Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with

Sleeping Pills

Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with

Sleeping Pills

11 STEM J

Group V

Leader:

Salamat, Arabella Beatrix F.

Members:

Ballan, Marychelle T.

Buenaventura, Rigel A.

Dino, Darren M.

Brigida B. Quema

Practical Research I

Marcelo H. Del Pilar National High School

SHS Department

Science, Technology, Engineering and Mathematics

S.Y. 2021-2022
Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
Sleeping Pills
Table of Contents

Introduction……………………………………………………………………………………… 1

Review of Related Literature…………………………………………………………………. 3

Statement of the Problem……………………………………………………………………. 11

Definition of Terms………………………………………………………………………….. 12

Significance of the Study……………………………………………………………………. 12

Scope and Delimitations……………………………………………...……………………… 13

Methodology……………………………………………………………………………………. 14

Research Design…………………………………………………………………………...… 14

Respondents and Sampling Method…………………………………………………………. 14

Instruments…………………………………………………………………………………... 15

Data Collection Procedure and Ethical Considerations……………………………………... 15

Data Analysis………………………………………………………………………………... 15

References……………………………………………………………………………………… 16
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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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Introduction

Sleep is a physiological process essential to life. In this generation, sleep deprivation is a

growing problem among the majority of the Senior High School Students in the province of

Bulacan, Philippines due to an abundance of school work that must be completed on time.

Additionally, teens' late-night use of mobile phones and tablets has always been associated with

low levels of sleep (Weale, 2017). Disruptions such as sports or other physical activity around

bedtime may also make it more difficult to fall asleep. When students do not obtain the optimal 8

to 10 hours of sleep they need, they risk their potential to succeed academically. Students have

trouble retaining information and comprehending, coping with stress, and staying focused.

Without proper sleep people, especially teenagers, cannot function properly and the risk of

several different health problems increases (Persky, 2018). This includes risk for diabetes and

cardiovascular mortality.

Being in the digital age, senior high school students who experience sleep deprivation or

insomnia symptoms rely on the internet which forces them to self-diagnose instead of consulting

a medical professional. In an attempt to reduce stress symptoms or deal with the associated

mental health difficulties, including sleep, students have adapted a variety of mechanisms,

including cognitive responses, stress management techniques, enhanced assertiveness skills,

time-management tactics, and counseling sections (Dalui, 2017). However, most of them are

redirected to inappropriate responses such as taking over-the-counter sleeping pills. The lack of

medication instructions often leads to substance abuse.

Self-medication is the most popular self-treatment approach in the Philippines and across

multiple countries. The global prevalence rate of self-medication ranges from eleven and two

tenths percent (11.2%) to ninety-three seven tenths percent (93.7%), depending on the target
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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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population and country (Chautrakarn, 2021). The majority of those are with the use of sleeping

aids including pills. Self-treatment with over-the-counter sleeping aids has become a global

phenomenon that has resulted in a greater probability of incorrect or undue therapy, missed

diagnosis, delays in the appropriate treatment, and increased morbidity.

The number of Senior High School Students in the province of Bulacan using sleeping aids

including sleeping pills without proper diagnosis is at an alarming rate. Like most medications,

sleeping pills have side effects. This includes burning sensations, changes in appetite,

constipation, diarrhea, balance problems, problems with attention or memory, uncontrollable

shaking of a part of the body, and a lot more that may have chronic effects on their body (Bruce,

2008). These teenagers may also develop dependency or addiction to the substance that they

intake which will just make their sleeping problems worse.

The prominent issue in this topic is that a lot of people are continuing to self-medicate

using sleeping pills. Based on the C.S. Mott Children’s Hospital National Poll on Children’s

Health, twenty-eight percent (28%) of teenagers aged 13 to 18 are using over the counter

sleeping aids and most of the teenagers are using melatonin and a lot of Doctors warn that

sleeping aids might bring serious issues for teenagers but taking natural sleeping medication does

not bring serious effects for teenagers (Haller, 2018). A lot of people are becoming more reliant

on their medication, and because of their continuing to use the medication, their tolerance for

using sleeping pills is increasing and it may result in taking a larger dosage of the pill (Juergens

& Parisi, 2021). When sedatives are not used in a prescribed way by the Doctor, it would be

considered abuse. When taking prescribed or over-the-counter sleeping pills, various effects such

as reducing anxiety, dreamless sleep, lack of coordination, dizziness, lightheadedness, and

hallucinations.
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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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There is a pressing need to perform the study as the number of Filipino Senior High School

students who self-medicate with sleeping medications keeps increasing. Without proper

knowledge of this medication, it may cause harm, mental health problems such as anxiety or

depression, or even death.

