Throughout this essay, all names of patients, clinicians and the hospital trust have been changed to maintain confidentiality as per the General Pharmaceutical Council (GPhC, 2017).
‘’The GPhC (GPhC, 2017) states that only a qualified non-medical prescriber who has successfully completed the non-medical prescribing course may write a prescription. While this essay has been written from the perspective of a prescriber, in reality the actual prescription issued for this consultation was written by a qualified prescriber’’.
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The concept of non-medical prescribing by registered pharmacists in the UK is relatively new, with the first prescribers registered in 2006 (Cope, et al., 2016). The General Pharmaceutical Council (GPhC) provides standards under which all pharmacy professionals work. It encourages pharmacists to work closely with other healthcare professionals whilst using their knowledge and skills to the benefit of patients and their careers, at the same time recognising their limitations within their professional competences (GPhC 2017). Reaffirming this, the Royal Pharmaceutical Society (2016), the pharmacy leadership and support organisation, states that non-medical prescribers must work within the scope of their knowledge and experience to provide patient-centred, safe and effective care.
For this piece of work, the scope of practice is the management of asthma in children, with the prescribing intervention taken place in a general practice consultation. As a medicines optimisation clinical pharmacist working for a Clinical Commissioning Group (CCG), my remit is medicines management in complex children which encompassess a wide range of chronic conditions including asthma.
Asthma is a chronic condition characterised by bronchconstriction due to inflammation of the airway linings and tightening of airway muscles of the lungs causing them to be narrower than normal . In the UK, asthma is the most common lung condition in children, affecting 1 in 10 children (BTS/SIGN, 2016). These affected children often present with variations in symptoms such as cough, wheezing, shortness of breath and/or chest tightness. These symptoms may be worse when exposed to certain triggers (such as pollen, dustmites, mould, pets, air pollutants, colds, exercise or strong emotions), at night or early morning. Increasingly, it is being recognised that there are different inflammatory phenotypes of asthma in children, with the eosinophilic type being the most predominant (Wang et al, 2011). This, in addition to the fact that there are no reliable and validated objective criteria for accurate diagnosis and monitoring of response to treatment, causes major challenges for healthcare professionals in the management of asthma in children.
Evidently, there is poor diagnosis of childhood asthma (WHO, 2003; NRAD, 2015; GINA, 2018) steming from various issues, most especially the incapability of children to perfom objective tests reliably and misunderstanding around asthma symptoms that are significant. The findings of the 2015 National Review of Asthma Deaths (NRAD) in England and Wales also revealed some of these issues and concluded that the overall standard and quality of care for children and young people is inadequate (NRAD, 2015). As such, the most recent national guidelines from the National Institute of Health and Care Excellence (NICE) for asthma focuses on recommendations for diagnosis and management of patients with mild to moderate asthma in primary care settings (NICE, 2017).
NICE recommends that before starting or adjusting treatment lack of adherence, suboptimal inhaler technique, smoking (active or passive), environmental factors, psychosocial factors should be considered and taking into account (NICE, 2017). It further recommends the use of self-management programme comprising a written personalised action plan that focuses on simple to implement treatment pathways for symptom control. In children, this plan in combination with spriometry or peak flow variability testing results, ensures best possible treatment effective for patient’s symptom control underpined by shared care decision between the clinician and patient and / or parent /carer.
Miss SA is a 9year old girl, diagnosed of asthma in 2017. She had been booked in to see her GP following increase in asthma symptoms. This was the 2nd similar visit in 5months. She has a past medical history of atopic conditions – eczema and hayfever, hence increase in pollen count triggers her asthma. Miss SA suffers no other significant medical conditions. Her medication history when taken and confirmed by the GP patient record system included Salbutamol inhaler 100 MDI 2puffs when needed, Eumovate cream to be applied twice a day and Cetraben cream to use as a moisturiser. The GP records showed she’d previously been prescribed Montelukast 5mg tablet at night and Beclometasone 50mcg inhaler 2puffs twice a day but hadn’t ordered any of this for over 3months. She has also been taking simple linctus, mother bought over the counter but no herbal remedies or recreational drugs. She has no known allergies. She lives with her family in a relatively ventilated house. Although, she has significant family history, with dad and older sister being asthmatics too.
The history of presenting complaint included having increase in cough and breathlessness for about 3 days, using Salbutamol daily and waking at night due to coughing and had to prop her pillow up the night before. On examination, Miss SA had slight increase work of breathing using intercostal abdominal muscles, a polyphonic wheeze on auscultation, pulse rate 138bpm, oxygen saturation of 98% and temperature 36.7oC. No presence of congestion in the nose or throat and no swollen nodes. This information in combination with her presenting complaints and history, made a clinical impression of an acute exacerbation of asthma secondary to poor adherence to treatment combined with recent increase in pollen count.
