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Description of Individual Course Units
| Course Unit Code | Course Unit Title | Type of Course Unit | Year of Study | Semester | Number of ECTS Credits |
|---|---|---|---|---|---|
| 9382015082018 | Risk Management in Clinical Pharmacy | 1 | 2 | 5,00 |
Level of Course Unit
Yüksek Lisans
Language of Instruction
Turkish
Objectives of the Course
The aim of this course is to introduce students to the concept of risk management related to drugs and discuss the importance of this concept in terms of patient-oriented pharmacy services.
Name of Lecturer(s)
Learning Outcomes
| 1 | To be able to explain drug development process and the safety and efficacy data collected through this process. |
| 2 | To be able to explain the limitations of the evidence for the efficacy and safety of the drug. |
| 3 | To be able to explain the contribution of Pharmacovigilance and Pharmacoepidemiology to risk management. |
| 4 | To be able to explain how to apply risk management on patient and community basis. |
| 5 | To be able to explain the pharmacist's contribution to the prevention and management of drug-related risks (adverse effects, etc.). |
| 6 | To be able to explain the importance of communication in risk management with examples. |
| 7 | To be able to approach drug use in pregnancy with risk management principles. |
Mode of Delivery
Face to Face
Prerequisities and Co-Requisities
None
Recommended Optional Programme Components
-
Content of the Course
• Drug Safety • Medication Safety Systems • Medication Safety Issues • Common Medication Errors • Impact of Infrastructure Deficiencies on Medication Safety • The Future of Hospital Pharmacy: Basel Declaration • The Role of the Clinical Pharmacist in the Identification and Prevention of Medication Errors • Improving Patient Safety in Primary Care • Targeted Medication Safety Best Practices for Hospitals (ISPM 2018 - 2019) • Safe Preparation of Parenteral Products in Hospital • High Risk Drugs in Hospital • Safety in Drug Dispensing • Safety in Drug Administration • Optimization of Safe Subcutaneous Insulin Use in Adults • Pharmacovigilance • Adverse Drug Reactions and Drug Interactions • Drug Use in Pregnancy as an Example of Risk Management • Controlled Drugs and Patient Safety • Reporting Medication Errors and Near Miss Events
Weekly Detailed Course Contents
| Week | Subjects (Theoretical) | Teaching Methods | Preparatory |
|---|---|---|---|
| 1 | Drug Safety | Question-Answer, Discussion | T.C. Sağlık Bakanlığı, İlaç Güvenliği Rehberi (versiyon 2) 2015, ISBN: 978-975-590-586-0, Sayfa: 5-15. ISMP, High alert medication lists. ismp.org |
| 2 | Medication Safety Systems | Question-Answer, Discussion | T.C. Sağlık Bakanlığı, İlaç Güvenliği Rehberi (versiyon 2) 2015, ISBN: 978-975-590-586-0, Sayfa: 15-19. ISMP, High alert medication lists. ismp.org |
| 3 | Medication Safety Issues Common Medication Errors Impact of Infrastructure Deficiencies on Medication Safety | Question-Answer, Discussion | T.C. Sağlık Bakanlığı, İlaç Güvenliği Rehberi (versiyon 2) 2015, ISBN: 978-975-590-586-0, Sayfa: 19-32. |
| 4 | The Future of Hospital Pharmacy: Basel Declaration | Question-Answer, Discussion | Lecture notes |
| 5 | The Role of the Clinical Pharmacist in the Identification and Prevention of Medication Errors | Question-Answer, Discussion | Therapeutic Risk Management of Medicines, 1st Edition, Stephen J. Mayall, Anjan Swapu Banerjee, eBook ISBN: 9781908818270, Hardcover ISBN: 9781907568480, Woodhead Publishing, 2014. |
| 6 | Evidence based pharmacy | Question-Answer, Discussion | Hamzaçebi, K. & Gümüşel, B. (2014). Kanıta dayalı eczacılık . Marmara Pharmaceutical Journal , 16 (3) , 155-158 . Retrieved from http://dergipark.org.tr/tr/pub/marupj/issue/17910/188092 |
| 7 | Mid-term exam | Question-Answer | Lecture notes |
| 8 | Targeted Medication Safety Best Practices for Hospitals (ISMP 2018 - 2019) | Question-Answer, Discussion | ismp.org |
| 9 | Safe Preparation of Parenteral Products in Hospital | Question-Answer, Discussion | Guidelines for Safe Preparation of Compounded Sterile Preparations, https://www.ismp.org/guidelines/sterile-compounding Scheepers H, Beaney AM, Le Brun P, et al. Aseptic preparation of parenteral medicinal products in healthcare establishments in Europe. Eur J Hosp Pharm. 2016;23(1):50-53. doi:10.1136/ejhpharm-2015-000709 |
