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APF24 Complementary Medicines Monographs Reference List

1. Therapeutic Goods Administration. Complementary medicines. 2017. At: www.tga.gov.au/complementary-medicines

2. Braun L, Cohen M. Herbs and natural supplements: an evidence-based guide. 4th edn. Chatswood: Elsevier; 2015.

3. Cancer Council Australia. Position statement: complementary and alternative therapies. 2013. At: http://wiki.cancer.org.au/policy/Position_statement_-_Complementary_and_alternative_therapies

4. Therapeutic Goods Administration. Complementary medicines reforms. 2017. At: www.tga.gov.au/complementary-medicines-reforms

5. World Health Organization. Traditional, complementary and integrative medicine. 2017. At: www.who.int/traditional-complementary-integrative-medicine/en

6. Byard RW, Musgrave I, Maker G, et al. What risks do herbal products pose to the Australian community? Med J Aust 2017;206(2):86–90.

7. Royal Pharmaceutical Society of Great Britain. Herbal medicines. 4th edn. London: Pharmaceutical Press; 2013.

8. Therapeutic Goods Administration. Complementary medicine presentation. 2016. At: www.tga.gov.au/book-page/complementary-medicine-presentation

9. Australian Government. Therapeutic Goods Advertising Code. 2015. At: www.tga.gov.au/publication/therapeutic-goods-advertising-code

10. MacLennan AH. Four harms of harmless therapies. Climacteric 1999;2(2):73–4.

11. Memorial Sloan Kettering Cancer Center. Cancer care. 2017. At: www.mskcc.org/cancer-care

12. United States Department of Health and Human Services. National Center for Complementary and Integrative Health. 2017. At: https://nccih.nih.gov

13. Australian and New Zealand College of Anaethestists. Herbal and dietary supplements. 2017. At: www.anzca.edu.au/patients/frequently-asked-questions/herbal-and-dietary-supplements

14. Frawley J, Adams J, Sibbritt D, et al. Prevalence and determinants of complementary and alternative medicine use during pregnancy: results from a nationally representative sample of Australian pregnant women. Aust N Z J Obstet Gynaecol 2013;53(4):347–52.

15. Pharmaceutical Society of Australia. Position statement: complementary medicines. 2015. At: www.psa.org.au/policies/complementary-medicines

16. Pharmaceutical Society of Australia. Code of ethics for pharmacists. Canberra: PSA; 2017.

17. National Health and Medical Research Council. Statement on homeopathy. 2015. At: www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02_nhmrc_statement_homeopathy.pdf

18. Gregory PJ. Natural medicines. 2017. At: https://naturalmedicines.therapeuticresearch.com

19. Wooltorton E. Too much of a good thing? Toxic effects of vitamin and mineral supplements. CMAJ 2003;169(1):47–8.

20. Saxena RC, Singh R, Kumar P, et al. A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection. Phytomedicine 2010;17(3–4):178–85.

21. Coon JT, Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy. Planta Med 2004;70(4):293–8.

22. Poolsup N, Suthisisang C, Prathanturarug S, et al. Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infection: systematic review of randomized controlled trials. J Clin Pharm Ther 2004;29(1):37–45.

23. Therapeutic Goods Administration. Products containing Andrographis paniculata. Safety advisory: risk of allergic reactions. 2015. At: www.tga.gov.au/alert/products-containing-andrographis-paniculata

24. Williamson E, Driver S, Baxter K, eds. Stockley’s herbal medicines interactions. 2nd edn. London: Pharmaceutical Press; 2013.

25. Memorial Sloan Kettering Cancer Center. About herbs, botanicals and other products. 2017. At: www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs

26. Ma HY, Sun DX, Cao YF, et al. Herb-drug interaction prediction based on the high specific inhibition of andrographolide derivatives towards UDP-glucuronosyltransferase (UGT) 2B7. Toxicol Appl Pharmacol 2014;277(1):86–94.

27. Wider B, Pittler MH, Thompson-Coon J, et al. Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database of Systematic Reviews 2013, Issue 3.

28. Rondanelli M, Giacosa A, Morazzoni P, et al. MediterrAsian diet products that could raise HDL-cholesterol: a systematic review. Biomed Res Int 2016;Epub 2016 Nov 1.

29. Chen MH, May BH, Zhou IW, et al. Integrative medicine for relief of nausea and vomiting in the treatment of colorectal cancer using oxaliplatin-based chemotherapy: a systematic review and meta-analysis. Phytother Res 2016;30(5):741–53.

30. Tian QE, De Li H, Yan M, et al. Effects of Astragalus polysaccharides on P-glycoprotein efflux pump function and protein expression in H22 hepatoma cells in vitro. BMC Complement Altern Med 2012;12:94.

31. Zhou Q, Ye Z, Ruan Z, et al. Investigation on modulation of human P-gp by multiple doses of Radix Astragali extract granules using fexofenadine as a phenotyping probe. J Ethnopharmacol 146(3):744–9.

32. Brayfield A, eds. Martindale: the complete drug reference. London: Pharmaceutical Press; 2017.

33. Fuchikami H, Satoh H, Tsujimoto M, et al. Effects of herbal extracts on the function of human organic anion-transporting polypeptide OATP-B. Drug Metab Dispos 2006;34(4):577–82.

34. Beer AM, Neff A. Differentiated evaluation of extract-specific evidence on Cimicifuga racemosa’s efficacy and safety for climacteric complaints. Evid Based Complement Alternat Med 2013; Epub 2013 Aug 25.

35. Fritz H, Seely D, McGowan J, et al. Black cohosh and breast cancer: a systematic review. Integr Cancer Ther 2014;13(1):12–29.

36. Franco OH, Chowdhury R, Troup J, et al. Use of plant-based therapies and menopausal symptoms: a systematic review and meta-analysis. JAMA 2016;315(23):2554–63.

37. Therapeutic Goods Administration. Black cohosh (Cimicifuga racemosa). 2007. At: www.tga.gov.au/alert/black-cohosh-cimicifuga-racemosa

38. Leach MJ, Moore V. Black cohosh (Cimicifuga spp.) for menopausal symptoms. Cochrane Database of Systematic Reviews 2012, Issue 9.

