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Drug Utilization Study in Hospitalized Patient with Cerebrovascular Attack (CVA) at Dr. Saiful Anwar General Hospital, Malang-Indonesia Suharjono1, Padmasari P1, Yulistiani1, and Sidharta B2 of Biomedical Pharmacy, Faculty of Pharmacy, Airlangga University, Surabaya, East-Java, Indonesia 2Department of Pharmacy, Dr.Saiful Anwar General Hospital, Malang, East-Java, Indonesia
1Department
INTRODUCTION Stroke caused disability Stroke caused highest mortality in the world & no 3 in USA (>160,000 in >700,000 incidence/year) Indonesia (2002)Æmortality of 123,684 Relation of multi diseases Æcomplex therapy (Polypharmacy) & high cost Need appropriate and the best management
Email : [email protected]
Aims : Objective : The objective of this prospective study was to identify drug therapy profile for the management of CVA at RSU Dr. Saiful Anwar Malang
General To study the profile of drug use for CVA patient at Dr.Saiful Anwar General Hospital, Malang Indonesia Specifics 1. To study type of drugs, dosage forms, dosage regimen & route of administration 2. To analysis relation between laboratory data and clinical data with therapy outcomes 3. To identify actual and potential drug related problems with clinical outcome
Benefit of Study 1. To provide information regarding drug use profile (selection and use) for future evaluation and hospital policy 2. To optimize the quality services of hospital pharmacy
DEFINITION OF CVA 1.Deficit of neurologic acute 2.Duration ≥ 24 hours 3.There was failure of blood brain circulation
3. To increase the quality of pharmaceutical care
1
Pathogenesis of Ischaemic Stroke
Pathogenesis of Haemorrhagic Stroke “Rupture” Vessel
Intracerebral Subarachnoid Subarachdinoid Haemorrhagic
Intracerebral Haemorrhagic
Conceptual Scheme
Operasional Scheme RISK FACTOR
CVA
•Thrombus •Emboli CBF↓ Ischaemi
•HT •Amyloid angiopathy •Aneurism •AVM
O2↓
ATP↓
Modifiable
Unmodifiable
Age, herediter, race, life style, Gender, diseases (HT,DM,CHF, Hyperlipidemia)
Smoking, Alcohol, “illicit drug”
Rupture PD Ca int↑ Na int↑
EAA↑
CVA patient at neurology department room Patient Medication Record
Bleeding Drug Therapy
Oedema Cytotoxic
Stroke Antithrombotic
ADP ↑
Free Radical ↑
Microcirculatory Damage
Patient Condition
Thrombolitic
Cell death
Neuroprotective
Anti Oedema
Comorbid TX HT TX CHF TX DM TX Hyperlipidemia
Non-Drug Therapy Triple-H CEA VP Shunting Ventriculostomy Baloon Angioplasty Clipping Aneurism
Clinical data Lab data Brain Image
Infarct Inflammation
Vasogenic Oedema
Research Data
Death
Therapy
To study : Drug types
Patient factor : •Underlying disease •Complication •Age
Drug factor : •Tx class •Dosage and frequency •Route of administration •Dosage forms
Indication Dosage forms Dosage regimen
DRP
DUS
Route of administ.
