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Abstract
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first_page
Introduction
Methods
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Open Access Article
Results domain=www.mdp
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Discussion
Understanding
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Conclusions Patient Needs Regarding
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Adverse Drug Reaction Reporting
announcement
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Author
Contributions
Smartphone
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Applications: A Qualitative
Funding Help
lensInsight from Saudi Arabia

Institutional
by Review Cite
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Board
Lamyaa M. Kassem (https://sciprofiles.com/profile/1248400?utm_source=mdpi.com&utm
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(mailto:l.mahmoud@qu.edu.sa) (https://orcid.org/0000-0003-1673-5303),
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Bushra Alhabib (https://sciprofiles.com/profile/author/bWRGd3JtUDZ1UmxvREpWQ2h4UT
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(mailto:bushra.e.alhabib@gmail.com),
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Khaledah Alzunaydi (https://sciprofiles.com/profile/author/SEtJS1hvWUkvdzBMaWo0dWR
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 (mailto:khaledah_abdullah@hotmail.com) and
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Maryam Farooqui (https://sciprofiles.com/profile/2345256?utm_source=mdpi.com&utm_m
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 (mailto:m.farooqui@qu.edu.sa) (https://orcid.org/0000-0002-3380-5855) Endorse
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Acknowledgments
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Conflicts
Department of Pharmacy Practice, Unaizah College of Pharmacy,
of Comment
Qassim University, Unaizah 51911, Saudi Arabia
Interest
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References
Int. J. Environ. Res. Public Health 2021, 18(8), 3862;
https://doi.org/10.3390/ijerph18083862 zoom_out_map (/toggle_desktop_layout_cookie)
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(https://doi.org/10.3390/ijerph18083862)
Submission received: 7 December 2020 / Revised: 28 March 2021 /

Accepted: 31 March 2021 / Published: 7 April 2021
(This article belongs to the Special Issue Health Care and Health
Services Digital Revolution (
/journal/ijerph/special_issues/Care_Services_Digital ))
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Abstract
Background: A pragmatic shift in the

zoom_out_map
healthcare
characterized by moving from curative to preventive approaches
sector
searchmenu
highlights the role of pharmacovigilance in patient safety. There
have been few published studies on patient reporting of adverse
drug reactions (ADRs) in Saudi Arabia. This qualitative study aims
to explore the community opinions and the need for patient-
friendly smartphone applications (SPAs) to enhance their
participation in ADR reporting. Methods: Purposeful sampling was
followed to recruit study participants, a semi-structured interview
guide was used to conduct interviews, and the saturation was
reached after the 13th interviewer; no new information was
obtained after two subsequent interviews. All the interviews were
audio-recorded, transcribed verbatim, and analyzed by means of a
standard content analysis framework. Results: As per the WHO
guidelines, eleven participants were aware of the term “ADR”. All
the participants denied receiving any prior education and
attending events about ADRs and were unaware of the Saudi FDA-
ADR reporting systems. The use of technologies such as SPAs
has been widely accepted with a high level of concern for data
confidentiality and privacy. Conclusions: These findings point out
the need to build patient-oriented educational programs to
increase their awareness of ADR reporting and to prioritize the use
of artificial intelligence (AI) to be integrated in the Saudi
healthcare system to develop future SPAs for improving both
patient safety and signal detection of ADRs.
Keywords: adverse drug reactions (/search?
q=adverse+drug+reactions); reporting system (/search?
q=reporting+system); technology (/search?q=technology);
patient (/search?q=patient); healthcare professionals (/search?
q=healthcare+professionals); KSA (/search?q=KSA); qualitative
(/search?q=qualitative)
1. Introduction
The World Health Organization (WHO) and the European

