Extemporaneous Compounding Practices: Case Study in Thai Hospitals
Main Article Content
Keywords
Extemporaneous preparations, Thai hospitals
Abstract
Objective: To collect and analyze information on extemporaneous compounding practices in Thai hospitals and compare stability data from previous studies and reports. Methods: This study has focused on collaborative hospitals that had been using specific extemporaneous formulations for over a year without reported adverse effects whilst also documenting stability data. This study involved data collection from three hospitals and comparing their extemporaneous preparations with additional data from academic journals and reports. Data were analyzed using descriptive statistics. Results: Three hospitals participated in this study. Each hospital produced a notable quantity of extemporaneous formulations; Hospitals A and B each reported 50 and 52 formulations, respectively, whereas Hospital C reported 50. These formulations span various types, including oral liquids, solids, and eye drops. This study identified several key areas of variation among the extemporaneous formulations produced by participating hospitals. These differences include storage and stability conditions, dosage forms, vehicles used, and strength of the medications. Conclusion: This study highlights significant variability in extemporaneous compounding practices across Thai hospitals. This underscores the need for standardized guidelines to ensure the consistent quality and safety of compounded medications. Establishing uniform protocols can help optimize therapeutic outcomes and enhance the stability and efficacy of extemporaneously prepared medications, ultimately improving patient care in hospital settings. In addition, sharing best practices and stability data among hospitals could further refine compounding techniques and medication management.
References
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7. AlKhatib HS, Jalouqa S, Maraqa N, et al. Prevalence, determinants, and characteristics of extemporaneous compounding in Jordanian pharmacies. BMC Health Serv Res. 2019;19(1):816. https://doi: 10.1186/s12913-019-4684-y.
8. Mohiuddin AK. Extemporaneous compounding: selective pharmacists with separate skill. Int J Pharm Chem Analysis. 2018;5(4):165-178. https://doi.org/10.18231/2394-2797.2018.0027.
9. Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Pharm Sci. 2006;9(3):398-426.
10. Nahata MC, Morosco RS, Hipple TF. Stability of spironolactone in an extemporaneously prepared suspension at two temperatures. Ann Pharmacother. 1993;27(10):1198-9. https://doi: 10.1177/106002809302701009.
11. Vugigi S. Extemporaneous compounding: prevalence, risks and quality assurance. Afr J Pharm Alt Med. 2023;1(1):39-54.
https://doi.org/10.58460/ajpam.v1i1.33.
12. Kristina SA, Wiedyaningsih C, Widyakusuma NN, et al. Extemporaneous compounding practice by pharmacists: a systematic review. Int J Pharm Pharm Sci. 2017;9(2):42-6. https://doi.org/10.22159/ijpps.2017v9i2.15681.
13. Cokro F, Arrang ST, Chiara MA, et al. Prevalence of pharmacist knowledge on beyond-use date (BUD) of various non-sterile compounding drugs in Indonesia. Pharm Pract (Granada). 2022;20(1):2630. https://doi: 10.18549/PharmPract.2022.1.2630.
14. Hapsari I, Marchaban M, Wiedyaningsih C, et al. The extemporaneous compounding at primary health care centers: Characteristic and personnel. Glob J Health Sci. 2018;10(9):112. https://doi:10.5539/gjhs.v10n9p112
15. Yuliani SH, Putri DCA, Virginia DM, et al. Prevalence, risk, and challenges of extemporaneous preparation for pediatric patients in developing nations: A review. Pharmaceutics. 2023;15(3):840. https://doi.org/10.3390/pharmaceutics15030840
16. Lass J, Naelapää K, Shah U, et al. Hospitalised neonates in Estonia commonly receive potentially harmful excipients. BMC Pediatrics. 2012;12(1):136. https://doi: 10.1186/1471-2431-12-136.
