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276
F. van Hunsel et al.
reported factors. Older age groups and individuals with higher level of education were more
likely to report ADRs. Underreporting was
related to knowledge, attitudes, and excuses for
not reporting [11]. Another systematic review on
this topic found that in addition to poor awareness, factors such as confusion about who should
report the ADR, difculties with reporting procedures, lack of feedback on submitted reports,
mailing costs, ADRs being resolved, and prior
negative reporting experiences affected patient
reporting [12]. While behavioural determinants
that inuence patient and public reporting of
ADRs have been studied [13], less is known
about the effects of having to deal with multimorbidity and use of multiple medicines, and the
nature and severity of a patient’s indication on
reporting behaviour.
2 Patient Involvement
inPharmacovigilance
2.1 Start ofPatient Reporting
Schemes
inPharmacovigilance
Although there have been pharmacovigilance
centres worldwide where patients have been able
to report since the start, such as in the United
States, Canada, and Australia since the 1960s, it
was still unusual in many countries in the early
2000s to accept reports directly from the public.
In 1983, following the withdrawal of benoxaprofen, a Committee on Safety of Medicines working group considered patient reporting, but
concluded it was essential to have the expert
medical opinion of the treating doctor [14]. As
recently as 2002, an editorial in the Lancet argued
that ‘without careful thought this latest move to
involve patients in health care could end up overwhelming an already struggling system, and risk
being seen as politically rather than scientically
driven’ [15].
Arguments against patient reporting were that
the reports would be of relatively lower quality
than those from healthcare providers, that patients
would report only non-serious ADRs, and that a
large bulk of non- serious and well-known ADRs
would interfere with actual signal detection [15].
This view on signal detection implies taking pertinent information from noise, with an implicit
connotation that some reporting is more valid
than others. However, allowing patients to report
was described by others as a new step in pharmacovigilance that could have benecial effects
[16–18].
2.2 Current Patient Reporting
Schemes
inPharmacovigilance
Direct patient reporting in pharmacovigilance is
an essential method for collecting information on
ADRs directly from patients or their caregivers.
By involving patients actively in the monitoring
process, it enhances the comprehensiveness and
accuracy of drug safety data. Some examples of
the implementation and impact of direct patient
reporting in pharmacovigilance globally are
listed below:
1. European Union: In the European Union
(EU), direct patient reporting has gained
momentum as an integral part of
pharmacovigilance systems. The EMA
supports patient reporting through the
‘Strengthening Collaboration for Operating
Pharmacovigilance in Europe’ (SCOPE)
project [19]. Various studies have investigated the utility and potential benefits of
patient reporting [20–22]. This led to the
implementation of European (EU)-wide
legislation, making it mandatory in the EU
to have direct patient reporting schemes in
place. Patient reports are collected in
EudraVigilance, the system for managing
and analysing information on suspected
ADRs to medicines which have been
authorised or being studied in clinical trials in the European Economic Area and
operated by EMA [23].
2. United Kingdom: The Medicines and
Healthcare products Regulatory Agency
(MHRA) launched patient reporting in 2005 as
12 Patient andPublic Involvement inPharmacovigilance
277
a pilot programme, and patients can now report
online, by phone, or by completing paper forms
available at GP surgeries and pharmacies.
Direct patient reporting through the Yellow
Card Scheme is valued by users as a way to
provide their unique perspective on ADRs,
which can benet pharmacovigilance [24].
3. United States: In the United States, the Food
and Drug Administration (FDA) has been
actively encouraging patient reporting through
their MedWatch programme. The FDA recognises that patients can provide unique insights
into ADRs due to their direct experience with
medications [25]. A study by Golder et al.
evaluated the patient reporting programme at
the FDA, nding that patients reported a substantial number of ADRs not captured through
healthcare professionals (HCPs) reporting
alone [26]. This emphasised the importance
of patient involvement in pharmacovigilance
efforts.
4. Canada: Health Canada, the regulatory
authority responsible for drug safety in
Canada, also recognises the importance of
patient reporting. The Canada Vigilance
Program encourages patients to report ADRs
directly using the online reporting form [27].
