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Hemşirelik Eğitiminde Farmakovijilansın ve Ekofarmakovijilansın Önemi

Yıl 2019, Cilt: 2 Sayı: 1, 70 - 77, 25.04.2019

Öz

Tıptaki
ilerlemelere yeni bilginin birikiminin eşlik etmesi yükseköğretim kurumlarını
sağlık bakımı sağlayacak mezunlarını hazırlama şekillerini değiştirmeye
zorlamaktadır.
Bu
makalede amaç, farmakovijilansın ve ekofarmakovijilansın önemi hakkında
yükseköğretimdeki hemşirelik akademisyenleri arasında farkındalık yaratmak ve
geleceğin hemşirelerinin eğitimindeki rollerinin altını çizmektir.
Farmakovijilans farmasötiklerin
insandaki advers etkilerini izler. Çevre için bir tür farmakovijilans olan
ekofarmakovijilans ise, farmasötiklerin çevredeki ve ayrıca dolaylı yoldan
insanlar üzerindeki terapötik olmayan düzeylerde farmasötiklere maruziyete
bağlı advers etkilerini izler. Yükseköğretimdeki hemşirelik eğitimi
uygulayıcıları mezuniyet öncesi ve sonrası hemşirelik öğrencilerinin akademik
performanlarında ilerleme sağlayacak ders programlarını farmakovijians ve
ekofarmakovijilans alanlarında güncel duruma uygun hale getirmelidirler. 