17. Gonçalves ACdS, Reis AMM, Marçal ACG, et al. Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. Braz J Pharm Sci. 2017;53(3):e00252. https://doi.org/10.1590/s2175-97902017000300252
18. Cook GK, Ling JW, Lee R. Extemporaneous compounding in Queensland Hospitals. J Pharm Pract Res. 2007;37(3):204-9. https://doi.org/10.1002/j.2055-2335.2007.tb00745.x
19. Ploylearmsang C, Kanjanasilp J, Kessomboon N, et al. Hospital pharmacy practice and the way forward for pharmacy education in Thailand. Can J Hosp Pharm. 2019;72(1):34-41.
20. The Association of Hospital Pharmacy (Thailand). The hospital pharmacist standard performance 2013. 2013 [cited 2024 6 March]; Available from: https://thaihp.org/index.php?lang=th&option=contentpage&sub=29.
21. Fois RA, Mewes BT, McLachlan AJ, et al. Compounded medicines and ‘off label’ prescribing - a case for more guidance. Aust Fam Physician. 2009;38(1-2):16-20.
22. Jaidee S, The pharmaceutical production system in district hospital. 1984, Bangkok: Faculty of Chula.
23. Pitchayajittipong C, Sriboon S, Kulmee S, et al. An overview of pharmaceutical production in Thai hospitals. Hosp Pharm. 2019;56(4):265-75. https://doi: 10.1177/0018578719890090.
24. Supapaan T, Jamlongpeng C, Yangyuen N, et al. Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations. Pharm Pract (Granada).
2023;21(4):1-12. https://doi.org/10.18549/PharmPract.2023.4.2892.
25. Allen Jr LV, Erickson III MA. Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1996;53(16):1944-9. https://doi: 10.1093/ajhp/53.16.1944.
26. Pharmaceutical Services Division Ministry of Health Malaysia. Extemporaneous Formulation. 2015 [cited 2023 22 May]; Available from: https://www.invotek.com.tr/images2/MOH_Malaysia_Extemporaneous_Formulation.pdf.
27. Silva MRMd, Dysars LP, Santos EPd, et al. Preparation of extemporaneous oral liquid in the hospital pharmacy. Braz J Pharm Sci. 2020;56e18358. https://doi.org/10.1590/s2175-97902019000418358.
28. Selam M, Ababu A, Extemporaneous compounding practice for dermatologic preparations in Ethiopian Public Hospitals: regulatory requirements and quality concerns. Risk Manag Healthc Policy. 2021;14:1933-38. https://doi:10.2147/RMHP.S300906.
29. Belayneh A, Tessema Z. A Systematic review of the stability of extemporaneous pediatric oral formulations. Sci World J. 2021;20218523091. https://doi: 10.1155/2021/8523091.
30. Sherr Z, Karara AH. Evaluation of the most frequently prescribed extemporaneously compounded medications in a rural setting: a case study from the Delmarva Peninsula. Int J Pharm Compd. 2014;18(6):462-8.
31. Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr. 2003;92(4):486-90. https://doi: 10.1111/j.1651-2227.2003.tb00583.x.
32. Hossain MF, Levesque D, Frye J, et al. Incorporating quality assurance in pharmaceutical compounding-related courses in the PharmD curricula. Int J Pharm Compd. 2020;24(4):322-6.
33. McElhiney LF. Establishing a quality-assurance program for hospital compounding. Int J Pharm Compd. 2008;12(2):116-20.
34. Taylor S, Hays C, Glass B. Compounding medications in a rural setting: an interprofessional perspective. J Multidiscip Healthc. 2018;11:197-204. https://doi: 10.2147/JMDH.S156161.
35. Isles M. Patient safety issues associated with the use of compounded medicines as alternatives to approved pharmaceutical products in Europe and how best practice can improve outcomes. Int J Risk Saf Med. 2020;31(3):133-44. https://doi: 10.3233/JRS-200002.
36. Boocharam T, Koonto I, Kuncharoenrut N, et al. Chemical and physical stability study of cefazolin ophthalmic solution for extemporaneous preparation using artificial tear with different preservatives. Isan J Pharm Sci. 2014;9(supplement):50-4.
37. Boscolo O, Perra F, Salvo L, et al Formulation and stability study of omeprazole oral liquid suspension for pediatric patients. Hosp Pharm. 2020;55(5):314-22. https://doi: 10.1177/0018578719844704.
