My talk at the Scientific Research Day of Medical colleges, UQU 5 March 2019 where I presented my publication (Patient-Centered Pharmacovigilance: A review)

1. Patient-Centered
Pharmacovigilance
Dr. Hager Ali Saleh

2. Background
• Pharmacovigilance (PV) is defined as the science and activities
relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug-related problem.
https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/

3. Background
• Patient centeredness is defined as “health care that establishes a
partnership among practitioners, patients, and their families to ensure that
decisions respect patients' wants, needs, and preferences and that patients
have the education and support they need to make decisions and
participate in their own care”.
Agency of Health Care Research and Quality. National Healthcare Disparities Report, Chapter 5. Patient Centeredness

4. Background
• Recently, the patients’ perspectives were incorporated into
pharmacovigilance (PV) activities including Adverse drug reaction
(ADR) reporting, signal detection and evaluation, risk management,
medication error assessment, benefit–risk assessment and risk
communication
• The involvement of patients in adverse drug reactions (ADRs)
reporting is one of patient-centered PV activities.
Smith MY, Benattia I. The Patient’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization. Drug Saf. 2016

5. Background
• New, unexpected and rare ADRs are often discovered when drugs are
used in larger or in a different population than studied during initial
clinical trials.
• Since the early 1960s, spontaneous reporting has been the main
method of notifying adverse reactions where healthcare professionals
(HCPs) are the main source of information.

6. Background
• Because underreporting is a known problem, therefore receiving
reports from patients/ consumers will be an extra source of
information which may help in reducing this limit.
• consumers reporting provides the first-hand information about their
experience with drugs which helps in early detection of ADRs,
especially with over the counter (OTC) and herbal drugs.

7. Background
• Some studies showed that patients identify and report ADRs quickly
and early than HCPs and they provided more information related to
their quality of life.
• Direct patients’ reporting will promote their rights and improve their
involvement in their health management.

9. Methods
• Seven databases were considered to identify relevant publications related to
patients participation on ADRs reporting.
- Google Scholars.
- Medline.
- Academic Search Complete “EBSCO”.
- Health and Medical Complete ProQuest.
- Science Direct- Elsevier
- SCOPUS.
- Wiley online Library.
• Time range were 2010 to 2016.

10. • Papers inclusion criteria were:
1- Papers with clear objectives for examples studies aimed to assess patients’
experiences, analysis the patients’ reports, and any objective compatible with
the presented review objectives.
2- Papers written in English.

11. 3227 relevant
publications
resulted from 7
databases by
using keywords.
• 3174 publications excluded
on the basis of the title.
53 publications
retrieved for
assessment of
abstract.
• 22 publications excluded,
irrelevant or unclear
objective.
31 full text
obtained
18 publications
retrieved for
assessment of
full article.
11
publications selection process from the selected databases.
Results (1): Articles selection process
• 13 duplicate
articles

12. Results (2): Articles according to the
countries of the studies12
0
1
2
3
4
5
6
7
8
9

13. 13
Results (3): articles according to the study
technique
0
1
2
3
4
5
6
7
8
9
10
11
12
Descriptive retrospective analysis of patients’ reports prospective observational study

14.  Patients were unaware of the existence of PV system (44.1%), they believed
that drug prescribed physicians were completely safe, and physicians are
responsible for any side effect that occurred (67.9% and 70.8%, respectively).
 Patients believed that they would benefit from reporting, (range 51%-
93.7%) and stated that they felt responsible for reporting, (range 27.8%-
92.5%).
 Patients reported between 1 to 5 symptoms, (range, 19.4% - 59%) and they
stated that the report form was easy to complete, (93.6%).
 Patients identify the ADRs by sitting a relationship between time of starting
the drug and the reported symptoms, (range, 16.7%- 74%)
14
Results (4): Patients’ knowledge, attitude,
and experience with ADRs reporting:

15. 15
Results (5): Methods of patients’ reporting
of ADRs
Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014 Jun;37(6):409–19.

16.  Patients tended to report a significantly higher number of suspected
ADRs per YC report than HCPs where the median was (3 [2–5] and 2
[1–3], respectively).
 The combination of data from patients and HCPs reports identified an
extra 508 signal.
 (74.8%) of reports included at least one aspect of association of the drug
and the symptom.
 Reports were classified as serious, medically serious, and non-serious
ADRs (2.3%, 6.2%, and 91.5%, respectively). Moreover, 91.3% of
serious ADRs were ranked as possible
16
Results (6): analysis of patients’ reports

17. Results (7): Encouraging factors and
barriers of reporting
Why did patients report? Why did patients not report?
- The ADRs were serious.
- They were worried about their situation.
- They wanted to share their experience
and to be heard.
- They wanted actions to be taken.
- They want extra information.
- The ADR was not mentioned in the
leaflet.
- Someone tell them about the possibility
of reporting.
- A family member assists them to report.
- The side effect was not serious.
- The side effect was expected or known.
- They were discouraged by someone.
- They discouraged by their GP.
- An HCP refused to make a report on their
behalf.
- Their GP were unaware of direct patient
reporting.
- The lack of personal feedback.
17

18. Results (8):Patients’ suggestions for
improvement
18
 Greater publicity and promotion of the scheme by HCPs.
 Wider availability and accessibility of the reporting forms.
 Suggestions for improvement to the forms:
1. More space.
2. Simplifying questions.
3. Simpler language.

19. Discussion (1)19
Patients have inadequate knowledge and attitude regarding ADRs
reporting and drug safety
 Although we are in the era of technology, only one country used
text messages and 3 countries used application for mobile devices as
means of reporting.
 The quality of patients’ reports were relatively good and no major
qualitative differences between patients and HCPs’ reports.
Furthermore, patients reported a significantly higher number of
suspected ADRs when compared to HCPs’ reports

20. Discussion (2)20
 Where, HCPs are considered the prime source of information for
patients, it is necessary to improve their awareness, attitude
regarding direct patients reporting, and their culture about the
partnership with their patients and encourage HCPs to involve their
patients may by incentives, education, and decrease their
workload.
 HCPs should encourage their patients to report, educate their
patients about how to report and how to identify the ADRs.

21. Discussion (3)21
 Due to the leap of using social media and technologies we can
exploit it in increasing patients’ awareness through sending text
messages, phone calls, and reminders emails to patients to encourage
them to speak up and establishing mobile applications to be means of
reporting.
 PV centers may establish their own twitter and Facebook accounts
to spread the culture of reporting to the community, and patients may
report to these accounts.
 It is needed to establish projects for data mining of safety
information published by the community through the social media.

22. Discussion (4)22
 The means of reporting should be well known, easily
accessible, have enough space and have a simple language.
 Information from patients’ reports should be available to them
through PV centers’ websites or newsletters.

23. Conclusions
• This review provided data about patients’ KAP, quality of patients’
ADRs reporting, and direct patients reporting status in many
countries.
• It showed poor knowledge and inadequate attitude of patients about
ADRs reporting.

24. Conclusions
• It provided information about how to improve ADRs reporting by
patients.
• It enforced the need for patients’ education and health care
professionals training about the patients partnership.

25. Thank you