evidence & practice / CPD / medicines management

ADVERSE DRUG REACTIONS

Adverse drug reactions: classification,

susceptibility and reporting
NS856 Kaufman G (2016) Adverse drug reactions: classification, susceptibility and reporting. Nursing Standard. 30, 50, 53-61.
Date of submission: 8 July 2015; Date of acceptance: 23 December 2015. doi: 10.7748/ns.2016.e10214

Gerri Kaufman Abstract

Senior lecturer in adult Adverse drug reactions (ADRs) are increasingly common and are a significant cause of morbidity
nursing and lead for and mortality. Historically, ADRs have been classified as type A or type B. Type A reactions are
specialist skills post- predictable from the known pharmacology of a drug and are associated with high morbidity
registration development, and low mortality. Type B reactions are idiosyncratic, bizarre or novel responses that cannot be
Department of Health predicted from the known pharmacology of a drug and are associated with low morbidity and
Sciences, University of high mortality. Not all ADRs fit into type A and type B categories; therefore, additional categories
York, York, England have been developed. These include type C (continuing), type D (delayed use), and type E (end
of use) reactions. Susceptibility to ADRs is influenced by age, gender, disease states, pregnancy,
Correspondence ethnicity and polypharmacy. Drug safety is reliant on nurses and other healthcare professionals
gerri.kaufman@york.ac.uk being alert to the possibility of ADRs, working with patients to optimise medicine use and
exercising vigilance in the reporting of ADRs through the Yellow Card Scheme.
Conflict of interest
Keywords
None declared
adverse drug reactions, drug interactions, medicines management, patient safety,
Review polypharmacy, risk management, therapeutic index, Yellow Card Scheme
All articles are subject
to external double-blind
peer review and checked Aims and intended learning with patients to identify and prevent
for plagiarism using outcomes ADRs.
automated software This article discusses adverse drug
reactions (ADRs), which are a significant Introduction
Revalidation cause of morbidity and mortality. Nurses and other healthcare professionals
Prepare for revalidation: After reading this article and completing may inadvertently overlook the burden of
read this CPD article, the time out activities you should be treatment, including ADRs, when helping
answer the questionnaire able to: patients to cope with illness (Jordan 2008).
and write a reflective »» Describe the classification of ADRs. Any drug given to a patient can cause an
account: nursingstandard. »» Differentiate between type A and unintended harmful effect, which may be
com/revalidation type B reactions, and type C, D and E described as an ADR (Cossey 2010). ADRs
reactions. are increasingly common and estimated
Online »» Explain the terms ‘therapeutic index’ to occur in 10-20% of patients who are
For related articles visit and ‘drug interactions’. prescribed drugs (Cossey 2010).
the archive and search »» Identify patient groups at risk of ADRs. ADRs impose a burden on the NHS and
using the keywords »» Explain why ADRs may not be account for significant morbidity, mortality
detected before a drug becomes and cost (Pirmohamed et al 2004). A
To write a CPD article available on the market and is included study attempting to quantify this burden
please email gwen. in the British National Formulary found that ADRs account for one in 16
clarke@rcni.com. (BNF). hospital admissions and 4% of hospital
Guidelines on writing for »» Explain pharmacovigilance and the bed capacity (Pirmohamed et al 2004).
publication are available purpose of the Yellow Card Scheme. ADRs are estimated to occur in 10-20%
at: journals.rcni.com/r/ »» Outline the ways in which nurses and of hospital inpatients (Medicines and
author-guidelines other healthcare professionals can work Healthcare products Regulatory Agency

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evidence & practice / CPD / medicines management
(MHRA) 2015a), and more than 2% of
patients admitted to hospital with an ADR
died (Pirmohamed et al 2004).
In the primary care setting, up to 10%
of all GP consultations are related to
ADRs (Cossey 2010). Approximately
60-70% of serious ADRs are preventable
(Greener 2014), but often go unrecognised
(Cossey 2010). Patients who present with
an ADR are often seeking treatment of a
new symptom and do not realise that their
symptom may be linked to medicines they
are already taking (Stone 2010). Nurses
and other healthcare professionals may not
recognise that symptoms could be related
to medicines being taken and unwittingly
prescribe new medicines to counter the
adverse effects of other drugs. This is
known as ‘incremental prescribing’ or the
‘prescribing cascade’ (Duerden et al 2013).
