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11 Communicating Drug Safety
255
Sender
Message
(content)
Receiver 1
Media 1
Receiver 2
Pre-communication
behaviour
Media 2
Post-communication
behaviour
Pre-communication
Media 3
behaviour
Post-communication
behaviour
Fig. 11.1 Map of the communication model. This
gure presents an example of a risk communication map.
In the general owchart, the roles and paths of communication are identied and dened. In the specic example,
the regulatory agency (sender) communicates the risks of
a possible interaction between drug A and drug B (message). The receivers are healthcare professionals and
patients. Communication takes place through two distinct
media: a general one (radio and TV) that reaches all recip-
Health authority
Drug A and Drug
B can interact to
Radio and TV
cause adverse
event
Healthcare professionals
Patients
Drug A and Drug B co-
prescribed
Dear doctor letterVerbal communication
Drug A and Drug B are
not co-prescribed
Drug A and Drug B are
taken together
Drug A and Drug B are
not taken together
ients, and a specic one, dear doctor letter, for healthcare
professionals. The languages of the two messages can be
the same or tailored for the recipient. In this case, recipient 1 (healthcare professionals) acts as an amplier and in
turn becomes a sender toward the patient through verbal
communication during the visit. The measurable outcome
of the communication process is the change in the behavior of both types of recipients
other health professionals (departmental teams,
professional organizations, scientic societies,
and scientic board); (3) the inter-group (or interorganization) level: refers to communications
system into the social sphere. Levels and spheres
essentially describe the dimensions of communicative events and are interrelated in particular for
public communication events [6].
between groups such as pharmaceutical industry,
regulatory authorities, patient organizations; (4)
mass level: messages are publicly disseminated
using universally accessible means of communication (social media threads, newspapers, scientic journals, newsletters, and bulletins) [13].
Referring to socio-ecological models, com-
different audiences, taking into account the characteristics of these audiences in the development
of a communication strategy is the key element for
achieving an effective communication [15]. Some
of the key considerations for communicating drug
safety information to different audiences are:
munication can also be classied into three different spheres of relevance: the private sphere,
the community sphere, and the social sphere [14].
The communicative interaction can take place in
several spheres simultaneously and at different
levels. For example, communication between
doctor and patient may occur on an interpersonal
level in the private sphere, but some information
may be shared with other caregivers of the medical department in the community sphere and furthermore interpersonal communication
contributes to (and is inuenced by) both general
culture and from the infrastructure of the health
Since drug safety communication may have
– The purpose and goals of the communication:
What are the main messages and actions that
you want to convey and achieve with your
communication? How do they align with the
needs and expectations of your audience?
– The characteristics and preferences of the
audience: Who are they? What are their back-
grounds, knowledge levels, attitudes, beliefs,
values, and motivations regarding drug safety?
How do they prefer to receive and process
information? What are their barriers and facil-
itators in understanding and acting on your
256
M. Tuccori et al.
communication? Barriers to communication
should be carefully considered. Barriers could
be (a) emotional barriers, which refer to the
feelings and emotions that can affect the way
people communicate and interpret messages.
For example, fear, anxiety, distrust, anger, or
resentment can hinder effective communication; (b) language barriers, which refer to the
differences in language, dialect, accent, or terminology that can make it difcult for people
to understand each other. For example, the use
of unfamiliar, technical, or ambiguous words
can create confusion or misunderstandings.
Numbers may also represent an element of disturbance in communication and replacing
them with easily understandable graphic can
be a successful choice; (c) physical barriers,
which refer to the material or environmental
obstacles that can interfere with the transmission or reception of messages. For example,
background noise, geographical distances,
closed doors, or faulty equipment can reduce
the quality or accessibility of communication;
(d) cultural barriers, which refer to the differences in values, beliefs, norms, or habits that
can inuence the way people communicate
and perceive messages. For example, different
expectations, preferences, or conventions
regarding verbal and non-verbal language can
cause misunderstandings or conicts; (e) attitudinal barriers, which refer to the biases, stereotypes, or discriminations that can affect the
way people communicate and relate to others.