The purpose of this study is to determine the variables that lead the Senior High School

Students in the province of Bulacan to take sleeping medications without a formal diagnosis

from a medical expert, despite the harmful consequences. Furthermore, the study aims to raise

public awareness about the issue in order to avoid more severe problems from occurring as a

result of this action.

Pharmacovigilance is defined as the research and actions concerned with the detection,

assessment, comprehension, and prevention of adverse effects and other drug-related safety

issues. In regard to this broad definition, the basic goals of pharmacovigilance are to avoid harm

from adverse reactions in humans caused by the use of health goods within or outside the terms

of marketing authorization and during the product's life cycle (Nour & Plourde, 2019).

Sleep deprivation is sleeping less than the recommended amount of time per night for

adults, which is between seven and nine hours. Children and teenagers require much more sleep

every night than adults (Suni, 2022). Teenagers are the most likely to suffer from sleep

deprivation as a result of several distractions such as social media, entertainment, or activities

with friends. Constant worrying and pressure from school and family are also interfering with

their sleep, as is their fear of what they may become in the future. Because of this, they are

tempted to take sleeping pills to help sleep at night and shut out their own thoughts.

Sleeping pills, as the name implies, help you sleep. People who suffer from sleep disorders,

such as insomnia, may use these drugs to help them sleep. Sleeping pills might also help you stay
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asleep if you wake up in the middle of the night (Sleeping Pills: Types, Side Effects &

Treatment, 2022). Other types of sleep aids are available over-the-counter (OTC) without a

prescription and can be used to treat insomnia and other sleep difficulties, but you should still

exercise caution and consult with a doctor about risk factors, adverse effects, and other potential

harm before taking these medications for the first time.

Some sleep drugs, such as orexin receptor antagonists and benzodiazepines, must be

prescribed by a doctor. Melatonin, Diphenhydramine, Doxylamine, and Valerian are the

over-the-counter sleeping aids that are available in the pharmacies. Melatonin drug symptoms are

depression, dizziness, enuresis (bedwetting), excessive daytime sleepiness, headache, and

nausea. Diphenhydramine symptoms include dizziness, disturbed coordination, epigastric pain,

and thickening of bronchial secretions. Doxylamine symptoms also include dizziness,

drowsiness, thickening of mucus in the nose or throat, and dry mouth, throat, and nose. Valerian

symptoms include Headache, upset stomach, cognitive dysfunction, dry mouth, feelings of

excitement or unease, strange dreams, and daytime drowsiness (Pacheco, 2022c).

Sleep medicines are simply one component of a comprehensive treatment regimen for

sleeplessness. Because they can be addictive and have a variety of negative effects, the American

College of Physicians and the American Academy of Sleep Medicine strongly recommend trying

other methods before turning to pharmaceutical sleep aids. Many sleep issues are the result of an

undetected sleep disorder or medical ailment. A sleep study or other testing can shed light on

these issues, which may need to be treated in addition to insomnia itself (Pacheco, 2022b).

According to one of the new findings in the study of Mitra et al. (2019) when compared to

students with a healthy educational background, students with a non-health educational

background had a greater incidence rate of non-prescription medication. Despite the fact that
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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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fifty percent (50%) of their respondents said they had appropriate information, fifty-three and

three tenths percent (53.3%) were found to have poor knowledge about the negative impacts of

self-medication. This emphasizes the significance of enhancing the undergraduate curriculum in

order to provide college students with adequate health information. Failure to address the issue

of indiscriminate use of nonprescription medication will result in the problem persisting or even

worsening because the public does not recognize its importance. Given the high probability that

irresponsible self-medication among young adults is due to a lack of awareness, as found in the

study, the most important goal would be to educate the public about the dangers of widespread

and inappropriate self-medication.

