What`s Inside

Newsletter
Pharmacy
Vol. 27 Jan-Feb 2015
Editorial Board
What’s
Inside
Pn Saidatul Raihan
Ibrahim
Pn Julia Shamsudin
Pn Afzan Raihan
Izzati Hamzah
Safe Drug Use After A
Natural Disaster

Editor
Mohd Hafiz Abdull
Seddek


GST In Pharmacy
Phytobiophysics
Contributor
Gooi Ying Ying
Joane Dai Jia Wen
Focus
1-2
Safe Drug Use After A Natural Disaster
Topic of Current Interest
3-5
GST in Pharmacy
Complementary Medicine
6-8
CONTENTS
Phytobiophysics
Drug Comparison
9
oxynorm vs oxycontin
10-11
Drug Safety
Shelf life of traditional products &
supplements
12
Counselling
Medication therapy adherence clinic
(mtac)
13-14
Drug Profile
Products Containing Topiramate
15
16-17
Pharmacy joke
Anouncement
Jamuan perpisahan & SAMBUTAN HARI JADI
2
Safe Drug Use After
A Natural Disaster
By: Joane Dai Jia Wen
Drugs Exposed to Unsafe Water
Drugs that are exposed to flood or unsafe municipal water may become
contaminated. This contamination
may lead to diseases that can cause
serious health effects. We recommend
that drug products, even those in their
original containers should be discarded if they have come into contact with
flood or contaminated water.
Lifesaving Drugs Exposed
To Water
For lifesaving drugs, if the
container is contaminated
but the contents appear unaffected–if the pills are dry–
the pills may be used until a
replacement can be obReconstituted Drugs
tained. However, if a pill is
wet, it is contaminated and
For children's drugs that have to be made into a should be discarded.
liquid using water (reconstituted), the drug
should only be reconstituted with purified or bottled water.
13
Drugs that Need Refrigeration
Temperature sensitive drugs lose potency if not
refrigerated, they should be replaced with a new
supply as soon as possible. However, if the drug
is absolutely necessary to sustain life (insulin,
for example), it may be used until a new supply
is available.
If a contaminated product is considered medically necessary
and would be difficult to replace quickly, you should contact
a healthcare provider for guidance. If you are concerned
about the efficacy or safety of a particular product, contact
your pharmacist, healthcare provider or the manufacturer's
customer service department.
Information Regarding Insulin Storage
Insulin loses some effectiveness when exposed
to extreme temperatures. The longer the exposure to extreme temperatures, the less effective
the insulin becomes. This can result in loss of
blood glucose control over time. Under emergency conditions, you might still need to use insulin that has been stored above 86°F or 30°C.
You should try to
keep insulin as cool as possible. If you are using
ice, avoid freezing the insulin. Do not use insulin that has been frozen. Keep insulin away from direct heat and
out of direct sunlight.
When properly stored insulin becomes available again, the insulin vials that have been exposed to these extreme conditions should be
discarded and replaced as soon as possible.
Reference:
1.
FDA website: http://www.fda.gov/Drugs/EmergencyPreparedness/ucm085200.htm
24
GST in Pharmacy
By: Mohd Hafiz Abdull Seddek
GST (Goods & Services Tax), which is also known as
VAT or the value added tax in many countries is a
multi-stage consumption tax on goods and services.
GST is levied on the supply of goods and services at
each stages of the supply chain from the supplier
up to the retail stage of the distribution. It shall be
levied and charged on the taxable supply of goods
and services made in the course or furtherance of
business in Malaysia by a taxable person.
Exempt supplies:
Supplies of goods or services which
are not subject to GST. In this context,
businesses do not collect any GST on
their supplies and are not entitled to
claim credit on his business inputs.
Zero-rated supplies:
Standard-rated supplies:
Taxable supplies of goods
and services which are subject to GST at zero percent
rate. In this respect, businesses do not collect any GST
on their supplies but are entitled to claim credit on inputs
used in the course of further-
Taxable supplies of goods and
services which are subject to a
proposed rate of 6%. A taxable
person who is registered under
GST has to collect GST on the
supply and is eligible to claim
input tax credit on his business
inputs in making taxable supplies.
ance of the business.
Supplies which do not fall within
the charging provision of the GST
Act:
Non-business transactions, sale of
goods from a place outside Malaysia to
another place outside Malaysia as well
as services provided by the Govern-
35
Businesses making taxable supplies have to
be registered under GST if their annual sales
turnover has exceeded the prescribed threshold. Only a registered person can charge and
collect GST on the taxable supplies of goods
and services made by him. GST is charged on
the value or selling price of the products. The
amount of GST incurred on input (input tax)
can be deducted from the amount of GST
charged (output tax) by the registered person.
Price Changes
GST will cause price changes in some services and goods.
Deputy of Finance Minister said GST will be implemented
on 689 goods. 73 of them will experienced price drops,
287 increase and 329 no changes. According to Health
Minister, private medical cost maybe increased when GST
is introduced.
Services in the government facilities will have no or little effect. Pharmaceutical
services not provided by government or private healthcare facilities are standard rated supplies. For example;

