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Description A growing international consensus urges change in several areas toward the goal of recognizing effective treatment for pain as a fundamental human right, according to a special article in the July issue of Anesthesia & Analgesia, the official publication of the International Anesthesia Research Society. |
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Newswise — A growing international consensus urges change in several areas—including increased availability of controlled medications such as opioids—toward the goal of recognizing effective treatment for pain as a fundamental human right, according to a special article in the July issue of Anesthesia & Analgesia, the official publication of the International Anesthesia Research Society and published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
Dr. Frank Brennan of Calvary Hospital in Kogarah, N.S.W., Australia and colleagues summarize the medical, legal, and ethical arguments for transforming access to pain management into a global human right. They write, "Medicine is at an inflection point, at which a coherent international consensus is emerging: the unreasonable failure to treat pain is poor medicine, unethical practice, and is an abrogation of a fundamental right."
Inadequate pain treatment is an entrenched problem around the world, related to cultural, societal, religious, and political factors—including, the authors believe, the acceptance of torture. Poorly controlled pain has many and potentially serious adverse effects, both physical and psychological, as well as "massive social and economic costs to society," Dr. Brennan and coauthors write. Cancer pain is a special concern, with up to 70 percent of cancer patients experiencing severe pain caused by their disease or its treatment.
Contributors to inadequate management of pain from cancer and other causes include "opiophobia and opioignorance": fear and ignorance of the strong pain medications classified as opioids—morphine and related drugs. For physicians, a lack of training in the proper use of opioids is compounded by rare but highly publicized cases in which doctors are prosecuted for opioid prescribing.
The authors outline the "complex and overlapping" reasons for delay in recognizing the ethical and legal importance of pain management. Although pain relief is clearly a core value of medical ethics, the legal foundation for a right to pain management is less clear. Frustrated with the slow pace of change, many pain medicine professionals are promoting legislative solutions. Some governments, notably including Australia and the state of California, have passed statutes explicitly defining the right to adequate pain management, protecting medical practitioners who treat pain in terminally ill patients, or introducing requirements for pain management and education.
Laws related to medical negligence, elder abuse, and public interest litigation all have ramifications for promoting adequate pain treatment, as do standards for pain management developed by professional organizations. Other approaches look to international law, including the United Nations (UN) covenants regarding human rights.
Since pain is an international problem, the World Health Organization (WHO), as the UN's supreme health agency, is likely to play a critical role in any solution. The WHO's previous efforts in the areas of cancer pain relief and palliative care have had a major impact on pain treatment around the world. Building on these successes, the WHO is spearheading efforts toward deregulating the availability of medical opioids and making these powerful pain-reducing drugs more affordable for poor countries.
Dr. Brennan and colleagues call on the UN to consider declaring an International Year of Pain Management, and on the WHO and other international bodies to create a single organization unifying all aspects of obligation on national governments in the area of pain control. "Much work and continuing vigilance will be required to make the transition from asserting that pain management is a fundamental human right, to a future in which appropriate pain management is a global reality," the authors conclude.
An accompanying editorial, Willem Scholten, PharmD, MPA, and colleagues at the WHO summarize their organization's role in "freeing people from the shackles of pain." A centerpiece of the WHO's efforts is its Access to Controlled Medications Program (ACMP). The ACMP seeks to remove barriers to appropriate use of controlled medications through legislative and administrative initiatives, education for health care and law enforcement professionals, improved understanding of international drug control treaties, and measures to ensure a steady supply of controlled medications at controlled prices. "The human suffering due to lack of pain relief is an affront to human dignity," Dr. Sholten and colleagues write. "WHO, through its ACMP, will support governments in the realization of their obligation under the right to 'the enjoyment of the highest attainable standard of health.’”
About Lippincott Williams & Wilkins
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About the International Anesthesia Research Society
The International Anesthesia Research Society (IARS) is a not-for-profit medical
society founded in 1922 to foster progress and research in all phases of
anesthesia. The IARS is completely nonpolitical, focused only on the advancement
and support of education and scientific research related to anesthesiology and
pain management. The motto on the IARS logo since 1922 has been “We strive
always for world conquest of pain.” The IARS has a world-wide membership of
15,000 physicians and others with doctoral degrees. For more information,
contact iarshq@iars.org
Claud Regnard
FRCP, Newcastle Hospitals NHS Trust, Northumberland Tyne & Wear NHS Trust, and St. Oswald’sHospice, Newcastle upon Tyne.
