Drugs and Adverse Drug ReactionsHow Worried Should We Be?

JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 05/1998; 279(15):1216-1217. DOI: 10.1001/jama.279.15.1216


Physicians can hardly pick up a medical journal or a newspaper today
without reading about some new medication, and how it promises to completely
change the course of a disease or relieve some troublesome symptom. Indeed,
the wonders of pharmacology are numerous. It is clear, for example, that after
a myocardial infarction patients will live longer if they take β-blockers 1 and that patients with congestive heart failure live
longer and feel better when they take angiotensin-converting enzyme inhibitors.2 However, medications are a double-edged sword.


Available from: David W Bates
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    • "Outpatient medication use is common, but may confer health risks that compromise its therapeutic benefits [1-3]. Health risks associated with medications have been shown to vary substantially in clinical practice from those observed in published randomized controlled trials [4,5]. "
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    ABSTRACT: Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data. We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data. Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0--11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%). Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.
    BMC Health Services Research 11/2013; 13(1):473. DOI:10.1186/1472-6963-13-473 · 1.71 Impact Factor
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    • "In about 3-6% patients of varying ages, ADRs lead to hospital admissions whereas this number can go as high as 24% in elders. About 5.9-22.3% of all emergency cases can be attributed to ADRs.[17181920] ADRs rank among the 4-6th highest cause of mortality in the US, leading to as many as 106,000 deaths on a yearly basis.[121] In Southern India, Ramesh et al. found that in a small tertiary care hospital, 0.7% cases were admitted as a result of ADRs and as many as 18 among 1000 patients died because of the same.[5] "
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    ABSTRACT: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists' participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012. Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.
    Perspectives in clinical research 03/2013; 4(4):204-210. DOI:10.4103/2229-3485.120168
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    • "In some estimates, ADIs represent the fourth-to sixth-leading cause of death in the United States (Lazarou et al., 1998; Bates, 1998). Induction or inhibition of cytochrome P450s (CYPs) represents one of the most common causes of DDIs, and many of these interactions involve CYP3A4 (Guengerich, 1997). "
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    ABSTRACT: Adopted orphan nuclear receptor (NR), pregnane X receptor (PXR), plays a central role in the regulation of xeno- and endobiotic metabolism. Since the discovery of the functional role of PXR in 1998, there is evolving evidence for the role of PXR agonists in abrogating metabolic pathophysiology (e.g., cholestasis, hypercholesterolemia, and inflammation). However, more recently, it is clear that PXR is also an important mediator of adverse xeno- (e.g., enhances acetaminophen toxicity) and endobiotic (e.g., hepatic steatosis) metabolic phenotypes. Moreover, in cancer therapeutics, PXR activation can induce drug resistance, and there is growing evidence for tissue-specific enhancement of the malignant phenotype. Thus, in these instances, there may be a role for PXR antagonists. However, as opposed to the discovery efforts for PXR agonists, there are only a few antagonists described. The mode of action of these antagonists (e.g., sulforaphane) remains less clear. Our laboratory efforts have focused on this question. Since the original discovery of azoles analogs as PXR antagonists, we have preliminarily defined an important PXR antagonist pharmacophore and developed less-toxic PXR antagonists. In this review, we describe our published and unpublished findings on recent structure-function studies involving the azole chemical scaffold. Further work in the future is needed to fully define potent, more-selective PXR antagonists that may be useful in clinical application.
    Drug Metabolism Reviews 02/2013; 45(1):60-72. DOI:10.3109/03602532.2012.746363 · 5.36 Impact Factor
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