Ders Seviyesi / Course Level Second Cycle / Second Cycle
Ders Akts Kredi / ECTS 5.00
Haftalık Ders Saati (Kuramsal) / Course Hours For Week (Theoretical)
2.00
Haftalık Uygulama Saati / Course
Hours For Week (Objected) 0.00 Haftalık Laboratuar Saati / Course
Hours For Week (Laboratory) 0.00 Dersin Verildiği Yıl / Year 1
Öğretim Sistemi / Teaching System Face to Face / Face to Face Eğitim Dili / Education Language
Ön Koşulu Olan Ders(ler) /
Precondition Courses Yok None
Amacı / Purpose Bu dersi başarıyla tamamlayan öğrencinin steril ürünler ve tehlikeli ilaçların hazırlanması
ve hastaya uygulaması süreçleri hakkında ileri düzey bilgi edinmesi amaçlanmaktadır. It is aimed that the student who successfully completes this course will gain advanced knowledge about the preparation of sterile products and hazardous drugs and their application to patients.
İçeriği / Content Bu ders kapsamında steril ürünlerin ve sitotoksik ilaç preparatlarının hazırlanması, radyofarmasötiklerin hazırlanması, tehlikeli ilaçlar ve tehlikeli ilaçlarla güvenli çalışma konuları anlatılacak ve ileri farmasötik hesaplamalar konusu örneklerle açıklanacaktır.
In this course, the preparation of sterile products and cytotoxic drug preparations, the preparation of radiopharmaceuticals, hazardous drugs and safe working with hazardous drugs will be explained and advanced pharmaceutical calculations will be explained with examples.
Önerilen Diğer Hususlar / Recommended Other Considerations
Yok None
Staj Durumu / Internship Status Yok None
1 / 21
Member (Members) Sinem Yaprak KARAVANA, Doç. Dr. Mesut ARICI, Öğr. Gör. Dr. Mehmet Ali EGE, Prof.
Dr. Ercüment KARASULU, Prof. Dr. Emel Öykü ÇETİN UYANIKGİL, Doç. Dr. Derya İLEM ÖZDEMİR, Prof.Dr. Fehime Esra ÖZER, Doç. Dr. Buket REEL, Doç. Dr. Ceren GÖNEN, Doç.Dr. Ecz. Mehmet ARUN, Doç.Dr. Ecz. Elif ERTUNA, Prof. Dr. Didar Zümrüt BAŞBAKKAL
Dr. Sinem Yaprak KARAVANA, Doç. Dr. Mesut ARICI, Öğr. Gör. Dr. Mehmet Ali EGE, Prof. Dr. Ercüment KARASULU, Prof. Dr. Emel Öykü ÇETİN UYANIKGİL, Doç. Dr.
Derya İLEM ÖZDEMİR, Prof.Dr. Fehime Esra ÖZER, Doç. Dr. Buket REEL, Doç. Dr.
Ceren GÖNEN, Doç.Dr. Ecz. Mehmet ARUN, Doç.Dr. Ecz. Elif ERTUNA, Prof. Dr.
Didar Zümrüt BAŞBAKKAL
ÖĞRENME ÇIKTILARI / LEARNING OUTCOMES
1 İleri farmasötik hesaplamalar yapabilme To be able to make advanced pharmaceutical calculations
2 Steril üretim prensiplerini tanımlayabilme. To be able to define the sterile production principles.
3 Sitotoksik ilaçlarla güvenli çalışma prensiplerini açıklayabilme. To be able to explain the principles of safe working with cytotoxic drugs.
4 Parenteral ilaçlarla tedavinin temel ilkelerini açıklayabilme. To be able to explain the basic principles of parenteral drug therapy.
HAFTALIK DERS İÇERİĞİ / DETAILED COURSE OUTLINE
2 / 21
1
•Steril Ürünlerin Hazırlanması
-Çalışma ortamını ve uygulamalarını kavrama -Steril ürünleri hazırlama ve sunma
-TPN Çözeltileri
Soru-Yanıt, Tartışma
İnforma heathcare
3.Pharmaceutical Dosage Forms - Parenteral Medications Ed.
Sandeep Nema, John D. Ludwig- CRC press
4.USP General Chapter Hazardous Drugs – Handling in Healthcare Settings
5.https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7.Aseptic Pharmaceutical Manufacturing, Ed. Wayne P.
