Clinical Pharmacy in Malaysia: Past,Present and Future

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1 Clinical Pharmacy in Malaysia: Past,Present and Future Noraini bt Mohamad Senior Principal Assistant Director Pharmaceutical Services Division Ministry of Health, Malaysia

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4 VISION, MISSION & OBJECTIVE Vision To provide the best pharmacy service for the health and well being of the nation Mission To lead a dynamic pharmacy service emphasizing on the highest level of integrity, professionalism, and excellence, that meets the application and challenges of the nation Objective To ensure quality, safe efficacy, and affordable pharmaceutical and healthcare products are available and accessible to the public

5 MAIN OBJECTIVES Optimising drug therapy through effective pharmaceutical control & up-to-date clinical & professional services Providing dynamic pharmaceutical services & progresses with current global Formulating policies development on drugs & pharmaceuticals Ensuring drug expenditure is at economic level & quality medicines are available at point of need Generating consumer awareness on issues of rational use of medicines & adverse events through consumer education Optimising utilisation of manpower for pharmaceutical services in Malaysia 5

6 Definition: Clinical pharmacy Clinical pharmacy is an area of pharmacy concerned with the science and practice of rational use of medicine. - with specialized therapeutic knowledge - with experience and judgment to ensure optimal patient outcomes A health science discipline where pharmacist provides patient care by: - optimizing the use of medication - promotes health, wellness, and disease prevention

7 Pharmacist Dietitian Patient Care Nurses Doctors

8 ROLES OF PHARMACISTS DzJoint FIP / WHO Guidelines on GPP : Standards for Quality of Pharmacy Servicesdz ROLE 1: Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medical products ROLE 2: Provide effective medication therapy management ROLE 3: Maintain and improve professional performance ROLE 4: Contribute to improve effectiveness of the healthcare system and public health

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10 Clinical Pharmacy in Malaysia In 1980 s, there was a change from product oriented service to patient focused service. Total Parenteral Nutrition Drug Information Services Concept of Clinical Pharmacy was introduced in 90 s Cytotoxic Drug Reconstitution Therapeutic Drug Monitoring

11 The next major step in the drug distribution system Introduction of an individualised drug supply system on the ward by Unit Dose or Unit of Use systems. These two systems allow the distribution of drugs to wards to be done in an efficient and cost-effective manner. It also minimises medication errors and wastage. 11

12 onwards

13 EXPANSION OF CLINICAL PHARMACY SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) DRUG SURVEILLANCE HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE MAINTENANCE THERAPY 6. QUALITY INITIATIVES

14 1 - WARD PHARMACY Part of medical team in assisting pharmacotherapy decision-making Activities; ward rounds patient assessment pharmaceutical care plan bedside counseling Identify drug-related problems

15 Patient assessment Past medication history Patient s disease & medication knowledge Patient s medication adherence

16 Documentation Patient s progress note Lab results Drug monitoring Pharmaceutical care issues Intervention

17 Documentation

18 WARD PHARMACY ACTIVITIES Medication History Taking Pharmacist Surgical round 18 Medical round

19 Bedside Counseling Bedside Dispensing 19

20 GERIATRIC WARDS Pharmacist 20

21 Routine Daily Rounds at Medical Wards Cardiology Round Pharmacotherapy Round 21

22 Ward Pharmacy Statistics (Jan Dis 2013) Documentation Placement of Full Time Pharmacists in the Wards (Major Hospitals) ICU Number of ICU/Ward Number of pharmacists (full time) % ICU/Ward with full time pharmacists 56 Medical Wards 236 No. of medication history taking 213,692 No. of cases clerked 209,441 No. of cases reviewed 258,610 Interventions Done by Inpatient Pharmacists in the Year % % 54% 83.9% Incomplete prescription (27.6%)

23 EXPANSION OF CLINICAL PHARMACY SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) DRUG SURVEILLANCE HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE MAINTENANCE THERAPY 6. QUALITY INITIATIVES

24 2.0 Medication Therapy Adherence Clinic (MTAC) In 2004, Medication Therapy Adherence Clinics (MTAC) were initiated by the Pharmaceutical Services Division, Ministry of Health Malaysia in ambulatory settings. The primary objectives: to optimise drug therapy, to improve medication adherence and to reduce or prevent the occurrence of adverse events and complications due to the drug regimen.

