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286
F. van Hunsel et al.
patient records. PRIs and PROs can help nd new
safety signals, check the safety of medicines in
real-life situations, track how well safety measures are working, monitor the effectiveness of
safety interventions, and create better safety measures [77–79]. Further information could be
found in Case Study 1.
5.3 Patient Engagement Special
Interest Group
The International Society of Pharmacovigilance
(ISoP), an international non-prot scientic
organisation, which aims to foster pharmacovigilance both scientically and educationally
and enhance all aspects of the safe and proper
use of medicines, has recently established the
Patient Engagement Special Interest Group
(PatEG-SIG) to describe, develop, and promote
patient engagement in pharmacovigilance. The
vision of this SIG is to enhance the core role of
patients in medication safety, which will ‘ulti-
mately result in best practices that can be integrated into operational everyday
pharmacovigilance both in healthcare and at
the health policy level, and hence contribute to
enabling informed therapeutic choices and
keeping patients safe’ [57].
5.4 Medication Safety inClinical
Practice
While the involvement of patients in pharmacovigilance has been the focus of this chapter, it
should not be forgotten that patients are a key
stakeholder in the wider healthcare system. When
it comes to their own health, patients have to
make benet-harm judgements to consent to
treatment, have a high awareness of the potential
harms of the medication, and can be the last line
defence in the case of an error. The role of the
patient in clinical safety has been categorised into
three main areas [80].
1. Interventions to directly support patient safety
2. Contributing to self-management (e.g. self-
3. To provide feedback on the quality of care
engagement in healthcare safety found that while
there was good evidence for a number of interventions (self-management of anticoagulants,
adverse event monitoring, and medical record
accuracy) that these were not widely implemented [81]. The review also found that adherence to medication could be improved by patient
engagement with patient education programmes,
self-management, and online access to medical
notes. As well as conrming the role of patients
in pharmacovigilance reporting, there was also
some positive impact of patient reporting of medication errors.
strategies to improve medication safety found
over 19 studies targeted at mainly older adults
[82]. These were based on either patient education or medicines reconciliation—the latter
including medication lists, drug safety information, bringing medications to appointments, and
checking procedures when patients arrive at
healthcare centres. While patients, the public,
and families appear to be generally well disposed
to medication safety, some have argued that the
evidence remains poor. Patients may be concerned about damaging relationships with healthcare professionals [82].
care found a number of contributory factors for
medications errors in primary care [83]. Key
contributing factors for medication errors were
related to communication issues, patient- and
carer-related factors, HCP factors, computer
systems and programmes, and supply of medication and appliances. A Patient Medication
Safety Framework (P-MEDs) was created with
(e.g. challenging healthcare staff when they
see a medication error).
adjustment of warfarin or insulin dosing).
(e.g. reporting of medication errors or ADRs).
A review of current evidence of patient
A systematic review of patient and family
A patient-centred framework for primary
12 Patient andPublic Involvement inPharmacovigilance
287
communication issues at the centre, since failures of communication were common—particularly across primary and secondary care
interfaces [83].
In the hospital sector, there is some evidence
that both patients and HCPs would welcome
better patient involvement in medication safety
[84], and there have been attempts to create
patient-centred medication measure concepts
for that sector in order to orientate future
research into patient-centred activity [85].
These were aligned to health system- orientated
safety measures, such as improved patient
reporting of adherence, reporting of drug–drug
interactions, side effects, and medication errors,
and enabling patients to report on the treatment
burden they are carrying. Others were more
patient centred, including patient preferences
on communication methods, ensuring that
patient medication goals are understood in the
context of preferences and any patient concerns
about safety.
6 Summary and Conclusions
It is clear that the patient and public involvement
in pharmacovigilance adds value. However, actually normalising this practice goes beyond allowing patient reporting, with much work to be done
to increase actual patient involvement in the
wider arena of pharmacovigilance. Patients make
a clear contribution in giving information about
the impact of the ADR on their daily life and this
information could be more routinely used in
pharmacovigilance.
