Study On The Knowledge Of Medicine Registration and Cosmetic Notification
Among Health Clinic Personnel (HCP) In Kota Bharu
Canthira Eh Di, Nadwanie Harniza Ibrahim, Mohamad Redzuan Abdul Hadi, Nur
Syuhada Mohd Sharip
Pharmacy Enforcement Branch, Pharmaceutical Services Division, Kelantan State
Health Department, Ministry of Health Malaysia, Taman Maktab, Pengkalan Chepa,
16100 Kota Bharu, Kelantan
Introduction:
All pharmaceutical products in Malaysia must be registered with the Drug Control
Authority (DCA) whereas cosmetics must be notified with the National Pharmaceutical
Regulatory Agency (NPRA). It is to ensure the safety, quality and efficacy of medicinal
products before they can be sold or marketed to consumers. It isimportant that all HCP
can act as educator to properly advise the public on this issue.
Objectives:
This study aims to determine the level of knowledge towards registered products and
notified cosmetics among various groups of HCP in Kota Bharu.
Methods:
A cross sectional study with convenient sampling was conducted from May to August
2021. A validated 12 questions questionnaire was distributed and a total of 332
respondents were obtained which overall response rate of 100%. Those who scored
10 marks and above is considered having good knowledge while those who scored 8
and below were considered as poor. Parametric analysis was used to analyze the
collected data using SPSS version 21.
Results:
From the study, only 28.9% (n=96) of the study population had good knowledge
towards registered products and notified cosmetics despite 90.7% (n=302) claiming
that they have exposure on the topic at hand. Individually, doctors/dentists have the
highest score of good knowledge at 50% (n=20) followed by allied health professionals
(AHP) stood at 34.6% (n=28), nurses at 25.3 (n=38) and others at 16.4% (n=10).
Pearson Chi-square analysis demonstrates that the level of knowledge among various
groups of HCP and educational level are significantly different (p<0.001).
Conclusion:
The level of knowledge towards registered products and notified cosmetics among
HCP in Kota Bharu city is low. Doctor/dentist shows a significant better knowledge
compared to others. Further re- education and re-evaluation on the knowledge of HCP
in Kota Bharu should be conducted with regards to this topic.
Keywords:
Registered products, notified cosmetics, health clinic personnel, knowledge, Kota
Bharu
INTRODUCTION
All pharmaceutical products in Malaysia must be registered with the Drug
Control Authority (DCA) whereas cosmetics must be notified with the National
Pharmaceutical Regulatory Agency (NPRA) before being marketed for sale/use in
Malaysia1.
Registered drug that is approved by (DCA) has been evaluated and tested for its quality,
safety and efficacy (except for traditional preparations and health supplements) to ensure
safety of the public2. Every registered product is given a registration number, which must
be printed on its label or package which start with ‘MAL’, followed by 8 digit numbers and
end with capital such as A, X, T ,N regarding to their category. Under Regulation 7(1)(A)
Control of Drugs and Cosmetics Regulations 1984, “No person shall manufacture, sell,
supply, import, possess or administer any product unless the product is a registered
product”3.
Cosmetics is defined as “any substance or preparation intended to be placed in contact
with various external parts of the human body (epidermis, hair system, nails, lips and
external genital organs) or with teeth and the mucous membranes of the oral cavity, with
a view exclusively or mainly to cleaning them, perfuming them, changing their appearance
and/or correcting body odours and/or protecting them or keeping them in good condition”.
The company or person responsible for placing a cosmetic product in the local market
must notify the Director of Pharmaceutical Services (DPS) through the National
Pharmaceutical Regulatory Agency (NPRA) prior to market, manufacture or import a
cosmetic product. This notification process will allow the NPRA to gather adequate
information on the cosmetic products that are placed in the local market to ensure that it
is safe to be sell to consumers. Notification number will be given to the cosmetics once it
is notified 3.
In this modern technology, people tend to buy drug through online. Medicine sold online
exposes unwary consumers to certain dangers and undesirable risks. Buying drug online
will cause difficulty for consumers to check seller legitimacy and to determine product
registration status before making a purchase. In order to prevent consumer from getting
effect after using unregistered drug, all primary health care must first have knowledge
about registered drug in order to deliver it to the patients/consumers. Education must be
given to patients/consumer in order for them to be aware of the pharmaceutical products
that they bought. They need to know on how to check the registration number and to
confirm that the hologram label is authentic. It is the fundamental requirement that every
consumer need to be aware and understands so that they will not easily buy drug that is
promoted through online5.
This study aims to assess the level of knowledge towards medicine registration and
notified cosmetics among health clinics’ staff in Kota Bharu and compare the level of
knowledge in term of demographic characteristics. This study group was chosen since
they represent the data for healthcare careers in Kota Bharu and Kota Bharu is the capital
city in Kelantan that has the highest distribution of people.