Prompt recognition that the patient’s new
signs and symptoms may be drug related is
central to the appropriate management of
ADRs (Beard and Lee 2006). Therefore, it is
important that nurses and other healthcare
professionals are vigilant and consider ADRs
in the differential diagnosis of a wide range
of conditions (Beard and Lee 2006).
TIME OUT 1
Consider the meaning of the term ADR. Ask your
colleagues and other healthcare professionals you work
with how they would define the term. Are their definitions
of ADRs similar to yours? Write a brief summary to define
this term in your own words.
TABLE 1. Characteristics of type A and type B adverse drug
reactions
Characteristics Type A Type B
Pharmacologically predictable: Yes No
Related to dose: Yes Rarely
Mortality: Low High
Morbidity: High Low
Responsive to a reduction in dose: Yes No
Rechallenge: Yes, with caution No
(Beard and Lee 2006, Stone 2010)
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Adverse drug reactions
An ADR is ‘an unwanted or harmful reaction
experienced following the administration of a
drug or combination of drugs under normal
conditions of use, which is suspected to be
related to the drug’ (Greener 2014).
Classification of adverse drug reactions
The classification of ADRs can be complex,
but the classification of type A and type B
reactions has been widely used for decades
(Cox 2008, Greener 2014). Type A reactions
represent an exaggeration (augmentation) of
the pharmacological actions of a drug when
given at the recommended therapeutic dose
(Pirmohamed et al 1998, Greener 2014). By
contrast, type B reactions are idiosyncratic,
bizarre or novel responses that cannot be
predicted from the known pharmacology of
the drug (Pirmohamed et al 1998, Greener
2014). The main differences between type A
and type B reactions are shown in Table 1.
TIME OUT 2
Consider the definitions of type A and type B reactions.
How would you classify the following reactions?
»» Excessive bleeding with warfarin, which reduces the
clotting ability of blood.
»» Postural hypotension in a patient taking medicine for
hypertension.
Write brief notes on the meaning of the terms ‘therapeutic
index’ and ‘safety margin’ in relation to drugs.
Type A adverse drug reactions
Type A reactions are usually dose
dependent and predictable, and are often
recognised before a drug is marketed
(Beard and Lee 2006). Type A reactions
are readily reversible by reducing the drug
dose or withdrawing the drug. Many
commonly documented ADRs are type A
reactions (Cossey 2010). Type A reactions
can result from the primary pharmacology
of the drug, representing an exaggeration
of the drug’s therapeutic actions
(Pirmohamed et al 1998). For example, the
expected therapeutic action of warfarin is a
reduction in the ability of the blood to clot,
but excessive bleeding is an exaggeration
of that action (Scott and McGrath 2008).
Similarly, the expected therapeutic action
of antihypertensive drugs is to lower
other uses without permission.

blood pressure, but hypotension is an
exaggeration of the anticipated action.
Type A reactions may also be caused by
the secondary pharmacology of a drug,
representing a response that is different
from the drug’s therapeutic actions, but
that can be predicted from its known
pharmacology, that is, a known side effect.
The therapeutic action of inhaled salbutamol
in the management of respiratory disease is
relaxation of airway smooth muscle (Lymn
2010a). Salbutamol achieves its therapeutic
action by targeting beta-2 adrenergic
receptors in the smooth muscle. However,
salbutamol can also target similar receptors
located in the cardiac muscle, which can
cause tachycardia (Lymn 2010a). This
represents a secondary pharmacological
adverse effect, since it signifies a response
that is different from the drug’s therapeutic
action, but is predictable from the known
pharmacology of the drug (Pirmohamed
et al 1998).
Type A reactions are particularly
problematic when the drug has a narrow
therapeutic index (Greener 2014). The
therapeutic index describes the relationship
between a drug’s desired therapeutic effects
and its adverse effects; it is also referred
to as the drug’s margin of safety (Scott
and McGrath 2008). A drug with a low
therapeutic index has a narrow range of
safety between an effective dose and a toxic
dose, whereas a drug with a high therapeutic
index has a wide range of safety and fewer
toxic effects (Scott and McGrath 2008).