39. Rockwell S, Liu Y, Higgins SA. Alteration of the effects of cancer therapy agents on breast cancer cells by the herbal medicine black cohosh. Breast Cancer Res Treat 2005;90(3):233–9.

40. Einbond LS, Shimizu M, Nuntanakorn P, et al. Actein and a fraction of black cohosh potentiate antiproliferative effects of chemotherapy agents on human breast cancer cells. Planta Med 2006;72(13):1200–6.

41. Royal Women’s Hospital. Herbal and traditional medicines in pregnancy. 2013. At: www.thewomens.org.au/patients-visitors/clinics-and-services/support-services/medicines-information

42. Royal Women’s Hospital. Herbal and traditional medicines in breastfeeding. 2013. At: www.thewomens.org.au/patients-visitors/clinics-and-services/support-services/medicines-information

43. Oltean H, Robbins C, van-Tulder MW, et al. Herbal medicine for low-back pain. Cochrane Database of Systematic Reviews 2014, Issue 12.

44. Griebeler ML, Morey-Vargas OL, Brito JP, et al. Pharmacologic interventions for painful diabetic neuropathy: an umbrella systematic review and comparative effectiveness network meta-analysis. Ann Intern Med 2014;161(9):639–49.

45. Derry S, Rice AS, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database of Systematic Reviews 2017, Issue 1.

46. Yong YL, Tan LT, Ming LC, et al. The effectiveness and safety of topical capsaicin in postherpetic neuralgia: a systematic review and meta-analysis. Front Pharmacol 2016;7:538.

47. eMIMS cloud. Sydney: MIMS Australia; 2017.

48. Hakas JF. Topical capsaicin induces cough in patient receiving ACE inhibitor. Ann Allergy 1990;65:322–3.

49. Zhu HD, Gu N, Wang M, et al. Effects of capsicine on rat cytochrome P450 isoforms CYP1A2, CYP2C19, and CYP3A4. Drug Dev Ind Pharm 2015;41(11):1824–8.

50. Han Y, Tan TM, Lim LY. Effects of capsaicin on P-gp function and expression in Caco-2 cells. Biochem Pharmacol 2006;71(12):1727–34.

51. Toxicology Data Network. LactMed database. 2017. At: https://toxnet.nlm.nih.gov

52. Derry S, Sven-Rice A, Cole P, et al. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database of Systematic Reviews 2013, Issue 2.

53. Puig L, de-Moraqas JM. Enhancement of PUVA phototoxic effects following celery ingestion: cool broth also can burn. Arch Dermatol 1994;130(6):809–10.

54. Peterson S, Lampe JW, Bammler TK, et al. Apiaceous vegetable constituents inhibit human cytochrome P-450 1A2 (hCYP1A2) activity and hCYP1A2-mediated mutagenicity of aflatoxin B1. Food Chem Toxicol 2006;44(9):1474–84.

55. Moses G. Thyroxine interacts with celery seed tablets? Aust Prescr 2001;24:6–7.

56. Melzer J, Rösch W, Reichling J, et al. Meta-analysis: phytotherapy of functional dyspepsia with the herbal drug preparation STW 5 (Iberogast). Aliment Pharmacol Ther 2004;20(11–12):1279–87.

57. Ottillinger B, Storr M, Malfertheiner P, et al. STW 5 (Iberogast): a safe and effective standard in the treatment of functional gastrointestinal disorders. Wien Med Wochenschr 2013;163(3–4):65–72.

58. eTG complete. Melbourne: Therapeutic Guidelines; 2017.

59. Madisch A, Holtmann G, Plein K, et al. Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multi-centre trial. Aliment Pharmacol Ther 2004;19(3):271–9.

60. Segal R, Pilote L. Warfarin interaction with Matricaria chamomilla. CMAJ 2006;174(9):1281–2.

61. Kassi E, Papoutsi Z, Fokialakis N, et al. Greek plant extracts exhibit selective estrogen receptor modulator (SERM)-like properties. J Agric Food Chem 2004;52(23):6956–61.

62. Sridharan S, Archer N, Manning N. Premature constriction of the fetal ductus arteriosus following the maternal consumption of camomile herbal tea. Ultrasound Obstet Gynecol 2009;34(3):358–9.

63. Brayfield A, ed. Martindale: the complete drug reference. London: Pharmaceutical Press. At: www.medicinescomplete.com

64. van Die MD, Burger HG, Teede HJ, et al. Vitex agnus-castus extracts for female reproductive disorders: a systematic review of clinical trials. Planta Med 2013;79(7):562–75.

65. Jang SH, Kim DI, Choi MS. Effects and treatment methods of acupuncture and herbal medicine for premenstrual syndrome/premenstrual dysphoric disorder: systematic review. BMC Complement Altern Med 2014;14:11.

66. Braun L, Cohen M. Herbs and natural supplements: an evidence based guide. 3rd edn. Elsevier; 2010.

67. Dugoua JJ, Seely D, Perri D, et al. Safety and efficacy of chastetree (Vitex agnus-castus) during pregnancy and lactation. Can J Clin Pharmacol 2008;15(1):e74–79.

68. Banach M, Serban C, Ursoniu S, et al. Statin therapy and plasma coenzyme Q10 concentrations: a systematic review and meta-analysis of placebo-controlled trials. Pharmacol Res 2015;99:329–36.

69. Bank G, Kagan D, Madhavi D. Coenzyme Q10: clinical update and bioavailability. J Evid Based Complementary Altern Med 2011;16(2):129–37.

70. Fotino AD, Thompson-Paul AM, Bazzano LA. Effect of coenzyme Q₁₀ supplementation on heart failure: a meta-analysis. Am J Clin Nutr 2013;97(2):268–75.

71. Madmani ME, Yusuf Solaiman A, Tamr Agha K, et al. Coenzyme Q10 for heart failure. Cochrane Database of Systematic Reviews 2014, Issue 6.

72. Mortensen SA, Rosenfeldt F, Kumar A, et al. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail 2014;2(6):641–9.

73. Ho MJ, Li ECK, Wright JM. Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension. Cochrane Database of Systematic Reviews 2016, Issue 3.

