Community-Based Cancer Treatment Model

Introduction

Patient-centred care

In 2010, the UK’s National Health Service published a white paper that advocated for the extension of patient choices and elimination of bureaucracy within care pathways (Crowe, et al., 2010). Consequently, chemotherapy service providers extended their services from secondary care to community-level care, building upon previous NHS initiatives to deliver patient-centered care at community level. More importantly, the white paper formed the foundation for the shift from Primary Care Trust (PCT) to a GP-led commissioning in 2012 (Fife, 2011). Consequently, there was a general expectation that the NHS would commission all the anti-cancer drug supply services at community levels as part of the strategy to enhance NHS primary care services (Crowe, et al., 2010). Against this backdrop, there has been a strong motivation among NHS commissioners to devolve services and move them closer to patients based on statistical predictions of an increased number of people requiring those services in future (Arlow, 2011). provision of cancer care was one of the services that faced capacity pressure due to the increase in number of patients undergoing systemic anticancer treatments (SACT). As a result, alternative models of chemotherapy emerged, one of them being the cyclical dispensing at the Christie NHS Foundation Trust. This model was adopted in support of Christie’s healthcare professionals and pharmacists who had gone beyond the boundaries of their professional job descriptions to care for cancer patients. Furthermore, it was based on the realisation that there were numerous pharmacists who would be involved in dispensing, administering and monitoring cancer patients receiving anti-cancer care within the community (Erning, et al., 2016). However, there have been increasing concerns over the safety of dispensing and supply of oral cancer drugs within the UK especially after a safety alert issued in 2008 by the National Patient Safety Agency (NPSA). Particularly, this report highlighted the risks associated with incorrect oral anti-cancer drug dosages prescribed and dispensed (Verger, et al., 2017).

Patient safety

The challenge of maintaining drug safety has evolved over many years. Consequently, there have been radical changes in what can be considered a benefit or risk of drug safety as well as the safety requirements following various therapeutic development and disastrous outcomes associated with those developments (Suda, et al., 2017). For instance, the United States of America (USA) experienced a major drug safety issue in 1937 with sulfanilamide elixir containing diethylglycol, triggering the Food and Drug Administration (FDA) to request toxicity essays as one of the requirements for sale of new drugs authority (Erning, et al., 2016). As a result, health authorities around the world have embarked on developing oversight measures to reduce drug-induced adverse effects as well as other drug safety surveillance measures to minimize effects on the general population. Consequently, Christie NHS Trust, through cyclic drug dispensing, has developed a patient-focused drug dispensing system that aims at risks associated with drugs where side effects are expected and the effect of adherence on outcomes is significant. Added to that is prevent the potential for incorrect medicine usage due to stockpiling and the financial aspect of preventing unnecessary dispensing.

The Christie NHS Foundation Trust

As the largest single site cancer centre in Europe, The Christie is involved in the care and treatment of over 40,000 patients annually. The Christie Pharmacy Company was set up in 2017 with the aim of providing high-quality pharmacy services to both in- and out-patients of the Trust. It acts as a subsidiary company of The Christie NHS Foundation Trust and it is fully owned by it. In the publication of the Five-Year Forward View (FYFV) and Achieving World-Class Cancer Outcomes: A Strategy for England (NHS, 2016), several recommendations on how to achieve improvements across the NHS when it comes to cancer treatments and care were outlined. These were set out in a response to the pressures formed by the increasing population diagnosed with cancer. A common theme was central in both publications mentioned above, that being the practice of providing a patient-centred care with the views of improving patient experiences, as well as their outcomes. The FYFV has suggested that networks of services which integrate organisations and services around the patient, should be developed as a mean of improving cancer care. Furthermore, the FYFV described novel models of care, some of which were piloted by The Cancer Vanguard. The models in question would ensure that patients are provided with innovative and high-quality care. The Cancer Vanguard is … and is made up of … The Christie hospital, together with other trusts located in London, has become a spearhead for The Cancer Vanguard’s aim to establish novel care models. The Joint Medicines Optimisation Group was established under The Vanguard with the purpose of improving the delivery of medication to patients and the access to anti-cancer drugs. Considering the set out aims and recommendations by the FYFV and The Cancer Vanguard, the current audit was initiated to evaluate whether the newly implemented dispensing model at the Christie Hospital can deliver low-risk systemic anticancer therapy (SACT) in a patient-centred and cost-effective way.

Cyclic treatment at the Christie Hospital

Anticancer medication is given in diverse ways (Some IV, some oral, sometimes in cycles and sometimes continuously), as opposed to a single treatment. The cyclic medication is characterized by several breaks in between that combine to form a cycle of on and off oral drug taking (Kulesskiy, et al., 2016). Many oral anticancer drugs treating different conditions are being supplied to the patients under the care of The Christie Hospital. Sometimes, supply is done via a dispensing scheme, which was recently implemented in 2015. Under the scheme those oral medicines are being supplied one cycle at a time and despite patient review dates. It is though that this type of dispensing may bring positive outcomes such as better patient adherence and therefore improved patient safety, as well as reduced medicine wastage. However, no previous research on this has been done to show this.

Justification of the study

Identifying the safety and cost of cyclical dispensing at the Christie NHS Foundation Trust is an important policy and regulatory item that seek to ensure both health and economic well-being of cancer patients. Medicine dispensing is a health practice that involves various procedures, protocols, technology and management practices that form part of the system of operation at the Christie NHS Foundation Trust. These elements could be improved by identifying the level of safety and cost effectiveness of the entire system. Furthermore, cancer medication and chemotherapy cost a lot of money to the NHS. Therefore, in the spirit of quality healthcare, the findings of this study will help identify the areas for improvement in such an important system and develop interventions that may not only save on costs but also eliminate health risks that may emanate from unsafe dispensing service.

