Self-medication with over-the-counter and prescribed drugs causing adverse-drug-reaction-related hospital admissions: Results of a prospective, long-term multi-centre study

Drug Safety

Volumn 37, Issue 4, 2014, Pages 225-235

  Schmiedl, Sven ^a,b   Rottenkolber, Marietta ^c   Hasford, Joerg ^c   Rottenkolber, Dominik ^c,d   Farker, Katrin ^e,f   Drewelow, Bernd ^g   Hippius, Marion ^e   Saljé, Karen ^h   Thürmann, Petra ^a,b  

^a HELIOS KLINIKUM WUPPERTAL   (Germany)

^b UNIVERSITY OF WITTEN HERDECKE   (Germany)

^c UNIVERSITY OF MUNICH   (Germany)

^d INSTITUTE OF EPIDEMIOLOGY   (Germany)

^e JENA UNIVERSITY HOSPITAL   (Germany)

^f Sophien und Hufeland Klinikum Weimar   (Germany)

^g UNIVERSITY OF ROSTOCK   (Germany)

^h UNIVERSITY OF GREIFSWALD   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANALGESIC AGENT; ANTICOAGULANT AGENT; ANTIDIABETIC AGENT; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; DEXIBUPROFEN; DICLOFENAC; DIPYRONE; ERYTHROMYCIN; FUROSEMIDE; GLIBENCLAMIDE; GLYCERYL TRINITRATE; IBUPROFEN; MELOXICAM; NAPROXEN; NON PRESCRIPTION DRUG; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PHENPROCOUMON; PRESCRIPTION DRUG; PROPYPHENAZONE; SILDENAFIL; TORASEMIDE;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGED; ALLERGIC REACTION; ARTICLE; DRUG SAFETY; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; GINKGO BILOBA; GROUPS BY AGE; HOSPITAL ADMISSION; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; POLYPHARMACY; PRIORITY JOURNAL; PROSPECTIVE STUDY; SELF MEDICATION; UNSPECIFIED SIDE EFFECT; VERY ELDERLY; CLINICAL TRIAL; DRUG INTERACTION; DRUG SURVEILLANCE PROGRAM; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HOSPITALIZATION; MIDDLE AGED; MULTICENTER STUDY; PATIENT SAFETY; PHYSIOLOGY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; DRUG INTERACTIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; NONPRESCRIPTION DRUGS; PATIENT SAFETY; PRESCRIPTION DRUGS; PROSPECTIVE STUDIES; SELF MEDICATION;

EID: 84899115872     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-014-0141-3     Document Type: Article

References (42)

1. Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Pharmadaten 2012. 2012 [cited 14/JAN/2014]. http://www.bpi.de/fileadmin/media/bpi/Downloads/ Internet/Publikationen/Pharma-Daten/Pharmadaten-2012-DE.pdf.
2. Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027-37.
3. Soller RW. Evolution of self-care with over-the-counter medications. Clin Ther. 1998;20 Suppl C:C134-40.
4. Olivier P, Bertrand L, Tubery M, Lauque D, Montastruc JL, Lapeyre-Mestre M. Hospitalizations because of adverse drug reactions in elderly patients admitted through the emergency department: a prospective survey. Drugs Aging. 2009;26(6):475-82.
5. Hersh EV, Pinto A, Moore PA. Adverse drug interactions involving common prescription and over-the-counter analgesic agents. Clin Ther. 2007;29(Suppl):2477-97.
6. Wilcox CM, Cryer B, Triadafilopoulos G. Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal antiinflammatory drugs. J Rheumatol. 2005;32(11):2218-24.
7. Hasford J, Moore N, Hoye K. Safety and usage pattern of low-dose diclofenac when used as an over-the-counter medication: results of an observational cohort study in a community-based pharmacy setting. Int J Clin Pharmacol Ther. 2004;42(8):415-22.
8. Bond C, Hannaford P. Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf. 2003;26(15):1065-74.
9. Du Y, Knopf H. Self-medication among children and adolescents in Germany: results of the National Health Survey for Children and Adolescents (KiGGS). Br J Clin Pharmacol. 2009;68(4):599-608.
10. Grigoryan L, Monnet DL, Haaijer-Ruskamp FM, Bonten MJ, Lundborg S, Verheij TJ. Self-medication with antibiotics in Europe: a case for action. Curr Drug Saf. 2010;5(4):329-32.
11. Rottenkolber D, Schmiedl S, Rottenkolber M, Farker K, Salje K, Mueller S, et al. Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations. Pharmacoepidemiol Drug Saf. 2011;20(6):626-34.
12. Schneeweiss S, Gottler M, Hasford J, Swoboda W, Hippius M, Hoffmann AK, et al. First results from an intensified monitoring system to estimate drug related hospital admissions. Br J Clin Pharmacol. 2001;52(2):196-200.
13. WHO. International drug monitoring. In: The role of hospital. Geneva: World Health Organisation; 1969.
14. Rzany B, Correia O, Kelly JP, Naldi L, Auquier A, Stern R. Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis during first weeks of antiepileptic therapy: a case-control study. Study Group of the International Case Control Study on Severe Cutaneous Adverse Reactions. Lancet. 1999;353(9171):2190-4.
15. Schneeweiss S, Hasford J, Gottler M, Hoffmann A, Riethling AK, Avorn J. Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: a longitudinal population-based study. Eur J Clin Pharmacol. 2002;58(4):285-91.
16. WHO. Anatomical therapeutic chemical (ATC) classification index. Geneva: WHO Collaborating Centre for Drug Statistics Methodology; 1992.
17. Begaud B, Evreux JC, Jouglard J, Lagier G. [Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France]. Therapie. 1985;40(2):111-8.
18. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109-17.
19. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
20. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32.
21. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(R2). 2001 [cited 14/JAN/2014]. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/ E2B/Step4/E2B-R2-Guideline.pdf.
22. World Health Organization. Patient Safety Programme. 2004 [cited 14/JAN/2014]. http://www.who.int/patientsafety/about/en/.
23. The Joint Commission. 2013 National Patient Safety Goals. 2013 [cited 14/JAN/2014]. http://www.jointcommission.org/standards-information/npsgs.aspx.
24. Arzneimittelkommision der deutschen Ärzteschaft. Aktionsplan des Bundesministeriums für Gesundheit zur Verbesserung der Arzneimitteltherapiesicherheit (AMTS) in Deutschland. 2010 [cited 14/JAN/2014]. http://www.ap-amts.de/.
25. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329(7456):15-9.
26. Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother. 2008;42(7):1017-25.
27. Beitz R, Doren M, Knopf H, Melchert HU. Self-medication with over-the-counter (OTC) preparations in Germany. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2004;47(11):1043-50.
28. Paulose-Ram R, Hirsch R, Dillon C, Losonczy K, Cooper M, Ostchega Y. Prescription and non-prescription analgesic use among the US adult population: results from the third National Health and Nutrition Examination Survey (NHANES III). Pharmacoepidemiol Drug Saf. 2003;12(4):315-26.
29. Lewis SC, Langman MJ, Laporte JR, Matthews JN, Rawlins MD, Wiholm BE. Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol. 2002;54(3):320-6.
30. Daban F, Pasarin MI, Rodriguez-Sanz M, Garcia-Altes A, Villalbi JR, Zara C, et al. Social determinants of prescribed and non-prescribed medicine use. Int J Equity Health. 2010;9:12.
31. Onder G, Pedone C, Landi F, Cesari M, Della Vedova C, Bernabei R, et al. Adverse drug reactions as cause of hospital admissions: results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc. 2002;50(12):1962-8.
32. Eickhoff C, Hammerlein A, Griese N, Schulz M. Nature and frequency of drug-related problems in self-medication (over-the-counter drugs) in daily community pharmacy practice in Germany. Pharmacoepidemiol Drug Saf. 2012;21(3):254-60.
33. Lewis JD, Kimmel SE, Localio AR, Metz DC, Farrar JT, Nessel L, et al. Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005;129(6):1865-74.
34. Huang ES, Strate LL, Ho WW, Lee SS, Chan AT. Long-term use of aspirin and the risk of gastrointestinal bleeding. Am J Med. 2011;124(5):426-33.
35. Singh G. Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther. 2000;7(2):115-21.
36. Langley PC. The prevalence, correlates and treatment of pain in the European Union. Curr Med Res Opin. 2011;27(2):463-80.
37. Lanas A, Serrano P, Bajador E, Fuentes J, Sainz R. Risk of upper gastrointestinal bleeding associated with non-aspirin cardiovascular drugs, analgesics and nonsteroidal anti-inflammatory drugs. Eur J Gastroenterol Hepatol. 2003;15(2):173-8.
38. Klemenc-Ketis Z, Kersnik J. Sources and predictors of home-kept prescription drugs. Int J Clin Pharmacol Ther. 2010;48(11):705-7.
39. Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie. 1978;33(3):373-81.
40. Macedo AF, Marques FB, Ribeiro CF. Can decisional algorithms replace global introspection in the individual causality assessment of spontaneously reported ADRs? Drug Saf. 2006;29(8):697-702.
41. Gallagher RM, Kirkham JJ, Mason JR, Bird KA, Williamson PR, Nunn AJ, et al. Development and inter-rater reliability of the Liverpool adverse drug reaction causality assessment tool. PloS One. 2011;6(12):e28096.
42. Theophile H, Andre M, Miremont-Salame G, Arimone Y, Begaud B. Comparison of three methods (an updated logistic probabilistic method, the Naranjo and Liverpool algorithms) for the evaluation of routine pharmacovigilance case reports using consensual expert judgement as reference. Drug Saf. 2013;36(10):1033-44.