With increasing numbers of direct patient
reports, it is crucial to look towards new methodologies in pharmacovigilance to make the best
use of patient-reported information. This also
means that our methods and systems used for collecting, coding, and analysing patient reported
information need to be further developed. Patient
involvement should be a two-way street where
pharmacovigilance benets from patient-reported
information, but also provides relevant information back to patients and involves them in decision making.
7 Case Studies
7.1 Case Study 1: Developing
Patient-Reported Outcome
Measures toCapture
andTrack Patients’
Experiences withMedications
1. What are patient-reported outcome measures
(PROMs)?
They are tools used to capture patients’
perspectives on their health and well-being.
2. What is the purpose of developing PROMs?
PROMs can be used to track patients’
experiences with medications, including side
effects, efcacy, and quality of life. This
information can be used to improve patient
care, inform pharmacovigilance efforts, and
support research and the development of new
medications [78, 86–90].
3. Describe the steps involved in developing
PROMs to capture patients’ experiences with
medications?
There are a number of steps involved in
developing PROMs to capture patients’ experiences with medications [78, 86–90]. These
steps include:
(a) Identifying the patient population of
interest and the specic medication experiences that are important to measure:
This can be done through literature
reviews, focus groups with patients, and
interviews with patients and HCPs.
(b) Generating items for the PROM: Items
should be clear, concise, and relevant to
the patient population of interest. They
should also be easy to read, understand,
and complete.
(c) Evaluating the PROM for content valid-
ity: This can be done by having a panel of
experts review the PROM items to ensure
that they are relevant, comprehensive, and
appropriate for the intended use.
(d) Pilot testing the PROM in a small sample
of patients to assess its feasibility,
acceptability, and psychometric properties: This may involve making changes
to the PROM items or format to improve
288
F. van Hunsel et al.
their usability. Qualitative research may
play an important role here as what the
experts reect upon may not represent
what the burden and experience is of the
patient.
(e) Validating the PROM in a larger sample
of patients to assess its reliability and
responsiveness: This can be done by comparing the PROM scores to other measures of the same construct, such as
clinical outcomes or clinician ratings.
4. How could we involve patients in the develop-
ment of PROMs?
It is important to involve patients in all
stages of the PROM development process.
This helps to ensure that the PROM is relevant
to patients’ needs and concerns and that it is
easy to understand and complete. Patients can
be involved in generating items for the PROM,
evaluating the PROM for content validity, and
pilot testing the PROM.
5. Provide an example of a PROM to capture
patients’ experiences with medications:
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a
set of validated PROMs that can be used to
measure a wide range of patient-reported outcomes, including medication experiences [78,
86–90].
The PROMIS Medication Experience
Module (PEM) is a 10-item PROM that can
be used to assess patients’ experiences with
medications, including side effects, efcacy,
and quality of life.
The PEM items are:
(a) In the past week, how often have you had
any side effects from your medications?
(b) In the past week, how much have your
side effects bothered you?
(c) In the past week, how much did your side
effects limit your activities?
(d) In the past week, how often did you take
your medications as prescribed?
(e) In the past week, how condent were you
that your medications were working?
(f) In the past week, how satised were you
with the overall effect of your
medications?
(g) In the past week, how much did your
medications improve your quality of life?
(h) In the past week, how much did your
medications make it difcult to do your
job or go to school?
(i) In the past week, how much did your
medications make it difcult to manage
your daily activities?
(j) In the past week, how much did your
medications make it difcult to enjoy
your life?
The PEM items are rated on a 5-point Likert
scale, with higher scores indicating more severe
side effects, lower efcacy, and lower quality of
life. The PEM has been validated in a number of
studies and has been shown to be reliable and
responsive to changes in patients’ medication
experiences [78, 86–90].
