“Action Research on Drug Safety Assessments”

Andres Soriano Colleges Of Bislig

Mangagoy Bislig City

ACTION RESEARCH DESIGN

ABSTRACT

" Drug safety assessment in clinical trials: methodological challenges and opportunities"

Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and

duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world

patients. We summarize the principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials using

recent examples from systematic reviews. These challenges include the lack of an evidentiary gold standard, the limited statistical power of randomized controlled trials and resulting type 2 error, the lack of adequate

ascertainment of adverse events and limited generalizability of trials that exclude high risk patients. We discuss potential solutions to these

challenges. Evaluation of drug safety requires careful examination of data from heterogeneous sources. Meta-analyses of drug safety should include

appropriate statistical methods and assess the optimal information size to avoid type 2 errors. They should evaluate outcome reporting biases and

missing data to ensure reliable and accurate interpretation of findings. Regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety.

Andres Soriano Colleges

Mangagoy, Bislig City

QUESTIONAIRE (STUDENT)

Name: _________________________ Year and Section: ___________________________ Directions: Please accomplish honestly all of the questions and the information will be treated

highly confidential. There are no wrong answers.

1. How long have you been abusing drugs?

Why: to determine if acute or chronic.

2. Which drugs have you been abusing?

Why: including prescribed drugs, over the counter drugs, illegal drugs or social drugs.

3. What is your drug of choice?

Why: many people who abuse drugs use multiple different drugs.

4.Do you drink alcohol?

Why: if so estimate specific weekly consumption and maximum consumption at one sitting in the last month?

5.Do you smoke tobacco cigarettes?

Why: if so estimate daily number of cigarettes smoked?

I. BACKGROUND/STATEMENT OF THE PROBLEM

Randomized controlled trials are primarily designed to provide reliable information on the efficacy of interventions . They form the primary basis of regulatory approval for a drug in the US, which involves demonstrating evidence of efficacy and safety in two well-conducted studies.

With rare exceptions, these are generally interpreted as statistically significant data from two randomized clinical trials. Several advances have been made in the approach to the conduct,

analysis and interpretation of data from randomized controlled trials on efficacy outcomes . Since trials are typically carried out to define therapeutic benefit for regulatory approval, safety receives less attention . The role of drug safety regulation is to protect patients from rare, severe

adverse reactions; most efforts are directed at early detection and prevention of serious events such as that seen with thalidomide. Post-marketing surveillance through spontaneous adverse

event reporting systems are the mainstay of drug safety evaluation. Methodological issues around the analysis of safety data from clinical trials have received less attention. Systematic reviews and meta-analyses of clinical trials have recently raised concerns about an

increase in the risk of serious adverse cardiovascular outcomes associated with varenicline , an increased risk of mortality associated with the tiotropium Respimat inhaler, and adverse

cardiovascular outcomes associated with inhaled anticholinergics (including the ipratropium and tiotropium inhaler) . Similarly, increased risks of myocardial infarction associated with rosiglitazone and congestive heart failure and fractures associated with the thiazolidinediones

(rosiglitazone and pioglitazone) in clinical trials have resulted in regulatory warnings . These findings have been widely debated with conflicting interpretation by the academic community,

regulators and industry sponsors . Regulators have emphasized the limitations to defining and measuring adverse outcomes in randomized controlled trials and have called for caution in drawing any robust conclusions . The lack of access to individual participant data, the

heterogeneous nature of safety data, and the statistical challenges of analyzing rare events make safety data from such meta-analyses difficult to analyze and interpret . This review summarizes

the principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials. We discuss potential solutions to these challenges. SOURCE:

Friedman LM, Furberg CD, DeMets DL: Fundamentals of Clinical Trials. 4th edition. Springer, New

York; September 21, 2010.

II. BREAKDOWN OF PROBABLE CAUSES

1.Stress

College brings many sources of new stress for students. As well as keeping up with their studies,

coping with new financial arrangements and making a new circle of friends, students may be

living away from home for the first time. The CASA study noted the most common reason

students gave for using alcohol or drugs was it helped them relax and forget about their

problems.

2.Peer Pressure and Student Expectations

Drugs and alcohol are widely available on many campuses, and some students accept that

substance abuse is an inevitable part of their experience. ''College is almost meant for that," says

one student quoted in the New York Times. "Get good grades, but have a really good time

because after that, you have to deal with the real world.'' To avoid standing out, many students

experiment with drugs and alcohol during their college years.

3.Performance Boosting

Students abuse prescription drugs like amphetamines to keep them awake all night.

The Office of National Drug Control Policy states that nationally, the abuse of prescription drugs

is now second only to marijuana use. Abuse of this type is a growing problem in colleges:

students hope to boost their academic performance taking drugs like dextroamphetamine,

methylphenidate and oxycodone, often having obtained them from other students who have had

them legitimately prescribed.

