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390
V. Tong et al.
organizations are key stakeholders when representing their profession, a key information
product is clinical practice guidelines which
would be relevant for their membership and
other HCPs working in collaboration.
2.3 Independent
Academic Institutions/
Research Groups/
Organizations
Research centers and drug information initiatives have been established with the primary
aim of providing information independent
from commercial and policy interests. An
important driver for such activities is the perceived risk of bias in information about drugs
and drug safety. Therefore, independent organizations employ editorial policies that emphasize transparency, rigorous peer review, and
requirement for declarations of potential conict of interests. The International Society of
Drug Bulletins is an international network of
such drug information initiatives that are independent of the pharmaceutical industry both
nancially and intellectually [6]. The
Therapeutics Initiative based at the University
of British Columbia is another example [7].
The primary information outlet is the
Therapeutics Letter, a bimonthly newsletter
that aims to provide physicians and pharmacists with up-to-date, evidence-based, practical
information on prescription drug therapy. The
publication process typically involves systematic literature reviews by different working
groups and peer review conducted by national
and international specialists.
A range of academic journals about drug
safety and pharmacovigilance are also available.
These include Drug Safety (Electronic ISSN
1179-1942), Pharmacoepidemiology and Drug
Safety (ISSN:1099-1557), Therapeutic Advances
in Drug Safety (ISSN: 2042-0994), and Expert
Opinion on Drug Safety (ISSN: 1744-764X).
They are all international peer-reviewed academic journals that publish review articles and
research articles on all aspects of drug treatment
safety issues, including clinical implications of
drug safety issues.
2.4 Commercial Organizations
HCPs also search and retrieve drug safety information from a range of for-prot sources.
WebMD.com and drugs.com are two US-based
examples. While the for-prot information
sources differ from not-for-prot sources in
important ways, the dividing line is not always
clear. For example, in Denmark, the online medical compendium, which is widely used by HCPs
and integrated in various ways in informational
platforms, is privately owned by the federation of
the Danish pharmaceutical companies and operates on a for-prot basis of fees from drug companies per drug. However, in order to reduce risk
of commercial bias, the articles in the compendium are authored by independent experts who
are compensated, reviewed by independent
reviewers, and overseen by an editorial board [8].
2.5 Patient Groups/Organizations
Patient groups or organizations exist to provide
appropriate and relevant information and
empower patients in their own healthcare journey
or the journey of those they care for. They may
also provide information about drug safety to
HCPs, in addition to information to patients.
Such information can emphasize patients’ perspectives in pharmaceutical care in ways that
other sources cannot. In general, however, while
some patient organizations have well-established
and longstanding relations with medical professions and other healthcare communities, it is
important to note that patient organizations may
receive various forms of funding from industry
[9]. HCPs should therefore consider the potential
biases of information in relation to the nancial
interests held by those who sponsor these
organizations.
Medical condition-specic organizations may
focus on specic conditions, the medicines used
to treat those conditions, and the subsequent ben-
17 Information Sources forDrug Safety andCommunicating Risks inPractice
391
ets and harms, e.g., Arthritis Australia and the
rheumatological drug fact sheets available [10].
Videos, interactive media, and other print
resourcesmay also be available. Other organizations offer a platform to facilitate patient-specic
information and engagement to improve drug
safety, for example, the former organization NPS
Medicinewise in Australia [11] and the National
Council on Patient Information (NCPIE)/
NeedyMeds and the BeMedWise program in the
United States [12].
The benets of information sources that have
been endorsed and published by patient organizations (or organizations with a patient-centered
arm) are that information would be more likely to
be t for purpose for the target audience and
worded using consumer-friendly language. The
transformation of more complex data into easy- tounderstand information that reect the interests of
the patient groups/patient organizations is benecial as these resources can then be used as patient
education and counseling tools to supplement spoken information provided in consultations.