For example, arrogance, presumption, resistance to change, or lack of respect can hinder
open and constructive communication.
– The content and format of the communica-
tion: What are the most relevant and credible
sources of information for your audience?
How can you present the information in a
clear, accurate, balanced, and engaging way?
How can you use language, visuals, stories,
examples, and other elements to enhance your
communication? How can you tailor your
communication to suit different audiences or
contexts?
– The channels and methods of communication:
What are the most effective and appropriate
ways to reach and interact with your audi-
ence? How can you use different media, plat-
forms, tools, and strategies to deliver your
communication? How can you ensure acces-
sibility, timeliness, consistency, and feedback
for your communication?
– The evaluation and improvement of the com-
munication: How can you measure the out-
comes and impacts of your communication?
How can you collect and use feedback from
your audience and other stakeholders to
improve your communication? How can you
monitor and address any emerging issues or
challenges related to your communication?
5 Drug Safety Communication
Research
5.1 Study Design
A risk communication event usually can trigger a
risk modication (worsening or improvement)
through certain “changes” that are expected to be
implemented by the receivers. A communication
can therefore be more or less effective in generating this risk modication, and it is appropriate to
identify indicators (outcomes) to be able to measure it. When the risk communication strategy is
intended with the aim of obtaining a risk mitigation, and the effectiveness of the same is not
observed to be that expected, the entire communication process can be studied to identify its
weaknesses and introduce improvements.
The evaluation of the effectiveness of a risk
communication has traditionally been carried out
through surveys and expert assessments [16], but
the trend in recent years is to rely on more robust
and reliable analytical studies. These studies can
measure risk outcomes before and after the introduction of the communication itself by integrating
different data sources and are able to consider and
subsequently control different variables simultaneously [6]. To improve the reliability of the
results, it is recommended that research protocols
to study the impact of drug risk communication be
designed using a multidisciplinary approach,
involving the contribution of pharmacoepidemiologists and experts in social sciences, rhetoric,
media, and cognitive and behavioral sciences [17].
11 Communicating Drug Safety
257
Systematic reviews, which outline the state of
the art evidence from interventional (e.g., randomized clinical trials) and observational studies
(e.g., cohort, case–control, and case series
designs) [18], show that the available studies to
assess the impact of risk communication of
medicinal products have been conducted taking
into account a single perspective, often that of the
health system or the regulatory one. This is far
enough from an integrated view of the disciplines, which should include, for example, the
behavior of the population among the outcomes,
to give a comprehensive view of the impact of a
risk communication intervention [6, 19].
5.2 Outcome Assessment
To assess risk communication and design- specic
studies, the denition of outcomes of interest is
essential. These outcomes can be classied as
intended or unintended. The rst categoryconcerns
outcomes that try to interpret the effect of predetermined communication events that have the purpose
of avoiding or realizing the object of the communication. The second includes general positive and
negative outcomes regardless of any communication objectives [6]. An example of unintended neg-
ative outcomes could be the situation in which
following a certain communication, the patient
decides to voluntarily discontinue the drugs they
are taking without medical support. In this case, the
outcome of interest could be the percentage of subjects who stop treatment in the population in a
dened period following the date of the communication of interest. An unintended positive outcome
is characterized by positive behavior achieved by
patients as a result of communication. This positive
attitude, deriving from the communication related
to a specic drug, affects the awareness of the management of all the drugs taken by the patient [20].
In light of the above, the rst outcome of the communication that should be measured corresponds to
the purpose of the communication itself, and that is
the behavior and not the impact on health. The latter is in fact the result of the change in behavior
stimulated by communication. Actually, the ow of
information and the associated effects give light to
a labyrinthine environment, whereby communication can lead to several concomitant and interconnected outcomes, which inevitably change over
time and within different groups of the population.
