INTRODUCTION

Antibiotics are medicines used to prevent and treat bacterial

infections. Antibiotic resistance occurs when bacteria change in

response to the use of these medicines.

Bacteria, not humans or animals, become antibiotic-resistant.

These bacteria may infect humans and animals, and the infections

they cause are harder to treat than those caused by non-resistant

bacteria.

Antibiotic resistance leads to higher medical costs, prolonged

hospital stays, and increased mortality.

The world urgently needs to change the way it prescribes and uses

antibiotics. Even if new medicines are developed, without

behaviour change, antibiotic resistance will remain a major threat.

Behaviour changes must also include actions to reduce the spread

of infections through vaccination, hand washing, practicing safer

sex, and good food hygiene.

PHARMACY BULLETIN

HOSPITAL SEGAMAT, ISSUE 4/2017

Editorial Boards:

Advisor:

Puan Nur Shazrina binti Ahmad Editor:

Cik Yee Chiou Yann

Co-Editors:

Cik Pang Kai Le Cik Siti Nur Afiqah Cik Siti Nor Amirah

ANTIBIOTIC AWARENESS

IN THIS ISSUE:

Antibiotic Awareness 1-3

Safety Updates: 4

PPIs: Potential

Long-term Safety Issues

Product Brand Changes 5-7

New Medications 8-9

available in Hospital Segamat

Pharmacy Activities 10-11

EKSA 12 SCOPE OF THE PROBLEM

Antibiotic resistance is rising to dangerously high levels in all parts

of the world. New resistance mechanisms are emerging and

spreading globally, threatening our ability to treat common

infectious diseases. A growing list of infections – such as

pneumonia, tuberculosis, blood poisoning, gonorrhoea, and

foodborne diseases – are becoming harder, and sometimes

impossible, to treat as antibiotics become less effective.

Where antibiotics can be bought for human or animal use without

a prescription, the emergence and spread of resistance is made

worse. Similarly, in countries without standard treatment

guidelines, antibiotics are often over-prescribed by health workers

and veterinarians and over-used by the public.

Without urgent action, we are heading for a post-antibiotic era, in

which common infections and minor injuries can once again kill.

Disclaimer: While all care is taken to ensure that the information presented in this bulletin is accurate, the board of editors and authors of this bulletin disclaim all responsibilities for any liability, loss or harm incurred as a result of misinterpretation or inaccuracies within this bulletin. The content of this bulletin is provided for general informational purposes only and is not intended as, nor should it be considered substitute for professional medical advice.

PREVENTION AND CONTROL Antibiotic resistance is accelerated by the misuse and overuse of antibiotics, as well as

poor infection prevention and control. Steps can be taken at all levels of society to reduce

the impact and limit the spread of resistance.

ISSUE 04/2017 PAGE 2

Tackling antibiotic resistance is a high priority for WHO. A global action plan on antimicrobial resistance, including

antibiotic resistance, was endorsed at the World Health Assembly in May 2015. The global action plan aims to ensure

prevention and treatment of infectious diseases with safe and effective medicines.

The “Global action plan on antimicrobial resistance” has 5 strategic objectives:

To improve awareness and understanding of antimicrobial resistance.

To strengthen surveillance and research.

To reduce the incidence of infection.

To optimize the use of antimicrobial medicines.

To ensure sustainable investment in countering antimicrobial resistance.

A political declaration endorsed by Heads of State at the United Nations General Assembly in New York in September 2016

signaled the world’s commitment to taking a broad, coordinated approach to address the root causes of antimicrobial

resistance across multiple sectors, especially human health, animal health and agriculture. WHO is supporting Member

States to develop national action plans on antimicrobial resistance, based on the global action plan.

World Antibiotic Awareness Week

Held every November since 2015 with the theme “Antibiotics: Handle with care”, the global, multi-year campaign has

increasing volume of activities during the week of the campaign.

WHO, Antibiotic resistance, Fact sheet, Updated November 2017

PAMERAN SEMPENA

MINGGU KESEDARAN

ANTIBIOTIK

HOSPITAL SEGAMAT

8 NOVEMBER 2017

ISSUE 04/2017 PAGE 3

CERAMAH SEMPENA

MINGGU KESEDARAN

ANTIBIOTIK

HOSPITAL SEGAMAT

14 NOVEMBER 2017

*DISCLAIMER: The information in the WHO ADR database comes from a variety of sources, and the likelihood that the suspected adverse reaction is drug related is not the same in all cases. This information does not represent the opinion of WHO.