Most drugs used in clinical practice
have a high therapeutic index (Lymn
2010b). However, some drugs have a
very low therapeutic index, for example
tricyclic antidepressants, which can cause
serious cardiovascular ADRs and are fatal
in overdose (Greener 2014). Warfarin,
phenytoin and theophylline also have a low
therapeutic index (Lymn 2010b). Many other
factors can also affect the safety margin of a
drug, for example variations in how different
individuals metabolise a drug, underlying
disease, pregnancy and interactions with
food or other drugs (Greener 2014).
Type A reactions are more common
than type B reactions, and account for
approximately 95% of the ADRs that
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result in hospital admissions in the UK
(Pirmohamed et al 2004); they are associated
with high morbidity but low mortality
(Beard and Lee 2006). However, they can
be avoided with increased awareness and
vigilance, given their predictability.
Type B adverse drug reactions
Type B reactions are unrelated to the
known pharmacological actions of a drug
(Beard and Lee 2006) and account for
approximately 20% of all ADRs (Greener
2014). Type B reactions are less common
than type A reactions, but they are often
serious and associated with high mortality
(Pirmohamed et al 1998). Type B reactions
are often caused by immunological and
pharmacogenetic mechanisms (genetically
determined variability in response to drugs)
(Beard and Lee 2006). Immunological
reactions, such as anaphylaxis in response
to penicillin, are classed as type B reactions.
Other examples of type B reactions include
aplastic anaemia caused by chloramphenicol
and malignant hyperthermia in response to
anaesthetics (Beard and Lee 2006).
Additional categories of adverse drug
reactions
The type A and type B system of classifying
ADRs simplifies categorisation. However,
not all adverse reactions to medicines fit
into either category (Beard and Lee 2006).
Therefore, additional categories have been
developed to mitigate difficulties in using
the type A and type B classification system
(Aronson and Ferner 2003). The additional
categories include type C (chronic), type
D (delayed) and type E (end of use)
reactions. Characteristics of type C, D and
E reactions are shown in Table 2.
TABLE 2. Characteristics of type C, D and E adverse drug
reactions (ADRs)
Type Characteristics
C (continuing) Relatively chronic.
D (delayed) ADRs emerge after a person starts taking the drug.
E (end of use) ADRs occur when the person stops taking the drug.
(Adapted from Greener 2014)
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evidence & practice / CPD / medicines management
KEY POINT Type C reactions, or continuing
‘Interactions between reactions, persist for a relatively
drugs that have a low long period of time, for example
therapeutic index are osteonecrosis of the jaw with the use
of particular concern of bisphosphonates (Greener 2014,
because the potential MHRA 2015a). Type D, or delayed
for life-threatening drug reactions, appear sometime after the
toxicity is high (Fulton use of a medicine. The timing of type D
and Allen 2005)’ reactions can make them difficult to
detect. For example, lomustine, which is
used to treat certain cancers, can cause
leucopenia (a reduction in the number
of white blood cells) up to 6 weeks
after treatment starts (Greener 2014,
MHRA 2015a). Type E, or end of use,
reactions are linked to the withdrawal
of a medicine. For example, the
withdrawal symptoms associated with
the discontinuation of benzodiazepines
for the treatment of anxiety can be
prolonged and difficult. Adverse effects
can include insomnia, anxiety and
perceptual disturbances (MHRA 2015a).
These symptoms can be difficult to
distinguish from the underlying anxiety
disorder (Greener 2014).
TIME OUT 3
List the main differences between type A and type B
reactions. Explain the differences between type C, D and
E reactions. Access the following website to review the
classification of ADRs:
www.gov.uk/government/uploads/system/uploads/
attachment_data/file/403098/Guidance_on_adverse_
drug_reactions.pdf (MHRA 2015a).
Drug interactions
Drug interactions are also implicated
in ADRs. Drug interactions occur when
the effects of one drug are altered by the
presence of another drug, or a particular
food or drink (Stone 2010). Such changes
can affect the effectiveness of one, or
more, of the drugs involved. However,
the changes can also increase the
potential for drug toxicity and ADRs. For
example, if a statin such as simvastatin,
which is used to decrease blood lipid
concentrations, is administered with
an imidazole antifungal agent, such as
ketoconazole, the toxicity of the statin
is increased. This can increase the risk
of severe muscle damage, which is a rare
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but significant adverse effect of statins
(Joint Formulary Committee 2016).