7.2 Case Study 2: Creating
Patient-Friendly Educational
Materials
onPharmacovigilance
Pharmacovigilance is the process of monitoring
the safety of medicines after they have been
marketed. However, many patients are not
aware of the importance of pharmacovigilance
or how to recognise and report ADRs. It is
important to involve patients in pharmacovigilance so that they can recognise and report
ADRs.
1. What is the purpose of patient-friendly educa-
tional materials on pharmacovigilance?
Patient-friendly educational materials can
be used to inform patients about the importance of pharmacovigilance and how to recognise and report ADRs.
2. What are the basic characteristics of patient-
friendly educational materials on
pharmacovigilance?
These materials should be written in clear
and concise language, and they should be easy
to understand for patients with all levels of
health literacy [91–94].
12 Patient andPublic Involvement inPharmacovigilance
289
3. Describe the steps for developing patientfriendly educational materials on
pharmacovigilance:
(a) Identify the target audience and their
needs: What do patients need to know
about pharmacovigilance and ADRs?
What level of health literacy do patients
have?
(b) Develop learning objectives: What do
patients need to be able to do after reading the educational materials? For example, patients should be able to dene
pharmacovigilance, identify ADRs, and
report ADRs to the appropriate
authorities.
(c) Choose the right format: What format of
educational materials will be most
effective for the target audience? For
example, educational materials could
be in the form of brochures, leaets,
infographics, posters, videos, or online
resources.
(d) Write and design the educational materi-
als: The educational materials should be
written in clear and concise language, and
they should be visually appealing. It is
also important to use plain language and
avoid jargon.
(e) Pilot test the educational materials: The
educational materials should be pilot
tested with a small yet diverse group of
patients to ensure that they are easy to
understand and effective.
(f) Disseminate the educational materials:
Once the educational materials have been
nalised, they should be disseminated to
the target audience. This could be done
through clinics, hospitals, pharmacies,
and other healthcare settings.
4. Provide examples of patient-friendly educa-
tional materials on pharmacovigilance:
(a) Brochures that explain what pharmaco-
vigilance is, why it is important, and how
to report ADRs.
(b) Videos that explain pharmacovigilance in
a clear and engaging way.
(c) Infographics that provide easy-to-
understand information on
pharmacovigilance.
(d) Websites of regulatory authorities with a
dedicated section on pharmacovigilance
for patients.
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Scheme’: literature review, descriptive and qualitative
analyses, and questionnaire surveys. Health Technol
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CIOMS Working Group XI on Patient involvement.
Patient involvement in the development, regulation
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Council for International Organizations of Medical
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van Hunsel F, Harmark L, Rolfes L. Fifteen years
of patient reporting—what have we learned and
where are we heading to? Expert Opin Drug Saf.
2019;18(6):477–84.
Collaborative Approaches
toEstablishing andImplementing
Pharmacovigilance Systems
BrianEdwards andAngelaCaro-Rojas
13
Abstract
Pharmacovigilance is neither one single discipline nor is it conned to a single professional
group. The concept of pharmacovigilance
originated with clinical pharmacologists based
on the principles of clinical examination of a
patient for evidence of causality and then
blending these ideas with epidemiological
concepts. This was triggered by the thalidomide catastrophe in the 1960s and the need to
identify safety signals for medicines much
more promptly. Initially, the main priority was
the detection of serious and unexpected
adverse reactions primarily through analysis
of spontaneous reports. Now it is a multidisciplinary topic which requires collaboration
from various stakeholders within a complex
system to demonstrate that the benet–harm
arm proles of healthcare products remain
acceptable for millions of patients throughout
the life cycle of a medicine. These stakehold-
B. Edwards (*)
Husoteria Ltd., Ashtead, Surrey, UK
International Society of Pharmacovigilance,
Geneva, Switzerland
e-mail: husoteriabe@gmail.com
A. Caro-Rojas
Ponticia Universidad Javeriana, Bogotá, Colombia
International Society of Pharmacovigilance,
Geneva, Switzerland
ers include all types of healthcare providers,
industry professionals, regulatory agencies,
patients and their families, and the wider public. To optimise the use of medicines, we need
to understand the role of each stakeholder and
strive towards closer cooperation. This
requires a exible and adaptable approach to
implementing pharmacovigilance systems in
various settings according to different regulatory requirements and the needs of public
health both nationally and internationally. It is
important for professionals during their development, throughout their career starting as an
undergraduate, to understand and appreciate
the steps involved in setting up and collaborating within the pharmacovigilance systems at
different levels. As ISO 9001 states, a system
is how a certain set of processes operate to
work towards a particular goal which for pharmacovigilance is to optimise benet and mitigate harm of medicinal products to enhance
patient safety. Unfortunately, the importance
of effective implementation of pharmacovigilance as a system based on organisational science including human factors remains
under-recognised by many responsible for
education and development. Putting human
performance at the heart of thepharmacovigilance system design is critical for success.