Industrial pharmaceutical company, retail pharmacy selling medicines or
products which are not under the National Essential Medicine List of the
Ministry of Health approved by the Minister of Finance to be treated as
standard rated supplies.
46
Medicines – Standard rated, 6%
Although medicines are subject to a standard rate, medicaments and medical
gases in the National Essential Medicine List (NEML) issued by the Ministry of
Health and approved by the Minister of Finance and put up in measured doses
or in forms of packaging for retail sale are zero rated. According
to announcement made by the PM, there are 320 chemical compounds used in manufacturing of pharmaceutical products and
4200 brands of medicines under NEML will be exempted from
GST. Therefore, other categories of medicines for example OTC
Malaysian Pharmaceutical Society stated that
many other medicines outside the NEML are
widely prescribed and use in private sector.
They found that only 13% of registered medicines in this country are actually in the list. If
these medicines are not zero rated, there will
likely be an increase in the cost of medicines,
making them unaffordable to many patients
who are on long term medication.
The effect of GST on pharmacy practice in Malaysia is uncertain. The potential
effect of price rise of medical cost on healthcare should be paid a close attention to, towards a healthy nation.
References;
1.
http://gst.customs.gov.my/
2.
http://www.mps.org.my/
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Phytobiophysics
By: Gooi Ying Ying
Phytobiophysics
The science of infinite plant energy to restore
balance and harmony of the world in spiritual,
mental, emotional and physical ways.1,2 They
are in the form of small tablets, and should be
sucked until dissolved.1,3 It is for cold, emotional problems, post-surgery and other illnesses.1
Phytobiophysics is developed by Diana Mossop and practiced since 2000.3 Thousands of
plant essences have been gathered worldwide
and combined based on the Mossop Philosophy, to produce Phytobiophysic Flowers and
Trees formulas.4 By using vibrational energy
of plants for healing, it has become the primary remedial aspect of the Mossop Philosophy.4
There is an inter-relationship between our
souls and being and the physical manifestations which appear as symptoms of illness.2,4
8
6
Spiritual has no beginning and end, it is
the most profound journey of all.4 Mental is the intellectual journey, related to
the used of oxygen and skeleton structural disorders.4 Emotional relates to
functional disorders and physical is
about growth, breathing, heartbeat, digestion, elimination and living.4
Also, through the five senses (touch,
taste, sight, hear, smell), we can experience emotions that have great effect on
our souls and change the function and
structure of the body.2,4 Trauma and
tragedy also create wounds that leave
scars on the soul.2,4
Method
Thousands of tree nuts, seeds, plants and flower essences are gathered from around the world to combine their frequencies, to produce 20 Phytobiophysics Flower Formulas and 10 Superfit Tree formulas.2,4 Following the colour spectrum of the Rainbow, they have been formulated to resonate on very
precise and specific frequencies.2,4 This is because
every healthy person resonates on the colour spectrum.2,4 Therefore, each Flower Formula is specifically created to match the resonance of healthy
cells in the body, they act as neurotransmitters and
regulate the electro-magnetic frequency of the system when it is taken orally.2,4 Then, the body can be
healed by own innate ability.4
79
Each level of human body vibrates on a specific colour frequency, living cells can admit and transmit light fast.4 White light splits into the rainbow, it varies in colour
depending on frequency and wavelength.4 The radiation measurement of the pure
colour is as follows:
Ultra Violet
Violet
Indigo
Blue
Green
Yellow
Orange
Red
Infra Red
380 nm
423 nm
449 nm
475 nm
512 nm
573 nm
607 nm
680 nm
780 nm
The shorter wavelength of colour, the higher the frequency, the higher the
