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INTELEK Repository
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Online Access
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https://intelek.unisza.edu.my/intelek/pages/search.php?search=!collection407072
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2024-08-27 16:31:46
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Restricted Document
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13089
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UniSZA
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1. World Health Organization (WHO). Safety of Medicines: a guide to detecting and reporting adverse drug reactions. Geneva: World Health Organization. 2002. Available from URL: http://apps.who.int/iris/bitstream/10665/67378 /1/WHO_EDM_QSM_2002.2.pdf (Accessed on 7/4/2015). 2. World Health Organization (WHO). Requirements for adverse reaction reporting. World Health Organization: Geneva, Switzerland. 1975. Available from URL: http://apps.who.int/iris/bitstream/10665/40514 /1/9241560428_eng.pdf Accessed on 7/4/2015 3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998; 279(15): 1200-1205. 4. Agarwal R, Daher AM, Ismail NM. Knowledge, Practices and Attitudes towards Adverse Drug Reaction Reporting by Private Practitioners from Klang Valley in Malaysia. Malays J Med Sci, 2013; 20 (2): 52-61. 5. Showande JS, Oyelola FT. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university. Internet Journal of Medical Update-EJOURNAL, 2013, 8: 24-30. 6. Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA. Pharmacy students’ knowledge and perceptions about pharmacovigilance in Malaysian public universities. Am J Pharm Educ, 2011; 75(5): 96. 7. Adedeji WA, Ibrahem WA, Fehintola FA. Attitude and Practice of Doctors toward Adverse Drug Reactions (ADRs) Reporting In a Nigerian Tertiary Health Facility. Ann Ibd Pg Med, 2013; 1(2): 77-80. 8. Awodele O, Akinyede A, Adeyemi OA, Awodele DF. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. The International Journal of Risk & Safety in Medicine. 2010; 23(4): 217-226. 9. Iffat W, Shakeel S, Rahim N, Anjum F, Neesar S, Ghayas S. Pakistani physicians’ knowledge and attitude towards reporting adverse drug reactions. African Journal of Pharmacy and Pharmacology, 2014; 8(14):379-385. 10. Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharmacy Practice, 2011; 9(4):228-235. 11. Uppsala Monitoring Centre (UMC). Report from the World Health Organisation collaborating centre for international drug monitoring. Activities July 2012 – June 2013. 2013. Available from URL: http://www.who-umc.org/graphics/27871.pdf Accessed on 13/5/2015 12. Hanafi S, Torkamandi H, Hayatshahi A, Kheirollah G, Javadi M: Knowledge, attitudes and practice of nurses regarding adverse drug reaction reporting. IJNMR, 2012, 17(1):1–7. 13. Uppsala Monitoring Centre (UMC). Uppsala Reports. 2012. Available from URL: http://www.who-umc.org/graphics/26656.pdf Accessed on 12/10/2015 14. Lindquist M. VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008; 42: 409–419. 15. Uppsala Monitoring Centre (UMC). Being a member of the WHO Programme for International Drug Monitoring. Available from URL: http://whoumc.org/graphics/25642.pdf Accessed on 12/10/2015 16. DrugControlAuthority(DCA)News.(2001).Availablef romURL:http://portal.bpfk.gov.my/images/PDF/ DCA%20News/DCA%20News%202001.pdf Accessed on 25/11/2015. 17. WHOPharmaceuticalsNewsletterNo.1,2003,1- 10.AvailablefromURL: http://www.who.int/medicines/publications/news letter/en/news2003_1.pdf Accessed on 27/11/2015 18. MADRACNews.BeritaUbatubatan19:3.2002.AvailablefromURL: http://portal.bpfk.gov.my/images/Publications/N ewsletter_Berita_Ubatubatan/2002/BUU2002Apr.pdf Accesssed on 26/11/2015 19. Sivadasan S, Yuong NY, Chyi NW, Ching ALS, Ali AN, Veerasamy R, Marimuthub K, Arumugama DS. Knowledge and Perception towards Pharmacovigilance and Adverse Drug Reaction Reporting among Medicine and Pharmacy Students. WJPPS, 2014; 3(3): 1652-1676. 