4.Depressive Disorders Of the CASA study participants, 44.1 percent of marijuana

users reported depression.

In their report, "Wasting the Brightest and the Best," CASA researchers noted that students

who experienced even minor forms of mental illness — like mild depression — before arriving

on campus are more likely to abuse drugs and alcohol at colleg

III. SCOPE AND DELIMITATION OF THE STUDY

The Scope of Alcohol Abuse

The scope of alcohol abuse is widespread. National surveys and reports show that it is the most

commonly abused drug among most age groups. Sadly, it is also most abused in youth age

groups. While it is the most treated substance in

addiction programs, reports say that less than 10%

of individuals with alcohol problems get help. Many

individuals we care about struggle with drinking and

with addiction to alcohol. It can be up a loved one to

reach out and get that person the help they need

before it is too late.

More on Alcohol Abuse Estimates report that about 18 million adults (18 and older) struggle with some form of alcohol abuse problem in the United States. Alcohol related problems (traffic accidents, medical incidents, productivity lost in businesses, accidental death) combined costs this nation over 200 billion dollars annually. Alcohol abuse and addiction are a problem in society. This is something that is not going to go away, but for those individuals in your life that struggle with drinking.Who the alcoholic immediately influences. Spouses, parents and children can suffer from their loved one's drinking habits. Employment relationships can be strained by those same lines. Individuals lose their jobs to alcohol related problems quite often. The alcoholic on the other hand has developed a stigma or mindset where their drinking is not the problem. Meanwhile, they continue to lose control of their lives. There are answers for addiction and alcohol abuse. For most individuals, this answer requires inpatient alcohol rehab.

IV. ANALYSIS AND FINDINGS RELATED TO SURVEY

New Survey: Misuse and Abuse of Prescription Stimulants Becoming

Normalized Behavior Among College Students, Young Adults

1

~ Young Adults Abuse Rx Stimulants to Manage Overscheduled, Stressful Lives ~

~ “Under Pressure: College Students and the Abuse of Rx Stimulants”

Panel Discussion Taking Place Today at New York University ~

The new research found that 1 in 5 college students (20 percent) report abusing prescription

stimulants at least once in their lifetime, compared to 1 in 7 non-students (15 percent). Older

students are also more prone to engage in these behaviors: the data found that among current

students, sophomores, juniors, seniors and graduate students are significantly more likely to abuse

Rx stimulants than college freshmen.

Among young adults between the ages of 18 to 25, 1 in 6 (17 percent) has abused a prescription

stimulant at least once in their lifetime. Overall, young adults are most likely to abuse the prescribed

stimulants Adderall (60 percent), Ritalin (20 percent) and Vyvanse (14 percent), which are

prescribed for Attention Deficit Hyperactivity Disorder (ADHD).

Overscheduled, Overstressed and Overworked: Young People Turn to Rx Stimulants to Manage Stress

The reasons that current college students and other young adults give for abusing these Rx

medications are focused on achieving functional goals such as studying, working or staying awake.

They clearly seem to recognize the importance of succeeding at school and work, yet they value

maintaining a vibrant social life at the same time, and feel that it can be difficult to maintain a

balance between the two priorities.

The new study confirms that young adults generally misuse and abuse prescription stimulants for

functional reasons:

Half of all young adults surveyed (50 percent) report abusing Rx stimulants to study or improve

academic performance

More than 4 in 10 (41 percent) say they misuse or abuse them to stay awake

Almost one-fourth (24 percent) misuse or abuse Rx stimulants to improve work performance at a job

Among current college students specifically:

More than 4 in 10 (44 percent) say they abuse Rx stimulants in order to study and improve academic

performance, while 31 percent say they abuse in order to stay awake

More than 1 in 5 (21 percent) report abusing Rx stimulants in order to improve work performance at their jobs

More than a quarter of students (27 percent) who report abuse of Rx stimulants also hold full-time jobs, in

addition to attending school (compared to 12 percent of those who do not abuse Rx stimulants)

The research also shows that college students perceive tangible rewards after they abuse Rx

stimulants. Nearly two-thirds of college students (64 percent) who report abusing Rx stimulants

indicate that doing so helped them obtain a higher grade, improve work performance or gain a

competitive edge.

Current college students who do report abuse of prescription stimulants are also more likely to feel

pressure to abuse prescription stimulants to improve academic performance, compared to those

who do not abuse (50 percent vs. 19 percent). They are also less likely to think that their parents

would be upset if she or he were to abuse prescription medicines to increase academic performance

(62 percent vs. 79 percent).

“Students need help in learning how to manage their busy lifestyles effectively ,” said Dr. Josh

Hersh, Staff Psychiatrist at Miami University.

