Introduction

March 1999 was a landmark date for pharmacists working in the UK. The final report submitted to ministers by the review team for prescribing, supply and administration of medicines—the second Crown Report—proposed a new framework whereby non-medical healthcare professionals should be permitted to take on additional prescribing responsibilities [1]. This group of healthcare professionals included pharmacists, nurses, midwives, radiographers, podiatrists, physiotherapists and optometrists.

Two new types of prescriber were defined in the Crown Report: the independent prescriber and the dependent prescriber. The Health and Social Care Act 2001 introduced dependent prescribing for pharmacists and other non-medical professional groups [2]. Dependent prescribing was implemented into practice as supplementary prescribing. Supplementary prescribing is defined as a voluntary partnership between an independent prescriber—a doctor or dentist—and a supplementary prescriber to implement an agreed patient-specific clinical management plan with the patient’s agreement.

In 2003, the Robert Gordon University in Aberdeen ran the first pharmacist prescribing course in the UK with this intake registering as pharmacist supplementary prescribers in 2004. Supplementary prescribing required a prior diagnosis and preparation of a clinical management plan which had to be jointly agreed and signed by the medical prescriber, the supplementary prescriber and the patient [3]. Whilst there were no legal restrictions placed on the supplementary prescriber with respect to medical condition and choice of medicine, the requirement to use a patient-specific clinical management plan was found by some pharmacist prescribers to be limiting. The clinical management plan (CMP) described the medicines which could be prescribed for defined conditions and any associated medicines for supportive care, but did not allow freedom to add other medicines for transient unpredicted conditions. For example, the CMP might describe the prescribing of capecitabine and the standard supportive medicines for metastatic breast cancer. But if the patient presented with oral thrush or an itchy rash perhaps, adding additional medicines which were not listed on the CMP required referral back to the medical prescriber. At this time, supplementary prescribing was deemed more suitable for an outpatient clinic environment, where patients were more predictable, rather than an acute hospital ward accepting unplanned admissions.

In 2006, independent prescribing was introduced for non-medical prescribers and the first cohort qualified in 2007. An independent prescriber is defined as a practitioner who is responsible and accountable for the assessment of patients with diagnosed or undiagnosed conditions and for decisions about the clinical management required including prescribing. A hospital pharmacist independent prescriber can prescribe any medicine within their competency including unlicensed medicines, off-label medicines and controlled drugs. The legal responsibility rests with the independent prescriber. Since 2003, approximately 900 pharmacists within Scotland have undertaken a prescribing course. A number of these pharmacists work in cancer care in Scottish cancer centres and units. Recently National Health Service (NHS) Education for Scotland published a Guide to Good Prescribing Practice for Prescribing Pharmacists in NHS Scotland (July 2012) [4]. This is an excellent resource written to support pharmacist prescribers working in all sectors.

The evolving role of the cancer care pharmacist in Scotland

The past 20 years has seen a major change in the duties and role of the cancer care pharmacist working in Scottish cancer centres and units. In the late 1980s to early 1990s, with the exception of the bigger cancer centres, we were often lone specialists, and many employed in split posts with aseptic services. Services were fragmented across the country resulting in duplication of effort. However, this was to change. In 1992, the Scottish cancer pharmacists established a national group, a network to bring together our expertise. This pioneering work drove our clinical and strategic aims. Our role within multidisciplinary teams was already established and clinical patient-centred care was delivered at the bedside and in the clinics.

In the late 1990s, individual health boards came together to form three cancer networks based on Scotland’s geography. Individual tumour teams within these networks formed tumour-specific managed clinical networks, a virtual cohesive multi-professional group with the aim of improving the patient experience and assuring the consistency and quality of cancer care. Cancer in Scotland: Action for Change was published in 2001 and with this came an investment of some 40 million pounds. Some of this investment was in pharmacy services, both personnel and equipment. Cancer care pharmacists were recognised as leaders in horizon scanning, capacity planning, protocol/guideline development and clinical effectiveness. National standards for systemic anticancer therapy (SACT) quality and safety place the cancer care pharmacist at the centre of patient care and demanded that all SACT prescriptions were verified before dispensing [5].

The advent of non-medical prescribing, and in particular, independent prescribing, and the emergence of oral SACT helped set the direction of travel for clinical pharmacy cancer services. There were several drivers for the introduction of pharmacist prescribing:

• redesign of cancer services—skill mix, workforce planning
• repatriation of patients from regional cancer centres to local hospital cancer units
• capacity and demand for SACT
• emergence of oral SACT
• reports of incorrect dosing of oral SACT
• switch from inpatient treatment to day-case/outpatient treatment.

