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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). A recent
systematic review showed the superiority of ACT over ACQ in
clinical practice (Jia et al., 2013). The same study also noted
the need for cross validity for the ACQ and concluded that neither of these tests are suitable for uncontrolled asthma (ibid).
46
The low, medium and high doses recommended for all of
the available ICS in Saudi Arabia are previously noted in
Table 1.
Appendix E.
Example of asthma action plan adapted from the American
Lung Association
S. Almarshad
Decision making framework designed for non-medical prescribers
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