Interactions between drugs that
have a low therapeutic index are of
particular concern because the potential
for life-threatening drug toxicity is high
(Fulton and Allen 2005). The risk of
drug interactions and the potential for
ADRs increases significantly the more
drugs the patient takes (Karalliedde et al
2016). The list of drug interactions in the
BNF (Joint Formulary Committee 2016)
is an important source of information
to determine which interactions are
clinically significant in patients prescribed
multiple therapies.
Drug development
Drug development is a complex process
that involves laboratory and animal
studies before progressing to testing
in clinical trials in humans (Greener
2014). By law, a medicine must be given
a marketing authorisation (product
licence) by a medicines regulator before
it reaches the market. The role of the
medicines regulator is to review all the
available evidence from research studies
and clinical trials and to decide whether
a marketing authorisation should be
awarded. The UK medicines regulator is
the MHRA.
Much of the information that
pharmaceutical companies present to
regulatory authorities relies on what is
known from phase three clinical trials,
designed to assess a drug’s relative
efficacy against an established treatment
or placebo in several thousand patients
(Greener 2010). However, clinical trials
designed to test drugs in humans often
contain a detailed list of inclusion and
exclusion criteria (Greener 2010). These
criteria aim to protect participants,
for example by excluding people with
specific diseases or those who are taking
other medicines that could increase the
risk of toxicity (Greener 2010). As a
result, people who are the most seriously
ill, and those that most need treatment,
are likely to be excluded from clinical
trials. Similarly, some clinical trials
specifically exclude older people; this
other uses without permission.

may reduce risk but older people are the
group most likely to take the majority
of medicines and are also increasingly
likely to be taking multiple medicines
(polypharmacy) (Greener 2010).
Rare adverse events may not be
identified, even though large numbers
of people are enrolled in clinical trials
(Greener 2010). In general, type B
reactions are identified only after the
drug reaches the market (Beard and Lee
2006, Greener 2014). An increasing
number of drugs undergo post-marketing
trials to establish their clinical
effectiveness and safety in clinical use.
These post-marketing trials overcome
the difficulties arising from the strict
inclusion and exclusion criteria in the
early phases of clinical testing (phase
one, two and three clinical trials) and
involve a larger patient population than
is practicable in earlier clinical trials
(Greener 2010, 2014).
Post-marketing studies of registered
drugs are important in providing
additional safety data. The types
and incidence of ADRs are usually
determined in this phase, which can lead
to the early withdrawal of a drug. For
example, the drug rosiglitazone, which
was used in the management of type 2
diabetes, was withdrawn by the MHRA
in 2010 after ongoing research into the
safety of the drug raised concerns about
an increased risk of cardiovascular
disease (MHRA 2010).
TIME OUT 4
Explain the difficulties associated with detecting ADRs
before a drug can be listed in the BNF and prescribed
for the general public. How would you identify a newly
licensed drug in the BNF?
Additional monitoring: the black
triangle
An inverted black triangle symbol in
the BNF (Joint Formulary Committee
2016) and the summary of product
characteristics (SPC) identifies newly
licensed medicines that require additional
monitoring (Greener 2014). The BNF
is a joint publication of the British
Medical Association and the Royal
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Pharmaceutical Society of Great Britain KEY POINT
that provides prescribers, pharmacists ‘Various criteria may affect
and other healthcare professionals with a person’s susceptibility
comprehensive, up-to-date information to ADRs. These include: age,
about the use of medicines. The SPC pregnancy, gender, disease
provides information about a drug based states, ethnicity
on research from clinical trials. SPCs and polypharmacy’
are used by healthcare professionals,
including doctors, nurses and pharmacists,
and explain how to use and prescribe a
medicine. SPCs can be accessed via the
Electronic Medicines Compendium (2016).