To analysis relation lab / clinical data with therapy
Identify of DRPs:: Need Additional Tx Inappropriate Drugs Un needed drug Appropriate drugs Adverse drug reaction Drug Interaction Patient compliance
METHODS Study Design Non-experimental (observational), descriptive & prospective data Inclusion Criteria Px with end diagnosis : CVA Hospitalized Duration : minimum 7 days Exclusion Criteria End Diagnosis Transient Ischaemic Attack Incomplete Patient Medication Record (PMR) Hospitalized Duration < 7 days
Sample Study Medical Record of hospitalized CVA patients in Dr.Saiful Anwar Teaching Hospital, Malang
Sample Size All medical record from CVA patients in Dr.Saiful Anwar Hospital Malang & between 1st April – 31st May 2006 (prospective data)
2
…Continued
Location of DUS
Dept of Neurology Dr. Saiful Anwar Teaching Hospital, Malang, Indonesia Beds 800 Standard of Drug Therapy Used Formulary, Dx & Tx & Antibiotic Guideline
Data Analysis Data will be analyzed which include: 1. Patient CVA Classification 2. Table of profile of drug used 3 Table of drug interaction 4. Table of appropriate dosage 5. Diagram patient condition after discharge
• Data collection Patient’s identity, drug therapy history, physician diagnosis, laboratory data, clinical patient data, also drug therapy list during patient hospitalization were all recorded in collecting data
Surabaya Malang
BEFORE DONE THIS STUDY, THE PROPOSAL MUST BE PRESENTED TO INTERNALMEDICINE STAFFS IN DR.SAIFUL ANWAR HOSPITAL ALSO WAS PRESENTED AFTER DONE
RESULTS & DISCUSSION Number of CVA Patients
Female 48%
Male 52%
Classification of CVA Patients Ages – Stroke Types Ages (Years)
Ischemic CVA
Numbers of Patients ISH CVA
SAH CVA
< 45
-
1
-
45-54
9
5
1
55-64
10
6
-
65-74
4
-
-
≥ 75
1
3
-
Total
24 (60 %)
15 (38 %)
1 (2 %)
3
Duration of Hospitalization
Patients
Numbers of
Risk Factor
Duration of
35
40
Number of Patients
Care (days)
18
12
20
12
11
Ischemic CVA
ISH CVA
DAH CVA
< 10
8
-
-
10-20
12
3
1
21-25
3
7
-
Total
24
15
1
0
Types of Risk Factor Hypertention
Hyperlipidem ia
DM
CHF
Sm oking
Drug Used Profile
Identify Drug Related Problems
Therapy
Primer Fluids Resuscitation Neuroprotectan Antiaggregation Platelet Vitamin Drugs for Tx underlying disease (antihypertension, CHF, lipid lowering drug, antidiabetic) Antieodema
Supportive Antibiotic Drugs for GIT Analgesic & Antipyretic Respiratory Drugs Antipsychotic, antianxiety, anticonvulsan, antidepressan Drug for gout Antifungal
Value
Need Additional Therapy Inappropriate Drugs Appropriate drugs Un-needed drug Adverse drug reaction Drug Interaction Patient compliance
Fluids Resusitation
Quality Values of Neurology Function Responses
• • • • • • •
Numbers Hospitalized
Discharged
Spontaneous
4
33
39
Obey Direction
3
5
1
40
Pain
2
1
-
35
No response
1
-
-
Good orientation
5
26
37
25
Failure orientation
4
2
-
20
Spelling not clear
3
3
1
Not understand talking
2
-
-
10
No response
1
2
-
5
Eye open
Verbal responses
38
30
12
15
2
0
Motoric responses Obey Direction
6
34
39
Localization Pain
5
4
1
Attracting flexion
4
-
-
Abnormal flexion
3
1
-
Abnormal extension
2
-
-
No response
1
-
-
Normal Saline
Ringer Lactate
Dextrose
4
Neuroprotectans Used
Antiaggregation Platelets
26
23 21
13 5
2
cit ich ol in e Pi ra ce ta m Pe nt ox ify llin N im od ip in
Numbers
No 30 25 20 15 10 5 0
Intravenous
Antiplatelets
Numbers of Patients
1
ASA (Aspirin)
21
2
ASA+Clopidogrel
1
3
ASA+Ticlopidine
1
4
Ticlopidine
1
Per Oral
