Newsletter Pharmacy

Vol. 27 Jan-Feb 2015

What’s

Inside Safe Drug Use After A

Natural Disaster

GST In Pharmacy

Phytobiophysics

Editorial Board

Pn Saidatul Raihan

Ibrahim

Pn Julia Shamsudin

Pn Afzan Raihan

Izzati Hamzah

Editor

Mohd Hafiz Abdull

Seddek

Contributor

Gooi Ying Ying

Joane Dai Jia Wen

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CO

NTENTS

1-2 Focus

Safe Drug Use After A Natural Disaster

Topic of Current Interest

GST in Pharmacy

3-5

Complementary Medicine

Phytobiophysics

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Drug Comparison

oxynorm vs oxycontin 9

10-11

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13-14

15 Pharmacy joke

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Drug Safety

Shelf life of traditional products & supplements

Counselling

Medication therapy adherence clinic (mtac)

Drug Profile

Products Containing Topiramate

Anouncement

Jamuan perpisahan & SAMBUTAN HARI JADI

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Safe Drug Use After A Natural Disaster

By: Joane Dai Jia Wen

Lifesaving Drugs Exposed To Water

For lifesaving drugs, if the container is contaminated but the contents appear un-affected–if the pills are dry–the pills may be used until a replacement can be ob-tained. However, if a pill is wet, it is contaminated and should be discarded.

Drugs Exposed to Unsafe Water Drugs that are exposed to flood or un-safe 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 discard-ed if they have come into contact with flood or contaminated water.

Reconstituted Drugs

For children's drugs that have to be made into a liquid using water (reconstituted), the drug should only be reconstituted with purified or bot-tled water.

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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.

Information Regarding Insulin Storage

Insulin loses some effectiveness when exposed to extreme temperatures. The longer the expo-sure to extreme temperatures, the less effective the insulin becomes. This can result in loss of blood glucose control over time. Under emer-gency conditions, you might still need to use in-sulin 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 insu-lin that has been frozen. Keep in-sulin away from direct heat and out of direct sunlight.

When properly stored insulin becomes available again, the in-

sulin vials that have been exposed to these extreme conditions should be

discarded and replaced as soon as possible.

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.

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Reference: 1. FDA website: http://www.fda.gov/Drugs/EmergencyPreparedness/ucm085200.htm

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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.

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-

Standard-rated supplies:

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 sup-

plies.

Zero-rated supplies:

Taxable supplies of goods and services which are sub-ject to GST at zero percent rate. In this respect, busi-

nesses do not collect any GST on their supplies but are enti-tled to claim credit on inputs used in the course of further-

ance of the business.

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.

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Businesses making taxable supplies have to be registered under GST if their annual sales turnover has exceeded the prescribed thresh-old. 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 per-son.

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 stand-ard 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.

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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 com-pounds 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

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 atten-tion to, towards a healthy nation.

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 medi-cines 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.

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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, emo-tional problems, post-surgery and other ill-nesses.1

Phytobiophysics is developed by Diana Mos-sop and practiced since 2000.3 Thousands of plant essences have been gathered worldwide and combined based on the Mossop Philoso-phy, to produce Phytobiophysic Flowers and Trees formulas.4 By using vibrational energy of plants for healing, it has become the prima-ry remedial aspect of the Mossop Philosophy.4 There is an inter-relationship between our souls and being and the physical manifesta-tions which appear as symptoms of illness.2,4

Spiritual has no beginning and end, it is the most profound journey of all.4 Men-tal is the intellectual journey, related to the used of oxygen and skeleton struc-tural disorders.4 Emotional relates to functional disorders and physical is about growth, breathing, heartbeat, di-gestion, elimination and living.4

Also, through the five senses (touch, taste, sight, hear, smell), we can experi-ence 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

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Method

Thousands of tree nuts, seeds, plants and flower es-sences are gathered from around the world to com-bine their frequencies, to produce 20 Phytobio-physics Flower Formulas and 10 Superfit Tree for-mulas.2,4 Following the colour spectrum of the Rain-bow, they have been formulated to resonate on very precise and specific frequencies.2,4 This is because every healthy person resonates on the colour spec-trum.2,4 Therefore, each Flower Formula is specifi-cally created to match the resonance of healthy cells in the body, they act as neurotransmitters and regulate the electro-magnetic frequency of the sys-tem when it is taken orally.2,4 Then, the body can be healed by own innate ability.4

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Each level of human body vibrates on a specific colour frequency, living cells can ad-mit 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 380 nm

Violet 423 nm

Indigo 449 nm

Blue 475 nm

Green 512 nm

Yellow 573 nm

Orange 607 nm

Red 680 nm

Infra Red 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, non-addictive

Safe for babies, young children and elder-ly

Can enhance the effect of other therapies

Improves immune system, memory, emo-tional trauma

Antidote for pollution, toxicity, radioac-tivity, geopathic stress Assimilate nutrients

Disadvantages

Lack convincing findings to confirm their benefits

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References: 1. Huneidi S. Phytobiophysics Complementary Medicine Products. Ketheric Well-being; http://www.ketheric.com/phytobiophysics-

complementary-medicine-products/ 2. Mossop D. Phytobiophysics-A New Philosophy. England: Positive Health Online. http://www.positivehealth.com/article/flower-

essences/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

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oxynorm vs oxycontin

By: Gooi Ying Ying

Drug Oxynorm (Oxycodone ) Oxycontin (Oxycodone)

Indication1 Moderate to severe pain Moderate to severe pain, chronic pain non-responsive to Morphine

Strengths Available1 5mg, 10mg 10mg, 20mg

Dose1 Initially 5 mg every 4-6 hours, increased if necessary to a max of 400 mg daily. Some patient may require higher doses.