Table 11.1 proposes a classication of the outcomes that could allow the overcoming of heterogeneities and obtain comparable results from a
multidisciplinary standpoint [6].
Table 11.1 Examples of outcomes to assess risk communication effectiveness [6]
Type of
outcome Study question Outcome (Endpoints)
Exposure to
message
Debate Was the communication
Risk
knowledge
Attitude Did the communication affect
How many subjects did the
communication touch?
interesting for the target
audience?
What is the level of knowledge
in the target audience about
therisk object?
the behavior of the target
audience?
Amount of person receiving the message (number of message
receipt received)
Amount of person receiving a video communication (number of
visualizations or number of people connected to a direct broadcast
on social media)
Volume of debate on social media (number of people sharing
message in social media, number of comments, and number of
emoticons)
Volume of debate on journals (number of articles, volumes of
articles, and page in which the information is given)
Volume of debate on TV (number of TV shows or TV news which
dedicates time for the message)
Knowledge about risk using questionnaires and survey (number
and percentage of people aware about the risk, number and
percentage of people aware of the correct behavior to avoid the
risk)
Behavior following communication (number andpercentage of
target audiencefollowing recommendations andtrends in
dataow)
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M. Tuccori et al.
5.3 Investigating Social Media
Over the past two decades, communication via
the internet and social media has increased signicantly. According to the latest “Digital 2022”
report from the “We Are Social” agency, global
internet users rose to 4.95 billion at the beginning
of 2022, to include more than 4.6 billion social
media users, 58.4% of the world population [21].
Billions of people interacting with the internet
can therefore generate traces of important information that can be aggregated and analyzed for
research purposes. While most of this research
was conducted for marketing purposes, social
media can be an interesting source of information
for health research as well. The communication
of the risk of medicinal products also uses the
social media channel extensively. In particular, a
great deal of daily social media discussions is
about health and disease information, as well as
biomedical and medical products that address
these conditions (medicines, devices, vitamins,
supplements, etc.) [22]. Many of these healthrelated discussions are patient-generated and
include a large body of free-text narratives that
can be leveraged for health-specic research
[22]. A specic line of pharmacovigilance
research was born and developed to conduct signal detection research using these data, developing a specic methodology. These studies can be
very interesting for measuring the perception of
the risk of medicinal products in the population,
the response of the population to certain communication stimuli, and also for building communication strategies that are based on the needs of the
population itself. In particular, for example, the
exchange of information between users of a
patient community can be studied to understand
their feelings in relation to the therapies they use
(enthusiasm for efcacy, complaints about
adverse events) and develop a communication
that helps them to better manage the therapies
according to their need [6, 23].
Social media is a privileged observatory for
exploring the use of drugs in the real world. They
can help identify safety problemsand risk factors
and can offer additional information not typically
captured by existing reporting systems, such as
benets, misuse, or lack of effectiveness.
Furthermore, online discussions among patients
about medicines often extend to broader aspects
of use, such as off-label use (i.e., use not in accordance with the terms of the marketing authorization), as well as problems with product quality,
formulation, handling, disposal, sensitive or stigmatized topics (e.g., events involving the sexual
sphere), and reluctance to adhere to treatment
due to bothersome adverse reactions experienced
by the patient [6, 24–26]. A very interesting
approach to measure the risk communication
response of medicinal products could be sentiment analysis, a semantic technique that evaluates in posts shared by the community the
combination of words that express positive, negative, or neutral feelings in combination with the
medicinal products subject of the communication
itself [6, 24–26]. Of course, there is still a long
way to go, but undoubtedly the potential offered
by these approaches in the eld of risk communication for medicinal products is enormous.
6 Building aMedicinal Product
Risk Communication
Strategy: AMultidisciplinary
Approach
Building an effective risk communication strategy
for medicinal products can require the contribution of different expertise. Similarly, a communicative event can be analyzed from different
perspectives. In the next paragraphs, we will
briey analyze the main disciplines that can play a
key role in the construction and analysis of a risk
communication strategy for medicinal products.
