4.14 The contribution of the clinical pharmacist in palliative care

The judicious use of the best available evidence, moderated by patient circumstances and preferences to guide our practice to improve the quality of clinical judgements and facilitate effective health care.

Reproduced from Sackett DL et al., Evidence-based medicine: what it is and what it isn’t, British Medical Journal, Volume 312, Issue 7023, pp. 71–72, Copyright © 1996 with permission from BMJ Publishing Group Ltd.

Many sets of therapeutic guidelines now exist in the United Kingdom and on the whole, the list of drugs used for symptom control is broadly consistent. Guidance and core formularies have also been developed by palliative and supportive care networks, which were established as a model of integrated service provision alongside cancer networks, in response to The NHS Cancer Plan to improve coordination of cancer and palliative care (Department of Health, 2000b). Clinical pharmacists have been involved in many of the network subgroups, coordinating drug treatment and availability. In the United States, the introduction of standardized, evidence-based medication use guidelines is encouraged (Weschules, 2005).

As well as the choice of drugs, the clinical pharmacist can advise on the most appropriate formulation for individual patients. With some exceptions (such as strong opioids and drugs where the avoidance of peak effects in drug blood concentrations may lead to fewer side effects), prescribers are now encouraged to avoid the use of slow-release preparations on economic grounds. In palliative care, our patients’ tablet ‘burden’ can often be a real problem and so use of a more expensive once- or twice-daily preparation, such as slow-release metoclopramide, may be justified.

Managing a drug regimen for a patient who has swallowing difficulties or is being tube fed has pharmaceutical implications. Crushing tablets is to be discouraged, as changing the form of a dose not only takes it outside the terms of its licence, but can also be hazardous as it may change its pharmacokinetics—especially dangerous with a slow-release formulation. Liquid or soluble tablets can be very expensive, so alternative drugs may need to be substituted. The decision to substitute any drug in a situation of stable symptom control has to be considered carefully.

The pharmacist may also alert colleagues to the sensitive issue of discontinuing medication. Effectiveness and tolerability of each medication will be reviewed regularly but decisions on whether a patient nearing the end of life needs to continue with such medication as statins or oral hormonal treatments normally need to be negotiated with the patient and possibly their carers. The goals of care and treatment should be considered in relation to prognosis and the patient’s ability to manage their medicines. Initiating drugs with a long onset of action, such as the older antidepressants may not be appropriate if the time to benefit may exceed the patient’s life expectancy. These are emotive issues but unfortunately their cost implications can be considerable (Holmes et al., 2006). Moreover, the burden of any side effects at initiation, will have been for no gain.

It is almost inevitable that we have a degree of wastage when drugs are dispensed for patients at the end of their life and although it is a difficult moral issue to destroy what seem to be perfectly sound drugs, we have a statutory responsibility not to re-supply any drugs that have been dispensed to a particular patient to others as we are unable to guarantee their integrity. The only practical way to counter this is to minimize waste by ensuring that appropriate quantities are ordered.

Nurses need also to be aware of the relative costs of dressings and skin and mouth-care preparations. Wound care and mouth care are often challenging areas of palliative care and there is a huge variety of products on the market. With pharmacist input, guidance or decision-making tools can encourage nurses to use the most appropriate and economical choices.

The majority of dying people in the United Kingdom would prefer to die in their own home, although currently only about 20% do so and many are admitted to hospices and more to hospitals in the last days of life (National Council for Palliative Care, 2010). This is a statistic that has rightly occupied a great deal of attention in recent years and strategies are being introduced to improve this. Good end-of-life care at home requires the input of a team of health-care professionals and the role of the pharmacist is expanding. The traditional medicine supply role is of paramount importance but more direct patient care is part of the pharmacist’s role in some community teams in the United Kingdom and Australia. Pharmacists are members of the team visiting patients at home, where they can optimize medicines management and reduce medication-related problems (Hussainy et al., 2011). The opportunity to practise as an independent prescriber is a newer role in the United Kingdom and this can speed up access to medicine supply.

