การรายงานเหตุการณ์ไม่พึงประสงค์จากยาสมุนไพร: การทบทวนวรรณกรรมอย่างเป็นระบบ
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มิ.ย. 11, 2019
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ยาสมุนไพร ระบบรายงาน เหตุการณ์ไม่พึงประสงค์ การทบทวนวรรณกรรมอย่างเป็นระบบ
Main Article Content
บทคัดย่อ
วัตถุประสงค์: เพื่อวิเคราะห์สถานการณ์ปัจจุบันของระบบการรายงานความปลอดภัยจากการใช้ยาสมุนไพรที่สืบค้นได้จากงานวิจัยในอดีต วิธีการ: ผู้วิจัยสืบค้นงานวิจัยที่เกี่ยวกับระบบการรายงานความปลอดภัยจากการใช้สมุนไพร ตั้งแต่วันเริ่มต้นของฐานข้อมูลอิเล็กทรอนิกส์ ได้แก่ PubMed, Embase, Scopus, CINAHL, ThaiLIS และการสืบค้นด้วยมือเพื่อหางานวิจัยที่ไม่ได้ถูกตีพิมพ์ คัดเลือกและคัดย่อบทความโดยผู้วิจัย 2 คนที่เป็นอิสระต่อกัน หากผลการประเมินงานวิจัยไม่สอดคล้องกันจะหาผู้ประเมินคนที่ 3 และตัดสินผลการประเมินโดยใช้ฉันทามติ ผลการวิจัย: การสืบค้นพบงานวิจัยที่สอดคล้องกับเกณฑ์ในการคัดเลือกวรรณกรรม 26 ฉบับ ทุกฉบับได้รับการประเมินคุณภาพงานวิจัยตามเกณฑ์ Crombie’s items งานวิจัยที่พบเป็นการรายงานตามความสมัครใจ (spontaneous reporting system หรือ SRS) 19 ฉบับ, intensive monitoring programme (IMP) หรือ cohort event monitoring (CEM) 2 ฉบับ เป็นการรายงานด้วยระบบ SRS ร่วมกับ IMP 3 ฉบับ และระบบ electronic health record (EHR) ร่วมกับ CEM 2 ฉบับ ระบบ SRS มีข้อจำกัด คือ ชื่อของสมุนไพรมีความหลากหลาย ปัญหาคุณภาพของผลิตภัณฑ์สมุนไพรหรือการมีองค์ประกอบหลายชนิดในผลิตภัณฑ์สมุนไพร ทำให้ยากต่อการประเมินการเกิดเหตุการณ์ไม่พึงประสงค์ (adverse events: AE) และปัญหาในด้านความสมบูรณ์ของรายงาน รวมทั้งการรายงานที่ต่ำกว่าความเป็นจริง ระบบ IMP/CEM หรือระบบ IMP ร่วมกับ SRS หรือระบบ CEM ร่วมกับ EHR มีข้อจำกัดในด้านเวลาของการประเมินความปลอดภัยที่สั้น อาจทำให้ไม่สามารถค้นพบ AE ที่เกิดยากและพบน้อย การมีองค์ประกอบหลายชนิดในผลิตภัณฑ์สมุนไพรทำให้ยากต่อการประเมินการเกิด AE สรุป: สถานการณ์ปัจจุบันของระบบการรายงาน AE จากยาสมุนไพรยังอาศัยระบบ SRS เป็นส่วนใหญ่ ระบบรายงานอื่นที่สามารถใช้ในการเฝ้าระวังความปลอดภัยจากยาสมุนไพรได้ คือ ระบบ CEM/IMP และ EHR การกำหนดให้การรายงานในลักษณะจูงใจด้วยผลตอบแทน ตลอดจนการพัฒนากลไกการมีส่วนร่วมของประชาชน อาจช่วยลดปัญหาการรายงานที่ต่ำกว่าความเป็นจริงได้
Article Details
บท
บทความวิจัย
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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12. Xu HM, Wang Y, Liu NF. Safety of an injection with a mixture of extraxts from Herba Artemisiae, Fructus Gardeniae and Flos Lonicerae. Pharm World Sci 2009; 31:458-63.
13. Jacobsson I, Jonsson AK, Gerden B, Hagg S. Spontaneously reported adverse reactions in associa- tion with complementary and alternative medicine substances in Sweden. Pharmacoepidemiol Drug Saf 2009; 11:1039-47.
