PHARMACY BULLETIN 5 S W O R K S H O P. 5S comprised of a list of five Japanese. The Malaysian Administrative Modernisation and Management

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1 Pharmacy Department, Seri Manjung Hospital PHARMACY BULLETIN Drug & Poison Information Service / 2nd Edition 2014 INSIDE THIS ISSUE: 5S Workshop 1-2 Pharmacy Dept. Operating Hours & Contact No. Information on Xarelto (Rivaroxaban) Updates on MOH Formulary ADR Statistics of HSM Staff Information 10 5 S W O R K S H O P 5S comprised of a list of five Japanese words, i.e. Seiri (Sort), Seiton (Set in order), Seiso (Shine), Seiketsu (Standardize), and Shitsuke (Sustain). This 5S practice is one of the strategies that has been implemented by the Pharmacy facilities of KKM to establish convenient, organized and Advisor Mdm. Zahariah bt. Zainul Abideen Chief Editor Miss Noorsidah bt. Md. Yusoff Board of Editors Mr. Ahmad Firdaus b. Shamsuddin Miss Nurhazirah bt. Saridin Miss Nurul Hidayah bt. Jusoh Miss Yue Yoke Xin safe working environment that stimulates the culture of continuous development (Kaizen), which contributes towards enhancing the quality and productivity of Pharmacy. This practice was shown to reduce the risks in medication error while dispensing, therefore adapted in all Pharmacy facilities in KKM. The Malaysian Administrative Modernisation and Management Planning Unit (MAMPU) has taken initiatives to improve the implementation of 5S, which has been rebranded to Ekosistem Kondusif Sektor Awam (EKSA). This is consistent with the efforts to strengthen the organizational culture of high performance and innovative among public sector agencies through the provision of an environment, culture and values into practice. 1

2 On 24th May 2014, a 5S Workshop organized by Pharmacy Department was held at Dewan Mutiara, Seri Manjung Hospital with the objectives, 1) to develop the principles of 5S practice in general, 2) to guide the execution of 5S practice inside the public sector, and 3) to help instill 5S culture through internal audit. There were around 102 participants from various departments in Hospital Seri Manjung and Health Clinics in Manjung district. The lectures were delivered by Mr. Daniel Liew Ching Yien, a Pharmacist from Setapak Health Clinic who attended the Training of Trainers (TOT) EKSA Programme, organized by MAMPU in February The topics included were: 1) Introduction to EKSA, 2) Ethics in Auditing, and 3) Audit Procedures for EKSA. There was also an experience sharing session. 5S starts from home, and working place is our second home, says Mr. Daniel Liew, therefore the working area condition is critical to the morale of employees and the basis of customers first impressions. It is also important towards improving the effectiveness, efficiency and productivity in work. The workshop ended successfully with the closing speech by the Coordinator of 5S Programme, Mr. Gobi Hariyanayagam, followed by a visit to Satellite Pharmacy and Ward Supply Pharmacy. 2

3 Pharmacy Department Operating Hours & Contact No. OPERATING HOURS: CONTACT NO: Services: Outpatient Pharmacy Methadone Replacement Therapy (Methadone Clinic) Ward Supply Pharmacy Satellite Pharmacy TDM Pharmacy (Clinical Pharmacokinetic Service) CDR Pharmacy (Oncology Pharmacy) Drug & Poison Information Service (DPIS) Week Days (Monday Friday) 7.30am pm 7.00am am 5.00pm 7.00am 5.00pm 5.00pm 5.00pm Store Pharmacy 5.00pm Saturday, Sunday & Public Holiday 11.00am 7.00am am am am ON-CALL: After Office Hour (for toxic case & appointment case ONLY) Tel. No : Ext: Head of Department 6688 Outpatient Pharmacy 6683/6684/ 6686 Methadone Clinic 6937 Ward Supply Pharmacy 6687 DPIS 6691 Galenical 6693 CDR 6694 Satellite Pharmacy 6695 TDM 6696 Store Pharmacist 6698 Store (Drugs) 6702/6699 Store (Non-drugs) 6703/6700 After office hour of weekdays & 11.00am- 7.00am Saturday, Sunday & Public Holiday, the supply of medicines to patients from the emergency department, ward & discharge patients are conducted at the Satellite Pharmacy. 3