20. Isa NM, Borhanuddin B, Shuid AN, Fozi NFM. Attitudes, Perception and Knowledge of General Practitioners towards Adverse Drug Reaction (ADR) Reporting In Malaysia – A Pilot Study. Research Updates in Medical Sciences, 2013; 1(1): 21-26. 21. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of underreporting in Malaysia. Pharmacoepidemiol Drug Saf, 2007; 16 (2): 223-228. 22. Agu KA, Oparah AC. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria. Perspectives in Clinical Research, 2013; 4(2): 117-124. 23. Iwokwagh N.S. Assessment of New Media Use in the Fight against Counterfeit Medicines in Nigeria. International Conference on Communication, Media, Technology and Design. Famagusta – North Cyprus. (02-04 May, 2013). Available from URL: http://www.cmdconf.net/2013/makale/PDF/5.p df Accesssed on 23/4/2015 24. National agency for food and drug administration and control (NAFDAC). ‘NAFDAC ACT/LAWS’. 2012. Available from URL:http://www.nafdac.gov.ng/images/PUBLICA TIONS/NAFDAC_ACT/Nafdac_Act_Real_Copy.p df. Accessed on 12/3/2015 25. Oshikoya KA, Senbanjo IO. Providing safe medicines for children in Nigeria: The impediments and remedies. Annals of African medicine, 2010. 9(4): 203-212. 26. Fadare JO, Enwere OO, Afolabi AO, Chedi BAZ, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Tropical Journal of Pharmaceutical Research, 2011; 10(3): 235-242. 27. Okezie EO, Olufunmilayo F. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiol Drug Saf, 2008; 17(5): 517-522. 28. Oshikoya KA, Chukwura H, Njokanma OF, Senbanjo IO, Ojo I. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria. Sao Paulo Med J, 2011; 129(3): 153-164. 29. Ahmed AM, Izham IM, Subish P. The Importance of the Consumer Pharmacovigilance System in Developing Countries: A Case of Malaysia. JCDR, 2010; 4: 2929-2935. 30. Lei HS, AB Rahman AF, Haq AHSM. Adverse Drug Reaction Reports in Malaysia: Comparison of Causality Assessments. Malaysian Journal of Pharmaceutical Sciences. 2007; 5(1): 7–17. 31. Isa NM. Pharmacovigilance and reporting adverse drug reactions. Medicine & Health. 2014; 9 (2): 92- 102. 32. MADRAC News. Berita-Ubatubatan. 2003; 21(2):1- 3.Available from URL: http://portal.bpfk.gov.my/images/Publications/N ewsletter_Berita_Ubatubatan/2003/BUU2003Aug.pdf Accesssed on 26/11/2015 33. MADRACBulletin.2009.AvailablefromURL:http://po rtal.bpfk.gov.my/images/Publications/Newsletter _MADRAC_Bulletin/May-2009.pdf Accesssed on 26/11/2015 34. Uppsala Monitoring Centre (UMC). National pharmacovigilance guidelines. 2010. 35. AvailablefromURL:http://www.whoumc.org/DynPage.aspx?id=127878&mn1=734 7&mn2=7252&mn3=7253&mn4=7745 Accessed on 13/5/2015 36. MADRACBulletin.2015.AvailablefromURL:http://po rtal.bpfk.gov.my/images/Publications/Newsletter _MADRAC_Bulletin/Bulletin_MADRAC_April_201 5.pdf Accessed on 25/11/2015 37. Uppsala Monitoring Centre. Reporting Trends: Reporting to the WHO database. 2015. Available from URL: http://www.whoumc.org/DynPage.aspx?id=108476&mn1=734 7&mn2=7252&mn3=7322&mn4=7558 (Accessed on 27/11/2015). 38. MADRAC Bulletin. 2014. http://portal.bpfk.gov.my/index.cfm?&menuid= 149&parentid=17 Accessed on 12/11/2015. 39. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology & Therapeutics, 1981; 30 (2): 239-245. 40. Rosamund MA, Foluke GF. Spontaneous reporting of paediatric adverse drug reactions in a Nigerian tertiary health centre–any relationship to severity? Int J Pharm Sci Invent. 2013; 2(1): 5-11. 41. Ogundele SO, Dawodu CO, Ogunyele OO. Adverse Drug Reaction Monitoring among Health care Workers at Tertiary Hospital. A Comparative Cross-sectional Survey of Health Care Professionals. Global Research Journal of Medical Sciences, 2012; 2(2): 032-037. 42. Okechukwu RC, Odinduka SO, Ele GN, Okonta MJ. Awareness, Attitude, and Practice of Pharmacovigilance among Health Care Professionals in Nigeria: Survey in a Teaching Hospital. International Journal of Hospital Research, 2013; 2(3): 98-107. 43. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Pharmacology and Toxicology, 2009; 9(1): 14. 44. Ojemene V. NAFDAC DG laments under reporting of adverse drug reactions. (April 24, 2012). http://www.vanguardngr.com/2012/04/nafdacdg-laments-under-reporting-of-adverse-drugreactions/ Accessed on 23/11/2015