Olsan, Micheal J Groves, Iterpharm Press
8.Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Preparation of Sterile Products
- Understanding the working environment and applications - Preparing and presenting sterile products
- TPN Solutions
Question-Answer, Discussion
3 / 21
2
-Çalışma ortamını ve uygulamalarını kavrama -Sitotoksik ilaç preparatlarının hazırlanması ve sunumu -Sitotoksik ilaç preparatlarının güvenli kullanımı -Sitotoksiklerle çalışırken bireysel sağlığın korunması
Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Preparation of Cytotoxic Drug Preparations
- Understanding the working environment and applications - Preparation and presentation of cytotoxic drug preparations Safe use of cytotoxic drug preparations
- Protecting individual health when working with cytotoxics
Question-Answer, Discussion
4 / 21
3
•Radyofarmasötiklerin Hazırlanması -Çalışma ortamını ve uygulamalarını kavrama
-Radyofarmasötik ilaç preparatlarının hazırlanması ve sunumu -Radyofarmasötik ilaç preparatlarının güvenli kullanımı -Radyofarmasötikler ile çalışırken bireysel sağlığın korunması -Radyofarmasötikler ile ilgili hesaplamalar
Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Preparation of Radiopharmaceuticals
- Understanding the working environment and applications - Preparation and presentation of radiopharmaceutical drug preparations
Safe use of radiopharmaceutical drug preparations - Protection of individual health when working with radiopharmaceuticals
- Calculations on radiopharmaceuticals
Question-Answer, Discussion
5 / 21
4 Klinikte Total Parenteral Beslenme (TPN) Uygulamaları Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
Total Parenteral Nutrition (TPN) Applications in the Clinic Question-Answer, Discussion
6 / 21
5
•Steril Üretim ve Steril Hizmetlere İlişkin Yasal Düzenlemeler ve Ulusal Kılavuzlar
İyi İmalat Uygulamaları (GMP) Kılavuzu Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Legal Regulations and National Guidelines on Sterile Production and Sterile Services
Good Manufacturing Practice (GMP) Guide Question-Answer, Discussion
7 / 21
6 Steril Üretim Teknikleri ve Sterilizasyon Süreci Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
Sterile Production Techniques and Sterilization Process Question-Answer, Discussion
8 / 21
7 Ara sınav Soru-Yanıt
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
Mid-term exam Question-Answer
9 / 21
8 Sterilizasyon Validasyonu Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
Sterilization Validation Question-Answer, Discussion
10 / 21
9
•Steril ve Tehlikeli Ilaçların Hazırlanmasında Karşılaşılan Sorunlar -Stabilite
-Geçimsizlik
-Dökülme ve saçılmalar -Atık yönetimi
Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Problems Encountered in Preparation of Sterile and Hazardous Drugs
- Stability - Incompatibility - Spills and scattering - Waste management
Question-Answer, Discussion
11 / 21
10 Tehlikeli İlaçlar ve Tehlikeli İlaçlarla Güvenli Çalışma Standartları Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health Safe Working Standards with Hazardous Drugs and Hazardous
Drugs Question-Answer, Discussion
12 / 21
11
Parenteral tedavinin temelleri
Parenteral İlaçlarla Tedavide İyi Yönetim İlkeleri
Parenteral Tedavide Bireysel Uygulayıcıların Genel Sorumlulukları Parenteral Tedavinin Avantajları ve Dezavantajları
Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health Basics of parenteral therapy
Good Management Principles in Treatment with Parenteral Drugs General Responsibilities of Individual Practitioners in Parenteral Therapy
Advantages and Disadvantages of Parenteral Therapy
Question-Answer, Discussion
13 / 21
12
•İntravasküler cihazlar
•İnfüzyon cihazları
•Enjektör sürücüleri
•Parenteral ilaçlarla çalışırken risk derecelendirmeleri
Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health - Injection Techniques and Ways in Children and Adults
- Extravasation - Intravascular devices - Infusion devices - Injector drivers
- Risk ratings when working with parenteral drugs
Question-Answer, Discussion
14 / 21
13
•İleri Farmasötik Hesaplamalar - I -Farmasötik hesaplamaların temelleri
-Yüzde, Yüzde Bileşim ve Diğer Konsantrasyon İfadeleri -Doz hesaplamları: Hasta parametreleri (çocuk, yaşlı, vücut alanı, vücut ağırlığı)
