AVOIDING HARM: Tackling Problematic Polypharmacy through
strengthening Expert Generalist
Practice
Prof Joanne Reeve BClinSci MBChB MPH PhD FRCGP
Academy of Primary Care, Hull York Medical School
Joanne Reeve, Hull York Medical School, Allam Medical Building,
Cottingham Road, Hull HU67RX
Word count: 3103 Tables: 1 Boxes: 5 Reference: 49
Keywords: polypharmacy, problematic polypharmacy, generalism,
multimorbidity
Abstract
Problematic polypharmacy is a growing challenge. Medication that is
intended to improve patients’ health and wellbeing is instead becoming
part of the problem. The way we practice medicine has become one of the
drivers for the problems. Dealing with the challenge will need us to
think differently about how we do clinical care.
A 2013 Kings Fund report stated that tackling problematic polypharmacy
requires us to actively build a principle of ‘compromise’ in to the way
we use medicines. There are implications for how we consult and make
decisions with patients, in how we design health practice and systems to
support that decision making, and in our understanding of the process of
research – how we generate the knowledge that informs practice.
This review considers the current state of play in all three areas and
identifies some of the work still need to do in order to generate the
practice-based evidence needed to tackle this most challenging problem.
Finding a way to redesign practice to address problematic polypharmacy
could offer a template for tackling other related complex issues facing
medical practice such as multimorbidity, chronic pain and complex mental
health.
The Challenge of Problematic Polypharmacy
Polypharmacy is now a routine medical intervention. Defined as the
concomitant use of multiple medicines on a long-term basis, it
represents an approach to medical care that has expanded significantly
in scale and scope over the last twenty years [1]. Around one third
of people aged 75 and over take 6 medicines or more a day [2]. The
last two decades has seen the number of people prescribed 5+ medicines a
day increase four-fold [2].
Appropriate Polypharmacy offers significant potential benefit to both
individual and population health [1. However, the 2013 Kings Fund
report also recognises a new challenge – that of Problematic
Polypharmacy [1]. A person on ten or more medicines a day is over
three times more likely to be admitted to hospital than someone on 1-3
medicines per day [3]. The risk of adverse reactions and medication
errors increases with higher prescribing [1]. 40% of people taking
5 or more medicines a day report feeling burdened by their use [4].
Many factors contribute to problematic polypharmacy, including patient,
professional and health system issues. The Kings Fund therefore defines
problematic polypharmacy with reference to what is experienced by the
patient: being when the “intended benefit of the medication is not
realised” [1]. This definition requires us to consider explicitly
what we mean by ‘intended benefit’.
Work to date to address the challenges associated with polypharmacy has
centred on the principles of medicines optimisation: “ensuring people
get the right choice of medicines, at the right time, and are engaged in
the process by the clinical team” [5]. In practice, this focuses on
the safe and effective use of medicines to enable the best outcomes
[5], involving whole practice teams in safely delivering medicines
to patients. The intended benefit is optimal medical impact from
medication with minimal side effects or risk.
Medicines optimisation programmes have been criticised for a lack of
person-centred focus in defining ‘best’ practice and outcomes with
relation to decisions about medication use [6]. Indeed, the 2013
Kings Fund report described that addressing problematic polypharmacy
would require compromise between medical and patient perspectives
on the use of medicines [1]. Intended benefit may still be
biomedical outcomes. For some patients, priorities for care may reflect
different benefits.
Achieving compromise is the expertise of the medical generalist.
Generalist practice describes the skills needed to integrate biomedical
and biographical perspectives of individual illness to generate an
individually tailored interpretation of what is wrong and what
needs doing [7]. The goal of generalist practice is to support
health as a resource for daily living – a means to an end rather than
the end itself [7]. Generalist skills offer a mechanism to deliver
robust, safe compromise.
However, the 2019 NHS Long Term Plan recognises a shortage of capacity
of generalist skills in the hospital setting [8]. IN the
community/primary care setting, research highlights four barriers to use
of generalist skills in practice [9,10]. A 2017 survey of
prescribers including GPs, pharmacists and nurse prescribers described
that tailoring of medicines was inhibited by the 4Ps of Permission,
Prioritisation, Professional training and Performance management
[10]. Professionals described a perceived lack of permissionto work beyond guidelines – an approach needed to achieve tailoring and
compromise. They highlighted a failure to prioritise this complex
task in a multitude of other competing priorities in their daily work,
meaning they lacked the ‘head space’ to tailor medication use. People
described both a lack of professional training in the complex
decision making required for tailoring, exacerbated by a lack of
confidence in using the skills they did have. Finally, they challengedperformance management processes which at best ignored , and at
worse criticised, this area of practice.