Union recognized the importance of patient self-reporting of ADRs
[1]. Historically, spontaneous reporting (SR) of ADRs was
performed only by healthcare professionals; however, patient
(/)
engagement is the latest step towards more effective
pharmacovigilance (PhV). Patient reporting of ADRs has been
zoom_out_map
described in the literature as a noteworthy resource of collecting searchmenu
new data about the safe use of drugs. The patients’ first-hand
reports have been issued in Europe since 2010 according to the
European PhV legislation (Directive 2010/84/EU) which
introduced a new framework for drug surveillance and proposed
valuable changes to improve drug safety [2]. The patient ADR
reporting system is well-established in some developed countries
but has not yet been adopted in most countries including the
developing countries [1]. Policymakers around the world are
making tremendous efforts to develop an innovative healthcare
technology holding a considerable promise for the future of PhV
[3,4]. Over the last decades, several patient-friendly SPAs have
been developed and incorporated into the patient day-to-day life in
different healthcare and services sectors. The Food and Drug
Administration (FDA) has expressed increased concerns over
health informatics including SPAs, and the entities concerned
decided that all health applications have to be monitored and
regulated by the FDA. Christy Foreman, FDA Director of the
Product Assessment Office, said, “The FDA finds it necessary to
take a balanced approach to mobile medical devices, which
encourages innovation and ensures proper patient safety.”
Examples of the best FDA-approved and -certified patient-friendly
mobile health SPAs are as follows: AliveCor, Well Doc’s Diabetes
Boss, Welch Allyn iExaminer Adapter Ophthalmoscope, and
AirStrip ONE [5]. Patient reporting adds new information on ADRs
that are not widely available otherwise. This can help improve the
legislative decision-making processes. A systemic review of
patients reporting to the PhV system conducted by Inácio et al. (of
a total of thirty-four trials) showed that patient reporting is useful
in providing a detailed description of ADRs where patients often
explain the extent and impact of ADRs on their daily lives [1]. As a
part of the WEB-RADR pharmacovigilance project, WEB-RADR
introduced mobile applications to enable patients, caregivers, and
healthcare professionals to report adverse drug reactions (ADRs)
and receive medication updates and news notifications. The Med
Safety smartphone application released by the collaboration
between WEB-RADR and the WHO, the Medicines and Healthcare
products Regulatory Agency (MHRA), and the Uppsala Monitoring
(/)
Center (UMC) has been launched in Burkina Faso, Zambia,
zoom_out_map
Armenia, Ghana, Ethiopia, Botswana, Ivory Coast, and Uganda.
There are also some country-specific SPAs such as MHRA (UK), searchmenu
Lareb (the Netherlands), and Halmed (Croatia), and they
constantly contribute a lot to the flourishing mobile health
industry [6]. In general, smartphone applications aim to benefit
patients and thus improve treatment outcomes. Several
technologies have been successfully used to achieve those
therapeutic goals in terms of communication with patients [7] and
monitoring and improving patient compliance [8] like asthmatic
patients’ adherence [9] and monitoring [10]. Smartphone
applications are also used for patient education [11] and diabetic
patient care [12].
Convergence of healthcare and information technologies
provides promising new trends to improve access to high-quality
healthcare services at affordable prices, thus helping meet
evolving customer needs [13]. To achieve this goal, Saudi Arabia is
creating a new, independent, and evidence-based health
technology assessment (HTS) agency to help it optimize health
benefits by using the resources efficiently. The KSA is undergoing
a major healthcare transition to achieve its own new national
“Vision 2030” [14]. The Ministry of Health (KSA) utilized a number
of public-targeted applications to enforce the COVID-19 curfew
and track contagious cases and increase public safety, such as
Tawakkalna, Tabaud, Mawid, Sehaty, and Tetamman. Those
applications have all been successfully used by all the citizens in
Saudi Arabia [15,16]. A patient ADR reporting form (online) was
developed by the Saudi FDA several years ago but has not been
promoted yet [17,18]. Given the monthly reporting list of Saudi
Food and Drug Authority (SFDA) hospital ADRs (May 2020), only
42 out of all the Saudi hospitals reported 1819 ADRs, with six
hospitals reporting hundreds of ADRs, nine hospitals reporting up
to 100 ADRs, and only one ADR reported by most hospitals in one
month. SFDA ADR lists released by the agency’s official LinkedIn
page do not contain a single patient self-report [19]. The latest
published statistics (2019) indicated that the number of
smartphone users in Saudi Arabia is estimated to reach 28.8
million, which the higher authorities have taken into account when
introducing and generalizing new laws to meet the new population
needs and the 21st century technologies; moreover, the number of
(/)
smartphone users is expected to increase further in the Middle
zoom_out_map
East [20]. Despite the increasing number of smartphone users in
the KSA and the Middle East and the presence of well-established searchmenu
pharmacovigilance centers in the KSA as well as in many Gulf
countries, the ADR reporting is dependent on HCPs and hospitals
and patient self-reporting has not been highlighted yet. Patients’
involvement in reporting improves signal detection and both drug
and patient safety. The patient needs regarding portable ADR
reporting tools have not been well-explored among the Saudi
population and there are no previously published studies to
address their needs and highlight the importance of developing a
patient-friendly ADR reporting smartphone application. With
regard to launching a new patient care service that improves
medication safety, we conducted the current study. The objective
of the study was to address the actual patients’ and community
needs in the context of patient-friendly ADR reporting. Through
this qualitative study, we can deeply explore the real needs of the
patients and population regarding ADR reporting and their
awareness, intentions, and attitudes towards using information
technologies (IT) and technological smartphone applications.
2. Methods
2.1. Study Setting and Design
This qualitative study was conducted at Unaizah College of