Structure of the dissertation

After the introduction and setting the background of the study, the author will move into the literature review section, which identifies the existing literature on medicine dispensing and its related safety and cost issues. Also, in the literature review section, the author will identify existing research gaps in this area of research and how the study fills these gaps. After the literature review, chapter three will be the research methodology section. Here, the author will identify the techniques, strategies and procedures through which the study objectives will be achieved. In doing so, the author will state and justify various elements of research methodology such as research approach, research philosophy, data collection and data analysis among other elements. The next section will be the results. Here, the author will present and interpret results of the study. Finally, a discussion of the results will be presented, as well as a conclusion of the study.

Literature Review

Existing pharmaceutical research agree that effective medication dispensing entails giving medicine to the right person based on the correct prescriptions (Cheung, Bemt, Bouvy, Wensing, & Smet, 2014). The dispensing pharmacist must correctly interpret the prescriber’s intentions and wishes so that they can accurately prepare and label the medicine for a safer use by the patient. Meanwhile, because medication dispensing may take place in many places including community pharmacies, public or private clinics, hospitals and health centres, safety and cost effectiveness of medication dispensing has been explored in many research directions, with little success on what constitutes a safe and economically viable dispensing (Cheung, Bemt, Bouvy, Wensing, & Smet, 2014). In this section of the study, we explore existing literature on medication dispensing, what is known and what is yet to be established about the safety and cost effectiveness of medication dispensing. In the process, we compare the different elements of the cyclical dispensing at the Christie NHS Foundation Trust. Ultimately, we identify existing research gaps within the contexts of these elements and speculate whether the current research will close those gaps. While dispensing is often perceived as a simple task, all the resources involved in it can go into waste if the medicine does not end up in the hands of the person for which the drugs are prescribed, or if the person receives incorrect drugs or incorrect dosage advice. Consequently, researchers have been keen to evaluate factors that influence medication dispensing, which therefore ensures correct medication dispensing.

Dispensing Environment

Agrawal (2009) asserts that pharmacists must ensure that they operate in a clean environment. This is particularly important for cancer medication because most of them are for internal use and therefore they must be uncontaminated and hygienic. Similar remarks are made by (Azad & King, 2008) who insist that the accuracy and efficiency of dispensing depends on how the environment is organized. In this regard, Polischuk, et al. (2012) and Azad & King (2008) consider the dispensing environment to be composed of the physical surrounding, the staff, packaging materials and equipment, work surfaces, storage and shelving. Moreover, all the staff involved in dispensing should wear clean clothes/uniforms and maintain good personal hygiene. However, there is unclear evidence on whether the cyclical dispensing at the Christie NHS Foundation Trust observes these environmental hygiene factors in their dispensing process. While the NHS Foundation Trust indicate that dispensing can either be done at the hospital or through a delivery service (Anto, Barlow, Oborne, & Whittlesea, 2011), less has been established whether the delivery hygiene protocols are observed in the process. Thus, through the current study, it would be interesting to address this grey area of knowledge by investigating the hygiene levels maintained at the Christie NHS Foundation Trust. Furthermore, there is a lack of evidence on the availability of any routine cleaning of dispensing surfaces and storage shelves implemented by Christie NHS Foundation Trust. Another important element of dispensing environment that many studies have given attention to is the location of dispensaries. While the dispensaries must be in easily accessible points, they should also be located in protected areas and not in open places such as close to reach, where they are exposed to dust, pollution or dirt (Gebicki, Mooney, Chen, & Mazur, 2014). Existing research has also taken a keen interest in the dispensing equipment (e.g. those used in counting tablets and measuring liquids) as one of the most important elements of medication dispensing that would of interest to this study. For instance, uncoated tablets leave layers of powder on the dispensing surfaces that can easily be transferred to other tablets if the surfaces are not well-cleaned (Tora, Bo and Bodil). This may lead to cross-contamination and can be dangerous to the patient if the contaminating agent is one that the patient is sensitive to. Therefore, cleaning the dispensing environment and surfaces is an important process of medicine dispensing process that keeps patient safe. An organized dispensing environment is also another important part of dispensing safety. Organizing the dispensing environment regardless of the existing dispensing system is an important safety measure that cannot be ignored. In this regard, some pharmacists organize their stock shelves in dosage forms such as tablets, capsules, mixture sand syrups to ensure safe selection of medicine especially when patients come in person to buy the medicine (Carroll, Ellis, Luckett, & Raebel, 2011). (Chou, Yip and Lee) observe that in most cases, people assume that dispensing only entails giving medicine to patients based on written prescriptions and therefore anyone can do the job without any professional qualification or supervision, an assumption that is dangerous and irrational. In this regard, supplying medicine and supplying goods differ in the sense that in the former case, the recipient may not have the expertise to judge the correct quality or know the correct use of the product they receive. Therefore, the responsibility of ensuring quality and correct use solely lies on the person dispensing them (Cina, et al., 2006). This justifies why in the UK and other jurisdiction; the law requires that dispensing and distribution of medicine is conducted by professionally qualified pharmacists. However, where there is a shortage of qualified pharmacists, dispensing and delivery of medicine may be left to individuals with limited training in medicine or in the safe use of medicine (X, et al., 2009). Moreover, medicine dispensing, and distribution requires pouring, counting, and writing skills in addition to the right attitudes, knowledge and mentality to complete the dispensing process. Similar observations are made by (Goel & Gupta, 2011) who identify five basic skills that every individual tasked with dispensing or distributing medicine must have. First, they must have enough knowledge about the medicine being dispensed, including the correct dosage, methods of use, storage guidelines, and interactions with food and beverages. Secondly, the person must have arithmetic and calculation skills as well as skills for quality preparation of the medicine (Sears, et al., 2010). They must also have the attributes of honesty, cleanliness and accuracy. Lastly, persons tasked with dispensing medicine must have the right attitude and skills for effective communication (Karthikeyan & Lalitha, 2013). In the context of the current study, it is still difficult to establish whether the Christie NHS Foundation Trust’s staff tasked with implementing the cyclical medical dispensing system have all these skills and attributes. It would be interesting to find out the skill gap among the staffs and the necessary interventions put in place by the Trust to equip them with the skills. Dispensing staff must be well-trained to oversee a correct dispensation of medicine as prescribed in the facility. Regardless of working in the public or private sector, professional training on basic pharmaceutical handling skills is important (Pérez-Cebrián, et al., 2011). Some NHS Trusts have a limited range of prescribed medicine and a small number of handled patients and thus they may only require basic but highly structured training on dispensing that is based on the practitioners’ background health training (Gross, Zhang, & Grossberg, 2005). However, dispensing assistants with basic level training can also be employed in high ranking hospitals but should be supervised by trained pharmacist (Richardson, Kenny, Peklar, & Bennett, 2013).