14. Petronijevic M, Ilic K, Suzuki A. Drug induced hepatotoxicity: data from the Serbian pharmacovigi- lance database. Pharmacoepidemiol Drug Saf 2011; 4: 416-23.
15. Lores D, Lazo Y. Characterization of suspected adverse reactions to herbal medicines reported to the Provincial Coordinating Unit of pharmacovigilance Santiago de Cuba. Revista Mexicana de Ciencias Farmacéuticas 2011; 42:37-44.
16. Saokaew S, Suwankesawong W, Permsuwan U, Chaiyakunapruk N. Safety of herbal products in Thailand an analysis of reports in the Thai Health Product Vigilance Center database from 2000 to 2008. Drug Saf 2011; 34:339-50.
17. Salvador KR, Milian JG, Lopez GJ, Orta IA, Hernandez BP, Lee AC. Pharmacovigilance of phytomedicines and apimedicines in Cuba, 2006-2010. Revista Cubana de Plantas Medicinales 2013; 2:173-86
18. Shin HK, Jeong SJ, Lee MS, Ernst E. Adverse events attributed to traditional Korean medical practices: 1999–2010. Bull World Health Organ 2013; 91:569-75.
19. Hunsel FV, Groothest V. Adverse reactions to herbal remedies: Analysis of reported adverse reactions in the Netherlands. Ned Tijdschr Geneeskd 2013; 157: A6615.
20. Skalli S, Chebat A, Badrane N, Bencheikh RS. Side effects of cade oil in Morocco: An analysis of reports in the Moroccan herbal products database from 2004 to 2012. Food Chem Toxicol 2014; 64:81-5.
21. Wechwithan S, Suwankesawong W, Sornsrivichai V, McNeil EB, Jiraphongsa C, Chongsuvivatwong V. Signal detection for Thai traditional medicine: Examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk. Regul Toxicol Pharmacol 2014; 70:407-12.
22. Suwankesawong W, Saokaew S, Permsuwam U, Chaiyakunapruk N. Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database. BMC Complement Altern Med 2014; 14:1-7.
23. Li haona, Deng J, Yue Z, Zhang Y, Sun H. Detecting drug–herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection. Eur J Clin Pharmacol 2015; 71:1139–45.
24. Li XL, Tang JF, Li WX, Li CX, Zhao T, Zhao BC et al. Postmarketing safety surveillance and reevaluation of Danhong injection: clinical study of 30888 cases. Evid Based Complement Alternat Med 2015; 2015:1-9
25. Kalaiselvan V, Saurabh A, Kumar R, Singh GN. Adverse reactions to herbal products: An analysis of spontaneous reports in the database of the Pharmaco vigilance Programme of India. J Herb Med 2015; 5:48-54.
26. Hoban CL, Byard RW, Musgrave IF. A comparison of patterns of spontaneous adverse drug reaction reporting with St. John’s Wort and fluoxetine during the period 2000–2013. Clin Exp Pharmacol Physiol Suppl 2015; 42:747-51.
27. Salvador KR, Milian JG, Carbonell LA, Lopez GJ, Orta IA, Lee AC. Vigilance of adverse reactions of herbal medicines in Cuba for the period 2003-2010. Revista Cubana de Plantas Medicinales 2015; 1:14-24.
28. Lude S, Vecchio S, Sinno-Tellier S, Dopter A, Mustonen H, Vucinic S, et al. Adverse effects of plant food supplements and plants consumed as food: Results from the poisons centres-based PlantLIBRA study. Phytother Res 2016; 30:988-96.
29. Kim M, Han C. Adverse drug reactions in Korean herbal medicine: A prospective cohort study. Eur J Integr Med 2017; 9:103-9.
30. Svedlund E, Larsson M, Hagerkvist R. Sponta neously reported adverse reactions for herbal medicinal products and natural remedies in Sweden 2007–15: Report from the medical products agency. Drugs Real World Outcomes 2017; 4:119-25.
31. Timbo BB, Chirtel SJ, Ihrie J, Oladipo T, Velez-Suarez L, Brewer V et al. Dietary supplement adverse event report data from the FDA Center for food safety and applied nutrition adverse event reporting syetem (CAERS). Ann Pharmacother 2018; 52:431-38.