5. Global Initiatives: The World Health
Organization (WHO), through the International
Drug Monitoring Program, actively promotes
patient reporting as part of global pharmacovigilance efforts. VigiBase, the WHO global
database for the individual case safety reports,
maintained by the Uppsala Monitoring Center
in Sweden, also accepts non-HCPs like consumers, patients, and caregivers reports alongside those from HCPs. Currently, reports from
patients in 141 countries constitute around
32% of the total number of reports in the
VigiBase, which contains more than 36 million reports. Across the years, there was an
increase in the number of reports received
from patients submitted to the VigiBase as
shown in Fig.12.1. The accelerated increase in
reporting in 2021 and 2022 is related to a large
inux of reports on COVID- 19 vaccines.
2.3 Clinical Quality ofPatient
Reports
If we focus on ADR reporting in a spontaneous
reporting system, good documentation of clinical
information is important for a proper assessment
of an ADR report. A Dutch study investigated the
clinical information of duplicate cases of ADRs
reported by both patients and HCPs. A total of
197 cases were included, and in 54.3% of these
cases, patients and HCPs reported a similar quality of clinical information. Statistical analysis
demonstrated no overall differences between
patients and HCPs in the presence of clinical
information [21]. However, a study in France,
investigating 16 key elements of information in
reports, found that patient reports often need to
be completed on key elements of information that
were required for case assessment. For instance,
data on medical history and concomitant medication were missing in 75% of the initial reports.
Contacting the reporter helped to increase the
informativeness of most elements of information
for more than 90% of the reports [28].
2.4 Dierences withHealthcare
Professional Reports
Studies have found both differences and similarities in the reporting patterns of patients and
HCPs. An analysis of the European ADR database Eudravigilance® found that patients were
more likely than HCPs to report for genito-urinary, hormonal, and reproductive indications.
Patients reported more general disorders and
administration site conditions, whereas HCPs
reported more ADRs related to investigations. It
should, however, be noted that 13 of the 20 reactions most frequently reported by patients were
also among the top 20 reactions reported by
HCPs [18]. A review study by Inch et al. [22]
from 2012 found that in the Netherlands and the
UK, ADR reports by patients and HCPs were
about similar drugs, with medicines such as
statins and proton pump inhibitors in the top ve
278
25%
Consumer reports in the global ADR database VigiBase until 2022
20%
200
2007
15%
10%
5%
F. van Hunsel et al.
0%
2001
2000
Fig. 12.1 Patients reports across the years in the VigiBase (source: VigiBase)
2002
2003
2004
5
2006
2008
2009
drugs. Patients and HCPs reported ADR about
different organ classes. Table12.1 shows the differences between patient ADR reports and those
of HCPs.
2010
20
11
20
13
12
20
20
Recently a thematic analysis [28] identied
themes associated with ADR burden in patientreported information consisting of ‘effect on
medication prescription,’ ‘impact on appearance,’ ‘impact on autonomy,’ ‘impact on daily
life,’ ‘psychological consequences,’ ‘distressing
2.5 Understanding theBurden
ofAdverse Drug Reactions
aspects of ADR,’ and ‘physical consequences.’
This study concluded that patients describe per-
ceived ADR burden in both physical and psyThe inuence of ADRs on daily life, the so-called
burden of an ADR, is information that is considered important by patients and patients also report
about this more often than HCPs [29, 30]. Research
has shown that the decrease in quality of life due to
ADRs can be mapped in a structured way and used
by pharmacovigilance centres [31, 32].
chological themes, which was comparable with
HCP-reported information. However, HCP per-
spective put more focus on psychological impact,
which is only part of the burden that patients
describe themselves [33]. In addition to infor-
mation on the burden of ADRs, aspects char-
acterising the course of ADRs from the patient
20
16
15
20
14
20
18
17
20
20
2020
2021
2022
19
12 Patient andPublic Involvement inPharmacovigilance
Table 12.1 The differences between patient ADR reports and those of HCPs
Characteristics Patient ADR reports HCPs ADR reports
Source of information Patient’s own experience, family,
friends, and other patients
Level of detail May include information about
lifestyle and habits, course of the
ADR, and adherence
Medical terminology Patient reports may use less medical
terminology
Completeness Patient reports may be incomplete, as
patients may not be able to provide all
of the relevant information
Impact May include more detailed information
on the impact or burden of an ADR on
the patient’s life
Causality May perceive the ADR's cause
differently than HCP
Perspective Personal experience and symptoms.