Underpinning all of the above was the one indisputable fact. A pharmacist is an ‘expert’ in medicines. The strength of a pharmacist prescriber lies in their knowledge of clinical therapeutics, pharmacology, pharmacokinetics, pharmacodynamics and pharmaceutical chemistry. Cancer networks established governance arrangements for pharmacist-led services and the West of Scotland Cancer Network developed a framework for pharmacist/nurse-led clinics. The framework includes all the steps necessary to manage a patient case load and can be divided into three overarching segments:

• clinical planning, organizational issues, documentation
• pre-treatment processes, e.g. patient assessment, fitness for treatment
• on treatment processes, e.g. patient monitoring (toxicity and response), transfer of information to other healthcare professionals.

Pharmacists are prescribing in many cancers and the remainder of this article will discuss the author’s role within the lung cancer team in South Glasgow, part of the West of Scotland Cancer Network. Aside from intravenous drugs, there are three oral SACT used in Scotland for the treatment of lung cancer namely erlotinib, oral vinorelbine and oral topotecan. All cancer therapies are prescribed by the hospital cancer teams and dispensed by hospital pharmacies. Community pharmacists do not aseptically prepare SACT. Some of the steps included in pharmacist prescribing in lung cancer are:

• assessment of performance status compared to baseline/previous cycle
• grading of toxicity using the common toxicity criteria, graded 0–4
• check of critical tests, e.g. full blood count, biochemistry, liver function tests (LFT)
• medication review—check for interactions
• review of interval scan and referral back to medical prescriber if there are signs of disease progression.

In the UK, all prescriptions for SACT require pharmaceutical verification [5, 6]. This is a structured systematic check of the prescription to ensure the right dose, at the right time for the right patient. As I am a single pharmacist practitioner in my hospital, maintaining compliance with this national standard has meant that I no longer prescribe SACT. However, I do prescribe supportive medicines for cancer patients such as antiemetics, mouthcare preparations, bowel preparations, pre-meds such as steroids, granulocyte colony-stimulating factor and skin preparations, e.g. for erlotinib rash management.

The patient pathway for erlotinib can be described as below:

*Figure pending to upload.

The first consultation I have with a patient starting oral therapy is the most important one. I spend an average of 40 minutes with a new patient. It is helpful if a family member is present. This is time very well spent as patient education is crucial to early recognition and management of toxicity. Patients are given instructions about who to seek advice from out with clinic visits and also what to do if advice is needed at evenings and weekends.

I use various support materials, some produced for patients by the pharmaceutical industry, others developed by ourselves. Of particular help is a hand-held erlotinib treatment card, see Figure 1, developed by myself in collaboration with the Lung Cancer Managed Clinical Network. The aim of this card is to provide immediate advice on management of the common erlotinib toxicities and to give advice on when treatment must be stopped, e.g. suspected bowel perforation, interstitial lung disease or suspected corneal ulcer.

*Figure 1 pending to upload.

I like to conduct a full medication review at this stage as there are significant drug interactions with erlotinib. The patient is asked to bring in all their medicines so that I can ascertain which they are taking and how, and discuss any compliance issues. I can also refer them to smoking cessation if they wish. A common intervention is managing the interaction between erlotinib and protein pump inhibitors (PPI). We aim to stop the PPI but this can result in painful reflux for the patient. We do not wish to worsen quality of life and sometimes co-prescribing of erlotinib and a PPI has to happen.

The patients are given my NHS mobile phone number and I do ask them not to hesitate to contact me. Some are frequent callers and sometimes I am called by their general practitioner for specialist advice.

The patient pathway for oral vinorelbine and oral topotecan is slightly different, as illustrated below:

*Figure pending to upload.

This treatment requires a full blood count on the day of treatment. To avoid the patient having to wait until the critical tests are reported; the pharmacist, with the agreement of the medical prescriber, will verify treatment in advance of the results and allow the patient to collect their medication from the hospital pharmacy then leave the hospital. The patient is instructed not to take any treatment until contacted by the pharmacist. If there was any doubt that the patient would or could not comply with this instruction then the patient has to wait until the test results are known or, they can arrange to return to the hospital later in the day to collect the SACT. This arrangement has worked well thus far with only 1–2 doses being cancelled over a number of years.

The lung cancer service is truly multiprofessional and this brings many benefits. Oncology, pharmacy, surgery, palliative care, nursing, clinical trials and respiratory are all in the same place at the same time. This allows best use of skilled staff and timely resolution of clinical problems. The time I spend with the patient releases medical staff time for longer consultations with complicated patients or breaking bad news. Allowing patients to go home with SACT reduces waiting time, and although we have not evaluated this, I believe we have improved the patient experience.