| 10 | High Risk Drugs in Hospital Safety in Drug Dispensing | Question-Answer, Discussion | WHO, Medication safety in High Risk Situations, Technical Report, 2019. How-to Guide: Prevent Harm from High-Alert Medications. Cambridge, MA: Institute for Healthcare Improvement;, 2012. (Available at www.ihi.org). |
| 11 | Safety in Drug Administration | Question-Answer, Discussion | Hughes RG, Blegen MA. Medication Administration Safety. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 37. Available from: https://www.ncbi.nlm.nih.gov/books/NBK2656/ |
| 12 | Optimization of Safe Subcutaneous Insulin Use in Adults | Question-Answer, Discussion | Guidelines for Optimizing Safe Subcutaneous Insulin Use in Adults, https://www.ismp.org/guidelines/subcutaneous-insulin. |
| 13 | Pharmacovigilance | Question-Answer, Discussion | Therapeutic Risk Management of Medicines, 1st Edition, Stephen J. Mayall, Anjan Swapu Banerjee, eBook ISBN: 9781908818270, Hardcover ISBN: 9781907568480, Woodhead Publishing, 2014. Drug benefits and risks: International Textbook of Clinical Pharmacology, Revised 2nd Edition, C.J. van Boxtel, Budiono Santoso, I. Ralph Edwards, ISBN 978-1-58603-880-9, IOS Press, 2008. |
| 14 | Drug Use in Pregnancy as an Example of Risk Management | Question-Answer, Discussion | National clinical guidelines for the management of drug use during pregnancy, birth and the early development years of the newborn. Commonwealth of Australia 2006. ISBN 0 7347 3890 0. https://www.msdmanuals.com/home/women-s-health-issues/drug-use-during-pregnancy/drug-use-during pregnancy#:~:text=In%20general%2C%20drugs%20should%20not,pregnant%20woman%20and%20the%20fetus. |
| 15 | Controlled Drugs and Patient Safety Reporting Medication Errors and Near Miss Events | Question-Answer, Discussion | https://www.titck.gov.tr/dinamikmodul/43 T.C. Sağlık Bakanlığı, İlaç Güvenliği Rehberi (versiyon 2) 2015, ISBN: 978-975-590-586-0, Sayfa: 20-31 T.C. Sağlık Bakanlığı, SKS-Hastane (Sürüm 6), ISBN: 978-975-590-766-6, Sayfa: 173-183. P.E. Macintyre, Safety and efficacy of patient-controlled analgesia. BJA, VOLUME 87, ISSUE 1, P36-46, JULY 01, 2001, DOI:https://doi.org/10.1093/bja/87.1.36 |
| 16 | Final exam | Question-Answer | Lecture notes |
Text Book / Material / Recommended Resources
Therapeutic Risk Management of Medicines, 1st Edition, Stephen J. Mayall, Anjan Swapu Banerjee, eBook ISBN: 9781908818270, Hardcover ISBN: 9781907568480, Woodhead Publishing, 2014. Drug benefits and risks: International Textbook of Clinical Pharmacology, Revised 2nd Edition, C.J. van Boxtel, Budiono Santoso, I. Ralph Edwards, ISBN 978-1-58603-880-9, IOS Press, 2008.
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
| Term (or Year) Learning Activities | Quantity | Weight |
|---|---|---|
| Midterm Examination | 1 | 100 |
| Total | 100 | |
| End Of Term (or Year) Learning Activities | Quantity | Weight |
| Final Examination | 1 | 100 |
| Total | 100 | |
| Term (or Year) Learning Activities | 40 | |
| End Of Term (or Year) Learning Activities | 60 | |
Work Pacement(s)
None
Workload Calculation
| Activities | Number | Time (hours) | Total Work Load (hours) |
|---|---|---|---|
| Midterm Examination | 1 | 1 | 1 |
| Final Examination | 1 | 2 | 2 |
| Makeup Examination | 1 | 2 | 2 |
| Attending Lectures | 14 | 2 | 28 |
| Criticising Paper | 1 | 4 | 4 |
| Individual Study for Mid term Examination | 14 | 2 | 28 |
| Individual Study for Final Examination | 14 | 3 | 42 |
| Reading | 15 | 2 | 30 |
| Total Work Load (hours) | 137 | ||
Contribution of Learning Outcomes to Programme Outcomes
| PO 1 | PO 2 | PO 3 | PO 4 | PO 5 | PO 6 | PO 7 | PO 8 | PO 9 | PO 10 | |
| LO 1 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
| LO 2 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
| LO 3 | 5 | 4 | 5 | 5 | 5 | 4 | 5 | 5 | 4 | 5 |
| LO 4 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
| LO 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
| LO 6 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
| LO 7 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 4 | 5 |
* Contribution Level: 1 Very low 2 Low 3 Medium 4 High 5 Very High