| _version_ |
1860797121848934400
|
| building |
INTELEK Repository
|
| collection |
Online Access
|
| collectionurl |
https://intelek.unisza.edu.my/intelek/pages/search.php?search=!collection407072
|
| date |
2016-02-22 15:09:13
|
| format |
Restricted Document
|
| id |
11453
|
| institution |
UniSZA
|
| internalnotes |
1. World Health Organization. Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines: Geneva. 2004. 2. Aggarwal R, Dwivedi S, Aggarwal M. Unfamiliar manifestations of anti-tubercular therapy. J Fam Med Primary Care 2014; 3: 72-3. 3. Kaswala DH. Drug rash with eosinophilia and systemic symptoms syndrome due to anti-TB medication. J Fam Med Primary Care 2013; 2:83-5. 4. Solanki JD, Makwana AH, Mehta HB et al. A study of prevalence and association of risk factors for diabetic vasculopathy in an urban area of Gujarat. J Fam Med Primary Care 2013; 2: 360-4. 5. Inman WHW. Post-marketing surveillance of adverse drug reactions in general practice I: Search for new methods. Br Med J (Clin Res Ed) 1981; 282: 1131–32. 6. Mohamed IN, Borhanuddin B, Shuid AN et al. Attitudes, perception and knowledge of general practitioners towards adverse drug reaction (ADR). Reporting in Malaysia – A pilot study. RUMeS 2013; 1:21-6. 7. Worst pills, best pills: a consumer's guide to avoiding drug-induced death or illness, 2005. 8. Ray WA, Griffin MR, Shorr RI. Adverse drug reactions and the elderly. Health Aff (Millwood) 1990; 9: 114-22. 9. Ray WA, Fought RL, Decker MD. Psychoactive drugs and the risk of injurious motor vehicle crashes in elderly drivers. Am J Epidemiol 1992; 136: 873- 83. 10. Mustansir MA, Likhan MMI, Rahim ZB et al. Past, present and future prespectives of pharmacovigilance in Bangladesh: safety issues for patient care. MJSR 2013; 2: 49-58. 11. Corrigan OP. A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises. Soc Sci Med 2002; 55: 497- 507. 12. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. UK. 2002. 13. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255–59. 14. Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol Drug Saf 1996; 5: 363-75. 15. Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang & Dale’s Pharmacology. 7thEd. Spain, Elsevier Churchill Livingstone; 2012. 16. Pharma & Healthcare. Forbes. The Cost of Creating a New Drug Now $5 Billion, Pushing Big Pharma to Change; 2013. 17. Brewer T, Colditz GA. Post-marketing surveillance and adverse drug reactions, current perspectives and future needs. JAMA 1999; 281: 824-29. 18. Stephens MDB. Has the patient suffered an ADR? - Assessment of drug causality. In: Drug Safety. A Shared Responsibility. Glaxo Group Research. International Drug Surveillance Department (IDSD) 1st Ed. Edinburgh, Churchill Livingstone; 1991. pp 47-56. 19. Fine LTA. Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER 2013. 20. Berlin JA, Glasser SC, Ellenberg SS. Adverse Event Detection in Drug Development: Recommendations and Obligations beyond Phase 3. Am J Public Health 2008; 98: 1366-71. 21. Inbaraj SD, MunIappan M, MuthIah NS et al. Pharmacovigilance of the cutaneous drug reactions in outpatients of dermatology department at a tertiary care hospital. J Clin Diagn Res 2012; 6: 1688-1691. 22. Mishra S, Swain TR, Mohanty M. Adverse drug reaction monitoring of antidepressants in the psychiatry outpatients department of a tertiary care teaching hospital. J Clin Diagn Res 2013; 7: 1131- 1134. 23. Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341-44. 24. MHRA. Department of Health. UK. 2010. Reporting suspected adverse drug reactions [online]. 25. FDA. Department of Health and Human Services. USA. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 2009. 26. The Uppsala Monitoring Centre (The UMC). WHO Collaborating Centre for International Drug Monitoring Safety Monitoring of Medicinal Products. Guidelines for Setting up and Running a Pharmacovigilance Centre, Uppsala: WHO-UMC. 2000. 