74. Hernandez-Ojeda J, Cardona-Munoz EG, Roman-Pintos LM, et al. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Diabetes Complications 2012;26(4):352–8.

75. Fakhrabadi A, Ghotrom AZ, Mozaffari-Khosravi H, et al. Effect of coenzyme Q10 on oxidative stress, glycemic control and inflammation in diabetic neuropathy: a double blind randomized clinical trial. Int J Vitam Nutr Res 2014;84(5–6):252–60.

76. Negida A, Menshawy A, Ashal GE, et al. Coenzyme Q10 for patients with Parkinson’s disease: a systematic review and meta-analysis. CNS Neurol Disord Drug Targets 2016;15(1):45–53.

77. Zhu ZG, Sun MX, Zhang WL, et al. The efficacy and safety of coenzyme Q10 in Parkinson’s disease: a meta-analysis of randomized controlled trials. Neurol Sci 2017;38(2):215–24.

78. Banach M, Serban C, Sahebkar A, et al. Effects of coenzyme Q10 on statin-Induced myopathy: a meta-analysis of randomized controlled trials. Mayo Clin Proc 2015;90(1):24–34.

79. Therapeutic Goods Administration. Complementary Medicines Evaluation Committee extracted ratified minutes, 11th meeting. 1999. At: www.tga.gov.au/sites/default/files/cmec-minutes-11.pdf

80. Baskaran R, Shanmugam S, Nagayya-Sriraman S, et al. The effect of coenzyme Q10 on the pharmacokinetic parameters of theophylline. Arch Pharm Res 2008;31(7):938–44.

81. DiNicolantonio JJ, Bhutani J, McCarty MF, et al. Coenzyme Q10 for the treatment of heart failure: a review of the literature. Open Heart 2015;2:e000326.

82. Liska DJ, Kern HJ, Maki KC. Cranberries and urinary tract infections: how can the same evidence lead to conflicting advice? Adv Nutr 2016;7(3).

83. Jepson RG, Williams G, Craig JC. Cranberries for preventing urinary tract infections. Cochrane Database of Systematic Reviews 2012, Issue 10.

84. Durham SH, Stamm PL, Eiland LS. Cranberry products for the prophylaxis of urinary tract infections in pediatric patients. Ann Pharmacother 2015;49(12):1349–56.

85. Maki KC, Kaspar KL, Khoo C, et al. Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection. Am J Clin Nutr 2016;103(6):1434–42.

86. Jepson RG, Mihaljevic L, Craig JC. Cranberries for treating urinary tract infections. Cochrane Database of Systematic Reviews 1998, Issue 4.

87. Mohammed Abdul MI, Jiang X, Williams KM, et al. Pharmacodynamic interaction of warfarin with cranberry but not with garlic in healthy subjects. Br J Pharmacol 2008;154(8):1691–700.

88. Royal Women’s Hospital. Pregnancy and breastfeeding medicines guide. 2017. At: www.thewomenspbmg.org.au

89. Dugoua J, Seely D, Perri D, et al. Safety and efficacy of cranberry (vaccinium macrocarpon) during pregnancy and lactation. Can J Clin Pharmacol 2008;15(1):e80–6.

90. Davis SR, Panjari M, Stanczyk FZ. DHEA replacement for postmenopausal women. J Clin Endocrinol Metab 2011;96(6):1642–53.

91. Therapeutic Goods Administration. Personal importation scheme. 2015. At: www.tga.gov.au/personal-importation-scheme

92. World Anti-Doping Agency. List of prohibited substances and methods. 2017. At: www.wada-ama.org/en/prohibited-list

93. Scheffers CS, Armstrong S, Cantineau AE, et al. Dehydroepiandrosterone for women in the peri- or postmenopausal phase. Cochrane Database of Systematic Reviews 2015, Issue 1.

94. Labrie F, Archer DF, Koltun W, et al. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause 2016;23(3):243–56.

95. Nagels HE, Rishworth JR, Siristatidis CS, et al. Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction. Cochrane Database of Systematic Reviews 2015, Issue 11.

96. Peixoto C, Devicari-Cheda JN, Nardi AE, et al. The effects of dehydroepiandrosterone (DHEA) in the treatment of depression and depressive symptoms in other psychiatric and medical illnesses: a systematic review. Curr Drug Targets 2014;15(9):901–14.

97. Corrigan AB. Dehydroepiandrosterone and sport. Med J Aust 1999;171(4):206–8.

98. Jenkinson D, Harbert A. Supplements and sports. Am Fam Physician 2008;78(9):1039–46.

99. Thompson R, Carlson M. Liquid chromatographic determination of dehydroepiandrosterone (DHEA) in dietary supplement products. J AOAC Int 2000;83(4):847–57.

100. Kim C, Halter JB. Endogenous sex hormones, metabolic syndrome, and diabetes in men and women. Curr Cardiol Rep 2014;16(4):467.

101. Labrie F, Diamond P, Cusan L, et al. Effect of 12-month dehydroepiandrosterone replacement therapy on bone, vagina, and endometrium in postmenopausal women. J Clin Endocrinol Metab 1997;82(10):3498–505.

102. Brien S, Lewith GT, McGregor G. Devil’s claw (Harpagophytum procumbens) as a treatment for osteoarthritis: a review of efficacy and safety. J Altern Complement Med 2006;12(10):981–93.

103. Chrubasik JE, Roufogalis BD, Chrubasik S. Evidence of effectiveness of herbal antiinflammatory drugs in the treatment of painful osteoarthritis and chronic low back pain. Phytother Res 2007;21(7):675–83.

104. Devil’s claw root: ulcers and gastrointestinal bleeding? Prescrire Int 2013;22(144):296.

105. Cuspidi C, Sala C, Tadic M, et al. Systemic hypertension induced by Harpagophytum procumbens (devil’s claw): a case report. J Clin Hypertens (Greenwich) 2015;17(11):908–10.

106. Shaw D, Leon C, Kolev S, et al. Traditional remedies and food supplements: a 5-year toxicological study (1991–1995). Drug Saf 1997;17:342–56.