Pharmacy (UCP), Qassim Region, KSA. Adverse drug reactions
and attitudes towards using technology are likely to be perceived
contrarily by different patients; the social constructivism paradigm
was adopted [21]. The typical examples of elements found
important by participants were illustrated by quotes.
2.2. Ethical Considerations
This study was approved by the Qassim University’s Research

Ethics Committee (No. 20-05-06). Prior to the interview,
information regarding their voluntary participation, anonymity, and
right to withdraw at any time was provided to all the participants.
The authorized informed consent to the recording and use of
transcripts of the interviews for research purposes was received
from each participant. The data were analyzed after participants’
approval of their respective interview transcripts. All the data were
(/)
properly transcribed, safely stored, and read by authors only to
maintain privacy and confidentiality.
2.3. Sampling and Recruitment
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For the present study, participants were selected from
Unaizah College of Pharmacy (UCP) between January and March
2020. Staff members aged between 18 and 65 years including
both administrative and academic staff were invited to
participate. Participants who were familiar with smartphone
applications and had previous personal, family, or friends’
experience with ADRs were specifically included. The purposeful
sampling technique was adopted to look for information-rich
cases. We approached the participants at their offices and briefed
them about the study objectives. The participants were also
informed about the nature of qualitative interviews and the
consent was obtained to record the interviews. Those who
declined to be recorded were excluded. Since the staff members
were from different age groups with different socioeconomic
status and educational background, we believe that we were able
to recruit a representative population. All the participants were
provided with a study information sheet in Arabic (the national
language), while verbal information was also provided as per
participant’s request. Sampling continued until the theoretical
saturation was believed to have been achieved and no new
information was added. Two subsequent interviews were
conducted to confirm saturation; however, they were not included
in the final analysis. The interview time and place were chosen
according to the participant’s preferences.
2.4. Study Tool
For the data collection purpose, a comprehensive literature

review [22,23] and consultations with experts in the field were
undertaken to develop a semi-structured, open-ended questions
interview guide (Table 1). The interview guide consisted of
possible questions to assess patient expectations, understanding,
and experience with ADRs. Most of the questions were open-
ended as they offer the best opportunity to represent views of the
participants and allow a deeper grasp of the related issues. After
several rounds of consultations, the preliminary draft of the
interview guide was reviewed by the authors and modified
(/)
accordingly. To ensure that the set of questions developed was
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useful for objective information retrieval, pilot interviews were
conducted with five participants. Those included during piloting searchmenu
were excluded from the final analysis. The draft interview guide
was updated again based on the specific observations during the
pilot interviews. Cohen’s kappa coefficient (κ) was used to ensure
the degree of agreement [24]. Participants’ demographics and
other relevant data such as the type of ADRs were also recorded
in a separate datasheet.
Table 1. Interview guide.
2.5. Procedure and Interview Process
Face-to-face open-ended interviews were conducted in Arabic

by the principal investigator (L.K.). The other two researchers
(B.H. and K.Z.) attended the interviews to take notes and to
facilitate the interview process. Interviews were audio-recorded.
Verbatim transcriptions were in formal Arabic and translated to
English for individual interview sessions following forward and
backward revision between two authors (L.K. and M.F.) with the
help of an English expert in English translation. Transcripts were
shared with the respective study participants for their approval.
2.6. Data Coding and Analysis
Finally, after the receipt of verbatim transcripts from the

participants, a thematic content analysis framework was used to
analyze the data and assist in identifying evolving categories
(themes). All the themes initially identified by the principal
investigator were examined by an independent experienced
qualitative researcher. The parts of transcripts related to the study
were chosen as meaning units. As per Graneheim and Lundman,
meaning units are described by their content and context as
“words, sentences, or paragraphs containing aspects of the other”
[25]. The units of meaning were stratified and counted, and codes
were then categorized according to the particular meaning of the
(/)
text (Table 2) [25]. Coding and categorization were frequently
zoom_out_map
discussed within the study team to verify validity and adequacy of
codes and categories.
searchmenu
Table 2. Example of coding process.
3. Results
3.1. Demographic Data of the Participants
A total of 15 participants (P1–15) aged between 18 and 65