Melatonin is the most popular sleeping drug, and it is available without a prescription.

Despite the possible danger or risk of the sleeping drug, the usage of melatonin for sleep has

increased since the pandemic began, and some people may be taking it in large doses. Many

individuals mistake melatonin for a herbal supplement or vitamin since it may be obtained over

the counter, according to specialists. Melatonin is a hormone produced by the pineal gland deep

inside the brain and released into the circulation to control the body's sleep cycles (LaMotte,

2022).

There are several natural ways to prevent and treat sleep problems, such as taking Valerian

Root, or we may assist ourselves without using sleeping drugs by disciplining ourselves. We

should remember that melatonin is not a herb, but there are a lot of herbs that can help us with

our sleep like Valerian root. Valerian Root is a plant that grows wild throughout Europe and Asia.

For millennia, Valerian root has been used as a sedative. The efficacy and safety of valerian root

as a therapy for various sleep disorders were evaluated in a review and meta-analysis published

in 2020. The data imply that valerian root may be useful in the treatment of certain conditions.
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However, due to the various valerian formulations and dosages used in the research, making

comparisons between them is difficult. (Caporuscio, 2020).

The use of tranquilizers, sedatives, and sleeping pills (TSSp) by adolescents has increased

in recent decades, according to a study by Cobo et al. (2021), and TSSp are currently among the

substances with the lowest age of onset. This study utilized individualized secondary data from

the 2016 Spanish State Survey on Drug Use in Secondary Education (16–18-year-olds) to

include all individuals who reported taking TSSp at any time, but omitted those who began

during the previous year (n = 1502). Adjusted odds ratios (aOR) for relationships between early

TSSp intake (<14 years) and current TSSp use patterns, adjusted for sociodemographic factors,

were calculated using logistic regression models. As a result, seventeen and nine tenths percent

(17.9%) of respondents (average age of onset = 13.7) used TSSp, with forty-five percent (45%)

of those using it without a prescription. At the age of 14, males and non-repeaters consumed

more TSSp. TSSp use was connected to a higher likelihood of use in the previous month (aOR =

1.41; ninety-five percent (95%) CI:1.12–1.77) and daily/almost daily use (aOR = 1.56; 9%

CI:1.16–2.08) in people who had used it for less than 14 years.

A descriptive study on the sleeping habits of senior high school students of St. Mary’s

College Quezon City in S.Y. 2018-2019 was conducted by Arroyo et al. (2019), ninety percent

(90%) of the 190 responders are between the ages of 16 and 17. According to the study, seventy

percent (70%) of respondents receive four to six hours of sleep. On a night when there is no

school the next day, most kids obtain three or more hours of sleep. Only four percent (4%) of

people get one to three hours of sleep per night. The majority of pupils begin sleeping between

ten p.m. and one a.m. Only one percent (1%) of pupils begin sleeping before 7:00 p.m. On
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non-school nights, most students begin sleeping around midnight or later. Only two percent (2%)

of senior high students claimed they go to bed between the hours of five and nine p.m. On a

typical school day, most senior high students get up between four and six a.m. Only a third of

students rise at six a.m. or later. On non-school days, the majority of students wake up at 6 a.m.

or later, whereas just eight percent (8%) of students wake up earlier than 6 a.m. Device use,

which was picked by 74 respondents as the most likely cause of sleeping problems, is the most

likely cause, followed by insomnia (32 respondents). Alarm clocks are the most common way for

students to get up, followed by people in their homes waking them up. Adolescents do not get

the quantity of sleep they require due to a variety of circumstances. This could be viewed as an

indication of poor sleeping patterns. Teachers and parents should help SHS students develop

good sleeping habits. Students should be able to learn new tactics, improve their sleeping habits,

and better manage their time.

Sleeping drugs do help with insomnia, but only temporarily. People are being reliant on it

as they continue to use it, and it may lead to addiction, even if they are unaware that they are

addicted. Abuse occurs when sedatives are taken in ways that are not recommended by a doctor.