25 Types of MTAC Until year 2013, there are 13 types of MTAC offered in MOH, with established protocol published by the Pharmaceutical Services Division: 13 MTACs with Established Protocols Diabetes Stroke Warfarin Psychiatry Retrovirus Disease (RVD) Rheumatology Respiratory Hemophilia Nephrology Psoriasis -Chronic Kidney Disease -Post renal transplant -Dialysis Geriatric 2014 Hepatitis MTAC Protocol

26 Development of MTAC Services The 1st MTAC in Malaysia, Post-Renal Transplant MTAC, was started in year Number of MOH Facilities Offering MTAC Services ( ) Number of Facilities MTAC

27 Ambulatory Care Services : MTAC Diabetes - MTAC Warfarin MTAC Teaching & Consultation

28 EXPANSION OF CLINICAL PHARMACY SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE MAINTENANCE THERAPY 5. DRUG SURVEILLANCE 6. QUALITY INITIATIVES

29 Why HMR? Increase in medication expenditure but many patients fail to achieve the targeted goals of treatment: RM 206m medicine expenditure (1995) vs. RM 1.5b (2008) in Ministry of Health Malaysia (MOH) Only ~26.3% patients who received antihypertensive treatment were able to reach the targeted blood pressure (National Health and Morbidity Survey 2006) High value of returned medications (RM 200k in 2008 and RM 700k in 2009)(Pharmaceutical Services Division, MOH). MOH Strategic Plan ( ) Mid-Term Review bringing care closer to home with a focus on domiciliary care.

30 Current Focus for HMR Psychiatric Geriatrics Stroke

31 Responsibilities ofimplementation Pharmacist in services HMRwillteam Involving Pharmacists in the of HMR ensure better therapeutic outcomes in the overall management of the patient. Discussion with patient s caregiver Counselling to improve patients adherence toward medication Proper storage and disposal of unused medication

32 Number of facilities offering Home Medication Review (Jan June 2014) Total (93) Hospital 38 Health Clinic 55

33 EXPANSION OF CLINICAL PHARMACY SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE DISPENSING PROGRAM 5. DRUG SURVEILLANCE 6. QUALITY INITIATIVES

34 4. Methadone Dispensing Program Initiated and collaborated with MOH Disease Control Division in 2005 Objective: To support the success of MOH Methadone Maintenance Therapy program via DOT Develop strong pharmacist-patient relationships, collaborate with the physician and promote other health care providers to create seamless care and to achieve better retention rate As June 2014, there are 412 MOH methadone center 58 hospitals, 286 health clinic, 21 GP, 50 National Anti-Drugs Agency Service available everyday (365 days/year) 33,000 patient with retention rate at 75%

35 Methadone Dispensing Process Patient verification & assessment Dose preparation Direct Observed Therapy (DOT)

36 EXPANSION OF SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE MAINTENANCE THERAPY 5. DRUG SURVEILLANCE 6. QUALITY INITIATIVES

37 5. Drug Surveillance National antibiotic usage: DDD (twice a year) 26 types of antibiotics 43 facilities National Antiretroviral drug usage (yearly) Surgical Prophylaxis Audit (2014) Antibiotic Point Prevalence Survey (2015)

38 National Surveillance on Antibiotics Utilisation in Malaysia ICU All wards 1200 Mean DDD/1000 PD Mean DDD/1000 PD % Mean DDD/1000 PD No. of Contributors No. of Antibiotics % No. of DDD/1000 Pt Days No. of Contributors No. of Antibiotics 0