Although routine symptom control medicines are prescribed and supplied in the community, the provision of drugs for patients who deteriorate unexpectedly has always been complicated by legislative limits on the ability to hold ‘stock’ injectable drugs outside pharmacies and hospitals. In addition, many doctors no longer carry their own supply of opioids for security reasons. Medical and nursing cover varies from area to area but the simple lack of availability of the required drugs has led too often to an inappropriate hospital admission, and significant distress, especially during the out-of-hours (OOH) period, which is almost 70% of the week. OOH care in England and Wales underwent a substantial National Health Service (NHS) review in 2000 (Department of Health, 2000a) and other reviews of practice, such as those initiated by Macmillan Cancer Care resulting in the Gold Standards Framework (National Gold Standards Framework (GSF) Centre in End of Life Care, n.d.), have contributed to subsequent re-organization in recent years.

Systems for stocking small quantities of injectable drugs in designated community pharmacies have been set up in various localities. Whilst these schemes are an invaluable back-up, they have not always been a success. This may be because they are not always well publicized to the relevant professionals but, more importantly, there is an inevitable delay in getting the pharmacist and prescription to the pharmacy and back to the patient’s house. Underuse of pharmacy schemes leads to expiry of stock. The system should be used in conjunction with immediate access to the necessary drugs by the on-call medical service. Commissioners are responsible for ensuring that there is a safe system in place for providing all the drugs on the national OOH formulary to providers of OOH medical care. A list of essential and desirable drugs is shown in Box 4.14.3. The details of the OOH arrangements need to be agreed locally to suit the geography and population. They should encompass the NICE guidance for improving supportive and palliative care (NICE, 2004), be supported by improved communications, facilitated by introducing the Gold Standards Framework after the publication of Caring for the Dying at Home (Thomas, 2003) for community care of the dying, and take into account the Preferred Place of Care (Cohen Fineberg and O’Connor, 2011) initiative.

Clinical pharmacists have been instrumental in establishing so-called just in case schemes where general practitioners (GPs) prescribe a small quantity of injectable drugs for individual patients identified as nearing the end of their life. These drugs can be kept safely in the patient’s home in case of a sudden deterioration. In a pilot scheme in Hertfordshire, United Kingdom (Amass and Allen, 2005) over 6 months in 2004, 23 ‘just in case’ boxes were issued, enabling 16 patients to have their symptoms managed and to die at home, which was their expressed preference. Each pack of drugs cost only £10 and the potential saving on an admission to hospital or hospice. Clearly, however, the satisfaction for the patient and their family resulting from good end-of-life care is immeasurable.

Medicines management in hospitals encompasses the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed to optimize the contribution that medicines make to producing informed and desired outcomes of patient care.

Reproduced with permission from The Audit Commission, A Spoonful of Sugar: Medicines Management in NHS Hospitals, Audit Commission Publications, Wetherby, UK, Copyright © 2001, available from <http://archive.audit-commission.gov.uk/auditcommission/sitecollectiondocuments/AuditCommissionReports/NationalStudies/nrspoonfulsugar.pdf>.

When patients have a planned admission to an inpatient unit in the United Kingdom, they are encouraged to bring their current medicines in with them. This has several benefits; it is essential to establish a drug ‘history’, particularly if symptoms are out of control. It can also clarify whether the patient is actually taking the regimen as prescribed and note what has been used in the past and what the outcomes were. Patients may have a number of symptoms and coexistent pathologies, making it common for them to be taking a large number of medicines, so this is often a time-consuming job involving rummaging through bags full of dispensed medicines. Although the admitting doctor or specialist nurse will normally do this as part of any admissions process, pilot studies have shown that a pharmacy-led medicines review process uncovers issues and is highly acceptable to the patient. Unfortunately, time limitations have not enabled these to become routine.

Bringing in their existing medication also ensures that patients have an ongoing supply, as most units will not have an exhaustive range of stock drugs. It also prevents duplication, reduces waste, and, ultimately, saves money. Not all patients’ own drugs can be used so they must be screened for suitability using a checklist, ensuring they are suitably packed, identifiable, not time expired, and labelled correctly for the patient. This also forms part of an audit trail for medicines.

