adverse drug reaction (ADR)
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Introduction
A harmful or inpleasant reaction resulting from an intervention related to a medicinal product, which predicts hazard of future administration & warrants prevention &/or specific treatment, alteration of drug dosage or discontinuation of a drug.
Etiology
- risk factors
- number of drugs (> 4)
- heart failure
- liver disease
- multiple medical problems (4-6 or more)
- renal failure
- older age
- lower body weight or lower body mass index
- prior adverse drug reaction
Epidemiology
- 0.4% of people/year visit emergency departments (ED) for adverse drug events (ADE)
- 25% result in hospitalization
- 1% of elderly visit ED for ADE
- almost 50% are hospitalized[8]
- 1.5-5% of hospital admissions
- 6.7% of hospitalized patients
- few anecdotal reports of adverse drug reactions later corroborated[2]
- four medications account for 2/3 of drug-related emergency department visits & hospitalizations in the elderly[3][8]
- anticoagulants, especially warfarin (33%)
- insulins (14%) & oral hypoglycemics (11%)
- antiplatelet agents (13%)
- opioids[8]
- Beer's criteria meds account for < 4% of elderly patient emergency department visits for adverse drug events[8]
Complications
- prolongation of hospitalization
- morbidity & mortality
- drug-induced systemic reactions can last for weeks after stopping offending drug[7]
Management
- stop offending drug
- systemic glucocorticoids for systemic drug reactions
- may be needed for months[7]
Notes
- see drug adverse effect or the drug itself for adverse effects of a specific drug or classes of drug
- as a general rule, the drug would need to be administered at >= 3x the frequency of the adverse drug event to observe 1 event with 95% confidence; thus if frequency is 1%
- probability of observance = 1 - (1 - frequency) exp (number of participants)
- if 100 participants,
- probability of observance = 1 - (1 - 0.01) exp 100 = 0.63
- if 100 participants,
- probability of observance = 1 - (1 - frequency) exp (number of participants)
More general terms
More specific terms
- drug eruption; drug rash
- drug-induced fever
- drug/toxin-induced hepatitis
- NSAID enterocolopathy
- NSAID gastropathy
- serum sickness; serum sickness-like reaction
- type A drug reaction
- type B drug reaction; drug-induced hypersensitivity syndrome; drug rash with eosinophilia & systemic symptoms (DIHS, DRESS)
Additional terms
References
- ↑ Pirmohamed M & Park BK, Toxicology 192:23-32, 2003
- ↑ 2.0 2.1 Loke YK at al, Case reports of suspected drug reactions - Systematic literature survey of follow-up BMJ 2006; 332:335 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16421149
- ↑ 3.0 3.1 Budnitz DS et al. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011 Nov 24; 365:2002 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22111719 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMsa1103053
- ↑ Onder G, Petrovic M, Tangiisuran B, et al. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: The GerontoNet ADR Risk Score. Arch Intern Med 2010; 170(13):1142-1148 PMID: https://www.ncbi.nlm.nih.gov/pubmed/20625022
- ↑ FDA MedWatch program http://www.fda.gov/medwatch/report/hcp.htm
- ↑ Geriatric Review Syllabus, 7th edition Parada JT et al (eds) American Geriatrics Society, 2010
- ↑ 7.0 7.1 7.2 Medical Knowledge Self Assessment Program (MKSAP) 16, 18. American College of Physicians, Philadelphia 2012, 2018.
- ↑ 8.0 8.1 8.2 8.3 8.4 Shehab N, Lovegrove MC, Geller AI et al. US Emergency department visits for outpatient adverse drug events, 2013-2014. JAMA 2016 Nov 22/29; 316:2115 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27893129
Kessler C, Ward MJ, McNaughton CD. Reducing adverse drug events: The need to rethink outpatient prescribing. JAMA 2016 Nov 22/29; 316:2092. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27893112 - ↑ FDA News Release. Sept 28, 2017 FDA improves access to reports of adverse drug reactions. New online tool makes it easier for users to search the FDA Adverse Event Reporting System. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578105.htm
- ↑ Ferner RE. Adverse drug reactions in dermatology. Clin Exp Dermatol. 2015 Mar;40(2):105-9; PMID: https://www.ncbi.nlm.nih.gov/pubmed/25622648
- ↑ Darlenski R, Kazandjieva J, Tsankov N. Systemic drug reactions with skin involvement: Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS. Clin Dermatol. 2015 Sep-Oct;33(5):538-41. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26321400
- ↑ FDA Adverse Events Reporting System (FAERS) Public Dashboard https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm
- ↑ Hajjar ER, Hanlon JT, Artz MB et al Adverse drug reaction risk factors in older outpatients. Am J Geriatr Pharmacother. 2003 Dec;1(2):82-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15555470