32. Uppsala Monitoring Centre. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre [online]. 2000 [cited Sep 11, 2017]. Available from: www.who.int/medi cinedocs/en/d/Jh2934e
33. World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems [online]. 2004 [cited Sep 11, 2017]. Available from: www.who.int/iris/handle/10665 /43034
34. Kidkueakarun R, Suwankesawong W, Jarupoonpol P, Nantamongkolchai S. Criteria for the World Health Organization's report on adverse drug reactions to the problems found in Thailand's report. Medicinal and Health Product Bulletin 2000; 3: 20-3.
35. Bergvall T, Noren GN, Lindquist M. VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 2014; 37:65–77.
36. Durrieu G, Jacquot J, Mege M, Bondon-Guitton E, Rousseau V, Montastruc F, et al. Completeness of spontaneous adverse drug reaction reports sent by general practitioners to a regional pharmacovigi- lance centre: A descriptive study. Drug Saf 2016; 39:1189-95.
37. Center for Drug Evaluation and Research (CBER) FDA. Guidance for industry. good pharmacovigi lance practices and pharmacoepidemiologic assess ment. [online]. 2005 [cited Sep 16, 2017]. Available from: www.fda.gov
38. Kelly W, Arellano F, Barnes J, Bergman U, Edwards R, Fernandez A, et al. International society of pharmacoepidemiology; international society of pharmacovigilance. guidelines for submitting adverse event reports for publication. The´rapie 2009; 64:289–94.
39. Bracchi R, Houghton J, Woods F, Thomas S, Smail S, Routledge P. A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme. Br J Clin Pharmacol 2005; 2:221-3.
40. Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Saf 2003; 26:829–51.
41. Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf 2013; 36:75-81.
42. Gandhi T, Weingart S, Borus J, Seger A, Peterson J, Burdick E, et al. Adverse drug events on ambulatory care. N Engl J Med 2003; 348:1556-64.
43. MBA Board of Science. Reporting adverse drug reactions: A guide for healthcare professionals [online]. 2006 [cited Sep 20, 2017]. Available from: www.isoponline.org
44. Elland I, Belton K, van Grootheest A, Meiners A, Rawlins M, Sticker B. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48:623-7.
45. Hamilton RJ, Goldfrank LR. Poison center data and the Pollyanna phenomenon. J Toxicol Clin Toxicol 1997; 35:21–3.
46. Harmark L, Grootheest V. Pharmacovigilance: methods, recent developments and future pers- pectives. Eur J Clin Pharmacol 2008; 64:743-52.
47. Liu M, Matheny ME, Hu Y, Xu H. Data mining methodologies for pharmacovigilance. SIGKDD Explorations 2012; 14:35-42.
48. Haerian K, Varn D, Vaidya S, Ena L, Chase HS, Friedman C. Detection of pharmacovigilance-related adverse events using electronic health records and automated methods. Int J Clin Pharmacol Ther 2012; 92:228-34.
2. Smith T, Kawa K, Eckl V, Johnson J. Sales of herbal dietary supplements in US increased 7.5% in 2015 consumers spent $6.92 billion on herbal supplements in 2015, marking the 12th consecutive year of growth [online]. 2016 [cited Aug 4, 2018]. Available from: cms.herbalgram.org/herbalgram/issue111/hg111-mktrpt.html
3. Ministry of Public Health. National master plan for Thai herbs development vol.1 2017-2021 [online]. 2016 [cited Aug 1, 2018]. Available from: www.dtam.moph.go. th/index.php?option=com_content&view=article&id=1672
4. Debbie S, Graeme L, Pierre D, Elizabeth W, Kelvin C. Pharmacovigilance of herbal medicine. J Ethnopharma col 2012; 140:513-8.
5. Zeng X, Zhang Y, Kwong JS, Zhang C, Li S, Sun F, et al. The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis and clinical practice guideline: A systematic review. J Evid Based Med 2015; 8:2-10.
6. Dennehy CE, Tsourounis C, Horn AJ. Dietary supplement-related adverse events reported to the California poison control system. Am J Health Syst Pharm 2005; 62:1476-82.
7. Gryzlak BM, Wallace RB, Zimmerman MB, Nisly NL. National surveillance of herbal dietary supplement exposures: the poison control center experience. Phar macoepidemiol Drug Saf 2007; 9:947-57.