10mg every 12 hours. Re-nal/hepatic impairment: 5mg bd

Mechanism of Action2 Acts on narcotic agonist-analgesic of opiate receptors (kappa, mu, delta) in brain and spinal chord. It inhibits as-cending pain pathways, altering response to pain; has anal-gesia, respiratory depression and sedation effect.

Immediate release Controlled release

ADME2,3

Absorption 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 Duration: <12 hr

Peak plasma time: 1.5-1.9 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 5mg-RM1.10/cap 10mg-RM2.80/cap

10mg-RM3.30/tab 20mg-RM7.00/tab

Alternatives1 Dihydrocodeine, Fentanyl, Morphine, Pethidine, Tramadol.

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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-oxycontin-

oxycodone-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

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Shelf life of traditional products & supplements By: Joane Dai Jia Wen

In recent years, Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) has re-ceived 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 sup-plements 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 require-ments are complied with:

Requirements Nowadays

Local products and imports Generally, the need of requirements for stability study data is same as pre-

vious 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.

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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 com-

pound, where the content is placed on the label, the stability studies conduct-ed 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 ingre-

dients / 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 scien-tific 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 Sta-bility 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.

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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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Medication therapy adherence clinic (mtac)

By: Gooi Ying Ying

MTAC Person in charge

Warfarin Ms Tai Siew Yin

Diabetes Mellitus Pn Hafiza Abd Halim

Pain Pn Ummi Kalsum Lambak

Respiratory Pn Suhadah Ahad

Respiratory, RVD Paeds Ms Wong Shien Woan

RVD Pn Syamsiah Shariff

CRP/ Heart Failure Cik Siti Rahmah Johari

Psoriasis Ms How Siok Peng

Nephrology Ms Ong Zee Yun

Hemophilia/ Thalasse-mia

Cik Nurul Hidayah bt Md Shariff

Neurology Ms Sharon Chew

Hepatitis Cik Nurul Nadiah Abd Rahim

Hari 8 pagi—1 tgh 1 –2 ptg 2—5 ptg

Isnin Diabetes & RVD Rehat Warfarin

Selasa Neurologi Rehat Warfarin

Rabu Cardiac Rehabilitation Pro-

gramme & Heart Failure Rehat RVD

Khamis Warfarin & Respiratori De-

wasa Rehat

Respiratori Pae-diatrik

Jumaat Warfarin Rehat -

Jadual klinik

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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, safe-

ty and cost-effectiveness of patient care. MTAC is operated by pharmacists who provide drug therapy moni-

toring and patient’s education in improving their ability to successfully manage disease condition and pre-

venting debilitating symptomps together with reducing the likelihood of medication errors. The service also

includes clinical pharmacokinetic consultation, laboratory monitoring and dosage adjustment of relevant med-

ications.

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In the meeting on December 4, 2014 , Drug Control Authorities (DCA) has de-cided to include warning regarding the risk of visual defective for all products which contain topiramate.

Products containing topiramate

By: Joane Dai Jia Wen

Special Warnings and Precautions For Use of Products which contain To-piramate.

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 intra-ocular pressure should be taken, and topiramate stopped as rapidly as is clini-cally feasible. Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss.

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SF Protect & Perfect Day Cream

Notification

No. : NOT130604475K

Name of Product No-tification Holder: SF Infinity Re-sources

Scheduled Poison De-tected: Mer-cury.

Name of Manufactur-er: Sireh Emas Mar-keting Sdn. Bhd., Malay-sia.

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 kid-neys and the nervous sys-tems. It may also interfere with the brain develop-ment of unborn and very young children. Mercury can get into their bodies from inhaling the mercury vapours. Infants and chil-dren 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.

Anyone who is in posses-sion of this product is ad-vised to immediately cease selling/distributing/using it. Sellers are reminded that possession of this product is an offence under the Con-trol Of Drugs and Cosmetics Regulations .

Consumers who experience any allergic reations or ad-verse events are advised to contact the National Phar-maceutical Control Bureau (NPCB) at:

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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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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. Un-

fortunately, 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?"

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Jamuan perpisahan & SAMBUTAN HARI JADI (16 jan 2015)

By: Mohd Hafiz Abdull Seddek

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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 Az-ura Kassim and Cik Lai Yik Shan.

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