Kaynakça

  • Angamo MT, Chalmers L, Curtain CM, Bereznicki LRE. (2016) Adverse drug reaction related hospitalisations in developed and developing countries: a review of prevalence and contributing factors. Drug Safety.;39(9):847–57.
  • Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. (2013) An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian Journal Pharmacology. Nov-Dec;45(6):616-8
  • Avinash D. .P, Nandkishor P. , Rohini P. ( 2015) Accentuating the Role of Pharmacovigilance and Ecopharmacovigilance in Context to Man and Ecology - A Review International Journal of Science and Research Volume 4 Issue 6, June
  • Aydınkarahaliloğlu N.D. •Aykaç E • Atalan Ö • Demir N• Hayran M (2018) Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016 Pharmaceutical Medicine 32:353–364
  • 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, 2010 www.europarl.europa.eu/sides/getDoc. do?pubRef=-//EP// NONSGML+REPORT+A7-2010-0159+0+DOC+WORD+V0//EN
  • Daughton CG, Ruhoy IS. (2008) The afterlife of drugs and the role of pharmEcovigilance. Drug Safety;31(12):1069-82.
  • Daughton CG (2010) "Drugs and the Environment: Stewardship & Sustainability," National Exposure Research Laboratory, Environmental Sciences Division, US EPA, Las Vegas, Nevada, report NERL-LV-ESD 10/081, EPA/600/R-10/106, 12 September 2010, 196 pp; available: http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf
  • Daughton CG, Ruhoy IS. (2011) Green pharmacy and pharmEcovigilance: prescribing and the planet. Expert review of clinical pharmacology.. Mar;4(2):211-32.
  • Daughton CG, Ruhoy IS. (2013) Lower-dose prescribing: minimizing "side effects" of pharmaceuticals on society and the environment. The Science of the total environment.. Jan 15;443:324-37.
  • Daughton CG. (2014) Eco-directed sustainable prescribing: feasibility for reducing water contamination by drugs. The Science of the total environment. Sep 15;493:392-404.
  • Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. (2018) Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. International health. Sep 28. DOI: 10.1093/inthealth/ihy073
  • Joss A, Zabczynski S, Gobel A, Hoffmann B, Loffler D, McArdell CS, (2006)l. Biological degradation of pharmaceuticals in municipal wastewater treatment: Proposing a classification scheme. Water Research.;40:1686-96.Guner MD, Ekmekci PE.(2019) Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. Journal of Drug Assessment. Jan 5;8(1):13-20
  • GVP 2018 Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population cited:19.03.2019 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-iv_en-0.pdf
  • Holm G, Snape JR, Murray-Smith R, Talbot J, Taylor D, Sörme P. (2013) Implementing ecopharmacovigilance in practice: challenges and potential opportunities. Drug Safety. Jul;36(7):533-46
  • Kummerer K, Velo G. (2006) Ecopharmacology: a new topic of importance in pharmacovigilance. Drug Safety.;29(5):371–3.
  • LAREB 2017, Netherlands Pharmacovigilance Centre Lareb, https://www.pv-education.org/ cited: 12.03.2019
  • Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PMLA. (2008) HARM Study group. Frequency of and risk factors for preventable medication related hospital admissions in The Netherlands. Archives of internal medicine;168(17):1890–6.
  • Official Gazette 2005, Regulation on the monitoring and assessment of the safety of medicinal products for human use. Cited 12.03.2019 http://www.resmigazete.gov.tr/eskiler/2005/03/20050322-7.htm.
  • Official Gazette 2014 Regulatıon On The Safety Of Medıcınal Products By Turkish Medicines and Medical Devices Agency Legislation on Drug Safety Official Gazette No: 28973 2014
  • Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND (2016) Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs - Real World Outcomes 3:33–43
  • Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. (2018) The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Frontiers in Pharmacology. Jan 25;9:9.
  • Murray-Smith R. (2013) Ecopharmacovigilance: a drug company perspective 10th Annual Meeting of the International Society of Pharmacovigilance, Accra, Ghana. 4 November 2010. Available from URL: http://isop2010.isoponline.org/uploads/prog/Progra mme_-3rd_-_7th_November-.pdf. Accessed 4 Apr
  • Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley T, Farrar K, Park BK, Breckenridge AM. (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ.;329(7456):15–9.
  • Rahman SZ, Khan RA. (2006) Environmental pharmacology: a new discipline. Indian Journal Pharmacology;38:229–30.
  • Rahman SZ, Khan RA, Gupta V, Uddin M. (2007) Pharmacoenvironmentology: a component of pharmacovigilance. Environmental Health.;6:20.
  • Taylor D. (2010) Ecopharmacostewardship: a pharmaceutical industry perspective. In: Kt‹mmerer K, Hempel M, editors. Green and sustainable pharmacy, p. 105–26.Berlin/Heidelberg: Springer.
  • TMMDA Turkish Medicines and Medical Devices Agency, Turkish Pharmacovigilance Center. Cited 14.02.2019 https://www.titck.gov.tr/faaliyetalanlari/ilac/farmakovijilans
  • TMMDA (2010) Notification on the principles and procedures related to the warning system of medical devices cited 12.03.2019 http://www.farmakovijilansdernegi.org/files/2010.07.14 Notification_on_the_principles_and_procedures_related_to_the_warning_system_of_medical_devices
  • TMMDA (2014) 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
  • TMMDA (2016) T.C. Sağlık Bakanlığı Türkiye Tıbbi Cihaz Sektörü Strateji Belgesi Ve Eylem Planı 2016-2020.Pages 1-19
  • Toklu HZ, Uysal MK. (2008) The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharmacy world & science. Oct;30(5):556-62
  • UMC https://www.who-umc.org/about-us/our-story/ cited 12.03.2019
  • Van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L. (2018) 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 Safety. Nov;41(11):1003-1011
  • Velo G, Moretti U. (2010) Ecopharmacovigilance for better health. Drug Safety. Nov 1;33(11):963-8
  • Vural F, Ciftci S, Vural B (2015) the knowledge attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. Northern Clinics of İstanbul. Jan 24;1(3)
  • WHO (2002) The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products pages 1-14.
  • WHO (2004) Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines.