Report on ADRs that are important to
them
HCPs observations of ADRs in their patients
May provide a higher level of clinical details,
includes a medical history and lab results
HCP reports may use more medical
terminology
HCP reports may be more complete, as HCPs
have access to medical records and other
clinical information
Generally includes less information on impact
and burden
HCP perspective on causality with clinical
expertise
Clinical and medical expertise, often focused
on serious, new, or rare ADRs
279
perspective could be information that is useful for
patients and HCPs and not always readily available. Recently, a framework was developed based
on common themes in the course of ADRs identied from patient descriptions in patient-reported
ADRs. The identied themes could be used for
improving the systematic data collection of more
extensive details about ADRs from patients [34].
One problem is that ADR reports in pharmacovigilance databases often contain coded information and, in addition, large amounts of
unstructured or semi-structured information in
plain text format. Harnessing and using this
information could help to give more insight in the
patient perspective on ADRs. Analysis techniques designed for free text analysis could be
helpful in identifying topics in these reports [35].
2.6 Impact ofPatient-Reported
Adverse Drug Reactions
onPharmacovigilance
Patient-reported ADRs play a vital role in pharmacovigilance. They can help identify new
safety signals, which can lead to improved
patient safety. ‘A “Safety Signal” is dened as
information on a new or known adverse event
that is potentially caused by a medicine and that
warrants further investigation. Signals are generated from several sources such as spontaneous
reports, clinical studies, and the scientic literature [36].’ For example, a study found that
patient reports accounted for 26.3% of all ADR
reports in Dutch drug safety signals between
2010 and 2015 [24]. There are signals that are
based entirely on reports from healthcare providers. However, there are also a number of signals
that would not have been found without the input
of patients [24]. For instance, patient reports
were essential in identifying a safety signal for
high-dose vitamin B6 products and the development of neuropathy, which led to a regulatory
action in the Netherlands to restrict the maximum dosage of vitamin B6 in vitamin supplements [27].
Patient-reported ADRs can also help to identify safety concerns for medications that are not
typically monitored by pharmacovigilance systems, such as herbal products and over-thecounter medications [25, 26]. It should be noted
that a signal is more than just a ‘new’ ADR; it
could also relate to a previously unknown aspect
of an ADR, such as risk factors or severity of the
reaction. This is information that is often missing
from ofcial patient information leaets. For
280
F. van Hunsel et al.
healthcare providers and patients, this information is important for making choices and expectations about the use of medicines. The reporting of
ADRs should not be limited to the unknown, serious ADRs.
Patient-reported ADRs are a valuable source
of information for pharmacovigilance systems.
They can help identify new safety signals,
improve our understanding of the safety of medications, and lead to regulatory actions to protect
patients.
2.7 Patient Experiences onSocial
Media
Multiple attempts have been made to nd utility
in the patient experience of medicines shared on
the internet [37–39]. The widespread uptake of
social media following the growing use of smartphones intensied interest in this area, for
instance for signal detection or signal strengthening purposes. However, knowledge of the
mere existence of this unstructured information
has also presented problems, since it has at times
been in danger of creating an impossible obligation for market authorisation holders to scan for
potential harms from their products [40]. A
3-year-long EU project called WEB- RADR
explored the value of social media in nding new
ADRs through signal detection. Despite developing some novel analytical tools to utilise such
data, they were unable to nd evidence that
Twitter (nowadays rebranded as X) and Facebook
added value compared to existing spontaneous
reporting systems, although there may be niche
usage cases (such as pregnancy-related outcomes or drug abuse) [38].