This chapter charts how our current pharmacovigilance system arose based on principles
of surveillance and regulation and discusses
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
J. Jose et al. (eds.), Principles and Practice of Pharmacovigilance and Drug Safety,
https://doi.org/10.1007/978-3-031-51089-2_13
295
296
what should happen now and in the future
using systems thinking based on organisational science using a collaborative approach.
Keywords
Benet–harm · Complex systems · Human
factors · Medication safety ·
Pharmacovigilance · Collaborative
approaches
Learning Objectives
• To understand from where and how pharmacovigilance arose to help explain today’s processes and the advances that have occurred
over time.
• To gain insight into the fundamental principles, challenges, and barriers for setting up a
system with a focus on human performance to
ensure safe and proper use of medicines.
• Recognise the importance of international
pharmacovigilance guidelines and the need
for collaboration and cooperation between
multiple stakeholders across the system.
• To dene principles of a pharmacovigilance
quality system and how each task is part of a
process with multiple components, links, and
inuences.
Key Points
• Pharmacovigilance requires a multidis-
ciplinary approach among patients,
healthcare professionals (HCPs), and
with others such as the industry and
government.
• Pharmacovigilance has moved from
passive surveillance to active risk management requiring the cooperation of
HCPs, patients, and their families.
• Pharmacovigilance is more than just
safety but also about designing a system
to improve the use of all medicinal
products for the benet of patients.
• HCPs have a critical role in ensuring
adequate quality in pharmacovigilance
systems to help meet public health needs
for society.
B. Edwards and A. Caro-Rojas
• Together as a team, we can apply the science of human factors and organisational
learning in the design of better processes
that focus on optimising human performance in the global pharmacovigilance
system.
1 Introduction
Pharmacovigilance is neither one single discipline nor is it conned to experts of a single professional group. It is a multidisciplinary topic,
which refers to the policies, the regulatory
structures, processes, technology, information,
resources, and medicinal products requiring collaboration from various stakeholders within a
complex global sociotechnical system. All this
happens round the clock under the scrutiny ofpoliticians, the public, and, more recently, social
media. This chapter will discuss the role of the
different participants such as healthcare providers
(for example, physicians, pharmacists, nurses,
and dentists), industrial professionals, regulatory
agencies, academics and patients, their families,
and the wider public, and the importance and
opportunities for partnership between them.
Setting up pharmacovigilance systems in various areassuch as hospitals, industry, and regulatory agencies needs different requirements and
approaches. It is important for professionals during their development to understand and appreciate the steps involved in setting up, and
collaborating within, pharmacovigilance systems
at different levels.
2 Why aPharmacovigilance
System Is Essential
toReassure Society About
theEectiveness andSafety
ofMedicines
A successful pharmacovigilance system is key to
help reassure that medicines are effective and
safe regardless of whether they are traditional or
natural medicines, generic versions of well-
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