The Importance of Pharmacovigilance and Ecopharmacovigilance in Nursing Education

Yıl 2019, Cilt: 2 Sayı: 1, 70 - 77, 25.04.2019

Öz

Advancements
in medicine accompanied by the accumulation of new knowledge force higher
education institutions to change the way they prepare their graduates to
deliver healthcare. The aim of this review is to raise
the awareness of
the importance of pharmacovigilance and
ecopharmacovigilance among nursing academics in
higher education and
to underline their role in educating future nurses. Pharmacovigilance aims
to monitor the adverse effects of pharmaceuticals on patients. Ecopharmacovigilance,
as a kind of pharmacovigilance for the environmental, aims to monitor the
adverse effects of pharmaceuticals both on the environment and on humans
through indirect non-therapeutic exposure. Nursing education administrators in
higher education should update their curricula in the fields of
pharmacovigilance and ecopharmacovigilance that will yield the improvements in
the academic performance of undergraduate and postgraduate nursing students.



 

Kaynakça

  • Angamo MT, Chalmers L, Curtain CM, Bereznicki LRE. (2016) Adverse drug reaction related hospitalisations in developed and developing countries: a review of prevalence and contributing factors. Drug Safety.;39(9):847–57.
  • Alan S, Ozturk M, Gokyildiz S, Avcibay B, Karataş Y. (2013) An evaluation of knowledge of pharmacovigilance among nurses and midwives in Turkey. Indian Journal Pharmacology. Nov-Dec;45(6):616-8
  • Avinash D. .P, Nandkishor P. , Rohini P. ( 2015) Accentuating the Role of Pharmacovigilance and Ecopharmacovigilance in Context to Man and Ecology - A Review International Journal of Science and Research Volume 4 Issue 6, June
  • Aydınkarahaliloğlu N.D. •Aykaç E • Atalan Ö • Demir N• Hayran M (2018) Spontaneous Reporting of Adverse Drug Reactions by Consumers in Comparison with Healthcare Professionals in Turkey from 2014 to 2016 Pharmaceutical Medicine 32:353–364
  • 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, 2010 www.europarl.europa.eu/sides/getDoc. do?pubRef=-//EP// NONSGML+REPORT+A7-2010-0159+0+DOC+WORD+V0//EN
  • Daughton CG, Ruhoy IS. (2008) The afterlife of drugs and the role of pharmEcovigilance. Drug Safety;31(12):1069-82.
  • Daughton CG (2010) "Drugs and the Environment: Stewardship & Sustainability," National Exposure Research Laboratory, Environmental Sciences Division, US EPA, Las Vegas, Nevada, report NERL-LV-ESD 10/081, EPA/600/R-10/106, 12 September 2010, 196 pp; available: http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf
  • Daughton CG, Ruhoy IS. (2011) Green pharmacy and pharmEcovigilance: prescribing and the planet. Expert review of clinical pharmacology.. Mar;4(2):211-32.
  • Daughton CG, Ruhoy IS. (2013) Lower-dose prescribing: minimizing "side effects" of pharmaceuticals on society and the environment. The Science of the total environment.. Jan 15;443:324-37.
  • Daughton CG. (2014) Eco-directed sustainable prescribing: feasibility for reducing water contamination by drugs. The Science of the total environment. Sep 15;493:392-404.
  • Ergün Y, Ergün TB, Toker E, Ünal E, Akben M. (2018) Knowledge attitude and practice of Turkish health professionals towards pharmacovigilance in a university hospital. International health. Sep 28. DOI: 10.1093/inthealth/ihy073
  • Joss A, Zabczynski S, Gobel A, Hoffmann B, Loffler D, McArdell CS, (2006)l. Biological degradation of pharmaceuticals in municipal wastewater treatment: Proposing a classification scheme. Water Research.;40:1686-96.Guner MD, Ekmekci PE.(2019) Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. Journal of Drug Assessment. Jan 5;8(1):13-20
  • GVP 2018 Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population cited:19.03.2019 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-iv_en-0.pdf
  • Holm G, Snape JR, Murray-Smith R, Talbot J, Taylor D, Sörme P. (2013) Implementing ecopharmacovigilance in practice: challenges and potential opportunities. Drug Safety. Jul;36(7):533-46