One of the main aims of the NHS medicines management programme is to encourage patients to keep charge of their medicines in a bedside locker and to continue to take them independently. Clearly not all patients admitted to a hospice are suited to self-administration, but those whose admission is for respite or symptom control should be encouraged to do so with multidisciplinary team agreement. Patients need to understand their regimen and manage practical issues such as their ability to open containers, read labels, and appreciate their responsibility for security of their medicines. An agreed assessment process needs to be part of the hospice medicines policy. Almost all patients who are given the chance to self-administer prefer it, because it gives them more control and promotes confidence in managing what may be a complex regimen (Ausburn, 1981). This confidence can be a major contribution to a successful discharge, as many admissions and re-admissions arise because of problems with managing medication. We know that low adherence to instructions with medication affects outcome so patients must be given sufficient information to make an informed choice on the benefits and risks of a therapeutic ‘alliance’ (Royal Pharmaceutical Society of Great Britain, 1997). Patient counselling by pharmacists promotes understanding of the purpose of each medicine and awareness of potential adverse effects (Al-Rashed et al., 2000). It can also provide an opportunity to discuss practical issues such as the provision of medicines in concordance aids (‘dosette boxes’), which may be continued on discharge. Most GP surgeries and pharmacies have a delivery system for prescriptions from surgery to pharmacy and then on to the patient at home.

Community pharmacists establish relationships with their regular patients and their families and have a wider role to play than simply drug supply. In some countries, community pharmacists are responsible for preparing pre-filled syringes for syringe drivers. In the United Kingdom, groups of community pharmacists have undergone additional training in order to support palliative care patients, by setting up prescription monitoring and supply services.

Another important role for palliative care pharmacists is to provide ‘seamless’ pharmaceutical care for patients as they move from one care setting to another (Scally and Donaldson, 1998). A common NHS electronic patient record system has not been successful, so we rely on a number of different methods of transmitting medication information, some of which are less reliable than others. A medication list will normally be drawn up on discharge and sent to the GP or other doctor looking after a patient, but their community pharmacist can sometimes be left out of the loop and both may be faced with an urgent prescription for an unusual drug unless prior explanation has been provided. Where medicines management systems exist, patients’ discharge medication will often be dispensed well before the expected discharge. This can present last-minute problems if doses or drugs have been changed in the interim. The importance of timely prescribing and supply to patients, for whom time is limited, needs to be communicated to all health-care professionals providing services. Pharmacists have a major educational role in fulfilling this particular objective (see Box 4.14.4: scenario 1).

A framework through which [NHS] organizations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.

Reproduced from G. Scally and L.J. Donaldson, Clinical governance and the drive for quality improvement in the new NHS in England, British Medical Journal, Volume 317, Issue 7150, Copyright © 1998 with permission from BMJ Publishing Group Ltd.

Pharmacists have a major role in clinical governance issues involving medicines, with many sitting on their hospice Medicines Management or Drug and Therapeutics Groups. The terms of reference of these groups may vary but usually include the review of drugs coming on to the market or drugs being suggested elsewhere for symptom control as well as ensuring the correct application of new drug-related guidance or legislation.

Palliative care practice often involves using drugs outside the terms of their product licence. In order for any new drug to reach the market, the manufacturer must be able to prove that it is a safe and effective treatment. Once this has been proved in a drug development programme, it will be granted a licence for the conditions for which it has been tested. Licensing is both a commercial and medico-legal issue but a doctor may prescribe, a pharmacist may dispense, and a nurse may administer drugs outside the terms of their licence, as long as the drug was being used in accordance with a practice accepted at the time by a responsible body of medical opinion. There is encouragement from UK authorities to discuss the use of medicines outside licence with our patients and although we aim to involve patients in all prescribing decisions, terminology such as ‘outside the terms of a drug’s licence’ may sound more worrying than it need be. Most of the drugs used in this way are long established with well-documented safety and adverse effect profiles, so the main issue is ensuring that there is sufficient evidence for this use, whilst the main issue for patients is to avoid any potential confusion arising from information they may read in the patient information leaflet (PIL), which must be supplied with their dispensed medicines. Hospice pharmacists have written PILs for their own establishment and are usually happy for such information sheets to be used by others. At a small hospice user group this was not an issue of great concern, with patients saying they trusted the health-care professionals to do what they could for them (User Forum, 2012).

