News

Professionals who care for people at the end of life do much more than prescribe drugs, a new study has shown. The qualitative analysis published last month in the journal PLoS Medicine revealed that the day-to-day activities of palliative caregivers throughout Europe are highly multifaceted and complex.

The study used qualitative research methods to identify types of Non-Pharmacological Caregiving Activities (NPCAs) undertaken at 16 different palliative care facilities in nine countries. The responses clearly indicated that the respondents undertook a huge variety of activities which went beyond pharmacological interventions.

The most common NCPA was carrying out or abstaining from bodily care or contact, with many respondents reporting holding hands to provide emotional support as well as maintaining the patient’s oral hygiene.

Somewhat surprisingly, another frequently reported activity was “creating an aesthetical, safe and pleasing environment”, which included applying perfume, making sure there is pleasant lighting, repositioning pictures so that they are visible to the patient and playing the patient’s favourite music. Respondents also indicated that they often provided support not just for the patient but for their loved ones, offering professional advice as well as practical assistance (such as arranging for medical equipment to be removed from the house so that they don’t have to see it after the patient has died).

Whilst the varied nature of palliative care may be obvious to those who work within the field, it is not always apparent to outsiders, and this paper paves the way for future research into the frequency and efficacy of NCPAs.

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Drug updates

Extemporaneous thalidomide oral suspension stability study

A stability study of thalidomide oral suspension 20mg/mL, using the contents of oral thalidomide capsules and a 1:1 mixture of Ora-Plus and Ora-Sweet, has been published. The HPLC method demonstrated stability for at least 35 days when stored in amber plastic bottles under refrigeration. For more information click here.

NPC review oxycodone/naloxone

The NHS National Prescribing Centre (NPC) has published a review of modified release oxycodone/naloxone in cancer pain discussing the results of a published 4 week clinical trial. For more information click here.

US FDA approve fentanyl sublingual spray

The US Food and Drug Administration (FDA) has approved a fentanyl sublingual spray (Subsys^®, Insys Therapeutics, Phoenix, Arizona) for the treatment of adults with breakthrough cancer pain, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. For more information click here.

AWMSG approve tapentadol m/r for restricted use

The All Wales Medicines Strategy Group (AWMSG) has recommended tapentadol modified release (m/r) (Palexia^® SR, Stokenchurch, Buckinghamshire) as an option, within NHS Wales, for restricted use for patients with severe chronic pain in whom morphine sulphate m/r has failed to provide adequate pain control or is not tolerated.

The Group does not recommend tapentadol m/r for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics, outside of the subpopulation described above.

The Group also recommends that tapentadol m/r should initially be prescribed by a specialist. For more information click here.

SMC accepts fentanyl single dose nasal spray

The Scottish Medicines Consortium (SMC) has accepted fentanyl single dose nasal spray (Instanyl^®, Nycomed, Marlow, Buckinghamshire) for use within NHS Scotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Its use is restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. For more information click here.

Prepared by Sarah Charlesworth and Andrew Wilcock.

Selected items from the News and Latest Additions sections of www.palliativedrugs.com , the world’s leading palliative care website.

Safety updates

Citalopram and escitalopram maximum daily doses restricted

Restrictions on the maximum daily doses of citalopram and escitalopram have been made following the evaluation of a QT study by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The study showed dose-dependent QT interval prolongation with citalopram and escitalopram, and post-marketing reports of prolonged QT interval have also been received. A similar decision was taken by the US Food and Drug Administration (FDA) last year (see our news item 25-08-11).

Citalopram: the maximum daily dose of citalopram is restricted to 40mg, and to 20mg in the elderly or those with hepatic impairment.

Escitalopram: the maximum daily dose of escitalopram for adults <65 years remains 20mg daily; for those >65 years, the dose has been reduced to 10mg daily.