2.6 Social Networking Sites
Online communities have been conceptualized
and are commonplace within social networking
sites, which contribute toward user-created
sources of information by both consumers and
HCPs. Social networking sites provide an important forum for users to exchange and mutually
learn from insights and experiences about medical conditions and subsequent treatment(s).
From a user perspective, side effects are a key
driver prompting online information searching
[13]. Interestingly, information derived from the
personal experiences of others when using medicines was valued and seen as less generic in
comparison to information provided by medicine sponsors [13]. Perceived advantages of
user- created content include the personal nature
of the information, with documented experiences from actual reported medicine users that
then resonate with potential medicine users,
which can in turn impact treatment decisionmaking and adherence [13].
Social media use among online communities
of fellow HCPs, medicine users, or parents/carers
of children or older persons who may also be living with similar medical conditions or have similar medication use provide opportunities to create
online conversation about experienced side
effects. This may be a data source for signal
detection, monitoring of side effects, and additional adverse drug reaction (ADR) reporting,
where individuals collectively create insight into
real-world drug safety data via discussing their
experiences [14]. However, with this opportunity
to leverage this type of data in drug safety monitoring initiatives alongside more “traditional”
ADRreporting avenues, variation in how online
discussions ensue needs to be considered [14].
3 Types ofInformation
onDrug Safety
Given the wealth of information sources, both
patient and HCP-centered, that provide information to end users, there are several different information types that are relevant to refer to and help
communicate risks in clinical practice. This section details some of the types of information
sources available to HCPs, depending on their
drug safety information needs.
3.1 Research Studies
Research informs the available evidence base for
drug safety. Clinical guidelines should be
evidence- based and rely on high-quality research
studies to inform them. Given the emergence of
new medicines and health technologies over time
and their implications on guidelines, keeping
abreast of empirical research such as high-quality
clinical trials in the clinical area(s) specic to
one’s clinical practice will help HCPs establish
an understanding of the specic evidence that
informs clinical guidelines and practice.
Drug safety evidence can be derived from
multiple research study types and available data
such as case reports, randomized clinical trials,
non-randomized studies such as cohort and case-
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V. Tong et al.
control studies, and meta-analysis of controlled
observational studies and/or trials [15]. The
resulting drug safety data are therefore inuenced
by the study design and how it was obtained [15].
One notable example is that the shorter duration
of clinical trials may mean that long-term drug
safety issues may not be detected [15].
Literature reviews collate and critique available evidence. They are designed to address specic research aim(s) and objective(s) and are
useful if wanting to access a summary of existing
drug safety evidence within certain parameters.
There are several review types that are commonly
seen in the context of healthcare, such as systematic reviews with or without meta-analyses, scoping reviews, rapid reviews/rapid evidence
assessments, and narrative reviews, to name a
few, each with their pros and cons [16]. Systematic
reviews are regarded as the gold standard of the
review types, seeking to answer a focused clinical question through the utilization of welldocumented, reproducible methods of literature
searching, appraisal, and reporting [16].
Database searches yield relevant peerreviewed research publications. Common databases that are available to use when searching the
literature include MEDLINE, Embase, PubMed,
CINAHL, and Cochrane Library, among others.
Other search platforms are also available such as
Scopus and Web of Science.
3.2 Product Information/
Summary ofProduct
Characteristics
As part of their market approval, drugs are also
accompanied by a comprehensive document that
describes the approved uses and characteristics of
the drug, for example, the Summary of Product
Characteristics (SPC; sometimes abbreviated as
SmPC, and also known as the Product Information
(PI) in Australia). In a review conducted on the
regulations for written medicine information
across Australia, the United States, and Europe,
regulatory similarities were seen between the
regions with respect to PI/SPC (and the package
insert, as it is known in the United States) [17].
The SPC is generally considered the denitive
source of drug information [17, 18]. This information is generally written for HCPs, where clinical trials data and adverse effects information
are included alongside other product-specic
information such as contraindications and precautions, directions for use,and product details
[17]. The incorporation of data derived from
research in PI/SPC emphasizes the important role
that research plays in informing these sources of
drug safety information.