EXAMPLE ANTI HIYPERTENSIVE AGENTS Patients
Blood Pressure (mmHg)
PMR No 33 CVA Thrombosis HT uncontrolled ± 10thn Heart Failure St B ec LVH
Day 1 210/120 2 230/160 4 240/140 5 220/120 6 200/140 7 190/120 10 180/120
Day 11 200/150 13 180/120 14 180/120 15 180/110 17 150/100 18 190/120
Therapy Day 3 Captopril 3x12,5 mg, spironolactone 50 mg-0-0 Day 4 Captopril 3x25 mg Dayi 5 Captopril 4x25 mg Day 6 Captopril 3x25 mg, spironolactone stop, diltiazem drip 34-36 drops /min Day 7 Captopril stop Day 11 Captopril 3x25 mg, diltiazem drip stop switch oral 1x30 mg Day 15 Captopril 4x25 mg Discharged Captopril 4x25 mg, diltiazem 1x30 mg PO
Additional Drug Therapy
There were medical condition not received therapy Ælab data /clinical condition not normal (+), but therapy not given
Example Lipid Lowering Drug Patient
Blood Cholesterol
Mr Ran (48 thn) •DM •Hypertension •CHF
Day 2 Total Cholsterol: 273 HDL: 45 LDL: 181 TG: 236
Criteria
High High High
Therapy Day 3-11 Simvastatin 0-0-10 mg
Drug ASA was given for Px with Dx ISH CVA
Example Antidiabetics Patient Mrs SS DM (+), ± 5 years
Laboratory Data Day 1 Random Glucose level 30 Day 2 Fasting Glucose 72 2 h Post prandial 109 Day 6 Fasting Glucose 179 2 h Post prandial 275 Day 9 Fasting Glucose 67 2 h Post prandial 128
EXAMPLE WRONG DRUG CRITERIA Description ASA not recommended for ISH CVA because caused re-bleeding
Therapy Day 7-10 Insulin Regular 6-6-6 IU Insulin NPH 0-10 IU
EXAMPLE ADVERSE DRUG REACTION Adverse Drug Reaction Cough because Captopril
Solution • Captopril was continued, given antitussive • Captopril stopped, changed to Lisinopril
5
Unnescesary Drug Therapy Criteria
Drug Interaction Probable Criteria
Antihypertensive given for : Patient with BP<180/105 or mean arterial BP<145 mmHg For phase acute stroke Without organ target damage
Digoxin - FurosemideÆprobable Captopril - FurosemideÆsuspected Ranitidine - NifedipineÆsuspected HCT - AllopurinolÆsuspected Gemfibrozil - SimvastatinÆsuspected
Antibiotic given for patient without leucocyte data and clinical condition not shown infection symptoms More one antihipertensives class given in the same event
Appropriate Dosage Regimen Analysis Drug Type
Dosage
Literatur
Dosage Appropriate Analysis Drug Type
Antihypertensive Captopril
2x6,25 mg – 4x25 mg
Lisinopril
1x5 mg – 2x10 mg
HCT
1x12,5 mg – 3x12,5 mg
Spironolactone Furosemide Nifedipine
1x50 mg 1x20 mg-1x40 mg 3x5 mg-3x10 mg (conventional tablet) 1x30 mg (OROS) 1x30 mg
Diltiazem
2x 6,25 – 3x25 mg Combination HCT: 25 mg Captopril + 12.5 mg HCT 1 dd 1 Initial Dosage: 1x5 mg-1x10 mg Maintenance Dosage: 20-40 mg/day Comb with HCT: 10 mg lisinopril-12,5 mg HCT 1x12,5 mg - 1x50 mg Comb with other antiHT : 1x12,5 mg1x25 mg Comb with ACE inh: 12,5-25 mg/day 2x20 mg-2x40 mg 3x10 mg – 3x20 mg (coventional)
Dosage
Literature
Antiaggregation platelet ASA Ticlopidine Clopidogrel
1x80 mg-1x200 mg 2x250 mg 1x75 mg
50 mg-325 mg 2x250 mg 1x75 mg
Lipid lowering Drug Simvastatin Gemfibrozil
1x10 mg 1x300 mg
1x10 mg-1x20 mg 2x600 mg
1x30mg – 1x60 mg (SR) Initial Dosage: 3x30 mg
CONCLUSIONS 1. Drug Therapy for CVA patients were fluids resuscitation, neuroprotectan, vitamin, anti aggregation platelet, lipid lowering drug, antihypertensive, CHF, anti diabetic, drug for oedema, other tx for underlying diseases 2. Drug Tx were based patient’s clinical condition and lab data. Monitoring therapy is a must during hospitalization according to clinical & lab data 3. DRPs in this study were classified as need additional drug therapy, unneeded drug, wrong drug, side effects and potential drug interactions Dr Soetomo Teaching Hospital – Surabaya - Indonesia