107. Zielinsky P, Busato S. Prenatal effects of maternal consumption of polyphenol-rich foods in late pregnancy upon fetal ductus arteriosus. Birth Defects Res C Embryo Today 2013;99(4):256–74.

108. Shou C, Li J, Liu Z. Complementary and alternative medicine in the treatment of menopausal symptoms. Chin J Integr Med 2011;17(12):883–8.

109. Yu C, Chai X, Yu L, et al. Identification of novel pregnane X receptor activators from traditional Chinese medicines. J Ethnopharmacol 2011;136(1):137–43.

110. Sevior DK, Hokkanen J, Tolonen A, et al. Rapid screening of commercially available herbal products for the inhibition of major human hepatic cytochrome P450 enzymes using the N-in-one cocktail. Xenobiotica 2010;40(4):245–54.

111. Karsch-Völk M, Barrett B, Kiefer D, et al. Echinacea for preventing and treating the common cold. Cochrane Database of Systematic Reviews 2014, Issue 2.

112. Schapowal A, Klein P, Johnston SL. Echinacea reduces the risk of recurrent respiratory tract infections and complications: a meta-analysis of randomized controlled trials. Adv Ther 2015;32(3):187–200.

113. Ardjomand-Woelkart K, Bauer R. Review and assessment of medicinal safety data of orally used echinacea preparations. Planta Med 2016;82(1–2):17–31.

114. Gorski JC, Huang SM, Pinto A. The effect of echinacea (Echinacea purpurea root) on cytochrome P450 activity in vivo. Clin Pharmacol Ther 2004;75(1):89–100.

115. Hermann R, Richter OV. Clinical evidence of herbal drugs as perpetrators of pharmacokinetic drug interactions. Planta Med 2012;78(13):1458–77.

116. Liu R, Tam TW, Mao J, et al. The effect of natural health products and traditional medicines on the activity of human hepatic microsomal-mediated metabolism of oseltamivir. J Pharm Pharm Sci 2010;13(1):43–55.

117. Qiang Z, Hauck C, McCoy JA, et al. Echinacea sanguinea and Echinacea pallida extracts stimulate glucuronidation and basolateral transfer of Bauer alkamides 8 and 10 and ketone 24 and inhibit P-glycoprotein transporter in Caco-2 cells. Planta Med 2013;79:266–74.

118. Gurley BJ, Swain A, Williams DK, et al. Gauging the clinical significance of P-glycoprotein-mediated herb–drug interactions: comparative effects of St John’s wort, Echinacea, clarithromycin, and rifampin on digoxin pharmacokinetics. Mol Nutr Food Res 2008;52(7):772–9.

119. Organization of Teratology Information Specialists. Echinacea preparations. 2014. At: https://mothertobaby.org/fact-sheets-parent/

120. Heitmann K, Havnen GC, Holst L, et al. Pregnancy outcomes after prenatal exposure to echinacea: the Norwegian Mother and Child Cohort Study. Eur J Clin Pharmacol 2016;72(5):623–30.

121. Bamford JTM, Ray S, Musekiwa A, et al. Oral evening primrose oil and borage oil for eczema. Cochrane Database of Systematic Reviews 2013, Issue 6.

122. Dante G, Facchinetti F. Herbal treatments for alleviating premenstrual symptoms: a systematic review. J Psychosom Obstet Gynaecol 2011;32(1):42–51.

123. Cameron M, Gagnier JJ, Chrubasik S. Herbal therapy for treating rheumatoid arthritis. Cochrane Database of Systematic Reviews 2011, Issue 2.

124. Puri BK. The safety of evening primrose oil in epilepsy. Prostaglandins Leukot Essent Fatty Acids 2007;77(2):101–3.

125. Dove D, Johnson P. Oral evening primrose oil: its effect on length of pregnancy and selected intrapartum outcomes in low-risk nulliparous women. J Nurse Midwifery 1999;44(3):320–4.

126. Wedig KE, Whitsett JA. Down the primrose path: petechiae in a neonate exposed to herbal remedy for parturition. J Pediatr 2008;152(1):140.

127. Wider B, Pittler MH, Ernst E. Feverfew for preventing migraine. Cochrane Database of Systematic Reviews 2015, Issue 4.

128. Holland S, Silberstein SD, Freitag F, et al. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults. Neurology 2012;78(17):1346–53.

129. Loder E, Burch R, Rizzoli P. The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines. Headache 2012;52(6):930–45.

130. Johnson ES, Kadam NP, Hylands DM, et al. Efficacy of feverfew as prophylactic treatment of migraine. Br Med J (Clin Res Ed) 1985;291(6495):569–73.

131. Unger M, Frank A. Simultaneous determination of the inhibitory potency of herbal extracts on the activity of six major cytochrome P450 enzymes using liquid chromatography/mass spectrometry and automated online extraction. Rapid Commun Mass Spectrom 2004;18(19):2273–81.

132. Nestel P, Clifton P, Colquhoun D, et al. Indications for omega-3 long chain polyunsaturated fatty acid in the prevention and treatment of cardiovascular disease. Heart Lung Circ 2015;24(8):769–79.

133. Balk EM, Adams GP, Langberg V, et al. Omega-3 fatty acids and cardiovascular disease: an updated systematic review. Evidence report/technology assessment no. 223. Rockville, MD: Agency for Healthcare Research and Quality (US); 2016.

134. Ulven SM, Holven KB. Comparison of bioavailability of krill oil versus fish oil and health effect. Vasc Health Risk Manag 2015;11:511–24.

135. Gunaratne AW, Makrides M, Collins CT. Maternal prenatal and/or postnatal n-3 long chain polyunsaturated fatty acids (LCPUFA) supplementation for preventing allergies in early childhood. Cochrane Database of Systematic Reviews 2015, Issue 7.

136. Bisgaard H, Stokholm J, Chawes BL, et al. Fish oil-derived fatty acids in pregnancy and wheeze and asthma in offspring. N Engl J Med 2016;375(26):2530–9.