38. Assefa D, Paulos G, Kebebe D, et al. Investigating the knowledge, perception, and practice of healthcare practitioners toward rational use of compounded medications and its contribution to antimicrobial resistance: a cross-sectional study. BMC Health Serv Res. 2022;22(1):243. https://doi.org/10.1186/s12913-022-07649-4.
39. Naveed S, Akhtar F, Khan S. An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension. J Bioequiv
Availab. 2017;9(4):452-4. https://doi: 10.4172/jbb.1000343.
40. Chong E, Dumont R, Hamilton D, et al. Stability of aminophylline in extemporaneously-prepared oral suspensions. J Informed Pharmacotherapy. 2000;2:100-6.
41. Allen LV Jr, Erickson MA 3rd. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1998;55(18):1915-20. https://doi:10.1093/ajhp/55.18.1915.
42. Thaweethamcharoen T, Tummarintra P, Komesmuneeborirak P, et al. Stability test in extemporaneous preparations: furosemide syrup, spironolactone suspension and hydrochlorothiazide suspension. Siriraj Med J. 2014;66(1):15-20.
43. Preechagoon D, Maha-orankul W, Pongphasuk N, et al. Stability of furosemide in extemporaneously compounded oral suspensions: effect of vehicle, pH, and storage conditions. Thai J Pharm Sci. 1999;23(3):119-27. https://doi.org/10.56808/3027-7922.2345.
44. Noppawinyoowong C, Chailertwanich O. Chemical stability of phenytoin extemporaneous oral suspensions. SRIMEDJ 2014;29(4):105.
45. Chen P, Mar Z, Giannetti A, et al. An Exploratory Study of a new vancomycin eye drops formulation for extemporaneous compounding. Hosp Pharm. 2020;57(1):69-75. https://doi: 10.1177/0018578720973885.
2. US Food and Drug Administration (FDA). Compounding and the FDA: questions and answers. 2018 [cited 2022 10 April]; Available from: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
3. Falconer JR, Steadman KJ. Extemporaneously compounded medicines. Aust Prescr. 2017;40(1):5-8.
4. Ramtoola Z, Catibusic A, Ameen H, et al. Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies. Explor Res Clin Soc Pharm. 2023;12:100380. https://doi: 10.1016/j.rcsop.2023.100380.
5. Abousheishaa AA, Sulaiman AH, Huri HZ, et al. Global scope of hospital pharmacy practice: a scoping review. Healthcare (Basel). 2020;8(2):143. https://doi: 10.3390/healthcare8020143.
6. Giam JA, McLachlan AJ, Krass I. Community pharmacy compounding–impact on professional status. Int J Clin Pharm. 2011;33(2):177-182. https://doi: 10.1007/s11096-011-9496-z.
7. AlKhatib HS, Jalouqa S, Maraqa N, et al. Prevalence, determinants, and characteristics of extemporaneous compounding in Jordanian pharmacies. BMC Health Serv Res. 2019;19(1):816. https://doi: 10.1186/s12913-019-4684-y.
8. Mohiuddin AK. Extemporaneous compounding: selective pharmacists with separate skill. Int J Pharm Chem Analysis. 2018;5(4):165-178. https://doi.org/10.18231/2394-2797.2018.0027.
9. Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Pharm Sci. 2006;9(3):398-426.
10. Nahata MC, Morosco RS, Hipple TF. Stability of spironolactone in an extemporaneously prepared suspension at two temperatures. Ann Pharmacother. 1993;27(10):1198-9. https://doi: 10.1177/106002809302701009.
11. Vugigi S. Extemporaneous compounding: prevalence, risks and quality assurance. Afr J Pharm Alt Med. 2023;1(1):39-54.
https://doi.org/10.58460/ajpam.v1i1.33.
12. Kristina SA, Wiedyaningsih C, Widyakusuma NN, et al. Extemporaneous compounding practice by pharmacists: a systematic review. Int J Pharm Pharm Sci. 2017;9(2):42-6. https://doi.org/10.22159/ijpps.2017v9i2.15681.