Sleeping Pills provide the same sleepy, feel-good effect as their extremely addictive relatives,

Benzodiazepines, at greater doses. When a person takes sleeping pills but resists the need to

sleep, the medicine might cause hallucinations (Juergens & Parisi, 2021). Instead of becoming

increasingly dependent on drugs, we should concentrate on ourselves and keep track of what we

eat and do, as this is one of the things that affect our sleep. We should be more responsible while

using any medications or drugs, and we should be more cautious and careful to aid ourselves.

Based on the study of Goodhines et al (2019) College students are at a higher risk of sleep

deprivation and related sleep issues. Emerging research shows that a large portion of college
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students self-medicate using alcohol, marijuana, or over-the-counter sleeping pills. The current

study examined demographic, psychosocial, and sleep- and alcohol-related characteristics of

sleep self-medication, as well as its contemporaneous and prospective relationships with

insomnia symptoms, alcohol use, and negative drinking outcomes. Reviewing the study will

provide you with a broader context in which this problem may exist at a lower school level,

primarily in senior high school.

As shown in the study by Selner (2019), Drug dependency occurs when you need one or

more drugs to function, and because people who take over-the-counter sleeping pills typically

have limited knowledge about proper medication usage, they are more prone to becoming

dependent on the drug.

Furthermore, the study of Ackermann et al (2021) supports the previous research

mentioned wherein several types of over-the-counter drugs are prone to misuse. If these

substances are used recreationally, they can become habit-forming and even harmful. It is also

relevant to the use of sleeping drugs without the assistance of a professional.

Without proper knowledge about sleeping pills, it can lead to addiction, based on the study

by Plumptre (2022) dependence may be both physiological and psychological in nature. When

the medication is stopped, the person experiences withdrawal symptoms. Psychological reliance

is the result of a felt need that cannot be fulfilled without medicine. When more doses are

necessary to fall asleep, it may indicate that tolerance to the medication has evolved, as well as

physiologic dependency. The misuse of these drugs is distinct. Some persons who are given these

sleeping pills take more than they are supposed to or utilize the medication for purposes other

than sleeping. This behavioral pattern may indicate an addiction, often known as a drug use
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disorder. Moreover, it is important that we raise awareness about how drug usage may negatively

impact a person's physical and psychological health.

Using sleeping pills without the assistance of a medical professional might put you at risk,

especially if you are unfamiliar with the medicine. According to Bruce (2021), while these drugs

may be useful for the short term, all benzodiazepines are potentially addictive and can cause

problems with memory and attention. They are not often recommended for long-term therapy of

sleeping disorders. In a similar vein, sleeping pills are extremely risky if you have asthma or

other health problems. Sleeping drugs can compromise regular breathing and can be harmful in

individuals who have chronic lung disorders such as asthma, emphysema, or types of chronic

obstructive pulmonary disease.

Aside from mental health problems, using sleeping pills can lead to physical health

problems. According to Pachecho (2020a), Some of the side effects of using sleeping pills on

your physical health are burning or tingling sensation in the hands, arms, feet, or legs, dry mouth

or throat, uncontrollable shaking, and weakness. Furthermore, These side effects can also

negatively affect work performance, social relationships, and overall well-being and quality of

life.

Prescription tranquilizers/sedatives misuse is a severe health risk for teenagers, and

focusing primarily on opioids may lead to the neglect of other drug misuses. The scientific

community should pay close attention to benzodiazepines in particular. It's critical to realize that

not all misuse is created equal. A teenager who misuses two or three times a year to control their

emotions and gets pills from their parents is not the same as an adolescent who misuses

frequently to get high and gets pills from a dealer. We must identify risk and protective factors

associated with patterns of usage that are more likely to result in unfavorable consequences.
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Furthermore, medical practitioners, parents, and teenagers must be educated about the dangers of

tranquilizer/ sedative abuse. Doctors must cautiously prescribe these medications and be aware

that adolescents may abuse them and get addicted (Ford, 2018).

Fifteen to eighteen Filipino teens receive just four to six hours of sleep when the epidemic

begins, and one of the reasons for this is tension and anxiety, which is exacerbated by the

increasing strain from their schoolwork and the inability to visit their classmates and family.

