Adverse drug reactions for CAM and conventional drugs detected in a network of physicians certified to prescribe CAM drugs

Journal of Managed Care Pharmacy

Volumn 18, Issue 6, 2012, Pages 427-438

  Tabali, Manuela ^a   Ostermann, Thomas ^b   Jeschke, Elke ^a   Witt, Claudia M ^c   Matthes, Harald ^a  

^a Havelhoehe Research Institute   (Germany)

^b UNIVERSITY OF WITTEN HERDECKE   (Germany)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLCYSTEINE; AMOXICILLIN; BENZATHINE PENICILLIN V; CEFACLOR; CEFUROXIME; CLARITHROMYCIN; COTRIMOXAZOLE; DROSERA EXTRACT; ERYTHROMYCIN; IVY EXTRACT; METHYLPHENIDATE; MUCOLYTIC AGENT; PARACETAMOL; PELARGONIUM SIDOIDES EXTRACT; PENICILLIN V; PLANT EXTRACT; PRIMULA EXTRACT; SALBUTAMOL; THYME EXTRACT; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION; ALTERNATIVE MEDICINE; ARTICLE; ASTHMA; CERTIFICATION; CHILD; DERMATOLOGIST; DISABILITY; DISEASE SEVERITY; DROSERA; ECZEMA; ELECTRONIC MEDICAL RECORD; FEMALE; GASTROINTESTINAL DISEASE; GENERAL PRACTITIONER; GYNECOLOGIST; HOSPITAL PATIENT; HOSPITALIZATION; HUMAN; INTERNIST; IVY; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MEDICAL EDUCATION; MENTAL DISEASE; MULTICENTER STUDY; NEUROLOGIST; OBSERVATIONAL STUDY; PEDIATRICIAN; PLANT LEAF; PLANT ROOT; PRESCRIPTION; PRIMULACEAE; PROSPECTIVE STUDY; PRURITUS; RESPIRATORY TRACT DISEASE; SKIN DISEASE; THORAX DISEASE; THYME; WORK EXPERIENCE;

EID: 84867822201     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2012.18.6.427     Document Type: Article

References (51)

