Pharmacist BY: ISMAEL RAMOS CARLOS REYES BLOCK 3 1 Pharmacist.
Pharmacist Counseling on Oral Antidiabetes...
Transcript of Pharmacist Counseling on Oral Antidiabetes...
Pharmacist Counseling on Oral Antidiabetes Drugs
(Focus on Usability of Glimepiride and Glimepiride-Metformin in Clinical Practice)
Name of Presenter
SAID.GLI.18.04.0171(04/18)
Evolution of Pharmacist Role
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Dispensed medicine to the public
(product oriented) Clinical pharmacy
Objective of Clinical Pharmacy: Optimizing Patients’ Quality of Life
Pharmacists Role in Diabetes Management
• Educate the proper use of medication
• Screening for drug interaction
• Explain monitoring devices
• Make recommendations for ancillary products and services
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Primary goals of DM Management : Reduce risk of micro and macrovascular complications
Diabetic counseling is one of essential part of Pharmacist Role
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Essential components of diabetic counselling
Diabetic Counselling
Disease
Lifestyle modificat
ion
medication
Acute & Chronic
Complication
Special Population
(elderly, children,
etc)
Self monitoring of
glucose
Foot and eye care
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Strategies to improve counseling in diabetes patients
• Patient information leaflets • lifestyle modifications and medications
• Compliance aids • medication envelopes
• medication calendar
• Audiovisual aids
• Establishing patient counseling center
• Requirements for counselling pharmacist
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Beberapa pertanyaan yang dapat diajukan pada saat pasien datang berkonsultasi atau menebus obat
• Kapan Anda terakhir kali melakukan pemeriksaan kadar gula darah Anda, dan bagaimana hasilnya?
• Obat diabetes apa yang Anda gunakan secara rutin? Bagaimana dosisnya?
• Apakah Anda mengalami kesulitan memenuhi dosis obat tersebut? Bagaimana Anda menyimpan obat-obat diabetes Anda di rumah?
• Apakah Anda menggunakan insulin? Apakah Anda mengalami kesulitan dalam menggunakan insulin sesuai dosis yang disarankan dokter? Bagaimana Anda menyimpan insulin di rumah?
Kemenkes. Pharmaceutical care untuk penyakit diabetes mellitus.2005
Challenges to increase patient adherence
Patient adherence to therapy
62% took tablets correctly in
relation to food
20% regularly forgot to take
their tablets
5% omitted tablets if their blood
glucose was too high
2% omitted tablets if their blood
glucose was too low
Browne DL, et al. Diabet Med 2000; 17:528–531.
Browne DL, et al. Diabet Med 2000; 17:528–531.
Adherence vs Compliance
Adherence : (kepatuhan)
• Perilaku patuh pasien terhadap pengobatan yang melibatkan kesediaan pasien untuk memenuhi kesepakatan dengan profesional kesehatan (mitra aktif) dalam perawatan diri mereka sendiri.
Compliance : (kesesuaian)
• Kepatuhan pasien terhadap hal yang telah disampaikan profesional kesehatan secara sepihak tanpa persetujuan pasien
Sumber: WHO 2003
Adherence vs Compliance.....
Adherence : (kepatuhan)
• Menyiratkan keputusan bersama antara pasien dengan profesional kesehatan utk menjalankan pilihan pengobatan yang tepat bagi pasien.
Compliance : (kesesuaian)
• Menyiratkan sudut pandang pasien yang pasif, dengan pengetahuan/pemahaman yang sedikit tentang pengobatan dirinya sendiri. Bila secara sengaja/tidak menolak pengobatan, sering disebut “tidak patuh”
Sumber: PKR.Evadewi, LMK Sukmayanti, 2013, Kepatuhan Mengonsumsi Obat Pasien Hipertensi di Denpasar Ditinjau Dari Kepribadian Tipe A Dan Tipe B.
peripheral glucose uptake
hepatic glucose production
pancreatic insulin secretion
pancreatic glucagon secretion
gut carbohydrate delivery & absorption
incretin effect
HYPERGLYCEMIA
?
Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011
Multiple, Complex Pathophysiological
Abnormalities in T2DM
_
_
+ renal glucose excretion
DA agonists
T Z D s Metformin
S U s Glinides
DPP-4 inhibitors
GLP-1R agonists
A G I s
Amylin mimetics
Insulin
Bile acid sequestrants
SGLT2i
Fixed-Dose Combination (FDC)
• Definition : combination of two or more actives drugs in a single dosage form
• Advantages of fixed dose combination:
improves patient compliance
more cost-effective compared to monotherapy and combination therapy.
minimises the adverse effects associated with high-dose monotherapy.
Gautam CS, Saha L. British Journal of Clinical Pharmacology. 2008;65(5):795–6 Kim H , Kim D, Cha B, et al. J Diabetes Investig. 2014;5(6):701–708.
Achieve better adherence to therapy with fixed-dose combination
Melikian C, et al. Clin Ther 2002; 24 (3): 460-467.
*p < 0.001
patients receiving combination therapy who are switched to fixed dose combination therapy exhibit significantly greater adherence after the switch
Counselling points for hypoglycemic agent
• Type of drugs
• Administration time
• Dosing schedule
• Possible side effects
• Drug interactions
• Precaution
Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Oral Hypoglycemic Agent Insulin
Type of insulin & device
Site of self injection
Injection techniques
Rotating the injection site
Disposal of the needles
Time of administration
Storage of insulin
Adverse drug reaction
Counselling regarding hypoglycemia
• Hypoglycemia is a condition caused by abnormally low level of blood glucose, characterized by decreased blood glucose level <70 mg/dl
• Hypoglycemia is caused by: • Taking too much of certain diabetic medicines
• Missing a meal or delaying a meal
• Exercising more than usual
• Drinking alcohol
Causes Missing meal, antidiabetic medications
Symptoms Sweating, weakness, confusion
Management Fruit juice, chocolates
Prevention Regular eating plans, regular blood glucose checkups
Table Counseling point regarding hypoglycemia
PERKENI. 2015. Role Of Pharmacist In Counseling Diabetes Patients. The Internet J of Pharmacology. 2005;4(1).
Mechanism of Action & Indication Glimepiride
Indications
to lower the blood glucose in patients with type 2 DM whose hyperglycemia cannot be controlled by diet and exercise alone
Glimepiride may be used concomitantly with metformin when diet, exercise, and glimepiride or Metformin alone do not result in adequate glycemic control.
Indicated for used with insulin to lower the blood glucose in patient whose hyperglycemia can’t be controlled by diet and exercise in conjunction with an oral hypoglycemic agent
K+
K+ Glimepiride Glibenclamide
Solubilisation
Glibenclamide glimepiride®
65 kDa
140 kDa
65 kDa 140 kDa
cell membrane
Sulfonylurea
receptor Potassium channels
AMARYL Product Information approved by BPOM 27 Mar 2015
Counselling points for hypoglycemic agent: Focus on Glimepiride
Pharmacokinetics • Completely absorbed and Cmax is about 2.5 hours • Half-life of 5-8 hours • Completely metabolized – main metabolite also has some antidiabetic effect, so, overall,
the hypoglycaemic action of a single dose lasts for 24 hours • Most of the metabolites are excreted in the urine
NH
O
CH3 SO2 NH
NH
O
C N
AMARYL Product Information approved by BPOM 27 Mar 2015
Practical Consideration for the Use of Glimepiride
• Governed by the blood sugar level
• Dosage of glimepiride must be the lowest
• Forgetting to take a dose, must never be corrected by subsequently taking a larger dose
• Timing and distribution of doses to consider of the patient’s current life-style. Single daily dose of glimepiride is sufficient