DRUG SAFETY UPDATES

Proton Pump Inhibitors (PPIs): Potential Long-term Safety Issues

Overview

Proton pump inhibitors (PPIs) have long been considered a safe and well-tolerated drug class. However, there are

emerging concerns on the safety of PPIs, particularly associated with long-term use. Overutilization of PPIs is

known to occur worldwide, in both inpatient and outpatient settings. PPIs are widely used for the treatment of

gastro-oesophageal reflux disease (GERD), Helicobacter pylori eradication, stress ulcer prophylaxis, as well as the

prophylaxis of gastrointestinal bleeding in patients on non-steroidal anti-inflammatory drugs (NSAIDS) or dual

antiplatelet

therapy post-percutaneous coronary intervention. The NPRA is currently reviewing several potential safety issues

which have been linked to PPI use, including the risk of subacute cutaneous lupus erythematosus (SCLE),

hypomagnesaemia, fractures, dementia, and rhabdomyolysis. It should be noted that some of these issues were

described in epidemiological studies, and no causal link has been established. The results of this review and any

risk minimisation action required will be communicated once the review is completed.

Adverse Drug Reaction Reports

The NPRA Malaysian ADR database contains

468 reports (823 adverse events) suspected to

be due to PPIs reported between year 2000-

June 2015. Majority of the reports involved

ADRs

occurring within 2 weeks of starting the PPI.

Only 7% (33 reports) stated a time to onset of

reaction of more than 2 weeks, with ADRs

including itching, maculopapular rash,

abdominal discomfort, and Stevens-Johnson

syndrome/ toxic epidermal necrolysis (SJS/

TEN) overlap.

A search of the WHO International ADR

database* revealed reported adverse events

involving the potential safety issues under

NPRA review, such as SCLE, hypomagnesaemia,

osteoporosis fracture, C. difficile infection, and

dementia. Details of these reports will be

further considered as part of the review.

Local Scenario

There are 72 products containing PPIs registered in Malaysia

currently, namely 58 oral products and 14 injectables. The types

of PPIs registered are omeprazole (30 products); pantoprazole

(22); lansoprazole (11); esomeprazole (4); rabeprazole (3); and

dexlansoprazole (2). Data from the National Medicines

Utilisation Survey and IMS Health Malaysia Sdn. Bhd. revealed

that omeprazole was the most commonly used PPI in Malaysia

in 2014 (3.449 DDD/1000 population/day), followed by

esomeprazole (1.470 DDD/1000 population/day).

Advice for Healthcare Professionals

Please review each individual patient’s need for PPI therapy at every follow-up, use ‘on-demand’ or ‘step-down’

therapy, and discontinue any unnecessary PPIs. Monitor patients for possible long-term ADRs, including

photosensitive dermatosis with arthralgia, cognitive impairment, falls or fractures. Please report all suspected ADRs

associated with PPI use to the National ADR Monitoring Centre, including ADRs following long-term use.

ISSUE 04/2017 PAGE 4

PRODUCT BRAND CHANGES (JULY- OCTOBER 2017)

MEDICATIONS PREVIOUS BRAND CURRENT BRAND

1.BETAHISTINE DIHYDROCHLORIDE

24MG TAB

Indications:

i) Meniere's Syndrome as defined by

the following core symptoms: -

Vertigo (with nausea/vomiting);

Hearing loss (Hardness of hearing);

Tinnitus (ringing in the ears) ii) Symptomatic treatment of

vestibular vertigo

Betaserc

Manufacturer: Abbott

Betanor

Manufacturer: Noripharma

2.BISOPROLOL FUMARATE 2.5MG

TAB

Indication:

Treatment of stable moderate to

severe congestive cardiac failure

in addition to ACEI's and diuretics

Concor

Manufacturer: Merck

Bisocor

Manufacturer: YSP

3.BISOPROLOL FUMARATE 5MG TAB

Indication:

Treatment of stable moderate to

severe congestive cardiac failure

in addition to ACEI's and diuretics

Concor

Manufacturer: Merck

Bisocor

Manufacturer: YSP

ISSUE 04/2017 PAGE 5

4.CLARITHROMYCIN 250MG TAB

Indication:

For i) Treatment of complicated

respiratory tract infection not

responding to standard macrolides ii) Eradication of Helicobacter

pylori infection

Clarithromycin

Manufacturer: Pharmaniaga

Claritrox

Manufacturer: SM Pharma

5. NAPROXEN 275 MG

Indication:

i) Rheumatic arthritis, osteoarthritis

and alkylosing spondylitis ii) Acute

gout iii) Muscular skeletal disorder

and dysmenorrhoea

Safrosyn S

Manufacturer: Pharmaniaga

Sonap

Manufacturer: Sriprasit

6. MONTELUKAST SODIUM 10MG

TAB

Indication:

Chronic treatment of asthma and

relief of symptoms of seasonal

allergic rhinitis for children more

than 15 years and adults.