27. Layton D, Heeley E, Hughes K et al. Comparison of the incidence rates of thromboembolic events reported for patients prescribed rofecoxib and meloxicam in general practice in England using prescription-event monitoring (PEM) data. Rheumatology (Oxford) 2003; 42: 1342-53. 28. Mann RD. Prescription-event monitoring-recent progress and future horizons. Br J Clin Pharmacol 1998; 46: 195-201. 29. Dunn NR, Thyrogood M, deCoestecker L, et al. Myocardial infarction and oral contraceptives, a retrospective case control study in England and Scotland (‘MICA’ study). Pharmacoepidemiol Drug Saf 1997; 6: 283-89. 30. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 567-69. 31. Miller E, Waight P, Farrington CP, et al. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child 2001; 84: 227-29. 32. Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. Qual Saf Health Care 2005; 14: 221–26. 33. Raschke RA, Gollihare B, Wunderlich WA. A computer alert system to prevent injury from adverse drug events, development and evaluation in a community teaching hospital. JAMA 1998; 280: 1317-20. 34. Mackay FJ, Dunn NR, Wilton LV, et al. A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies. Pharmacoepidemiol Drug Saf 1997; 6: 235- 46. 35. Bangladesh Association of Pharmaceutical Industries report. 2011. 36. Securing Industry. Available from: http://www.securingindustry.com/pharmaceuticals/ar rest-warrants-issued-after-deg-kills-26-infants-inbangladesh/s40/a206/. 37. Hanif M, Mobarak MR, Ronan A, et al. Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ 1995; 311: 88- 91. 38. Kar SS, Pradhan HS, Mohanta GP. Concept of Essential Medicines and Rational Use in Public Health. Indian J Community Med 2010; 35: 10–13. 39. Mustansir MA, Saha D, Paul S et al. Studies on Pharmacovigilance in Bangladesh: Safety Issues. IJPTP 2013; 4: 613-21. 40. Donabedian A. Evaluating quality of medical care. Milbank Q 1966; 44:166–203. 41. WHO. Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool. 2006. 42. Helali AM, McLay J, Mohamed IN. Prescribing trends of statins in Scotland: A Drug Utilization Study. Bangladesh J Pharmacol 2013; 8: 401-09. 43. Weir VL. Best-practice protocols: preventing adverse drug events. Nurs Manage 2005; 36: 24–30. 44. Salam A, Yousuf R, Islam MZ et al. Professionalism of future medical professionals in Universiti Sultan Zainal Abidin, Malaysia. Bangladesh J Pharmacol 2013a; 8: 124-30. 45. Salam A, Islam MZ, Helali AM et al. Comparative Study of Professionalism of Future Medical Professionals among Three Private Medical Colleges of Bangladesh. Asian J Pharm Clin Res 2013b; 6: 170-9. 46. Salam A, Haque M, Helali AM et al. Comparative Study of Professionalism of Forthcoming Medical Doctors between Two Private Medical Colleges in Savar, Bangladesh. Int J Pharm Pharm Sci 2013c; 5: 659-65. 47. Islam MZ, Salam A, Helali AM et al. Comparative study of Professionalism of future Medical Doctors between Malaysia and Bangladesh. J App Pharm Sci 2014; 4: 66-71. 48. Salam A, Haque M, Islam MZ et al. Addressing Rational Prescribers through the Pharmacology and Therapeutics Course Work of MBBS Syllabus in Bangladesh. Int Res J Pharm 2013; 4: 60-63. 49. Islam MZ, Rahman MF, Mossaddek ASM et al. Bangladeshi Interns’ Knowledge of Pharmacology and Therapeutics for Prescribing. J App Pharm Sci 2014; 4: 43-51. 50. Helali AM. Pharmacogenetics and Polymorphism: Future Tools for Optimizing Therapeutics Efficacy. BJPP 2010; 26(1&2): 34-42. 51. Sehgal V, Bajwa SS, Sehgal R et al. Polypharmacy and potentially inappropriate medication use as the precipitating factor in readmissions to the hospital. J Fam Med Primary Care 2013; 2: 194-9. 52. Kumar R. Helicopter Dropping of 50 Free Allopathic Medicines; Prescribed by Homoeopathic Doctors at Ground: Sorry this is not Universal Health Coverage. J Fam Med Primary Care 2014; 3: 91-3.