Dispensers who work in community pharmacies should also have a similar level of training that highlights the basic practices of dispensing and medicine handling (Ward, et al., 2012). It may also be useful to train them on basic medication adherence counselling in readiness for handling with poor medication adherence behaviours. Therefore, while the reviewed literature highlights the importance of dispenser training and education, there is little knowledge on whether the Christie NHS Foundation Trust has a training framework in place for its staff to equip them with the necessary skills they need in implementing the cyclical medicine dispensing. Furthermore, it would be interesting to identify whether the staffs have the necessary skills and knowledge to handle community level challenge of medicine non-adherence.

Theoretical Approaches to Medication dispensing

Many theories have been developed to best understand the different modalities of medication dispensing that would ensure safe and cost reduction while enhancing patient adherence. For instance, behavioural theories that have been to understand human behaviours can also be used in understanding pharmacist’s actions of cyclical medicine dispensation.

Theory of planned behaviour (TPB)

TPB has been used by some scholars to understand how pharmacists interact with patients when dispensing drugs. Particularly, believers in the TPB argue that developing a behavioural intention and actual performance of the behaviour depends on three major factors namely the individual’s behavioural attitude, perceived social pressures from other people’s behaviours and expectations, and one’s perceived ability to control the behaviour (Agrawal, 2009). If the individual has more favourable subjective norms and attitudes towards the behaviour as well as perceive control over the behaviour, they are more likely to practice that behaviour when an opportunity arises (Kaye, Sands and Donahue). Thus, regardless of any ethical or legal implication, scientist have attempted to use the TPB to analyse and understand what drives human behaviour. Similarly, TPB has been used to understand health practitioners’ behaviours towards patients, including how they communicate about drug abuse and misuse especially with regards to opioids and pain relievers (Romero and Malone). Similar observations are made in Azad & King (2008) who use TPB to understand pharmacists’ intention to educate patients on drug disposal and prescription drug monitoring programs. Because there is a paucity of studies that have used TPB to understand the Christie NHS Foundation Trust’s cyclical dispensing, the current study will apply the TPB theoretical framework in explaining cyclical dispensing as a behaviour-specific intervention plan and evaluate the extent to which pharmacists’ attitudes, perceived behavioural control abilities and subjective norm beliefs affect patient safety as they use the cyclical dispensing model.

Integrated dispensing Model

Some scholars (Polischuk, et al., 2012) and (White, et al., 2014) argue that to achieve rational drug use, drug dispensing should be conducted in a model that is integrated into the care process with key considerations on accessibility of the drugs, accountability, connection and accountability, as well as clinical pharmaceutical as illustrated in the figure below: Ideally, this model works based on service system frameworks that explore the pharmacists’ roles and the importance of effective drug dispensation to the healthcare system. For instance, with regards to accessibility of drugs and services, drug dispensing systems such as the cyclical dispensing at the Christie NHS Foundation Trust that are integrated into the care process should not only ensure effective drug dispensation but also improve access to healthcare services in all levels of care by identifying and meeting their demands and needs. However, it is important to note that access to dispensing services differs from access to drugs because as opposed to the latter, the former involves modifying institutional relations within the service network through social technologies (Anto, Barlow, Oborne, & Whittlesea, 2011). This implies that to guarantee access to medication, the dispensing unit must consider various elements of accessibility such as the location of delivery, the patients’ conditions when entering the dispensing facilities as well as the impact of bureaucratic rules (Ghimire, Nepal and Bhandari). Such considerations are important because they limit opportunities and influence both collective and individual treatment decisions while stimulating user criticism. In case a patient’s access to drug dispensation is inhibited by accessibility to the dispensing facility, the pharmacy should make efforts to overcome the barriers even if it entails changing the organizational technical routines or modifying existing policies of practice or developing an efficient drug delivery system (Gebicki, Mooney, Chen, & Mazur, 2014). In the current study, it would be interesting to find out how the Christie NHS Foundation Trust makes such considerations in their implementation of cyclical dispensing.

Cost Minimization

As the NHS struggles to cover the expenses of drugs and treatment, they shift those costs to the patients (Allen & Sequist, 2012). This implies that any drug dispensing system adopted by cancer care facilities must consider the cost burden on patients and how patents can be enabled to reduce the overall cost of cancer treatment. In the past few decades, the popularity of oral cancer drugs has increased, with most patients receiving a combination of chemotherapies consisting of both oral and intravenous drugs with the similar regimen, or as single therapies delivered within a sequence of different lines of therapy. The different modalities of treatment raise cost issues, and therefore treatment facilities must make more cost considerations in cancer drug dispensing than before (Benkirane, et al., 2009). Consequently, treatment facilities have come up with innovative ways of drug dispensing that minimize costs while delivering similar quality of treatment as conventional methods. For instance, the use of in-office dispensing (IOD) compared to delivery service dispensing in terms of cost-effectiveness (Carroll, Ellis, Luckett, & Raebel, 2011). The latter dispensing technique of interest to the current study because the cyclical dispensing at the Christie NHS Foundation Trust also delivery service, pharmacy model. Community oncology services have adopted a trend of establishing IODs or retail pharmacies that are offered within the oncologist’s practice or from alternative retail pharmacies – both approaches allowing a direct dispensation of drugs to cancer patients by oncologists while enhancing the oncologist’s close monitoring and management of the patient (Midlöv, et al., 2012). Before the adoption of the IOD trend, most oral cancer drugs were offered through mail order or speciality pharmacies. In the present study, it would be interesting to find out whether the cyclical dispensing at the Christie NHS Foundation Trust facilitates the delivery of these additional services thereby reducing costs while increasing value for the money spent on anti-cancer treatment and care.