3.3 Patient Information Leaets/
Consumer Medicines
Information
Alongside the PI or SPC, which are designed
with HCPs in mind, written medicine information leaets are produced for consumers to communicate medicine-specic information. The
content of these leaets is based on the respective
PI/SPC [17]. A core section included in this
information is that on adverse effects, where
known side effects for a medication are communicated together with an indication of the likelihood of experiencing the side effect(s) and/or
relevant action(s) to be taken by the patient, if
experienced. While in many countries, this information is produced by the medicine sponsor, in
the United States, for instance, depending on the
medicine and legislative requirements, some
information may be produced by the sponsor and
others by varying organizations/companies
which may lead to variation in content [17].
HCPs should be aware of these information
sources as they can be used to help communicate
benet and harm information to consumers/
patients in clinical practice.
3.4 Other Drug Information
Sources
3.4.1 Clinical Guidelines
Clinical guidelines summarize current medical
knowledge and provide evidence-based treatment recommendations for specic therapeutic
17 Information Sources forDrug Safety andCommunicating Risks inPractice
393
areas. They play an important role in assisting
clinicians in their healthcare decisions and synthesizing input from a range of different stakeholders in healthcare practices. While research
has shown that clinical guidelines are important
for drug safety, there is a lack of knowledge on
how postmarketing safety advisories are
integrated into clinical practice guidelines, and
particularly how quickly clinical guidelines are
updated to include new safety concerns [8].
Specically, detailed information on drug safety
may not be fully encapsulated in clinical guidelines, highlighting the role of other complementary drug information sources to gain a
comprehensive understanding of the individual
drug safety prole(s).
Clinical guidelines are available on a local
(institutional, e.g., hospital-based), national, and
international basis. Leading national organizations
may publish guidelines relevant to their remit, e.g.,
the National Heart Foundation of Australia and
guidelines on the management of cardiovascular
diseases [19]. Prominent guidelines that are wellknown internationally may be published by consortia or bodies such as The National Institute for
Health and Care Excellence (NICE) in the United
Kingdom. As detailed in “Developing NICE
guidelines: the manual—Process and methods
[PMG20],” a systematic review of the available
evidence is a critical component of the guideline
development process [20]. This reiterates that
research studies and rigorous literature reviews
form the evidence base on which evidence-based
clinical guidelines are formulated.
3.4.2 Drug Compendiums
In many countries, online drug compendiums
(also known as drug monographs or pharmacopoeia) source government-approved information
typically based on the SPC. However, information included in compendium monographs can
differ due to how quickly and frequently the
information is revised, and emergent safety concerns added in. Notwithstanding, due to their
ease of search and retrieval, medical compendia
are widely used by both HCPs and the public. For
example, the Electronic Medicines Compendium
(EMC) provides information about drugs licensed
for use in the United Kingdom [21]. EMC has
more than 14,000 documents on medicines
sourced from or approved by either the UK or
European government agencies that license drugs
[21]. Monthly Index of Medical Specialties
(MIMS) is a prominent source of medicines
information especially within the Asia-Pacic
region, offering medicines information references, as well as specialty resources and clinical
decision support [22].
3.4.3 Safety Advisories
Safety advisories are notications from regulators that inform HCPs, patients, and/or the public
about a potential or conrmed safety risk that is
inherent to a drug and not due to manufacturing
problems or improper use [23]. The identication
and conrmation of safety risk is based on regulatory surveillance and assessment of postmarketing data. A range of communication modalities
can be used to inform HCPs about newly identied safety risks in prescription drugs [2]. They
vary depending on how acute their message is
(e.g., acute risk or notication on ongoing drug
safety review), what their objective is (e.g., share
information, change beliefs, change behavior),
who the intended recipients are (e.g., various
groups of HCPs), and what the channel of communication is (e.g., hardcopy letter, website posting, newsletter article).