According to guidelines (BTS/SIGN, 2016; GINA, 2018), repetitive doses of short–acting inhaled bronchodilator using salbutamol 100microgram pressurised metered dose inhaler (pMDI) 10puffs every 20minutes via spacer for rapid reversal of airflow limitation was administered. Then a short course of systemic oral prednisolone 30mg daily for 5days to reduce inflammation in the airways was prescribed. In addition, as her symptoms at presentation indicated the need for maintenance therapy, a paediatric low dose inhaled corticosteroids was offered to the patient following discussion regarding importance of adherence, the risks and benefits of pharmacological treatment. A personalised asthma action plan was also completed with Miss SA and her mother, highlighting how to self-manage her symptoms appropriately and what to do when she’s not feeling good or when she starts to experience worsening symptoms. Considering available options, Beclometasone 50mcg pressurised metered dose inhaler (pMDI) was chosen and prescribed with the directions to inhale 2puffs twice a day via a spacer.
The author will examine the evidence supporting the prescribing choice, relevant professional responsibilities including principles of healthcare ethics, and application of the principles of clinical governance to the patient, with a focus on the clinical effectiveness pillar.
With prevalence between 17-23% in children, asthma is the most common chronic respiratory condition. Its symptoms are characterised by airway constriction with variable airway hyper-responsiveness and airflow obstruction. Recently, this has been increasingly linked with atopic origin paralleled with allergic conditions like rhinitis and eczema, which Miss SA suffers from. The aim of the pharmacological treatment of asthma is one or combination that offers complete control or achieves best possible lung function at the lowest possible dose with minimal side effects. This means no daytime symptoms, no night time awakening due to asthma, no need for rescue medication, no asthma attacks, no limitations on activity including exercise, normal lung function (PEF > 80% predicted or best) (BTS/SIGN, 2016).
NICE 2017 guidelines recommend children aged 5 to 16, should be initiated as step 1 on a short acting beta agonist (SABA) as a reliever therapy. This should be followed (step 2) by a paediatric low dose inhaled corticosteroid (ICS) as the first line maintenance therapy, if child has asthma related symptoms 3times or more in a week, waking at night or uncontrolled with SABA alone. According to the history taken from Miss SA and her mother, her treatment needed to be stepped up to achieve optimal control and prevent further exacerbations, hence the initiation of an ICS. It is paramount that guidelines are adhered to, as NRAD (2015), found out that 46% of asthma deaths identified were avoidable if appropriate guidelines were followed. ICSs work by reducing inflammation in the airways and regular use achieves maximum benefit of symptom control.
Of the ICSs existing only Beclometasone, Ciclesonide and Fluticasone are available as pressurised inhalers which is the recommended type with an appropriate spacer device for this group of children (NICE 2002). Ciclesonide does not currently have UK marketing authorisation for use in children under 12 years, thus it was not suitable for prescribing for Miss SA. The use of pressurised inhalation of ICSs is well established in the treatment of asthma with Beclometasone being one of the older ones.
An earlier study establishing the effectiveness of Beclometasone inhaler was a multi-centred double blinded randomised controlled trial (RCT) by Tinkelman et al (1993). The RCT involved 195 children aged 6 to 16years with mild to moderate asthma, compared treatment benefits and adverse effects of inhaled Beclomethasone (84micrograms four times a day) and sustained release Theophylline (adjusted doses twice a day) in achieving optimal control of symptoms. The outcomes included daily record of symptoms, peak flow rates, supplemental reliever and oral steroids, absence from school and side effects. The results showed Beclometasone to have comparable symptom control with less reliever use and oral steroids course compared to Theophylline but more adverse effect such as suppression of growth velocity. This trial was of high standard and good quality evidence. Firstly, it was double blinded and randomised. The method of randomisation was documented and to minimise bias, the participants were unaware of their allocation with the use of placebo arms. The design of the study was well documented and by stating the intention to treat analysis, the methods for determining outcome measures as power calculation were well defined within the trial.
The result of this pivotal trial changed the therapy focus in the management of asthma from less bronchodilation to more inflammation control. Evidently, in clinical practice nowadays, theophylline is rarely used without other underlying factors and ICSs are first line maintenance therapy for management of asthma. The result of this trial can be related to Miss SA, firstly like its participants, she falls within the age range and secondly her asthma is of mild to moderate origin, hence, it can be inferred that Beclometasone inhaler though, would be effective as a start in reducing and / or controlling her exacerbations.