1. Dunn JD, Cannon HE, Lewis T, Shane-McWhorter L. Development of a complementary and alternative medicine (CAM) pharmacy and therapeutics (P&T) subcommittee and CAM guide for providers. J Manag Care Pharm. 2005;11(3):252-58. Available at: http://www.amcp.org/WorkArea/ DownloadAsset.aspx?id=7132.
2. Myers SP, Cheras PA. The other side of the coin: safety of complementary and alternative medicine. Med J Aust. 2004;181(4):222-25. Available at: https://www.mja.com.au/journal/2004/181/4/other-side-coin-safety-complem entary-and-alternative-medicine. Accessed July 13, 2012.
3. Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006;54(3):226-33.
4. National Center for Complementary and Alternative Medicine. Homeopathy: an introduction. July 2009, updated April 2012. Available at: http://nccam.nih.gov/health/homeopathy. Accessed July 13, 2012.
5. Steiner R, Wegmann I. Extending Practical Medicine: Fundamental Principles Based on the Science of the Spirit. London: Rudolf Steiner Press; 1996.
6. American Botanical Council. Terminology. Available at: http://abc.herbalgram. org/site/PageServer?pagename=Terminology. Accessed July 13, 2012.
7. Spielberg, P. Schul- und Komplementärmedizin: Miteinander statt nebeneinander [Conventional and complementary medicine: joined instead of parallel]. Dtsch Ärztebl. 2007;104(46):A-3148. Available at: http://www.aerzteblatt. de/archiv/57593. Accessed July 13, 2012.
8. Zaffani S, Cuzzolin L, Benoni G. Herbal products: behaviors and beliefs among Italian women. Pharmacoepidemiol Drug Saf. 2006;15(5):354-59.
9. Jeschke E, Ostermann T, Tabali M, et al. Diagnostic profiles and prescribing patterns in everyday anthroposophic medical practice-a prospective multi-centre study. Forsch Komplementmed. 2009;16(5):325-33.
10. Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis. Phytomedicine. 2008;15(5):378-85.
11. Jeschke E, Lüke C, Ostermann T, et al. [Prescribing practices in the treatment of upper respiratory tract infections in anthroposophic medicine]. Forsch Komplementmed. 2007;14(4):207-15. [Article in German]
12. Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation (EPs 7630) in the treatment of acute bronchitis in adults and children. Phytomedicine. 2007;14(Suppl 6):S69-S73.
13. Fazio S, Pouso J, Dolinsky D, et al. Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients. Phytomedicine. 2009;16(1):17-24.
14. Kemmerich B, Eberhardt R, Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung. 2006;56(9):652-60.
15. Kemmerich B. Evaluation of efficacy and tolerability of a fixed combination of dry extracts of thyme herb and primrose root in adults suffering from acute bronchitis with productive cough. A prospective, doubleblind, placebo-controlled multicentre clinical trial. Arzneimittelforschung. 2007;57(9):607-15.
16. Farah MH, Edwards R, Lindquist M, Leon C, Shaw D. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Saf. 2000;9(2):105-12.
17. Baber N. Complementary medicines, clinical pharmacology and therapeutics. Br J Clin Pharmacol. 2003;55(3):225. Available at: http://www.ncbi.nlm. nih.gov/pmc/articles/PMC1884207/?tool=pubmed. Accessed July 13, 2012.
18. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-05.
19. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.
20. Arzneimittelkommission der Deutschen Ärzteschaft. Arzneiverordnungen in der Praxis. 1. Aufl. Berlin: AkdÄ; 2005.
21. Stausberg J, Hasford J. Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from 2003 to 2007 of ICD-10-coded routine data. BMC Health Serv Res. 2011;11:134. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116475/?tool=pubmed. Accessed July 13, 2012.
22. Mockenhaupt M. Severe drug-induced skin reactions: clinical pattern, diagnostics and therapy. J Dtsch Dermatol Ges. 2009;7(2):142-60.
23. Weber-Schoendorfer C, Schaefer C. The safety of cetirizine during pregnancy. A prospective observational cohort study. Reprod Toxicol. 2008;26(1):19-23.
24. Grohmann R, Engel RR, Rüther E, Hippius H. The AMSP drug safety program: methods and global results. Pharmacopsychiatry. 2004;37(Suppl 1): S4-S11.
25. Tabali M, Jeschke E, Bockelbrink A, et al. Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine. BMC Public Health. 2009;9:274. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2728721/?tool=pubmed. Accessed July 13, 2012.
26. Chenot J-F, Heidenreich R. [The role of ethics committees in primary care research projects]. Z Allg Med. 2004;80:271-91. [Article in German] Available at: http://www.allgemeinmedizin.med.uni-goettingen.de/en/ media/2004_Chenot_Chronifizierung.pdf. Accessed July 13, 2012.
27. Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten der Deutschen Gesellschaft für Sozialmedizin und Prävention; Arbeitsgruppe Epidemiologische Methoden der Deutschen Gesellschaft für Epid e miologie; Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie; Deutschen Gesellschaft für Sozialmedizin und Prävention [Good practice of secondary data analysis, first revision]. Gesundheitswesen. 2008;70(1):54-60.