39 Antiretroviral Drug Surveillance - 38 Items monitored Lamivudine 100 mg (Tab/Cap) Lamivudine 150 mg (Tab/Cap) Zidovudine 300 mg/lamivudine 150 mg (Tab/Cap) Efavirenz 20 0mg (Tab/Cap) Efavirenz 600 mg (Tab/Cap) Indinavir 400 mg (Tab/Cap) Ritonavir 100 mg (Tab/Cap) Lopinavir/Ritonavir 200/50 mgkaletra Stavudine/Lamivudine/Nevirapine SLN 30 mg (Tab/Cap) Didanosine 100 mg (Tab/Cap) Didanosine 2 g Oral Solution (Bot) Didanosine 25 mg (Tab/Cap) Didanosine 250 mg (Tab/Cap) Didanosine 400 mg (Tab/Cap) Zidovudine 1 % Inj. (Vial) Zidovudine 10 mg/ml Syrup (Bot) Zidovudine 300 mg (Tab/Cap) Zidovudine 100 mg (Tab/Cap) Lamivudine 10 mg/ml Oral Solution (Bot) Raltegravir 400 mg (Tab/Cap) Stavudine 1 mg/ml Oral Solution (Bot) Stavudine 30 mg (Tab/Cap) Stavudine 40 mg (Tab/Cap) Efavirenz 50 mg (Tab/Cap) Efavirenz 100mg (Tab/Cap) Nevirapine 200 mg (Tab/Cap) Tenofovir 300 mg (Tab/Cap) Ritonavir 80 mg/ml Oral Solution (Bot) Tenofovir 300 mg/emtricitabine 200 mg (Tab/Cap) Lopinavir/ Ritonavir Oral Solution 533/13.3 mg -Kaletra (Bot) Abacavir 20 mg/ml (Bot) Abacavir 300 mg (Tab/Cap) Abacavir 600 mg + Lamivudine 300 mg (Tab) Atazanavir 300 mg (Tab/Cap) Darunavir 300 mg (Tab/Cap) Nevirapine 50 mg/5 ml Oral Suspension (Bot) Lopinavir/ Ritonavir 100/25mg Kaletra Tenofovir DF 300 mg + Lamivudine 300mg (Tab)

40 Antiretroviral Drug Surveillance Hospital No Health Clinics State Perlis Kedah Pulau Pinang 1,378 1,706 1, Perak , Selangor 4,280 5,548 3, HKL NA NA 0 7 Negeri Sembilan Melaka Johor 1,425 1,241 1, Pahang Terengganu Kelantan 1, Sabah Sarawak WP Labuan WPKL Total 12,853 13,610 11,980 1,149 1,

41 EXPANSION OF CLINICAL PHARMACY SERVICES WARD PHARMACY MEDICATION THERAPY ADHERENCE CLINIC (MTAC) HOME MEDICATION REVIEW (HMR) HARM REDUCTION PROGRAM METHADONE MAINTENANCE THERAPY 5. DRUG SURVEILLANCE 6. QUALITY INITIATIVES

42 Quality Initiatives R & D Pharmacist as part of the team in Hospital Clinical Research Centre Part time or fulltime As preceptor for PRP research projects Involvement in clinical trials Involvement in QA studies

43 National R & D Conference (organized every 2 years) as a platform to present findings..

44 How it happened?

45 Approaches to Success 1. Strengthen Services Establishment of Clinical Working Committees International partnership Development of training module and teaching material Establish training centers Appointment of dedicated preceptors 2. Standardization of Practices Development of guidelines & protocols 3. Quality Assurance Clinical & Pharmacy Practice Audit (ADAF)

46 Clinical Pharmacy Working Committees / Task Forces, MOH NEPHROLOGY CARDIOLOGY GERIATRICS METHADONE CRITICAL CARE ANTIBIOTICS PARENTERAL NUTRITION ONCOLOGY PSORIASIS NUCLEAR PHARMACY RESPIRATORY HEPATITIS PHARMACOKINETICS PSYCHIATRIC EMERGENCY RETROVIRAL DISEASE DIABETES RHEUMATOLOGY 46

47 Protocols For more information, please visit MOH website:

48 Counseling Guidelines Fully Registered Pharmacist : Peer review for ensuring everyone have the same knowledge and skill Minimum counseling target was set for every health facility Provisionally Registered Pharmacist Validation Counseling Technique : Must pass at least 80% types of counseling within 2 months of report duty

49 Training Modules MTAC DIABETES MTAC RESPIRATORY MTAC WARFARIN

50 Developing Expertise. Short courses/attachment -Abroad or local Postgraduate study : Master & PhD * Fully/Partially sponsored by the government Pharmacists with postgraduate degrees in MOH, Malaysia Master 372 Clinical Pharmacy : 190 PHD 19 Pharmacotherapy /Clinical : 6