As yet, and for a variety of reasons that I shall return to, we have no
evidence-based description of an expert-generalist-prescribing
intervention. However, we do have a growing body of research evidence
and professional scholarship that offers us insights in how we could
overcome the described barriers. This review aims to provide an
evidence-informed overview of the state of play and proposes next
actions for avoiding harm from problematic polypharmacy through
strengthening expert generalist practice.
Building a generalist
response
This review will therefore consider, can strengthening expert generalist
practice support the compromise needed to tackle problematic
polypharmacy? Underpinning generalist practice and the delivery of
compromise is the principle of person-centred care: that care is guided
by the needs and preferences of the individual [11], recognising
health as a resource for living and not an end in itself[12].
Healthcare decisions require an interpretation of illness and need based
on understanding of the individual in their context, not just their
disease status. Delivering person-centred care is a complex intellectual
task, and certainly not a ‘soft skill’ [13].
To explore this further, I will examine three areas of practice: the
consultation (the clinical intervention), the practice setting (the
context), and scaling and sustaining practice (implications for research
and scholarship).
Rethinking the
consultation
Compromise needs an approach to clinical practice that supports robust
and safe construction of “contextualised meaning” driving clinical
decision making [14,p11]. Generalist practice constructs
whole-person-centred meaning in context through the integration of
knowledge/evidence on both the biomedical and biographical aspects of
individual illness experience. Decisions are informed by, rather than
based on, guidelines/evidence, with the clinician exercising the skills
and clinical judgement of the expert generalist to robustly work beyond
guidelines to deliver whole-person tailored care [15,16].
A (still limited) body of scholarship describes how clinicians work
beyond guidelines in practice. Gabbay’s account of generating
practice-based evidence, and the construction of mindlines, describes
how GPs actively construct knowledge-in-practice-in-context through the
use of clinical scholarship [16]. Similarly, Donner-Banzhoff used
ethnographic methods to observe GPs in practice, and described the
“inductive foraging” used by these clinicians to construct tailored
understanding of patients’ illness and needs [13]. Both describe the
knowledge work [17], or clinical scholarship [18,19], undertaken
by clinicians to robustly construct tailored interpretations in context.
Drawing on the scientific principles of epistemology (the theory of
knowledge), I have described a framework (or consultation model) that
can be used to establish the trustworthiness of this work [15,20].
The importance of interpretive practice – the exercise of clinical
judgement – is recognised within key systems that currently govern
clinical practice. The National Institute for Health and Care Excellence
(NICE) produces most UK guidelines describing best practice. The Chair
of NICE, Professor Haslam, has repeatedly described that NICE produces
“guidelines not tramlines” [21], with all NICE documents calling
for professional judgement. Guidelines are constructed from a review of
best evidence (see Box 1). The Evidence Based Medicine (EBM) movement
also supports the use of clinical judgement in deciding if and when to
apply evidence to an individual patient [22]. Both NICE and EBM
emphasise the importance of clinical judgement. However, both can be
criticised for failing to provide a robust account describing what is
clinical judgement – and in particular, how it can be distinguished
from the ‘clinical opinion’ that appears at the bottom of the EBM
hierarchy of evidence [23].
INSERT BOX 1 ABOUT HERE
As highlighted in my own research [9,10], and within informal
discussions with colleagues, clinicians feel that they lack the skills
and confidence to robustly defend clinical judgement and beyond protocol
decisions. Professional training (and assessment) focuses on
demonstrating what you know, rather than how you make use of what you
know (for example, to deliver tailored decisions) [25].
Professionals feel unable to defend complex decisions, and so they do
not make them. This undermines the capacity for compromise, and so
contributes to problematic polypharmacy.
Tools for generalist practice
A number of tools help a clinician with specific tasks related to
medicines use such as deprescribing. However, and surprisingly, there is
still limited specific evidence for whole-person-centred prescribing.
However, I describe two evidence-informed approaches currently available
which address the barriers of permission and professional skills. Both
share in a goals-focused approach to using medication.
Scottish polyphArmAcy guidANCE
[26]
This tool describes 7 steps to ‘appropriate polypharmacy’. The first
step, which informs all that follows is to determine what matters to the
patient – to set the goals for care. The clinician is then guided
through identifying essential drug therapy and unnecessary therapy; an
assessment of whether therapeutic goals are being achieved and at what
costs (in terms of adverse effects). The cost-effectiveness of the
medication from a service perspective is considered, along with the
question of whether the patient is able or willing to take the
medication as prescribed.
