Prevalence and perceived preventability of self-reported adverse drug events--a population-based survey of 7099 adults

Katja Marja Hakkarainen, Karolina Andersson Sundell, Max Petzold, Staffan Hägg, Katja Marja Hakkarainen, Karolina Andersson Sundell, Max Petzold, Staffan Hägg

Abstract

Purpose: Adverse drug events (ADEs) are common and often preventable among inpatients, but self-reported ADEs have not been investigated in a representative sample of the general public. The objectives of this study were to estimate the 1-month prevalence of self-reported ADEs among the adult general public, and the perceived preventability of 2 ADE categories: adverse drug reactions (ADRs) and sub-therapeutic effects (STEs).

Methods: In this cross-sectional study, a postal survey was sent in October 2010 to a random sample of 13 931 Swedish residents aged ≥ 18 years. Self-reported ADEs experienced during the past month included ADRs, STEs, drug dependence, drug intoxications and morbidity due to drug-related untreated indication. ADEs could be associated with prescription, non-prescription or herbal drugs. The respondents estimated whether ADRs and STEs could have been prevented. ADE prevalences in age groups (18-44, 45-64, or ≥65 years) were compared.

Results: Of 7099 respondents (response rate 51.0%), ADEs were reported by 19.4% (95% confidence interval, 18.5-20.3%), and the prevalence did not differ by age group (p>0.05). The prevalences of self-reported ADRs, STEs, and morbidities due to drug-related untreated indications were 7.8% (7.2-8.4%), 7.6% (7.0-8.2%) and 8.1% (7.5-8.7%), respectively. The prevalence of self-reported drug dependence was 2.2% (1.9-2.6%), and drug intoxications 0.2% (0.1-0.3%). The respondents considered 19.2% (14.8-23.6%) of ADRs and STEs preventable. Although reported drugs varied between ADE categories, most ADEs were attributable to commonly dispensed drugs. Drugs reported for all and preventable events were similar.

Conclusions: One-fifth of the adult general public across age groups reported ADEs during the past month, indicating a need for prevention strategies beyond hospitalised patients. For this, the underlying causes of ADEs should increasingly be investigated. The high burden of ADEs and preventable ADEs from widely used drugs across care settings supports redesigning a safer healthcare system to adequately tackle the problem.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Study flow diagram.
Figure 1. Study flow diagram.