Pharmacists regularly advise nurses on the correct methods of administration of drugs. With tube-fed patients or other patients who may find swallowing difficult, it is common practice to consider crushing a tablet or opening a capsule and sprinkling the resultant powder on food or mixing it with a drink. Any of these alterations to the original product renders it outside its licence. Pharmacists have written a number of reference sources to offer advice about the best method of administration of the drug in these circumstances. This may involve changing the drug to an alternative where a licensed liquid or soluble form is available. The use of medicines without any licence is a slightly different issue. It is unlikely that a palliative care unit would wish to use an unlicensed drug but we often wish to mix or compound known drugs in unlicensed formulations to suit individual patients. Some examples of this are the use of alfentanil injection made into a cutaneous solution that can be sprayed onto the nasal or buccal mucosa and the addition of lignocaine (lidocaine) to a thermoversible gel for the management of painful wounds. Both products are made in regional hospital pharmacies in the United Kingdom. Although US pharmacists are permitted to compound individual preparations for patients, this practice has become very limited in the United Kingdom and is now restricted to a few commercial ‘specials’ manufacturers and regional, licensed hospital pharmacy manufacturing units. Information on unlicensed medicines is limited, as products have not been subjected to the same regulatory processes as licensed medicines so as much evidence as possible is required that such products are being appropriately and with accountability. Prescribers and pharmacists must both be involved in the decision-making process, using a committee or the clinical governance team to approve and document the rationale for using unlicensed products. Once sufficient experience has been gained in their use, specialists may start suggesting to generalists that these products be used. The production of referenced information leaflets is important in supporting this. The Brompton Hospitals and some hospices have produced their own leaflets either covering this subject in general or for specific drugs such as the use of haloperidol to treat nausea and vomiting.

The use of the subcutaneous route is outside the license for the majority of drugs used in symptom management. The major area of potential problems is where drugs are mixed together in the same syringe. Although the drugs used are familiar and well established, it is not necessarily in a company’s financial interests to investigate the compatibility of its injections with those of others. Additionally, many of the drugs we use have lost their patent and are made by generic manufacturers who would be even less inclined to carry out such studies. Pharmacists have been largely responsible for gathering data on the mixing of drugs in syringes for subcutaneous infusions (Dickman and Schneider, 2011). Our knowledge in this area comes from a combination of clinical observation and laboratory tests and ongoing data collection continues to add to this (Palliativedrugs.com, 2014).

The use of complementary medicines needs to be considered as a safety issue. Understandably, many patients are concerned about the safety of conventional medicines but there is a perception, fuelled by marketing that if a product is herbal or marketed as ‘natural’, then it may be safer. There are countless products available supported by testimonials and claims that they work wonders—from improving digestion to curing cancer. When taking a drug history, pharmacists will also make specific enquiries, as patients may not mention complementary therapies because they are not regarded as ‘drugs’. The quality of information on complementary medicines is in general not required to be of the same standard as that of conventional medicines, as they are not subject to the same legal controls. This makes it difficult to unpick the evidence. Clinical pharmacists can review the information available critically and offer guidance on potential beneficial and adverse effects of complementary medicines, as well as advising on possible contraindications and drug interactions. Research and data collection on herbal medicines and supplements is enabling us to offer better guidance and the Medicines and Healthcare Regulatory Authority regularly releases bulletins warning of serious safety issues with these medicines. In offering guidance on these products, pharmacists need to carefully word their findings in order to indicate the level of evidence for their statements and to take into account the patient’s individual choice to continue with such products.

Practical and pragmatic guidance from the pharmacist is also required for some drug–food interactions that may impact on patients. For example, the ingestion of excessive amounts of vitamin K-containing green vegetables can affect coagulation, but a normal portion of such vegetables on a regular basis presents very low risk. Similarly, the presence of a drinks trolley on hospice wards and day centres prompts pharmacists to alert staff involved in ‘administration’ to the possible interaction between alcohol and drugs.

Incidents involving drugs account for about 10% of all adverse events reported in NHS hospitals, although over 80% result in no apparent patient harm (National Reporting and Learning Service, 2009). These figures are not necessarily applicable to hospices but the need to review and take appropriate action following adverse drug events is no less important. The ethos of drug error reporting has changed in recent years with a ‘no blame’ reporting system instigated in many hospitals and the involvement of staff in reporting ‘near misses’. The focus is now on systems rather than individuals and we are asked to review our practice by the NHS Commissioning Board Special Health Authority in the United Kingdom, which disseminates guidance and safety notices for areas of risk such as the alert on potential for confusion between strengths of opioids (unpublished data). Pharmacists are able to advise on systems for reporting errors and improving safety and are essential members of the group within a hospice that reviews incidents. Writing additional safety steps into policies and sending round awareness bulletins have had positive results in that incidents have not recurred (Anonymous, 2006). Sharing information with other hospice pharmacists has also highlighted common areas for concern and constructive changes, such as persuading a company to improve its packaging, have been achieved.