Working from a clinic is far removed from a ward environment and it takes time to feel comfortable there. Whilst I completed all the required period of learning in practice during my prescribing training, some of it in outpatients, pharmacists are not trained for this environment. Patients with lung cancer tend to have multiple co-morbidities and can be a challenging patient group. Some logistical issues in outpatients include getting a clinic template set up, lack of secretarial support, booking tests and dictation. My time spent with the lung cancer team evolved from the need to verify SACT prescriptions and was not ring fenced.

My take home messages from reflecting on what I do now compare to what I hoped to do are:

• write a business case for your role as a prescriber in clinic
• ensure you have support from the Director of Pharmacy and Clinical Director
• start small and grow with the service
• gain confidence—perhaps start with toxicity management
• start with less complex SACT—oral treatments are ideal
• know your limitations
• some blurring of traditional roles is OK
• sell yourself—pharmacists are the ideal professional group to support patients on oral SACT
• make the best use of your unique skills and training.

Thinking about other drugs and future developments, there are many prescribing opportunities for pharmacist prescribers, for example, with sunitinib imatinib/nilotinib/dasatinib and abiraterone. But there are simply not enough hospital cancer care pharmacists to take on these roles in the traditional medical prescriber model. So how do we manage capacity and an increasing workload? I believe we need to rethink our verification processes and target it to complex, intensive SACT. Some oral therapies and indeed, some non-complex parenteral treatments probably do not need all the steps currently performed. We could consider telephone follow-up as opposed to direct face-to-face contact. Clinical pharmacy triage and referral are established in some Scottish hospitals whereby specialist care and intervention is directed to where it is needed most. There are junior pharmacists who could manage the less complex patients. We certainly should extend the role of pharmacy technicians to deliver patient education for less complex SACTs and we must develop clinical technicians.

I also believe that in the future, community pharmacists will have much more input. Patients can access community pharmacy when the hospital clinics are closed and often have a well-established relationship with their local pharmacist.

We are in an age of information technology and social media – let’s not forget that well-designed applications, for example, can be used as medication reminders to deliver direct advice on toxicity management and be a means of communication across traditional boundaries.

You are a pharmacist. You are an ‘expert’ in medicines. Good luck!

Further reading

Stewart D, Cunningham S, Diack L, et al. Report: Exploring and evaluating pharmacist prescribing. Robert Gordon University, Aberdeen. 2010 June. Available from: www.4.rgu.ac.uk/files/RGU%20Prescribing%20Research%20Group%20Report.pdf

Author

Fiona MacLean, MRPharmS, MSc, IPres
Lead Clinical Pharmacist
Regional Services Directorate
Cancer South & Clyde and Neurosciences
NHS Greater Glasgow & Clyde
Level 2, Clinic P, Pharmacy Workstation
New Victoria Hospital
Grange Road, Langside
Glasgow G42 9 LF, UK

References

1. Crown J. Review of prescribing, supply and administration of medicines. Final report. London: Department of Health; 1999 March [cited 2013 Mar 12]:1-133. Available from: www.dh.gov.uk/prod_ consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4077153.pdf
2. The Health and Social Care Act 2001. London: Stationery Office; 2001 [cited 2013 Mar 12]. Available from: www.legislation.gov.uk/ukpga/2001/15/contents
3. Baqir W, Miller D, Richardson G. A brief history of pharmacist prescribing in the UK. Eur J Hosp Pharm. doi:10.1136/ejhpharm-2012–000189
4. NHS Education for Scotland. A guide to good prescribing practice for prescribing pharmacists in NHS Scotland. 2012 July [cited 2013 Mar 12]. Available from: www.nes.scot.nhs.uk/media/1457463/nesd0061_goodprescribingpractice.pdf
5. The Scottish Government. [Revised] Guidance for the safe delivery of systemic anti-cancer therapy. CEL30 (2012). 2012 July. [cited 2013 Mar 12]. Available from: www.sehd.scot.nhs.uk/mels/CEL2012_30.pdf
6. British Oncology Pharmacy Association. BOPA Standards for Clinical Pharmacy Verification of SACT FINAL 29.1.10. Standards for clinical pharmacy verification of prescriptions for cancer medicines. 2010 Jan 29 [cited 2013 Mar 12]. Available from: www.bopawebsite.org/contentimages/publications/BOPA_Standards_for_Clinical_Pharmacy_Verification_of_SACT_FINAL_29.1.10.pdf