Presented to the House of Lords All party Committee on Dying Well, 7
th November, 2006Background
In early 2006 Clive Seale published an anonymous survey
of UK doctors that was widely but selectively reported in
the media.
1 There was little mention in the media of thevery low rates reported by UK doctors of voluntary
euthanasia (0.16%), involuntary euthanasia (0.33%) with
no mention of the fact that none of the doctors surveyed
had been involved in patient assisted suicide. In contrast,
much was made of the 33% of UK doctors who reported
their belief that they had possibly shortened life of patients
by a few days during treatment for the alleviation of
symptoms. Despite statements trying to clarify the facts,
2the article was interpreted as demonstrating that UK
doctors were already shortening lives, and it was suggested
that legalisation of patient assisted suicide was an obvious
and necessary next step.
3Of the 94% of specialists in palliative care who opposed
any change in the law,
4 many were puzzled by the belief ofso many doctors that they had shortened patients’ lives
while treating symptoms. This was not the experience of
specialists treating symptoms at the end of life.
How do UK doctors compare with other countries
?Since his first paper Seale has carried out a further analysis
of his survey data.
5 He points out that those who argue foreuthanasia claim that prohibition results in secretive
medical decision-making. In contrast, those against
legalization are concerned about the permissiveness leading
to an inappropriate readiness to shorten life. Seale suggests
that the optimum situation is one where the underlying
inhibitions about inappropriately shortening life exist with
high levels of shared decision-making
Seale compared UK doctors with permissive countries
(ie those that allow PAS and/or euthanasia- Netherlands,
Switzerland, Belgium) and non-permissive countries
(ie. those where PAS and euthanasia are not legal- Italy,
Sweden, Denmark). He found that UK doctors had the
following characteristics:
•
UK doctors are particularly cautious about decisions toshorten life.
•
UK doctors are more open than non-permissivecountries in their openness about discussing end-of-life
decisions (ELD) with patients and relatives.
•
UK doctors are the same or more likely than doctors inpermissive countries to report discussions on ELD with
medical and nursing colleagues.
Seale concluded that UK doctors do exhibit that ‘optimum’
situation with
- a particularly cautious approach towards shortening life
- a high level of shared decision-making.
Dutch public attitudes
Rietjens and colleagues surveyed the attitudes of the Dutch
public towards euthanasia, terminal sedation and increasing
doses of opioids.
6 The characteristics that the Dutch publicconsidered to be important for a good death were: saying
goodbye to loved ones (94%), dying with dignity (92%),
and dying free of pain (87%). Fear of being a burden was
more important than control and the authors point out that a
previous study showed 17% of euthanasia patients were
uncomfortable about burdening relatives.
These attitudes were similar for euthanasia, terminal
sedation and high dose opioids, suggesting that they
viewed these as equivalent approaches (see Fig 1).
Fig 1:
issues of importance for the Dutch public in thoseaccepting euthanasia, terminal sedation or high dose morphine.
From Rietjens
et al 60%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Saying
goodbye
Dignity No pain No
burden
Control
Accept
euthanasia
Accept sedation
Accept high dose
morphine
2
Paradoxical beliefs about opioids & sedatives
•
33% of UK doctors believe they had possibly shortenedlife during alleviation of symptoms.
1•
UK doctors are particularly cautious about shorteninglife,
5•
Palliative care physicians are not faced with thedilemma of relieving symptoms at the risk of shortening
life.
•
Dutch public equate high dose morphine and sedationwith euthanasia.
6•
Doctors are secretly killing patients.3•
Shipman was convicted of giving 30 times anacceptable dose of diamorphine.
7•
Two North East doctors have been acquitted of chargesafter using a starting dose of morphine or diamorphine up
to 60 times higher than would be used in palliative care.
8, 9Acquittal was on the basis of the defence of double-effect.
Double-effect
This is based on an 800 year old principle. It states that the
unintended, harmful effect of an action is defensible (e.g.
an early death) if
1. The nature of the act is itself good (e.g. the relief of pain
and distress)
2. The intention is for the good effect and
not the bad3. The good effect outweighs the bad effect in a situation
that is sufficiently grave to merit the risk of that bad effect
(e.g. overwhelming suffering in a dying patient)
4. The good effect (the symptom relief) is
not through thebad effect (eg. death)
How safe are opioids and sedatives? A world view
•
Morphine and sedatives do not hasten deathUK
- Double doses of bedtime morphine did not increaseovernight deaths.
10UK
- Sedative dose increases were not associated withshortened survival (n=237).