A black triangle symbol may also
indicate that the regulatory authorities
have given conditional approval for
the drug, subject to the pharmaceutical
company providing additional data, for
example, where further studies need to
be done to provide long-term data or to
investigate a rare side effect discovered
during clinical trials. Products usually
retain a black triangle for 5 years, but
regulators can extend the time frame
or reimpose the symbol if additional
monitoring is required (Greener 2014,
Joint Formulary Committee 2016).
Susceptibility to adverse drug
reactions
Various criteria may affect a person’s
susceptibility to ADRs. These include: age,
pregnancy, gender, disease states, ethnicity
and polypharmacy.
Age
The very old and the very young are
particularly susceptible to ADRs (Beard
and Lee 2006). In older people, age-
related changes may affect the way the
body handles drugs (pharmacokinetics)
but also how the body responds to
drugs (pharmacodynamics) (Beard and
Lee 2006). Medicines associated with
increased sensitivity in older people
include psychotropic (antipsychotic,
hypnotic and anxiolytic drugs), diuretic
and non-steroidal anti-inflammatory
drugs (NSAIDs) (Anathhanam et al 2012,
Davies and Nutall 2016, Joint Formulary
Committee 2016). Older people often
have comorbidities and may be taking
several drugs, which increases their risk of
experiencing ADRs (Beard and Lee 2006).
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evidence & practice / CPD / medicines management
KEY POINT ADRs can present in a vague, non-specific
‘Many drugs and herbal manner in older people, for example
remedies are not confusion, constipation, low blood
recommended during pressure and falls may suggest illness but
pregnancy (Jordan 2008), they can also suggest an ADR (Beard and
yet it is estimated that Lee 2006).
approximately 80% of All children, and neonates in particular,
pregnant women take are thought to be at high risk of ADRs,
between three and eight because they differ from adults in the
medicines, either prescribed way they handle and respond to drugs
or purchased over the (Beard and Lee 2006). There is limited
counter (McElhatton 2006)’ information about the safe use of drugs
in this age group, because children have
not been included routinely in clinical
trials. However, since 2007, regulatory
changes have placed greater emphasis
on ensuring that new medicines are
appropriately licensed for use in children
(European Medicines Agency 2015). It
is now mandatory for pharmaceutical
companies to submit a paediatric
investigation plan to the Paediatric
Committee at the European Medicines
Agency that outlines how the company
proposes to test a new medicine in
children as well as adults. If there is no
indication for use of the drug in children,
the company can apply for a waiver
of testing in this age group (European
Medicines Agency 2015).
Pregnancy
Pregnant women may also be at increased
risk of an ADR. Profound physiological
changes occur during pregnancy (Little
2006), including alterations in how the
body handles and responds to drugs.
Many drugs and herbal remedies are
not recommended during pregnancy
(Jordan 2008), yet it is estimated
that approximately 80% of pregnant
women take between three and eight
medicines, either prescribed or purchased
over the counter (McElhatton 2006).
Transgenerational, or second generation,
ADRs affect the fetus and the breastfed
baby. Thalidomide is probably the most
well-known example, but warfarin, anti-
epileptic drugs and lithium can also affect
the fetus (Jordan 2008). No drugs have
been tested in studies to detect adverse
effects in human pregnancy and lactation,
since such studies would be ethically
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unsound. Consequently, no drug has
been demonstrated as safe in pregnancy
(Jordan 2008).
Gender
In general, women are at greater risk
of ADRs than men. The reasons for
this are not entirely clear, but gender-
related factors, such as hormonal and
immunological factors, differences
in pharmacokinetics and patterns of
medicines use are contributory factors
(Beard and Lee 2006, Alder et al 2016).
Disease states
Specific disease states, such as
reduced renal functioning and liver
impairment, can predispose individuals
to ADRs (Alder et al 2016). Reduced
renal excretion of drugs can cause
accumulation of the drug in the body
and may therefore lead to toxicity. This
is particularly serious for individuals
taking drugs that have a low therapeutic
index (Alder et al 2016). Changes in liver
metabolism can also affect the risk of
ADRs. Some type B reactions occur more
frequently in patients with liver disease
(Alder et al 2016). Other disease states
that can predispose individuals to ADRs
include human immunodeficiency virus
and infectious mononucleosis (Beard and
Lee 2006).