6
NATIONAL CLINICAL PHARMACY SEMINAR
NATIONAL CLINICAL PHARMACY SEMINAR
HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
THANK YOU
FOR YOUR KIND ATTENTION
TILL WE MEET AGAIN
IN SURABAYA, INDONESIA on your next host of 8th ACCP JULY 1-4, 2008
NATIONAL CLINICAL PHARMACY SEMINAR HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
7
1Department
INTRODUCTION Stroke caused disability Stroke caused highest mortality in the world & no 3 in USA (>160,000 in >700,000 incidence/year) Indonesia (2002)Æmortality of 123,684 Relation of multi diseases Æcomplex therapy (Polypharmacy) & high cost Need appropriate and the best management
Email : [email protected]
Aims : Objective : The objective of this prospective study was to identify drug therapy profile for the management of CVA at RSU Dr. Saiful Anwar Malang
General To study the profile of drug use for CVA patient at Dr.Saiful Anwar General Hospital, Malang Indonesia Specifics 1. To study type of drugs, dosage forms, dosage regimen & route of administration 2. To analysis relation between laboratory data and clinical data with therapy outcomes 3. To identify actual and potential drug related problems with clinical outcome
Benefit of Study 1. To provide information regarding drug use profile (selection and use) for future evaluation and hospital policy 2. To optimize the quality services of hospital pharmacy
DEFINITION OF CVA 1.Deficit of neurologic acute 2.Duration ≥ 24 hours 3.There was failure of blood brain circulation
3. To increase the quality of pharmaceutical care
1
Pathogenesis of Ischaemic Stroke
Pathogenesis of Haemorrhagic Stroke “Rupture” Vessel
Intracerebral Subarachnoid Subarachdinoid Haemorrhagic
Intracerebral Haemorrhagic
Conceptual Scheme
Operasional Scheme RISK FACTOR
CVA
•Thrombus •Emboli CBF↓ Ischaemi
•HT •Amyloid angiopathy •Aneurism •AVM
O2↓
ATP↓
Modifiable
Unmodifiable
Age, herediter, race, life style, Gender, diseases (HT,DM,CHF, Hyperlipidemia)
Smoking, Alcohol, “illicit drug”
Rupture PD Ca int↑ Na int↑
EAA↑
CVA patient at neurology department room Patient Medication Record
Bleeding Drug Therapy
Oedema Cytotoxic
Stroke Antithrombotic
ADP ↑
Free Radical ↑
Microcirculatory Damage
Patient Condition
Thrombolitic
Cell death
Neuroprotective
Anti Oedema
Comorbid TX HT TX CHF TX DM TX Hyperlipidemia
Non-Drug Therapy Triple-H CEA VP Shunting Ventriculostomy Baloon Angioplasty Clipping Aneurism
Clinical data Lab data Brain Image
Infarct Inflammation
Vasogenic Oedema
Research Data
Death
Therapy
To study : Drug types
Patient factor : •Underlying disease •Complication •Age
Drug factor : •Tx class •Dosage and frequency •Route of administration •Dosage forms
Indication Dosage forms Dosage regimen
DRP
DUS
Route of administ.
To analysis relation lab / clinical data with therapy
Identify of DRPs:: Need Additional Tx Inappropriate Drugs Un needed drug Appropriate drugs Adverse drug reaction Drug Interaction Patient compliance
METHODS Study Design Non-experimental (observational), descriptive & prospective data Inclusion Criteria Px with end diagnosis : CVA Hospitalized Duration : minimum 7 days Exclusion Criteria End Diagnosis Transient Ischaemic Attack Incomplete Patient Medication Record (PMR) Hospitalized Duration < 7 days