Similarly, an FDA study looking at the combined use of FDA Adverse Event Reporting
System data and Twitter data found that while
spontaneous data improved the signal from
Twitter, Twitter did not add value to the use of
spontaneous data [41]. It should be noted that
both projects were performed some years ago
and data mining techniques are quickly advancing. During the COVID-19 pandemic, the WHO
invested in technology for digital real-time online
listening, the Peek Platform which is an early
warning system for COVID-19 vaccine-related
events. This platform uses articial intelligence
(AI) to identify information on COVID-19 vaccine-related events on the internet and public
social media platforms and news outlets in
English, Spanish, and Russian [42]. This eventbased surveillance system, which serves as a
complement to information from other routine
surveillance systems, was used to detect a potential ADR of nephrotic syndrome following the
administration of the second dose of the COVID19 vaccine in early 2022. Researchers from the
Uppsala Monitoring Centre had detected a similar signal in the global adverse event database
VigiBase nearly a year before, where IgA
nephropathy was linked to the COVID-19 vaccine. The alert provided by this PEEK early
warning system gave more context on this signal,
helping them see the bigger clinical picture for
this ADR and the vaccine [43]. While there may
be future renements and opportunities in the use
of social media data, continuing instability of
platforms, including researcher access to data,
and format changes may mean that future work in
this area is hampered.
3 Role ofPatient Reporting
inVaccine
Pharmacovigilance
3.1 The Signicance ofPatient
Reports ofVaccine Safety
Issues
Patient reports of adverse events following
immunisation (AEFIs) are essential for monitoring the safety of vaccines and identifying
potential safety signals. Nowadays, in the
Netherlands, for instance, the majority of AEFI
on the childhood immunisation programme and
the yearly inuenza vaccination programme are
reported by parents or care-takers and vaccinated persons themselves [38]. Also for new
vaccines, patients can help to elucidate the
12 Patient andPublic Involvement inPharmacovigilance
281
safety prole of a vaccine; the spreading of the
MPox (previously known as monkeypox) virus
in 2022 led to a vaccination campaign in the
Netherlands for individuals at high risk of infection. Vaccinated persons were actively encouraged to report any AEFI to the spontaneous
reporting system and almost all reports on this
new vaccine were made by vaccinated persons
themselves, including reports on serious AEFIs
[44]. Patient reports can provide valuable
insights into the types of AEFIs that are occurring and the populations that are most affected.
This information can be used to [45]:
• Identify new AEFIs: Patient reports can help
to identify safety signals for AEFIs, for
example, those with a longer time-to-onset
and especially those for which medical attention is generally less often sought but are
important from a patient perspective.
• Monitor the safety of vaccines in real-world
settings: Patient reports can provide insights
into the safety of vaccines in real-world settings, where people are receiving vaccines in
combination with other vaccines and may
have underlying health conditions. This information can be used to monitor the safety of
vaccines over time and identify new safety
risks.
• Improve the understanding of the impact of
AEFIs on patients’ lives: Patient reports can
provide valuable insights into the impact of
AEFIs on patients’ lives, including the impact
on their quality of life, work productivity, and
relationships. This information can be used to
inform decision-making about risk management and to develop interventions to help
patients cope with AEFIs.
In addition to the traditional spontaneous
reporting system, cohort event monitoring studies, using Patient-Reported Outcomes (PROs),
have made an important contribution to vaccine
pharmacovigilance over the years. This type of
study has been used, for instance, in the monitoring of the H1N1 vaccine in 2010 [46], inuenza vaccines [47], and COVID-19 vaccines
[48, 49].
3.2 The COVID-19 Pandemic
andPatient Reporting
The pandemic has affected patient reporting of
adverse effects. Early in the pandemic, there was
a decrease in patient reporting, likely due to concerns about COVID-19 exposure and disruptions
to healthcare services. A similar decrease was
seen, for instance, in France, for HCP reports
[50]. However, the COVID-19 vaccination cam-
paign has resulted in a surge in the number of
ADR reports from the general public in many
countries. In the Netherlands, over 250,000
reports were received in the rst 1.5years after
the rst vaccines were registered, with the majority being reported by vaccinated persons themselves [51]. Consumers report on ADRs that
concern them, such as was seen by a huge number
of reports on menstrual disorders after COVID-19
vaccination which led to a subsequent signal and
addition of heavy menstrual bleeding as an ADR
to the Summary of Product Characteristics for the
commonly used mRNA vaccines in Europe [52].