Citalopram and escitalopram are contra-indicated in patients with known QT interval prolongation or congenital long QT syndrome and in conjunction with other products known to prolong the QT interval. These include:

• class IA and III antiarrhythmics (e.g. amiodarone, dronedarone, quinidine)
• antipsychotics (e.g. fentiazine derviatives, pimozide, haloperidol)
• tricyclic antidepressants
• some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment, particularly halofantrine)
• some antihistamines (e.g. astemizole, mizolastine)
• some antiretrovirals (e.g. ritonavir, saquinavir, lopinavir).

Caution is advised in patients with underlying heart conditions and those at risk of low plasma levels of potassium and magnesium. Doses of citalopram and escitalopram may also need to be reduced if used in conjunction with drugs that increase their plasma levels, e.g. some antiretrovirals, omeprazole and cimetidine. For more information click here.

Reminder about fentanyl transdermal (TD) patches and heat sources

The Royal Pharmaceutical Society has issued a reminder about counselling patients regarding avoiding heat sources when using fentanyl TD patches. This follows reports in the press about the dangers of using them in the bath, with one reported fatality.

Patients using fentanyl TD patches should avoid heat sources such as hot water bottles, heat patches, electric blankets, heat lamps, hot whirlpool spa baths and prolonged hot baths, as an increase in temperature can increase the rate of absorption of fentanyl from the patch. This information is contained in the patient information leaflet. For more information click here.

This advice is echoed in our Quick Practice Guide: Use of transdermal fentanyl patches. It further advises that patients may shower but should not soak in a hot bath.

Prepared by Sarah Charlesworth and Andrew Wilcock

Californians are not having important discussions about end-of-life preferences with doctors and loved-ones, even though they would like to.

A poll conducted by the California Healthcare Foundation (CHFC) shows that a large majority of respondents would either ‘definitely’ (47%) or ‘probably’ (32%) like to speak to a doctor about their wishes for medical treatment at the end of their life, but a staggering 92% had never had this conversation.

The survey, entitled ‘Final Chapter: Californians’ Attitudes and Experiences with Death and Dying’, saw a representative sample of 1669 people asked about their opinions on end-of-life care, with some interesting findings.

The three most important factors relating to end of life care, according to the majority of respondents, were making sure that family were not financially burdened, being comfortable and without pain and being at peace spiritually.

Another question assessed how familiar respondents were with end-of-life terms. The results are shown in the figure below (source: California Healthcare Foundation), with only 17% of people saying that they had heard of palliative care and just 13% familiar with POLST (physician orders for life-saving treatment).

Furthermore, there was a large discrepancy between respondents’ desired place of death and the actual place of death of people who died in the state in 2009 (a frequently recurring theme in end-of-life care surveys throughout the world).  Whilst 70% of people surveyed said that they’d prefer to die at home, only 32% of deaths in California occurred at home in 2009.

Read the full report here.

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Hot topics

Draft specialist care measures consultation

A draft version of the specialist palliative care measures for inclusion in the Manual for Cancer Services has been issued by the UK Department of Health for a 12 week consultation period. It is aimed at interested stakeholders only and ends 27 February 2012. For more information click here.

NICE end of life care commissioning guide

NICE has published a guide for commissioners of end-of-life care services. The guide aims to support local implementation of the Department of Health (2008) End of Life Care Strategy and the NICE (2011) Quality Standard for end of life care for adults, and is aligned with the NHS Outcomes Framework and supports commissioning for Quality, Innovation, Productivity and Prevention (QIPP). For more information click here.

Latest additions

PCF4 reprint changes

We would like to thank members for their support which has seen the first print run of the fourth edition of the Palliative care Formulary (PCF4) sell out. In preparing for the second print run, we have made several corrections to the text. We recommend that you amend your first print run copy accordingly. All necessary changes have already been made on the www.palliativedrugs.com website.

We endeavour to achieve the highest levels of accuracy in the text and are always grateful for your feedback (hq{at}palliativedrugs.com). For details of the reprint changes click here.

Prepared by Sarah Charlesworth and Andrew Wilcock

The American Society of Clinical Oncology (ASCO) have published a provisional clinical opinion (PCO) which suggests that palliative care should play a larger role in standard cancer care, and that cancer patients should be offered palliative care earlier in their treatment.