  • Kummerer K, Velo G. (2006) Ecopharmacology: a new topic of importance in pharmacovigilance. Drug Safety.;29(5):371–3.
  • LAREB 2017, Netherlands Pharmacovigilance Centre Lareb, https://www.pv-education.org/ cited: 12.03.2019
  • Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PMLA. (2008) HARM Study group. Frequency of and risk factors for preventable medication related hospital admissions in The Netherlands. Archives of internal medicine;168(17):1890–6.
  • Official Gazette 2005, Regulation on the monitoring and assessment of the safety of medicinal products for human use. Cited 12.03.2019 http://www.resmigazete.gov.tr/eskiler/2005/03/20050322-7.htm.
  • Official Gazette 2014 Regulatıon On The Safety Of Medıcınal Products By Turkish Medicines and Medical Devices Agency Legislation on Drug Safety Official Gazette No: 28973 2014
  • Ozcan G, Aykac E, Kasap Y, Nemutlu NT, Sen E, Aydinkarahaliloglu ND (2016) Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation. Drugs - Real World Outcomes 3:33–43
  • Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. (2018) The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore. Frontiers in Pharmacology. Jan 25;9:9.
  • Murray-Smith R. (2013) Ecopharmacovigilance: a drug company perspective 10th Annual Meeting of the International Society of Pharmacovigilance, Accra, Ghana. 4 November 2010. Available from URL: http://isop2010.isoponline.org/uploads/prog/Progra mme_-3rd_-_7th_November-.pdf. Accessed 4 Apr
  • Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley T, Farrar K, Park BK, Breckenridge AM. (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ.;329(7456):15–9.
  • Rahman SZ, Khan RA. (2006) Environmental pharmacology: a new discipline. Indian Journal Pharmacology;38:229–30.
  • Rahman SZ, Khan RA, Gupta V, Uddin M. (2007) Pharmacoenvironmentology: a component of pharmacovigilance. Environmental Health.;6:20.
  • Taylor D. (2010) Ecopharmacostewardship: a pharmaceutical industry perspective. In: Kt‹mmerer K, Hempel M, editors. Green and sustainable pharmacy, p. 105–26.Berlin/Heidelberg: Springer.
  • TMMDA Turkish Medicines and Medical Devices Agency, Turkish Pharmacovigilance Center. Cited 14.02.2019 https://www.titck.gov.tr/faaliyetalanlari/ilac/farmakovijilans
  • TMMDA (2010) Notification on the principles and procedures related to the warning system of medical devices cited 12.03.2019 http://www.farmakovijilansdernegi.org/files/2010.07.14 Notification_on_the_principles_and_procedures_related_to_the_warning_system_of_medical_devices
  • TMMDA (2014) 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
  • TMMDA (2016) T.C. Sağlık Bakanlığı Türkiye Tıbbi Cihaz Sektörü Strateji Belgesi Ve Eylem Planı 2016-2020.Pages 1-19
  • Toklu HZ, Uysal MK. (2008) The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharmacy world & science. Oct;30(5):556-62
  • UMC https://www.who-umc.org/about-us/our-story/ cited 12.03.2019
  • Van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L. (2018) 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 Safety. Nov;41(11):1003-1011
  • Velo G, Moretti U. (2010) Ecopharmacovigilance for better health. Drug Safety. Nov 1;33(11):963-8
  • Vural F, Ciftci S, Vural B (2015) the knowledge attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital. Northern Clinics of İstanbul. Jan 24;1(3)
  • WHO (2002) The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products pages 1-14.
  • WHO (2004) Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines.
Toplam 37 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Hemşirelik
Bölüm Derleme
Yazarlar

Evren Şavlı 0000-0001-5052-5436

Evrim Şavlı Bu kişi benim 0000-0002-7158-0984

Yayımlanma Tarihi 25 Nisan 2019
Gönderilme Tarihi 6 Nisan 2019
Yayımlandığı Sayı Yıl 2019 Cilt: 2 Sayı: 1

Kaynak Göster

APA Şavlı, E., & Şavlı, E. (2019). The Importance of Pharmacovigilance and Ecopharmacovigilance in Nursing Education. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 2(1), 70-77.