Tıp Lisans Eğitiminde Eğitimsel İlerlemenin Farmakolojik Bakış Açısından Bir Yansıması

Teknolojideki gelişmelere yeni bilginin hızlı birikiminin eşlik etmesi yüksek öğretim kurumlarını sağlık bakımı sağlayıcı sistemler için mezunlarını hazırlama şekillerini değiştirmeye zorlamaktadır. Yüksek öğretimdeki tıp eğitim uygulayıcıları mezun olacak tıp öğrencilerinin yaşam boyu akademik performanlarında ilerlemeler sağlayacak uygun ders programı revizyonlarını araştırmalıdırlar. Advers ilaç reaksiyonlarının ve tıbbi cihaz olaylarının çok ciddi sağlık sorunlarına yol açabileceği literatürde ortaya konmaktadır. Üniversitelerde tıp, eczacılık, diş hekimliği, hemşirelik ve ebelik öğrencilerine farmakovijilans öğretimi için bir uluslararası standart bulunmamaktadır. Bu derlemenin amacı yüksek öğretimde farmakoloji ders programında farmakovijilansın, ekofarmakovijilansın ve tıbbi cihaz olumsuz olaylarının önemine dair bir farkındalık yaratmak ve tıp akademisyenlerinin mezun olacak öğrencilerin advers ilaç reaksiyonlarını ve tıbbi cihaz olumsuz olaylarını ulusal yasalarla uyumlu bir şekilde vijilans sistemine uygun raporlamasını teşvik etmedeki ve uygun atık yönetiminin ve farmasötiklerin ve kişisel bakım ürünlerinin güvenli atılımının desteklenmesindeki rolünün altını çizmektir.

A Reflection of Educational Advancements In Undergraduate Medical Education From Pharmacological Perspective

Advances in technology accompanied by the rapid accumulation of new knowledge force higher education institutions to change the way in which they prepare their graduates for healthcare delivery systems. Medical education administrators in higher education should seek the appropiate curricular revisions that will yield the improvements in the lifelong academic performance of undergraduate medicine students. Adverse drug reactions and medical device incidents may cause “serious health issues” as shown in literature. There is no international standard exists for teaching pharmacovigilance at universities for undergraduate medical, pharmacy, dentistry, nursing and midwifery students. The aim of this review is to raise the awareness of the importance of pharmacovigilance, ecopharmacovigilance and medical device incidents in pharmacology curriculum in higher education and to underline the role of medical academics in encouraging undergraduate students for appropiate reporting of adverse drug reactions and medical device incidents to vigilance systems in accordance with national regulations and also in promoting for proper waste management and safe disposal of pharmaceuticals and personal care products.