penetration potential.4 High frequency range are effective in spiritual, emotional
and nervous system disorders.4 Low frequency colours are effective in the
physical body.4
Every chemical, element and substance on earth has its own energy frequency
that can be related to the colour-band. Through the interesting colour of the
flower petals, it can relate the vibration of each flower to a colour vibration.4
Advantages3,5
The flower essence are harmless, nonaddictive
Safe for babies, young children and elderly
Can enhance the effect of other therapies
Improves immune system, memory, emotional trauma
Antidote for pollution, toxicity, radioactivity, geopathic stress
Assimilate nutrients
Disadvantages
Lack convincing findings to confirm
their benefits
References:
1.
Huneidi S. Phytobiophysics Complementary Medicine Products. Ketheric Well-being; http://www.ketheric.com/phytobiophysicscomplementary-medicine-products/
2.
Mossop D. Phytobiophysics-A New Philosophy. England: Positive Health Online. http://www.positivehealth.com/article/floweressences/phytobiophysics-a-new-philosophy
3.
Elysium Sanctuary. Photobiophysics. Ireland; http://www.elysiumsanctuary.com/phytobiophysics.php
4.
Phytobiophysics The Mossop Philosophy. Phytobiophysics. Jersey; http://www.phytob.com/frame.asp
5.
Josephine Grimes Holisticare. The Power to Heal. Photobiophysics/ Podo- Rhacidian. Ireland;
http://www.holisticare.ie/PhytobiophysicsPodoRhacidian.htm
8
10
oxynorm vs
oxycontin
Drug
Indication1
Strengths Available1
Dose1
Mechanism of Action2
Absorption
ADME2,3
By: Gooi Ying Ying
Oxynorm (Oxycodone )
Moderate to severe pain
Oxycontin (Oxycodone)
Moderate to severe pain,
chronic
pain
nonresponsive to Morphine
5mg, 10mg
10mg, 20mg
Initially 5 mg every 4-6 hours, 10mg every 12 hours. Reincreased if necessary to a nal/hepatic impairment:
max of 400 mg daily. Some 5mg bd
patient may require higher
doses.
Acts on narcotic agonist-analgesic of opiate receptors
(kappa, mu, delta) in brain and spinal chord. It inhibits ascending pain pathways, altering response to pain; has analgesia, respiratory depression and sedation effect.
Immediate release
Controlled release
Bioavailability: 60-87%, high due to low pre-systemic and
first-pass metabolism
Onset: 10-15 min
Onset: Consistently over
12 hr
Duration: 3-6 hr
Peak plasma time: 1.5-1.9 hr
Duration: <12 hr
Peak plasma time: 4-5 hr
Distribution
Protein bound: 45%, Vd: 2.6L/kg, distributed to skeletal
muscle, liver, intestinal tract, lungs, spleen, brain
Metabolism
Metabolised in liver by CYP3A
Elimination
Half-life: 2-4 hr
Half-life: 4.5 hr
Excretion: Urine (83%)
Cost1
Alternatives1
5mg-RM1.10/cap
10mg-RM2.80/cap
10mg-RM3.30/tab
20mg-RM7.00/tab
Dihydrocodeine, Fentanyl, Morphine, Pethidine, Tramadol.
References:
1.
Drug Formulary Melaka 2014/2015, Melaka Drug Formulary Committee, KKM. Pharmaceutical Services Division, Melaka.
2.
Medscape. Oxycodone. New York: WebMD: Available from: http://reference.medscape.com/drug/roxicodone-oxycontinoxycodone-343321http://reference.medscape.com/drug/roxicodone-oxycontin-oxycodone-343321
3.
RxList The Internet Drug Index. Oxycontin. New York: WebMD; Available from: http://www.rxlist.com/oxycontin-drug.htm
911
Shelf life of
traditional products
& supplements
By: Joane Dai Jia Wen
In recent years, Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) has received numerous studies document which has dubious stability during the
processing and assessing of applications for the registration of new products
and product variations. BPFK take this situation seriously because inaccurate
or false data can affect the quality and safety of products and ultimately will be
detrimental to the health of consumers.
To avoid this situation from recurring, BPFK has decided
that the shelf life for the traditional products and health supplements categories to be set to 2 years if stored at 30°C±2°
C and 75°% Relative Humidity (RH) ± 5°% RH for both local
and import products. Application for the shelf life apart
from this period will be considered if the following requirements are complied with:
Requirements Nowadays
Local products and imports