4 INFORMATION ON XARELTO (RIVAROXABAN) Xarelto 15mg film coated tablet Xarelto 20mg film coated tablet Currently Approved Indication in HSM: Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. 3 DOSE: Switching patients with DVT or PE on VKA to Xarelto 1 For patients treated for DVT or PE or prevention of recurrent DVT and PE, treatment with Vitamin K antagonist (VKA) -Warfarin should be stopped To assess the residual effect of VKA closely monitor the international normalised ratio (INR) Xarelto therapy should be initiated when the INR is 2.5 Switching patients with DVT or PE on LMWH to Xarelto 1 Patients on anticoagulation therapy in the initial phase (first 21 days) 15 mg = First 3 weeks: One 15mg tablet, twice daily 20 mg= One 20 mg tablet, once daily as long as the risk persists 1 Xarelto should be administered as long as the risk of DVT/PE persists 1 A reduction of the dose from 20 mg once daily to 15 mg once daily in renally impaired patients should be considered if the patients assessed risk for bleeding outweighs the risk for recurrent DVT and PE 1 The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk of bleeds Xarelto is not recommended as an alternative to UFH in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy Xerelto 15mg and 20mg tablets should be taken with food 1 CHARACTERISTICS Drug class Direct Factor Xa Inhibitor 1 Administration Oral 1 Patients on anticoagulation therapy for more than 21 days Bioavailability % For 15 mg and 20 mg when taken with food Half -life 5-9 h in young adults h in elderly patients 1 Time to peak plasma 2-4 hours 1 concentration Renal excretion as ~ 33 % 1 unchanged drug References: 1. Xarelto 15mg and 20mg Malaysia Product Insert, April Xarelto Dosing and Prescriber Guide Pamphlet, April Formulary FUKKM Bil 1/2014 4

5 MECHANISM OF ACTION Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated. Xarelto is contraindicated in case of 1 Hypersensitivity to the active substance or to any of the excipients Clinically significant active bleeding Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C Pregnancy and breast feeding Lesion or condition at significant active bleeding Concomitant treatment with any other anticoagulant agent except under the circumstances of switching therapy to or from Xarelto or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter Xarelto is not recommended for use in patients 1 Below 18 years old of age With creatinine clearance < 15 ml/min Receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp such as azoleantimycotics ( ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitor (eg ritonavir) Co-administration with dronedarone (limited clinical data) References: 1. Xarelto 15mg and 20mg Malaysia Product Insert, April Xarelto Dosing and Prescriber Guide Pamphlet, April Formulary FUKKM Bil 1/2014 Benefits (Improving therapy adherence through) 1 : Oral administration Small, easy to swallow tablet Fixed dose No need for routine coagulation monitoring No dietary restrictions Low risk of drug- drug interactions Patients potentially at higher risk of bleeding 1 Patients with renal impairment due to potentially prolonged half life of Xarelto Patients with hepatic impairment Patients concomitantly receiving other medicinal products Patients with other haemorrhagic risk factors such as: Uncontrolled severe arterial hypertension Active ulcerative gastrointestinal disease Recent gastrointestinal ulcerations Vascular retinopathy Recent intracranial or intracerebral haemorrhage Intraspinal or intracerebral vascular abnormalities Recent brain, spinal or ophthalmological surgery Bronchiectasis or history of pulmonary bleeding Congenital or acquired bleeding disorders * Women of child-bearing potential should avoid becoming pregnant during treatment with Xarelto 1 5