Ethnicity
Ethnic differences can increase the risk
of ADRs in some individuals (Beard and
Lee 2006). For example, a deficiency
of the enzyme glucose-6-phosphate
dehydrogenase (G6PDH) is highly
prevalent in individuals originating from
many parts of Africa, Asia, Oceania
and Southern Europe (Alder et al
2016). G6PDH protects red blood cells
from damage caused by drugs such as
nitrofurantoin and quinolone antibiotics
that can cause haemolytic anaemia
(Alder et al 2016).
Polypharmacy
In simple terms, polypharmacy refers
to the prescribing of multiple medicines
to one person (Duerden et al 2013).
other uses without permission.

The incidence of ADRs increases
with the number of medicines taken.
Consequently, the most effective
intervention to minimise the risk of
ADRs is a reduction in the absolute
number of prescribed medicines
(Anathhanam et al 2012).
TIME OUT 5
Summarise the factors that increase susceptibility to
ADRs. Explain the meaning of the term pharmacovigilance
in your own words.
Pharmacovigilance and the
reporting of adverse drug reactions
Pharmacovigilance is the science of
collecting, monitoring, assessing and
evaluating reports from healthcare
professionals and patients on ADRs
(Alder et al 2016). Pharmacovigilance is
important because there is still much to
learn about ADRs, their risk factors and
epidemiology (Greener 2014).
The Yellow Card Scheme, the system
in the UK for reporting adverse incidents
with medicines, is a rich source of data
about ADRs that brings new information
to light (Greener 2014). The scheme was
started in 1964 after the thalidomide
incident (Cox 2008) and involves the
completion of a freepost Yellow Card,
available in the back of the BNF (Joint
Formulary Committee 2016) or online
(www.gov.uk/guidance/the-yellow-
card-scheme-guidance-for-healthcare-
professionals), by healthcare professionals
and patients, which enables information
about the suspected ADR to be recorded.
The information is then collated by the
MHRA, who can then publish warnings
and advice for healthcare professionals
about certain types of ADRs and how to
minimise them (Cossey 2010).
For new drugs and vaccines identified
by a black triangle in the BNF (Joint
Formulary Committee 2016) and under
intensive surveillance, all suspected ADRs
should be reported regardless of how
minor they seem. For established drugs
and vaccines, suspected serious reactions
should be reported even if the effect is
well recognised (MHRA 2015b). Serious
reactions include deadly, life-threatening
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or medically significant reactions such KEY POINT
as bleeding or congenital birth defects ‘The incidence of ADRs
(Cox 2008). It is important to note that increases with the number
causality does not have to be proven to of medicines taken.
report a suspected ADR, only suspicion Consequently, the most
(MHRA 2015b). effective intervention to
The Yellow Card Scheme is currently minimise the risk of ADRs is
underused (Cox 2008, Greener 2014), a reduction in the absolute
therefore reporting of ADRs by patients number of prescribed
and healthcare professionals should medicines (Anathhanam
be encouraged to help patients gain et al 2012)’
the maximum benefit from medicines
and reduce the associated harm. The
continued success of the Yellow Card
Scheme depends on the willingness of
people to report suspected ADRs (Cossey
2010).
TIME OUT 6
»» Refer to the following website and review the
information that should be included on a Yellow Card:
www.gov.uk/government/uploads/system/uploads/
attachment_data/file/396801/What_to_include_in_
your_Yellow_Card_of_an_adverse_drug_reaction.
pdf (MHRA 2015c).
»» Refer to the following website to read about specific
areas of interest for ADR reporting:
www.gov.uk/government/uploads/system/uploads/
attachment_data/file/403078/Specific_areas_of_
interest_for_adverse_drug_reaction_reporting.pdf
(MHRA 2015d).
»» Reflect on how nurses and other healthcare
professionals can be constantly vigilant in preventing
or identifying ADRs.
Remaining vigilant for adverse
drug reactions
Ensuring that medicines are used safely
is fundamental to the role of nurses and
other healthcare professionals. Prescribed
medicines have many advantages, but they
are also associated with adverse effects that
are ‘a nursing concern’ (Jordan 2008). It is
important that nurses and other healthcare
professionals are knowledgeable and aware
of ADRs, and always consider whether any
new symptoms a patient is experiencing
could indicate an ADR (Beard and Lee
2006). Being vigilant for ADRs requires an
awareness of all the medicines a patient is
taking, including prescribed medicines, any
over-the-counter medicines, and herbal and
homeopathic remedies (Beard and Lee 2006).