References

    1. World Health Organization (2009) WHO patient safety research - Better knowledge for safer care. France: World Health Organization.
    1. Ministry of Health and Social Affairs (2011) National medication strategy [in Swedish]. Stockholm: Ministry of Health and Social Affairs.
    1. Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, et al. (1995) Incidence of adverse drug events and potential adverse drug events: Implications for prevention. ADE prevention study group. JAMA 274: 29–34.
    1. Leendertse AJ, Visser D, Egberts AC, van den Bemt PM (2010) The relationship between study characteristics and the prevalence of medication-related hospitalizations: A literature review and novel analysis. Drug Saf 33: 233–244 10.2165/11319030-000000000-00000.
    1. Aronson JK, Ferner RE (2005) Clarification of terminology in drug safety. Drug Saf 28: 851–870.
    1. Kanjanarat P, Winterstein AG, Johns TE, Hatton RC, Gonzalez-Rothi R, et al. (2003) Nature of preventable adverse drug events in hospitals: A literature review. Am J Health Syst Pharm 60: 1750–1759.
    1. Thomsen LA, Winterstein AG, Sondergaard B, Haugbolle LS, Melander A (2007) Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother 41: 1411–1426 10.1345/aph.1H658.
    1. Winterstein AG, Sauer BC, Hepler CD, Poole C (2002) Preventable drug-related hospital admissions. Ann Pharmacother 36: 1238–1248.
    1. Hakkarainen KM, Hedna K, Petzold M, Hägg S (2012) Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions - A meta-analysis. PLoS ONE 7: e33236 10.1371/journal.pone.0033236.
    1. Krahenbuhl-Melcher A, Schlienger R, Lampert M, Haschke M, Drewe J, et al. (2007) Drug-related problems in hospitals: A review of the recent literature. Drug Saf 30: 379–407.
    1. Cano FG, Rozenfeld S (2009) Adverse drug events in hospitals: A systematic review. Cad Saude Publica 25 Suppl 3S360–72.
    1. Weissman JS, Schneider EC, Weingart SN, Epstein AM, David-Kasdan J, et al. (2008) Comparing patient-reported hospital adverse events with medical record review: Do patients know something that hospitals do not? Ann Intern Med 149: 100–108.
    1. Isacson D, Johansson L, Bingefors K (2008) Nationwide survey of subjectively reported adverse drug reactions in Sweden. Ann Pharmacother 42: 347–353 10.1345/aph.1K488.
    1. Weingart SN, Gandhi TK, Seger AC, Seger DL, Borus J, et al. (2005) Patient-reported medication symptoms in primary care. Arch Intern Med 165: 234–240 10.1001/archinte.165.2.234.
    1. Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, et al. (2003) Adverse drug events in ambulatory care. N Engl J Med 348: 1556–1564 10.1056/NEJMsa020703.
    1. Chrischilles EA, Segar ET, Wallace RB (1992) Self-reported adverse drug reactions and related resource use. A study of community-dwelling persons 65 years of age and older. Ann Intern Med 117: 634–640.
    1. Hutchinson TA, Flegel KM, Kramer MS, Leduc DG, Kong HH (1986) Frequency, severity and risk factors for adverse drug reactions in adult out-patients: A prospective study. J Chronic Dis 39: 533–542.
    1. Oladimeji O, Farris KB, Urmie JG, Doucette WR (2008) Risk factors for self-reported adverse drug events among medicare enrollees. Ann Pharmacother 42: 53–61 10.1345/aph.1K073.
    1. Gandhi TK, Burstin HR, Cook EF, Puopolo AL, Haas JS, et al. (2000) Drug complications in outpatients. J Gen Intern Med 15: 149–154.
    1. Green JL, Hawley JN, Rask KJ (2007) Is the number of prescribing physicians an independent risk factor for adverse drug events in an elderly outpatient population? Am J Geriatr Pharmacother 5: 31–39.
    1. Chrischilles E, Rubenstein L, Van Gilder R, Voelker M, Wright K, et al. (2007) Risk factors for adverse drug events in older adults with mobility limitations in the community setting. J Am Geriatr Soc 55: 29–34 10.1111/j.1532–5415.2006.01034.x.
    1. Shiyanbola OO, Farris KB (2010) Concerns and beliefs about medicines and inappropriate medications: An internet-based survey on risk factors for self-reported adverse drug events among older adults. Am J Geriatr Pharmacother 8: 245–257 10.1016/j.amjopharm.2010.06.002.
    1. Cuijpers P (2011) The patient perspective in research on major depression. BMC Psychiatry 11: 89 10.1186/1471-244X-11-89.
    1. Gibson PG, McDonald VM, Marks GB (2010) Asthma in older adults. Lancet 376: 803–813 10.1016/S0140-6736(10)61087-2.
    1. Zorba Paster R (2010) Chronic pain management issues in the primary care setting and the utility of long-acting opioids. Expert Opin Pharmacother 11: 1823–1833 10.1517/14656566.2010.491510.
    1. Al-Olah YH, Al Thiab KM (2008) Admissions through the emergency department due to drug-related problems. Ann Saudi Med 28: 426–429.
    1. Compton WM, Thomas YF, Stinson FS, Grant BF (2007) Prevalence, correlates, disability, and comorbidity of DSM-IV drug abuse and dependence in the united states: Results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry 64: 566–576 10.1001/archpsyc.64.5.566.