Research Aim

To examine the safety and cost implications of cyclical dispensing at the Christie NHS Foundation Trust.

Research objectives

• To investigate the safety of cyclical dispensing at the Christie NHS Foundation Trust by quantifying the instances when medication supply has been avoided/delayed or requested.

• Looking at the frequency of medication supply to determine whether costs and medication wastage have been reduced via the cyclical dispensing model.

• To explore the factors influencing the safety and the costs associated with the cyclical dispensing at the Christie NHS Foundation Trust

Methodology

Introduction

A well-developed research methodology facilitates an effective interrogation and evaluation of research findings with respect to the procedures that led to the achievement of the research objectives and the reliability of those procedures. Therefore, it is important to describe the techniques and instruments used in a study. The main aim of this section is to describe the research design, approaches, tools and techniques used to execute this study. It identifies important elements of research procedure including sampling, data collection, data analysis and ethical consideration made during the entire project. More importantly, this section gives a comprehensive justification of the various methods and techniques used herein, backed by existing literature on research methods. In the execution of this audit, the Trust’s prescribing platform iQemo, as well as the Christie’s in-house clinical electronic patient record (EPR) system; the Christie Web Portal (CWP) will be used to obtain data from a sample size of 50 patients’ electronic notes and pharmacy records. The appropriate training required for access to the mentioned computer systems was completed on the 29/11/19, which involved exercises and videos providing guidance on how to navigate around the two online platforms. The data was collected January and February 2020 following an approval from the trust’s audit committee. This is explained in detail in the “Ethical Issues” sub-paragraph.

Research Approach

Based on the assertions by Clark (2011), research approach refers to the systematic strategies and techniques used to gather data, assess the data and transform them into information that can be used to answer the research questions or conclusively achieve the research objectives. The descriptive framework adopted by the researcher to achieve the aims and objectives of the study. It involves a process that consist of data collection, analysis and formulation of conclusions based on the evidence gathered from the data (Jacobsen, 2017). Two dimensions are usually taken when describing the research approach namely data collection approaches and data analysis approaches (Sutton & Austin 2015). With respect to data collection, according to Cronin et al (2014), a study can either be quantitative, qualitative or mixed approaches. While quantitative approaches have gained much popularity in the recent past, mixed approaches have also been proven to be effective in achieving similar objectives (Jacobsen, 2017). In this regard, Cronin et al (2014) asserts that qualitative approaches involve an in-depth understanding of the problem form the perspective of people experiencing. On the other hand, quantitative approaches entail the understanding of interlinkages between variables by using empirical data to identify trends and generate hypotheses (Lapn et al, 2012). A significant advantage of quantitative approaches is that quantitatively collected data can easily be measured and validated (Sutton & Austin 2015) while it is disadvantageous in the sense that they sum up various aspects of the underlying variables into a single measurement, making it difficult to effectively evaluate their components (Katon et al, 2011). On the other hand, one advantage of qualitative approaches is that they enable researchers to understand aspects of the data that cannot be understood in figure, thereby facilitating a better understanding of observed results (Jacobsen, 2017). Against this background, the current study used mixed research approach, particularly to facilitate the understanding of costs associated with the cyclical dispensing at the Christie NHS Foundation Trust and the implications of it on the patients under the trust’s care. The data was obtained via audit forms that would statistically be analysed. With regards to data analysis approaches, a study can either use an inductive or deductive research approach. Inductive approach is described as the development of new hypotheses or theory-based research findings while deductive approaches seek to establish the validity of existing theories or frameworks. However, both approaches involve the collection of either primary or secondary data that are further analysed to develop comprehensive conclusions over the research topic (Jacobsen, 2017). As earlier mentioned, the main aim of this study is to identify the safety and cost of cyclical dispensing at the Christie NHS Foundation Trust. It aims to achieve this by collecting both secondary and primary data and analysing that data to establish whether the cyclical dispensing at the Christie NHS Foundation Trust is safe and determine the costs associated with it. Thus, the study used deductive approaches.

Research Design

Cronin et al (2014) describes research design as the general approach taken by a researcher to logically combine different aspects of a study to facilitate an effective answering of the research question. It integrates the various elements (e.g. data collection, analysis and measurement) of the study into a single framework that makes it easier for the researcher to develop and maintain the direction which the study would take (Mitchell, 2013). Based on the research problem: to investigate the safety and cost of cyclical dispensing at the Christie NHS Foundation Trust, the study adopted a descriptive research design. According to Cronin et al (2014), descriptive research design facilitates the answering of questions such as when, what, where, how and who is associated with the problem under investigation, although it may not conclusively give the answer to why. It is mostly used when the researcher aims to gather information the current i.e. what exists with respect to the problem under investigation (Jacobsen, 2017). Therefore, because the aim of the study was to investigate the safety and cost of cyclical dispensing at the Christie NHS Foundation Trust, descriptive research design was deemed fit because it would help describe how safe and cheap the NHS Trust’s cyclical dispensing is now. There are several other theoretical underpinnings as to why descriptive research design was selected for this study. First, according to Cronin et al (2014), descriptive research design is useful in situations where limitations are well understood because it helps to enhance the focus of the study.