Sample Study Medical Record of hospitalized CVA patients in Dr.Saiful Anwar Teaching Hospital, Malang
Sample Size All medical record from CVA patients in Dr.Saiful Anwar Hospital Malang & between 1st April – 31st May 2006 (prospective data)
2
…Continued
Location of DUS
Dept of Neurology Dr. Saiful Anwar Teaching Hospital, Malang, Indonesia Beds 800 Standard of Drug Therapy Used Formulary, Dx & Tx & Antibiotic Guideline
Data Analysis Data will be analyzed which include: 1. Patient CVA Classification 2. Table of profile of drug used 3 Table of drug interaction 4. Table of appropriate dosage 5. Diagram patient condition after discharge
• Data collection Patient’s identity, drug therapy history, physician diagnosis, laboratory data, clinical patient data, also drug therapy list during patient hospitalization were all recorded in collecting data
Surabaya Malang
BEFORE DONE THIS STUDY, THE PROPOSAL MUST BE PRESENTED TO INTERNALMEDICINE STAFFS IN DR.SAIFUL ANWAR HOSPITAL ALSO WAS PRESENTED AFTER DONE
RESULTS & DISCUSSION Number of CVA Patients
Female 48%
Male 52%
Classification of CVA Patients Ages – Stroke Types Ages (Years)
Ischemic CVA
Numbers of Patients ISH CVA
SAH CVA
< 45
-
1
-
45-54
9
5
1
55-64
10
6
-
65-74
4
-
-
≥ 75
1
3
-
Total
24 (60 %)
15 (38 %)
1 (2 %)
3
Duration of Hospitalization
Patients
Numbers of
Risk Factor
Duration of
35
40
Number of Patients
Care (days)
18
12
20
12
11
Ischemic CVA
ISH CVA
DAH CVA
< 10
8
-
-
10-20
12
3
1
21-25
3
7
-
Total
24
15
1
0
Types of Risk Factor Hypertention
Hyperlipidem ia
DM
CHF
Sm oking
Drug Used Profile
Identify Drug Related Problems
Therapy
Primer Fluids Resuscitation Neuroprotectan Antiaggregation Platelet Vitamin Drugs for Tx underlying disease (antihypertension, CHF, lipid lowering drug, antidiabetic) Antieodema
Supportive Antibiotic Drugs for GIT Analgesic & Antipyretic Respiratory Drugs Antipsychotic, antianxiety, anticonvulsan, antidepressan Drug for gout Antifungal
Value
Need Additional Therapy Inappropriate Drugs Appropriate drugs Un-needed drug Adverse drug reaction Drug Interaction Patient compliance
Fluids Resusitation
Quality Values of Neurology Function Responses
• • • • • • •
Numbers Hospitalized
Discharged
Spontaneous
4
33
39
Obey Direction
3
5
1
40
Pain
2
1
-
35
No response
1
-
-
Good orientation
5
26
37
25
Failure orientation
4
2
-
20
Spelling not clear
3
3
1
Not understand talking
2
-
-
10
No response
1
2
-
5
Eye open
Verbal responses
38
30
12
15
2
0
Motoric responses Obey Direction
6
34
39
Localization Pain
5
4
1
Attracting flexion
4
-
-
Abnormal flexion
3
1
-
Abnormal extension
2
-
-
No response
1
-
-
Normal Saline
Ringer Lactate
Dextrose
4
Neuroprotectans Used
Antiaggregation Platelets
26
23 21
13 5
2
cit ich ol in e Pi ra ce ta m Pe nt ox ify llin N im od ip in
Numbers
No 30 25 20 15 10 5 0
Intravenous
Antiplatelets
Numbers of Patients
1
ASA (Aspirin)
21
2
ASA+Clopidogrel
1
3
ASA+Ticlopidine
1
4
Ticlopidine
1
Per Oral
EXAMPLE ANTI HIYPERTENSIVE AGENTS Patients
Blood Pressure (mmHg)
PMR No 33 CVA Thrombosis HT uncontrolled ± 10thn Heart Failure St B ec LVH
Day 1 210/120 2 230/160 4 240/140 5 220/120 6 200/140 7 190/120 10 180/120
Day 11 200/150 13 180/120 14 180/120 15 180/110 17 150/100 18 190/120
Therapy Day 3 Captopril 3x12,5 mg, spironolactone 50 mg-0-0 Day 4 Captopril 3x25 mg Dayi 5 Captopril 4x25 mg Day 6 Captopril 3x25 mg, spironolactone stop, diltiazem drip 34-36 drops /min Day 7 Captopril stop Day 11 Captopril 3x25 mg, diltiazem drip stop switch oral 1x30 mg Day 15 Captopril 4x25 mg Discharged Captopril 4x25 mg, diltiazem 1x30 mg PO