    1. Jonsson AK, Spigset O, Tjaderborn M, Druid H, Hägg S (2009) Fatal drug poisonings in a Swedish general population. BMC Clin Pharmacol 9: 7 10.1186/1472-6904-9-7.
    1. Zargarzadeh AH, Emami MH, Hosseini F (2007) Drug-related hospital admissions in a generic pharmaceutical system. Clin Exp Pharmacol Physiol 34: 494–498 10.1111/j.1440-1681.2007.04600.x.
    1. Raschetti R, Morgutti M, Menniti-Ippolito F, Belisari A, Rossignoli A, et al. (1999) Suspected adverse drug events requiring emergency department visits or hospital admissions. Eur J Clin Pharmacol 54: 959–963.
    1. Franceschi A, Tuccori M, Bocci G, Vannozzi F, Di Paolo A, et al. (2004) Drug therapeutic failures in emergency department patients. A university hospital experience. Pharmacol Res 49: 85–91.
    1. Hallas J, Harvald B, Gram LF, Grodum E, Brosen K, et al. (1990) Drug related hospital admissions: The role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 228: 83–90.
    1. Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW (2004) Adverse drug events and medication errors: Detection and classification methods. Qual Saf Health Care 13: 306–314 10.1136/qhc.13.4.306.
    1. Edwards IR, Aronson JK (2000) Adverse drug reactions: Definitions, diagnosis, and management. Lancet 356: 1255–1259 10.1016/S0140-6736(00)02799-9.
    1. Goettler M, Schneeweiss S, Hasford J (1997) Adverse drug reaction monitoring - Cost and benefit considerations. Part II: Cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol Drug Saf 6 Suppl 3 S79–90: 2–O.
    1. World Health Organization (1972) Technical report series. International drug monitoring: The role of national centres. Geneva: World Health Organization.
    1. Uppsala Monitoring Centre (2013) Glossary of terms used in pharmacovigilance. Uppsala Monitoring Centre.
    1. van Gijssel-Wiersma DG, van den Bemt PM, Walenbergh-van Veen MC (2005) Influence of computerised medication charts on medication errors in a hospital. Drug Saf 28: 1119–1129.
    1. Hallas J, Harvald B, Worm J, Beck-Nielsen J, Gram LF, et al. (1993) Drug related hospital admissions: Results from an intervention program. Eur J Clin Pharmacol 45: 199–203.
    1. American Psychiatric Association (2000) Diagnostic and statistical manual of mental disorders (DSM-IV). Washington, DC: American Psychiatric Association.
    1. Gyllensten H, Rehnberg C, Jonsson AK, Petzold M, Carlsten A, et al... (2013) Cost of illness of patient-reported adverse drug events: A population-based cross-sectional survey. BMJ Open 3: 10.1136/bmjopen-2013-002574. Print 2013. 10.1136/bmjopen-2013-002574; 10.1136/bmjopen-2013-002574.
    1. Wettermark B, Hammar N, Fored CM, Leimanis A, Otterblad Olausson P, et al. (2007) The new Swedish Prescribed Drug Register - Opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Saf 16: 726–735 10.1002/pds.1294.
    1. World Health Organization (2009) Guidelines for ATC classification and DDD assignment 2010. Oslo: WHO Collaborating Centre for Drug Statistics Methodology.
    1. Danielsson M, Talback M (2012) Public health: An overview: Health in Sweden: The national public health report 2012. Chapter 1. Scand J Public Health 40: 6–22 10.1177/1403494812459457; 10.1177/1403494812459457.
    1. Weitoft GR, Ericsson O, Fastbom J (2012) Prescription drugs: Health in Sweden: The national public health report 2012. Chapter 18. Scand J Public Health 40: 293–304 10.1177/1403494812459623; 10.1177/1403494812459623.
    1. Medical Dictionary for Regulatory Activities (2011) Introductory guide MedDRA version 14.0, document MSSO-DI-6003-14.0.0. Geneva: Medical Dictionary for Regulatory Activities.
    1. Gurwitz JH, Field TS, Avorn J, McCormick D, Jain S, et al. (2000) Incidence and preventability of adverse drug events in nursing homes. Am J Med 109: 87–94.
    1. Masotti P, McColl MA, Green M (2010) Adverse events experienced by homecare patients: A scoping review of the literature. Int J Qual Health Care 22: 115–125 10.1093/intqhc/mzq003.
    1. de Souto Barreto P (2012) Participation bias in postal surveys among older adults: The role played by self-reported health, physical functional decline and frailty. Arch Gerontol Geriatr 55: 592–592 10.1016/j.archger.2012.03.008.
    1. Gyllensten H, Hakkarainen KM, Jonsson AK, Andersson Sundell K, Hägg S, et al. (2012) Modelling drug-related morbidity in Sweden using an expert panel of pharmacists. Int J Clin Pharm 34: 538–546 10.1007/s11096-012-9641-3.
    1. Hakkarainen KM, Alstrom D, Hägg S, Carlsten A, Gyllensten H (2012) Modelling drug-related morbidity in Sweden using an expert panel of physicians. Eur J Clin Pharmacol 68: 1309–1319 10.1007/s00228-012-1244-3.
    1. Swedish National Institute of Public Health (2010) Narcotics use in Sweden [in Swedish]. Östersund: Swedish National Institute of Public Health. 66 p.
    1. Koneri R, Prakasam K, Mishra V, Rajan H (2008) Drug-related hospitalizations at a tertiary level hospital in bangalore: A prospective study. J Clin Diagn Res 2: 736–740.