“Learning time management strategies such as ‘block scheduling’ and ‘syllabus tracking’ can help

prevent ‘cramming’ – the main reason people look to stimulants at whatever the price. In addition,

teaching students with ADHD who are prescribed stimulants about how to properly care for their

medication will help address misuse and prevent these drugs from getting into the hands of students

who might abuse the meds.”

Compared to those who do not abuse prescription stimulants, current college students and other

young adults who do report abuse tend to have more social and active lifestyles. These young adults

are influencers who are at the center of their social circles and are more likely to see themselves as

leaders (60 percent vs. 51 percent); enjoy being the center of attention (43 percent vs. 28 percent);

and consider themselves to be the “social hub” among their friends (38 percent vs. 22 percent).

Young adults who report abuse of Rx stimulants (40 percent) also tend to struggle more often to

balance their social and work lives than those who don’t abuse (27 percent). This trend is more

prevalent when comparing students who abuse Rx stimulants (50 percent) versus those students

who do not (33 percent).

V . ANALYSIS OF THE DATA GATHERED:

Patient Profile • Simultaneous display of large amount of

relevant information of a subject • Efficiently establish safety profile of a

subject • Easier to see drug effect, drug/drug

interaction, connections between lab test and adverse events, etc

What are the early signs of risk that may predict later drug abuse?

Some signs of risk can be seen as early as infancy or early childhood, such as aggressive behavior, lack of self-control, or difficult temperament. As the child gets older, interactions with family, at school, and within the community can affect that child’s risk for later drug abuse.

Children’s earliest interactions occur in the family; sometimes family situations heighten a

child’s risk for later drug abuse, for example, when there is:

a lack of attachment and nurturing by parents or caregivers; ineffective parenting; and a caregiver who abuses drugs.

But families can provide protection from later drug abuse when there is:

a strong bond between children and parents; parental involvement in the child’s life; and clear limits and consistent enforcement of discipline.

Interactions outside the family can involve risks for both children and adolescents, such as:

poor classroom behavior or social skills; academic failure; and association with drug-abusing peers.

What are the highest risk periods for drug abuse among youth?

Research has shown that the key risk periods for drug abuse are during major transitions in children’s lives. The first big transition for children is when they leave the security of the family and enter school.

Later, when they advance from elementary school to middle school, they often experience new academic and social situations, such as learning to get along with a wider group of peers. It is at

this stage—early adolescence—that children are likely to encounter drugs for the first time.

When they enter high school, adolescents face additional social, emotional, and educational challenges. At the same time, they may be exposed to greater availability of drugs, drug abusers,

and social activities involving drugs. These challenges can increase the risk that they will abuse alcohol, tobacco, and other substances.

When young adults leave home for college or work and are on their own for the first time, their

risk for drug and alcohol abuse is very high. Consequently, young adult interventions are needed as well.

VI. SUMMARY OF DATA INTERPRETATION

Every day the Food and Drug Administration (FDA) works to balance expeditious access

to drugs with concerns for safety, consonant with its mission to protect and advance the public health. The task is all the more complex given the vast diversity of patients and how they respond to drugs, the conditions being treated, and the range of pharmaceutical products and

supplements patients use. Reviewers in the Center for Drug Evaluation and Research (CDER) at the FDA must weigh the information available about a drug’s risk and benefit, make decisions in the context of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-

benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. These processes may have life-or-death consequences for individual patients, and for drugs

that are widely used, they may also affect entire segments of the population. The distinction between individual and population is important because it reflects complex determinations that FDA must make when a drug that is life-saving for a specific patient may pose substantial risk

when viewed from a population health perspective. In a physician’s office, the patient and the provider make decisions about the risk and benefits of a given drug for that patient, whereas

FDA has to assess risks and benefits with a view toward their effects on the population. The agency has made great efforts to balance the need for expeditious approvals with great attention to safety, as reflected in its mission—to protect and advance the health of the public.

In the first years of the 21st century, the issue of prescription drug safety came to the attention of the public with renewed intensity. Drug withdrawals, apparent delays in warning the public

about important drug risks, a erceived rush to approve drugs without sufficient attention to safety, and press coverage of internal problems in CDER may have contributed to a deterioration of public confidence in FDA. Academics, consumer organizations, professional societies, and

legislators debated the possible causes and solutions of what was seen by many as a major problem (Consumers Union, 2005; Grassley, 2005; NCL, 2005; US PIRG, 2006).

In its report, the committee considered the drug safety system as the sum of all activities

conducted by FDA and other stakeholders to monitor, evaluate, improve, and ensure drug safety. (See the committee’s Statement of Task . Although much of the committee’s work was focused

on drug review, safety surveillance, and related activities of CDER, the committee also reviewed some key aspects of the roles and considered the potential contributions of the pharmaceutical

industry, the academic research enterprise, Congress, the health care delivery system, patients, and the public.

Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is

not so. FDA approval does not represent a lifetime guarantee of safety and efficacy, and what is newest is not always the best. For several related reasons, even the best drug safety system would

not prevent adverse reactions to pharmaceuticals on the market. It is impossible to know everything about a drug at the point of approval because drugs’ mechanisms of action are complex, and because the clinical testing that happens before approval is generally conducted in

controlled settings in defined, carefully selected populations that may not fully represent the wide range of patients who will use the drug after approval, some chronically, and in

combination with other drugs. Thus, the understanding of a drug’s risk-benefit profile necessarily evolves over the drug’s lifecycle. CDER staff who review regulatory submissions, such as new drug applications, must strike a delicate balance in judging the drug’s risks and benefits, and

whether the need for more study to increase certainty before approval warrants delaying the release of the drug into the marketplace and into the hands of health care providers and their

patients.

SOURCE:

The National Academic Press

VII. ALTERNATIVE COURSES OF ACTION

Student Conduct and Discipline

Maintaining order and discipline is essential to creating a safe and effective learning environment. General rules about student

conduct are found in local school district policies and handbooks, while state and federal law creates a framework for student

discipline decisions.

"There are a couple of key concepts that must be conveyed to youth in a way

they can accept and understand to get them to start making educated choices in

this area".

1. Young people must feel that the risks of using drugs far outweigh what they see as the benefits. The person offering to sell them a joint or share beer or

prescription pills with them is not going to fill them in on the risks before he hands over the drugs. Drug education must fill this void with accurate

information about the risks of drug use, presented in a believable manner.

2. Drug use appeals to young people because it seems like it is going to solve

a problem. The problems could be shyness or inability to fit in, stress of social, school or family situations, boredom or lack of adventure or excitement in their

lives. Young people are capable of understanding this concept if it is expressed in their terms. Effective drug education must offer an alternative to the escape that seems like it will come from substance abuse.

The Narconon drug prevention and education curriculum makes the assumption that young people can understand these issues and learn how to

make educated decisions about drug use. In thousands of deliveries to hundreds of thousands of students, it’s been proven that they can and do gain an

understanding of the risks of drug abuse and as a result, more often make their own decisions to abstain. That decision, coming from their own hearts, is

stronger than any advice or counsel that comes from the outside. That’s what makes the Narconon drug prevention and education curriculum one of the most effective choices for prevention of substance abuse among youth.

VIII. ACTION

What does Mentor do?

Mentor is the leading international non-government organization working globally to prevent drug use and substance abuse.

We empower children and young people to make healthy decisions and

to avoid drug use.

We support donors / companies in doing good for children and young

people.

Together we make prevention effective and visible.

We help organizations and authorities reach out to children and young people.

Our Vision is a world where children and young people are empowered to

make healthy decisions and avoid drug use.

Instructions

Start by honestly acknowledging the drug addiction. Admitting drug use can ease anxiety about drugs taking over ones life and can motivate one to seek out help and treatment. Forgiving oneself is also essential to relieving guilt that can cause a person to avoid help.

Become surrounded by a positive support group. Friends, family, and drug treatment counseling organizations have been proven to provide drug users much needed emotional

support and morale. Cut off unhealthy relationships with people who are critical, abusive, and cause stress. Relapses are often caused by a person's surroundings, so it is essential that recovering users eliminate the crowd of people who indulge in drug use.

Work on improving self-esteem. Low self-esteem has been correlated with drug use in adults, teens, and adolescents. Florida State University Sociology Professor John Taylor

states, "Low self-esteem is kind of the spark plug for self-destructive behaviors, and drug use is one of these." Therefore, it is essential for drug abusers to learn to take care of their health and body, surround themselves with people who make them feel good about

themselves, do things that honor their unique talents and abilities, practice forgiveness, and seek out spiritual guidance.

Practice good nutrition and exercise. In a study conducted by the University Center for Behavioral and Preventive Medicine, drug addicts who practiced good nutrition and exercise were twice as likely to not only kick the habit, but to maintain a drug free life.

The reason for the success is due in part to the brain's ability to release the euphoria-inducing protein, dopamine. Exercises and a healthy diet also contribute to improving a

person's overall outlook on their life, their mind, and their health.

Seek out professional help. There are thousands of drug addiction programs, counseling, and rehabilitation centers to help users overcome a drug habit. There are also non-

traditional methods of drug treatment like hypnosis, acupuncture, chiropractic therapy, and meditation. All of these treatments should be considered as they can provide a

healthy support system and can help ease the drug recovery process.

Andres Soriano Colleges Of

Bislig

Mangagoy Bislig City

“Action Research on Drug Safety Assestment”

Researchers:

.Bargamento

Marvas

Arlan

Tabat

Merioles

Toro-toro

Submitted to:

Mr. Nilo D. Mesias Research Instructor

“Survey

Questionnaires”