Generally, the need of requirements for stability study data is same as previous requirements. The only difference is the permitted shelf life. For all
stability studies which were not carried out in zone IVb (30°C±2°C and
75°% RH±5°%), the shelf life was not allowed to exceed 2 years.
10
12

For product registration holders who wish to prolong the shelf life of
their products at a storage temperature in zone IVb (30°C±2°C and 75°%
RH±5°%RH) to more than 2 years, the following requirements need to be
complied:

The stability study shall be conducted in Malaysia.

The stability study data (real time) in Zone IV b (30°C±2°C and
75°% RH±5°%RH) for two groups must be submitted over the shelf
life of which the applicant proposed.
For traditional products that use standardized extract of isolated compound, where the content is placed on the label, the stability studies conducted shall examine the content of isolated compound (assay) over the period of
stability studies conducted.
If the assay results were not included, the shelf life of products is allowed
for two years only.
Applications that require the shelf life for more than 2 years of active ingredients / products which are not stable in zone IVb, stability studies should
meet the requirements below :
i.
The stability study shall be conducted in Malaysia.
ii. The stability study data (real time) in the zones which other than zones
IVb manufacturing for 2 groups must be submitted over the shelf life of
which the applicant proposed.
iii. Supporting documents to show that the active ingredient / product are
not stable in zone IVb.
iv. Documents which was given must be a stability study data showing the
degradation of the active ingredient / product in zone IV b or other scientific data.
NOTE: The frequency of testing for the stability study data must comply
with the frequency that has been stated in the ASEAN Guidelines on the Stability Study and Shelf Life of Traditional Medicines and Health Supplements
unless there is strong justification for the exclusion of the frequency of the
test set.
Reference:
1.
Tempoh Hayat Simpanan (Shelf-Life) Bagi Produk Tradisional dan Supplemen Kesihatan. http://portal.bpfk.gov.my/
newsmaster.cfm?&menuid=52&action=view&retrieveid=482#sthash.tcgummQM.dpuf
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13
Medication therapy
adherence clinic
(mtac)
By: Gooi Ying Ying
Introduction
Medication Therapy Adherence Clinic (MTAC) was introduced in 2004 as part of clinical pharmacy services
in the Ambulatory Clinic System which emphasizes on medication management to improve on quality, safety and cost-effectiveness of patient care. MTAC is operated by pharmacists who provide drug therapy monitoring and patient’s education in improving their ability to successfully manage disease condition and preventing debilitating symptomps together with reducing the likelihood of medication errors. The service also
includes clinical pharmacokinetic consultation, laboratory monitoring and dosage adjustment of relevant medications.
MTAC
Warfarin
Diabetes Mellitus
Pain
Respiratory
Respiratory, RVD Paeds
Person in charge
Ms Tai Siew Yin
Pn Hafiza Abd Halim
Pn Ummi Kalsum Lambak
Pn Suhadah Ahad
Ms Wong Shien Woan
RVD
CRP/ Heart Failure
Psoriasis
Nephrology
Hemophilia/ Thalassemia
Neurology
Hepatitis
Pn Syamsiah Shariff
Cik Siti Rahmah Johari
Ms How Siok Peng
Ms Ong Zee Yun
Cik Nurul Hidayah bt Md Shariff
Ms Sharon Chew
Cik Nurul Nadiah Abd Rahim
Jadual klinik
Hari
8 pagi—1 tgh
1 –2 ptg
2—5 ptg
Isnin
Diabetes & RVD
Rehat
Warfarin
Selasa
Neurologi
Rehat
Warfarin
Rabu
Cardiac Rehabilitation Programme & Heart Failure
Rehat
RVD
Khamis
Warfarin & Respiratori Dewasa
Rehat
Respiratori Paediatrik
Jumaat
Warfarin
Rehat
-
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14
Products containing
topiramate
By: Joane Dai Jia Wen
In the meeting on December 4, 2014 , Drug Control Authorities (DCA) has decided to include warning regarding the risk of visual defective for all products
which contain topiramate.
Special Warnings and Precautions For Use of Products which contain Topiramate.
Topiramate is used alone or with other medications to treat certain types of
seizures in people who have
epilepsy.
A syndrome consisting of acute myopia associated with secondary angle closure
glaucoma has been reported in patients receiving topiramate. Symptoms include
decreased visual acuity and ocular pain which generally appear within one
month of starting treatment; hyperaemia and raised intra-ocular pressure may
be present with or without mydriasis. Appropriate measures to reduce intraocular pressure should be taken, and topiramate stopped as rapidly as is clinically feasible. Elevated intraocular pressure of any aetiology, if left untreated,
can lead to serious sequelae including permanent vision loss.
13
15
Cosmetic Products Containing Poison
SF Protect & Perfect Day Cream
SF Protect & Perfect Day
Cream have been tested
and found to contain high
levels of mercury that is
prohibited in cosmetic
products and this products
are no longer allowed to be
sold in Malaysia.
Exposure to mercury can
cause damage to the kidneys and the nervous systems. It may also interfere
with the brain development of unborn and very
young children. Mercury
can get into their bodies
from inhaling the mercury
vapours. Infants and children can also accidently
ingest mercury when they
touch cosmetic product
containing mercury or
their parents who have
used these products.
Using products containing
mercury can also cause skin
rashes, irritation, and other
changes to the skin.
SF Protect &
Perfect Day
Cream


