Saudi Pharmaceutical Journal (2015) 23, 41–47 King Saud University Saudi Pharmaceutical Journal www.ksu.edu.sa www.sciencedirect.com ORIGINAL ARTICLE An example of using a decision making framework designed for non-medical prescribers as a method for enhancing prescribing safety for inhaled corticosteroids (ICS) Saja Almarshad * Respiratory Care Department, College of Applied Medical Science, Dammam University, Saudi Arabia Received 9 May 2014; accepted 5 June 2014 Available online 17 June 2014 KEYWORDS Non-medical prescribing; Asthma; Framework; Inhaled corticosteroids Abstract Non-medical prescribing is needed especially with the increased demand for health care and the physicians’ time constrains. Also, it is not well regulated in Saudi Arabia unlike the United Kingdom. This report aims to demonstrate the urged need for regulations to maintain a safe non-medical prescribing process. It also adapts the single competency framework provided by the United Kingdom national prescribing centre (NPC, 2012) to be utilised by the respiratory therapist for a safe prescribing process for inhaled corticosteroids (ICS) to control adult asthma as an example. The framework is thought to be an effective tool for safe non-medical prescribing and it is highly recommended to develop a national Saudi framework to maintain the patients’ safety and utilise resources. ª 2014 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. 1. Introduction The prescribers might bring in their expectation about the patient condition and treat accordingly (Cockburn and Pit, 1997), which is an approach that might cause inappropriate prescribing process. And as a trial to increase the accuracy of prescribing, spending time with each patient for assessment and history taking might be essential to create a trust relationship; * Tel.: +966 555690901. E-mail address: salmarshad@ud.edu.sa Peer review under responsibility of King Saud University. Production and hosting by Elsevier which is a valuable aspect to consider while prescribing (NPC, 2012; Dugdale et al., 1999). Additionally, prescribers should have enough time to take a full patient history, assess and diagnose for them to decide about the patient’s medical treatment if necessary. However, in general practice context the issue might lie within the availability of enough time to do that. Hence, there are restrictions on the physician’s time considering it as a resource that should be utilised (Davidoff, 1997); and that might have a strong influence on their time spent with their patients. However, it could be argued that efficient use of the prescribers’ time would help to reach accurate decisions about the patient’s condition; and ultimately lead to a successful treatment plan. The introduction of non-medical prescribing might thought to be a solution for the physicians’ time constrains. However, the quality of prescribing should be regulated to 1319-0164 ª 2014 King Saud University. Production and hosting by Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.jsps.2014.06.002 42 maintain the patient’s safety. Thus, this report would aim to apply the method used in the United Kingdom (UK) to regulate the practice for non-medical prescribers. One of the main aims of this report is to introduce the concept to the region as it is not yet officially permitted for specialised HCPs such as Respiratory Therapists in the hospital sittings to prescribe respiratory drugs and neither pharmacist, on the other hand, it is permitted for pharmacist working in a general chemist shops i.e. not affiliated with a hospital, to prescribe drugs without a physician prescription; which might be problematic if not dangerous for patients. Indeed, the patients are reaching these chemist shops as alternatives to save time and money. However, it is a dangerous practice and not well monitored. Acknowledging the need for non-medical prescribing is thought to be highly important especially with the increasing demand on health care. In Saudi Arabia, the current situation does not acknowledge the complexity of prescribing decisions. In the UK they are promoting the use of a systematic method of prescribing such as the prescribing pyramid (Appendix A) which is thought to address most of the key elements of prescribing. However, before prescribing decision is reached, the application of a decision making model might be valuable as well, especially for novice prescribers. Furthermore, this report would adapt such method used for non-medical prescribers in the United Kingdom as an example to regulate and maintain a safe prescribing process for a common respiratory drug used to control asthma. The framework was designed to address all aspects of the patients’ condition including other general issues such as reaching an accurate diagnosis while taking the legislative issues of prescribing into consideration. In the UK, the use of frameworks that are designed specifically for non-medical prescribers was the best solution for a safer practice, for example, the single competency framework provided by the national prescribing centre (NPC, 2012) (Appendix B). This report aims to demonstrate how RTs can use this framework to maintain a safer practice while prescribing inhaled corticosteroids (ICS). However, although the use of such decision making frameworks might be helpful, some evidence showed that using them might not necessarily provide an optimum therapy. Hence, other aspects such as the clinical experience might have an influence as well (Dordevic and Jankovic, 2006). Certainly, basing a decision-making process on a combination of good overall knowledge, clinical experience and researching the best available evidence will aid in reaching a successful prescribing decision (Llewelyn and Hopkins, 1993). However, the value of such approach to reach decision about patient care might be highly important to structure a safe practice especially for novice non-medical prescribers. It could be argued that expanding the discussion to involve all of the aspects of the treatment plan by applying a suitable decision making model would optimise the accuracy level of the prescribing decisions. Finally, this report would analyse process for RTs to safely prescribe inhaled corticosteroids (ICS) for adult asthmatics by applying the single competency framework (NPC, 2012) to address all the issues related to prescribing. 