8. Menniti-Ippolito F, Mazzanti G, Santuccio C, Moro PA, Calapai G, Firenzuoli F, et al. Surveillance of suspected adverse reactions to natural health products in Italy. Pharmacoepidemiol Drug Saf 2008; 17:626-35.
9. Haller C, Kearney T, Bent S, Ko R, Benowitz N, Olson K. Dietary supplement adverse events: report of a one-year poison center surveillance project. J Med Toxicol 2008; 4:84–92.
10. Wallace RB, Gryzlak BM, Zimmerman MB, Nisly NL. Application of FDA adverse event report data to the surveillance of dietary botanical supplements. Ann Pharmacother 2008; 42:653-60.
11. Jeschke E, Ostermann T, Luke C, Tabali M, Kroz M, Bockelbrink A, et al. Remedies containing Asteraceae extracts a prospective observational study of prescribing patterns and adverse drug reactions in German primary care. Drug Saf 2009; 8:691-706.
12. Xu HM, Wang Y, Liu NF. Safety of an injection with a mixture of extraxts from Herba Artemisiae, Fructus Gardeniae and Flos Lonicerae. Pharm World Sci 2009; 31:458-63.
13. Jacobsson I, Jonsson AK, Gerden B, Hagg S. Spontaneously reported adverse reactions in associa- tion with complementary and alternative medicine substances in Sweden. Pharmacoepidemiol Drug Saf 2009; 11:1039-47.
14. Petronijevic M, Ilic K, Suzuki A. Drug induced hepatotoxicity: data from the Serbian pharmacovigi- lance database. Pharmacoepidemiol Drug Saf 2011; 4: 416-23.
15. Lores D, Lazo Y. Characterization of suspected adverse reactions to herbal medicines reported to the Provincial Coordinating Unit of pharmacovigilance Santiago de Cuba. Revista Mexicana de Ciencias Farmacéuticas 2011; 42:37-44.
16. Saokaew S, Suwankesawong W, Permsuwan U, Chaiyakunapruk N. Safety of herbal products in Thailand an analysis of reports in the Thai Health Product Vigilance Center database from 2000 to 2008. Drug Saf 2011; 34:339-50.
17. Salvador KR, Milian JG, Lopez GJ, Orta IA, Hernandez BP, Lee AC. Pharmacovigilance of phytomedicines and apimedicines in Cuba, 2006-2010. Revista Cubana de Plantas Medicinales 2013; 2:173-86
18. Shin HK, Jeong SJ, Lee MS, Ernst E. Adverse events attributed to traditional Korean medical practices: 1999–2010. Bull World Health Organ 2013; 91:569-75.
19. Hunsel FV, Groothest V. Adverse reactions to herbal remedies: Analysis of reported adverse reactions in the Netherlands. Ned Tijdschr Geneeskd 2013; 157: A6615.
20. Skalli S, Chebat A, Badrane N, Bencheikh RS. Side effects of cade oil in Morocco: An analysis of reports in the Moroccan herbal products database from 2004 to 2012. Food Chem Toxicol 2014; 64:81-5.
21. Wechwithan S, Suwankesawong W, Sornsrivichai V, McNeil EB, Jiraphongsa C, Chongsuvivatwong V. Signal detection for Thai traditional medicine: Examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk. Regul Toxicol Pharmacol 2014; 70:407-12.
22. Suwankesawong W, Saokaew S, Permsuwam U, Chaiyakunapruk N. Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database. BMC Complement Altern Med 2014; 14:1-7.
23. Li haona, Deng J, Yue Z, Zhang Y, Sun H. Detecting drug–herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection. Eur J Clin Pharmacol 2015; 71:1139–45.
24. Li XL, Tang JF, Li WX, Li CX, Zhao T, Zhao BC et al. Postmarketing safety surveillance and reevaluation of Danhong injection: clinical study of 30888 cases. Evid Based Complement Alternat Med 2015; 2015:1-9
25. Kalaiselvan V, Saurabh A, Kumar R, Singh GN. Adverse reactions to herbal products: An analysis of spontaneous reports in the database of the Pharmaco vigilance Programme of India. J Herb Med 2015; 5:48-54.
