Advertisement

Drug Safety

, Volume 37, Issue 4, pp 225–235 | Cite as

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

  • Sven Schmiedl
  • Marietta Rottenkolber
  • Joerg Hasford
  • Dominik Rottenkolber
  • Katrin Farker
  • Bernd Drewelow
  • Marion Hippius
  • Karen Saljé
  • Petra Thürmann
Original Research Article

Abstract

Background

Self-medication, including both the use of over-the-counter (OTC) drugs and the use of formerly prescribed drugs taken without a current physician’s recommendation, is a public health concern; however, little data exist regarding the actual risk.

Objective

We aimed to analyse self-medication-related adverse drug reactions (ADRs) leading to hospitalisation.

Methods

In a multi-centre, observational study covering a hospital catchment area of approximately 500,000 inhabitants, we analysed self-medication-related ADRs leading to hospital admissions in internal medicine departments. Data of patients with ADRs were comprehensively documented, and ADR causality was assessed using Bégaud’s algorithm. The included ADRs occurred between January 2000 and December 2008 and were assessed to be at least ‘possibly’ drug related.

Results

Of 6,887 patients with ADRs, self-medication was involved in 266 (3.9 %) patients. In 143 (53.8 %) of these patients, ADRs were due to OTC drugs. Formerly prescribed drugs and potential OTC drugs accounted for the remaining ADRs. Most self-medication-related ADRs occurred in women aged 70–79 years and in men aged 60–69 years. Self-medication-related ADRs were predominantly gastrointestinal complaints caused by non-steroidal anti-inflammatory drugs (most frequently OTC acetylsalicylic acid [ASA, aspirin]). In 102 (38.3 %) of the patients with self-medication-related ADRs, a relevant drug–drug interaction (DDI), occurring between a self-medication and a prescribed medication, was present (most frequently ASA taken as an OTC drug and prescribed diclofenac).

Conclusion

In the general population, self-medication plays a limited role in ADRs leading to hospitalisation. However, prevention strategies focused on elderly patients and patients receiving interacting prescribed drugs would improve patient safety.

Keywords

Ibuprofen Phenprocoumon Internal Medicine Department Electronic Supplementary Table Anatomical Therapeutic Chemical Group 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The authors thank the following colleagues from the network of regional pharmacovigilance centres for their contribution over the years in data collection (regional centres Rostock, Greifswald, Jena and Weimar) and in quality assurance (Wuppertal): S. Müller, A. Zachow (Rostock), W. Siegmund, K. Wergin (Greifswald), D. Gruca, A. Scheuerlein (Jena), I.R. Günther, S. Surber, K. Fricke, B. Henzgen, R. Fünfstück (Weimar), S. Haffner and J. Szymanski (Wuppertal). We would also like to express our gratitude to Elizabeth Costello for language checking.

Conflicts of Interest

Bernd Drewelow has received lecture fees from BayerVital, Astra Zeneca and Pfizer; Katrin Farker has received third-party funding for research projects from Mitsubishi Pharma Deutschland GmbH and Novartis Pharma GmbH; Sven Schmiedl, Marietta Rottenkolber, Joerg Hasford, Dominik Rottenkolber, Marion Hippius, Karen Saljé and Petra Thürmann have no conflicts of interest to declare.

Sources of funding

The project was supported by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM], Bonn, Germany), V-11337/68605/2008-2010. The funding organization had no impact on study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Supplementary material

40264_2014_141_MOESM1_ESM.pdf (277 kb)
Supplementary material 1 (PDF 277 kb)