6 UPDATES ON MOH FORMULARY (FUKKM 1/2014) 1. DRUGS NEWLY APPROVED FOR INCLUSION IN MOH FORMULARY NO GENERIC NAME PRESCRIBER CATEGORY 1 Lidocaine Medicated Plaster 5% w/w A* Pain Specialist Only APPROVED INDICATIONS For the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN). 2 Zonisamide 100mg tablet A* As adjunctive therapy in the treatment of partial seizures in adults with epilepsy. 3 Beclomethasone dipropionate 100mcg and formoterol fumarate dehydrate 6mcg pressurized inhalation solution A/KK 4 Dienogest 2mg tablet A/KK Treatment of endometriosis Regular treatment of asthma where use of a combination product ( inhaled corticosteroid and long acting beta2 agonist) is appropriate in: i) Patient not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting beta2 agonist or ii) Patient already adequately controlled on both inhaled corticosteroids and long-acting beta2 agonists 5 Lactobacillus acidophilus 100 million viable cells and estriol 0.03mg vaginal tablet 6 Sodium glycerophosphate for addition into infusion solution, 20ml vial A/KK A i) Atrophic vaginitis due to estrogen deficiency during menopause and post-menopause, or as co-medication to systemic hormone replacement therapy. ii) Restoration of the Lactobacillus flora after local and/or systemic treatment with anti-infective agents or chemotherapeutic agents. Indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirement of phosphate. 7 1) Amlodipine besylate/valsartan/hydrochlorothiazide 5/160/12.5mg 2) Amlodipine besylate/valsartan/hydrochlorothiazide 10/160/12.5mg 3) Amlodipine besylate/valsartan/hydrochlorothiazide 10/160/25mg A/KK Treatment of essential hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension. 8 1) Everolimus 0.25mg tablet 2) Everolimus 0.75mg tablet A* Indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids. 6

7 2. ADDITIONS AND AMENDMENTS OF FORMULATION / STRENGTH / PRESCRIBER CATEGORY/ DOSAGE FORM / INDICATION APPROVED FOR INCLUSION IN MOH FORMULARY ADDITIONS OF INDICATION NO GENERIC NAME ADD INDICATIONS 1 Nilotinib 150mg capsule 2 Salmeterol/fluticasone propionate 50/250mcg dry powder inhaler 3 Ivabradine 5mg & 7.5mg film coated tablet 4 Vildagliptin 50mg tablet Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase. Regular treatment of COPD including chronic bronchitis and emphysema. 1) Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. 2) Treatment of chronic heart failure NYHA II to IV class with sinus rhythm and whose heart rate is 75bpm. 1) As a monotherapy in type 2 DM patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. 2) An adjunct to diet and exercise to improve glycaemic control in type 2 DM patients: as a dual therapy in combination with insulin in patients with insufficient glycaemic control. NO AMENDMENTS OF PRESCRIBER CATEGORY NO GENERIC NAME OLD CATEGORY 1 Irbesartan 300mg/ HCTZ 12.5mg tablet 2 Montelukast sodium 10mg tablet 3 Celecoxib 200mg capsule 4 Simvastatin 10mg, 20mg and 40mg tablet ADDITIONS OF STRENGTH EXISTING DRUG IN FORMULARY ADD STRENGTH 1 Nilotinib 200mg capsule Nilotinib 150mg capsule 2 Propofol 10mg/ml (1%) emulsion for injection of infusion 3 Clostridium botulinum Type A toxin haemagglutinin complex 500U/vial powder for injection NEW CATEGORY A* A/KK A* A/KK A* A A/KK B Propofol 20mg/ml (2%) emulsion for injection of infusion Clostridium botulinum Type A toxin haemagglutinin complex 300U/vial powder for injection 5 Triptorelin acetate 3.75mg injection Genital and extragenital endometriosis (stage I to stage IV). DRUG APPROVED TO BE REMOVED FROM FORMULARY NO GENERIC NAME REASON ALTERNATIVE 1 Lovastatin 20mg tablet Low total utility score in statin group Simvastatin 10mg, 20mg & 40mg tablet 7