Anyone who is in possession of this product is advised to immediately cease
selling/distributing/using
it. Sellers are reminded that
possession of this product is
an offence under the Control Of Drugs and Cosmetics
Regulations .
Consumers who experience
any allergic reations or adverse events are advised to
contact the National Pharmaceutical Control Bureau
(NPCB) at:


Notification
No. :
NOT130604
475K
Name of
Product Notification
Holder: SF
Infinity Resources
Scheduled
Poison Detected: Mercury.
Name of
Manufacturer: Sireh
Emas Marketing Sdn.
Bhd., Malaysia.
Reference:
1.
Direktif untuk semua produk yang mengandungi Topiramate: Amaran berkaitan risiko gangguan penglihatan.
http://portal.bpfk.gov.my/newsmaster.cfm?&menuid=52&action=view&retrieveid=484#sthash.PXnav4t4.dpuf
2.
SF PROTECT & PERFECT DAY CREAM: PRODUK KOSMETIK YANG DIKESAN MENGANDUNGI RACUN BERJADUAL.
http://portal.bpfk.gov.my/newsmaster.cfm?&menuid=52&action=view&retrieveid=470#sthash.ghsusle6.dpuf
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16
Pharmacy jokes
By: Mohd Hafiz Abdull Seddek
Customer gets a topical cream. Direction: apply locally two times a day. Customer says to the
pharmacist: "I can't apply locally, I'm going overseas."
A pharmacist is going over the directions on a prescription
bottle with an elderly patient. "Be sure not to take this
more often than every 4 hours," the pharmacist says. "Don't
worry," replies the patient. "It takes me 4 hours to get the
lid off".
A man goes into a drugstore and asks the pharmacist if he can
give him something for the hiccups. The pharmacist
promptly reaches out and slaps the man's face. "What did
you do that for?" the man asks. "Well, you don't have the
hiccups anymore, do you?"
The man says, "No, but my wife out in the car still does!"
A doctor is to give a speech at the local AMA dinner. He jots down notes for his speech. Unfortunately, when he stands in front of his colleagues later that night, he finds that he
can't read his notes. So he asks, "Is there a pharmacist in the house?"
17
15
Jamuan perpisahan &
SAMBUTAN HARI JADI
(16 jan 2015)
18
16
By: Mohd Hafiz Abdull Seddek
On 16th January 2015, the Outpatient Pharmacy had organised an event of
‘Jamuan Perpisahan’ at the Main Pharmacy, Hospital Melaka. The event was
held to celebrate the staffs leaving Hospital Melaka as an appreciation for their
excellent services. They are Pn Norazlinda Yacob, Pn Fatimah Othman, Cik Azura Kassim and Cik Lai Yik Shan.
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