4 Quality andReliability
ofDrug Safety Information
As HCPs rely on up-to-date, clear, and evidencebased information for their decisions, it is important to assess the independence, usability, and
evidential strength of the information when
choosing which sources to rely on. When assessing the quality and reliability of information,
there are several factors that must be considered,
which would also be dependent on the type of
information source being evaluated. Overall,
information should be assessed for risk of bias,
currency, and reliability and trustworthiness.
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V. Tong et al.
4.1 Risk ofBias
In a clinical context, HCPs should continually
strive to source and utilize information of the
highest available quality. However, given the
sheer amount of information available via several
sources, as outlined earlier in the chapter, HCPs
need to be cognizant of the information they are
sourcing and utilizing to inform their practice.
Assessing the risk of bias for drug benet and
safety-related information (e.g., clinical trials)
and other relevant information to inform clinical
decision-making guidelines is an imperative step.
Established tools are available to assess the risk
of bias, which essentially helps the user determine the strengths and limitations of the research
that was conducted and reported, and potential
factors that can contribute toward interpretation
of study results [24]. For example, nonrandomized interventional studies can be assessed
for the risk of bias using tools such as the
ROBINS-I or SIGN checklist (case-control and
cohort studies) [24]. For randomized trials, the
Cochrane RoB 2.0 Tool or SIGN checklist for
randomized controlled trials can be used [24]. A
review conducted by Ma etal. in 2020 provides
an overview of the risk of bias assessment tools
that are available for use when examining medical research [25]. Risk of bias assessment is also
reiterated in guidelines developed to support
guidelines development [24]. Through understanding the risk of bias, conclusions based on
the available body of research can be contextualized within the parameters of the studies that
were conducted. This will facilitate a grounded
approach to evidence-based practice.
4.2 Currency ofInformation
safety proles may not lead to signicant uctuations of information over time. Novel medicines,
where postmarketing surveillance is helping to
inform understanding of risks that become clearer
once medicines are taken by a broader population, may see a substantial difference in data
when stratied by currency. A recent global
example would be the COVID-19 vaccine rollout and the ensuing changes to COVID-19 vaccination guidelines due to the emergent adverse
effects and safety prole aspects—one notable
example was observed with the AstraZeneca
COVID-19 vaccine and age-related guidelines
for use [26].
When retrieving drug safety information from
the available literature, it is important to
consider:
• When the research was conducted, if referring
to empirical research papers
• When the systematic review or meta-analysis
was conducted and the years of published lit-
erature that was captured and critically
reviewed as part of the review; for instance,
consider whether known recent seminal
research has been captured
• Whether there have been any review updates
subsequently conducted since the initial
review to provide further information about
evolving safety information drawn from phar-
macovigilance efforts—search strategies may
be repeated in review updates, which may
contribute to slight differences in interpreta-
tion of all available data
• The currency of evidence utilized to inform
clinical guidelines in comparison to available
literature. Guidelines may not be updated as
quickly as evidence emerges; therefore, clini-
cal practice may rely on other update avenues
Currency of information is informed by the date
of availability of the risk information, when the
risk data were obtained or made available, e.g.,
when a clinical trial was conducted in which side
effects risk information was obtained, and when
the information was last reviewed and/or updated.
Currency of information for well-established,
longstanding medicines with largely unchanged
4.3 Reliability
andTrustworthiness
ofInformation
Reliability of information can refer to the level of
trust in the information source as well as its
“repeatability” or consistency of information
17 Information Sources forDrug Safety andCommunicating Risks inPractice
395
being delivered about the medicine. Mandatory
safety information that is required to be reported
by medicine sponsors helps to ensure reliable and
consistent safety information for a specic
medicinal product. Sourcing information directly
from the sponsor, regulator repository, or wellknown, trusted drug compendiums/pharmacopoeias will help to ensure that the correct
information about the product is being accessed.