11Australia
- No link between doses of opioids,benzodiazepines or haloperidol and survival.
12•
Opioids & sedatives do not hasten death in dyingpatients
Taiwan
- Giving morphine to treat breathlessness onadmission and in last 48hrs did not affect survival.
13Japan
- The survival of patients of high dose opioids andsedatives in last 48hrs was the same as those not on such
drugs.
14USA
- After ventilator withdrawal, opioids did not speeddeath, while benzodiazepines resulted in longer survival
(n=75).
15•
Morphine does not hasten death in elderly, breathlesspatients or those with poor lung function
Switzerland
- Morphine given to elderly patients forbreathlessness showed no effect on respiratory function
(n=9, randomised controlled trial).
16UK
- The respiratory rate was not changed by morphinegiven for breathlessness to patients with poor respiratory
function (n=15).
17Canada
- Injections of morphine given subcutaneously topatients with restrictive respiratory failure did not change
their respiratory rate, respiratory effort, arterial oxygen
level, or end-tidal carbon dioxide levels.
18Opioids are ineffective euthanasia agents
Netherlands -
Opioids are not considered ‘standard’ drugsfor euthanasia with reported use reducing by half from
1995 to 2001.
19Using morphine and diamorphine safely.
In palliative care the aim is always to relieve symptoms
while minimising mild to moderate adverse effects, and
avoiding serious adverse effects.
Starting doses:
a person who has never been on analgesicswould be started on oral morphine 2.5 – 5mg 4-hourly (or
diamorphine by injection 1 – 2.5mg 4-hourly). Higher
doses can be used if the patient was already on weaker
analgesics.
Titration:
this describes the adjustment of a drug dose to anindividual patient, while allowing the patient’s body time
to adjust to the drug to minimise adverse effects (see Fig
3). Titration is done in 25-50% steps every 1-2 days.
Safety margin of opioids:
morphine and diamorphine havea wide safety margin or ‘therapeutic range’ (see Fig 3).
Toxicity
Pain relief
Pain
Breakthrough doses
Fig 3:
the titration of morphine to an individual patient3
The unsafe use of morphine and diamorphine
Shipman gave 30mg diamorphine intravenously to patients
who had no pain. Others have given 60mg diamorphine IV
to patients who have never had an opioid before. Such
doses are 30-60 times higher than would be used in
palliative care. The result is to breakthrough the safety
margin and cause dangerously high levels of drug in the
blood (see Fig. 4). The high levels will be reached more
rapidly, and to higher levels, if the drug is given
intravenously – the route chosen by Shipman. Even if death
does not occur, agitation and distress can occur.
Toxicity
Pain relief
Pa
iinFig 4
: the effect of a single, high dose, intravenous dose onblood levels of diamorphine
Double effect- a myth with a double life?
The principle of double effect is not used in palliative care.
Doctors are not faced with the dilemma of giving a
potentially lethal drug dose to a distressed patient.
A palliative care doctor gives repeated, small doses of one
or more drugs, each titrated to an individual until the
symptoms are eased, while doing everything possible to
avoid toxicity. Doctors who give 30-60 times the required
dose of morphine or diamorphine, usually as a single
intravenous dose, are acting either negligently or
maliciously. Since drug records should exist for opioids,
there is a clear audit trail to follow if a subsequent
investigation is required.
With exceptions such as Shipman, UK doctors are very
cautious about shortening life. The persistent belief that
opioids and sedatives shorten life or hasten death stems
from the experiences of bad practice in the use of the drugs.
Evidence in the last 20 years has shown that opioids and
sedatives are safe when following palliative care protocols.
Clinicians who believe otherwise should be challenged to
provide robust clinical evidence to support their view.
Morphine and diamorphine are inherently safe when used
correctly, but they are powerful drugs with the potential for
harm. There is a parallel here with modern cars which are
inherently safe unless they are driven by negligent or
malicious drivers:
- no one blames cars for road deaths, when bad drivers are
at fault, so why blame the morphine when bad prescribers
are at fault?
Further reading
Pharmacological resource for palliative care:
www.palliativedrugs.com
Online textbook of palliative care:
http://book.pallcare.info/
Self learning worksheets on opioids and othe aspects of
palliative care:
CLiP (Current Learning in Palliative Care)
on:
www.helpthehospices.org.uk (click on ‘e-;earning’)Glossary of terms
Adverse effects:
unwanted effects of a drug. Some are easilytreated (eg. constipation), others wear off quickly (eg.
drowsiness) while a few uncommon effects are uncommon (eg.
confusion) and every effort is made to avoid serious adverse
effects.