3.3 Building Public Condence
inCOVID-19 Vaccines
Effective communications are essential with
regard to medicines safety. A good example of
this is the management of the public communications about COVID-19 vaccines. While there
have been concerns about a lack of knowledge on
the process of vaccine and medicines development for patients and the general public, both the
UK’s MHRA and the EU’s EMA had prepared
extensive pharmacovigilance plans for the vaccines in the months prior to their launch [53].
These focused on ensuring the safety of the vaccines, but also on seeking to ensure there was
public condence in the regulatory systems that
monitored safety. Both agencies tried to be open
and transparent about the reported harms of vaccines, while setting up new safety studies to
actively look for harms.
Both the UK and EU also regularly published
contextualised reports on spontaneous reports
related to COVID-19 vaccines and held public pan-
282
F. van Hunsel et al.
els on safety issues as they arose. In the UK, discussions on vaccine benet and harms were held
live on television with experts from the MHRA, the
health service, and the committee in charge of vaccines, leading to open discussion about benets
and harms of the vaccines. This was also the case in
the Netherlands, where the media attention and
public interest for vaccines were unprecedented.
This also meant that many patients actively sought
information on vaccine safety. In 2021, there were
more than 4.6 million visits to the Lareb website,
where a dedicated section was made covering
safety information for COVID-19 vaccines [54].
Compared to 2020, before COVID-19 vaccines
were registered, this was a 500% increase in access.
Lareb’s active media contributions also rose from
52in 2020 to 288in 2021 [54].
In addition to the efforts of the UK’s MHRA and
the EU’s EMA, the International Society of
Pharmacovigilance Special Interest Group on
Medicinal Product Risk Communication (ISoP
CommSIG), as an expert group on medicinal product risk communication, contributed to the development of infographics for patients; one on the safe use
of medicines during the pandemic and a later one on
the safety of COVID-19 vaccines [55].
3.4 Overcoming Misinformation
andIncreasing Public Trust
inPharmacovigilance
Misinformation, for instance on social media, has
been an issue pharmacovigilance had to deal with,
although during the initial vaccination campaign,
uptake was high. A lot of misinformation was
seemingly generated by a very small number of
sources [56]. In this light, quickly identifying and
addressing public concern about vaccination
should be a priority. Patient involvement should be
a two-way street, where organisations involved in
pharmacovigilance should strive towards providing comprehensive information for patients to
make an informed decision on vaccination in a
timely fashion, instead of only involving patients
by receiving their reports [7, 57].
4 Patients Involvement
inRegulatory
Decision-Making
4.1 The Journey Towards
Consistent Patient
Engagement
From the beginning of the twenty-rst century,
more and more countries started accepting
patient reports, with Denmark, the Netherlands,
and the UK became the rst countries within
the EU in 2003 [27].The rst scientic articles
from the Netherlands [21, 58], Denmark [59],
and the UK [20] showed that patients were able
to make high- quality reports. A well-designed
(online) report form, through which patients
are guided and know which data elements they
have to ll in, is a precondition for this [27]. In
2012, a handbook for consumer reporting of
ADRs was developed as part of the ‘Monitoring
Medicines project’ [60], funded by the FP-7
EU framework. This guidance aimed to provide practical guidelines on how to set up
national systems for consumers to report
adverse reactions to medicines and was published by the WHO [61].
A breakthrough in the acceptance of patient
participation came in 2012 when new European
pharmacovigilance legislation made it possible
for patients in all EU Member States to report
adverse reactions directly to the national
adverse drug reaction centre [62]. This gave
patients a permanent role in monitoring the
safety of medicines. The number of patient
reports in the European Eudravigilance® database rose from a total of 53,130 patient reports
in the 3years preceding the legislation operation period to 113,371 reports in the 3 years
after. However, there are still large differences
in the number of patient reports between the
various EU Member States. Member states
contributing the most patient reports to the
European ADR database (Eudravigilance®)
were the Netherlands, the UK, Germany,
France, and Italy [23].
12 Patient andPublic Involvement inPharmacovigilance
283
4.2 Frameworks forPatient
andConsumer Engagement
In recent years, more attention has been paid to
involving the patient’s perspective in decisions
about the registration and monitoring of medicines. In Europe, representatives for patients have
been involved in the European Pharmacovigilance
Risk Assessment Committee (PRAC) since 2012.