6.1 Rhetoric
Rhetoric is the art and science of persuading and
inuencing others through language. Rhetoric
can impact the communication of safety of
medicinal products in different ways, both positive and negative. For this reason, it is important
to analyze the language used in different sources
and situations of communication of safety of
11 Communicating Drug Safety
259
medicinal products, to evaluate its quality, credibility, and effectiveness.
Rhetorical analysis is the study of the ways in
which language is used to persuade and inuence
others. In the context of communication of safety
of medicinal products, rhetorical analysis can serve
to evaluate the quality and credibility of the sources
of information on medicinal products, verifying
their competence, reliability, and impartiality. This
helpsto identify the arguments and evidence used
to support the claims on the benets and risks of
medicinal products, verifying their validity, consistency, and relevance; to recognize the emotional
appeals and persuasive techniques used to inuence the attitudes and behaviors of the users of
medicinal products, verifying their appropriateness, ethics, and transparency; and to compare and
contrast the different perspectives and positions of
the stakeholders involved in the communication of
safety of medicinal products, verifying their representativeness, balance, and dialogue.
Some practical examples of rhetorical analysis in the communication of safety of medicinal
products are analyzing the language used in the
leaets of medicinal products, to verify if it is
clear, understandable, and suitable for the public
to whom it is addressed; analyzing the language
used in the information campaigns on medicinal
products, to verify if it is informative, educational, and motivational; analyzing the language
used in the reports of adverse events by patients
and health professionals, to verify if it is accurate, complete, and timely [27, 28].
6.2 Pharmacoepidemiology
Risk communication nds its backbone in pharmacoepidemiology, the science that evaluates the
utilization of drugs in the populations and the
related health determinants and outcomes [29–
31]. Pharmacoepidemiology overcomes several
limitations of clinical trials and provides a picture
of the real world of drug usage [32]. By applying
elaborated methods to control biases and confounding, the aim of pharmacoepidemiology is to
provide robust evidence of the causal association
between drug exposure and outcomes, featured
by the balance of statistics, clinical, and pharmacology elds [33, 34]. The communication of the
risks and the safe use of drugs based on pharmacoepidemiologic ndings is a tricky process since
this has to answer to the need to communicate to
the public the health hazards found in the studies,
switching from scientic to divulgation language,
and share decisions made by stakeholders accordingly. Several variables have to be taken into
account in communicating the ndings of a pharmacoepidemiology study, such as the quality, the
accuracy, and the robustness of the study performed, as well as the clinical and health implications. These variables are classied as dependent
variables of the risk communication. Examples
of independent variables are instead the intervention on drug usage and prescription, the patients’
adherence or the spontaneous adverse drug reaction reporting, and the spread of information
through the different media [35–39]. Guidelines
on transparency, funding, and conicts of interest
for disseminating pharmacoepidemiologic evidence have been outlined by the European
Network of Centres for Pharmacoepidemiology
and Pharmacovigilance (ENCePP) [32], and
adherence to these guidelines can be helpful to
achieve a good quality management of risk communication processes.
In a broad cyclic vision, pharmacoepidemiology
research and risk communication on medicinal
products are intimately connected [6]. Indeed, the
goal of good risk communication on medicinal
products, a whole meal of the risk minimization
measures, is the reduction of the exposure of patients
to specic risks related to medicine intakes and consequently of the related adverse reactions [40, 41].
Thereby the risk communication itself is a determinant of the exposure to drugs [42].
6.3 Cognitive andBehavioral
Sciences
In the construction and study of drug-related risk
communication, an important contribution comes
from the cognitive and behavioral sciences.
The cognitive sciences have shown the importance of the distinction between real risk and how
260
M. Tuccori et al.
it is perceived, and how in reality it is the latter
that has a decisive impact on people’s behavior.
While cognitive sciences explore which factors inuence risk perception, behavioral sciences have developed numerous theories on how
risk perception can affect behavior. The purpose
of these models is to predict people’s behavior
and the factors that determine it. The common
thread of these models is the importance of the
subjective perception of danger and efcacy or
the perception of one’s ability to implement a
protective action.