8 No. of Reports < 1 1 to 6 7 to > 60 No. of Reports ADVERSE DRUG REACTION STATISTICS OF SERI MANJUNG HOSPITAL (2013) Adverse Drug Reaction (ADR) is defined as a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. ADR are classified into six types: dose related, non-dose related and time-related, time related, withdrawal, and failure of therapy. The management of ADR includes withdrawal of the drug if possible and specific treatment of its effects. In 2013, there were 189 suspected ADR cases reported to Pharmacy Department in Seri Manjung Hospital. DEMOGRAPHIC DATA OF REPORTED CASES AGE OF ADR AFFECTED PATIENTS Age Category (Years) GENDER OF ADR AFFECTED PATIENTS RACE OF ADR AFFECTED PATIENTS Female 49.74% = 94 Male 50.26% = Malay Chinese Indian Others Race 8

9 Pharmacological Group System Organ Class CATEGORY OF ADR REPORTERS SEVERITY OF ADR REPORTS Medical Officer 5.82% = 11 Pharmacist 94.18% = 178 Moderate 49.74% = 94 Severe 12.70% = 24 Mild 37.57% = 71 ADVERSE DRUG REACTION BY SYSTEM ORGAN CLASS SKIN AND APPENDAGES DISORDERS. 66.7% BODY AS A WHOLE - GENERAL DISORDERS 17.5% RESPIRATORY SYSTEM DISORDERS GASTRO - INTESTINAL SYSTEM DISORDERS CENTRAL AND PERIPHERAL NERVOUS SYSTEMS DISORDERS 3.2% 1.6% 4.8% APPLICATION SITE DISORDERS MUSCULO - SKELETAL SYSTEM DISORDERS LIVER AND BILIARY SYSTEM DISORDER URINARY SYSTEM DISORDERS HEART RATE AND RHYTHM DISORDERS VISION DISORDERS PLATELET, BLEEDING & CLOTTING DISORDERS WHITE CELL AND RES DISORDERS 1.6% No. of Reports ANTIINFECTIVES ANALGESIC COMBINATION ANTIEPILEPTIC CARDIOVASCULAR ANTIGOUT OTHERS ANTICOAGULANT TRADITIONAL MEDICINE EYE PREPARATIONS ANTIEMETIC ANTIULCER ANTIPSYCHOTIC ANTIHYPERLIPIDEMIC ANTIVENOM ANTISPASMODIC ANTIHISTAMINE CONTRAST MEDIA CORTICOSTEROID ANTIASTHMATIC ANTIVIRAL ANTITUBERCULOSIS SUSPECTED ADR-CAUSING DRUG BY PHARMACOLOGICAL GROUP ANTIDIABETIC VACCINE 7.4% 4.2% 3.7% 3.2% 2.6% 2.6% 2.1% 1.6% 24.9% 38.1% No. of Reports 9

10 STAFF INFORMATION 11 MARCH 2014 MISS HAMIMAH BT ABD RAZAK (PEMBANTU AWAM H11) MISS SITI NURUL IDAYU BT MOHD ROSEDI (PEMBANTU AWAM H11) 19 MAY 2014 MISS SYAKIRAH BT KHAIRUDDIN (PEGAWAI FARMASI PROVISIONAL U41) MISS NGIENG HSERN LIN (PEGAWAI FARMASI PROVISIONAL U41) MISS WONG SIEN YIH (PEGAWAI FARMASI PROVISIONAL U41) 16 JUNE 2014 MISS KUMALATHA A/P PRASAD (PEGAWAI FARMASI PROVISIONAL U41) 7 MAY 2014 MADAM ANIS BT AHMAD PUAZIL (PEGAWAI FARMASI PROVISIONAL U41) 19 MAY 2014 MR CHOONG CHIE WENG (PEGAWAI FARMASI U41) 5 JUNE 2014 MADAM NEETHIAVATHI A/P SUBRAMANIAM (PEMBANTU TADBIR N22) 11 APRIL 2014 MADAM ZAWIAH BT ZAINAL (PEGAWAI FARMASI U54) 16 MAY 2014 MISS NURUL ZUHANIS BT MOHAMED (PEGAWAI FARMASI U41) 10