Medication Safety in Polypharmacy - Technical Report - World Health Organization
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Medication Safety in
Polypharmacy
Technical ReportMedication Safety in
Polypharmacy
Technical ReportWHO/UHC/SDS/2019.11 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules). Suggested citation. Medication Safety in Polypharmacy. Geneva: World Health Organization; 2019 (WHO/UHC/SDS/2019.11). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Designed by CommonSense, Greece Printed by the WHO Document Production Services, Geneva, Switzerland
Contents
Abbreviations .................................................................................................................................... 4
Preface .............................................................................................................................................. 5
Executive summary: medication safety in polypharmacy ............................................................ 10
1. Introduction.................................................................................................................................. 11
1.1 Polypharmacy .......................................................................................................................... 11
1.2 Prevalence of polypharmacy .................................................................................................. 12
1.3 Economic impact of polypharmacy ........................................................................................ 13
1.4 Other factors influencing appropriate polypharmacy.............................................................. 14
2. Medication safety in polypharmacy .......................................................................................... 15
2.1 Medication-related harm in polypharmacy.............................................................................. 15
2.2 Medication review in polypharmacy ...................................................................................... 16
3. Implementing polypharmacy initiatives .................................................................................... 20
3.1 Implementing sustainable programmes to address polypharmacy........................................ 20
3.2 Programmes on appropriate polypharmacy .......................................................................... 21
4. Health systems approach to polypharmacy .............................................................................. 23
4.1 Patients and the public............................................................................................................ 24
4.2 Health care professionals ...................................................................................................... 25
4.3 Medicines................................................................................................................................ 25
4.4 Systems and practices of medication .................................................................................... 26
4.5 Monitoring and evaluation ...................................................................................................... 27
5. Points of consideration for countries ........................................................................................ 29
References ...................................................................................................................................... 30
Annexes .......................................................................................................................................... 38
Annex 1. Glossary ............................................................................................................................ 38
Glossary references .......................................................................................................... 41
Annex 2. Global prevalence of polypharmacy ................................................................................ 43
Annex 3. Internationally available guidance on appropriate polypharmacy management .............. 47
Annex 4. Case studies .................................................................................................................... 49
Annex 5. List of contributors ............................................................................................................ 59
MEDICATION SAFETY IN POLYPHARMACY 3Abbreviations
ACE angiotensin-converting enzyme
ADR adverse drug reaction
ARB angiotensin II receptor blocker
BP blood pressure
COPD chronic obstructive pulmonary disease
eGFR estimated glomerular filtration rate
NNH number needed to harm
NNT number needed to treat
NSAID non-steroidal anti-inflammatory drug
OTC over-the-counter
PESTEL political, economic, social, technological, environmental and legal
PIM potentially inappropriate medication
RLS reporting and learning systems
SWOT strengths, weaknesses, opportunities and threats
UHC universal health coverage
WHO World Health Organization
4 MEDICATION SAFETY IN POLYPHARMACYPreface
Health care interventions are intended to prescribed, dispensed or sold inappropriately,
benefit patients, but they can also cause with many of these leading to preventable harm
harm. The complex combination of processes, (2). Given that medicines are the most common
technologies and human interactions that therapeutic intervention, ensuring safe
constitutes the modern health care delivery medication use and having the processes in
system can bring significant benefits. place to improve medication safety (see Annex
However, it also involves an inevitable risk of 1) should be considered of central importance
patient harm that can – and too often does – to countries working towards achieving UHC.
result in actual harm. A weak safety and
quality culture, flawed processes of care The Global Patient Safety Challenges of the
and disinterested leadership teams weaken World Health Organization (WHO) shine a light
the ability of health care systems and on a particular patient safety issue that poses a
organizations to ensure the provision of safe significant risk to health. Front-line interventions
health care. Every year, a significant number are then developed and, through partnership
of patients are harmed or die because of with Member States, are disseminated and
unsafe health care, resulting in a high public implemented in countries. Each Challenge has
health burden worldwide. so far focused on an area that represents a
major and significant risk to patient health and
Most of this harm is preventable. Adverse safety (see Annex 1). In 2005, the Organization,
events are now estimated to be the 14th leading working in partnership with the (then) World
cause of morbidity and mortality in the world, Alliance for Patient Safety, launched the first
putting patient harm in the same league as Global Patient Safety Challenge: Clean Care Is
tuberculosis and malaria (1). The most important Safer Care (3), followed a few years later by the
challenge in the field of patient safety (see second Challenge: Safe Surgery Saves Lives
Annex 1) is how to prevent harm, particularly (4). Both Challenges aimed to gain worldwide
avoidable harm, to patients during their care. commitment and spark action to reduce health
care-associated infection and the risks
Patient safety is one of the most important associated with surgery, respectively.
components of health care delivery which is
essential to achieve universal health coverage Recognizing the scale of avoidable harm
(UHC), and moving towards the UN Sustainable linked with unsafe medication practices and
Development Goals (SDGs). Extending health medication errors, WHO launched its third
care coverage must mean extending safe care, Global Patient Safety Challenge: Medication
as unsafe care increase costs, reduces Without Harm in March 2017, with the goal
efficiency, and directly compromises health of reducing severe, avoidable medication-
outcomes and patient perceptions. It is related harm by 50% over the next five years,
estimated that over half of all medicines are globally (5).