years (mean = 34 years), including 9 (60%) females and 6 (40%)
males, were interviewed. Table 3 demonstrates the detailed
demographic distribution of the participants.
Table 3. Demographic data of the participants.
3.2. Main Themes
Thematic content analysis revealed three major themes: (1)

experience with ADRs, (2) identification and needs of participants
regarding ADRs, and (3) awareness of ADR reporting systems and
opinions on the use of technology in ADR reporting. Seven
subthemes were as follows: (i) familiarity with ADRs, (ii) ADR
experiences and actions taken, (iii) certainty of the symptoms, (iv)
prior knowledge about ADRs, (v) awareness of international and
the Saudi FDA adverse drug reaction reporting (SFDA-ADR)
systems, (vi) opinions on the role of information technology (IT) in
ADR reporting, and (vii) preference to have a free or paid ADR
supporting service.
3.2.1. Participants’ Experiences, Identification, and Needs
When the patients were asked if they had suffered ADRs, not
(/)
all the participants had ADRs on their own, but they were all ready
to talk about them because they observed ADRs as a usual
zoom_out_map
problem among their family members and friends receiving searchmenu
medication.
P4: “Not me, I heard from my mother that after taking her
antihypertensive medication, she had a cough that was never
relieved even with an inhaler.”
P10: “No, personally, it has never happened to me, but I’ve seen
this situation many times with my family and friends who would
go to the prescriber or just quit taking the medication because of
the seriousness of the side effect.”
3.2.2. Meaning of ADRs

They all describe ADRs with the same interpretation as the
WHO definition of ADRs.
P4: “Side effects are harmful effects of drugs, which sometimes I

can’t differentiate from the symptoms that may be caused by my
illness.”
P7: “Nasty unpleasant drug effects that make the patient

dissatisfied with treatment in such a way that they can quit all
medication.”
P14: “Any drug has benefits and risks and, if consumed in a larger
amount than required, will cause bad effects.”
3.2.3. ADR Experiences

Participants provided varying levels of experience with ADR
severity, ranging from mild to serious. Some experienced minor
ADRs which they managed by changing to other therapies, but
others (three participants) quitted taking drugs and started
looking for herbal medicines.
P12: “I assume that if I stop taking the recently used drug, this
unwanted effect will resolve.”
(/)
P13: “I believe that ADRs are not as severe as the patient’s
zoom_out_map searchmenu
condition and if they are certain to harm the patient and worsen
health, the doctor surely will not prescribe such a drug to the
patient.”
3.2.4. Severity of ADRs

Some patients described the fact that ADRs affect
compliance, as carrying medicine along or swallowing it was
difficult due to the fear of experiencing ADRs. Finally, some
mentioned that despite recognizing that these ADRs are not likely
to be risky, they nevertheless have faith in the physician
intervention. The decision to proceed or quit using the medicine
after a patient encountered ADRs varied depending on the severity
of the ADR. The patients used to receive their medication details
from the insert or the Internet or by seeking help of doctors or
pharmacists at hospitals and pharmacies.
P3: “Yeah, after using some analgesics, I used to have abdominal

pain, and I read that it’s a normal analgesic effect if I take them on
an empty stomach, so I started taking them only after a meal.”
P5: “Ammm, don’t remind me of this incident, my mother was

about to die after a penicillin injection, it was a very difficult time
until she was saved at the hospital, I ‘m scared if me or anyone in
my family gets sick just because of the fact that we’re going to
take medications.”
P10: “Sure, muscle pain and extremely dry mouth after about six
months of using cholesterol medication Crestor and I went to a
doctor who forwarded me to another doctor.”
3.2.5. ADR Counseling

When we asked the participants if they had already received
or engaged in patient education services, activities, or awareness
campaigns about ADRs, almost all (12) the participants claimed
that they had not received or attended any events regarding
patient education on ADRs; they indicated that their doctors only
discussed the ADRs after they had already occurred. The patients
thought that perhaps implementing some patient education
(/)
programs about ADRs may result in better patient compliance and
zoom_out_map
bring a positive aspect to medication safety. The participants’
responses thus reflect their need for counselors or healthcare searchmenu
professionals (HCPs) to assist them with ADRs.
P6: “No, only after I returned back to my physician, he told me that

these drowsiness and continuous nausea are usual side effects
with contraceptive pills which I wasn’t comfortable with and I
decided to use an IUD, and then I asked him if there were any
adverse effects if I used an IUD, he said no, but after using an IUD,
my cycle became so heavy with abdominal cramps, my sister said
it was normal after an IUD, and I’m not sure it might be natural IUD
action to prevent pregnancy or it was a usual side effect.”
P9: “No, there’s always no one concerned in educating me about

the adverse effects of our prescribed medications, they can only
teach us how to use them.”
P10: “I attended one adverse drug event at a mall.”
3.2.6. Participants’ Awareness of the SFDA Adverse Drug Reaction