|
| originalfilename |
5697-01-FH02-FP-16-05373.jpg
|
| person |
norman
|
| recordtype |
oai_dc
|
| resourceurl |
https://intelek.unisza.edu.my/intelek/pages/view.php?ref=11453
|
| spelling |
11453 https://intelek.unisza.edu.my/intelek/pages/view.php?ref=11453 https://intelek.unisza.edu.my/intelek/pages/search.php?search=!collection407072 Restricted Document Article Journal image/jpeg inches 758 96 96 norman 88 88 1425 2016-02-22 15:09:13 1425x758 5697-01-FH02-FP-16-05373.jpg UniSZA Private Access The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh International Journal of Pharmaceutical Research Adverse drug reactions are a major public health issue and safety of drugs is a major concern particularly among children, pregnant women, and the elderly. Every society has the right to be protected against such odds. There are multiple methods for detecting the adverse drug reactions at different stages of drug development and also in the market life of a new drug. Single system alone is not sufficient to cover all the demands. Therefore multiple methods are needed for observing and quantifying the adverse drug reactions. Monitoring of adverse drug reactions by applying well developed IT enabled system in primary and secondary health care also can be an effective measure. Adverse drug reactions should be taken into account more seriously and critically as often they are life threatening and a burden to the patient. Thus, more effort should be put in making methods available for detection of adverse drug reactions specially in post-marketing stage of a drug and only then it will be possible to ameliorate the risk-benefit ratio of a treatment. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Bangladesh. A number of clinical trials and studies are currently ongoing in Bangladesh which necessities an immense needs to understand and implement pharmacovigilance. In Bangladesh, the mindset of people working in regulatory agency and the Bangladesh Pharmaceutical companies needs to change regarding pharmacovigilance. 6 4 31-37 1. World Health Organization. Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines: Geneva. 2004. 2. Aggarwal R, Dwivedi S, Aggarwal M. Unfamiliar manifestations of anti-tubercular therapy. J Fam Med Primary Care 2014; 3: 72-3. 3. Kaswala DH. Drug rash with eosinophilia and systemic symptoms syndrome due to anti-TB medication. J Fam Med Primary Care 2013; 2:83-5. 4. Solanki JD, Makwana AH, Mehta HB et al. A study of prevalence and association of risk factors for diabetic vasculopathy in an urban area of Gujarat. J Fam Med Primary Care 2013; 2: 360-4. 5. Inman WHW. Post-marketing surveillance of adverse drug reactions in general practice I: Search for new methods. Br Med J (Clin Res Ed) 1981; 282: 1131–32. 6. Mohamed IN, Borhanuddin B, Shuid AN et al. Attitudes, perception and knowledge of general practitioners towards adverse drug reaction (ADR). Reporting in Malaysia – A pilot study. RUMeS 2013; 1:21-6. 7. Worst pills, best pills: a consumer's guide to avoiding drug-induced death or illness, 2005. 8. Ray WA, Griffin MR, Shorr RI. Adverse drug reactions and the elderly. Health Aff (Millwood) 1990; 9: 114-22. 9. Ray WA, Fought RL, Decker MD. Psychoactive drugs and the risk of injurious motor vehicle crashes in elderly drivers. Am J Epidemiol 1992; 136: 873- 83. 10. Mustansir MA, Likhan MMI, Rahim ZB et al. Past, present and future prespectives of pharmacovigilance in Bangladesh: safety issues for patient care. MJSR 2013; 2: 49-58. 11. Corrigan OP. A risky business: the detection of adverse drug reactions in clinical trials and post-marketing exercises. Soc Sci Med 2002; 55: 497- 507. 12. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. UK. 2002. 13. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255–59. 14. Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol Drug Saf 1996; 5: 363-75. 15. Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang & Dale’s Pharmacology. 7thEd. Spain, Elsevier Churchill Livingstone; 2012. 16. Pharma & Healthcare. Forbes. The Cost of Creating a New Drug Now $5 Billion, Pushing Big Pharma to Change; 2013. 17. Brewer T, Colditz GA. Post-marketing surveillance and adverse drug reactions, current perspectives and future needs. JAMA 1999; 281: 824-29. 18. Stephens MDB. Has the patient suffered an ADR? - Assessment of drug causality. In: Drug Safety. A Shared Responsibility. Glaxo Group Research. International Drug Surveillance Department (IDSD) 1st Ed. Edinburgh, Churchill Livingstone; 1991. pp 47-56. 19. Fine LTA. Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER 2013. 20. Berlin JA, Glasser SC, Ellenberg SS. Adverse Event Detection in Drug Development: Recommendations and Obligations beyond Phase 3. Am J Public Health 2008; 98: 1366-71. 21. Inbaraj SD, MunIappan M, MuthIah NS et al. Pharmacovigilance of the cutaneous drug reactions in outpatients of dermatology department at a tertiary care hospital. J Clin Diagn Res 2012; 6: 1688-1691. 22. Mishra S, Swain TR, Mohanty M. Adverse drug reaction monitoring of antidepressants in the psychiatry outpatients department of a tertiary care teaching hospital. J Clin Diagn Res 2013; 7: 1131- 1134. 23. Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84: 341-44. 24. MHRA. Department of Health. UK. 2010. Reporting suspected adverse drug reactions [online]. 25. FDA. Department of Health and Human Services. USA. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 2009. 26. The Uppsala Monitoring Centre (The UMC). WHO Collaborating Centre for International Drug Monitoring Safety Monitoring of Medicinal Products. Guidelines for Setting up and Running a Pharmacovigilance Centre, Uppsala: WHO-UMC. 2000. 27. Layton D, Heeley E, Hughes K et al. Comparison of the incidence rates of thromboembolic events reported for patients prescribed rofecoxib and meloxicam in general practice in England using prescription-event monitoring (PEM) data. Rheumatology (Oxford) 2003; 42: 1342-53. 28. Mann RD. Prescription-event monitoring-recent progress and future horizons. Br J Clin Pharmacol 1998; 46: 195-201. 29. Dunn NR, Thyrogood M, deCoestecker L, et al. Myocardial infarction and oral contraceptives, a retrospective case control study in England and Scotland (‘MICA’ study). Pharmacoepidemiol Drug Saf 1997; 6: 283-89. 30. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 567-69. 31. Miller E, Waight P, Farrington CP, et al. Idiopathic thrombocytopenic purpura and MMR vaccine. Arch Dis Child 2001; 84: 227-29. 32. Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. Qual Saf Health Care 2005; 14: 221–26. 33. Raschke RA, Gollihare B, Wunderlich WA. A computer alert system to prevent injury from adverse drug events, development and evaluation in a community teaching hospital. JAMA 1998; 280: 1317-20. 34. Mackay FJ, Dunn NR, Wilton LV, et al. A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies. Pharmacoepidemiol Drug Saf 1997; 6: 235- 46. 35. Bangladesh Association of Pharmaceutical Industries report. 2011. 36. Securing Industry. Available from: http://www.securingindustry.com/pharmaceuticals/ar rest-warrants-issued-after-deg-kills-26-infants-inbangladesh/s40/a206/. 37. Hanif M, Mobarak MR, Ronan A, et al. Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ 1995; 311: 88- 91. 38. Kar SS, Pradhan HS, Mohanta GP. Concept of Essential Medicines and Rational Use in Public Health. Indian J Community Med 2010; 35: 10–13. 39. Mustansir MA, Saha D, Paul S et al. Studies on Pharmacovigilance in Bangladesh: Safety Issues. IJPTP 2013; 4: 613-21. 40. Donabedian A. Evaluating quality of medical care. Milbank Q 1966; 44:166–203. 41. WHO. Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool. 2006. 