Analgesics:
drugs capable of easing pain. Examples are the weakopioids (eg. codeine) and the strong opioids (eg. morphine).
Benzodiazepines:
drugs related to diazepam. In palliative care,only very short acting drugs are used (eg. midazolam, lorazepam)
to avoid excessive sedation.
Diamorphine:
inactive opioid that needs to be converted tomorphine in the body before it can be effective. Similar potency
to morphine. Used in the UK for injections and infusions because
of its high solubility in water.
Morphine:
the ‘gold standard’ opioid with over 30 yearsunderstanding of its use in palliative care.
Opioid:
a strong pain killer like morphine. Only used for painrelief- never used as a sedative in palliative care.
Sedative:
drug used to calm a frightened or agitated patient. Thebenzodiazepines are the commonest types used.
Terminal sedation:
the use of sedatives at the end of life toreduce fear or agitation, but without hasten death.
Therapeutic range:
the margin between the dose needed toproduce a good effect and the dose needed to produce adverse
effects.
Titration:
the adjustment of a drug dose to an individual patient,while allowing the patient’s body time to adjust to the drug to
minimise adverse effects. Done in 25-50% steps every 1-2 days.
Toxicity:
levels of drug in the blood causing serious adverseeffects eg. agitation, coma, respiratory depression. In palliative
care these are actively avoided or treated if they occur.
4
References
1
Seale C. National survey of end-of-life decisions made by UKmedical practitioners.
Palliative Medicine 2006; 20(1): 3-10.2
Help the Hospices. Statement. End of Life Care. 30th January,2006.
(
http://www.helpthehospices.org.uk/news/index.asp?submenu=5&newsid=209 )
3
Dignity in Dying. The Problem with the Current Law.(http://www.dignityindying.org.uk/information/factsheets.asp?id
=84 )
4
Survey. Association of Palliative Medicine, 2006.(http://www.carenotkilling.org.uk/?show=193)
5
Seale C. Characteristics of end-of-life decisions: survey of UKmedical practitioners.
Palliative Medicine 2006; 20(7): 653-96
Rietjens JAC et al Preferences of the Dutch general public for agood death and associations with attitudes towards end-of-life
decision-making.
Palliative Medicine 2006; 20(7): 685-92.7
The Shipman Inquiry. http://www.the-shipman-inquiry.org.uk/8
The Guardian. 11th May, 1999.(http://www.guardian.co.uk/uk_news/story/0,3604,298532,00.ht
ml )
9
BBC News, 14th December, 2005.(http://news.bbc.co.uk/1/hi/england/4502722.stm )
10
Regnard C and Badger C. Opioids, sleep and the time of death.Palliative Medicine
, 1987; 1(2): 107-110.11
Sykes N. Thorns A. Sedative use in the last week of life andthe implications for end-of-life decision making.
Arch Int Med2003: 163(3): 341-4
12
Good PD, Ravenscroft PJ, Cavenagh J. Effects of opioids andsedatives on survival in an Australian inpatient palliative care
population.
Int Med J. 2005: 35(9): 512-713
Hu WY, Chiu TY, Cheng SY, Chen CY. Morphine fordyspnoea control in terminal cancer patients: is it appropriate in
Taiwan?
J Pain & Symp Manag. 2004: 28(4): 356-63.14
Morita T, Tsunoda J, Inoue S, Chihara S. Effects of high doseopioids and sedatives on survival in terminally ill cancer patients.
J Pain & Symp Manag.
2001: 21(4): 282-9.15
Chan JD et al. Narcotic and benzodiazepines use afterwithdrawal of life support: association with time of death?
Chest.2004: 126(1): 286-93.
16
Mazzocato C, Buclin T, Rapin CH. The effects of morphine ondyspnoea and ventilatory function in elderly patients with
advanced cancer: a randomized double-blind control trial.
Annals of Oncology.
1999: 10(12): 1511-4.17
Boyd KJ. Kelly M. Oral morphine as symptomatic treatment ofdyspnoea in patients with advanced cancer.
Palliative Medicine.1997: 11(4): 277-81.
18
Bruera E, Macmillan K, Pither J, MacDonald RN. Effects ofmorphine on the dyspnoea of terminal cancer patients.
J Pain &Symp Manag
, 1990: 5(6): 341-44.19
Rurup ML. Et al. Nederlands Tijdschrift voor Geneeskunde.2006: 150(11): 618-24.
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