MEDICATION SAFETY IN POLYPHARMACY 5This Challenge follows the same philosophy as and effective management to protect patients
the previous Challenges, namely that errors are from harm while maximizing the benefit from
not inevitable, but are very often provoked by medication, namely:
weak health systems, and so the challenge is to • medication safety in high-risk situations
reduce their frequency and impact by tackling • medication safety in polypharmacy
some of the inherent weaknesses in the system. • medication safety in transitions of care.
As part of the Challenge, WHO has asked Consider the following case scenario
countries and key stakeholders to prioritize describing a medication error (see Annex 1)
three areas for strong commitment, early action involving these three areas.
Medication error: case scenario
Mrs Poly, a 65-year-old woman, came to the outpatient clinic complaining of abdominal pain and
dark stools. She had a heart attack five years ago. At her previous visit three weeks ago she was
complaining of muscle pain, which she developed while working on her farm. She was given a
non-steroidal anti-inflammatory drug (NSAID), diclofenac. Her other medications included aspirin,
and three medicines for her heart condition (simvastatin, a medicine to reduce her serum
cholesterol; enalapril, an angiotensin-converting enzyme (ACE) inhibitor; and atenolol, a beta
blocker). She was admitted to hospital as she developed symptoms of blood loss (such as
fatigue and dark stools). She was provisionally diagnosed as having a bleeding peptic ulcer due
to her NSAID, and her doctor discontinued diclofenac and prescribed omeprazole, a proton
pump inhibitor. Following her discharge, her son collected her prescribed medicines from the
pharmacy. Among the medicines, he noticed that omeprazole had been started and that all her
previous medicines had been dispensed, including the NSAID. As his mother was slightly
confused and could not remember exactly what the doctor had said, the son advised his mother
that she should take all the medications that had been supplied. After a week, her abdominal
pain continued and her son took her to the hospital. The clinic confirmed that the NSAID, which
should have been discontinued (deprescribed), had been continued by mistake. This time Mrs
Poly was given a medication list when she left the hospital which included all the medications
she needed to take and was advised about which medications had been discontinued and why.
6 MEDICATION SAFETY IN POLYPHARMACYThe events leading to the error in this scenario and how these could have been prevented are
reflected in Figure 1, and the text below.
Figure 1. Key steps for ensuring medication safety
1.
Appropriate
prescribing
and risk
assessment
5.
Medication Risks
reconciliation Benefit
at care transitions
2.
Medication
review
3.
4. Dispensing,
Communication preparation and
and patient engagement administration
In this scenario the key steps that should have 2. Medication review
been followed to ensure medication safety A comprehensive medication review (see
in the inpatient setting include: Annex 1) is a multidisciplinary activity whereby
the risks and benefits of each medicine are
1. Appropriate prescribing and risk considered with the patient and decisions
assessment made about future therapy. It optimizes the use
Medication safety should start with appropriate of medicines for each individual patient.
prescribing and a thorough risk–benefit Multiple morbidities usually require treatment
analysis of each medicine is often the first step. with multiple medications, a situation described
In this case scenario, prophylactic aspirin as polypharmacy (see Annex 1). Polypharmacy
and NSAID without a gastroprotective agent can put the patient at risk of adverse drug
left Mrs Poly at an increased risk of events (see Annex 1) and drug interactions
gastrointestinal bleeding. NSAIDs can also when not used appropriately. In this case,
increase the risk of cardiovascular events, there should have been a review of
which is of particular concern, as she had had medications, particularly as Mrs Poly was
a myocardial infarction (heart attack) five years prescribed aspirin and diclofenac together.
ago. This is a good example of a high-risk The haemodynamic changes following blood
situation requiring health care professionals loss should have also prompted temporary
to prescribe responsibly after analysing stopping the ACE inhibitor before restarting once
the risks and benefits. the episode of blood loss has been resolved.
MEDICATION SAFETY IN POLYPHARMACY 73. Dispensing, preparation and 5. Medication reconciliation at care
administration transitions
This is a high-risk situation as the medication Medication reconciliation is the formal process
(diclofenac) has the potential to cause harm. in which health care professionals partner
However, this medication was continued after with patients to ensure accurate and complete
discharge when the patient transitioned from medication information transfer at interfaces
hospital to home. Dispensing this medicine and its of care. Diclofenac, the NSAID that can cause
administration caused serious harm to Mrs Poly. gastrointestinal bleeding and increase the risk
Dispensing this medicine and its administration of cardiotoxicity and had led to this hospital
caused significant harm to Mrs Poly. admission, was discontinued, and this
information should have been communicated
4. Communication and patient engagement at the time of discharge (in the form of a
Proper communication between health care medication list or patient-held medication
providers and patients, and amongst health record). This would have helped her and her
care providers, is important in preventing caregivers in determining what the newly added
errors. When Mrs Poly was severely ill due to and discontinued medications needed to be.
gastric bleeding, the NSAID was discontinued.
However, the decision to discontinue the Medication-related harm is harm caused to
medicine was not adequately communicated a patient due to failure in any of the various
either to the other health care professionals steps of the medication use process or due
(including the nurse or the pharmacist) or to to adverse drug reactions (see Annex 1 for
Mrs Poly. Initial presenting symptoms due to glossary). The relationship and overlap between
adverse effects could have been identified medication errors and adverse drug events
earlier if she had been warned about the risks. is shown in Figure 2.