Sampling

The main aim of this study was to evaluate the safety and cost of cyclical dispensing at the Christie NHS Foundation Trust. Therefore, the author needed a sample population to include in the study as opposed to including the entire population under cyclical dispensing at the Christie NHS Foundation Trust. The author therefore relied on non-probability sampling method to obtain the medical records of 50 patients under the care of the Christie hospital. Particularly, non-probability sampling was selected for the study because it would facilitate the collection of rich data (Mitchell, 2013). Under non-probability sampling, the study used purposive sampling, whereby the author relied on their own judgment when selecting the participants. The first reason why purposive sampling was considered appropriate is that the researcher wanted to access a specific subset of population (i.e. those receiving cancer drugs from cyclical dispensing at the Christie NHS Foundation Trust) and the selected participants fitted that profile. Secondly, purposive sampling was selected because this is a new project with undefined/loosely defined standards of measurement therefore results were expected to be exploratory – to describe the current situation and allow for measurement against previous performance in the future.

Data Collection

In academic research, data collection is the process of gathering the necessary information for answering the research questions (Mitchell, 2013). According to Cronin et al (2014), it is an important component of the study because the reliability of study results depends on how reliable the data collection process was. In the current study, data collection involved both primary and secondary sources of data. Primary sources entailed results from audit forms containing both open and close ended questions, as well as surveys, while qualitative data was derived from resources and documentation retrieved from Christie NHS foundation Trust archives.

Audit forms

The data collection tool was designed to achieve all the research objectives. For instance, to quantify where medication supply has been either avoided or requested in order to ensure the safe and correct use of medication by the patient, explore the frequency of medication supply and determine whether costs and medication wastage have been reduced, and to explore the frequency of reporting adverse drug reactions (ADRs) and side effects by patients. In the designing the data collection tool it was imperative that patient anonymity was ensured, therefore a separate patient hospital number list was created. The list assigned each patient to a unique code and it was kept secure at the hospital. When filling out the collection forms, the code was used to ensure the patient was not identifiable. Both notes created by healthcare staff during follow up phone calls and pharmacy records for medication supplies made to the patients, were used to determine the frequency of side effects reported by patients on any of the targeted therapies. This is done in order to evaluate the effect of the scheme on patient safety. Data on the amount of medication supply, such as the days of supply left, as well as the reasons and times that medication supply has been rescheduled were also recorded. Regarding those, investigation on whether possible incidents such as oversupply have been avoided, as well as whether the scheme brings about a potential reduction in medicines wastage, and therefore bringing financial benefits in terms of cost savings was carried out. Prior to initiating data collection in January, the audit form which consists of open and multiple-choice questions was piloted on 13/12/2019 using a small sample of patient records to ensure that relevant and suffice qualitative and quantitative results were obtained, as well as to highlight the areas that needed improvement. As an outcome of this the audit forms were made more concise to avoid the gathering of unnecessary information.

Data analysis

Upon collecting data, the study used Windows 2010 excel data analytic tools to analyse and present the data Excel data analysis tool has widely been used by researchers across the world (Mitchell, 2013). It is a powerful data analysis tool that can be used to analyse and present both qualitative and quantitative data even by researchers with little skills in quantitative data analysis (Katon et al, 2011). Particularly, excel was chosen for this study due to its simplicity and the ease with which it facilitates quantitative data analysis. Moreover, its ready availability (for windows 10 users) made it convenient and cheap to apply. The gathered data was coded using a key before its input for analysis. A Microsoft Excel spreadsheet for data entry was used alongside the key. Additionally, Microsoft Excel was the analysis tool of choice for the descriptive statistics, as the sample size of this study is not considered to be large.

Ethical Issues

In any research involving humans, researchers are obligated to make ethical considerations and sort pout any ethical issues that might arose during the study (Katon et al, 2011). Ethical considerations are not only advocated for by the Nursing and Midwifery Council (2015) but also by university ethics committees because of the need to ensure safety of the participants involved in the study. Fundamentally, ethical considerations involve moral values and how to separate right from wrong within the study context (Mitchell, 2013). According to Cronin et al (2014), it defies the decision-making process that the researcher must go through to identify the safest and most appropriate research instruments, tools and techniques that will not harm the participants. Therefore, in the current study, the researcher made several ethical considerations. First, before beginning the study, the researcher conducted an evaluation of the significance and relevance of the study to identify if it was really needed. Particularly, this evaluation was conducted because it would be a waste of time and resources to engage in an unjustified study (Katon et al, 2011). The author also ensures that no participant was exposed to any harm through harassment, anxiety or embarrassment. To do so, the author conducted a thorough evaluation of any possible unethical practice that might be encountered during the study such as inappropriate use of data and gathering of unauthorized information from the participants records. In a broader context, the author obeyed the principles of beneficence, non-maleficence, justice, confidentiality and truthfulness. Regarding beneficence, the author ensured that the participants’ interests were protected by only doing the good with the study (Katon et al, 2011). Conversely, non-maleficence was observed by ensuring that any decision made during the study would not have any negative implication on the participant. Even if participants were safeguarded from any harm, it is possible that they might still suffer certain psychological consequences (Mitchell, 2013). This implies that the researcher had to be sensitive in all aspects of the study including storage and dissemination of the study results. Therefore, based on the principles of non-maleficence and beneficence, all the data collected from the participants were stored in a password-protected data stick to prevent any non-authorised individual from accessing it. Other ethical considerations made by the researcher included avoiding the use of names and personal data (e.g. email address, residential address or workplace) in the research report. Approval for this audit was granted from the local trust audit committee. The approval was gained following a completion of a Quality Improvement and Clinical Audit (QICA) project proposal form. Based on what the NHS Health Research Authority guidance (63) describes as “research”, an ethical approval for this study was not required, as it did not fall within this definition. Instead, this piece of work was defined as a “service evaluation”. This was because it aimed to assess the current standards of care by particularly looking to evaluate the cyclical dispensing scheme. Furthermore, the researcher maintained high standards of professional practice.