In building an effective communication of
the risk of a medicinal product with the patient,
the objective must be to put them in a position
to make decisions and adopt behaviors with
respect to that drug that do not involve avoidable risks for their health. In this sense, it can
be important to know the heuristics, or mental
paths, often called “shortcuts,” which allow you
to make decisions in uncertain situations or that
cannot be fully understood. The decision you
make is not necessarily the right one, but it is
certainly satisfactory enough. Usually these
paths are guided by the experience of everyday
life and by the observation of what happens to
the people close to us. Let us discuss some
examples.
In the heuristic of representativeness, one
tends to consider a valid sample of experiences as
the representativeness of one’s own knowledge,
leaving out fundamental details for fully understanding a problem. For example, a patient may
be reluctant to take a drug because the neighbor
who took it had a stroke. In this case, the patient
neglects various elements necessary to reach an
informed decision such as, for example, the number of subjects who take that drug without problems or the fact that the neighbor had important
risk factors for stroke. In this case, the doctor
must provide the patient with the missing information in a very simple way in order to obtain
greater compliance.
In the availability heuristic, the patient tends
to attribute frequency to an event on the basis of
how often he receives information about that
event and the emotional impact of the informa-
tion provided. For example, a patient may not
want to be vaccinated because the media have
very often reported in the last week that the vaccine caused a fatal case of thrombosis in a
40-year-old patient, father of two children. This
unique case is “amplied” many times based on
how many times it has been heard of (media
hype) and as the effect increases, the greater the
empathy developed so that in the end its frequency is perceived as very probable. Also in this
case, the doctor must clearly provide information
on the frequency of the event (number of subjects
with thrombosis and number of subjects treated,
the use of infographics can be useful) and use the
frequencies of “emotionally similar” events in
subjects not vaccinated.
In the anchoring heuristic, the probability of
an event is inuenced by terms of comparison
that are also far from the context of interest but as
close as possible to everyday experience. In the
previous example, in order to support the patient
in the understating of the magnitude of the risk of
thrombosis with the vaccine, it could be useful to
provide a comparison with the risk of thrombosis
associated with exposures that are commonly
experienced (e.g., use of oral contraceptives), not
recommended but socially accepted (e.g., cigarette smoking) or even linked to desirable situations (travel with long ights).
The complexity of the processes underlying
people’s behavior toward their own health problems has made it necessary to implement specic research methods and approaches to
evaluate the ways of communicating on the
safety of drugs. Research in this eld is divided
into formative research and evaluative
research. Formative research examines people’s perceptions and understanding of risks and
preferences regarding drug safety information.
This type of research can be conducted through
qualitative and quantitative studies in the area of
social and behavioral sciences. In a classic
example of educational research, participants in
these studies are interviewed before and after
having undergone a certain information campaign in order to understand users’ preferences
in terms of risk communication. Evaluation
11 Communicating Drug Safety
261
research, on the other hand, operates through
analytical studies and compares the effectiveness of various tools and strategies in obtaining
a change in preferences or behavior.
Effective risk communication on drug use
requires going beyond the simple “knowledge
decit communication model” [43, 44], that is,
with a simple statement of facts. Communication
strategies should be instead dynamically designed
taking into account the point of view and needs of
the person receiving the information.
6.4 The Social Sciences
Social research is a method used by social scientists and researchers to learn about people and
societies with the aim of designing products/services that meet their specic needs. Social
research is conducted following a systematic
strategy that includes different observation methods that can also be applied to risk communication on medicinal products. In particular,
qualitative, investigative, and quasi-experimental
methods commonly used in the social sciences
can greatly contribute to the creation of generalizable knowledge to inform the development of
new risk communication approaches and to evaluate established ones [6].
