pharmacist counseling on oral antidiabetes drugs · beberapa pertanyaan yang dapat diajukan pada...

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


Primary goals of DM Management : Reduce risk of micro and macrovascular complications

Diabetic counseling is one of essential part of Pharmacist Role


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


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


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


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


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


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)


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)


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


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


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


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


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”


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.

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