Additional Drug Therapy
There were medical condition not received therapy Ælab data /clinical condition not normal (+), but therapy not given
Example Lipid Lowering Drug Patient
Blood Cholesterol
Mr Ran (48 thn) •DM •Hypertension •CHF
Day 2 Total Cholsterol: 273 HDL: 45 LDL: 181 TG: 236
Criteria
High High High
Therapy Day 3-11 Simvastatin 0-0-10 mg
Drug ASA was given for Px with Dx ISH CVA
Example Antidiabetics Patient Mrs SS DM (+), ± 5 years
Laboratory Data Day 1 Random Glucose level 30 Day 2 Fasting Glucose 72 2 h Post prandial 109 Day 6 Fasting Glucose 179 2 h Post prandial 275 Day 9 Fasting Glucose 67 2 h Post prandial 128
EXAMPLE WRONG DRUG CRITERIA Description ASA not recommended for ISH CVA because caused re-bleeding
Therapy Day 7-10 Insulin Regular 6-6-6 IU Insulin NPH 0-10 IU
EXAMPLE ADVERSE DRUG REACTION Adverse Drug Reaction Cough because Captopril
Solution • Captopril was continued, given antitussive • Captopril stopped, changed to Lisinopril
5
Unnescesary Drug Therapy Criteria
Drug Interaction Probable Criteria
Antihypertensive given for : Patient with BP<180/105 or mean arterial BP<145 mmHg For phase acute stroke Without organ target damage
Digoxin - FurosemideÆprobable Captopril - FurosemideÆsuspected Ranitidine - NifedipineÆsuspected HCT - AllopurinolÆsuspected Gemfibrozil - SimvastatinÆsuspected
Antibiotic given for patient without leucocyte data and clinical condition not shown infection symptoms More one antihipertensives class given in the same event
Appropriate Dosage Regimen Analysis Drug Type
Dosage
Literatur
Dosage Appropriate Analysis Drug Type
Antihypertensive Captopril
2x6,25 mg – 4x25 mg
Lisinopril
1x5 mg – 2x10 mg
HCT
1x12,5 mg – 3x12,5 mg
Spironolactone Furosemide Nifedipine
1x50 mg 1x20 mg-1x40 mg 3x5 mg-3x10 mg (conventional tablet) 1x30 mg (OROS) 1x30 mg
Diltiazem
2x 6,25 – 3x25 mg Combination HCT: 25 mg Captopril + 12.5 mg HCT 1 dd 1 Initial Dosage: 1x5 mg-1x10 mg Maintenance Dosage: 20-40 mg/day Comb with HCT: 10 mg lisinopril-12,5 mg HCT 1x12,5 mg - 1x50 mg Comb with other antiHT : 1x12,5 mg1x25 mg Comb with ACE inh: 12,5-25 mg/day 2x20 mg-2x40 mg 3x10 mg – 3x20 mg (coventional)
Dosage
Literature
Antiaggregation platelet ASA Ticlopidine Clopidogrel
1x80 mg-1x200 mg 2x250 mg 1x75 mg
50 mg-325 mg 2x250 mg 1x75 mg
Lipid lowering Drug Simvastatin Gemfibrozil
1x10 mg 1x300 mg
1x10 mg-1x20 mg 2x600 mg
1x30mg – 1x60 mg (SR) Initial Dosage: 3x30 mg
CONCLUSIONS 1. Drug Therapy for CVA patients were fluids resuscitation, neuroprotectan, vitamin, anti aggregation platelet, lipid lowering drug, antihypertensive, CHF, anti diabetic, drug for oedema, other tx for underlying diseases 2. Drug Tx were based patient’s clinical condition and lab data. Monitoring therapy is a must during hospitalization according to clinical & lab data 3. DRPs in this study were classified as need additional drug therapy, unneeded drug, wrong drug, side effects and potential drug interactions Dr Soetomo Teaching Hospital – Surabaya - Indonesia
6
NATIONAL CLINICAL PHARMACY SEMINAR
NATIONAL CLINICAL PHARMACY SEMINAR
HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
THANK YOU
FOR YOUR KIND ATTENTION
TILL WE MEET AGAIN
IN SURABAYA, INDONESIA on your next host of 8th ACCP JULY 1-4, 2008
NATIONAL CLINICAL PHARMACY SEMINAR HYATT HOTEL, SURABAYA, 16-17 JANUARY 2007
7
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