    1. Nelson KM, Talbert RL (1996) Drug-related hospital admissions. Pharmacotherapy 16: 701–707.
    1. Hallas J, Gram LF, Grodum E, Damsbo N, Brosen K, et al. (1992) Drug related admissions to medical wards: A population based survey. Br J Clin Pharmacol 33: 61–68.
    1. Rogers S, Wilson D, Wan S, Griffin M, Rai G, et al. (2009) Medication-related admissions in older people: A cross-sectional, observational study. Drugs Aging 26: 951–961 10.2165/11316750-000000000-00000.
    1. Johnson JA, Bootman JL (1995) Drug-related morbidity and mortality. A cost-of-illness model. Arch Intern Med 155: 1949–1956.
    1. Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, et al... (2011) Evaluation of patient reporting of adverse drug reactions to the UK ‘yellow card scheme’: Literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess 15: 1–234, iii–iv. 10.3310/hta15200; 10.3310/hta15200.
    1. Pirmohamed M, James S, Meakin S, Green C, Scott AK, et al. (2004) Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ 329: 15–19 10.1136/bmj.329.7456.15.
    1. Kongkaew C, Noyce PR, Ashcroft DM (2008) Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann Pharmacother 42: 1017–1025 10.1345/aph.1L037.
    1. Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, et al. (2009) Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes. PLoS ONE 4: e4439 10.1371/journal.pone.0004439.
    1. Wiffen P, Gill M, Edwards J, Moore A (2002) Adverse drug reactions in hospital patients – A systematic review of the prospective and retrospective studies. Bandolier Extra: 1–16.
    1. Millar JS (2001) Consultations owing to adverse drug reactions in a single practice. Br J Gen Pract 51: 130–131.
    1. Dequito AB, Mol PG, van Doormaal JE, Zaal RJ, van den Bemt PM, et al. (2011) Preventable and non-preventable adverse drug events in hospitalized patients: A prospective chart review in the netherlands. Drug Saf 34: 1089–1100 10.2165/11592030-000000000-00000.
    1. Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, et al. (2007) Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 63: 136–147 10.1111/j.1365–2125.2006.02698.x.
    1. Edwards IR (2012) Prevention and pharmacovigilance: What should we do, what can we do? Drug Saf 35: 87–90 10.2165/11630510-000000000-00000.
    1. Bates DW, Miller EB, Cullen DJ, Burdick L, Williams L, et al. (1999) Patient risk factors for adverse drug events in hospitalized patients. ADE prevention study group. Arch Intern Med 159: 2553–2560.
    1. Runciman WB, Edmonds MJ, Pradhan M (2002) Setting priorities for patient safety. Qual Saf Health Care 11: 224–229.
    1. Basch E (2010) The missing voice of patients in drug-safety reporting. N Engl J Med 362: 865–869 10.1056/NEJMp0911494; 10.1056/NEJMp0911494.
    1. Lau PM, Stewart K, Dooley M (2004) The ten most common adverse drug reactions (ADRs) in oncology patients: Do they matter to you? Support Care Cancer 12: 626–633 10.1007/s00520-004-0622-5.
    1. Vincent C (2010) Clinical interventions and process improvement. In: Vincent C, editor. Patient Safety. West Sussex: Wiley-Blackwell. 211–229.
    1. Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, et al. (1998) Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 280: 1311–1316.
    1. Leape LL, Cullen DJ, Clapp MD, Burdick E, Demonaco HJ, et al. (1999) Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 282: 267–270.
    1. Nanji KC, Rothschild JM, Salzberg C, Keohane CA, Zigmont K, et al. (2011) Errors associated with outpatient computerized prescribing systems. J Am Med Inform Assoc 18: 767–773 10.1136/amiajnl-2011-000205; 10.1136/amiajnl-2011-000205.
    1. Patterson ES, Cook RI, Render ML (2002) Improving patient safety by identifying side effects from introducing bar coding in medication administration. J Am Med Inform Assoc 9: 540–553.
    1. Woods DD (2000) Behind human error: Human factors research to improve patient safety. National Summit on Medical Errors and Patient Safety Research, Quality Interagency Coordination Task Force and Agency for Healthcare Research and Quality.
    1. Nolan TW (2000) System changes to improve patient safety. BMJ 320: 771–773.
    1. Vincent C (2010) High performing healthcare systems. In: Vincent C, editor. Patient Safety. West Sussex: Wiley-Blackwell. 390–404.
    1. Leape LL (2006) System analysis and redesign: The foundation of medical error prevention. In: Cohen MR, editor. Medication errors. Washington DC: American Pharmacists’ Association. 3–14.
    1. Hakkarainen KM, Andersson Sundell K, Petzold M, Hägg S (2012) Methods for assessing the preventability of adverse drug events: A systematic review. Drug Saf 35: 105–126 10.2165/11596570-000000000-00000.
    1. Boström G (2009) The impact of non-response bias in public health surveys [in Swedish]. Östersund: National Institute of Public Health. 2 p.

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