Figure 2. Relationship between medication errors and adverse drug events
Adverse drug events
Injury No injury
Outcomes
Adverse Preventable Potential Trivial
drug adverse drug adverse drug medication
reactions events events errors
Causes
Not preventable Preventable
Inherent risk Medication errors
of drugs
Source: Reproduced, with the permission of the publisher, from Otero and Schmitt (6).
8 MEDICATION SAFETY IN POLYPHARMACYWHO is presenting a set of three technical This report – Medication safety in
reports – Medication safety in high-risk polypharmacy – outlines the problem, current
situations, Medication safety in polypharmacy, situation and key strategies to reduce
and Medication safety in transitions of care – medication-related harm in polypharmacy.
to facilitate early priority actions and planning It should be considered along with the
by countries and key stakeholders to address companion technical reports on Medication
each of these areas. The technical reports are safety in high-risk situations and Medication
intended for all interested parties, particularly safety in transitions of care.
to inform national health policy-makers and
encourage appropriate action by ministries
of health, health care administrators and
regulators, organizations, professionals,
patients, families and caregivers, and all who
aim to improve health care and patient safety.
MEDICATION SAFETY IN POLYPHARMACY 9Executive summary:
medication safety
in polypharmacy
Ensuring medication safety in polypharmacy and/or services may be necessary to help
is one of the key challenges for medication medical practitioners manage workload
safety today. Due to the traditional focus related to polypharmacy in order to improve
of both medical research and health care medication safety.
delivery models on single-disease
interventions, there has been a notable lack In complex health care setting with many
of evidence-based solutions. Conventionally competing priorities, it is useful to outline
polypharmacy has been perceived as an the safety, clinical and economic implications
overuse of medicines, whereas it may be more for appropriate polypharmacy management.
useful to perceive in terms of appropriateness, It can also be helpful to develop an
as there are many cases where the concurrent implementation plan which applies change
use of multiple medicines may be deemed management and implementation theories
necessary and beneficial. Globally the and tools. The four domains in the strategic
prevalence of polypharmacy is set to rise as framework of the third WHO Global Patient
the population ages and more people suffer Safety Challenge: Medication Without Harm
from multiple long-term conditions. Countries can assist in providing a guiding structure
should therefore prioritize raising awareness to create a medication safety strategy
of the problems associated with inappropriate addressing polypharmacy.
polypharmacy and the need to address this
issue.
All stakeholders have a vital role to play
in driving change for the management
of polypharmacy. Polypharmacy management
involves multifaceted decision-making and
necessitates the combined knowledge of
physicians, nurses, pharmacists and other
health care professionals, including the
systematic involvement, engagement and
empowerment of patients. Thus it is important
to implement interventions, such as medication
reviews, whenever possible in collaboration
with the patient and/or the caregiver. Good
communication and accurate sharing of
information is essential and can be facilitated
by the use of patient-held medication records.
Furthermore, a redesign of care processes
10 MEDICATION SAFETY IN POLYPHARMACYIntroduction
1
This technical report does not attempt Polypharmacy is the concurrent use
to cover the entire scope of polypharmacy, of multiple medications. Although there
but merely aims to introduce polypharmacy is no standard definition, polypharmacy
as a concept, and examine some approaches is often defined as the routine use of five
for the appropriate management of or more medications. This includes
polypharmacy, which are crucial for ensuring over-the-counter, prescription and/or
greater medication safety. traditional and complementary medicines
used by a patient (see Annex 1).
1.1 Polypharmacy
Despite the increasing prevalence While polypharmacy is often defined as
of polypharmacy, the term continues to lack routinely taking a minimum of five medicines,
a clear universal definition. A recent systematic it is being more frequently suggested that
review of the definitions of polypharmacy the emphasis should be on evidenced-based
showed that the term was most commonly practice (7). The goal should be to reduce
applied to situations where patients took five inappropriate polypharmacy (irrational
or more medications, and this numerical prescribing of too many medicines)
definition was used by 46.4% of the studies and to ensure appropriate polypharmacy
evaluated (7). Furthermore, there are (rational prescribing of multiple medicines
inconsistencies with the use regarding based on best available evidence and
duration of therapy and whether to include considering individual patient factors and
over-the-counter (OTC), and traditional and context) (7–11). Therefore, appropriate
complementary medicines in the definition polypharmacy should be considered at every
or not. However, with the aim of reducing point of initiation of a new treatment for the
medication-related harm, it is important patient, and when the patient moves across
to verify to the fullest extent possible all different health care settings.
the medications that the patient is taking,
including all OTC, and traditional and
complementary medicines.
MEDICATION SAFETY IN POLYPHARMACY 11Appropriate polypharmacy is present, when (a) all medicines are prescribed for the purpose of
achieving specific therapeutic objectives that have been agreed with the patient; (b) therapeutic
objectives are actually being achieved or there is a reasonable chance they will be achieved in
the future; (c) medication therapy has been optimized to minimize the risk of adverse drug
reactions (ADRs); and (d) the patient is motivated and able to take all medicines as intended (12).
Inappropriate polypharmacy is present, when one or more medicines are prescribed that are
not or no longer needed, either because: (a) there is no evidence based indication, the indication
has expired or the dose is unnecessarily high; (b) one or more medicines fail to achieve the
therapeutic objectives they are intended to achieve; (c) one, or the combination of several
medicines cause ADRs, or put the patient at a high risk of ADRs or because (d) the patient is not
willing or able to take one or more medicines as intended (12).
Polypharmacy has been described as 1.2 Prevalence of polypharmacy
a significant public health challenge (13).