Results

Patient sample size background

A total of 50 patients were sampled for this study. The majority of those were males (n =28), which accounted for 56% of the sample size. Each of these randomly selected patients was on an anti-cancer drug for their specific condition. In total the patients were on 12 different type of drugs, which are shown below in Table 2.

The majority of the patients were on Palbociclib (n=12; 24%) or Enzalutamide (n=11; 22%).

Palbociclib is a drug used for the treatment of breast cancer in women, while Enzalutamide is used for prostate cancer in men. In the pie chart below are presented the percentages of cancer conditions treated by the drugs previously shown in Table 2.

Frequency of medication supply

following initial supply medicines patients are contacted approximately one week before their next supply is due. Thus, the researcher was interested in evaluating the frequency with which the patients receives medication and how this frequency affects cost and safety. In this regard, the study found that a majority (n= 46; 92%) of the patients received drugs significantly within one month after the reception of previous cycle’s dosage, with an allowance of at most two days before and after the 30th date meaning that the frequency with which they were to receive new drugs was maintained. This can be seen in the graph below (Figure 2) and it implies that by using the cyclical dispensing scheme the hospital saved on costs by not prescribing excess drugs and maintained the safety of the patients by ensuring they only took the prescribed amounts.

From the patients who did not receive supply, 2 patients were not re-supplied (4%), while the other 2 patients (4%) did not have this information on their record.

Thus, it is possible to extrapolate that the cyclical dispensing at the Christie NHS Foundation Trust maintains its frequency of supply and ensures that costs are kept to minimal, as well as taking care to not expose the patients to safety implications by interrupting the prescribed supply frequency and potentially preventing supply of medication which is no longer indicated (in the case of no re-supply)

Patient safety

One of the questions on the audit form that evaluate the safety of the cyclical dispensing at the Christie NHS Foundation Trust was whether patients made or avoided medication orders to ensure continuity with and safety of medication. Therefore, the researcher sought to know the expected date of medication supply for each patient, whether the pharmacy staff at the hospital placed an order of that supply and whether that order correspondent with the correct date of supply. Following data analysis, it was found that the supply of medication for a number of 43 patients out those who had received further supply of medication (n=46; 92%) corresponded with the due date for resupply (Figure 3). In addition to that, the researcher looked at the reasons for the non-correspondence for the rest of the patients who received their medication and found that there were three different reasons for this and those being:

Patient was feeling unwell.

Due to holiday period

Patient was short of medicine.

It was difficult to tell whether the patients, who did not have this information present on their medical records observed the correct medication re-ordering.

Furthermore, all the patients who were observed to have had a correct reordering of medication had no excess supply of medications at home. It would have been considered a safety hazard if they had received a re-supply while still having some stored medication. Thus, it is highly likely that the patients who observed correct re-supply had completed their medication cycle on time and were ready to begin their next cycle, suggesting they were adhering to prescribed doses and frequencies

Side effects and adverse drug reactions (ADRs)

The occurrence of these is a key safety element that both patients and practitioners must be on the lookout for. In the current study, the author was interested in understanding whether there are any side effects or ADRs associated identified through the cyclical dispensing at the Christie NHS Foundation Trust and the frequency with which such cases are reported. Besides, the study was interested in identifying any intervention measures put in place for patients that experience adverse drug reactions.

Following completion of the data analysis it was seen that side effects were experienced by a very small number of patients (n=2; 4%), even though not to an adverse level. Those patients had received a practitioners’ immediate attention and a measure taken was taken in order to ensure that no patient was at a severe health risk due to the reaction. The results showed that the same number of patients who had experienced a side effect or an ADR, also have had their treatment stopped (Figure 4). However, after completion of a Chi-test to determine whether there was a relationship between those two categorical variables, it was found that the p-value was higher than 0.5 (p=1.08979). This meant that the variables were independent of each other and there was no statistical relationship or in other words if a patient had their treatment stopped it would not mean that they had experienced a side effect. Another Chi-test was performed to determine whether re-supply was dependant on having experienced side effects. The p-value for this was also higher than 0.5 (p=1.57422) showing no relationship between the two variables. Only a very small number of patients had experienced a side effect and had their treatment stopped/interrupted at the time of being considered for a re-supply. This means that the majority of them were correctly meant to proceed to the next cycle of medication. A possible implication of this finding is that most of the patients received their medication according to the cycle prescription and received their next supply at the correct time when they were supposed to do so.

The low frequency of drug reactions among the patients point to the level of safety procedures maintained by Christie NHS Foundation Trust during prescriptions. While there are no explanations to the few cases of drug reactions, the significantly high number of patients who did not experience any drug reactions illustrate the due diligence observed in medical prescription by the Trust.