Patient representatives sit as full members of the
Committee. As a result, patients are now fully
involved with the difcult assessments of benet–risk that sit at the heart of the regulatory process [63]. In 2017, the rst public hearing where
European citizens representing patients, carers,
HCPs, and academia shared their experience with
valproate occurred [64]. As input from patients
and HCPs to regulatory assessments is increasingly essential for benet–risk management of
medicines, Bahri and Pariente studied the ways
to obtain patient input in different risk scenarios
[65]. Their proposed decision guide aims at
ensuring systematic and consistent engagement
across regulatory assessments, to effectively
obtain real- world input for regulatory decision
making [65].
In 2019, Bahri and Brown published a rst
conceptual and methodological framework for
‘Engagement of patients and healthcare professionals in regulatory pharmacovigilance’ [66],
and EMA has published an engagement framework in 2022. This framework describes the
objectives and methodologies for EMA’s engagement with patients, consumers, and their organisations in relation to medicines for human and
veterinary use [67]. In addition to the European
efforts that are being made to involve patients,
there have also been national initiatives. In the
Netherlands, the Dutch Medicines Evaluation
Board appointed a new board member for Patient
and Consumer Perspective in 2015 [68].
Despite increasing efforts to involve patients
in pharmacovigilance, a qualitative study has
noted the level of actively involving patients as
rather low and scattered across the different
phases of the lifecycle of medicines [69]. The
authors describe barriers which hamper the transitioning of patient involvement from theory to
practice [69]. In order to overcome some of
these barriers, best practices in patient involvement in pharmacovigilance were studied based
on a qualitative multi-stakeholder interview
study across Europe, including representatives
of patient organisations, regulators, and pharmaceutical companies at both the national and
European level. Best practices involved patient
education and empowerment, engagement from
the start, structured involvement and guidelines,
patients as same-level partners, face-to-face
communication, and setting common goals
(Fig.12.2) [70].
4.3 The Patient’s Role inDecision
Making
Patients carry not only the risk of harms from
medicines but also the benets of medicines.
While there has been a move away from a paternalistic framework when using medicines to a
shared decision-making model at an individual
level, regulatory agencies still operate by making
decisions at a population level—using a public
health model. However, decisions to withdraw
drugs are not always universally welcomed.
There will be a set of patients who are deriving
benets from the withdrawn medicine, without
adverse effects, or at least willing to accept the
risks that the regulator has deemed too high at a
population level.
When benoxaprofen was withdrawn in the
United States in the 1980s, the FDA received
hundreds of letters from doctors and patients asking if benoxaprofen would still be available to
them [71]. In the UK, the famous playwright
Dennis Potter, who lived with psoriatic arthritis
for most of his life, complained that he had been
left ‘high and dry’ following the withdrawal [72].
Following the withdrawal of alosetron in 2000,
which had been associated with severe ADRs
such as ischaemic colitis and death, the FDA and
GlaxoSmithKline were lobbied by thousands of
patients to keep the drug on the market. The drug
was made available again under a risk management programme run by GlaxoSmithKline in
2002 [73].
284
Building trust
Engagement from the start
Face-to-face communication
Full circle feedback
Same level partners
Structured involvement
Setting common goals
F. van Hunsel et al.
•
For example; Making sure that patient representatives can voice their opinion
freely to PV representatives
For example; Engage patients from the design phase of projects/activities
•
•
Activities include seminars, conferences and meetings
•
Having a contact person in place
•
Use patient organizations as a communication platform
•
For example; Tr eating patients as same level partners in public hearings
Having patient representatives in boards or other high level representation
•
Activities can include designing educational materials together and work on
•
review of communcation strategies
Patient education and
empowerment
Fig. 12.2 Best practices in pharmacovigilance for patient involvement and the activities that relate to them
The case study of the conditional approval of
•
Work with patient organisations on educational programmes
4.4 Getting Engagement
bevacizumab for use in breast cancer in the
United States is a particularly interesting intersection of public views on benets and harms,
compared to a regulator’s assessment. Following
the withdrawal, over 450 public submissions
arrived at the FDA, mostly asking for the drug to
remain on the market. Such differences of opinion can be driven by differing interpretations of
evidence, differing expectations and values, risk/
benet weightings which are shaped by
socio- cultural processes, trust, hope and their
rootedness in vulnerability and a need to cope,
and lastly, newspaper reporting of drug benets.