It increases the likelihood of adverse effects, Polypharmacy is a major and growing public
with a significant impact on health outcomes health issue occurring within all health care
and expenditure on health care resources settings worldwide (8, 13). The issue is well
(14–16). Although co-prescribing multiple described in literature from countries in North
medicines increases the risk of adverse events, America (10, 18), Europe (8, 22) and the
it is important to note that assigning a numeric Western Pacific (23), with more data becoming
threshold to define polypharmacy is not always available from other countries in recent years.
useful. There are cases where polypharmacy Additional information from selected countries
is necessary and beneficial, such as the is available in Annex 2, illustrating that
secondary prevention of myocardial infarction, polypharmacy is a global problem. However,
which requires the use of four different classes variation in the structure of health care delivery
of medications (a beta blocker, a statin, an and data collection systems, compounded
antiplatelet agent and an ACE inhibitor) (8, 12). by the different operational definitions of
Appropriate polypharmacy recognizes that polypharmacy, makes country comparison
patients can benefit from multiple medications difficult.
if the patients’ clinical conditions,
comorbidities, allergy profiles, the potential Multimorbidity is defined as the presence
drug–drug and drug–disease interactions of two or more long-term health conditions,
are considered, and the medicines are which can include (a) defined physical and
prescribed based on the best available mental health conditions such as diabetes
evidence (17). Thus, it is critical to distinguish or schizophrenia; (b) ongoing conditions
appropriate polypharmacy from inappropriate such as learning disability; (c) symptom
polypharmacy (12). complexes such as frailty or chronic pain;
(d) sensory impairment such as sight or
The most vulnerable patient groups to the risks hearing loss; and (e) alcohol and substance
of polypharmacy are susceptible to events misuse (see Annex 1).
such as drug–drug interactions, higher risk
of falls, ADRs, cognitive impairment,
non-adherence and poor nutritional status While its true magnitude is not known,
(18–20). Vulnerable patient groups often the prevalence of polypharmacy is expected
include older patients above the age of to rise due to a multitude of factors (8). First,
65 years and patients who are living in care the global population faces a demographic
homes (19–21). shift with the proportion of older population
12 MEDICATION SAFETY IN POLYPHARMACYgroups on the rise. It has been estimated 1.3 Economic impact
that the global population aged over 65 years of polypharmacy
will double from 8% in 2010 to 16% in 2050
(24). In 2015, approximately 5% of the Advancing the responsible use of medicines:
population in OECD countries were aged applying levers for change identified several
80 years and above, this percentage is opportunities to reduce health care spending
expected to rise more than double by 2050 through more responsible use of medicines
(25). Second, epidemiological data indicates worldwide. The authors estimated that
that multimorbidity increases markedly mismanaged polypharmacy contributed to 4%
with age. In a Scottish study, multimorbidity of the world’s total avoidable costs due
was prevalent in 81.5% of individuals aged to suboptimal medicine use. A total of US$ 18
85 years and over, with a mean number of 3.62 billion, 0.3% of the global total health
morbidities (26). Ornstein et al. found that the expenditure could be avoided by appropriate
most prevalent chronic conditions in primary polypharmacy management. Some of the
care were hypertension (33.5%), hyperlipidemia specific recommendations outlined in the
(33.0%), and depression (18.7%) (27). The report included (33):
presence of multiple morbidities is associated • investment in medical audits targeting older
with multiple symptoms, impairments and patients with multiple medications;
disabilities. Multimorbidity may result in • support for a greater role of pharmacists in
a combined negative effect on physical medication management and in collaboration
and mental health, and can have a major with health care professionals for review
impact on a person’s quality of life, limiting of therapeutic plans;
daily activities and reducing mobility (28, 29). • identification of high-risk patients and
The need to take multiple medications can be preparation of targeted medicine
just as problematic, resulting in frequent health management plans for this group; and
care contacts and an increase in the likelihood • to establish a system for blame-free reporting
of medication-related harm (30). Furthermore, of medication errors.
it imposes a large economic burden due
to patients’ complexity of health care needs The objectives of polypharmacy management
and frequent interaction with health services, should be comprehensive, addressing such
which may be fragmented, ineffective and issues as improved health outcomes for
incomplete (31). the patient and population, greater patient
engagement in therapeutic decision-making
Despite extensive advances in and cost-effectiveness of health care systems
pharmacotherapy, the availability of clinical and resources. This comprehensive approach –
guidelines for older adults with multiple embracing care, health and cost – has been
morbidities is limited (28). Prescribing is largely termed the “triple aim” strategy, and it is
based on evidence-based guidance for single designed to guide health system performance
diseases, which does not generally take into optimization (34). The term has been built
account multimorbidity (21, 28, 32). upon to become a “quadruple aim” upon
Consequently, patients are often prescribed recognizing that staff wellbeing is essential
several medicines recommended by a number to ensure good care for the public (35).
of specialists using disease-specific guidelines
which in combination makes the management Improved safety and quality leading
of any single disease challenging and may to economic benefits
even lead to patient harm (21, 26). In a randomized control trial by Gillespie et al.
clinical pharmacists performed comprehensive
medication reviews (see Annex 1) of older
hospitalized patients. Patients that received
MEDICATION SAFETY IN POLYPHARMACY 13a medication review experienced 16% 1.4 Other factors influencing
fewer hospital visits and 47% fewer visits appropriate polypharmacy
to the emergency department within a 12-
month follow-up period, compared to those Social determinants of health and lifestyles
with usual care. In addition, medication-related A proactive approach to sustainable and
readmissions were reduced by 80%. After appropriate medication regimens should target
factoring in the intervention costs, the lifestyles as part of the health management
comprehensive medication reviews were found process. It is recognized that an unhealthy
to lower the total hospital-based health care lifestyle can contribute to multimorbidity,
cost per patient by US$ 230. The conclusion requiring treatment with multiple medications
presumed that the addition of clinical (37). Unhealthy lifestyle factors should be
pharmacists to health care teams on a wider discussed with patients when considering
scale could result in even greater health care alternatives to medication. The WHO Active
cost reductions and reducing morbidity (36). ageing: a policy framework identified three
important economic factors for active ageing:
income, work and social protection (38).