2. Decision making model: the use of the single competency framework According to Edwards and Elwyn (2009), decision-making theories enable clinicians to anticipate and comprehend, or even S. Almarshad change, phenomena by the availability of the frameworks these theories provide. From a psychological point of view, Rachlin (1989) stated that whenever we understand how daily decisions are made by people, we soon realise that people rarely decide the best decisions that would help establish long-term goals. Furthermore, in the healthcare profession, decision-making has a great deal of uncertainty as well (Thompson and Dowding, 2002). Thus, the use of the single competency framework (Appendix B) would be used to optimise the level of certainty in introducing ICS to the treatment plan of adult asthmatic patients. 2.1. Domain A: the consultation option, knowledge and decision making Asthma is a disease consisting of recurrent attacks of shortness of breath and wheezing with a variation in its severity from individual to another, which occurs due to the airway inflammation and bronchial hyper-responsiveness (WHO, 2013). According to a local report in Saudi Arabia, the incidents of asthma are increasing (Abudahish and Bella, 2006) affecting more than two million Saudis (AlFrayh et al., 2001). The complexity of asthma pathophysiology lies within the causes of the airway hyper-responsiveness and inflammation (Hamid and Tulic, 2007). In asthmatic attack, the stimulation of mast cells, neutrophils, eosinophils and T lymphocytes and other immune cells, will aggravate the inflammation process(Miner and Yamamoto, 1991) especially type 2 T-helper cells (Th2) which will activate the production of many mediators such as the interleukins (IL) IL-3, IL-4, IL-5, IL-13 among which some of them are related to the production of immunoglobulin E (IgE) while others cause eosinophilic inflammation (Schüle and Evans, 1991). Although, the treatment plan for asthma might develop in the future due to the variety of the mediators that could be targeted by pharmacological agents, currently there are only few available. It could be argued that it might be due to the heterogeneous nature of asthma that limits the pharmacological options targeting the control of all of the mediators besides steroids. However, there is new emerging evidence available on monoclonal antibody, mepolumizab, which shows exacerbation risk reduction in severe eosinophilic airway inflammation; while the patients were on their corticosteroid treatment (Pavord et al., 2012). The indication of such drug however, was not to exchange steroid use, but as an additional therapy for severe uncontrolled asthma (Robinson, 2013) and phase III trial was started in 2012 by GlaskoSmithKline which targets the safety extension of this new drug (GSK, 2012) Unfortunately, this drug option is still not available in Saudi Arabia for that the current available guidelines recommend the use of steroids as the only option to control asthma. 2.1.1. Glucocorticosteroid GCS mechanism of action Steroids work by inhibiting the transcription of many steroidresponsive genes, and most importantly, they inhibit cytokine gene transcription and cytokine effects. Furthermore, the down regulating of the glucocorticoids receptors (GR) after the expositor to steroids will also contribute to the reduction of the chronic inflammation in the asthmatic patients. Moreover, steroids work also by inhibiting the transcription of several cytokines that are related to asthma attacks, including Decision making framework designed for non-medical prescribers IL-1,TNFa, granulocyte–macrophage colony stimulating factor (GM-CSF), IL-3, IL-4, IL-5, IL-6, and IL-8 (Guyre et al., 1988). Furthermore, chronic GCS treatment was found to cause a marked reduction in mucosal mast cell number (Laitinen et al., 1992). Fig. 1 adapted from Barnes and Pedersen (1993) explains the mechanism of action of GCS in detail. It should be noted to the patient that a single dose of inhaled steroid will not treat an acute asthmatic attack, while more prolonged treatment dose does. The reason for such is due to the reduction of mast cell number with prolonged use; which as a consequence will lead to the reduction of airway hyper-responsiveness (Burge, 1982). 2.1.2. Routes of administration There are many routes of administrating GCS to the asthmatic patients such as oral, intravenous and intramuscular; which are the preferred routes to use in emergencies while the inhaled route is preferred when using GCS as a controlling agent for asthma exacerbation. The evidence shows no superiority over the oral, intravenous or intramuscular routes in case of acute asthma exacerbation and they all share the same approximate onset of action around 4 h (Rowe et al., 2001). On the other hand, the inhaled method is usually chosen for the aim of administering ICS as s controller agent. Additionally, it has three methods; metred dose inhalers (MDI), dry powder inhaler (DPI), and nebulised ICS. Moreover, the preferred method of delivery for ICS was discussed thoroughly in Appendix C. The focus of this report will target prescribing ICS to control asthma. 