METHODS
Design and study population
A cross sectional study using convenient sampling was performed on Health Clinic
Personnel (HCP) under the Kota Bharu District Health Department from May to August
2021. The inclusion criteria included all healthcare personnel that are available during the
conduct of the study. Personnel who were absent or on leave during the conduct of the
study were excluded. Based on a population of roughly 1172 (data provided by the Human
Resource Section, Kelantan State Health Department), the sample size was calculated
using Raosoft sample size calculator (margin of error = 5%, confidence level = 95%,
response distribution = 50%) which yielded the minimum sample size of 290
participants.To account for possibility of missing data, another sample’s increment of 20%
making total respondents of 348.
Instrumentation
Questionnaires were distributed to HCP in 12 Health Clinics under Kota Bharu District
Health Department. The self-administered questionnaires in Malay Language comprised
of two sections. The first section is about the socio-demographic data of respondents
whereas the second section consisted of 12 questions which will evaluate the knowledge
of registered products and notified cosmetics. A total of 332 respondents were obtained.
Those who scored 10 marks and above were considered to have good knowledge on
registered products and notified cosmetics. The grading scale used is “0.5” for Tidak pasti, “1” for
Ya or correct answer, “0” for Tidak or incorrect answer. Those who scored 9 marks and below
were considered to have poor knowledge. This grading system was decided upon
discussion with Chief Assistant Director of Kelantan Pharmacy Enforcement Branch who
is expert in this field.
Statistical Analysis
Socio-demographic data and categorical data were presented as frequencies and
percentages. Pearson Chi Square was performed using IBM Statistical Package for the
Social Sciences (SPSS) version 21 for data analysis. A p-value of <0.001 was considered
as statistically significant.
Ethical Approval
Ethical approval for this study was obtained from the Medical Research and Ethics
Committee (MREC), Ministry of Health Malaysia
RESULTS
Socio-demographic characteristics
The highest respondents from government healthcare personnel were mostly nurses
(45.2%, n=150) and most of the participants fall within the age group of 40-45 years old
(82.0%, n=82). There were more female participants (74.1%, n=246) and there were more
diploma holders compared to degree holders (47.0%, n=156) [Table 1].
Table 1. Socio-demographic characteristics among study population presented in
percentages
Characteristics
Gender
Male
Female
Education level
≤ SPM
Diploma
Degree
Age
20-25
26-30
31-35
36-40
40-45
> 46
Occupation
Doctor/Dentist
Nurse
Allied Healthcare Professional
Others
All (%) n = 332
86 (25.9%)
246 (74.1%)
114 (34.3%)
156 (47.0%)
62 (18.7%)
6 (1.8%)
32 (9.6%)
60 (18.1%)
80 (24.1%)
82 (24.7%)
72 (21.7%)
40 (12.0%)
150 (45.2%)
81 (24.4%)
61 (18.4%)
Knowledge scores
From the study, only 28.9% (n=96) of the study population had good knowledge towards
registered products and notified cosmetics despite 90.7% (n=302) claiming that they have
exposure on the topic at hand. 31.7% of female participants with good understanding
(n=78)
Individually, doctors/dentists have the highest score of good knowledge at 50% (n=20)
followed by allied health professionals (AHP) stood at 34.6% (n=28), nurses at 25.3 (n=38)
and others at 16.4% (n=10).
Table 2 Tabulated responses to questionnaire
Occupation
Doctor/Dentist (n=40)
Good Understanding
20 (50.0%)
Nurse (n=150)
38 (25.3%)
Allied Health Professional (n=81)
28 (34.6%)
Others (n=61)
Total
10 (16.4%)
96 (28.9%)
Pearson Chi-square analysis demonstrates that the level of knowledge among various
groups of HCP are significantly different (p<0.001). 0 cells (0.0%) have expected count
less than 5. The minimum expected count is 11.57 Therefore, the assumptions are fulfilled.
The Pearson Chi Square analysis value is 15.5 with a degree of freedom of 3. The p-value
is less than 0.001 thus this study is statistically significant.
DISCUSSION
The increasing use of unregistered medications by the public is a cause of great concern
because these products are not only available ‘on the streets’ but can be easily found
online. In a mass raid throughout the year 2021 to January 2022 facilitated by the Ministry
of Health, Pharmacy Enforcement Division, unregistered health products worth up to RM
23 million were seized from over 1,330 premises6.
When the public has any doubts or any enquiries with regards to this topic, the government
healthcare personnel are usually the first person they will get professional health advice
from as they are among the front-liners for healthcare in Malaysia4.