Individuals with low incomes may be restricted
in their choice of healthy ageing options as
healthy foods, health care and housing may be
less affordable and accessible, and are thus
at higher risk of ill health and disability (39),
which can be exacerbated for patients with
polypharmacy.
Non-adherence
Non-adherence to prescribed medication is
a major challenge in polypharmacy, particularly
among older persons and/or in patients with
multimorbidity. Older patients who receive
treatment for several chronic health conditions
simultaneously present both pharmacological
and medication adherence (see Annex 1) risks
(40). A systematic review of older patients with
polypharmacy found a correlation between
medication non-adherence and the number
of medicines being taken (41).
14 MEDICATION SAFETY IN POLYPHARMACYMedication safety
in polypharmacy
2
This section outlines the case for managing Learning from medication incidents is vital
polypharmacy at the point of initiation of for the implementation of preventive strategies
treatment, when prescribing, when adding and interventions in order to reduce risk and
a new medication to a patient’s list of prevent harm from occurring again (46).
medications, during a medication review, or
during a medication reconciliation (see Annex 1) Polypharmacy at transitions of care
when a patient moves across care settings. When patients move across care settings,
medication reconciliation is an important issue
2.1 Medication-related harm that needs to be addressed. A systematic
in polypharmacy review of hospital based medication
reconciliation practices showed a consistent
Studies conducted in many countries have reduction in medication discrepancies (see
estimated the rate of medication errors both Annex 1), potential adverse effects and adverse
in hospitals and in general practice (42–45). drug events after medication reconciliation,
One study by Avery et al. found that over a with the most success seen in high-risk patient
12-month period, patients receiving five or more populations such as polypharmacy patients
medications had a prescribing or monitoring (50). Discrepancies in medication orders are
error rate of 30.1%, while in those receiving common, and they increase with the number
10 or more medications the error rate was 47%, of medications prescribed (51). A study of
demonstrating that the error rate increased post-discharge patients found that almost one
with the number of medicines prescribed (42). fifth of currently used prescription medicines
Another study conducted across eight had not been recorded during hospitalization
countries found that the incidence of patient- and that less than half of the medications used
reported errors increased with the number had been registered in the patients’ discharge
of medications that were taken (43). letter. This illustrates the challenge that health
care professionals encounter at transitions
Reporting of medication incidents such as of care (see Annex 1), as polypharmacy in
medication errors and ADRs associated with combination with an insufficient knowledge of
polypharmacy could provide useful information the patients’ medication history is an important
to improve patient safety (46). Polypharmacy contributor to prescribing errors, which can
may have harmful implications for patients potentially result in adverse drug events (52).
such as an increased risk of medication errors,
drug–drug interactions, suboptimal patient Polypharmacy in care homes
adherence and reduced quality of life (8, 47, Residents of care homes may be at higher
48). Health care professionals together with risk of complications from polypharmacy and
patients and caregivers play a crucial role in inappropriate prescribing (21). Findings suggest
reporting medication-related events (46, 49). that up to 40% of prescriptions for nursing
MEDICATION SAFETY IN POLYPHARMACY 15home residents may be inappropriate or 2.2 Medication review
suboptimal (53). Barber et al. found that in polypharmacy
the average care home resident in England
was taking eight medications a day and Medication review is a structured
over two thirds of these residents had one evaluation of patient’s medicines with
or more medication errors (54). Inappropriate the aim of optimizing medicines use and
prescribing contributes toward the medication improving health outcomes. This entails
burden and exacerbates the problem of detecting drug related problems and
inappropriate polypharmacy. This is particularly recommending interventions (see Annex 1).
evident with regards to the widespread
prescribing of antipsychotic medications Medication reviews are widely used to address
in patients with dementia in nursing and inappropriate polypharmacy globally and are
residential homes (55). also recommended by many polypharmacy
guidance documents, see Annex 3. It provides
Non-prescribed medications a structured evaluation that can be used to
In addition to prescribed medications, many prevent harm, optimize treatments and improve
patients self-medicate by purchasing OTC outcomes by optimizing the use of medicines
medicines. OTC medicines, such as NSAIDs for each individual patient (8, 61). Medication
for pain and some medications for allergies reviews in polypharmacy should take into
and coughs, may interact with their prescribed account the effectiveness and the risk–benefit
medications and have the potential to cause ratio of the medication treatment options, and
harm. In some cases, patients may also be examine these criteria for the specific patient
sharing prescription medicine with other group in which the medication is being used.
individuals (8, 56). Therefore it is important Where possible medication reviews should be
to carefully ask patients about the use performed in collaboration with the patient or
of all types of medicines or remedies (8). their caregiver (8, 13).