The PCO is based on evidence from seven recently published randomised controlled trials which suggest that for some forms of cancer, patients benefit from being offered both palliative and standard oncologic care at initial diagnosis. Whilst this approach has not been definitively linked to better survival rates, the studies did show that it generally leads to “better patient and caregiver outcomes” and higher quality of life.

The guidelines highlighted the results of a recent trial by Temel et al, which indicated that patients recently diagnosed with metastatic non-small-cell lung cancer who were given palliative care concurrently with standard treatment had fewer depressive symptoms and a longer median survival time from first diagnosis.

ASCO noted that whilst there is mounting evidence that this kind of combined care is beneficial, there are currently barriers to its implementation, including a dearth of health policy and reimbursement mechanisms. They also state that more palliative care doctors will be required to cope with the increasing demand.

Read the full report here.

A new film by a group of award-winning Australian filmmakers aims to raise awareness of the pain suffered by millions of people each year who die without access to palliative care. LIFE Before Death, which is being released to coincide with World Cancer Day, includes footage from 11 countries around the world and highlights the lack of effective pain treatment and the unnecessary suffering that this causes.

The film is accompanied by 35 poignant and thought-provoking short films which can be viewed here.

The importance of improving access to effective palliative care around the world becomes even more apparent when considering the impact of population ageing upon the incidence of chronic, painful diseases. Changes in mortality and birth rates during the last century or so mean that the demographic phenomenon of population ageing is now an issue facing nearly every country in the world – regardless of levels of development and income.  The Union for International Cancer Control (UICC) reports that 3.3 million people suffering from cancer or HIV will die in severe pain this year and that 99.9% of those deaths will be in low to middle income countries.

LIFE Before Death is narrated by British actor David Suchet and has already received four international film awards. It is available here.

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Hot topics

Evidence for unlicensed and off-label medicines

The UK Department of Health (DH) has announced that it will commission expert assessments of the evidence on the use of unlicensed or off-label medicines, including in rare conditions. These assessments will be designed to inform doctors’ decision-making and patients’ choices, not to provide a yes or no recommendation. The work will be delivered by the National Institute for Health and Clinical Excellence (NICE), through its NHS Evidence arm, beginning in spring 2012. For more information click here.

DH ‘Never Events’

The UK DH has published the list of ‘Never Events’ for 2011-12 which has expanded to 25 from the previous 8. These represent very serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures are in place:

Existing: Wrong site surgery; Retained foreign object post-operation; Wrong route administration of chemotherapy; Suicide using non-collapsible rails; Escape of a transferred prisoner.

Modified: Misplaced naso- or oro-gastric tubes; Maladministration of potassium-containing solutions; Maternal death due to post partum haemorrhage after elective caesarean section.

New: Wrong implant/prosthesis; Wrongly prepared high-risk injectable medication; Wrong route administration of oral/enteral treatment; Intravenous administration of epidural medication; Maladministration of insulin; Overdose of midazolam during conscious sedation; Opioid overdose of an opioid-naïve patient; Inappropriate administration of daily oral methotrexate; Falls from unrestricted windows; Entrapment in bedrails; Transfusion of ABO-incompatible blood components; Transplantation of ABO or HLA-incompatible organs; Wrong gas administered; Failure to monitor and respond to oxygen saturation; Air embolism; Misidentification of patients; Severe scalding of patients.

For more information click here.

A review of nabilone for chronic pain management

The Canadian Agency for Drugs and Technologies in Health (CADTH) has published a review of clinical effectiveness, safety and guidelines for the use of nabilone for chronic pain management. It includes studies for neuropathic pain, cancer pain, non-cancer pain, spasticity-related pain resulting from MS and spinal pain. For more information click here.

Monitoring unwanted effects of antipsychotics

A recent article in the Drug and Therapeutics Bulletin (DTB) discusses monitoring for undesirable effects of antipsychotics in adults, with a particular focus on second-generation antipsychotics. For more information click here (subscription required for full text).

Prepared by Sarah Charlesworth and Andrew Wilcock

Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.