2.2. Domain B: Prescribing effectively safe, professional and always improving In regard to drug prescribing, each country differs in their drug options available for certain medical condition. Table 1 shows the ICS drug available in Saudi Arabia and the daily doses in micrograms recommended for adult patients adapted from the Saudi thoracic society (Al-Moamary et al., 2013). Although, all of the listed drugs are available, the Saudi initiatives for asthma (SINA) guidelines did not recommend one agent over the other (Appendix D). Thus, refereeing to the available evidence is needed to make such decision by searching for comparative trails. The study by Rafferty et al. (1985) was a double blinded crossover study which compared between 43 beclomethasone dipropionate (BOP) and budesonide and concluded that there was no difference in their outcomes. Moreover, a recent article in press by Cukier et al. (2013) compared between inhaled fluticasone versus budesonide inhalers, both were combined with long acting beta 2 agonist formoterol. The study included adults and adolescents with uncontrolled or partially controlled asthma and the superiority of fluticasone over budesonide was noted in terms of lung function and asthma control. However, although prescribing inhaled fluticasone as part of the asthma treatment regime is thought to be recommended, the available studies might be confounded with their patient selection and the method of their drug delivery. In addition, there are many factors that might influence the prescribing process for ICS, Most importantly patient education. Hence, educating patients about their disease and their drugs was shown to significantly influence asthmatic patients (Cote et al., 1997, 2001). Furthermore, in our practice we have sensed this need and as a result, the development of the asthma education clinic (AEC) as a new service as part of the respiratory care department was initiated. The clinic was managed by the respiratory department accepting referrals from the pulmonology clinic. The referred patient would be educated about the asthma triggers, how to monitor it using peak expiratory flow rate (PEFR) following the recommended action plan (example provided in Appendix D), how to use the MDI or DPI with spacer/holding champers, how to clean and maintain the equipment (Appendix C) and finally, answering any further question they might have about their disease and providing them with resources such as educational brochures. The clinic was a new service developed by the respiratory care department which did save the physicians’ time in the clinic and improved patients’ understanding; which was the conclusion of one of the department auditing results. However, it might be interesting to assess the influence of such service on the emergency asthma exacerbation rates attending the hospital, which could be the aim of a future project. It is very important to note to the patients the aim of the controller drugs such as ICS, since the literature notes a problem with adherence especially with ICS when asthma symptoms are improving. Since the patients cannot see a direct improvement after the treatment they tend to quiet it when they feel better and that might lead to worsening in the patient condition. According to Vathenen et al. study (1991) one week Figure 1 Molecular mechanism of glucocorticosteroid (GCS) action. GCS binds to a cytosolic glucocorticoid receptor (GR) that is normally bound to two molecules of heat shock protein (hsp 90). The activated GR trans-locates to the nucleus where it binds to specific glucocorticoid response elements (GRE) in the upstream regulatory region of genes which either inhibit (nGRE) or stimulate (+GRE) transcription in steroid-responsive target genes (of which many or likely to be relevant in asthma therapy). 44 S. Almarshad Table 1 ICS available and the recommended dosage. Low dose Medium dose High dose Beclomethasone dipropionate Budesonide Ciclesonide Fluticasone propionate Table 2 200–500 200–400 80–160 100–250 >500–1000 >400–800 >160–320 >250–500 >1000–2000 >800–1600 >320–1280 >500–1000 Common side effects of ICS Local side effects Oral candidiasis Dysphonia Cough and throat irritation Increase in infections Systemic side effect Cataracts Osteoporosis Growth retardation <<in children Table 3 Differential diagnosis of asthma adapted from Gershwin and Albertson (2011). Initial stages of upper airway obstruction or laryngeal oedema If asthmatic type clinical features are present with a localised wheeze, then consider: s Foreign body obstruction s Bronchial stenosis s Adenoma or carcinoma A recurrent bronchospasm, for example, due to: s Chronic obstructive airway disease s Multiple pulmonary emboli s Carcinoid syndrome s Eosinophilic pneumonia s Systemic vasculitis Pulmonary oedema – ‘cardiac asthma’ Drug induced asthma: s Aspirin and NSAID’s s Beta blockers s Drugs that may cause pulmonary eosinophilia the current RBV for the ICS available at the market does not provide the maximised value, leaving chances for the development of more safe future agents. Additionally, the prescribers’ knowledge about such concepts could help in reducing the side effects by both educating the patients and also controlling prescribing dosage. Hence there are two types of side effects that could be caused by ICS; local and systemic (Table 2). It is important to note that the systemic side effects occur when the ICS reaches the systemic circulation. And that could occur after the drug absorption in the lungs as well as in the GI track after 1st pass metabolism. Finally, the main causes of ICS side effects relate to the absorption aspect of the pharmacokinetics; which might be aggravated with poor inhalation techniques and the lack of coordination during MDI use leading to large oropharyngeal deposition. As a trial to reduce such undesired absorption, the use of spacer and mouth washing after the therapy is highly recommended. Finally, it is also important for the prescriber to be aware of the differential diagnosis (DD) of asthma symptoms, to decrease the chances of misdiagnosis. Table 3 lists the DD for asthma. 