Traditional and complementary medicines The main purpose of medication reviews is to
The use of herbal medicines is widespread improve the appropriateness of medications,
and often taken in combination with reduce harm and improve outcomes. Therefore,
conventional medicines to treat diseases it is essential to reassure that the review is not
(49, 57, 58). Health care providers should viewed merely as a mechanism to reduce
ask their patients if they use traditional and or stop medications.
complementary medicines or remedies
and include these products in the medication A systematic review and meta-analysis
review, as these will contribute to the indicated that pharmacist-led medication
polypharmacy burden (8). Alongside drug–drug reviews led to a reduction in hospital
interactions, herb–drug interactions should be admissions (62). In addition, medication
considered, as they can cause a considerable reviews may have an effect on the reduction
patient safety risk (49, 59, 60). Further of medication-related problems (63, 64).
high-quality research is needed to identify For example, a study by Schnipper et al.
interactions of herbal medicines (60). found that medication reviews reduced
the number of preventable adverse drug
events 30 days after patient discharge (64).
One Cochrane review found that medication
reviews may have a preventive effect on
reducing the number of emergency
department contacts, however it did not
reduce mortality or hospital readmissions.
16 MEDICATION SAFETY IN POLYPHARMACYThe reducing effect on emergency department considered for individual patients during the
visits was more significant in high-risk groups decision making process. In polypharmacy
(such as older persons or patients with multiple this ratio may vary considerably between
medications) (65). The general consensus patients (61). For several commonly used
is that more evidence is necessary to medications, there are some NNT and NNH
determine the effect of medication reviews estimates available (61, 71).
due to the heterogeneity of the studies and
limitations in follow-up time (62, 66, 67). Ideally, such information on risks and benefits
is made accessible and comprehensible
Assessing risks and benefits for the public, in order to include patients in
To facilitate the medication review, prescribers the decision-making process. For example,
need practical tools and information to help a Scottish polypharmacy guidance tool helps
with decision-making on the safety and health care professionals work in partnership
effectiveness of medicines and the with patients. This resource is available as
appropriateness of initiating or continuing long a combined mobile application and website
term medications (11). One useful measure that outlines the process for initiation and
which helps prescribers to understand the the review of treatments (72).
probable clinical efficacy of a medicine
is the number needed to treat (NNT). The NNT Medication review process in polypharmacy
can be defined as the average number of The review process should include
patients who require to be treated over a time engagement with the patient. The perspective
period for one patient to benefit compared of the patient on managing and taking multiple
with a control; it can also be expressed as the medications should be assessed, as well
reciprocal of the absolute risk reduction (61). as the patient’s goal of care. The intentions
The ideal NNT, being one, signifies that every of the patient would need to be aligned with
patient improves on the outcome with the the prescribers’ view of improving outcomes
treatment. The higher the NNT, the less and treatment goals (8). The information and
effective the treatment is in terms of the trial changes derived from the medication review
outcome and timescale. The NNT is only should be made available to other health care
a statistical estimate of the average benefit of professionals, especially as the patient
treatment, usually calculated based on clinical moves across different care settings, in order
trials. It is rarely possible to know precisely to enable collaboration in appropriate
the likely benefit for a particular patient. polypharmacy management. An example
However, NNT still remains a universal concept of a step-by-step method to conduct
to assess the efficacy of medicine. Several a medication review while using a patient-
tables and further information are available on centered approach is elaborated in Table 1.
NNT, which can support prescribers in decision Annex 4 outlines how this process can be
making and aid discussions with patients further applied to selected clinical scenarios.
regarding the potential benefits of their
treatment (61, 68–71).
Similarly to NNT, another measure used in
decision making is the Number Needed to
Harm (NNH). The NNH is the average number
of people taking a medication over a time
period in order for one adverse event to occur
(61). This concept is not as widely used as
the NNT. Combined with NNT, the overall
benefit to risk ratio (NNT/NNH) should be
MEDICATION SAFETY IN POLYPHARMACY 17Table 1. Step-by-step approach to conducting a patient-centred medication review
Aims 1. What matters Review diagnoses and identify therapeutic objectives with
to the patient respect to:
• Understanding of goals of medication therapy
• Management of existing health problems
• Prevention of future health problems
Need 2. Identify Identify essential medications (not to be stopped without
essential specialist advice) such as:
medications • Medications that have essential replacement functions
(e.g. thyroxine)
• Medications to prevent rapid symptomatic decline
(e.g. medications for Parkinson’s disease)
3. Does the Identify and review the (continued) need for medications:
patient take • With temporary indications
unnecessary • With higher-than-usual maintenance doses
medications? • With limited benefit in general for the indication they are used
for
• With limited benefit for the particular patient under review
Effectiveness 4. Are Identify the need for adding/intensifying medication therapy
therapeutic in order to achieve therapeutic objectives:
objectives • To achieve symptom control
being • To achieve biochemical/clinical targets
achieved? • To prevent disease progression/exacerbation
Safety 5. Does the Identify patient safety risks by checking for:
patient have/ • Drug–disease interactions
is at risk of • Drug–drug interactions
adverse drug • Robustness of monitoring mechanisms for high-risk
reactions? medications
• Risk of accidental overdosing
Does the Identify adverse drug effects by checking for:
patient know • Specific symptoms/laboratory markers (e.g. hypokalaemia)
what to do if • Cumulative adverse drug effects
they are ill? • Medications that may be used to treat adverse drug
reactions caused by other medications
Costs 6. Is therapy Identify unnecessarily costly medication by:
cost-effective? • Considering more cost-effective alternatives (but balance
against effectiveness, safety, convenience)
Patient- 7. Is the patient Does the patient understand the outcomes of the review?
centeredness willing and • Does the patient understand why they need to take their
able to take medication?
medication • Consider teach-back techniquea to ensure full understanding
as intended? Ensure medication changes are tailored to patient preferences:
• Is the medication in a form the patient can take?