Since the pandemic began, thirty-four and five tenths percent (34.5%) of the chosen group have

slept at three a.m. thirty-two and seven tenths percent (32.7%) sleep between one a.m. to two

a.m., while the remainder sleeps from nine p.m. to twelve a.m. (Philstar, 2021). As the pandemic

progresses, we should acquire a pastime that will help us avoid or reduce our tension and anxiety.

We may now travel to various areas as the number of covid cases decreases, but we must

continue to follow health rules to protect our health.

Self-medication is an important practice, but it can lead to a variety of issues, including

incorrect self-diagnosis, delays in seeking appropriate medical advice and treatment, potential

adverse reactions, worsening of the condition the individual is attempting to self-treat, dangerous

drug interactions, masking of severe diseases, and the risk of dependence and abuse (Linskey,

2020). Self-medication is beneficial for small ailments, but additional study is needed. However,

in situations like this, we should seek expert assistance because one wrong step might worsen our

problems. Seek professional treatment since they are more knowledgeable, and the internet may

be deceiving when we are trying to self-medicate. When we feel something is wrong, we should

see our local doctor or physician.

According to C.S. According to the Mott Children's Hospital National Poll on Children's

Health, twenty-eight percent (28%) of teenagers aged thirteen to eighteen use over-the-counter
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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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sleeping aids, with melatonin being the most popular. Many doctors warn that sleeping aids can

cause serious problems for teenagers, but natural sleeping medication does not (Haller, 2018).

For parents reading this, we should not allow our children to take vitamins or medications on

their own; instead, we should take them to a doctor. It is preferable to check with their own

physician or doctor than to take that risk. We should keep an eye on them and assure their safety,

as it is your responsibility to look after them.

Statement of the Problem

This study intends to identify and analyze the variables that lead the Senior High School

Students during the academic year 2021-2022 in Bulacan, Philippines to take sleeping drugs

without a prescription from a medical practitioner. This study will increase public awareness of

those who continuously use over-the-counter sleeping medication without adequate prescription

and research about the drug they take and what it could do harm to their health. Specifically, it

will set out and describe the potential impetuses of self-medication with sleeping pills in

teenagers which will be answered in the following questions:

1. What are the reasons why senior high school students have difficulty sleeping at night?

2. How will sleeping pills influence the general health of the student?

3. What are the factors that cause the students to take over-the-counter sleeping pills?

4. What are the reasons they continue to take more pills after their initial attempt?

5. Why did the students not arrange a proper consultation and get a prescription from a

medical professional?
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Definition of Terms

Impetuses - factors and motives that cause something to happen or develop.

Over-the-counter - refers to the process of how you can buy drugs without a prescription.

Pharmacovigilance - is the science and activities relating to the detection, assessment,

understanding, and prevention of adverse effects or any other medicine-related problem.

Self-Medication - is the act or process of medicating oneself, especially without the advice of a

physician.

Significance of the Study

As teenagers slowly enter the reality of the world, piling up responsibilities and worries

affect their sleeping habits, heightening the temptation of taking OTC sleeping pills. Determining

the specific potential driving factors of self-medication will provide substantial assistance in

preventing further self-diagnosing, self-medication, and misuse of sleeping pills. The finding of

this study will also redound to the benefit of society to raise pharmacovigilance. Using individual

interviews with the participants, this study will be conducted to gain in-depth and detailed

information on the multi-faceted causes and experiences of self-medicating with sleeping pills of

Senior High School students in Bulacan. This investigation will be a great help to:

● Senior High School students. Through this study, the proponents aim to recognize and

acknowledge the rationality behind the students’ self-medication with sleeping pills. It

will also serve as a platform for the teenagers to articulate their concerns about what

pushes them to take over-the-counter medicines.

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● Physicians and medical professionals. This research will help medical practitioners in

identifying the inducement of self-medication among teenagers. The data that will be

obtained will also be able to help them in diagnosing patients, add more information

regarding the effects of misused pharmacy drugs, and raise pharmacovigilance.

● Parents. The result of this research may help parents to comprehend the possible

impetuses of self-diagnosing and self-medicating and its effects on their children. This

study will also help them to better understand their children’s behavior to be able to guide

them effectively.