137. Schindler T, Sinn JKH, Osborn DA. Polyunsaturated fatty acid supplementation in infancy for the prevention of allergy. Cochrane Database of Systematic Reviews 2016, Issue 10.

138. Königs A, Kiliaan AJ. Critical appraisal of omega-3 fatty acids in attention-deficit/hyperactivity disorder treatment. Neuropsychiatr Dis Treat 2016;12:1869–82.

139. National Heart Foundation of Australia. Healthy hearts position statement. Fish and seafood. 2015. At: www.heartfoundation.org.au/for-professionals/food-and-nutrition/position-statements

140. Siscovick DS, Barringer TA, Fretts AM, et al. AHA science advisory. Omega-3 polyunsaturated fatty acid (fish oil) supplementation and the prevention of clinical cardiovascular disease. Circulation 2017;135(15):e867–84.

141. Cooper RE, Tye C, Kuntsi J, et al. Omega-3 polyunsaturated fatty acid supplementation and cognition: a systematic review and meta-analysis. J Psychopharmacol 2015;29(7):753–63.

142. Tan ML, Ho JJ, Teh KH. Polyunsaturated fatty acids (PUFAs) for children with specific learning disorders. Cochrane Database of Systematic Reviews 2016, Issue 9.

143. Sydenham E, Dangour AD, Lim WS. Omega-3 fatty acid for the prevention of cognitive decline and dementia. Cochrane Database of Systematic Reviews 2012, Issue 6.

144. Burckhardt M, Herke M, Wustmann T, et al. Omega-3 fatty acids for the treatment of dementia. Cochrane Database of Systematic Reviews 2016, Issue 4.

145. Gould JF, Treyvaud K, Yelland LN, et al. Seven-year follow-up of children born to women in a randomized trial of prenatal DHA supplementation. JAMA 2017;317(11):1173–75.

146. Delgado-Noguera MF, Calvache JA, Bonfill Cosp X, et al. Supplementation with long chain polyunsaturated fatty acids (LCPUFA) to breastfeeding mothers for improving child growth and development. Cochrane Database of Systematic Reviews 2015, Issue 7.

147. Moon K, Rao SC, Schulzke SM, et al. Longchain polyunsaturated fatty acid supplementation in preterm infants. Cochrane Database of Systematic Reviews 2016, Issue 12.

148. Jasani B, Simmer K, Patole SK, et al. Long chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database of Systematic Reviews 2017, Issue 3.

149. Hill CL, March LM, Aitkin D, et al. Fish oil in knee osteoarthritis: a randomised clinical trial of low dose versus high dose. Ann Rheum Dis 2016;57(1):23–9.

150. Senftleber NK, Nielsen SM, Andersen JR, et al. Marine oil supplements for arthritis pain: a systematic review and meta-analysis of randomized trials. Nutrients 2017;9(1):e42.

151. Molina-Leyva I, Molina-Leyva A, Bueno-Cavanillas A. Efficacy of nutritional supplementation with omega-3 and omega-6 fatty acids in dry eye syndrome: a systematic review of randomized clinical trials. Acta Ophthalmol 2017;Epub 2017 Mar 30.

152. James M, Proudman S, Cleland L. Fish oil and rheumatoid arthritis: past, present and future. Proc Nutr Soc 2010;69(3):316–23.

153. Miles EA, Calder PC. Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis. Br J Nutr 2012;107(Suppl 2):S171–84.

154. Lee YH, Bae SC, Song GG. Omega-3 polyunsaturated fatty acids and the treatment of rheumatoid arthritis: a meta-analysis. Arch Med Res 2012;43(5):356–62.

155. Proudman SM, James MJ, Spargo LD, et al. Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use. Ann Rheum Dis 2013: Epub 2013 Sep 30.

156. Therapeutic Goods Administration. Compositional guideline: fish oil—natural. 2012. At: www.tga.gov.au/compositional-guideline/fish-oil-natural

157. Begtrup KM, Krag AE, Hvas AM. No impact of fish oil supplements on bleeding risk: a systematic review. Dan Med J 2017;64(5):A5366.

158. Preston CL, ed. Stockley’s drug interactions. Pharmaceutical Press; 2017. At: www.medicinescomplete.com

159. Akedo I, Ishikawa H, Nakamura T, et al. Three cases with familial adenomatous polyposis diagnosed as having malignant lesions in the course of a long-term trial using docosahexanoic acid (DHA)-concentrated fish oil capsules. Jpn J Clin Oncol 1998;28(12):762–5.

160. World Health Organization. Marine oil supplementation to improve pregnancy outcomes. 2011. At: www.who.int/elena/titles/bbc/fish_oil_pregnancy/en

161. Food Standards Australia New Zealand. Pregnancy and healthy eating. 2016. At: www.foodstandards.gov.au/consumer/generalissues/pregnancy/Pages/default.aspx

162. National Heart Foundation of Australia. Fish and omega-3: questions and answers for health professionals. 2015. At: www.heartfoundation.org.au/images/uploads/main/Programs/Health_Professional_QA_Fish_Omega3_Cardiovascular_Health.pdf

163. Schwingshackl L, Missbach B, Hoffmann G. An umbrella review of garlic intake and risk of cardiovascular disease. Phytomedicine 2016;23(11):1127–33.

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PSA and the Morrison Government to work together to improve medicine safety

20 May 2019

 

The Pharmaceutical Society of Australia (PSA) today congratulates the re-elected Morrison Government and looks forward to working together to address medicine safety, negotiating the next Community Pharmacy Agreement and delivering better healthcare for all Australians.

 

PSA National President Dr Chris Freeman said pharmacists are among the most accessible health professionals, but they need to be better supported to practise to the full extent of their skills, expertise and training.

 

“PSA’s Pharmacists in 2023 report shows how an evolved healthcare system can empower pharmacists to provide more effective and efficient services. Prior to the election, PSA asked the Government to commit to several actions to make this possible.”

 

In response to pre-election commitment requests from the PSA, the Morrison Government made a number of important commitments to PSA and the pharmacy profession. Minister Hunt, on behalf of the Coalition stated “A re-elected Morrison Government will continue to support the pharmacy profession in meeting community health needs by ensuring that pharmacists are utilised to their full scope of practice”.