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evidence & practice / CPD / medicines management
KEY POINT Asking patients about herbal remedies
‘Patients need clear is important, since some herbal treatments
information about their can cause potentially serious ADRs. Some
medicines, how to take people believe that because herbs are
them, what side effects they ‘natural’ they are safer than conventional
might experience when medicines (Greener 2014). St John’s Wort
taking them and what to do is an effective herbal remedy for the
if they experience a harmful treatment of depression. However, it can
effect (Alder et al 2016)’ interact with a wide range of conventional
medicines, for example anticoagulant,
anticonvulsant, antiretroviral,
antidepressant, immunosuppressant,
antimicrobial and hypoglycaemic drugs, as
well as oral contraceptives (Greener 2014).
It is important to know whether patients
have a history of idiosyncratic reactions
or drug allergy so that the use of drugs
known to cause problems can be avoided.
It is also essential to be aware of at risk
patient groups, in particular older people,
children, patients with renal or liver
impairment, and pregnant women. Nurses
and other healthcare professionals should
consult appropriate sources of information
about medicines, such as the BNF (Joint
Formulary Committee 2016) or SPCs,
before prescribing or administering any
medicines that they are not thoroughly
familiar with.
Patients who are taking drugs known
to cause predictable dose-related adverse
effects should be carefully monitored
(Beard and Lee 2006). For example,
established medicines such as diuretic,
NSAIDs, anticoagulant and antiplatelet
drugs are responsible for a significant
burden of drug-induced morbidity and
mortality (Pirmohamed et al 2004,
Howard et al 2007). The risk of some
ADRs can be mitigated or eliminated
by avoiding the use of such drugs
(Cox 2008) or by ensuring that suitable
precautions are taken; for example,
in the case of a reaction to NSAIDs,
an alternative analgesia can be
prescribed or the lowest dose possible
prescribed for the shortest time necessary
(Howard et al 2007). For patients
for whom the drug is essential, the
appropriate use of concomitant treatment
to protect against ADRs might be
needed, such as co-prescribing a proton
pump inhibitor with NSAIDs to prevent
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gastrointestinal bleeding (Cox 2008).
It is especially important to be alert
for ADRs or unexpected events with
new medicines (Beard and Lee 2006).
It is essential to ensure that any specific
monitoring requirements, such as
biochemical testing such as liver function
tests, international normalised ratio
and blood counts, are carried out on
a regular basis (Beard and Lee 2006).
Nurses and other healthcare professionals
have an important role in medicines
optimisation, helping patients to improve
their quality of life and outcomes from
medicines use (Royal Pharmaceutical
Society 2013). Patients need clear
information about their medicines, how
to take them, what side effects they might
experience when taking them and what
to do if they experience a harmful effect
(Alder et al 2016).
Many patients are reluctant to disclose
information about ADRs, therefore
nurses and other healthcare professionals
need to look out for and specifically ask
about adverse effects when prescribing
or administering medicines (Greener
2014). Asking patients about their
experience of medicines use and listening
to any concerns they have is important
in revealing perceived and actual harms
to ensure appropriate interventions. The
notion of a drug as a ‘magic bullet’ that
targets disease and leaves the rest of the
body unscathed is as elusive today as it
was when the idea was first proposed by
the German chemist Paul Ehrlich almost
one century ago (Greener 2014). Drug
safety is reliant on nurses and other
healthcare professionals being alert to
the possibility of ADRs and vigilant in
their reporting (Cox 2008).
Conclusion
Nurses and other healthcare
professionals have a central role in
ensuring that medicines are used safely.
This requires knowledge and awareness
of common ADRs that cause morbidity
and mortality. There is still much to learn
about ADRs. It is essential that nurses
and other healthcare professionals work
with patients to optimise their medicines
other uses without permission.

use, are alert to the possibility of ADRs,
and report suspected reactions using
the Yellow Card Scheme to identify and
reduce harm from medicines.
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