2.3. Domain C: Prescribing in context the healthcare system, information, self and others According to a systematic review by Kawamoto et al. (2005) which targeted trials that implement clinical guidelines as a method to improve clinical decision-making; 68% of all trials involved in that study had a significant improvement. Thus, it could be argued that guidelines are highly important for supporting staff decision-making. Furthermore, the Saudi initiative for asthma has published guidelines used by most hospitals in Saudi Arabia for managing asthmatic patients (Al-Moamary et al., 2013). And they are regularly updated and published in the Annals of Thoracic Medicine Journal which is the official journal of the Saudi Thoracic Society (STS). Although the guidelines include all types of asthma medical treatments, due to the focus of this report, Appendix D will contain a detailed discussion on the guidelines’ recommendations about ICS as one of the medical approaches to treat asthma. 3. Summary of stopping the ICS was enough to return the lung function to pre-treatment values in mild to moderate asthma. Educating the patients about possible side effects of the ICS is important. It could be argued that if the prescriber is aware about the pharmacokinetics and pharmacodynamics of the prescribed drugs, the possible side effect as a result of the therapy might be reduced. Irwin and Richardson (2006) argue that the current studies available on the bioavailability of different types of ICS are limited, and if such studies could be established the ICS drug selection could be chosen by the least side effect causing agent. Until these studies shall be available, there will be no preferred agent with the least side effect to be recommended. By understanding such important concepts of pharmacology, the prescriber assessment of the risk benefit value (RBV) will be optimised. According to Rohatagi et al. (2004) In summary this report emphasises on the need to regulate nonmedical prescribing in Saudi Arabia by allowing specialised HCPs to prescribe within their speciality constrains as the practice in the UK. This report also discussed the value of using decision making framework to optimise the level of accuracy in the prescribing process. The discussion also extended the rationale behind choosing the single competency framework. This report might also recommend the development of national guidelines in Saudi Arabia to regulate the process of a licenced non-medical prescribing. This report adapted the national prescribing centre (NPC, 2012) framework for non-medical prescribing used in the UK and was applied to ICS prescribing. This report included the Asthma definition, epidemiology in Saudi Arabia, pathophysiology and available medical options to control and was discussed thoroughly. Furthermore, the mechanism of action for ICS was discussed and different avail- Decision making framework designed for non-medical prescribers able options with their recommended doses were demonstrated based on the available national guidelines. In addition, the factors that influence ICS prescription were illustrated for example patients’ education and how it might influence the extent of the ICS side effect. Besides, the SINA guidelines recommendation about the ICS was included. Finally, it is important for the prescriber to be aware of the emerging medical therapy to treat the condition, as well as the available evidence expected to develop about the variation of ICS bioavailability which might influence the prescribed options to cause the least side effect for the patients. Appendix A. The prescribing pyramid Reflect Record Keeping Review Negoate a contract Choice of product Which strategy 45 Appendix C. Metred dose inhalers MDI, dry powder inhalers DPI or small volume nebulisers SVN to deliver ICS, which one is better? There is a need for coordination between the actuation of the drug while using MDI devices and the patient breathing. However, DPI does not require such but it is more expensive than MDI with a spacer. However, the British thoracic society guidelines (BTS, 2012) recommend the use of MDI with spacer over the DPI and SVN. Hence, the evidence available support its superiority by means of being cost effective, no power sources needed and noise free (Cates et al., 2003). The guidelines also extend to the fact that even in acute exacerbation of asthma there is no enough evidence to support the use of nebulisers over inhalers except when an administration of O2 is also needed. There are many reasons why the use of holding chamber with MDIs or DPIs is highly recommended since, it eliminates the need for coordination (in MDI) and also decreases the amount of drug deposition in the oropharynx which might be highly important when administering ICS. Furthermore, it increases the drug deposition in the patients’ lungs by >5%. Thus, the use of MDI with spacer is the preferred method to deliver ICS both while administering to control asthma or in acute exacerbation. Consider the paent Appendix D. U The SINA guidelines recommendations about the use of ICS. Appendix B. The single competency framework. The guidelines recommend the introduction of ICS in low and medium doses in step two and step three asthma and high dose in step four. The steps approach is a wildly used system to assess asthma control based on the asthma control test (ACT). This test is one of the tests available to assess asthma control along with the asthma control questionnaire (ACQ). 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