 

Importantly, the Morrison Government endorsed PSA’s Pharmacists in 2023 report. “The Morrison Government agrees with the Pharmaceutical Society of Australia’s vision for the pharmacy profession outlined in the Pharmacists in 2023 report. This is in recognition that it will improve outcomes for patients, the profession and for Australia’s health system.”

 

PSA looks forward to progressing fair remuneration for pharmacists in recognition of their professional contribution in supporting people’s health – a key action from our Pharmacists in 2023 report.

 

“Pharmacists are underpaid noting their key role in healthcare. This needs to be addressed as we head into negotiations for the next Community Pharmacy Agreement,” Dr Freeman said.

 

PSA received a commitment from the Coalition to declare medicine safety a National Health Priority Area as requested by the PSA through our Federal Budget Submission and in response to PSA’s Medicine Safety: Take Care report which highlighted that $1.4 billion dollars is lost annually in our healthcare system because of safety issues associated with medicines.

 

In his response on behalf of the Coalition, The Hon Greg Hunt MP, Minister for Health, stated that the Coalition will work through the Council of Australian Governments Health Council, with the Australian Commission of Safety and Quality in Healthcare, PSA and key stakeholders to support the initiation of this priority. This commitment highlights the pivotal role PSA will play in shaping the future of medicine safety in Australia.

 

We also welcome the Coalition’s announcement earlier this year that PSA will be a signatory to the 7th Community Pharmacy Agreement (7CPA). As a signatory to 7CPA, PSA will work to preserve the accessibility of community pharmacy for the delivery of healthcare services such as vaccinations, medication management and minor illness care. We will also ensure that the 7CPA utilises pharmacists to their full scope of practice and has pharmacists delivering services tailored to community needs.

 

PSA will engage with the Government on aligning the incentives for pharmacists to support rural and remote communities with those of other health practitioners. Dr Freeman said that Australians living in rural and remote areas are more likely to have chronic conditions and poorer health outcomes than people in major cities.

 

“Pharmacists could play a much greater role in rural and remote areas, where they are often one of the only health providers. It’s only logical that the incentives for other health professionals should be available to pharmacists as well.

 

“All of these commitments, if fulfilled, will further unlock the potential of pharmacists and allow them to improve healthcare access and outcomes for Australians, and reduce variabilities in care.”

 

PSA offers its commiserations to the Labor Party on the election outcome and looks forward to continuing our constructive relationship with Catherine King and the Labor Party while they remain in Opposition.

 

“PSA looks forward to working closely with the Morrison Government and Minister Hunt, with whom we have an excellent working relationship, to make full use of pharmacists’ expertise and clinical training to improve access to care and medicine safety for all Australians,” Dr Freeman said.

 

Media contact:   
Carly Lusk
Public Affairs Officer
0487 922 176

Major parties commit to addressing medicine safety

May 15, 2019

 

The Coalition, Labor Party and the Greens have all responded to the Pharmaceutical Society of Australia’s (PSA) five election action items, ahead of the federal election – highlighting their support for the valuable role pharmacists play in our healthcare system.

 

Both the Coalition and the Greens have committed to declaring medicine safety a National Health Priority Area. Labor advised that the key role pharmacists play in the supply of medicines is reflected in their National Platform. Their Australian Health Reform Commission would no doubt highlight the issue of medicine safety and the need for investment in quality use of medicines.

 

PSA National President Dr Chris Freeman said this acknowledgement by the major parties is vital step forward in addressing the alarming issue of medicine-related harm.

 

“Medicine-related problems cause 250,000 hospital admissions and 400,000 emergency department presentations in Australia each year, costing the healthcare system $1.4 billion annually. At least half of this harm is avoidable, and pharmacists are the key to improving the safe and quality use of medicines,” Dr Freeman said.

 

Addressing medicine safety is the first of five commitments PSA has sought from an incoming Government:

 

  1. Address the alarming rate of medicine-related harm in our health system by declaring medicine safety a National Health Priority Area (NHPA)
  2. Provide funding to embed pharmacists within healthcare teams, particularly in residential aged care facilities
  3. Accept the MBS Review Taskforce’s recommendations to allow pharmacists to access allied health items to provide medication management services to patients with complex care requirements
  4. Align the incentives for pharmacists to support rural and remote communities with those of other rural and remote health practitioners
  5. Include PSA as a signatory to the Community Pharmacy Agreement.

 

“To meet community health needs, we must ensure pharmacists can practise to their full potential, develop within a team of health professionals and have a quality agenda for the services and care they deliver,” Dr Freeman said.

 

“PSA looks forward to working closely with an incoming Government to empower pharmacists to do more to deliver better healthcare for all Australians.”

 

Responses from:

 

 

Media contact:
Carly Lusk
Public Affairs Officer
0487 922 176

My Health Record Workshop presenter – Samantha Bowen

Samantha Bowen, B.Pharm, AACPA MSHP, is a Clinical Pharmacist working in the Private Hospital sector. She is also an Accredited Pharmacist, conducting both HMRs and RMMRs in the Nepean Blue Mountains region. Prior to this she  worked in community pharmacy for 8 years. Samantha first became involved with My Health Record in 2016 during one of two opt-out trials.

 

She was then recruited by the Digital Health agency as a Pharmacist Digital Health Leader; a network which aims to increase the awareness and promote usability of My Health Record among fellow Pharmacists. Samantha has been involved in facilitating the uptake of My Health Record since this time.

 

 

New principles for pharmacists to deliver safer and high quality pharmacy services

Clinical governance principles that champion the design and implementation of safe and high quality pharmacy services have been released today by the Pharmaceutical Society of Australia (PSA).

 

Clinical Governance Principles for Pharmacy Services 2018 provides pharmacists and organisations involved in the provision of pharmacy services the guidance to improve safety, quality and consistency of new and existing services in healthcare delivery.

 

Building on the work undertaken by the Australian Commission for Safety and Quality in Health Care, the principles describe aspects of design and delivery vital to providing high quality pharmacist care for all Australians.