Drug updates

NETAG does not recommend capsaicin cutaneous patch for neuropathic pain

The NHS North East Treatment Advisory Group (NETAG) does not recommend the use of capsaicin cutaneous patch (Qutenza) for neuropathic pain, the group were concerned about the clinical efficacy of the treatment and considered that it did not represent a cost-effective treatment option. More information is available in the decision summary and appraisal report.

NETAG does not recommend tolvaptan for hyponatraemia due to SIADH

Following an appeal, NETAG does not recommend the use of tolvaptan (Samsca) for hyponatraemia due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH). The group concluded that tolvaptan is unlikely to be cost-effective compared with existing treatment options and was concerned about the potential for unrestricted long-term treatment. The group recognised that long-term treatment could be appropriate in certain circumstances according to a local protocol. For more information clink here.

Single dose fentanyl nasal spray launched in UK

NycoMed has launched Instanyl (fentanyl) single-dose nasal spray for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Instanyl single-dose nasal spray is available as a pack of 6 individual child-resistant blisters in 50, 100 and 200microgram strength all costing about £36 i.e. £6 per dose (NHS list price). The single dose blisters do not need priming before use. For more information see the SPC.

SMC rejects aprepitant

Following a resubmission, the Scottish Medicines Consortium (SMC) does not recommend the use of aprepitant (Emend), within NHS Scotland, as part of combination therapy for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. The SMC concluded that the clinical and economic analyses submitted by the company were not sufficiently robust to gain its acceptance. For more information clink here.

Positive benefit-risk balance of pholcodine-containing cough medicines

The European Medicines Agency (EMA) has confirmed that the benefits of pholcodine-containing cough medicines outweigh their risks and that these medicines should remain available for the treatment of non-productive (dry) cough in children and adults.

A review was initiated following concerns that its use may put people at risk of developing anaphylactic reactions to neuromuscular blocking agents used during surgery. However the EMA Committee for Medicinal Products for Human Use (CHMP) found no firm evidence to substantiate the hypothesis. It also noted that pholcodine-containing medicines have been available for the treatment of non-productive cough in the EU for decades and existing data confirm a positive benefit-risk balance. For more information clink here.

EMA reject appeal for new indication for duloxetine

The CHMP of the EMA has confirmed its previous negative opinion on the application for a new indication for duloxetine (Cymbalta) for the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly. For more information clink here.

Palonosetron capsules launched in UK

Palonosetron capsules (Aloxi, IS Pharmaceuticals) have been launched in the UK for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. The dose is 500microgram administered approximately one hour before the start of chemotherapy. The cost of a 500microgram capsule is £56.

For more information see the SPC.

Prepared by Sarah Charlesworth and Andrew Wilcock

Professor Irene Higginson, Director of the Cicely Saunders Institute and Associate Editor of Supportive and Palliative Care, spoke today of the recent promising trend of more cancer deaths occurring at home in the UK.

In an interview with Radio 4’s Today programme, Professor Higginson highlighted the findings of a recent report which indicates that the long term trend in institutional dying is showing the first signs of reversal since 1974. She cited a “small but significant shift” in the proportion of cancer deaths which occur at home – up from around 22% to about 27% in recent years. The change is significant because whilst a large proportion of people suffering from long-term illness  in the UK express a wish to die at home, an overwhelming majority continue to die in hospitals and hospices. However, the increase seems to be limited only to cancer deaths, with the number of people dying at home from chronic, non-cancer conditions limited to only one in six.

Prof. Higginson also highlighted the extent of regional variation in the country, with some areas having rates of home death as high as 50% and others as low as 10%. When asked about the cause of this large disparity the Professor of Palliative Care responded that there exists a “complicated web of factors” which decide whether someone is able to die at home, some cultural and some relating to services, but that there were also other influences which are not yet fully understood and should be the topic of future research.

Furthermore, Prof. Higginson underlined the importance of effectively training medical professionals so that they are able to ask people about their end-of-life preferences, as this is an important factors in deciding where people will die.

If you’re living in the UK, the interview is available to listen to here for the next week or so, starting at around 53’30”.