The guidance provides data (for example on absolute benefit and harm
from medication use) and structure for complex decision making
(addressing the barrier of professional skills); as well as permission
and prioritisation for this model of practice. Case studies are offered
to bolster learning potential, with hot topics of common challenges
flagged.
The Scottish Guidance is a useful resource for clinicians embarking on
person-centred review of medication use. However, the Guidance lacks a
strong evidence base or theoretical framework informing its development
and implementation.
THE SAGE CONSULTATION MODEL
[20]
Epistemological principles describe five steps needed to support robust
generation of knowledge in practice in context [15]. These are
recognised within the SAGE consultation model [20] – see Box 2 .
Clinicians should pay attention to, and document their thinking/decision
making, with reference to: a clear statement of GOALS of care with the
default being to support health for daily living; a considered
EXPLORATION of a full data set; the construction of a TAILORED
EXPLANATION; a clear process of professional SAFETY NETTING; and follow
up of the patient for IMPACT ASSESSMENT. This fifth step recognises that
a tailored explanation is always an interpretation constructed to
support a goal. The quality of the interpretation lies in the process of
its construction (the first 4 stages) but also its utility – whether it
offers value to an outcome [15].
INSERT BOX 2 ABOUT HERE
The 5 Steps model provides a framework that addresses each of the 4P
barriers described: in recognising the legitimacy of professional
interpretive practice, and the complexity of the task (and so
prioritisation). It provides a framework to support the application of
skills, and an epistemologically robust framework for critically
reviewing and defending decision making; as well as performance
management/assessment.
Both the Scottish Guidance [26] and the 5 Steps SAGE model [20]
can be understood as complex interventions supporting professional
practice. As such, both can – and should – be subjected to critical
evaluation through research in order to understand the impacts on
professional practice and patient outcomes. The principles behind the
SAGE model have been assessed within Quality Improvement activity
[27]. Both models describe principles of practice that will be
recognised by and familiar to many professionals:
“The good physician treats the disease. The great physician treats the
person who has the disease” (Osler) [cited in 28]
However formal research evaluation of either consultation approach has
yet to be done.
Addressing barriers: rethinking the organisation of
practice
Both the Scottish guidance and the SAGE consultation model offer
evidence-informed guidance to inform the interaction between clinician
and patient. But consultations happen in an organisational context.
Contextual factors can both support and undermine practice [9,10].
Successful implementation of new ways of working requires us to pay
attention to the context as well as the intervention itself [29].
For generalist expertise to improve the ‘compromise’ needed to address
problematic polypharmacy, we need to look not just at what clinicians
and patients are doing, but also to think about the organisation of
practice.
Repeat prescribing supporting long term medication use occurs mainly in
the primary care (general practice) context. In the UK in 2018, 1.1
billion prescription items were dispensed in the community, at a cost of
£8.8billion [30]. Improvements to the organisation of prescribing
practice has come through the development of Medicines Optimisation
systems [5]. The principle behind Medicines Optimisation is simple:
to “improve outcomes and value” [5]. Measures to achieve these
goals include the introduction of practice systems that improve outcomes
for patients by helping them take their medicines correctly, avid
unnecessary medicines and reduce wastage, and improve safety [5].
Medicines Optimisation has contributed to significant improvements in
practice areas such as antibiotic prescribing and reducing the use of
medicines that are not clinically or cost effective. Utilisng the
clinical skills of pharmacy teams within primary care settings has been
a crucial part of this success [5].
But Medicines Optimisation approaches, to date, have not fully embraced
the challenge of implementing ‘compromise’ and in particular the 4P’s to
generalist practice that my work has described.
The principles of Medicines Optimisation recognise the importance of a
patient-centred approach (see Box 3) and so potentially addresses
‘Permission’ as a barrier to person-centred care. Although practice
models do not offer specific guidance on how to ensure that principle
#1 (understanding the patient’s experience) should be used to guide or
moderate choices raised by principle #2 (evidence based use of
medicines). But the approaches to strengthen generalist expertise that I
have already outlined may help address this challenge.
INSERT BOX 3 HERE
However further work is also needed to tackle the wider organisational
barriers to achieving compromise in practice. As discussed, these
include how to appropriately prioritise the work needed within the wider
context of a primary care service, how to build the teams and resources
needed to support professional practice, and how to appropriately
performance manage this complex area of work. Again, the research
literature offers us insights in to how we might address these wider
organisational gaps and challenges. Table 1 offers an overview.
