Third, they emphasised that
Electronic Healthcare Records are not the panacea, since there are often
discrepancies between what is listed in the record and the patient’s
actual use of the medicine. They believed that the type of supervision
needed was not digital, but rather in-person, patient-centred.
42. Our interlocutors at the Danish Rheumatism Association informed
us that every fifth Dane complained of chronic pain, mostly due
to rheumatic musculoskeletal diseases, leading to a very high consumption
of strong painkillers (opioids). With the pain itself having many
side effects (discomfort, sleeping problems, a negative influence
on one’s mood), 46% of their members who had answered a recent questionnaire
had taken opioids within the last year, of which 78% had not been
offered alternatives, 18% had acquired painkillers outside the healthcare
system and 19% had considered doing so. 58% considered that their
life with pain was overwhelming and unaffordable, and 11% had had
suicidal thoughts. The Association tried to support its members, inter alia, with counselling services,
pointing them towards non-pharmacological interventions such as
physiotherapy, weight loss, out-patient pain centres, and their
own in-patient holistic treatment centres, called Sanos. Their members complained
that waiting lists were too long (6-10 months for pain centres,
5-8 months for Sanos), and
it was still too easy to get prescriptions for opioids, while medical
cannabis was largely inaccessible.
43. Our discussion with Ms Anne Hansen, the Chief physician at
the out-patient Interdisciplinary Pain Center at Gentofte Hospital,
summed up all the lessons I believe we can learn from the Danish
good-practice experience. Patients with non-malignant chronic pain
need to have access to appropriate opioid pain treatment, but as
part of a holistic, multidisciplinary treatment plan which takes
into account their individual situation (including the social determinants
of health). They need to be properly informed and enabled to make their
own choices in how to best handle their condition. The stigmatisation
of patients with opioid treatment has to end. We all need to learn
to listen to our bodies more – before we develop severe and/or chronic
pain. Physicians need to be properly informed and educated on how
to deal better with pain (including surgeons), and their workload
needs to be reduced so that they can devote more time to patient
care. For that, adequate funding is needed.
4 Conclusions
and recommendations: finding the right balance
44. In 2021, the number of citizens
of the European Union using prescribed medicines reached 38%.
Note It is doubtful
that numbers for the whole Council of Europe area would differ significantly.
This indicates that the threat of epidemics of dependency on prescribed
medicines is real. At the same time, guaranteeing adequate availability
of drugs for medical purposes must be addressed. Regulations should
not limit distribution of prescribed medicines for those in need,
so that patients do not become hostage to restrictive national regulations.
Access to medicines is an integral part of the right to health.
Ensuring the availability and accessibility of medicines by member
States is a clear obligation of the competent national authorities.
Note Efforts should
thus be made in national laws and policies to ensure that the UN
Drug Conventions are not used as an obstructive measure, restricting
the access to and availability of prescribed medicines. The medical
needs of the population should be met and the right to health should
be ensured.
45. I am convinced that the topic of addiction to prescribed medicines
should be given a higher priority in Europe. With our different
specialised bodies (such as the Pompidou Group, the European Directorate
for the Quality of Medicines (EDQM), and the new Steering Committee
for Human Rights in the fields of biomedicine and health), we are
well-placed at the Council of Europe to contribute to preventing
and fighting nefarious addiction to prescribed medicines, as well
as to ensure that patients in need of prescribed medicines get their treatment
in a timely manner; in particular if we work in concert with WHO,
including on the possible drafting and issuance of guidance on prevention,
identification, management and treatment of addiction to prescribed medicines
at global and/or Council of Europe level.
46. My main recommendations can thus be summarised as follows:
- Council of Europe member States
should follow WHO’s evidence-based guidance and, inspired by European
good practice examples, if they have not already done so, develop
national guidelines on the proper use of prescribed medicines with
addictive potential, involving all relevant stakeholders in the drafting
process, including prescribers, pharmacists, patient groups and
academics;
- the Committee of Ministers of the Council of Europe should
consider issuing a recommendation on the rights of patients in relation
to the use of prescription medicines, containing, inter alia, the right to effective
access and availability of essential medicines, including those
that contain controlled substances under international law, as well
as the right to the enjoyment of the highest attainable standard
of physical and mental health, free of dependency or addiction.
47. If, in addition, we allocate the necessary funds to ensure
holistic treatment of patients’ illnesses (particularly, non-malignant
chronic pain, depression, sleep and anxiety disorders), which are
traditionally treated with prescribed medicines with addictive potential,
in particular by making non-drug interventions (such as counselling,
rehabilitation, etc.) accessible to all who need them, in as timely
a manner as possible, and we pay particular attention to the social
determinants of health and learn the lessons from the Covid-19 pandemic, we
will succeed to prevent and fight nefarious addiction to prescribed
medicines.