Reporting System
Most of the participants (9) were unaware of such health
service and some were genuinely surprised to know the existence
of online SFDA-ADRs patient reporting system which
demonstrates a lack of promotion for the ADR reporting system
for patients.
P3, P4, P5, P10, P13: “I have no idea.”
P4: “Mmm.... Is there a way I can disclose my adverse reactions?”
P6: “Are you sure we have this service in the KSA, if it’s there, why
doesn’t anyone address the patients so they can benefit?”
P14: “Yes, I think Europe has a Yellow Card reporting system.”

(/)
P15: “Yeah, I still call 937, I think it is the only service that the
Saudi Ministry of Health can help with, save time and provide me
with a reliable service.”
3.2.7. Opinions on the Use of Technology in ADR Reporting

The majority of the participants (11) liked the concept of
using technology such as smartphone applications to get
treatment for their ADRs; only two participants declined to use
technology and expressed an interest in seeking face-to-face
assistance by going to a healthcare setting; these two participants
were over 60 years old, which explains their resistance to coping
with technology.
P1: “Good and useful, it will help reduce the risk and incidence of
adverse effects on patients as it will provide advice to patients
with medications.”
P6: “Woow, will help reduce patient anxiety, they will be able to
seek help from doctors, pharmacists anytime.”
P7: “I think it will help people who suffer and worry about the
harmful effect of their medicines.”
P10: “It will help patients and reduce congestion in hospitals and
attempts to take appointments to see doctors again.”
P12: “Well, technology has become an essential part of our day,

and a rapid answer to our health problems via phone is good.”
P13: “I think it’s going to be very good because it will promote the
century of speed and help a lot of people.”
P15: “I don’t like technology, and I don’t feel comfortable with it,
and I prefer to have a phone call service that makes me feel safer.”
3.2.8. Preference to Have a Free or Paid ADR Supporting Service

As expected, only few participants (3, 20%) accepted the idea
of having a paid ADR reporting service on their cell phones but
preferred it as a free service; more than half (8, 53%) of the
(/)
participants preferred to have a free service, while two (13%)
participants agreed to pay for the service if they would receive
zoom_out_map
postal prescription care which also reflects their needs to receive searchmenu
educational advice from healthcare professionals regarding
proper and safe use of medication.
P1: “Of course, if free, but if costs a little, no problem.”
Another participant despite being willing to pay for such

services preferred to have it free.
P11: “I can pay for it, but I would like a free service.”
It is also noticeable that patient’s monthly income status

could be a confounding factor in accepting or rejecting such
services.
P12: “No, I won’t use it if it is paid because I can contact the

doctor or a pharmacist, they will direct me for free. Free service
will be more suitable for low-income patients.”
P10: “Depending on the need, for example, some people cannot

pay, so the service should be free, and there are people who can
pay fees. I suggest that fees are optional, maybe to receive other
services through the app.”
If paid service, patients prefer to receive some extra services

in addition to reporting of ADR. Although no further information
could be obtained in the regard it could be assumed that patient
may expect further advice on what to do next after reporting ADR.
P13: “If just reporting, a small fee can be charged, or it should be a

free service, and in case of providing me with extra services other
than reporting, I think I should pay a fee.”
P13: “If the patient reports ADRs, better if they are not charged,
but if the patient can receive additional services such as follow-up
or monitoring, I think it should be paid.”
Since the Saudi Ministry of Health offers a hotline service for
(/)
patients to contact in case of emergencies, some of the
zoom_out_map
participants preferred to upgrade the same service with ADR
reporting facilities.
searchmenu
P15: “I prefer it free, because we have a hotline number (937)
which is a free service provided by the Ministry of Health that we
can ask about any patient problems.”
Interestingly, a perception that a paid service would be more

efficient and effective than the unpaid one was observed.
P4: “I believe the paid service is going to be more professional.”
P9: “I wish the service to be charged so it can remain in place for

long, and I believe that a small fee can be applied so that everyone
can afford it.”
4. Discussion
With the growing dependence on medication therapy as the