13. Cokro F, Arrang ST, Chiara MA, et al. Prevalence of pharmacist knowledge on beyond-use date (BUD) of various non-sterile compounding drugs in Indonesia. Pharm Pract (Granada). 2022;20(1):2630. https://doi: 10.18549/PharmPract.2022.1.2630.
14. Hapsari I, Marchaban M, Wiedyaningsih C, et al. The extemporaneous compounding at primary health care centers: Characteristic and personnel. Glob J Health Sci. 2018;10(9):112. https://doi:10.5539/gjhs.v10n9p112
15. Yuliani SH, Putri DCA, Virginia DM, et al. Prevalence, risk, and challenges of extemporaneous preparation for pediatric patients in developing nations: A review. Pharmaceutics. 2023;15(3):840. https://doi.org/10.3390/pharmaceutics15030840
16. Lass J, Naelapää K, Shah U, et al. Hospitalised neonates in Estonia commonly receive potentially harmful excipients. BMC Pediatrics. 2012;12(1):136. https://doi: 10.1186/1471-2431-12-136.
17. Gonçalves ACdS, Reis AMM, Marçal ACG, et al. Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. Braz J Pharm Sci. 2017;53(3):e00252. https://doi.org/10.1590/s2175-97902017000300252
18. Cook GK, Ling JW, Lee R. Extemporaneous compounding in Queensland Hospitals. J Pharm Pract Res. 2007;37(3):204-9. https://doi.org/10.1002/j.2055-2335.2007.tb00745.x
19. Ploylearmsang C, Kanjanasilp J, Kessomboon N, et al. Hospital pharmacy practice and the way forward for pharmacy education in Thailand. Can J Hosp Pharm. 2019;72(1):34-41.
20. The Association of Hospital Pharmacy (Thailand). The hospital pharmacist standard performance 2013. 2013 [cited 2024 6 March]; Available from: https://thaihp.org/index.php?lang=th&option=contentpage&sub=29.
21. Fois RA, Mewes BT, McLachlan AJ, et al. Compounded medicines and ‘off label’ prescribing - a case for more guidance. Aust Fam Physician. 2009;38(1-2):16-20.
22. Jaidee S, The pharmaceutical production system in district hospital. 1984, Bangkok: Faculty of Chula.
23. Pitchayajittipong C, Sriboon S, Kulmee S, et al. An overview of pharmaceutical production in Thai hospitals. Hosp Pharm. 2019;56(4):265-75. https://doi: 10.1177/0018578719890090.
24. Supapaan T, Jamlongpeng C, Yangyuen N, et al. Enhancing extemporaneous preparations in Thai Hospitals: exploring variation, common formulations, and challenges and needs related to extemporaneous preparations. Pharm Pract (Granada).
2023;21(4):1-12. https://doi.org/10.18549/PharmPract.2023.4.2892.
25. Allen Jr LV, Erickson III MA. Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1996;53(16):1944-9. https://doi: 10.1093/ajhp/53.16.1944.
26. Pharmaceutical Services Division Ministry of Health Malaysia. Extemporaneous Formulation. 2015 [cited 2023 22 May]; Available from: https://www.invotek.com.tr/images2/MOH_Malaysia_Extemporaneous_Formulation.pdf.
27. Silva MRMd, Dysars LP, Santos EPd, et al. Preparation of extemporaneous oral liquid in the hospital pharmacy. Braz J Pharm Sci. 2020;56e18358. https://doi.org/10.1590/s2175-97902019000418358.
28. Selam M, Ababu A, Extemporaneous compounding practice for dermatologic preparations in Ethiopian Public Hospitals: regulatory requirements and quality concerns. Risk Manag Healthc Policy. 2021;14:1933-38. https://doi:10.2147/RMHP.S300906.
29. Belayneh A, Tessema Z. A Systematic review of the stability of extemporaneous pediatric oral formulations. Sci World J. 2021;20218523091. https://doi: 10.1155/2021/8523091.