Despite 91.0% (n=302) of the participants answering that they have received or were
exposed before to information related to registered products and cosmetics, only 27.4%
(n=91) have managed to score 10 questions or more correctly. Out of the 28.9%,
doctor/dentist (50%, n=20) have the highest knowledge compared to other groups. As their
main role is to treat patients and discuss on medications to be taken, it is understandable
that their knowledge is the highest11. Plus, doctors and dentists are responsible for a major
portion of the health care delivered.
Other healthcare personnel (16.4%, n = 10) have the poorest knowledge among all of the
participants. There may be several factors contributing to this, such as having a lack of
time to answer the questionnaire properly, or perhaps they do not understand the
magnitude of the issue at hand. A workshop focusing on this group should be formulized
to disseminate information regarding registered products and cosmetic’s notification.
Interestingly, analysis on 12 questionnaire questions found out that top 3 questions that
were most wrongly answered by respondents are related to tools used to identify the
genuine MAL Hologram which stood at 72.9%, cosmetic’s notification format at 61.4% and
role of NPRA as the authorized body in medicine’s registration at (59%). It’s probably due
to the hologram itself which changed periodically that causing confusion among
respondents.
Perhaps, further continuous professional development, such as organising more
workshops to improve the knowledge of Kota Bharu’s HCP’s should be recommended to
enhance and improve the existing knowledge of all GHPs from the Ministry of Health in
Kota Bharu towards registered products and notified cosmetics. Pharmacist who is
considered as expertise in this field can act as a mediator to involve other HCP’s in Training
of Trainee (ToT) programs regarding medication registration. The content of the workshop
should include hologram’s information so that they will be exposed to tools that can be
used to check on authenticity of the registered products. As for now, the Farmatag’s
hologram can be validated through Farmachecker application and pharmacy’s official
website, www.pharmacy.gov.my. This is to ensure all health care personnel able to act as
an educator to deliver proper information to the public. Patients and stakeholders who
counselled by HCP’s regarding this issue must be supplied with full information. Therefore,
the content of workshops relating product registration knowledge must be conclusive.
There were some limitations to our study. First, this was a non-randomized survey which
was conducted in a non-controlled environment. The participants may refer to materials
through various leaflets or brochures, search the answers online or even discuss the
questions among peers. The investigators expected that the performance of the
participants would be better with this limitation in place. The scale that was used to grade
the knowledge of the GHP was not based on any study and thus, may not be scientifically
accurate to determine the HCP’s exact knowledge levels. Finally, while the study
population had met the requirements of the sample size, some of the individual divided
groups of separate
healthcare personnel (e.g. doctors/dentist) may be too small to
represent the actual population.
CONCLUSION
In this study, the level of knowledge towards registered products and notified cosmetics
among doctors, pharmacist, nurses and allied health professional in Kota Bharu is poor as
only 28.9 % among the study population have good knowledge. This study shows a
significant association between the levels of knowledge among HCP varies between
groups of profession. Further re-education should be conducted to improve the knowledge
of HCP in Kota Bharu with regards to this subject.
REFERENCES
1.
2.
3.
4.
5.
6.
7.
Nur Wahida Zulkifli et al, A Survey on Knowledge of Registered Drugs amongst
Patients from the Specialist Clinic, Malaysia
Haniff Mohd Nawi et.al, Knowledge, Attitude And Practice Of Unregistered
Medicines Among Patients With Chronic Disease At Urban Health Clinic,
Kelantan, Malaysia
NPCB. (2014, April 3). FAQ: Product Registration. National Pharmaceutical
Control Bureau Official Homepage. Kuala Lumpur. Retrieved from
http://portal.bpfk.gov.my/index.cfm?&men uid=96
ZS Sujata Tan, Knowledge level of government healthcare personnel in Labuan
towards Registered Product and Notified Cosmetic.
Risk
of
Puchasing
medicine
via
internet.
https://www.pharmacy.gov.my/v2/en/content/risk-purchasing-medicationsinternet.html
Siew Chin Ong, Annushiah Vasan Thakumar, Guat See Ooi, Asrul Akmal
Shafie, Mohamed Azmi Ahmad Hassali, Perspectives of the public on the
consumption of unregistered health products in Malaysia, International Journal
of Pharmacy Practice, Volume 28, Issue 6, December 2020, Pages 579–590,
https://doi.org/10.1111/ijpp.12673
Izham MI. Peranan Ahli Farmasi Dalam Kesihatan. [Internet]. Malaysia: Pusat
Racun Negara, Universiti Sains Malaysia; 2017 [cited Feb 6, 2017]. Available
at: http://www.prn.usm.my/index.php/archive/magazines/dewan-kosmik/304peranan-ahli farmasi-dalam-kesihatan