Skip to main content
Erschienen in: Drug Safety 4/2014

01.04.2014 | Original Research Article

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

verfasst von: Sven Schmiedl, Marietta Rottenkolber, Joerg Hasford, Dominik Rottenkolber, Katrin Farker, Bernd Drewelow, Marion Hippius, Karen Saljé, Petra Thürmann

Erschienen in: Drug Safety | Ausgabe 4/2014

Einloggen, um Zugang zu erhalten

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.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
2.
Zurück zum Zitat Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027–37.PubMedCrossRef Hughes CM, McElnay JC, Fleming GF. Benefits and risks of self medication. Drug Saf. 2001;24(14):1027–37.PubMedCrossRef
3.
Zurück zum Zitat Soller RW. Evolution of self-care with over-the-counter medications. Clin Ther. 1998;20 Suppl C:C134–40. Soller RW. Evolution of self-care with over-the-counter medications. Clin Ther. 1998;20 Suppl C:C134–40.
4.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
5.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
6.
Zurück zum Zitat 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.PubMed 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.PubMed
7.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
8.
Zurück zum Zitat Bond C, Hannaford P. Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf. 2003;26(15):1065–74.PubMedCrossRef Bond C, Hannaford P. Issues related to monitoring the safety of over-the-counter (OTC) medicines. Drug Saf. 2003;26(15):1065–74.PubMedCrossRef
9.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
10.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
11.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
12.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
13.
Zurück zum Zitat WHO. International drug monitoring. In: The role of hospital. Geneva: World Health Organisation; 1969. WHO. International drug monitoring. In: The role of hospital. Geneva: World Health Organisation; 1969.
14.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
15.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
16.
Zurück zum Zitat WHO. Anatomical therapeutic chemical (ATC) classification index. Geneva: WHO Collaborating Centre for Drug Statistics Methodology; 1992. WHO. Anatomical therapeutic chemical (ATC) classification index. Geneva: WHO Collaborating Centre for Drug Statistics Methodology; 1992.
17.
Zurück zum Zitat 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. 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.
Zurück zum Zitat Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109–17.PubMedCrossRef Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109–17.PubMedCrossRef
19.
Zurück zum Zitat Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.PubMedCrossRef Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.PubMedCrossRef
20.
Zurück zum Zitat Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229–32.PubMed Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229–32.PubMed
24.
Zurück zum Zitat 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/. 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.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
26.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
27.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
28.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
29.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
30.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
31.
Zurück zum Zitat 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. 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.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
33.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
34.
35.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
36.
Zurück zum Zitat Langley PC. The prevalence, correlates and treatment of pain in the European Union. Curr Med Res Opin. 2011;27(2):463–80.PubMedCrossRef Langley PC. The prevalence, correlates and treatment of pain in the European Union. Curr Med Res Opin. 2011;27(2):463–80.PubMedCrossRef
37.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
38.
Zurück zum Zitat Klemenc-Ketis Z, Kersnik J. Sources and predictors of home-kept prescription drugs. Int J Clin Pharmacol Ther. 2010;48(11):705–7.PubMedCrossRef Klemenc-Ketis Z, Kersnik J. Sources and predictors of home-kept prescription drugs. Int J Clin Pharmacol Ther. 2010;48(11):705–7.PubMedCrossRef
39.
Zurück zum Zitat Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie. 1978;33(3):373–81. Dangoumau J, Evreux JC, Jouglard J. Method for determination of undesirable effects of drugs. Therapie. 1978;33(3):373–81.
40.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
41.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
42.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
Metadaten
Titel
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
verfasst von
Sven Schmiedl
Marietta Rottenkolber
Joerg Hasford
Dominik Rottenkolber
Katrin Farker
Bernd Drewelow
Marion Hippius
Karen Saljé
Petra Thürmann
Publikationsdatum
01.04.2014
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 4/2014
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-014-0141-3

Weitere Artikel der Ausgabe 4/2014

Drug Safety 4/2014 Zur Ausgabe