For proprietary medicines that go off patent,
information provided by generic medicine manufacturers should largely be consistent with the
safety prole information reported for the proprietary product. Any further changes in the safety
prole between marketed products should be
detected via pharmacovigilance systems overseen by the relevant regulatory bodies. This can
possibly lead to updated information about the
medicine itself. In these instances, with multiple
medicines on the market with the same active
ingredient, the reliability of information available
on the safety prole is improved if appropriate
documentation, reporting, and monitoring systems are in place from a regulatory and reporting
perspective.
With respect to online resources, mechanisms
to help verify whether the drug safety-related
information is from a reputable source should be
checked. For example, looking to see whether the
website/online resource had been Health On the
Net (HON) code certied was one way. Health
On the Net “promotes transparent and reliable
health information online” [27]; however, HON
was discontinued in December 2022. Previously,
HONcode certication could also be sought for
social networking sites [28].
timely points during the treatment continuum.
Appropriately conveying benet and harm information to the user and engaging in discussions
between users and their treating HCP(s) can help
facilitate informed treatment decision-making.
5.1 How toFrame
theInformation: Loss (Harm)
vs. Gain (Benet)
Benets are intrinsically tied in with the medicine’s indication or purpose and the harms with
potential side effects that can be experienced.
Framing of information can therefore have an
important impact upon people’s perception and
understanding of harms and benets of a medicine. For example, side effects information is
typically conveyed using negative framing, i.e.,
the proportion of people who will experience the
side effect. However, there is also the possibility
of positively framing information, e.g., conveying the proportion of people who will not experience a particular side effect [29]. However, given
the nature of medicine sponsor drafted information about their products, there may be reluctance
to positively frame harm information or convey
benet information upfront as it may be perceived as promotional in nature. In many ways,
information that medicine users receive, such as
patient information leaets, convey long lists of
side effects information and less benet information. This may lead to incomplete understanding
of the benets for starting and adhering to the
medicine and altered perceived safety of medication use due to this “imbalance” of information
presented before them.
5 Information onRisk
ofHarms, andBenets: How
toFrame theInformation
While it is important to know the types of harms
and benets that can be experienced when using
a medicine, it is important for the user to understand the proportion of people that experience
these benets versus harms so that the benets of
treatment can be appropriately weighed up at
5.2 Qualiers Versus Numbers
Empirical research has shown that people’s judgments about health risks may not only be inuenced by their individual risk tolerance and how
well they understand the health risk but also by
the ways in which risk information is presented.
For example, researchers presented a sample of
individuals with two different statements about a
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V. Tong et al.
cancer mortality risk and asked them which they
considered to present the highest risk: A cancer
that kills 1286 out of 10,000 people, or a cancer
that kills 24.14 out of 100 people? The rst statement was judged as being a much higher risk
even though the risk described in the second is, in
fact, twice as high [30].
Generally, research has shown that for both
written and oral information, patients gain a more
accurate perception of risk if probabilistic information is relayed in numbers rather than words
[31]. But there are multiple ways to numerically
present risk information to patients. Therefore, it
is important that HCPs understand what the different formats of risk information express and
when to use them most appropriately [32].
With respect to the likelihood of experiencing
side effects for a medicine, in order to simplify
messaging, patients have been exposed to verbal
descriptors for risk information. These verbal
descriptors have been mapped to specic numerical ranges, which can then in turn be expressed as
either percentages or frequencies, as detailed in
an earlier version of the European Commission
guidelines for readability of medicine labels and
leaets [33]. Similarly, for example, the New
Zealand Medicines and Medical Devices Safety
Authority have published on their website the
numerical descriptors mapped to each of the verbal descriptors very common, common, uncommon, rare, and very rare [34]. A very common
side effect equates to 1in 10 (or 10%) of those
taking the medicine experiencing the side effect
in comparison to a very rare side effect being less
than 1in 10,000 medicine users likely to experience that particular side effect [34]. These numerical frequency ranges may or may not be
explicitly stated in the information received by
patients, which can lead to misunderstanding of
what the likelihood of a “common” side effect is.