• Is the dosing schedule convenient?
• Consider what assistance the patient might have and when
this is available
• Is the patient able to take medicines as intended?
Agree and communicate plan:
• Discuss with the patient therapeutic objectives and
treatment priorities
• Decide with the patient what medicines have an effect of
sufficient magnitude to consider continuation or discontinuation
• Inform relevant health care and social care change
in treatments across care transitions
18 MEDICATION SAFETY IN POLYPHARMACYa Method to confirm that the information provided is being understood by getting people to ‘teach-back’
what has been discussed and what instruction has been given (73).
Source: Adapted, with permission of the publisher, from Scottish Government Polypharmacy Model
of Care Group (61).
Deprescribing is the process of tapering, criteria can be useful in deprescribing and
stopping, discontinuing, or withdrawing improving appropriate prescribing (72, 75).
drugs, with the goal of managing Examples of prescribing indicator sets
polypharmacy and improving outcomes which can be used to identify inappropriate
(see Annex 1). polypharmacy and appropriateness of
prescribing are available (8, 76). There are
Considerations for cessation of medication also algorithms available that could improve
should be a part of all medication reviews, medication therapy by deprescribing, which
and the process of “deprescribing” should be have been shown to be feasible (77). Hence
as robust as that of prescribing. The process it is important to undertake medication reviews
encompasses minimization of the medication with a holistic approach, as medications may
load in terms of dosage, number of tablets need to be started or stopped, both to prevent
taken and frequency of administration times harm from some medications and to prevent
(23, 74). Supporting tools such as STOPP/START health deterioration (8).
MEDICATION SAFETY IN POLYPHARMACY 19Implementing polypharmacy
3 initiatives
In order to address inappropriate polypharmacy that can be applied across the entire health
multiple programmes have been implemented, system to address the management of
particularly in high-income countries (78, 79). polypharmacy (22). PESTEL and SWOT
To illustrate the international initiatives, exercises enable organizations to evaluate
several polypharmacy guidance documents issues that need to be addressed to ensure
from different countries are listed in Annex 3. that barriers to implementation are removed
and enablers are optimized (11). To support
3.1 Implementing sustainable wider implementation of medication reviews
programmes to address in selected populations, an economic analysis
polypharmacy tool has been developed to help countries
assess the potential economic benefits
In the context of the third WHO Global Patient of introducing and undertaking medication
Safety Challenge: Medication Without Harm, reviews in polypharmacy (80).
countries are urged to take early priority action
to protect patients from harm arising from In addition to change management tools,
polypharmacy by implementing programmes some key factors that need to be considered
which help to reduce inappropriate are described in the following. Existing health
polypharmacy that are sustainable and can care delivery models for polypharmacy should
be delivered across the country. For the be reassessed to ensure the pharmacist
implementation of national, subnational plays a key role within a multidisciplinary
or local polypharmacy guidance and new team alongside physicians and nurses (33).
polypharmacy practices, it may be relevant Medication reviews performed by health care
to apply change management principles professionals would need to be incorporated
and theory-based implementation strategies. in the design of clinical pathways in the
management of patients with multimorbidity
Tools and theories to support the to facilitate workflow (81). Transfer of
implementation process include Kotter’s information across transitions of care is
eight step process for leading change; important to the management of appropriate
political, economic, social, technological, polypharmacy, because it ensures medications
environmental and legal (PESTEL); and that were reviewed and stopped are not
strengths, weaknesses, opportunities and restarted without proper justification.
threats (SWOT) (11). A recent case study
applied Kotter’s Eight step process for leading Addressing organizational culture
change and normalization process theory to and multidisciplinary working
assess successful polypharmacy management The organizational dynamics within health
activities in Europe, and provided advice care systems can be complex and include
20 MEDICATION SAFETY IN POLYPHARMACYthe values, beliefs and assumptions held OPtimising thERapy to prevent Avoidable
by those within an organization (33). Cultural hospital admissions in the Multimorbid elderly
factors can facilitate or hinder the (OPERAM), aims to optimize existing
implementation of innovative practices in pharmacological and non-pharmacological
managing polypharmacy. Failure to account therapies to reduce avoidable hospital
for organizational culture is one of the main admissions, particularly among older patients
reasons mentioned when evaluating why with multimorbidity in Europe. The goal of the
planned initiatives fail to overcome barriers (82). study is to assess the impact of a structured
Not only should the culture of the health system medication review with a software intervention,
as a whole be considered, but also the cultural obtain and compare intervention studies
norms within given professions (83, 84). The to find what is most effective and safe in order
results from a European Delphi study support to determine the best and most cost–effective
that “prior to implementation of polypharmacy measures for preventing avoidable hospital
management, the culture of an organization admissions. Initiated in 2015, this study
should be assessed for both strengths is ongoing until year 2020 (87, 88).
and potential barriers to implementation” (11).