Aspira

Manufacturer: Pharmaniaga

Monast

Manufacturer: Hetero Labs

7. LABETALOL HCL 100MG TAB

Indication:

Hypertension (including in

pregnancy)

Trandate

Manufacturer: Aspen

Trantalol

Manufacturer: CCM Duopharma

ISSUE 04/2017 PAGE 6

8. ETHAMBUTOL 400MG TAB

Indication:

Tuberculosis

Ethambutol

Manufacturer: CCM Duopharma

Ecox

Manufacturer: Macleods India

9. SULPIRIDE 200MG TAB

Indication:

Acute and chronic schizophrenia,

chronic delusional psychoses

Sulpin

Manufacturer: Taiwan Biotech

Negatil

Manufacturer: Malaysian

Pharmaceutical Industries

10. OFLOXACIN 0.3% EAR DROP

Indication:

Acute otitis media with tympanostomy

tubes, chronic suppurative otitis media

with perforated tympanic membranes

and otitis externa

Effexin

Manufacturer: Ildong Korea

Tarivid

Manufacturer: Daichi

11. BUDESONIDE NASAL SPRAY

64MCG

Indication:

Seasonal allergic, perennial rhinitis and

nasal polyposis

Budenase

Manufacturer: Cipla

Budenide

Manufacturer: HOE Pharmaceuticals

ISSUE 04/2017 PAGE 7

Cefuroxime 5% eye drop

Prescriber category in MOH drug list

Not in FUKKM

Indication Gram positive corneal ulcer

Dosage/treatment regimen Hourly until fully healed

Tenofovir 300mg & Emtricitabine 200mg tablet

Prescriber category in MOH drug list

A/KK

Indication Treatment of HIV-1 infection in adults in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors). *For needle stick injury (post-exposure prophylaxis) in Hospital Segamat

Dosage/treatment regimen 1 tablet once daily

ISSUE 04/2017 PAGE 8

Raltegravir 400mg tablet

Prescriber category in MOH drug list

A*

Indication Raltegravir combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in patients who are contraindicated to boosted Protease Inhibitor or who are intolerant to boosted Protease Inhibitor *For needle stick injury (post-exposure prophylaxis) in Hospital Segamat

Dosage/treatment regimen 400mg administered orally twice daily with or without food, to be given combination with other antiretroviral agent

Fentanyl 25mcg/hr transdermal patch

Prescriber category in MOH drug list

A*

Indication As a second line drug in the management of chronic cancer pain. The use is to be restricted to pain specialists, palliative medicine specialists and oncologists

Dosage/treatment regi-men

Patient who have not previously received a strong opiod analgesic, initial dose, one 25mcg/hour patch to be replaced after 72 hours. Patient who have received a strong opiod analgesic, initial dose based on previous 24 hours opiod requirement (oral morphine sulphate 90mg over 24 hours = one 25 mcg/hour patch). Not recommended in children

Lopinavir 100mg & Ritonavir 25mg tablet

Prescriber category in MOH drug list

A

Indication As a second line protease inhibitor if intolerant to indinavir/ritonavir as part of HAART regimen

Dosage/treatment regi-men

Adult: (Therapy-naïve patients) 400/100 mg BD or 800/100 mg once daily; (Therapy-experienced patients): 400/100 mg BD. Concomitant therapy (efavirenz, nevirapine, amprenavir, fosamprenavir or nelfinavir) 400/100 mg BD. Children > 40 kg or w/BSA > 1.4 m2 as adult dose

Paliperidone 9mg extended release tablet

Prescriber category in MOH drug list

A*

Indication Second or third line treatment of schizophrenia

Dosage/treatment regi-men

Adult: 6mg once daily in the morning, adjusted if necessary; usual range 3 – 12mg daily. Renal impairment (creatinine clearance between 10-50mL/min) 3mg once daily. Avoid if creatinine clearance less than 10mL/min.

ISSUE 04/2017 PAGE 9

PROGRAM KENALI UBAT ANDA DI

SEKOLAH KEBANGSAAN BANDAR PUTRA

17 SEPTEMBER 2017

PENYERTAAN JABATAN FARMASI DALAM PERTANDINGAN PSYCHODRAMA DAN PSYCHOGAMES SEMPENA HARI KESIHATAN MENTAL SEDUNIA 2017

PAMERAN KENALI UBAT ANDA DI

HOSPITAL SEGAMAT

ISSUE 04/2017 PAGE 10

PSYCHODRAMA: SAGUHATI PSYCHOGAMES: TEMPAT KE-2 & KE-3

PERPISAHAN ENCIK CHANG

KANG WEI

MAJLIS MAKAN MALAM ANJURAN BADAN KEBAJIKAN & SOSIAL JABATAN FARMASI

HOSPITAL SEGAMAT 23 OKTOBER 2017 DI VIP HOTEL

ISSUE 04/2017 PAGE 11

ISSUE 04/2017 PAGE 12