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Furthermore, a double-blinded parallel-grouped RCT comparing the efficacy and safety of moderate inhaled doses of Beclometasone 400microgram daily and Fluticasone 200micrograms daily reported lack of superiority of either drug and similar safety profile (Gustafsson et al 1993). This was a 6weeks large multicentre study that recruited 398 inadequately controlled children aged 4-19years to two active arms. Even though it was not clear if an intention to treat analysis was stipulated, it used PEFR as outcome for its power calculation. Again this trial had features of a well-conducted, good quality standard trial with the randomisation and blinding procedure stated. Although higher doses and different inhaler type to that prescribed for Miss SA was tested, inference can still be drawn as it was in children that were inadequately controlled like Miss SA with similar age group.
Nonetheless, both RCTs like evidence from meta-analysis (Barnes et al, 1998) and systematic review (Yeo et al, 2017) showed Beclometasone and Fluticasone to be similarly efficacious and measurement of growth velocity regularly in children being treated with maintenance therapy of ICSs is paramount. Miss SA height will be regularly measured to monitor her growth velocity. It is no doubt that larger and longer duration comparative trials in children younger than 12 years assessing side effects with established efficacy are needed. Considering cost effectiveness, clinical experience and patient choice, Beclometasone pMDI was concluded as the preferred option of ICS for Miss SA.
The GPhC is the regulatory body for pharmacy professionals and it has a set of professional standards that all pharmacists have to adhere by to ensure patient care delivered is safe and effective (GPhC, 2017). As professionals we have a duty to ensure that trust and confidence of the profession is maintained by the public and other healthcare professionals and in particular, when considering the role of a non-medical prescriber (NMP). At every consultation, patients need to be assured their care is at the centre and that the professional writing their prescription follows a code of conduct. The competency framework for prescribers reveals the challenges related with prescribing, such as prescribing in children and with regards to non-adherence to medicines (Royal Pharmaceutical Society, 2016).
According to NHS Digital (2019), prescribing is the highest frequent patient-level intervention and second largest spend in the NHS covering all sectors of care. It is therefore imperative that patients remain at the centre of the decision-making processes in order to maximise the benefits of this investment. As such, one of the most important standards that were delivered during this prescribing consultation was person-centred care. It is important as a non-medical prescriber to build a relationship with the patient in this case, the patient and her mother, so they can make informed decisions and agree a treatment plan which was stated in the personalised asthma action plan.
Furthermore, a non-medical prescriber is required to work within their scope and competency to provide safe, effective and quality care to their patients (Nuttall and Rutt-Howard, 2016). Early literature on non-medical prescribing highlighted this duty of care to the patient, the importance of patient-centred consultations and of cost-effective prescribing (Lovatt, 2010). NICE technical appraisal on the choice of treatment for a patient with asthma also states the least expensive product that is suitable for the individual patient within its marketing authorisation should be used (NICE, 2007). In addition, it advises that the patient should be involved in the choice of inhaler device and treatment option and should demonstrate good technique before a new device is used. For Miss SA, the risks and benefits of treatment were discussed with her and her mother and the decision to agree on recommendation of Beclometasone pMDI, was made with full consent.
There are four principles of health care ethics that play a key role in ensuring optimal patient safety and care is maintained at all times. These provide healthcare professionals with guidelines to make decisions when they inevitably face difficult situations involving their patients, ensuring they act in the best interest of the patients and not upon on preferences. These principles autonomy, beneficence, non-maleficence and justice were developed by Tom Beauchamp and James Childress in 1979 and are the backbone of professional responsibilities (Beauchamp and Childress, 2013).
The first of these principles is autonomy, the right of a patient to make his or her own decisions independently and according to his or her personal values and beliefs. Autonomy relates very much to consent and confidentiality. It is presumed that all adults are competent to make their own decisions but reverse is the case for children. Thus, healthcare professionals need to identify who can give consent to treatment on behalf of a child i.e. who has parental responsibility and be able to determine if a child is competent to making that decision. It is only in exceptional circumstances such as emergency, parental neglect, that a healthcare professional can justify proceeding with treating a child without parental knowledge and consent.
The ethical challenge lies in identifying the time for this i.e. the time when a child can make decision without parental knowledge and consent. According to the law as stated in the Department of Health (DoH, 2001), young people under 16years cannot provide valid consent unless they have been assessed as ‘Gillick’ competent. Gillick competency is a functional ability to give consent or make a decision by a child under the age of 16, taking into account their maturity and intelligence. In this case of Miss SA, she was not deemed Gillick competent and her mother who had parental responsibility had to consent to treatment and make informed decisions on her behalf. At the beginning of the consultation, Miss SA’s mother was fully informed about the professional status of the author and consent was sort to be present in consultation, to physically examine Miss SA and contribute to the consultation.