As with change management and systems Polypharmacy in chronic diseases: Reduction
thinking, there are multiple tools and of Inappropriate Medication and Adverse drug
frameworks available to help decision-makers events in older populations by electronic
identify the characteristics of the organizational Decision Support (PRIMA-eDS), aims to provide
culture and to make appropriate modifications, physicians with the best evidence regarding
in parallel with a safety culture assessment (85). medication therapy for older patients with
multimorbidity through an electronic decision
Various studies have identified the necessity support tool. The electronic decision support
and benefits of multidisciplinary collaboration tool comprises of an indication check,
when addressing polypharmacy (10, 22). recommendations based on guidelines,
Policy-makers would need to consider systematic reviews, drug interaction database,
addressing the legislative and contractual renal dosing database, adverse effect
barriers that are in place if appropriate database and the European list of inappropriate
polypharmacy is to be applied across medications for older people (89). The
the health care system. Political commitment practicability and relevance of the tool
is required to ensure that dedicated resources was evaluated through a randomized clinical
are allocated to the development of new trial to test if discontinuing inappropriate
systems to address polypharmacy, but more medications could improve patient outcomes,
importantly to strengthen the existing health such as reduction of hospitalization or death;
care system. Political support is important and the patient data entry was found to be too
to promote multidisciplinary team work (11). time-consuming. Recent findings provide
For example, Medicines Optimisation Quality more insight in the future development of
Framework of Northern Ireland recommends the tool and the potential risk groups (90, 91).
medicines optimization (see Annex 1) activities
to be delivered by multidisciplinary teams (86). Stimulating Innovation Management of
Polypharmacy and Adherence in The Elderly
3.2 Programmes on appropriate (SIMPATHY) project intends to stimulate,
polypharmacy promote and support innovation across
the European Union in the management
To assist countries in understanding the of appropriate polypharmacy and medication
hurdles and benefits of investing in adherence in older patients (78). This project
programmes addressing polypharmacy, this aims to contribute to developing efficient and
report presents some programmes below. sustainable health care systems. Through
MEDICATION SAFETY IN POLYPHARMACY 21stakeholder engagement, studies were
undertaken in a range of different health care
environments, including European Innovation
Partnership on Active and Healthy Ageing
reference sites. The studies provide a
framework and politico-economic basis for
a European Union-wide benchmarking survey
of strategies being employed for polypharmacy
and non-adherence management. Innovative
multidisciplinary models were developed to
support patients with long-term conditions
using the professional expertise of pharmacists
and physicians to reduce inappropriate
polypharmacy and promote innovation in
health care workforce development (11).
A set of contextualized change management
approaches and tools was developed to help
politicians, regulators, health service providers,
and other stakeholders to advance current
practice by implementing organizational
change, thereby improving the management
of patients on polypharmacy (11, 80).
In addition to creating a European knowledge-
sharing network on polypharmacy and
adherence management, the targeted
dissemination of these validated findings may
support policy development, implementation
of strategic organizational development
and the exchange of best practices (11).
There is still room for improvement,
as polypharmacy management is currently
not widely addressed within most EU
countries (22). This programme has generated
information on which benchmarks can be
applied for regional and national progress
measurements, a definitive guidance on
the role of key stakeholders and guidelines
on how to initiate and manage the change
process (11).
22 MEDICATION SAFETY IN POLYPHARMACYHealth systems
approach to polypharmacy
4
Initiatives to address polypharmacy can be prescribed. This can be harmful to patients,
complex and require strong leadership and leads to ineffective therapies and waste of
management. Identifying a lead organization resources, generating an unnecessary burden
and allocating responsibility could facilitate for the patient as well as the whole society.
the implementation of polypharmacy Inappropriate polypharmacy is a common
management initiatives at the regional or example of irrational use of medicines.
national level. Organizational leadership To address the challenge at the system level,
is vital in driving change to achieve effective effective policies such as supportive incentive
polypharmacy management (11). The need structures, education and management,
to address polypharmacy is universal, but clear clinical guidance and appropriate
the challenge of leading change goes training are considered far-reaching (93).
to the heart of the policies and culture of
organizations, requiring the active involvement When deciding how to address polypharmacy,
of policy-makers, health care professionals any solution needs to achieve the
and managers, as well as patients, families aforementioned “quadruple aim”, so that
and caregivers (61). Often the window quality of prescribing and outcomes from
of opportunity to ensure that change is medication are improved whilst delivering
implemented is small, with three components an economically sustainable solution that
being crucial: problem recognition, generation will promote patient engagement across
of policy proposals, and a supportive political the health care system without compromising
environment, to create a momentum for the work life of health care professionals (35).
a change in public policy (92). Countries may In many countries polypharmacy management
wish to consider using existing infrastructure may not be widely addressed, which makes
such as pharmacovigilance centres it important to establish change management
(see Annex 1) and patient safety incident strategies to support implementation
reporting and learning systems (RLS) to collect at a national scale (22). An initial step would be
reports as well as to disseminate learning to undertake a benchmarking survey so that
from harm occurring from polypharmacy countries can assess their current status
and drug interactions (46, 49). with regard to polypharmacy. Business
operation tools such as PESTEL and SWOT
The irrational use of medicines is a global analysis have been used for polypharmacy
issue. A WHO report, The World Medicines programmes, and are helpful in identifying
Situation, estimated in 2004 that half of all barriers and issues that countries would need
medicines are inappropriately prescribed, to address in order to improve polypharmacy
dispensed or sold. Furthermore, half of all management (11).
patients fail to take their medicine as
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