Discussion

The main aim of this study was to investigate the safety and cost effectiveness of cyclical dispensing at the Christie NHS Foundation Trust. This was achieved by evaluating issues of ADRs, patient drug supply and reordering dates, availability of excess supplies and whether patients received medication on time. The study findings showed that out of the 50 participants, only 6 patients experienced ADRs and of the six, all of them sought immediate medication attention and received an intervention in form of a change in prescription. Moreover, none of the patients experienced severe health risk as a result of the ADRs. These findings not only reveal the low frequency and severity of ADRs that Christie NHS Foundation Trust must deal with but also open to several other issues that the Trust must deal with such as ADR reporting. Considering the contribution of ADR reporting to patient safety, Christie NHS Foundation Trust should consider the level of knowledge among its staff over ADR reporting. While the study showed that patients were able to report ADR and received medical attention, there is appoint for Christie NHS Foundation Trust to enhance ADR reporting awareness among its staff. It is important to enhance awareness of ADR among the Trust’s staff because even pharmacists, doctors and nurses can also report ADRs (Rusk, et al., 2012). Goel & Gupta (2011) made similar observations but added that ADRs reporting can be enhanced by adopting technology and computer software to aid faster reporting. However, Christie NHS Foundation Trust should note that when adopting technology and software to enhance ADRs reporting, care should be taken on how patient data is handled (Zongqiang, 2011). Therefore, the technology should have the necessary risk management mechanisms to ensure that patient data is protected according to the government’s policies and regulations on data privacy and security. Another aspect that emerges from these findings is how Christie NHS Foundation Trust would handle ADRs among children patients. While Goel & Gupta (2011) acknowledges that there is a paucity of research on reporting pediatric related ADRs in cancer treatment, the findings of this study presents an opportunity to highlight the fact that children have a higher risk exposure to unknown or developing ADRs (Anacleto et al, 2005) and therefore there is a need to adopt a spontaneous reporting of ADRs among this population to facilitate early identification of warning signals. This implies that the pediatricians would play an important role in conducting an early identification of ADRs in children under cancer medication (Noyola, Jimeno, Castelblanque, & Dalmau, 2010). While the study did not dwell so much into the ADRs reporting process adopted by Christie NHS Foundation Trust, it is important to note that while healthcare pharmacists and healthcare practitioners can identify ADRs among their patients, the responsibility of reporting lies much on Christie NHS Foundation Trust as the authority responsible for drug dispensing (Tora, Bo, Bodil, Göran, & Birgit, 2014). Meanwhile, whereas there was a 100% reporting of ADRs in the present study, authorities sat Christie NHS Foundation Trust should be aware of factors that could prevent ADRs reporting in the future cases. For instance, Anacleto et al (2005) observe that a patient could fail to report an ADR due to the uncertainty of weather the reaction has been caused by the drug or not, poorly qualified pharmacists, lack of ADR reporting documents and forms, and patient’s lack of knowledge about the ADR reporting systems put in place by Christie NHS Foundation Trust. Nonetheless, patients may also fear to report ADR due to fear of financial burden that would come with the interventions (e.g. change into a new prescription). While all the other possible factors preventing ADRs can be addressed internally by Christie NHS Foundation Trust, the financial factor can be dealt with at government level. The study findings also point to the question of whether Christie NHS Foundation Trust has a drug utilization review program that provides vital information on whether cyclical dispensing at the Christie NHS Foundation Trust provides a system to review patient drug use with an aim of eliminating or reducing the risks of ADRs (Goel & Gupta, 2011). By establishing a drug utilization review programs, Christie NHS Foundation Trust can periodically gather information about and pointers to the system’s gaps that may increase the risk of ADRs.

The study findings revealed that most of the patients reordered for drugs at the date corresponding with the correct date of resupply. The study also found that no patient under cyclical dispensing at the Christie NHS Foundation Trust placed an order at the time when their medication had been stopped, interrupted or had a change of dose. These findings point to an effective communication and coordination system put in place by Christie NHS Foundation Trust to ensure that the patients are not exposed to risk of incorrect medication supply. However, there are several other issues of communication that Christie NHS Foundation Trust must consider enhancing the safety of their patients. For instance, it is a general rule that the prescription should relay the information regarding the prescribe drug and it should be relayed in a manner that anyone reading it should understand its content (Reeder, Demiris, & Marek, 2013). On the flipside, an incomplete, confusing or ambiguous prescription may make it difficult for a pharmacist to understand its content and effectively dispense and deliver the intended drug. In this regard, prescription readability has been a common cause of medication dispensing errors and one which Christie NHS Foundation Trust must be on the lookout for. The Trust should ensure that all prescriptions coming their way are easily readable so that the pharmacist does not interpret the information therein. This would help avoid exposing patients to dangers or even death (Cohen, 1999). In fact, Cohen (1999) observed that poorly interpreted prescriptions were at some point the second most prevalent complaint and the most associated with high cost of medication in a list of 90, 000 complaints by pharmacists gathered for over 7 years. This implies that while Christie NHS Foundation Trust uses printed writing in its dispensing system (Anacleto et al, 2005), manual writing should be avoided at all costs because it complicates the distinction of for example two different drugs with similar names. Many cancer drugs may have different names pronounced similarly, leading to confusion especially when the drugs are delivered through the same route. These are important risk mitigation considerations that Christie NHS Foundation Trust must consider regardless of how good they systems are in facilitating patient safety. While the study does not reveal the root cause of the 6 ADR, factors such as problems related to medication packaging and labelling must be considered by Christie NHS Foundation Trust. Particularly, Christie NHS Foundation Trust must be aware of drugs that have common package designs especially when they are sourced from the same manufacturer (Ishizuka, Horiguchi, Waki, Maeda, & Ishikura, 1991). Christie NHS Foundation Trust should even be more careful with injections where flasks and ampoules may be of similar shapes, colour, shape or size – and confusion may greatly occur during emergencies. Regardless of the seemingly well managed systems of cyclical dispensing at the Christie NHS Foundation Trust, it is undeniable that medicine dispensing is a complex activity that involves a team of people, organizational systems, physical space, pharmacy systems, and technology to effectively dispense cancer medication. For instance, the Christie NHS Foundation Trust requires staff and transport logistics to collect medicine from manufactures, a database to maintain records of stock flow, a customer information system to keep records of patients under repeat medication, reminder systems to ensure accurate medication resupply and professional pharmacies to help manage the dispensing processes. According to Tania, these components are inherently interconnected and dependent on each other so much so that it is challenging to identify whether the source of potential risks are as a result of people’s unsafe acts or as a result of organizational faults. However, from the positive safety results found by the study, Christie NHS Foundation Trust has maintained a clear and cohesive dispensing process that is operated with high standards of risk management throughout the dispensing journey. Based on the study results, it is possible to extrapolate that Christie NHS Foundation Trust maintains a flawless dispensing journey which starts with a counter assistant receiving prescription and places it in the correct portal for collection, the counter assistant then places the prescription in queue awaiting order filling after calling the pharmacist’s attention to it. A dispenser would then pick up the prescription order and checks into the computer database of the shelves to identify the medicine’s availability. After confirming the medicine’s availability, the dispenser would then place the medicine in another queue awaiting the pharmacist’s verification. Lastly, the pharmacist would check the packages and labels before handing it over to the customer or the delivery personnel (Tachi, et al., 2013).