Weighing the benefits against the risks of treatment addresses the principle of beneficence. As previously mentioned the patient being the centre of decision was considered when prescribing intervention was made to step up her asthma treatment. The benefits of prescribing beclomethasone inhaler as a maintenance therapy considering her past medical history, family history and social history, it would mean a better control of her asthma symptoms, allow her to take part in physical activities in school, sleep better and overall, give her a better quality of life. The risks of treatment are the side effects of inhaled corticosteroids. These and how to manage them were discussed with Miss SA and her mother, so that they were empowered to make an informed choice of consenting to treatment. For example, the prescribing of the lowest effective dose of beclometasone reduces long term systemic side effects and the use of appropriate spacer to reduce the incidence of sore throat or oral thrush, in addition to rinsing mouth after each dose were mentioned. It is imperative that as a prescriber to always support patient to achieve best outcomes from their medicine, thus acting for the good of the patient.
This principle of beneficence links in well with the next principle of avoiding the causation of harm, non-maleficence. Again, prescribers must ensure that any treatment they offer to patients must not harm them disproportionately when put against the benefits of the treatment. For Miss SA, the benefits she will gain from using beclometasone inhaler are greater than the possible side effect associated with using the inhaler.
The last principle, justice, requires prescribers to treat all patients equally and fairly (Beauchamp and Childress, 2013). In today’s NHS, this also means that prescribers should be mindful of the limited resources available and ensure that their prescribing should not only be safe but also cost-effective. (Lovatt, 2010; RPS, 2016). It is the responsibility of NICE as an NHS organisation to assess all available options before making recommendations on treatment appropriateness and related cost-effectiveness. Consequently, these then applies to all patients and ensures all patients as stated, are offered the same option as long as they meet the recommended criteria of treatment. Adherence to these guidelines and additional prescribing resource such as the local formulary, taking into account Miss SA characteristics and her preferences, essentially guides the decision-making process and ensures the principle of justice is maintained throughout the provision of pharmaceutical care in consultation to Miss SA.
Clinical governance is the framework that underpins all NHS organisations in ensuring they are accountable to provision of quality services and high standards of care (Scally and Donaldson, 1998) by building settings in which clinical excellence thrives (DoH). Halligan (2006) described it as the ‘’organisational conscience’’ of the NHS. It has 7 pillars – clinical effectiveness, patient involvement and experience, risk management, communication, strategic effectiveness, resource effectiveness and learning effectiveness integrated into quality improvement, risk management, quality assurance and incident management (Scally and Donaldson, 1998). As such it increases confidence to standards of competence, performance and conduct of healthcare professionals and underpinning this, is the commitment to continuing professional development. Thus, the GPhC acknowledges clinical governance as a system that supports non-medical prescribers in ensuring that they keep up to date with new evidence and guidance that ensures they provide safe and high quality care to their patients at all times. Of its pillars, clinical effectiveness is the most relevant to this prescribing consultation. In relation to the management of asthma in children, clinical effectiveness refers to a process of informing, changing and monitoring practice of applying the best knowledge that which is evidence based, clinical experience and patient preference to the care of patients in order to achieve optimum outcomes. Therefore following NICE guidance involved tailoring our clinical practice and to fulfil the needs of Miss SA, to optimise her care and outcome, making the consultation patient-centred. For Miss SA, this meant providing information to help her mother and herself make informed decision about her treatment, prescribing clinically effective, cost effective low dose Beclometasone inhaler, counsel them to improve their health literacy which will improve their treatment adherence and encourage them to self-care with the aid of a personalised action plan. A safety netting advice was also given in case symptoms worsen and a 2-week follow up appointment was agreed with Miss SA’s mother to support Miss SA’s new medication, check symptom control objectively, identify any initial problem, check inhaler technique and ascertain treatment adherence.
The establishment of pharmacist non-medical prescribers have created new opportunities in clinical practice to drive skill mix and change in workforce for the betterment of improving patient care and outcomes. The provision of evidence based treatment and patient-centred care underpinned by the principles of healthcare ethics and clinical governance safeguards healthcare professionals according to professional standards. In addition, adhering to national guidelines recommendations guarantees treatment equity and cost effectiveness within the NHS.
Asthma is an incurable chronic condition, so its management aim is to control symptoms, which was that of Miss SA. In order to achieve this and according to professional conduct, a prescribing intervention was initiated after a patient-centred informed decision was made and consent to treatment was given by her mother. Beclometasone inhaler is extensively used as the evidence-based first line inhaled corticosteroids in clinical practice and hence was the choice of step up treatment for Miss SA accordingly.
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