Research studying verbal descriptors advocated
for use by the European Commission has shown
that people misunderstand verbal descriptors
used to communicate side effect risk in patient
information leaets [35]. A systematic review
demonstrated that verbal descriptors contribute
to risk overestimation in comparison to numerical descriptors [36]. The authors concluded that
numerical risk information would be preferred
for communication in consumer-oriented information where possible [36].
However, HCPs should be educating patients
on what verbal descriptors for side effect risk
mean to avoid misunderstanding. Furthermore, it
is imperative that HCPs communicate to their
patients the relevant action to be taken if side
effects are experienced—while it may be of interest to understand the population statistics,
patients need to understand the relative severity
of the side effects/adverse events if experienced
and what to do. Seeking medical attention in a
timely manner could affect prognosis.
5.3 Understanding Numerical
Drug Safety-Related Data
There are several ways in which drug safety data
derived from clinical studies can be communicated. When reading clinical research data,
alongside frequencies and percentages, drug
safety studies may also report other numerical
data measures. While not exhaustive, below are
some relevant numerical data examples that
HCPs should be able to understand within the
context of drug harm and benet.
5.3.1 Absolute andRelative Risk
Reduction
Absolute risk refers to the number of harmful
events (e.g., ADRs) that occur in a group, divided
by the number of people in that group. The reduction of risk in absolute terms (absolute risk reduction or risk difference)is the difference between
risk of a harmful event in a control group and the
risk of an event in a treatment group.
In contrast to absolute risk, relative risk is the
ratio of risks of the treatment group and control
group. The reduction of risk in relative terms
(relative risk reduction)is the difference in the
rate of events between the control and treatment
group. For example, if 20% of patients experience ADRs before exposure to risk minimization
measures and 15% of patients experience ADRs
after exposure to a risk minimization measure,
the relative risk would be 15%/20%=0.75. The
17 Information Sources forDrug Safety andCommunicating Risks inPractice
397
relative risk reduction of the risk minimization
measure is therefore 25%. But to HCPs and lay
audiences, the magnitude of risk may be difcult
to interpret in light of relative risk measures and
related odds ratio reporting from a clinical perspective [37]. HCP and lay audiences can also
falsely conclude that strong statistical associations
or statistical signicance imply high clinical
importance [38].
The potential problem with explaining risk in
absolute and relative terms is the risk of bias.
Health researchers such as Leung [39] have
argued for providing a baseline level of risk for
consideration as well as the relative risk reduction. For example, when referring to the data
published as part of an older prescriber update
released several years ago [40], patients using a
third-generation oral contraceptive should not
only be told that the risk of venous thromboembolism is about twice that of alternative contraceptives containing levonorgestrel, but also be
informed about the absolute risk for venous
thromboembolism for these contraceptives to
provide further context for interpretation; for
example, observed to be about 10 per 100,000
women/years for second-generation contraceptives compared to about 21 for third generation
[40]. Experimental evidence about effectiveness
and safety information about vaccines suggest
that the inclusion of baseline levels of risk is a
key factor in people’s perception of risk and that
it may lead to increased levels of perceived effectiveness of vaccination and intention to be vaccinated [41]. Communicating baseline level of risk
information to patients is useful to support understanding of u risk whether it is presented in
absolute or relative risk formats [41].
5.3.2 Odds Ratio
The odds ratio refers to the odds of an event
occurring versus the odds of it not occurring. In
the context of pharmacovigilance, the odds ratio
may be used to express the odds of an ADR
occurring. So, an odds ratio of 3 in this case
means that a patient taking a specic treatment is
three times more likely to experience an ADR
than the patient who takes a placebo treatment.