primary intervention for most illnesses, patients are exposed to a
potential harm of their medications. Successful therapy is to
achieve the required medication treatment outcomes with the
least possible ADRs or toxicity which emerge in the field of
medication safety and related aspects. Technology plays a great
role in the way Saudi Arabia successfully manages COVID-19
where most governmental services have been smoothly
transformed to remote work using technology and smartphone
applications which support our idea of the need in developing a
patient-friendly tool for ADR reporting. The widespread use of
mobile phones among all genders and ages has paved the way for
the future adoption of this technology. The future objective is to
use technology to involve patients in spontaneous reporting of
ADRs, thus engaging health professionals in regular monitoring of
treatment, which improves patient safety and reduces therapy
costs. This will boost identification of ADRs at the national level
and will open up a new horizon for research to understand and
prevent different ADRs. A recently published national study (R.A.
Almubark et al., 2020) for community-based adverse drug
reactions in Saudi Arabia targeting community pharmacy visitors
(/)
estimated that over a quarter (28%) of the sample in the KSA
zoom_out_map
experienced symptoms of at least one ADR in the previous year,
which is higher than the prevalence in similar studies in Sweden searchmenu
(7.8%) and Italy (9.9%) [26,27]. Consumer reporting could become
crucial for the developing countries to implement a proper and
efficient PhV system that could reduce morbidity and mortality as
well as the economic burden of ADRs [28]. Patients’ participation
in the ADR reporting process has been shown to increase
spontaneous ADR reporting, which can directly or indirectly
minimize hospitalization rates, improve patient health services,
increase the safety of medication use, and, as a result, reduce the
cost of therapy, advance the national signal detection of ADRs,
and encourage the pharmacogenomic studies which will help to
understand the risk factors of serious ADRs similar to the
SWEDEGENE national study [29,30]. The content analysis of our
study revealed that the participants realized the high level of harm
that may arise from ADRs and were interested in discussing and
obtaining information about them. They expressed their needs to
receive an appropriate and prompt care regarding their ADR
events. Most participants were not aware of adverse drug reaction
reporting systems and they welcomed the use of technology to
report ADRs and receive care. While not all the participants had
previously had ADRs, they were uncertain about sufficient
understanding of ADRs; they mentioned their witnessing of
different ADR events with their close family members and friends,
in line with the findings of the questionnaire-based study by
Ibrahim Sales et al. regarding public awareness of ADRs in Riyadh,
KSA [31]. Although the majority of the participants talked about
mild-to-moderate ADRs, those who suffered severe ADRs still
remembered all details of the events, even the generic or brand
name of the possible causal active ingredient. Regarding the
occurrence of ADRs, the patients were uncertain whether the new
symptoms had been related to their disease or to the newly
administered medication. They needed to take a fast action, but
they did not know whom they should call to receive the best result.
The most commonly taken action by the majority of them
was to stop taking the drug with the highest possibility to cause
the event or to stop the treatment which caused the ADRs for sure
and could aggravate their health status altogether. Some started
to read the pamphlet insert of the medication or scour the
(/)
Internet; some would rather ask their family physician or
zoom_out_map
pharmacist, look for help at hospitals or pharmacies, or dial the
Saudi healthcare phone service “937.” While the participants searchmenu
reported that they proactively asked their healthcare providers for
information on their drugs and use them as an ADR resource,
most physicians did not actively encourage their patients and
consumers to report ADRs. Although the vast majority of health
professionals recognize the importance of ADR reporting, their
knowledge of the reporting system and reporting of ADRs in Saudi
Arabia are insufficient [32]. There is a hotline phone number of the
National Drug Information Center of the Saudi Ministry of Health,
“937,” which started to deliver pharmaceutical care services and
respond to public and professional inquiries in December 2013
[33].
Vander Stichele et al. (1991) concluded that medication
package inserts [34] usually provide simple instructions for
indications, proper use, dosing, precautions, potential adverse
reactions, and comprehensible risk information. These
information pieces affect the patients’ understanding, evaluation,
and management of medication risks [35]. To date, most patients
get information they want about the medications from the drug
insert. However, most patients may not read the patient
information insert and ultimately become confused about the new
side effects they may encounter [15]. The effect of witnessing
ADRs on patient understanding of drug usage varies depending on
the nature of the incident they have had. Many of them have tried
to avoid future use of medication and have opted for taking herbal
remedies or other alternative medicines [36]; others agreed that
they had to tolerate ADRs as they would have got worse if they
quitted the medication [37]. Patients and their caregivers should
be educated about the warning signs of potential ADRs, when,