The choice of research method must be appropriate to the type of question. In general, we can
distinguish qualitative approaches, surveys,
experimental and quasi-experimental methods,
and mixed approaches. Qualitative methods are
suitable for understanding perspectives through
open and conversational discussions between
people (listening) with the aim of generating theoretical concepts. In particular, the results of this
method are accurate and can be the basis for generalization. They are effective in incorporating
emotional, ethical, and cognitive aspects of risk
communication. Surveys are useful for studying
the prevalence (e.g., of attitudes toward the types
of risk communication or the resulting behaviors)
and correlations (e.g., perception of risk in relation to the severity of the health problem) through
the use of questionnaires [6]. Experimental and
quasi- experimental methods are suitable for measuring the effect of a risk communication intervention or of some of its elements or modalities.
Finally, mixed-approach studies that combine
investigative andqualitative methods are particularly suitable for evaluating established risk communication interventions, combining breadth and
depth. Indeed, mixed-method research can provide the in-depth and contextualized data of qualitative research along with the predictive power of
quantitative research. It is important to emphasize
that these studies could take a long time to be conducted and generate non- overlapping evidence
[6].
In recent years, there has been a growing
involvement of patients and the public in research
processes. Indeed, the importance of their participation is becoming increasingly recognized,
and social science methods should be further
developed for their efforts as co-researchers in
data collection, analysis, and dissemination.
Paying more attention to patient and public
involvement in research will undoubtedly in
itself lead to studies that more effectively address
the social and emotional context of the disease
and treatment. While numerous challenges
remain to be addressed, there is great potential in
increased collaboration between researchers in
pharmacovigilance and social sciences to
improve the study of drug risk communication
and thus improve the services that professionals
and organizations provide to patients, clients,
families, and the global public [6].
6.5 Media Science
Drugs and vaccines information are increasingly
being reported in the media, such as the press,
television, radio, websites, and social media;
therefore, the media are an important source of
information for the public, patients, and healthcare professionals. However, the sheer size of the
media offering can make it quite difcult for
patients and healthcare professionals to discern
valid and relevant information from unreliable
information. For the same reason, it can be dif-
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M. Tuccori et al.
cult for regulatory agencies and other pharmacovigilance stakeholders to speak out clearly to
provide information on the safe use of medicinal
products [6]. Communication on COVID-19 vaccines is certainly a recent example of how important it is to be able to manage all these aspects
[45, 46].
It becomes essential to understand how the
news media deals with drug-related topics and
how they provide information to their target audience. In a rapidly evolving media landscape,
media science-based research can make an essential contribution to drug risk communication, particularly in informing media communication
strategies, optimizing interactions with journalists, and evaluating communication outcomes in
the light of specic contents. In recent years,
much has been learned from academic studies
and professional practice about how media channels inform, educate, and persuade people,
including healthcare professionals, about the
benets, risks, and use of drugs [6].
For drug risk communication research, media
science applies a number of methods, many from
the social sciences. These methods include both
qualitative and quantitative approaches, ranging
from individual interviews to large-scale monitoring of traditional and social media content and
product mentions [6]. Most of these methods
have been described in the section devoted to
social sciences (Sect. 5.3). Future work on communicating information on drug risks is likely to
focus heavily on information that can be gleaned
from social media discussions and traditional
media analysis.
7 Ethical Frameworks
Bioethics is a discipline that deals with moral
issues related to biological research and medicine
[47]. The four principles of bioethics such as
autonomy, benecence, non-malecence, and justice must also be applied in the communication of
the risk of medicinal products. Autonomy recognizes the individual’s right to self- determination
and identies respect for the individual’s ability to
make informed decisions about personal matters.
According to the principle of benecence, healthcare professionals should make decisions aimed
at gaining patient interest in the clinical setting.
The principle of non-malecence, on the other
hand, underlines the importance of not causing
harm to the individual. When considering this
principle for possible harm caused by a drug, the
risk/benet ratio remains an important factor to be
considered. Justice guarantees the same patients
to be treated with the same treatment and different
patients to be treated with different treatments if
those differences are relevant to obtain the best
individual interest. The application of the principle of justice becomes critical when resources are
limited and not sufcient to cover the needs of all
patients requiring clinical treatment [47].