Clarity in public communications by regulators
towards the public and media have been suggested
to increase alignment of the public and regulators
[74]. However, patients’ experiences, knowledge,
opinions, and preferences about medicines were not
always considered as important as those of other
stakeholders in answering questions about the risks
Awareness that ADRs can be reported and that
it is important to do so is not always optimal
among patients or the general public. During
the annual ‘MedSafetyWeek’, the Uppsala
Monitoring Centre teams up with medicine
regulatory authorities and national pharmacovigilance centres across the world to run a
social media campaign that raises awareness
of ADRs [44]. Although, for some countries
the mass vaccination campaigns in 2021/2022
resulted in more awareness and reports in
patient reporting schemes, overall, there is
still much to gain in informing patients and the
general public about the possibility to report.
It would also be helpful if reporting functions
would be integrated into functionalities that
patients already use, such as apps [75, 76],
preferably those which are already used to
manage their disease.
and benets of medicines [63].
12 Patient andPublic Involvement inPharmacovigilance
285
4.5 The Role ofPatient
Organisations
One of the ways to create a more optimal reporting culture among patients is to get engagement
from patient organisations. Patient organisations,
either umbrella organisations or targeted towards
specic diseases, can have an important role in
encouraging patients to talk with their doctors/
pharmacists about ADRs experienced or to help
patients report the ADRs to the pharmacovigilance systems [45]. Patient organisations can
help enable effective communication of ADRs to
a relevant audience, for instance, through social
media posts. As an example, a signal on levothyroxine and panic reactions was communicated
via the Dutch thyroid organisation’s digital newsletter, social media channels, website, and print
magazine. The social media post generated the
most engagement [46].
However, barriers to being involved in pharmacovigilance for patient and patient organisations also still exist and include a lack of
awareness, a lack of resources and/or budget, and
support from regulators [45]. Strategies to stimulate patient-organisation participation are, among
others, the creation of more awareness campaigns, more research that creates awareness,
education for patient organisations, and a more
proactive approach from national competent
authorities [47].
5 Future Steps
5.1 Challenges andOpportunities
inPatient Involvement
Patient and public engagement in pharmacovigilance is essential for ensuring the safety of medications. However, there are a number of
challenges that can make it difcult for patients
to participate in this process [13]. One of the biggest challenges is that patients may not be aware
of the importance of pharmacovigilance or how
to report ADRs. Patients may also be hesitant to
report ADRs because they are worried about
being labelled as a ‘difcult patient’ or because
they believe that their report will not make a difference. Another challenge is that patients may
not have the time or resources to report ADRs.
Patients may be busy with work, family, and
other commitments, and they may not have
access to the internet or other resources needed to
report ADRs. Finally, some patients may not be
able to recognise ADRs or may not understand
the relationship between their adverse events and
the medications they are taking. This can be particularly challenging for patients who are taking
multiple medications or who have complex medical conditions. In addition, patients may just
accept ADRs as part of their illness trajectory.
Such stoicism may be linked to their disease condition but also to age or gender.
Despite these challenges, there are a number
of strategies for promoting patient engagement in
pharmacovigilance [12]. First, it is important to
educate patients about the importance of pharmacovigilance and how to report ADRs. This can be
done through public awareness campaigns,
development of patient education materials, and
healthcare provider training. Additionally, it is
important to make it easy for patients to report
ADRs. This can be done by providing patients
with easy-to-use reporting tools and by making
sure that healthcare providers are aware of and
willing to accept patient reports. Finally, it is
important to support patients who report ADRs
by providing them with feedback on their reports
and by following up on their concerns. This helps
to ensure that patients feel valued and respected
and that they are more likely to report ADRs in
the future.
5.2 Leveraging Patient-Reported
Information andPatientReported Outcomes
inPharmacovigilance
Patient-reported information (PRI) and patientreported outcomes (PROs) are valuable sources
of data for pharmacovigilance because they give
a unique view of the patient. PRI and PROs can
be collected through a variety of sources, such as
patient surveys, social media, and electronic
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