51 Short Course Attachment / International Partnership in Clinical Pharmacy Numbers of Pharmacist 40 Area or Fields Country Oncology (including palliative care) Pediatric Rheumatology Cardiology (Warfarin /Heart Failure) Critical care Emergency Neurology (Stroke) Geriatric Nuclear Psoriasis Pharmacogenomics USA Australia Korea UK Singapore Canada etc Sharing and gaining knowledge Develop expertise in specialized area

52 QUALITY ASSURANCE - AUDIT ON CLINICAL ACTIVITES

53 Objectives To ensure compliance towards the protocols and guidelines To ensure the monthly data reported in line with the activities carried out To find out problems or obstacles faced by pharmacists

54 Challenges Restricted budget Attachments (local or overseas) excellence centers Short courses Manpower: Multitasking and variation in job distribution ( types of facilities) High turnover rate of pharmacists (transfer, resign) Reluctant to expand job scope No Key Performances Indicator ward Pharmacy, HMR

55 THE FUTURE OF CLINICAL PHARMACY SERVICES

56 CREDENTIALING & PRIVILEGING 1. Ward Pharmacy Service: Critical Care Pediatrics Medical 2. MTAC: Diabetes Respiratory Warfarin Retroviral Disease Nephrology (Chronic Kidney Disease, Renal Transplant, Dialysis)

57 WAYS AND MEANS.. BCPS certification Pharmacotherapy Ambulatory Nuclear Pharmacy Oncology Pharmacy Psychiatry Emergency Medicine Antibiotic Stewardship Program Development of ASP Protocol for pharmacy

58 1st BCPS Examination in Malaysia UITM Puncak Alam

59 BPS Specialties : Pharmacotherapy, Ambulatory, Psychiatry & Oncology Specialties : Pharmacotherapy, Ambulatory 10 BCPS certified 18 BCPS certified (MOH) 59

60 SPECIALIZATION Specialist Paraspecialist Generalist

61 Carrier Pathway Pharmacist as Specialist Infectious Disease Nephrology Cardiology Oncology Critical Care Pharmacy

62 PROPOSAL FOR PHARMACIST CAREER PATHWAYS PHARMACY PRACTICE & MANAGEMENT CLINICAL PHARMACY RESEARCH Regulatory Pharmacy PHARMACY ENFORCEMENT Pharmacy Practice Manager Clinical Pharmacist Director/ Consultant Research Pharmacist Manager Regulatory Pharmacist Director/ Consultant Enforcement Pharmacist Director/ Consultant Senior Principal Pharmacist Senior Principal Clinical Pharmacist Senior Principal Research Pharmacist Senior Principal Regulatory Pharmacist Senior Principal Enforcement Pharmacist Principal Pharmacist Principal Clinical Pharmacist Principal Research Pharmacist Principal Regulatory Pharmacist Principal Enforcement Pharmacist Senior Pharmacist Senior Clinical Pharmacist Senior Research Pharmacist Senior Regulatory Pharmacist Senior Enforcement Pharmacist Pharmacist Clinical Pharmacist Research Pharmacist Regulatory Pharmacist Enforcement Pharmacist

63 CLINICAL PHARMACY/ PHARMACOTHERAPY SPECIALIST Pre-requisites Post graduate degree master in clinical pharmacy Board Certification Board of Pharmacy Specialty (optional) 2 year post graduate residency program in field of specialization

64 WHAT NEEDS TO BE DONE Framework for specialisation program Identify priority areas for recognition of specialisation Needs and acceptance by doctors Number of pharmacists already involved Grandfather pharmacists who can be accredited 2 year Residency Program Areas and assessment mechanism Preceptors pharmacists and doctors Training hospitals

65 Proposed Residency Program R1 6/12 R2 6/12 R3 6/12 R4 6/12 This Residency Program is proposed as a duration of 2 years, and divided into 4 semester, 6 months each. Participants will be assessed in the forms of written examinations, research in specialized area, viva, presentation and etc.

66 Endless opportunity for clinical pharmacist to grow.. 66

67 Hopefully, in two years time, pharmacists can be recognized as specialist in Malaysia

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