Appropriate communication on the risks and
safe use of medicines is associated with several
ethical challenges. Providing patients with relevant information can help them realize their
authentic preferences, thus fostering independent
choices. However, correct communication is
essential to avoid sending the wrong messages to
citizens that could lead to harmful actions. In this
case, the outcome of the communication (decisions and behaviors) can be conditioned by factors such as literacy and psychological reactance.
Psychological reactance is a situation where
some people have a cognitive bias in the way they
perceive the social order and their place within it.
This is why they are resistant to following rules,
guidelines, or patterns. They nd it more motivating to follow a different path [48].
When considering the risks of drug treatments, expert opinion from stakeholders and
regulatory agencies is based on observation of
the evidence. The quantity and quality of evidence, together with the risk–benet prole
described for a drug establish the level of uncertainty surrounding the safe use of drugs.
Uncertainty can generate ethical tensions in drug
safety communication. For example, experienced
scientists face both the duty to tell the truth and
the concerns of possible public reactions.
Strategies for overcoming this tension include the
concealment of uncertainty or the clear transmission of uncertainty [49, 50]. This is a clear example of a moral problem communicators face in
11 Communicating Drug Safety
263
communicating the risk and safe use of drugs
during public debates.
8 Examples on Communicating
Drug Safety from
Regulatory/Marketing
Authorization Holder's
Perspective
8.1 Rofecoxib
The withdrawal of rofecoxib represented an
epochal event for pharmacovigilance, especially
because it involved a market of about 80 million
users worldwide [51]. The ofcial US Food
andDrug Administration (FDA)statement attributing many deaths to this drug due to cardiovascular causes [52] produced a general loss of
condence for the population toward the regulatory agency perceived as too close to the interests
of the pharmaceutical industry, so much so as to
request greater transparency in the conduct of clinical trials and clearer post-surveillance safety
plans [53, 54]. Some Englishmedia declared the
failure of the regulatory process for approval of
marketing authorization for drugs, insinuating that
the FDA had “hidden” unfavorable data [55, 56].
While prescribers relied on guidelines issued by
regulatory agencies and discussed them in scientic journals, citizens needed to be reassured [57].
Newspapers reported the story of rofecoxib
from its commercialization until its withdrawal
using sensational and frightening headlines. The
fearful attitude of patients and prescribers automatically extended to drugs in the same class
[58]. Several studies conducted after the suspension of rofecoxib showed that users of COX-2
inhibitors discontinued treatment four times
more than users of similar analgesic drugs. The
problem is that patients switched to non-selective
NSAIDs without considering the risk of gastrointestinal bleeding or opioids in case of chronic illness [59]. The “reaction” times to communication
were quite rapid, but the speed depends a lot on
media hype. In 2013, the milder communication
about the increased risk of cardiovascular effects
with diclofenac compared to other non-selective
NSAIDs such as naproxen did not produce visible effects on the diclofenac market [60].
However, in 2015, naproxen prescription
increased from 20% to 55%, demonstrating that
the message had been received by prescribers
with a certain delay [61].
This case emphasizes the importance of transparency in maintaining public condence in the
regulatory agency. It is important to involve both
healthcare professionals and patients in the safety
communication process to avoid dangerous
behaviors such as the decision to suspend or
change treatment without medical supervision.
8.2 Thalidomide Re-introduction
The tragedy of thalidomide [7], always used as a
paradigmatic example of the need to monitor
drug safety, had a strong emotional impact on
public opinion, generating a distrust of this drug
(and probably drugs in general) that was very difcult to overcome. Yet a few years after its withdrawal, it was realized that the use of thalidomide
could have important applications, especially in
oncology [62].