● Teenagers intending to take over-the-counter tranquilizers. This study will contribute

in raising awareness of the causes and effects of using sleeping drugs without a

prescription from a physician.

● Succeeding researchers. This research will provide more information which will help

the succeeding researchers have a ground base on their research. Gaps in this study may

be filled by future investigators.

Scope and Delimitations

The main objective of the study is to determine the contributing factors that are driving

Senior High School Students from the province of Bulacan to self-medicate using sleeping pills.

Furthermore, in order to perform the study, the researchers will select 7 participants through

criterion sampling who claim to be self-medicating with sleeping pills. Individual interviews will

be conducted using online platforms such as Google Meet and Zoom to guarantee the

participants' safety while the world is still dealing with the COVID-19 pandemic. Lastly, this

study will take place throughout the school year 2021-2022.

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Methodology

Research Design

This study will utilize a qualitative case study. A case study is a descriptive and

exploratory analysis of a person, group, or event. A case study research can be single or multiple

case studies, includes quantitative evidence, relies on multiple sources of evidence, and benefits

from the prior development of theoretical propositions (PressAcademia, 2018)

Respondents and Sampling Method

In selecting participants, this study will utilize a non-probability sampling technique. The

purposive sampling technique, specifically criterion sampling, will be applied. Purposive

sampling is a method used when the researchers select a sample based on their knowledge about

the study and population (Ashley Crossman, 2020). Additionally, participants will be identified

through a particular set of criteria based on the needs of the study. The seven participants to be

chosen must be: 1) Taking sleeping pills or any tranquilizers without any form of consultation,

diagnosis, and/or prescription from a medical practitioner, 2) a senior high school student, and 3)

residing in Bulacan.

Instruments

The proponents will conduct intensive semi-structured individual interviews to gather the

data needed for the study. The interview will consist of twenty guide questions and additional

relevant follow-up questions that will analyze and delve into the possible reasons that senior high

school students take sleeping pills without consulting a physician.

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Data Collection Procedure and Ethical Considerations

As our country is still under restrictions brought by the COVID-19 pandemic, face-to-face

interviews are still prohibited, instead the researchers will conduct the individual interview

through online platforms such as Google Meet or Zoom. Alternatives for participants with

unstable internet can be done through cellular call interviews. A consent form on the data privacy

agreement will be sent to be completed by the participants on pre-data gathering. The interview

process will be held individually to maintain confidentiality and protect the privacy of the

participant, and will also be recorded with the consent of the participant.

Data Analysis

Data gathered from the interviews will be transcribed manually by the researchers and will

be analyzed through diagnostic analysis. Young (2002) defines the diagnostic approach as a

method for isolating environmental issues, recognizing elements of individual problems that are

significant from a problem-solving perspective, and arriving at conclusions about design features

necessary to address each of the factors identified. The researchers will gain insights into the

causes of patterns that they will observe from their data. This branch of analytics will be utilized

as it is best used in investigating the root cause of trends or the source of the problem that needs

to be solved.
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Arroyo, R. L., Depana, E. R., Gatdula, E. J. B., & Requejo, C. N. T. (2019, March 18). A

Descriptive Study on the Sleeping Habits of Senior High School Students of St. Mary’s

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Bruce, D. F., PhD. (2008, July 14). Understanding the Side Effects of Sleeping Pills. WebMD.

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Caporuscio, J. P. (2020, March 30). 4 herbs that can help sleep. J.P. Caporuscio. Retrieved May

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Cobo, B., Pulido, J., Pascual, S., Sáiz, A., Carrasco-Garrido, P., Carabantes-Alarcón, D., &

Sordo, L. (2021). The Effects of Early Onset Tranquilizers, Sedatives, and Sleeping Pills

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Crossman, A. (2020, March 19). What You Need to Understand About Purposive Sampling.

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Ford, J. A. (2018). The Prescription Drug Problem We Are Missing: Risks Associated with the

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https://www.jahonline.org/article/S1054-139X(18)30422-1/fulltext

Goodhines, P., Gelis, L., Kim, J., Fucito, L., & Park, A. (2019, June 1). Self-Medication for

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Reviving Pharmacovigilance: A Case Study on Potential Impetuses of Self-Medication with
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