Adverse drug reactions in medical intensive care unit of a tertiary care hospital
ABSTRACT Patients in the intensive care unit (ICU) have multiorgan dysfunction as well as altered pharmacokinetic parameters. Hence they are susceptible to adverse drug reactions (ADRs). The objective of the study is to assess the characteristics of ADRs among inpatients in the medical ICU and to compare the same with patients who have not experienced ADRs.
Prospective, observational study for a period of 1 year in medical ICU of a tertiary care hospital. Relevant data of patients with ADRS were analysed. Characteristics of patients with and without ADRs were compared.
Of 728 patients admitted in medical ICU, 222 (28.4%) had ADRs. Multiple ADRs (38.7%) implicated by the same drug and serious ADRs (37%) were noticed. Renal/electrolyte system (21%) was most commonly involved. Clinical spectrum included acute renal failure (ARF, 11.4%), hepatic injuries (5.4%), haematological dysfunction (4.2%), seizures (3.3%), upper gastrointestinal bleed (3.3%) and cutaneous ADRs (3.3%). Antimicrobials (27%) were the commonly implicated drug class. The most commonly implicated drug was furosemide (6.8%). Infrequently reported ADRs included azithromycin-induced erythema multiforme, leflunamide-induced erythema multiforme and vasculitis, ceftazidime-induced seizures and ceftriaxone-induced hepatitis. Co-morbidity, polypharmacy and duration of stay were significantly higher in patients with ADRs compared to those who have not experienced ADRs. Three patients died.
High incidence of serious and multiple ADRs noticed. A wide clinical spectrum of ADRs and infrequently reported ADRs to newer drugs were also observed.
- [Show abstract] [Hide abstract]
ABSTRACT: Animals recovered from acute renal failure are resistant to subsequent insult. We investigated whether rats recovered from mild proximal tubule (PT) injury without renal dysfunction (subclinical renal damage) acquire the same resistance. Rats 14 days after recovering from subclinical renal damage, which was induced by 0.2 mg/kg of uranyl acetate (UA) (sub-toxic dose), were rechallenged with 4 mg/kg of UA (nephrotoxic dose). Fate of PT cells and renal function were examined in response to nephrotoxic dose of UA. All divided cells after sub-toxic dose of UA insult were labeled with bromodeoxyuridine (BrdU) for 14 days then the number of PT cells with or without BrdU-labeling was counted following nephrotoxic dose of UA insult. Rats recovered from subclinical renal damage gained resistance to nephrotoxic dose of UA with reduced renal dysfunction, less severity of peak damage (necrotic and TUNEL+ apoptotic cells) and accelerated PT cell proliferation, but with earlier peak of PT damage. The decrease in number of PT cells in the early phase of rechallenge injury with nephrotoxic UA was more in rats pretreated with sub-toxic dose of UA than vehicle pretreated rats. The exaggerated loss of PT cells was mainly caused by the exaggerated loss of BrdU+ divided cells. In contrast, accelerated cell proliferation in rats recovered from sub-toxic dose of UA was observed mainly in BrdU- non-divided cells. The findings suggest that rats recovered from subclinical renal damage showed partial acquired resistance to nephrotoxic insult. Accelerated recovery with increased proliferative activity of non-divided PT cells after subclinical renal damage may mainly contribute to acquired resistance.Toxicology and Applied Pharmacology 02/2010; 243(1-243):104-110. DOI:10.1016/j.taap.2009.11.018 · 3.63 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: In the last years, many novel drugs have been introduced, generating new patterns of drug hypersensitivity. There are also novel clinical and biologic techniques that have enabled us to understand the mechanisms and diagnosis of reactions to old used drugs. This review summarizes current knowledge on the epidemiology, mechanisms, and clinical and in-vitro diagnosis of these reactions. Traditional and complementary alternate medicines are also causes of adverse drug reactions, and many of them are cataloged as allergy. Research in the field of skin and drug provocation test to antibiotics such as beta-lactams and carbapenems, and iodinated and gadolinium contrast media has allowed the understanding of cross-reactivity reactions and permitted the use of well tolerated alternate drugs in cases of proper negative drug allergy work-up. Many unique cases have been reported, including diverse drugs as infliximab, succinylcholine, hydroxychloroquine, that widen the spectrum of clinical manifestations of drug hypersensitivity to various drugs. Several studies have been published in the field of in-vitro diagnosis, including basophil activation tests, radioallergosorbent test, Immuno-Cap, ELISA, enzyme-linked immunospot assays, and T-cell proliferation tests allowing novel approaches to assess drug allergy. As new and old drugs continue to be used, new reports regarding new and known drug hypersensitivity manifestations are made. Advances in mechanisms are enhanced by the use of new in-vitro techniques to detect specific antibodies or T cells. Research in the field of skin and provocation tests has allowed the use of well tolerated alternate drugs in individuals with proven drug allergy.Current Opinion in Allergy and Clinical Immunology 10/2010; 10(5):457-62. DOI:10.1097/ACI.0b013e32833e0896 · 3.66 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated. This cross-sectional study investigated 299 medical records of patients hospitalized for 5 or more days in an ICU. ADEs were identified through intensive monitoring adopted in hospital pharmacovigilance and also ADE triggers. Adverse drug reactions (ADR) causality was classified using the Naranjo algorithm. Data were analyzed through descriptive analysis, and through univariate and multiple logistic regression. The most frequent ADEs were ADRs type A, of possible causality and moderate severity. The most frequent ADR was drug-induced acute kidney injury. Patients with ADEs related to DIs corresponded to 7% of the sample. The multiple logistic regression showed that length of hospitalization (OR = 1.06) and administration of cardiovascular drugs (OR = 2.2) were associated with the occurrence of ADEs. Adverse drug reactions of clinical significance were the most frequent ADEs in the ICU studied, which reduces patient safety. The number of ADEs related to drug interactions was small, suggesting that clinical manifestations of drug interactions that harm patients are not frequent in ICUs.European Journal of Clinical Pharmacology 06/2011; 67(6):625-32. DOI:10.1007/s00228-010-0987-y · 2.70 Impact Factor