In the early 2000s, the FDA approved thalidomide for the treatment of multiple myeloma. To
minimize the risk of teratogenicity, thalidomide
access is restricted through the System for
Thalidomide Education and Prescribing Safety
(STEPS) program [63]. The new drug authorization has elicited opposing reactions among adults
who developed phocomelia with thalidomideand
cancer patients who hoped for treatment with thalidomide. This has put regulatory authorities in
what is called “ambiguity” in terms of risk governance [64]. The European Medicine Agency
brought together the two organizations to comment on the thalidomide risk management plan
with the result of a re- approval of the drug in 2008.
During the meeting, a harsh pregnancy prevention
program (PP) was also drawn up [6].
In this case, risk communication had to aim on
one hand to overcome the demonization of the
drug and on the other hand to discourage its use
in risky conditions (e.g., “off-label” uses). The
strategy involves transmitting fundamental infor-
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mation such as, for example, that a single administration is sufcient for devastating damage to
occur to the fetus. Patients must be instructed on
the importance of following drug label warnings
and prescriber-recommended precautions. It is
important to consider that about 50% are
unplanned pregnancies and that the communication target must be all users of childbearing age.
Mistrust must instead be overcome by communicating that injuries to the fetus caused by thalidomide are absolutely preventable if the
recommendations are respected [63].
8.3 H1N1 Inuenza Vaccine
In the spring of 2009, the H1N1 A inuenza virus
spread around the world, causing a pandemic
which, according to WHO data, caused 18,156
deaths [65]. Thanks to the early identication of
the new virus and the contingency plans developed for years to contain a possible pandemic, a
vaccine was rapidly developed [66]. In December
2009, the immunization campaign began in
Europe and the USA [67, 68].
The management of communication on the
H1N1 A inuenza pandemic in France had some
problems. The information campaign for vaccination stimulated the entire population on the
need to be vaccinated with many messages in the
media, but the limited availability of the vaccine
required prioritization of at-risk subjects only
[69]. Family doctors and pediatricians were not
included in the priority populations, fueling skepticism about the vaccine and reducing collaboration by healthcare professionals [70]. This
emergency management has created confusion in
the population who have begun to underestimate
the risk of the virus [69]. The media also had
ample space for information on alleged safety
problems of a vaccine developed too quickly,
promoting doubtfully pertinent information such
as the safety of adjuvants and the comparison
with “historical” epidemics of adverse vaccine
events such as that of Guillain–Barré syndrome
in the H1N1 vaccination campaign of 1976in the
United States [71]. With increasing distrust in
vaccines and decreasing infection pressure on the
population, public attitudes toward vaccination
have been reduced to a minimum. As a result,
only about 11.1% of the overall population was
immunized [70].
The events in France during the vaccination
campaign are an example of how difcult it is to
communicate uncertainties when the population
perceive adisagreement between health authorities and experts. The experience with the H1N1
pandemic has been useful for developing integrated communication strategies for vaccination
campaigns, which take into account the social,
behavioral, and media aspects and the inuences
that these elements could have on the perception
of risk in the population [72, 73]. During a pandemic, where fear takes the place of logic, it is
imperative that public health agencies communicate very quickly and effectively not only with
the population (especially those at high risk of
developing serious disease) but also with journalists and healthcare professionals who can
amplify the message effectively, but also distort
it [6].
8.4 The COVID-19 Infodemic
Declared a pandemic by the WHO in March
2020, the COVID-19 disease caused by the
SARS-CoV-2 virus has had a profound impact on
the lives of millions of people and has changed
the economic and social statusof many countries
around the world. This important event still represents an exceptional challenge for the communication of health risk and could lead to the
understanding of new concepts related to the perception of risk and the pursuit of health by
people.
The spread of the new coronavirus has been
accompanied by the uncontrolled spread of an
enormous amount of information that the WHO
has dened as an “infodemic” [74]. This chaotic
stream of information has touched all the problems related to the disease, from the characteristics of transmissibility to possible treatments. In a
context of great uncertainty where scientic
research needed time to acquire evidence-based
knowledge, the infodemic incorporated contra-
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