30. Sherr Z, Karara AH. Evaluation of the most frequently prescribed extemporaneously compounded medications in a rural setting: a case study from the Delmarva Peninsula. Int J Pharm Compd. 2014;18(6):462-8.
31. Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr. 2003;92(4):486-90. https://doi: 10.1111/j.1651-2227.2003.tb00583.x.
32. Hossain MF, Levesque D, Frye J, et al. Incorporating quality assurance in pharmaceutical compounding-related courses in the PharmD curricula. Int J Pharm Compd. 2020;24(4):322-6.
33. McElhiney LF. Establishing a quality-assurance program for hospital compounding. Int J Pharm Compd. 2008;12(2):116-20.
34. Taylor S, Hays C, Glass B. Compounding medications in a rural setting: an interprofessional perspective. J Multidiscip Healthc. 2018;11:197-204. https://doi: 10.2147/JMDH.S156161.
35. Isles M. Patient safety issues associated with the use of compounded medicines as alternatives to approved pharmaceutical products in Europe and how best practice can improve outcomes. Int J Risk Saf Med. 2020;31(3):133-44. https://doi: 10.3233/JRS-200002.
36. Boocharam T, Koonto I, Kuncharoenrut N, et al. Chemical and physical stability study of cefazolin ophthalmic solution for extemporaneous preparation using artificial tear with different preservatives. Isan J Pharm Sci. 2014;9(supplement):50-4.
37. Boscolo O, Perra F, Salvo L, et al Formulation and stability study of omeprazole oral liquid suspension for pediatric patients. Hosp Pharm. 2020;55(5):314-22. https://doi: 10.1177/0018578719844704.
38. Assefa D, Paulos G, Kebebe D, et al. Investigating the knowledge, perception, and practice of healthcare practitioners toward rational use of compounded medications and its contribution to antimicrobial resistance: a cross-sectional study. BMC Health Serv Res. 2022;22(1):243. https://doi.org/10.1186/s12913-022-07649-4.
39. Naveed S, Akhtar F, Khan S. An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension. J Bioequiv
Availab. 2017;9(4):452-4. https://doi: 10.4172/jbb.1000343.
40. Chong E, Dumont R, Hamilton D, et al. Stability of aminophylline in extemporaneously-prepared oral suspensions. J Informed Pharmacotherapy. 2000;2:100-6.
41. Allen LV Jr, Erickson MA 3rd. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1998;55(18):1915-20. https://doi:10.1093/ajhp/55.18.1915.
42. Thaweethamcharoen T, Tummarintra P, Komesmuneeborirak P, et al. Stability test in extemporaneous preparations: furosemide syrup, spironolactone suspension and hydrochlorothiazide suspension. Siriraj Med J. 2014;66(1):15-20.
43. Preechagoon D, Maha-orankul W, Pongphasuk N, et al. Stability of furosemide in extemporaneously compounded oral suspensions: effect of vehicle, pH, and storage conditions. Thai J Pharm Sci. 1999;23(3):119-27. https://doi.org/10.56808/3027-7922.2345.
44. Noppawinyoowong C, Chailertwanich O. Chemical stability of phenytoin extemporaneous oral suspensions. SRIMEDJ 2014;29(4):105.
45. Chen P, Mar Z, Giannetti A, et al. An Exploratory Study of a new vancomycin eye drops formulation for extemporaneous compounding. Hosp Pharm. 2020;57(1):69-75. https://doi: 10.1177/0018578720973885.
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Extemporaneous Compounding Practices: Case Study in Thai Hospitals. Pharm Pract (Granada) [Internet]. 2025 Feb. 28 [cited 2025 Apr. 21];23(1):1-16. Available from: https://pharmacypractice.org/index.php/pp/article/view/3134
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How to Cite
1.
Extemporaneous Compounding Practices: Case Study in Thai Hospitals. Pharm Pract (Granada) [Internet]. 2025 Feb. 28 [cited 2025 Apr. 21];23(1):1-16. Available from: https://pharmacypractice.org/index.php/pp/article/view/3134