• Dose should be taken immediately before a substantial breakfast of if none is taken immediately before the first main meal
• It is very important not to skip meals after taking glimepiride
• Glimepiride must be swallowed without chewing with sufficient liquid
AMARYL Product Information approved by BPOM 27 Mar 2015
Kualitas AMARYL vs Glimpiride Generik
Metode Penelitian
• Sampel dari AMARYL and 23 glimepiride generik (sediaan 2 mg) diperiksa dalam penelitian ini
• Semua sampel disimpan pada suhu 60oC selama 21 hari untuk meniru suatu keadaan temperature-stressed
• Semua hasil analisis dibandingkan dengan spesifikasi-spesifikasi dari sanofi-aventis dalam memproduksi AMARYL
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
Jenis Tes yang Dilakukan Waktu Tes (hari ke-…)
0 7 21
Jumlah kadar bahan aktif √ √ √
Tingkat cemaran (impurities) √ √ √
Tingkat residual solvents √
Profil disolusi (daya larut) √ √
Spesifikasi dari AMARYL
Spesifikasi dari Sanofi dalam memproduksi
AMARYL (khususnya AMARYL 2 mg)
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
Shelf-life specification
Impurities
GS ≤ 2.5%
Other impurities (each) ≤ 0.5%
Total other impurities ≤ 1.0%
Total impurities ≤ 3.5%
Glimepiride content 1.8 – 2.1 mg
Dissolution ≥ 85%
Residual solvent
Methanol ≤ 1,400 ppm
Ethanol Absent
Hasil: Tingkat cemaran GS (glimepiride-sulfonamide)
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
0
2.5
5
7.5
10
12.5
15
17.5
Day 0 Day 7 Day 21
Spesifikasi
AMARYL
17% dari produk generik yang dites memiliki kadar cemaran GS
yang tinggi pada hari ke-21
Hasil: Tingkat Cemaran yang Lain
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
0
0.5
1
1.5
2
2.5
3
Any impurities other than GS Total impurities other than GS
Spesifikasi
AMARYL
Total tingkat cemaran lain ditemukan lebih tinggi pada 2 produk generik
(Amadiab-2 and glimepirida-Esterlina)
Hasil: Tingkat Residual Solvent - Ethanol
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
0
500
1000
1500
2000
2500
3000
Spesifikasi
AMARYL
Tingkat residual ethanol yang tinggi terdeteksi pada 2 produk generik (glimepirida-La Sante and Metrix) Hal ini tentu harus menjadi bahan
pertimbangan apabila berbicara tentang kualitas dari glimepiride generik
Hasil: Profil Disolusi yang Sangat Beragam
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
52% dari produk generik yang diuji ternyata gagal memperlihatkan
profil disolusi yang diharapkan (larut 85% dalam 15 menit),
bahkan sebagian hanya berhasil larut 23%
0
20
40
60
80
100
120
Day 0 Day 21
Spesifikasi
AMARYL
Rangkuman Hasil Analisa AMARYL/SOLOSA vs
Glimepiride Generik
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
Kesimpulan Penelitan
“Hasil studi ini mengindikasikan bahwa dibandingkan dengan glimepiride original, sebagian produk glimepiride generik ternyata memiliki kualitas dan performa yang lebih rendah”
“This study indicates that a relevant percentage of glimepiride generics may offer reduced quality and performance when compared with the original drug”
Attorrese G. Diabetes Technology & Therapeutics 2007; 9(3): 287 – 296
Pharmacist-Physician Collaboration
Murshid et at. Tropical Journal of Pharmaceutical Research July 2016; 15(7); 1549-57
Summary
• Diabetes is a chronic illness that requires a combination of pharmacological and non-pharmacological measures for better control.
• Patient adherence to medication and lifestyle modification plays an important role in diabetes management
• Pharmacist being an important member of the healthcare system in counselling diabetes patient.
• it is important to pay attention to the quality of the drug as part of treatment success.