42. Helali AM, McLay J, Mohamed IN. Prescribing trends of statins in Scotland: A Drug Utilization Study. Bangladesh J Pharmacol 2013; 8: 401-09. 43. Weir VL. Best-practice protocols: preventing adverse drug events. Nurs Manage 2005; 36: 24–30. 44. Salam A, Yousuf R, Islam MZ et al. Professionalism of future medical professionals in Universiti Sultan Zainal Abidin, Malaysia. Bangladesh J Pharmacol 2013a; 8: 124-30. 45. Salam A, Islam MZ, Helali AM et al. Comparative Study of Professionalism of Future Medical Professionals among Three Private Medical Colleges of Bangladesh. Asian J Pharm Clin Res 2013b; 6: 170-9. 46. Salam A, Haque M, Helali AM et al. Comparative Study of Professionalism of Forthcoming Medical Doctors between Two Private Medical Colleges in Savar, Bangladesh. Int J Pharm Pharm Sci 2013c; 5: 659-65. 47. Islam MZ, Salam A, Helali AM et al. Comparative study of Professionalism of future Medical Doctors between Malaysia and Bangladesh. J App Pharm Sci 2014; 4: 66-71. 48. Salam A, Haque M, Islam MZ et al. Addressing Rational Prescribers through the Pharmacology and Therapeutics Course Work of MBBS Syllabus in Bangladesh. Int Res J Pharm 2013; 4: 60-63. 49. Islam MZ, Rahman MF, Mossaddek ASM et al. Bangladeshi Interns’ Knowledge of Pharmacology and Therapeutics for Prescribing. J App Pharm Sci 2014; 4: 43-51. 50. Helali AM. Pharmacogenetics and Polymorphism: Future Tools for Optimizing Therapeutics Efficacy. BJPP 2010; 26(1&2): 34-42. 51. Sehgal V, Bajwa SS, Sehgal R et al. Polypharmacy and potentially inappropriate medication use as the precipitating factor in readmissions to the hospital. J Fam Med Primary Care 2013; 2: 194-9. 52. Kumar R. Helicopter Dropping of 50 Free Allopathic Medicines; Prescribed by Homoeopathic Doctors at Ground: Sorry this is not Universal Health Coverage. J Fam Med Primary Care 2014; 3: 91-3.
|
| spellingShingle |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| summary |
Adverse drug reactions are a major public health issue and safety of drugs is a major concern particularly among children, pregnant women, and the elderly. Every society has the right to be protected against such odds. There are multiple methods for detecting the adverse drug reactions at different stages of drug development and also in the market life of a new drug. Single system alone is not sufficient to cover all the demands. Therefore multiple methods are needed for observing and quantifying the adverse drug reactions. Monitoring of adverse drug reactions by applying well developed IT enabled system in primary and secondary health care also can be an effective measure. Adverse drug reactions should be taken into account more seriously and critically as often they are life threatening and a burden to the patient. Thus, more effort should be put in making methods available for detection of adverse drug reactions specially in post-marketing stage of a drug and only then it will be possible to ameliorate the risk-benefit ratio of a treatment. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Bangladesh. A number of clinical trials and studies are currently ongoing in Bangladesh which necessities an immense needs to understand and implement pharmacovigilance. In Bangladesh, the mindset of people working in regulatory agency and the Bangladesh Pharmaceutical companies needs to change regarding pharmacovigilance.
|
| title |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| title_full |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| title_fullStr |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| title_full_unstemmed |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| title_short |
The evolving role of pharmacovigilance and drug safety: The way forward for Bangladesh
|
| title_sort |
evolving role of pharmacovigilance and drug safety: the way forward for bangladesh
|