 

PSA National President Dr Chris Freeman said clinical governance was a key mechanism to reduce the harms caused by medicine misuse.

 

“We have a high-quality health system in Australia, and a high-quality pharmacy profession providing valued care to their communities and patients, but there are still unacceptable variations in health outcomes,” he said.

 

“PSA’s Medicine Safety Report found that 250,000 people are admitted to hospital each year because of medicine-related problems, at a cost of $1.4 billion. At least half of this harm is preventable.

 

“Pharmacists are the key to improving the safe and quality use of medicines but, while all pharmacy services have a degree of quality management and governance, the formal application of clinical governance varies considerably.

 

“These principles, released by the PSA today, will help guide service design which provides reassurance as to the safety and quality of the services pharmacists provide and can be applied by pharmacists in all settings, whether in community or hospital pharmacy, general practice or aged care.

 

“All the principles described in the document are essential to safe and effective care. The principles are not auditable accreditation criteria, but can be used to help identify safety and quality gaps when designing, monitoring and evaluating pharmacy services.

 

“These principles will also help to inform future high quality services to be funded in the upcoming Seventh Community Pharmacy Agreement negotiations and beyond.”

 

Dr Freeman acknowledged funding provided by the Federal Government’s Department of Health to develop the principles.

 

“I encourage pharmacists and all those involved in the management and design of pharmacy services to embrace these principles, reflect on them and continuously work towards them to ensure they provide the best possible care to patients,” he said.

 

9 May 2019

Thank you for completing the PSA Member Survey

Thank you for taking the time to complete the PSA Member Survey. Your feedback will help ensure we work hard on what matters most to you.

 

PSA is committed to create opportunities for pharmacists to practice to their full scope, and to increase remuneration and recognition of pharmacists as medicine experts.

 

To find out more about how we are working to improve opportunities for all pharmacists, please visit our Advocacy webpage.

 

Kind regards,
PSA Member Services

My Health Record Guidelines for Pharmacists Review

The PSA has recently undertaken a review of the My Health Record Guidelines for pharmacists that was originally published in 2018. This review is to ensure the Guidelines are current and address any changes in relation to My Health Record Amendment (Strengthening Privacy) Bill 2018.

 

PSA gratefully acknowledges the Australian Government for providing funding for this work.

 

During the public consultation period on the revised My Health Record Guidelines for Pharmacists, PSA welcomes comments from interested individuals and organisations, including members of the pharmacy profession as well as consumers, other health professional groups and practitioners, educators, researchers and government bodies. A survey has been created to assist with feedback and commentary.

 

Download the draft guidelines for review here
Provide your feedback here (external site – less than 10 minutes to complete)
Please note: The revised Guidelines will undergo professional copy-editing and production processes following this consultation. PSA requests feedback focus on the content of the revised Guidelines, unless otherwise specified in the question. The revised guidelines are still in consultation and as such have not been endorsed.

Open Letter to Royal Australian College of General Practitioners

18 April 2019

 

I am writing to object to the egregious assertions made in the RACGP’s submission to the Pharmacy Board of Australia – ‘Pharmacist Prescribing’ and the public statements that your President, Dr Harry Nespolon, has made against pharmacists, our role in healthcare, and the future role of pharmacists with regard to Collaborative Prescribing.

 

The RACGP submission to the Pharmacy Board of Australia makes several unfounded and prejudiced statements in relation to pharmacists being able to prescribe.

 

Statements such as the “the provision of medical services by health professionals lacking the necessary medical training or registration is an inappropriate and unsustainable solution to address the health needs of Australians and that pharmacists simple do not have the healthcare training required to safely deliver healthcare services” are inflammatory, disrespectful and ignore the five years of university and clinical training undertaken by pharmacists, in addition to ongoing regulated continuing professional development similar to other health professionals.

 

Indeed, pharmacists have the greatest level of clinical training regarding medicines compared to any other health professional. Indisputably, pharmacists are the medicines experts.

 

The ageing population, increasing incidence of chronic disease, advances in medicines and health technologies, rising health care costs, evolving health service delivery models, and a need for a responsive health workforce are all factors which have contributed to health practitioners, other than medical practitioners, to be authorised to prescribe within their scope of practice. The RACGP should be well aware that Australia’s healthcare system rates poorly on access and equity, an issue Australian pharmacists are all too familiar with, given the rising out of pockets costs that are prevalent in accessing general practice and general practitioners.

 

These factors, in addition to the alarming incidence of medication-related harm, the availability and access to pharmacist care and our medicines’ expertise all add to the need for pharmacists to be able to do more in our health system, including prescribing, just as dentists, midwives, nurse practitioners, optometrists and podiatrists are able to in Australia.

 

We must recognise and acknowledge that pharmacists already prescribe medicines. As much as the RACGP might like to rewrite history, and to dismiss the vital role that pharmacists in the community play, consumers and pharmacists know that the care that they deliver benefits patients and our healthcare system. Pharmacists already make clinical assessment and diagnoses within their scope of practice and prescribe lower-risk medicines. The Pharmacist Only Medicines schedule, which allows a pharmacist to assess the clinical needs of the patient, make an assessment, communicate and discuss that assessment with the patient and allows them (based on the risk of the medicine) to supply that medicine as well. In this context based on the risk profile of the medicine, pharmacists do both – prescribe and dispense. This vital primary care function of triage and referral, may result in the pharmacist referring the patient to a General Practitioner for additional assessment, without the provision of a medication and with no out of pocket expense to the patient.

 

The PSA has been very clear about the separation of prescribing and dispensing functions according to the risk profile of the medicine. In addition, we believe that where the independent decision is made to initiate a schedule four or eight medicine, that this should be separated from the dispensing activity. Within a collaborative prescribing agreement between a pharmacist and a general practitioner that the pharmacist, pharmacists should be able to adjust the doses of prescribed medicines to reach treatment targets, to extend the life of a prescription and to order any necessary tests to monitor the safety of the medicine. This role should be able to be performed across sectors, within the hospital, within general practice and importantly because of the accessibility of community pharmacists, within community pharmacy – but again, within a collaborative care agreement.