PDF

___

1. WHO. The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products, 2002; 1- 52.
2. WHO. Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines, 2004; 1-5.
3. UMC, cited 12.03.2019, https://www.who- umc.org/about-us/our-story.
4. TMMDA, Turkish Medicines and Medical Devices Agency, Turkish Pharmacovigilance Center, cited 14.02.2019 https://www.titck.gov.tr/faaliyetalanlari/ilac/farmak ovijilans.
5. Republic of Turkey Official Gazette. Regulation on the monitoring and assessment of the safety of medicinal products for human use, 2005, cited 12.03.2019 http://www.resmigazete.gov.tr/eskiler/2005/03/200 50322-7.htm.
6. Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND. Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs Real World Outcomes, 2016; 3(1):33–43.
7. Republic of Turkey Official Gazette. Regulatıon On The Safety Of Medıcınal Products By Turkish Medicines and Medical Devices Agency Legislation on Drug Safety, 2014; Official Gazette No: 28973 2014.
8. TMMDA Turkish Drug and Medical Device Agency. Guideline on Good Pharmacovigilance Practices: Module I - Management and reporting of adverse drug reactions Guideline on Good Pharmacovigilance Practices: Appendıx I – Definitions, 2014.
9. Guner MD, Ekmekci PE. Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. J Drug Assess. 2019; 8(1):13-20
10. TMMDA. T.C. Sağlık Bakanlığı Türkiye Tıbbi Cihaz Sektörü Strateji Belgesi Ve Eylem Planı 2016- 2020; 1-19
11. Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018; 25;9,9.
12. TMMDA. Notification on the principles and procedures related to the warning system of medical devices 2010, cited 12.03.2019 http://www.farmakovijilansdernegi.org/files/2010.0 7.14_Notification_on_the_principles_and_procedur es_related_to_the_warning_system_of_medical_de vices
13. Fitzpatrick D. Implantable Electronic Medical Devices, 1st ed. ISBN: 9780124165779; 2014.
14. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley T, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BM J 2004.;329(7456):15–9.
15. Angamo MT, Chalmers L, Curtain CM, Bereznicki LRE. Adverse drug reaction related hospitalisations in developed and developing countries: a review of prevalence and contributing factors. Drug Saf. 2016;39(9):847–57.
16. Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PM, HARM Study group. Frequency of and risk factors for preventable medication related hospital admissions in The Netherlands. Arch Intern Med. 2008;168(17):1890–6.
17. Vural F, Ciftci S, Vural B. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. Northern Clinics of İstanb. 2015;1(3):147-152
18. Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci. 2008;30(5):556-62
19. Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. Int. health. 2018. DOI: 10.1093/inthealth/ihy073
20. Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian J Pharmacol. 2013;45(6):616-8
21. Aydınkarahaliloğlu N.D., Aykaç E, Atalan Ö, Demir N, HayranM. Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016. Pharmaceutical Medicine 2018;32:353–364
22. Directive 2001/83/EC European Parliament. Draft European Parliament Legislative Resolution: proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0665 – C6 0514/2008- 2008/0260(COD)). Committee on the Environment, Public Health and Food Safety, European Parliament, Strasbourg, Session Document A7– 0159/2010,2010www.europarl.europa.eu/sides/get Doc.do?pubRef=//EP//NONSGML+REPORT+A7- 2010-0159+0+DOC+WORD+V0//EN
23. Daughton CG, Ruhoy IS. Green pharmacy and pharmEcovigilance: prescribing and the planet. Expert Rev Clin Pharmacol. 2011; 2:211-32
24. Daughton CG, Ruhoy IS. The afterlife of drugs and the role of pharmEcovigilance. Drug Saf.2008; 31(12):1069-82.
25. Velo G, Moretti U. Ecopharmacovigilance for better health. Drug Saf. 2010; 33(11):963-8
26. Holm G, Snape JR, Murray-Smith R, Talbot J, Taylor D, Sörme P. Implementing ecopharmacovigilance in practice: challenges and potential opportunities. Drug Saf. 2013;36(7):533- 46
27. Daughton CG. Eco-directed sustainable prescribing: feasibility for reducing water contamination by drugs. Sci Total Environ. 2014; 493:392-404.
28. Daughton CG, Ruhoy IS. Lower-dose prescribing: minimizing "side effects" of pharmaceuticals on society and the environment. Sci Total Environ. 2013;443:324-37.
29. YÖK Tıp eğitiminde intörnlük çalıştayı 10.01.2018, cited 12.03.2019, https://www.yok.gov.tr/Documents/Yayinlar/Yayin larimiz/Tip_egitiminde_intornluk_calistayi.pdf
30. Gulpinar M, Gürpinar E, Vitrinel A. Evaluation of the undergraduate medical education national core curriculum-2014: National frame of medical education in Turkey. KMJ 2018; 50(1): 43-53
31. Turkish Interuniversity Council. National Core Curriculum 2014. Cited12.03.19 https://www.yok.gov.tr/Documents/Kurumsal/egiti m_ogretim_dairesi/Ulusal-cekirdek-egitimi- programlari/tip_fakultesi_cep.pdf
32. Guner MD. Incentives to Increase Pharmacovigilance Practices from an Educational and Ethical Point of View. J of Pharmacol & Clin Res. 2017;3 (5)
33. Kummerer K, Velo G. Ecopharmacology: a new topic of importance in pharmacovigilance. Drug Saf. 2006;29(5):371–3.
34. Rahman SZ, Khan RA. Environmental pharmacology: a new discipline. Indian J Pharmacol. 2006;38:229–30.
35. Rahman SZ, Khan RA, Gupta V, Uddin M. Pharmacoenvironmentology: a component of pharmacovigilance. Environ Health2007.;6:20.
36. Taylor D. Chapter 7 - Ecopharmacostewardship – A Pharmaceutical Industry Perspective, In: K. Kümmerer, M. Hempel (eds.), Green and Sustainable Pharmacy, DOI 10.1007/978-3-642- 05199-9_7, C Springer-Verlag Berlin Heidelberg, 2010
37. Murray-Smith R. Ecopharmacovigilance: a drug company per-spective. 10th Annual Meeting of the International Society of Pharmacovigilance, Accra, Ghana. 2010. Cited 04.04.13 http://isop2010.isoponline.org/uploads/prog/Progra mme_-3rd_-_7th_November-.pdf.
38. Van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L. What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects. Drug Saf. 2018;41(11):1003-1011
39. LAREB, Netherlands Pharmacovigilance Centre Lareb,cited 03.01.17 https://www.pv-education.org/
40. GVP Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population,2008, cited:19.03.2019https://www.ema.europa.eu/en/doc uments/scientific-guideline/guideline-good- pharmacovigilance-practices-gvp-product- population-specific-considerations-iv_en-0.pdf

ISSN: 2822-4302
Yayın Aralığı: Yılda 3 Sayı
Başlangıç: 2017
Yayıncı: -

Arşiv

Sayıdaki Diğer Makaleler

Tıp Lisans Eğitiminde Eğitimsel İlerlemenin Farmakolojik Bakış Açısından Bir Yansıması

Evren Savlı, Evrim Savlı

Zuklopentiksol Dekanoat Uzun Etkili Depo Enjeksiyon Kullanımına Bağlı Yüz ve Periferik Ödem: Bir Olgu Sunumu

Mehmet Hamdi Örüm, Mahmut Zabit Kara

İlköğretim Okullarındaki Öğretmenlerin Sık Karşılaşılan Psikiyatrik Bozukluklar Hakkında Bilgi Düzeyleri ve Eğitimleri

Yasin Yıldız, Murat Kacar

Zonguldak Kadın Doğum Ve Çocuk Hastalıkları Hastanesine İsteğe Bağlı Kürtaj Nedeniyle Başvuran Gebelerin Aile Planlaması Pratikleri Açısından Değerlendirilmesi

Burak Ün, Besim Haluk Bacanakgil, İsa Şükrü Öz, Anıl Turhan Çakır

Küçük Yaşta Geç Gelen Tehlikeli Bir Yabancı Cisim Aspirasyonu Olgusu

Hüseyin Fatih Sezer, Abdulkerim Yılmaz, Hakan Dayanır