26. Hoban CL, Byard RW, Musgrave IF. A comparison of patterns of spontaneous adverse drug reaction reporting with St. John’s Wort and fluoxetine during the period 2000–2013. Clin Exp Pharmacol Physiol Suppl 2015; 42:747-51.
27. Salvador KR, Milian JG, Carbonell LA, Lopez GJ, Orta IA, Lee AC. Vigilance of adverse reactions of herbal medicines in Cuba for the period 2003-2010. Revista Cubana de Plantas Medicinales 2015; 1:14-24.
28. Lude S, Vecchio S, Sinno-Tellier S, Dopter A, Mustonen H, Vucinic S, et al. Adverse effects of plant food supplements and plants consumed as food: Results from the poisons centres-based PlantLIBRA study. Phytother Res 2016; 30:988-96.
29. Kim M, Han C. Adverse drug reactions in Korean herbal medicine: A prospective cohort study. Eur J Integr Med 2017; 9:103-9.
30. Svedlund E, Larsson M, Hagerkvist R. Sponta neously reported adverse reactions for herbal medicinal products and natural remedies in Sweden 2007–15: Report from the medical products agency. Drugs Real World Outcomes 2017; 4:119-25.
31. Timbo BB, Chirtel SJ, Ihrie J, Oladipo T, Velez-Suarez L, Brewer V et al. Dietary supplement adverse event report data from the FDA Center for food safety and applied nutrition adverse event reporting syetem (CAERS). Ann Pharmacother 2018; 52:431-38.
32. Uppsala Monitoring Centre. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre [online]. 2000 [cited Sep 11, 2017]. Available from: www.who.int/medi cinedocs/en/d/Jh2934e
33. World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems [online]. 2004 [cited Sep 11, 2017]. Available from: www.who.int/iris/handle/10665 /43034
34. Kidkueakarun R, Suwankesawong W, Jarupoonpol P, Nantamongkolchai S. Criteria for the World Health Organization's report on adverse drug reactions to the problems found in Thailand's report. Medicinal and Health Product Bulletin 2000; 3: 20-3.
35. Bergvall T, Noren GN, Lindquist M. VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 2014; 37:65–77.
36. Durrieu G, Jacquot J, Mege M, Bondon-Guitton E, Rousseau V, Montastruc F, et al. Completeness of spontaneous adverse drug reaction reports sent by general practitioners to a regional pharmacovigi- lance centre: A descriptive study. Drug Saf 2016; 39:1189-95.
37. Center for Drug Evaluation and Research (CBER) FDA. Guidance for industry. good pharmacovigi lance practices and pharmacoepidemiologic assess ment. [online]. 2005 [cited Sep 16, 2017]. Available from: www.fda.gov
38. Kelly W, Arellano F, Barnes J, Bergman U, Edwards R, Fernandez A, et al. International society of pharmacoepidemiology; international society of pharmacovigilance. guidelines for submitting adverse event reports for publication. The´rapie 2009; 64:289–94.
39. Bracchi R, Houghton J, Woods F, Thomas S, Smail S, Routledge P. A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme. Br J Clin Pharmacol 2005; 2:221-3.
40. Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Saf 2003; 26:829–51.
41. Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf 2013; 36:75-81.
42. Gandhi T, Weingart S, Borus J, Seger A, Peterson J, Burdick E, et al. Adverse drug events on ambulatory care. N Engl J Med 2003; 348:1556-64.
43. MBA Board of Science. Reporting adverse drug reactions: A guide for healthcare professionals [online]. 2006 [cited Sep 20, 2017]. Available from: www.isoponline.org
44. Elland I, Belton K, van Grootheest A, Meiners A, Rawlins M, Sticker B. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48:623-7.
45. Hamilton RJ, Goldfrank LR. Poison center data and the Pollyanna phenomenon. J Toxicol Clin Toxicol 1997; 35:21–3.
46. Harmark L, Grootheest V. Pharmacovigilance: methods, recent developments and future pers- pectives. Eur J Clin Pharmacol 2008; 64:743-52.
47. Liu M, Matheny ME, Hu Y, Xu H. Data mining methodologies for pharmacovigilance. SIGKDD Explorations 2012; 14:35-42.
48. Haerian K, Varn D, Vaidya S, Ena L, Chase HS, Friedman C. Detection of pharmacovigilance-related adverse events using electronic health records and automated methods. Int J Clin Pharmacol Ther 2012; 92:228-34.