References

  1. 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. 2.
    Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027–37.PubMedCrossRefGoogle Scholar
  3. 3.
    Soller RW. Evolution of self-care with over-the-counter medications. Clin Ther. 1998;20 Suppl C:C134–40.Google Scholar
  4. 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.PubMedCrossRefGoogle Scholar
  5. 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.PubMedCrossRefGoogle Scholar
  6. 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.PubMedGoogle Scholar
  7. 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.PubMedCrossRefGoogle Scholar
  8. 8.
    Bond C, Hannaford P. Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf. 2003;26(15):1065–74.PubMedCrossRefGoogle Scholar
  9. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  10. 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.PubMedCrossRefGoogle Scholar
  11. 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.PubMedCrossRefGoogle Scholar
  12. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  13. 13.
    WHO. International drug monitoring. In: The role of hospital. Geneva: World Health Organisation; 1969.Google Scholar
  14. 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.PubMedCrossRefGoogle Scholar
  15. 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.PubMedCrossRefGoogle Scholar
  16. 16.
    WHO. Anatomical therapeutic chemical (ATC) classification index. Geneva: WHO Collaborating Centre for Drug Statistics Methodology; 1992.Google Scholar
  17. 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.Google Scholar
  18. 18.
    Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109–17.PubMedCrossRefGoogle Scholar
  19. 19.
    Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.PubMedCrossRefGoogle Scholar
  20. 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.PubMedGoogle Scholar
  21. 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. 22.
    World Health Organization. Patient Safety Programme. 2004 [cited 14/JAN/2014]. http://www.who.int/patientsafety/about/en/.
  23. 23.
    The Joint Commission. 2013 National Patient Safety Goals. 2013 [cited 14/JAN/2014]. http://www.jointcommission.org/standards_information/npsgs.aspx.
  24. 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. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  26. 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.PubMedCrossRefGoogle Scholar
  27. 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.PubMedCrossRefGoogle Scholar
  28. 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.PubMedCrossRefGoogle Scholar
  29. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  30. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  31. 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.Google Scholar
  32. 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.PubMedCrossRefGoogle Scholar
  33. 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.PubMedCrossRefGoogle Scholar
  34. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  35. 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.PubMedCrossRefGoogle Scholar
  36. 36.
    Langley PC. The prevalence, correlates and treatment of pain in the European Union. Curr Med Res Opin. 2011;27(2):463–80.PubMedCrossRefGoogle Scholar
  37. 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.PubMedCrossRefGoogle Scholar
  38. 38.
    Klemenc-Ketis Z, Kersnik J. Sources and predictors of home-kept prescription drugs. Int J Clin Pharmacol Ther. 2010;48(11):705–7.PubMedCrossRefGoogle Scholar
  39. 39.
    Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie. 1978;33(3):373–81.Google Scholar
  40. 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.PubMedCrossRefGoogle Scholar
  41. 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.PubMedCentralPubMedCrossRefGoogle Scholar
  42. 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.PubMedCrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Sven Schmiedl
    • 1
    • 2
  • Marietta Rottenkolber
    • 3
  • Joerg Hasford
    • 3
  • Dominik Rottenkolber
    • 4
    • 5
  • Katrin Farker
    • 6
    • 7
  • Bernd Drewelow
    • 8
  • Marion Hippius
    • 6
  • Karen Saljé
    • 9
  • Petra Thürmann
    • 1
    • 2
  1. 1.Philipp-Klee Institute for Clinical PharmacologyHELIOS Clinic WuppertalWuppertalGermany
  2. 2.Department of Clinical Pharmacology, School of Medicine, Faculty of HealthWitten/Herdecke UniversityWittenGermany
  3. 3.Institute for Medical Information Sciences, Biometry, and EpidemiologyLudwig-Maximilians-Universität MünchenMünchenGermany
  4. 4.Institute of Health Economics and Health Care Management and Munich Centre of Health SciencesLudwig-Maximilians-Universität MünchenMünchenGermany
  5. 5.HelmholtzZentrum München, German Research Centre for Environmental HealthNeuherbergGermany
  6. 6.Department of Clinical Pharmacology, Institute of Pharmacology and ToxicologyJena University Hospital, Friedrich Schiller University JenaJenaGermany
  7. 7.Sophien- und Hufeland-Klinikum WeimarWeimarGermany
  8. 8.Institute of Clinical Pharmacology, Centre for Pharmacology and ToxicologyUniversity of RostockRostockGermany
  9. 9.Institute of Clinical PharmacologyUniversity of GreifswaldGreifswaldGermany

Personalised recommendations