Odds ratios are typically used in case-control
studies where the relative risk cannot be estimated. It can also be used in retrospective and
cross-sectional studies with the aim of examining
associations rather than differences [42].
5.3.3 Number Needed toTreat
To communicate the benets of a therapeutic
intervention, HCPs often use the “number needed
to treat” (NNT) format. In practice, NNT
expresses “the number of patients you need to
treat to prevent one additional bad outcome
(death, stroke, etc.)” [43]. NNT is the inverse of
absolute risk reduction (ARR; see Sect. 5.3.1),
i.e. NNT=1/ARR. It provides quantitative basis
for making decisions about therapies that align
better with patient perspectives, and it is often
preferred by patients and clinicians because it is
more intuitively understandable than other formats [44]. However, this is not always the case.
In a study conducted by Hamrosi etal. [45], when
the benet information in the form of NNT was
included in revised information leaets, some
had difculty understanding the NNT data presented. Additionally, people were surprised that
more people did not benet from taking the medicine [45].
However, there are notable limitations to
NNT. It is more difcult to compare different
NNTs than formats that use natural frequencies
(e.g., benet per hundred patients) because NNTs
are expressed as fractions with different denominators. Moreover, NNT reects the number but
not the importance of events. As different outcomes of a treatment are reected in separate
NNT values, using the NNT format may lead to
emphasizing less important outcomes [44].
NNT can also be calculated for harmful
events: “number needed to treat for an additional
harmful outcome” (NNTH). It has been used to
describe harmful drug effects in randomized clinical trials [46] and in observational studies [47].
Researchers argue that NNTH is a more intuitively understandable measure of risk than the
odds ratio and that it contains more information
than the odds ratio alone. However, while the
NNTH has been deemed a useful risk measure in
clinical practice and regulatory evaluation, a consensus on how to calculate NNTH in clinical
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V. Tong et al.
practice outside the randomized controlled trial
remains to be achieved [48].
6 Summary andConclusions
There are a multitude of information sources that
are relevant to drug safety. Government and nongovernment sources play an important role in disseminating safety-related information in a timely
and appropriate manner to both HCPs and the
public. Several organizational and systemsrelated factors, such as research, pharmacovigilance, and postmarketing surveillance
communication efforts, support the development
and quality assurance of different types of information sources communicating harms and
benets information to end users. The information “pipeline”, where drug research and development proceeds to inform sources of information
provided by drug sponsors and eventual postmarketing surveillance, has implications for clinical
practice via information inclusion and application in drug compendiums and clinical guidelines. A multidisciplinary approach to the
development and availability of information
sources can therefore help provide a more complete drug safety picture for all. Importantly,
patient/consumer information needs should be
taken into consideration when developing and
communicating drug safety information.
HCPs should have a strong understanding of
drug safety information in order to engage in
evidence-based practice. The quality of drug
safety information can be assessed by considering the risk of bias, currency, and reliability and
trustworthiness of the information at hand. When
appraising drug safety-related information, risk
information can be conveyed verbally using
descriptors, and numerically in various ways,
such as through absolute risk, relative risk, and
NNT. Understanding and communicating this
risk to others also relies on interpreting and communicating adequate context such as the baseline
level of risk and addressing common misunderstandings that are identied.
7 Case Studies
7.1 Case Study 1
A patient of yours comes to see you at the community pharmacy in which you work, expressing
concern about media reports regarding the risk of
myocarditis and pericarditis after receiving the
COVID-19 vaccination. He is a 51-year-old male
with a history of coronary artery disease. He has
already had his rst dose and wants to know
whether it would be safe for him to receive the
second dose of the mRNA vaccine.
Before coming to see you, he checked the
Consumer Medicine Information (CMI) leaet
for Comirnaty™ COVID-19 vaccine, and from
what he could see, it did not contain the detailed
information he was seeking. He would like to
know more about the harms and benets and specically, to have a stronger understanding of the
risks involved. He tried to look up information on
the Internet but was not sure if he was understanding the “numbers” correctly.