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7399-01-FH02-FP-16-06001.pdf
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Najib
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oai_dc
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https://intelek.unisza.edu.my/intelek/pages/view.php?ref=13089
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13089 https://intelek.unisza.edu.my/intelek/pages/view.php?ref=13089 https://intelek.unisza.edu.my/intelek/pages/search.php?search=!collection407072 Restricted Document Article Journal application/pdf Adobe Acrobat Pro DC 20 Paper Capture Plug-in with ClearScan 6 1.6 Najib 2024-08-27 16:31:46 7399-01-FH02-FP-16-06001.pdf UniSZA Private Access Pharmacovigilance Program: Malaysia Versus Nigeria, An Update International Journal of Pharmaceutical Research Spontaneous reporting and intensive monitoring are the conventional systems used for detecting, recording and reporting adverse drug reactions. Using spontaneous reporting a lot of successes was made as existing adverse drug reactions were identified and new ones were prevented. In general, regulatory authorities consider only the information and outcome of the premarketing clinical trial in controlled settings to approve and register a drug for human use. As such, not much is known about the drug beyond the data obtained from clinical trials in controlled settings. The outcome of pre-marketing studies for safety, efficacy, and quality of new medicines will not represent the whole population of patients that will use the drugs when they are approved. Henceforth, suitable and constant post-marketing surveillance (PMS) is indispensable. The two types of post-marketing studies are descriptive and analytical. Descriptive study is carried out to generate adverse drug reaction signals (hypotheses) while the analytical study is done to test hypotheses and determine associations or causal relations between observed effects and particular drugs. Examples of descriptive studies are spontaneous reporting and intensive monitoring while analytical studies include case-control studies, cohort studies, and post-marketing clinical trials. The aim of this review is to highlight the menace of adverse drug reactions, challenges of the spontaneous reporting system and, more importantly, the information available from Malaysia and Nigeria. 8 1 Association of Indian Pharmacist Association of Indian Pharmacist 8-12 1. World Health Organization (WHO). Safety of Medicines: a guide to detecting and reporting adverse drug reactions. Geneva: World Health Organization. 2002. Available from URL: http://apps.who.int/iris/bitstream/10665/67378 /1/WHO_EDM_QSM_2002.2.pdf (Accessed on 7/4/2015). 2. World Health Organization (WHO). Requirements for adverse reaction reporting. World Health Organization: Geneva, Switzerland. 1975. Available from URL: http://apps.who.int/iris/bitstream/10665/40514 /1/9241560428_eng.pdf Accessed on 7/4/2015 3. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 1998; 279(15): 1200-1205. 4. Agarwal R, Daher AM, Ismail NM. Knowledge, Practices and Attitudes towards Adverse Drug Reaction Reporting by Private Practitioners from Klang Valley in Malaysia. Malays J Med Sci, 2013; 20 (2): 52-61. 5. Showande JS, Oyelola FT. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university. Internet Journal of Medical Update-EJOURNAL, 2013, 8: 24-30. 6. Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA. Pharmacy students’ knowledge and perceptions about pharmacovigilance in Malaysian public universities. Am J Pharm Educ, 2011; 75(5): 96. 7. Adedeji WA, Ibrahem WA, Fehintola FA. Attitude and Practice of Doctors toward Adverse Drug Reactions (ADRs) Reporting In a Nigerian Tertiary Health Facility. Ann Ibd Pg Med, 2013; 1(2): 77-80. 8. Awodele O, Akinyede A, Adeyemi OA, Awodele DF. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. The International Journal of Risk & Safety in Medicine. 2010; 23(4): 217-226. 9. Iffat W, Shakeel S, Rahim N, Anjum F, Neesar S, Ghayas S. Pakistani physicians’ knowledge and attitude towards reporting adverse drug reactions. African Journal of Pharmacy and Pharmacology, 2014; 8(14):379-385. 10. Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharmacy Practice, 2011; 9(4):228-235. 11. Uppsala Monitoring Centre (UMC). Report from the World Health Organisation collaborating centre for international drug monitoring. Activities July 2012 – June 2013. 2013. Available from URL: http://www.who-umc.org/graphics/27871.pdf Accessed on 13/5/2015 12. Hanafi S, Torkamandi H, Hayatshahi A, Kheirollah G, Javadi M: Knowledge, attitudes and practice of nurses regarding adverse drug reaction reporting. IJNMR, 2012, 17(1):1–7. 13. Uppsala Monitoring Centre (UMC). Uppsala Reports. 2012. Available from URL: http://www.who-umc.org/graphics/26656.pdf Accessed on 12/10/2015 14. Lindquist M. VigiBase, the WHO Global ICSR Database System: Basic Facts. Drug Information Journal, 2008; 42: 409–419. 15. Uppsala Monitoring Centre (UMC). Being a member of the WHO Programme for International Drug Monitoring. Available from URL: http://whoumc.org/graphics/25642.pdf Accessed on 12/10/2015 16. DrugControlAuthority(DCA)News.(2001).Availablef romURL:http://portal.bpfk.gov.my/images/PDF/ DCA%20News/DCA%20News%202001.pdf Accessed on 25/11/2015. 17. WHOPharmaceuticalsNewsletterNo.1,2003,1- 10.AvailablefromURL: http://www.who.int/medicines/publications/news letter/en/news2003_1.pdf Accessed on 27/11/2015 18. MADRACNews.BeritaUbatubatan19:3.2002.AvailablefromURL: http://portal.bpfk.gov.my/images/Publications/N ewsletter_Berita_Ubatubatan/2002/BUU2002Apr.pdf Accesssed on 26/11/2015 19. Sivadasan S, Yuong NY, Chyi NW, Ching ALS, Ali AN, Veerasamy R, Marimuthub K, Arumugama DS. Knowledge and Perception towards Pharmacovigilance and Adverse Drug Reaction Reporting among Medicine and Pharmacy Students. WJPPS, 2014; 3(3): 1652-1676. 20. Isa NM, Borhanuddin B, Shuid AN, Fozi NFM. Attitudes, Perception and Knowledge of General Practitioners towards Adverse Drug Reaction (ADR) Reporting In Malaysia – A Pilot Study. Research Updates in Medical Sciences, 2013; 1(1): 21-26. 21. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of underreporting in Malaysia. Pharmacoepidemiol Drug Saf, 2007; 16 (2): 223-228. 22. Agu KA, Oparah AC. Adverse drug reactions to antiretroviral therapy: Results from spontaneous reporting system in Nigeria. Perspectives in Clinical Research, 2013; 4(2): 117-124. 23. Iwokwagh N.S. Assessment of New Media Use in the Fight against Counterfeit Medicines in Nigeria. International Conference on Communication, Media, Technology and Design. Famagusta – North Cyprus. (02-04 May, 2013). Available from URL: http://www.cmdconf.net/2013/makale/PDF/5.p df Accesssed on 23/4/2015 24. National agency for food and drug administration and control (NAFDAC). ‘NAFDAC ACT/LAWS’. 2012. Available from URL:http://www.nafdac.gov.ng/images/PUBLICA TIONS/NAFDAC_ACT/Nafdac_Act_Real_Copy.p df. Accessed on 12/3/2015 25. Oshikoya KA, Senbanjo IO. Providing safe medicines for children in Nigeria: The impediments and remedies. Annals of African medicine, 2010. 9(4): 203-212. 26. Fadare JO, Enwere OO, Afolabi AO, Chedi BAZ, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Tropical Journal of Pharmaceutical Research, 2011; 10(3): 235-242. 27. Okezie EO, Olufunmilayo F. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiol Drug Saf, 2008; 17(5): 517-522. 28. Oshikoya KA, Chukwura H, Njokanma OF, Senbanjo IO, Ojo I. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria. Sao Paulo Med J, 2011; 129(3): 153-164. 29. Ahmed AM, Izham IM, Subish P. The Importance of the Consumer Pharmacovigilance System in Developing Countries: A Case of Malaysia. JCDR, 2010; 4: 2929-2935. 30. Lei HS, AB Rahman AF, Haq AHSM. Adverse Drug Reaction Reports in Malaysia: Comparison of Causality Assessments. Malaysian Journal of Pharmaceutical Sciences. 2007; 5(1): 7–17. 31. Isa NM. Pharmacovigilance and reporting adverse drug reactions. Medicine & Health. 2014; 9 (2): 92- 102. 32. MADRAC News. Berita-Ubatubatan. 