 

The outrageous statement “that patients will be exposed to unnecessary risk, including increased incidences of medication misadventure” disregards the fact that there is already an enormous issue around medication-related harm in Australia, many of these medicines prescribed by general practitioners.

 

PSA’s report Medicine Safety: Take Care 2019 revealed the enormity of the issue of medication-related harm and its cost to our economy. The report found there were 250,000 hospital submissions annually as a result of medication-related problems with an additional 400,000 presentations to emergency departments due to medicine misuse costing $1.4 billion annually.

 

Three in five hospital discharge summaries, where pharmacists were not involved in their preparation, had at least one medication error and over 90 per cent of patients have at least one medication-related problem post-discharge from hospital.

 

The evidence is clear, pharmacists have significant potential to reduce the number of medication-related hospital admission and adverse medication events in Australia but are prevented from doing so due to barriers in fulfilling our scope of practice. As experts in medicines, pharmacists can identify medicines that are causing harm and reduce adverse events through monitoring, frequency of patient contact, and through our expertise and knowledge of how medicines interact.

 

RACGP’s statement that “the business needs of a pharmacy may be prioritised over the needs of patients” blatantly disregards the fact that GPs themselves work in a business that provides services that have their own potential conflicts of interests. All health professionals are subject to professional standards codes and guidelines which demand health professionals place the health and welfare of patients ahead of any other interest. In this context pharmacists are no different to general practitioners.

 

PSA has stated that clear risk frameworks would need to be put in place for any model for pharmacists’ prescribing to avoid business needs being prioritised over patients. Pharmacists should not be considered any different in the provision of health services to other health professionals.

 

PSA has argued that collaborative prescribing should be designed so that the pharmacist and the medical practitioner support each other. They are complementary roles that would be designed to actually address the safety concerns of patients in an already fragmented care system. PSA believes pharmacists, medical practitioners, other allied health professionals and consumers should all work together as part of a wider health care team for the benefit of patients.

 

Pharmacists have long identified and referred patients to doctors to help manage chronic disease and believe that any future collaborative prescribing model would strengthen and enhance these partnerships.

 

It is essential that all health professionals work together for the benefit of patients as part of health team and PSA is disappointed that RACGP has chosen to diminish the role of pharmacists and their role as a trusted, patient-focused health care professional rather than work together towards fostering relationships and models of care that will greater benefit all Australians.

 

Yours Sincerely,

Dr Chris Freeman

National President

Pharmacist-administered vaccination age lowered in the Australian Capital Territory

Pharmacists will be able to protect more Canberrans against vaccine-preventable diseases, ACT Health announced today in a move welcomed by the Pharmaceutical Society of Australia (PSA).

 

Pharmacists will be able to vaccinate more people following ACT Health’s announcement to lower the minimum age of pharmacist-administered vaccinations to 16 years.

 

ACT PSA Branch President, Renae Beardmore, congratulated ACT Health for allowing pharmacists to vaccinate more Canberrans.

 

“Allowing trained pharmacists to administer vaccines will significantly increase the immunisation rates within the community and reduce the incidence of vaccine-preventable diseases.

 

“The administration of vaccines by pharmacists complements the excellent work done by GPs, nurses, Indigenous Health Workers and other healthcare professionals. This change will increase immunisation and positively impact people’s health in the ACT.”

“As the peak body for pharmacists, PSA has advocated for many years to allow pharmacists to deliver more vaccinations to a wider range of patients and will continue to work closely with ACT Health to achieve this.”

 

Ms Beardmore commended Minister Fitzharris and ACT Health for making use of pharmacists’ expertise and training to better protect the community against vaccine-preventable diseases.

 

Media contact:   Michellé Mabille, Marketing and Communications Manager – 0487 922 176

Supporting collaborative prescribing to improve safe and effective use of medicines

The Pharmaceutical Society of Australia (PSA) supports collaborative prescribing of medicines by pharmacists to improve Australians’ access to safe and effective healthcare, in its response to the Pharmacy Board of Australia’s Public discussion paper on pharmacist prescribing.

 

PSA National President Dr Chris Freeman said PSA had advocated for collaborative pharmacist prescribing and recognised the work that had already been done to develop this role.

 

“PSA supports collaborative prescribing of medicines by pharmacists within a framework that allows them to practise to the full extent of their expertise,” Dr Freeman said.

 

“Pharmacists have more clinical training in medicines than any other health professional, they already perform clinical assessment and diagnosis within their scope of practice and prescribe other scheduled medicines. These activities are within the national competency framework for pharmacists.

 

“Prescribing Schedule 4 medicines is a logical next step and continuation of pharmacists’ role in medicines management.

 

“As stated in our Pharmacists in 2023 report, we are committed to enabling pharmacists to practise to their full scope by advocating for expanded roles and new opportunities in prescribing, consistent with their recognised competency framework.”

 

One of the actions for change outlined in Pharmacists in 2023 is to Facilitate pharmacist prescribing within a collaborative care model.

 

PSA surveyed pharmacists, interns and students to inform its response to the Pharmacy Board. Ninety-four per cent of respondents agreed pharmacists are already well placed to prescribe under a structured prescribing arrangement or under supervision.

 

The majority of respondents said they would prescribe under the proposed models, with 56% saying they planned to prescribe under a structured prescribing arrangement as soon as it was implemented.

 

In its submission to the Pharmacy Board, PSA outlined the core principles that must underpin pharmacist prescribing, including:

  • Safety and wellbeing of the patient are fundamental priorities
  • Patients are supported to receive patient-centred care in a timely manner
  • Pharmacist prescribers have professional accountability and responsibility to patients as well as other members of the healthcare team
  • The pharmacist prescriber works as a member of a collaborative care team with shared responsibility and implements highest standards of communication with patients and other team members
  • Separation of prescribing and dispensing functions in a risk based framework.

 

“PSA looks forward to working with the Pharmacy Board and the wider profession to support pharmacist prescribers by establishing training and recognition requirements, enabling legislative and regulatory change, and developing a framework for collaborative prescribing across practice settings,” Dr Freeman said.

 

Media contact:   Michellé Mabille, Marketing and Communications Manager – 0487 922 176