1. Whatwould be the best approach to address
the patient’s concern?
Step 1: Familiarize yourself with the information cited by the patient
• It is important, as a rst step, to familiarize your-
self with the information available in the CMI
leaet that the patient is referring to, so that you
have a baseline of the information presented and
the gaps in safety information that need to be
addressed based on the patient’s enquiry.
• You check the latest CMI available for
Comirnaty™ Covid-19 Vaccine (prepared in
April 2022 for the Australian market), and it
lists myocarditis and pericarditis under the
heading and table “Other side effects (fre-
quency unknown)” [49]. This was sourced
from the Australian Therapeutic Goods
Regulation repository of PI and CMI prod-
ucts—the regulator for a particular country
may have a similar one for approved informa-
17 Information Sources forDrug Safety andCommunicating Risks inPractice
399
tion in their jurisdiction. Alternatively, a drug
compendium such as MIMS will also be
another suitable repository to source PI and
CMI within clinical practice settings.
• It should be noted that previous research has
shown that people are strongly against stating
that the frequency or likelihood of side effects
is unknown [29]—later on when thinking
about how you will communicate what you
have found to the patient, consider explaining
the reason why this is stated as such here.
• Upon a quick Internet search, you also nd
an older CMI version that was drafted in
January 2021 [50] which does not mention
myocarditis or pericarditis as known side
effects. This is one example where currency
of information must be considered when
evaluating drug safety information as well as
where it was sourced from, given the emergent safety data from postmarketing surveillance. If referring to an older document
version, this may lead to further misunderstanding and the patient being misinformed
based on outdated information. Some online
repositories may update their hosted information more frequently than others—it is
important that HCPs and patients/consumers
are aware of this.
Step 2: Refer to the PI and relevant clinical
guidelines for further information
• Now that you have an understanding of the
information that the patient has read, it is
important to consult the PI and source relevant
clinical guidelines that are relevant to the context in which you practice—in this case,
evidence- based vaccination guidelines and
recommendations will be useful to seek out as
it will be helpful to understand the prevalence
of observed myocarditis and pericarditis, the
implications on vaccine recommendations,
and diagnosis and management pathways
where applicable.
• For example, if you were practicing in the
Australian context, you identify a clinical
guidance document entitled “Guidance on
myocarditis and pericarditis after mRNA
COVID-19 vaccines” which was rst published in July 2021 and updated in April 2022
[51]—this is a government publication that
has been developed and endorsed by reputable
groups, which provide reassurance on the currency and quality of drug safety information
provided specically around myocarditis and
pericarditis.
• When accessing the Comirnaty® PI [52], you
nd that myocarditis and pericarditis are
reported adverse effects from postmarketing
surveillance, with cases reported as very rare.
There is a cross-reference to refer to further
information found in clinical guidelines published by the Australian Technical Advisory
Group on Immunisation (ATAGI)—this triangulation of information and relevant references is also a point of assurance that you
have sourced the appropriate information
source and guidance.
Step 3: Identify and source further informa-
tion if required, e.g., from published research
studies or other empirical data
• While clinical guidelines provide an evidencebased summary, if you would like further
details, refer to the literature that has been
cited in clinical guidelines where applicable—
published research may be cited and included
as part of the references.
• Conduct a literature search for additional
research, such as reviews and highly cited
quality research published in high-impact,
reputable, international, peer-reviewed journals. They may help provide further insight
into real-world data research and statistics on
the observed rates of myocarditis/pericarditis.
Some papers that you may come across may
include:
– Risks of myocarditis, pericarditis and car-
diac arrhythmias associated with
COVID- 19 vaccination or SARS-CoV-2
infection [53]
– Myocarditis with COVID-19 mRNA vac-
cines [54]
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