who, and how to call and seek help to identify complications.
Patient awareness of ADR reporting is vital to improve safety and
signal detection. All the patients denied receiving education about
ADRs, attending any events about ADRs or rational use of
medications; they also denied their awareness of the ADR
reporting system in the KSA [38]. Physicians only take the
initiative to discuss ADRs after they have happened and that will
never benefit patients and may increase the risk of serious
adverse effects which, unluckily, may affect the treatment plan
(/)
and increase the cost and duration of therapy [39].
zoom_out_map
The only drawback in using this patient online form is the
detailed information that the patient should fill which mainly searchmenu
includes medical terms, which makes it difficult to be understood
by regular patients with little medical background and so
discourages patient self-reporting. Adverse drug reaction
reporting is mainly dependent on spontaneous reporting systems
that may be paper based (e.g., the UK’s “Yellow Card” system) or
based on electronic (online or mobile) applications. Regarding
awareness of the ADR reporting system, the results of this study
reflect those found in a systematic review of poor patient
awareness of ADR reporting systems. It is important to point out
that the SFDA system seeks to facilitate the online or telephonic
movement of ADR patient reports directly to the system. On the
other hand, some systems are mainly targeted at clinicians, which
tend not to improve patient awareness about such systems
[31,40].
The reference data on the patient needs to receive treatment
via ADR reporting technologies from related KSA studies are not
available. The majority of the participants supported the view that
using technology in ADR reporting would save time and effort,
where they would be able to obtain medical services and advice
from anywhere and at any moment; however, few objected to the
idea of using technology; they did not know how it would help
them; they want to meet their healthcare providers face to face.
We received participants’ reactions to the concept of having an
ADR smartphone application, where they felt relaxed, safe, and
efficient, commented that they liked the concept, and welcomed
such smartphone application ADR reporting. Some worried about
how they would get their necessary care and preferred that the
service was supported by or was maintained under the guidance
of the Health Ministry. The participants varied in reaction to the
cost; the majority of participants would never mind paying either a
little or any amount of money to receive a service that would save
their lives and save them while using medication, and some would
like it to be provided as a free patient care service. There are
hundreds of regional and international studies assessing
knowledge, attitudes, and perceptions of ADR reporting among
health practitioners (physicians, pharmacists, and nurses). Most
of these studies demonstrate poor practice, knowledge, and lack
(/)
of experience in reporting [41]. It was made compulsory for HCPs
zoom_out_map
in Europe by 2012 to report any ADRs suffered by patients, thus
improving the practice of ADR reporting. If the quality of ADR searchmenu
reporting by HCPs is poor, how will the patients become aware of
it? [42] ADR reporting has dramatically improved at the
international level over the last few years, but it is still emerging in
the KSA [26,43,44]. Implementation of clinical pharmacy services
at hospitals and awareness raising of the role of clinical
pharmacists in patient education may contribute to improving
ADR reporting and patient safety [45,46]. The key strength of this
study is that it was the first population-based assessment of ADR
reporting needs and preferences for using technology in the
reporting process. Qualitative research has a limitation that data
are not mathematically evaluated but rely on opinion and
judgment. The minimal analysis includes the risk of collection and
recall bias. Further studies should include opinions higher
authorities and healthcare providers and institutions towards the
possibility of integrating patient-centered ADR reporting
technology in the system. The participants were aware of the high
level of harm that may arise from adverse drug reactions, which
they were eager to discuss and gather information about. They
expressed their need to take prompt care of their adverse drug
reaction events. Most participants were not aware of adverse drug
reaction reporting systems and agreed to the use of technology to
report and receive treatment. The widespread use of mobile
phones among all genders and ages in the population has opened
up space for its integration. The authors assume that educational
campaigns to increase awareness of the benefits of ADR
reporting would be a step forward in the field of
pharmacovigilance. Furthermore, a strict law that requires HCPs
to escalate any patient-reported ADRs should be enforced; this
can further highlight the role of pharmacists in the field of
pharmacovigilance.
5. Conclusions
The results of this study show that while the public is eager to
gain information about ADRs and take advantage of ADR
reporting, their comprehension of ADRs is insufficient and they
still need training and support. Thus, the future goal should be to
(/)
use technology to involve patients in ADR reporting, to increase
zoom_out_map
the national signal identification of ADRs, and to provide a new
research pathway for understanding and prevention of various searchmenu
ADRs.
Author Contributions
L.M.K. was the principal investigator of this study who