2003; 21(2):1- 3.Available from URL: http://portal.bpfk.gov.my/images/Publications/N ewsletter_Berita_Ubatubatan/2003/BUU2003Aug.pdf Accesssed on 26/11/2015 33. MADRACBulletin.2009.AvailablefromURL:http://po rtal.bpfk.gov.my/images/Publications/Newsletter _MADRAC_Bulletin/May-2009.pdf Accesssed on 26/11/2015 34. Uppsala Monitoring Centre (UMC). National pharmacovigilance guidelines. 2010. 35. AvailablefromURL:http://www.whoumc.org/DynPage.aspx?id=127878&mn1=734 7&mn2=7252&mn3=7253&mn4=7745 Accessed on 13/5/2015 36. MADRACBulletin.2015.AvailablefromURL:http://po rtal.bpfk.gov.my/images/Publications/Newsletter _MADRAC_Bulletin/Bulletin_MADRAC_April_201 5.pdf Accessed on 25/11/2015 37. Uppsala Monitoring Centre. Reporting Trends: Reporting to the WHO database. 2015. Available from URL: http://www.whoumc.org/DynPage.aspx?id=108476&mn1=734 7&mn2=7252&mn3=7322&mn4=7558 (Accessed on 27/11/2015). 38. MADRAC Bulletin. 2014. http://portal.bpfk.gov.my/index.cfm?&menuid= 149&parentid=17 Accessed on 12/11/2015. 39. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology & Therapeutics, 1981; 30 (2): 239-245. 40. Rosamund MA, Foluke GF. Spontaneous reporting of paediatric adverse drug reactions in a Nigerian tertiary health centre–any relationship to severity? Int J Pharm Sci Invent. 2013; 2(1): 5-11. 41. Ogundele SO, Dawodu CO, Ogunyele OO. Adverse Drug Reaction Monitoring among Health care Workers at Tertiary Hospital. A Comparative Cross-sectional Survey of Health Care Professionals. Global Research Journal of Medical Sciences, 2012; 2(2): 032-037. 42. Okechukwu RC, Odinduka SO, Ele GN, Okonta MJ. Awareness, Attitude, and Practice of Pharmacovigilance among Health Care Professionals in Nigeria: Survey in a Teaching Hospital. International Journal of Hospital Research, 2013; 2(3): 98-107. 43. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Pharmacology and Toxicology, 2009; 9(1): 14. 44. Ojemene V. NAFDAC DG laments under reporting of adverse drug reactions. (April 24, 2012). http://www.vanguardngr.com/2012/04/nafdacdg-laments-under-reporting-of-adverse-drugreactions/ Accessed on 23/11/2015
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| spellingShingle |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
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| summary |
Spontaneous reporting and intensive monitoring are the conventional systems used for detecting, recording and reporting adverse drug reactions. Using spontaneous reporting a lot of successes was made as existing adverse drug reactions were identified and new ones were prevented. In general, regulatory authorities consider only the information and outcome of the premarketing clinical trial in controlled settings to approve and register a drug for human use. As such, not much is known about the drug beyond the data obtained from clinical trials in controlled settings. The outcome of pre-marketing studies for safety, efficacy, and quality of new medicines will not represent the whole population of patients that will use the drugs when they are approved. Henceforth, suitable and constant post-marketing surveillance (PMS) is indispensable. The two types of post-marketing studies are descriptive and analytical. Descriptive study is carried out to generate adverse drug reaction signals (hypotheses) while the analytical study is done to test hypotheses and determine associations or causal relations between observed effects and particular drugs. Examples of descriptive studies are spontaneous reporting and intensive monitoring while analytical studies include case-control studies, cohort studies, and post-marketing clinical trials. The aim of this review is to highlight the menace of adverse drug reactions, challenges of the spontaneous reporting system and, more importantly, the information available from Malaysia and Nigeria.
|
| title |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
|
| title_full |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
|
| title_fullStr |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
|
| title_full_unstemmed |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
|
| title_short |
Pharmacovigilance Program: Malaysia Versus Nigeria, An Update
|
| title_sort |
pharmacovigilance program: malaysia versus nigeria, an update
|