28. Europäisches Parlament und Rat. Richtlinie 2001/83/EG zur Schaffung eines Gemeinsschaftskodex für Humanarzneimittel. November 2001. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSL EG:2001L0083:20090720:DE:PDF. Accessed July 13, 2012.
29. Europäisches Parlament und Rat. Richtlinie 2004/24/EG zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodex für Humanarzneimittel hinsichtlich traditioneller pflanzlicher Arzneimittel. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:20 04:136:0085:0090:de:PDF. Accessed July 13, 2012.
30. Kopetsch T. Dem deutschen Gesundheitswesen gehen die Ärzte aus [German health care system runs out of physicians]. Bundesärztekammer und Kassenärztliche Bundesvereinigung: Berlin; 2010. Available at: http://www. kbv.de/publikationen/36943.html. Accessed July 13, 2012.
31. Jeschke E, Shad F, Pissarek J, et al. QuaDoSta-ein frei konfigurierbares System zur Unterstützung multizentrischer Datenerhebungen in medizinischer Versorgung und Forschung [QuaDoSta-a freely configurable system which facilitates multi-centric data collection for healthcare and medical research]. GMS Med Inform Biom Epidemiol. 2007;3(2):Doc10. Available at: http://www.egms.de/static/en/journals/mibe/2007-3/mibe000058.shtml. Accessed July 13, 2012.
32. WHO Collaborating Centre for Drug Statistics Methodology. ATC/ DDD Index 2012. Available at: http://www.whocc.no/atc_ddd_index/. Accessed July 13, 2012.
33. Veehof L, Stewart R, Haaijer-Ruskamp FM, Jong BM. The development of polypharmacy. A longitudinal study. Fam Pract. 2000;17(3):261- Available at: http://fampra.oxfordjournals.org/content/17/3/261.long. Accessed July 13, 2012.
34. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-59.
35. Jeschke E, Ostermann T, Vollmar HC, Tabali M, Schad F, Matthes H. Prescribing patterns in dementia: a multicentre observational study in a German network of CAM physicians. BMC Neurol. 2011;11:99. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178479/?tool=pubmed. Accessed July 13, 2012.
36. Süsskind M, Thürmann PA, Lüke C, et al. Adverse drug reactions in a complementary medicine hospital: a prospective, intensified surveillance study. Evid Based Complement Alternat Med. 2012;2012:320760. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3270557/?tool=pubmed. Accessed July 13, 2012.
37. Hanlon JT, Pieper CF, Hajjar ER, et al. Incidence and predictors of all and preventable adverse drug reactions in frail elderly persons after hospital stay. J Gerontol A Biol Sci Med Sci. 2006;61(5):511-15.
38. Gandhi TK, Burstin HR, Cook EF, et al. Drug complications in outpatients. J Gen Intern Med. 2000;15(3):149-54. Available at: http://www.ncbi.nlm. nih.gov/pmc/articles/PMC1495358/?tool=pubmed. Accessed July 13, 2012.
39. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003;289(9):1107-16. Available at: http://jama.jamanetwork.com/article. aspx?articleid=196099. Accessed July 13, 2012.
40. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol. 2001;52(1):77-83. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2014499/?tool=pubmed. Accessed July 13, 2012.
41. Thürmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf. 2001;24(13):961-68.
42. Kraft K. Tolerability of dried ivy leaf extract in children. Zeitschrift für Phytotherapie. 2004;(25):179-81.
43. Haidvogl M, Riley DS, Heger M, et al. Homeopathic and conventional treatment for acute respiratory and ear complaints: a comparative study on outcome in the primary care setting. BMC Complement Altern Med. 2007;7:7. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC1831487/?tool=pubmed. Accessed July 13, 2012.
44. Riley D, Fischer M, Singh B, Haidvogl M, Heger M. Homeopathy and conventional medicine: an outcomes study comparing effectiveness in a primary care setting. J Altern Complement Med. 2001;7(2):149-59.
45. Thomsen LA, Winterstein AG, Søndergaard B, Haugbølle LS, Melander A. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother. 2007;41(9):1411-26.
46. Honigman B, Lee J, Rothschild J, et al. Using computerized data to identify adverse drug events in outpatients. J Am Med Inform Assoc. 2001;8(3):254-66. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC131033/?tool=pubmed. Accessed July 13, 2012.
47. European Medicines Agency. ICH topic E 2 A. Clinical safety data management: definitions and standards for expedited reporting. June 1995. Available at: http://www.emea.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002749.pdf. Accessed July 13, 2012.
48. WHO Collaborating Centre for International Drug Monitoring. The WHO adverse reaction terminology-WHO-ART. December 2005. Available at: http://www.umc-products.com/graphics/3149.pdf. Accessed July 13, 2012.
49. MedDRA MSSO. Medical Dictionary for Regulatory Activities. Updated June 28, 2012. Available at: http://www.meddramsso.com. Accessed July 13, 2012.
50. Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. Available at: http://who-umc.org/ Graphics/24734.pdf. Accessed July 13, 2012.
51. World Health Organization. Medicines: safety of medicines-adverse drug reactions. October 2008. Available at: http://www.who.int/mediacentre/ factsheets/fs293/en/index.html. Accessed July 13, 2012.