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RESEARCH PROPOSAL

STUDY TITLE:
A RETROSPECTIVE STUDY ON THE REASON OF PATIENT RETURED
MEDICATION IN FARMASI KLINIK PAKAR (008)

KOAY KHANG SIEAN


LOW WEN PENG
NURUL

SUPERVISOR:
TAN HUI LOO

1.0 STUDY TITLE


A retrospective study on the misuse of paracetamol during after working hours.
2.0 INVESTIGATORS
Investigators will be the provisional registered pharmacists (Ding Siok Chen, Khoo Siok
Luan and Mohd Syamil) that are working in Outpatient Department situated in General
Hospital Pulau Pinang.

3.0 INTRODUCTION
Drug misuse occurs when someone uses a medication for purposes other than what it
was intended for, use more than the dose prescribed by the physicians or continue
prolonged use after the amount that was prescribed by the physicians was taken. [1]
Among all the pain killers, paracetamol is the commonest available analgesic and also
anti-pyretic. It is readily accessible from all the retail pharmacy, hospital pharmacy and
provision shops as over the counter drug, and this making it a potential drug for misuse.
[2]
Because over-the-counter medicines are legal and meant to be used to lessen
symptoms and treat illnesses, people perceive them as less dangerous than illegal drugs.
The medication is safe when used as directed. However, misuse of the medication,
whether the medication is taken incorrectly or by someone other than the prescribed
patient can have serious adverse health effects.
Furthermore, the misuse of it will increase the cost burden to the governmental
medical institutions as paracetamol was commonly overprescribed.

4.0 LITERATURE REVIEW


According to American Gastroenterological Association (AGA) study, over-thecounter painkillers such as paracetamol is the most often medications that are being used
inappropriately. However, many people are still not aware about the potential side effects
and harmful effects on their health. [3] If painkillers are given in the right dosage, it is not
associated with many side effects, however, prolong use of painkillers may lead to many
unwanted side effects. Paracetamol for example, prolong use may produce renal injury
and massive overdose may produce hepatic injury. [4]
According to Haslina et. al. research in 2007, out of the 1900 poisoning cases reported
to the National Poison Center (NPC), 32.2% were overdosed drugs with 12.6% been the
painkillers. [8]
According to Centers for Disease Control and Prevention of United States (CDC),
more than 12 million people reported using painkillers nonmedically in 2010, that is,
using them without a prescription or for the feeling they cause. [9]
In 2010, drug abuse remains a significant problem in the United States with the
medications that most commonly abuse are pain reliever. According to ACPM,
approximately half a trillion U.S. dollars are spent on expenses associated with medical,
economic, and social impact caused by the use and abuse of addictive substances. [10]
The cost was nearly $181 billion due to drug abuse in 2002. [11]
5.0 RATIONALE OF THE STUDY
In this study, we are expected to know how many prescription with paracetamol that
had been misused by the patients and the cost that beared by the institution due to the
misuse.
From this study, we are also able to determine the possible reasons of causing misuse.
Subsequently, we will able to evaluate the appropriate prescribing method of paracetamol
for the patient.

6.0 OBJECTIVES
6.1 Primary objectives
6.1.1

To evaluate the understanding of the patient regarding the rational use


of paracetamol.

6.2 Secondary objectives


6.2.1

To reduce the total cost beared by the institution due to the misuse of
paracetamol.

6.2.2

To determine the reasons of misuse of paracetamol.

7.0 METHODOLOGY
7.1 Study Design
This is a prospective study which will review on the reason of patient retured
medication.
7.2 Study population
Patients who returned medication at Farmasi Klinik Pakar (008).

7.3 Inclusion criteria


7.3.1 : Medicines returned by patients in Farmasi Klinik Pakar (008)

7.4 Exclusion criteria


7.4.1

Respondent 18 years old.

7.4.2

Respondent who appeared to be psychotic

7.4.3

Medication retured from Farmasi pandu lalu, Farmasi ACC,


Farmasi Pesakit Luar

7.5 Sample size


The convenient sampling method will be used, where the walk-in patient to return
medication will be interview based on the questionnaire designed.

7.6 Data collection procedure


7.6.1 The returned medication will be collected at Counter 8.
7.6.2 A questionnaire will be given to patient to be filled-up.
7.6.3 Questionnaires will be analysed using SPSS.
7.6.4 The returned medication will be collected and catogorized according to
pharmacological category.
7.6.5 Price of returned medications will be calculated.

7.7 Data Analysis


All data will be entered into and analyzed using the Statistical Package for
Social Sciences (SPSS).

8.0 ETHICAL ISSUES


Research proposal was also submitted to Medical Research Ethics Committee (MREC)
and trial will be conducted in compliance with GCP requirements.

9.0 INFORMED CONSENT PROCESS


For better patients understanding on this research
There are only minimal risks on the subjects that we are studying as the result of the
study has no direct interventions towards the care of the patient. Patients information
will be kept confidential throughout the study. Consent from the patient will be obtained
literally prior to the conduction of survey.

10.0 POTENTIAL BENEFIT


This study will be able to evaluate patients understanding on the use of paracetamol.
Any findings of the lacking of this program will followed by overcome steps in making it
a better and successful program.

11.0 POTENTIAL RISKS


Generally there is no risk as no human subject is involved
12.0 CONFLICT OF INTEREST
The authors declare that they have no competing interests.
13.0 PUBLICATION POLICY
This research is expected to show the understanding of the use of paracetamol. The
research finding will be presented in Pharmacy Department, Hospital Pulau Pinang.

14.0 STUDY PROJECT TIMELINE

Stage 1: Proposal writing and presentation ---- 1months

Stage 2: Data collection and data analysis ---- 3 months

Stage 3: Data presentation and publication ----1 months

Stage 4: Final write up report and presentation 2 month


January
2013

February
2013

March
2013

April
2013

Proposal
writing and
presentation
Data
collection,

May
2013

June
2013

July
2013

result analysis
and
discussion
Data
presentation

Research
presentation

Hand in write
up

DATA COLLECTION FORM

Section I: Demographic data


1. Age
2. Gender
3. Race :

: ____________
:
Male
Female
Malay / Chinese / Indian / Others, ____________

Section II: Medication data of patient


4. Concurrent use of other painkillers:
(a) _______________________

(c) _____________________

(b) _______________________

(d) _____________________

Section III: Patient prescription


5. How do you take paracetamol?
According to prescription
Not according to prescription (Refer to question 6)
6. What are the reasons of not taking paracetamol as prescribed?
No pain
Forgotten to take
Spare keeping
Lack of understanding
Concerned of the side effects
7. Do you take the paracetamol when you do not feel the pain?
Yes

No

8. Do you take paracetamol more than what is required?


Yes

No

9. Do you stop taking paracetamol when the pain subsides?


Yes

No

10. Do you take paracetamol before the pain or fever occurred?


Yes

No