INSERT TABLE 1 HERE
As yet, there are no research studies that pull all of these factors
together to evaluate a new generalist complex intervention to address
problematic polypharmacy. We do have a Cochrane review evaluating the
impact of introducing evidence-based medicines optimisation tools (eg
STOPP-START, Beers criteria, Medication Appropriateness Index) to
address polypharmacy [31]. Results demonstrate improved governance
outcomes (for example, a reduction in biomedically defined inappropriate
prescribing) but with uncertain evidence of benefit for ‘clinically
significant outcomes’ and patient-centred care. Newer studies now seek
to evaluate multi-faceted (complex) interventions that recognise the
range of clinician, patient and context components needed to address
problematic polypharmacy [37-42]. Each study has a slightly
different focus for its intervention. It is likely that we will need
innovative research methods, for example realist synthesis [43], to
help us integrate the findings and so draw wider conclusions on
redesigning prescribing practice.
Implications for research and
scholarship
This current body of research will provide us with ‘proof of concept’
statements: evidence of what could work to address problems associated
with polypharmacy. What comes next is the implementation stage –
assessing whether the principle works when we seek to deliver it at
scale in the primary care setting. Implementing complex interventions
into everyday practice and at scale requires yet another set of
knowledge and skills [29,44].
Yet there is a common theme running through each stage discussed here:
the theme of knowledge work and the robust generation and application of
knowledge in, and for, practice [17, 19, 45, 46]. At a consultation
level, the generalist clinician works to integrate biomedical and
biographical understanding of illness to generate new
knowledge-in-practice of compromise. At a practice level, the generalist
team works to integrate the multiple elements needed to enable and
support this complex knowledge work. Now, at the systems level
clinicians and academics must work together to integrate the knowledge
and insights from their different contexts to co-produce solutions to
shared problems.
Evans & Scarborough recognised this process as a new understanding of
how research works [46]. Their observations of health services
research in action revealed two types of practice: bridging and
blurring. Bridging refers to the (perhaps) more traditional review of
scholarship and research: where objective knowledge is generated in a
controlled setting, with the use of new ‘knowledge translation’ tools
and workers to deliver this new understanding to the context in which it
is to be used. They also observed examples of blurring: where academics
and applied workers came together to co-produce new
knowledge-in-context. Evans & Scarborough didn’t seek to judge between
the approaches. However, they did note that both produce different types
of knowledge and so raise questions for us on how we judge ‘best’
evidence.
Our understanding of best evidence is currently largely driven by the
epistemological assumptions of the Evidence Based Medicine movement
(EBM) [22]. Epistemology is the theory of knowledge, and offers us
insights in to how we judge between different types of knowledge. EBM
gave us a ‘hierarchy of knowledge’ which judges between different types
of knowledge based on the methodology used to generate it. EBM was
originally developed within a specialist, biomedical setting and the
epistemological assumptions (and so hierarchy) reflect the ontological
beliefs and knowledge work of that context. But its assumptions about
‘best evidence’ have been applied more broadly across health care
settings; with implications for achieving the compromises discussed
here.
Glasziou and Chalmers have challenged this methodological definition of
best evidence on the grounds that it is insufficient to prevent waste:
the generation of research that doesn’t deliver any impact [47,48].
They propose that research should be judged by three components: the
relevance or appropriateness of the research question, the
appropriateness of the methodology for the question , and the
impact of the research. This broader vision of research quality offers a
framework by which to judge the generation of knowledge from a blurred
model. Established epistemological frameworks allow us to judge the
knowledge output. Scaling these research processes to enable research to
be part of the solution to problematic polypharmacy challenges not only
the knowledge work of clinical practice, but also that of research
practice too [49].
In conclusion
Building capacity for clinical compromise in order to address
problematic polypharmacy needs a whole-system model of practice that
supports active generation and assessment of the robustness of knowledge
in real-time and in context.
Rethinking how we generate and use knowledge in practice has
implications for how we train practitioners in scholarship, how we
organise teams and practices to generate and use knowledge, and how we
organise systems to understand and support knowledge in practice.
These challenges and suggested changes apply to more than just
addressing problematic polypharmacy – but also other complex illness
such as multimorbidity, complex mental health, medically unexplained
symptoms and managing uncertainty.
We have an opportunity to address a key clinical challenge. Finding a
way to redesign practice to address problematic polypharmacy could also
offer a template for tackling other related complex issues facing
medical practice such as multimorbidity, chronic pain and complex mental
health. In tackling problematic polypharmacy, we may also describe a new
model for evidence-informed innovation of practice for the holy grail of
whole-person-centred healthcare.
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