-‘‘Ünite’’ ‘‘mcg/mg’’ ve diğer potentlik ölçütleri
-Belirli klinik hesaplamalar (heparin dozunun hesaplanması, kreatinin klirensine dayalı doz hesaplama, klinik laboratuvar test sonuçlarına dayalı doz hesaplama)
Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health Advanced Pharmaceutical Calculations - I
- Fundamentals of pharmaceutical calculations
- Percent, Percent Composition and Other terminologies gor Concentration
- Dose calculations: Patient parameters (child, elderly, body area, body weight)
- '' Unit '' '' mcg / mg 'and other potency criteria
- Specific clinical calculations (calculation of heparin dose, dose calculation based on creatinine clearance, dose calculation based on clinical laboratory test results)
Question-Answer, Discussion
15 / 21
14
-İntravenöz İnfüzyonlar, Parenteral Eklentiler ve Akış Oranı Hesaplamaları
-Enteral ve Parenteral Beslenme, Beden Kitle İndeksi ve Beslenme Desteği Etiketleri
-Ürün Yitiliğinin Değiştirilmesi, Stok Çözeltilerin Kullanımı ve Paçal hesaplama ile Problem Çözme
Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Advanced Pharmaceutical Calculations - II - Isotonic and Buffer Solutions
- Electrolyte Solutions: Milliequivalent, millimole and milliosmole - Intravenous Infusions, Parenteral Attachments and Flow Rate Calculations
- Enteral and Parenteral Nutrition, Body Mass Index and Nutritional Support Labels
- Changing Product Strength, Using Stock Solutions and Problem Solving with Blend Calculation
Question-Answer, Discussion
16 / 21
15
•İleri Farmasötik Hesaplamalar - III -Majistral İlaçlarla İlgili Bazı Hesaplamalar -Bitki Ekstreleri ile İlgili Bazı Hesaplamlar
-Kimyasal Bir Molekülde Aktif İlaç Miktarının Hesaplanması -Biyoyararlanım ve Farmakokinetik ile İlgili Bazı Hesaplamalar
Soru-Yanıt, Tartışma
Medications Ed. Sandeep Nema, John D. Ludwig- CRC press 4.
USP General Chapter Hazardous Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
• Advanced Pharmaceutical Calculations - III - Calculations About Magistral Drugs - Calculations About Plant Extracts
- Calculating the Amount of Active Drug in a Chemical Molecule - Calculations Related to Bioavailability and Pharmacokinetics
Question-Answer, Discussion
17 / 21
16 Final sınavı Soru-Yanıt, Tartışma Drugs – Handling in Healthcare Settings 5.
https://accesspharmacy.mhmedic al.com/multimedia.aspx#1398 6.
Pharmaceutical dosage forms, Ed. David S Jones,
Pharmaceutical Press 7. Aseptic Pharmaceutical Manufacturing, Ed. Wayne P. Olsan, Micheal J Groves, Iterpharm Press 8.
Ansel’s Pharmaceutical dosage forms and drug delivery systems, Ed. Loyd V. Allen, Nicolas G.
Poovich, Howard C. Ansel, Wolters Kluwer Health
Final exam Question-Answer, Discussion
18 / 21
Yarıyıl (Yıl) Sonu Etkinlikleri / End Of Term (or Year) Learning Activities Sayı / Number
Katkı Yüzdesi / Percentage of Contribution (%)
100 1
Final Sınavı / Final Examination
Toplam / Total: 1 100
Başarı Notuna Katkı Yüzdesi / Contribution to Success Grade(%): 60
Etkinliklerinin Başarı Notuna Katkı Yüzdesi(%) Toplamı / Total Percentage of Contribution (%) to Success Grade: 100
Değerlendirme Tipi / Evaluation Type:
19 / 21
Tartışma / Discussion 14 1.00 14.00
Soru-Yanıt / Question-Answer 14 1.00 14.00
Bireysel Çalışma / Self Study 14 2.00 28.00
Ara Sınav İçin Bireysel Çalışma / Individual Study for Mid term Examination 1 10.00 10.00
Final Sınavı içiin Bireysel Çalışma / Individual Study for Final Examination 1 10.00 10.00
Okuma / Reading 14 2.00 28.00
Toplam / Total: 75 33.00 137.00
Dersin AKTS Kredisi = Toplam İş Yükü (Saat) / 30.00 (Saat/AKTS) = 137.00/30.00 = 4.57 ~ / Course ECTS Credit = Total Workload (Hour) / 30.00 (Hour / ECTS) = 137.00 / 30.00 = 4.57 ~
20 / 21
3.Sitotoksik ilaçlarla güvenli çalışma prensiplerini açıklayabilme. / To be able to explain the principles of safe working with cytotoxic
drugs. 2 5 5 5 4 5 5 1 5 2
4.Parenteral ilaçlarla tedavinin temel ilkelerini açıklayabilme. / To
be able to explain the basic principles of parenteral drug therapy. 3 5 5 5 4 5 5 5 5 2
Katkı Düzeyi / Contribution Level : 1-Çok Düşük / Very low, 2-Düşük / Low, 3-Orta / Moderate, 4-Yüksek / High, 5-Çok Yüksek / Very high
21 / 21