developed the concept and made substantial contribution to the
research project planning and manuscript writing. B.A. and K.A.
helped with data collection, transcription, and preparation and
revision of the final manuscript. M.F. contributed to the study
concept and design, manuscript revision for intellectual concepts,
and final approval of the manuscript. All authors have read and
agreed to the published version of the manuscript.
Funding
This research received no external funding.
Institutional Review Board Statement
The study was conducted according to the guidelines of the

Declaration of Helsinki, and approved by the Committee of
Research Ethics, Deanship of Scientific Research, Qassim
University (protocol code 20-05-06, 16 February 2020).
Informed Consent Statement
Informed consent was obtained from all subjects involved in

the study.
Data Availability Statement
Data supporting the findings of this study are available from

the respective author on request. The information is not available
to the public due to privacy or legal constraints.
Acknowledgments
(/)
The authors gratefully acknowledge those who agreed to

participate in this study.
searchmenu
Conflicts of Interest
The authors declare no conflict of interest.
Abbreviations
ADRs Adverse drug reactions
WHO World Health Organization
MHRA Medicines and Healthcare products Regulatory Agency
UMC Uppsala Monitoring Center
SPAs Smartphone applications
FDA Food and Drug Administration
SFDA Saudi Food and Drug Authority
SRS Spontaneous reporting systems
EU European Union
PhV Pharmacovigilance
KSA Kingdom of Saudi Arabia
HCP Healthcare professional
IT Information technology
UK United Kingdom
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Kassem, L.M.; Alhabib, B.; Alzunaydi, K.; Farooqui, M.
Understanding Patient Needs Regarding Adverse Drug Reaction
Reporting Smartphone Applications: A Qualitative Insight from
Saudi Arabia. Int. J. Environ. Res. Public Health 2021, 18, 3862.
https://doi.org/10.3390/ijerph18083862
AMA Style
Kassem LM, Alhabib B, Alzunaydi K, Farooqui M. Understanding
Patient Needs Regarding Adverse Drug Reaction Reporting
Smartphone Applications: A Qualitative Insight from Saudi Arabia.
International Journal of Environmental Research and Public Health.
2021; 18(8):3862. https://doi.org/10.3390/ijerph18083862
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Kassem, Lamyaa M., Bushra Alhabib, Khaledah Alzunaydi, and
Maryam Farooqui. 2021. "Understanding Patient Needs Regarding
Adverse Drug Reaction Reporting Smartphone Applications: A
Qualitative Insight from Saudi Arabia" International Journal of
Environmental Research and Public Health 18, no. 8: 3862.
https://doi.org/10.3390/ijerph18083862
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lensInsight from Saudi Arabia

Submission received: 7 December 2020 / Revised: 28 March 2021 /

Background: A pragmatic shift in the

The World Health Organization (WHO) and the European

2.1. Study Setting and Design

This qualitative study was conducted at Unaizah College of

This study was approved by the Qassim University’s Research

For the data collection purpose, a comprehensive literature

Table 1. Interview guide.

2.5. Procedure and Interview Process

Face-to-face open-ended interviews were conducted in Arabic

Finally, after the receipt of verbatim transcripts from the

3.1. Demographic Data of the Participants

A total of 15 participants (P1–15) aged between 18 and 65

Table 3. Demographic data of the participants.

3.2. Main Themes

Thematic content analysis revealed three major themes: (1)

3.2.2. Meaning of ADRs

P4: “Side effects are harmful effects of drugs, which sometimes I

P7: “Nasty unpleasant drug effects that make the patient

3.2.3. ADR Experiences

3.2.4. Severity of ADRs

P3: “Yeah, after using some analgesics, I used to have abdominal

P5: “Ammm, don’t remind me of this incident, my mother was

3.2.5. ADR Counseling

P6: “No, only after I returned back to my physician, he told me that

P9: “No, there’s always no one concerned in educating me about

P10: “I attended one adverse drug event at a mall.”

3.2.6. Participants’ Awareness of the SFDA Adverse Drug Reaction

P3, P4, P5, P10, P13: “I have no idea.”

P4: “Mmm.... Is there a way I can disclose my adverse reactions?”

P14: “Yes, I think Europe has a Yellow Card reporting system.”

3.2.7. Opinions on the Use of Technology in ADR Reporting

P12: “Well, technology has become an essential part of our day,

3.2.8. Preference to Have a Free or Paid ADR Supporting Service

P1: “Of course, if free, but if costs a little, no problem.”

Another participant despite being willing to pay for such

It is also noticeable that patient’s monthly income status

P12: “No, I won’t use it if it is paid because I can contact the

P10: “Depending on the need, for example, some people cannot

If paid service, patients prefer to receive some extra services

P13: “If just reporting, a small fee can be charged, or it should be a

Interestingly, a perception that a paid service would be more

P4: “I believe the paid service is going to be more professional.”

P9: “I wish the service to be charged so it can remain in place for

With the growing dependence on medication therapy as the

L.M.K. was the principal investigator of this study who

This research received no external funding.