While the findings of this study reveal that cyclical dispensing at the Christie NHS Foundation Trust had a clear journey or protocol, there are several considerations that the Trust would have to make to enhance the process. For instance, the Trust must be on the lookout for unclear communication protocols that prevent the pharmacists from properly organizing the dispensing process (Casey, Adams, & Sibbritt, 2007). Other issues that the Trust might want to consider would be the inability of pharmacists to freely move around within the dispensary due to lack of space, increased workload, poor technical skills for handling computer databases, lack of effective management structure to minimize people’s unsafe acts, and the need to manage external sources of risks such as unclear prescriptions (Anto, Barlow, Oborne, & Whittlesea, 2011). From a more in-depth perspective, these considerations would be made in four broad categories namely dispensing personnels’ divided attention, work pressure, restricted spaces and external influences. With regards to divided attention, Christie NHS Foundation Trust, it is highly likely that medicine dispensing personnel might be working under latent conditions that are characterized by people indulging in unsafe acts such as dividing attention between socialization and completing the dispensing process, thereby creating a restriction in movement and subsequently dividing the attention of personnel between dispensing medicine and being mindful where they are stepping. On the other hand, Christie NHS Foundation Trust must ensure that the personnel do not work under pressure as a result of latent conditions including equipment sharing, heavy workload, and failure to effectively interact with the system to observe important procedures such as conducting a proper check on the medications. Through other unsafe acts such as poor communication, the personnel may make serious communication mistakes such as failure to communicate when there is a temporary alteration of the dispensing procedure (Brand, 2008). The study results did not reveal any information regarding the space the Christie NHS Foundation Trust is using to conduct all the medication dispensation. However, while the positive results regarding safety of the cyclical dispensing system hint to an organized dispensing procedure, more consideration is needed on the level of restrictions available within the dispensing space. Therefore, Christie NHS Foundation Trust should ensure that the dispensing space is decluttered so that personnel can be more organized when dispensing the drugs. Meanwhile the Trust should also be keen on external factors that, may influence patient safety such as poorly written prescriptions.

Conclusion

The cyclical dispensing at the Christie NHS Foundation Trust has demonstrated various levels of safety and cost effectiveness to the extent that majority of the participants have placed an order corresponding with the correct date of supply, no patient was in custody of excess medicine at home, no patient had placed an order at the time their treatments had been halted or changed, less ADRs have been reported and all the patients who reported ADRs had their issues resolved on time. While this implies that Christie NHS Foundation Trust had put in place various safety measures to protect patients’ health and well-being, there are several other aspects of safety measures that might have not been covered by the study but which may be important for consideration; if the Trust aims to enhance its safety levels. With regards to cost, the fact that patients under the cyclical dispensing at the Christie NHS Foundation Trust re-ordered for medicine on time, had no excess medicine under their custody, and sought immediate attention in case of ADRs means that they spent less money on drugs and medical emergencies. In this study, the low frequency and severity of ADRs point to low frequencies of incomplete prescription, omissions, and human prescription errors. It is assumed that with feedback of less dispensing errors characterizing cyclical dispensing at the Christie NHS Foundation Trust, further studies are required on the following aspects that were not much explored by the current study. Thus, future studies should concentrate on:

Christie NHS Foundation Trust staffs’ attitude to dispensing safety and how it affects patient safety

Christie NHS Foundation Trust pharmacy management structure and how activities within the pharmacy vicinity are coordinated to enhance safety

Christie NHS Foundation Trust’s physical environment and its organization to facilitate an easier and safer execution of dispensing process

Christie NHS Foundation Trust’s engagement with technology, the technological measure and their implication on costs and patient safety

Implications for Practice

While the pharmacy industry is not as risky as the aviation industry, the cyclical dispensing at the Christie NHS Foundation Trust could benefit from adopting an approach whereby the dispensary staff and how they with other components of the dispensing system are more focused on policy and practice. One of the ways in which the findings of this study can be adopted in policy and practice is by improving the interactions and relationships between key stakeholders by creating a standard dynamic environment of operation that has unique identities but with similar relationships and interactions that facilitate the existence of shared values that enable the introduction of stricter safety measures without the cognitive challenge of learning the new measures. By establishing a standard dynamic environment of operation, Christie NHS Foundation Trust will be able to introduce new and more safety-oriented operation protocols through an integration with the existing protocols.

Limitations and strengths of the study

Administering questionnaires to patients under the cyclical dispensing at the Christie NHS Foundation Trust enabled the researchers to obtain important data on safety and cost effectiveness of the dispensing system that may have been difficult to obtain through other data collection methods. The findings of this study could be important in developing and promoting better safety practices in community-based pharmacies by creating standard dynamic operational systems. The study is quantitative, and this promotes the generalizability of its findings. However, the results only provide a snapshot of pharmacy safety and cost issues characterizing the cyclical dispensing at the Christie NHS Foundation Trust and thus further research, as earlier recommended should be conducted on several other aspects of cost and safety.

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