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William N Kelly

Publications and source records attributed to William N Kelly.

5 recordsLinked to original sources
PubMed2005

Epidemiology, comparative methods of detection, and preventability of adverse drug events.

BACKGROUND: Adverse drug events (ADEs) continue to be of concern to all health professionals. Even serious ADEs are underreported in all patient-care environments. OBJECTIVE: To discover the incidence and the best detection methods and preventability for ADEs at Al Qassimi Hospital, a 360-bed facility in the United Arab Emirates. METHODS: During the first and fourth quarters of 2003, data collection for ADEs was limited to spontaneous reporting. During the second and third quarters, active monitoring for ADEs took place in the adult, pediatric medical, and intensive care wards. ADEs were assessed for causality using the Naranjo algorithm and for severity and preventability. The incidence of ADEs was calculated and the detection methods were compared. RESULTS: The incidence of ADEs detected through surveillance was significantly higher (p < 0.001) than for ADEs reported spontaneously for both inpatients (3.592 vs 0.068/100 patient days) and outpatients (0.299 vs 0.022/100 patient visits). Most ADEs were judged to be of mild to moderate severity. About 56% of ADEs were judged definite or probable and, of these, 13.8% were consistently judged preventable. The most prevalent drugs implicated were central nervous system (23.6%), antiinfective (17.1%), and cardiovascular (16.5%) agents. The best ADE detection method was using physicians' notes. CONCLUSIONS: Active surveillance for ADEs, with the aid of ADE trigger alerts, yields a significantly higher number of reports than spontaneous reporting. Such surveillance is useful in identifying areas where improvements in the safe use of drugs can be made.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

The quality of published adverse drug event reports.

BACKGROUND: Case reports of adverse drug events (ADEs) are an important source of information. OBJECTIVE: To determine what variables are reported in ADE case reports, how causality was assessed for each report, and what criteria are specified for publishing ADE case reports. METHODS: A descriptive analysis of highly significant ADE case reports published in English over a 20-year period was performed. Main outcome measures included frequency distributions for the types of variables reported. The presence of causality assessment and the criteria for submitting an ADE report to practitioner journals were also examined. RESULTS: A highly significant ADE was described in 1520 published case reports during the study period. Three patient variables were reported >90% of the time, while 12 others were reported <25% of the time. Only 1 drug variable was reported >90% of the time; 6 others were reported 14-74% of the time. Most of the relevant ADE variables were reported most often. Added information for drug interactions, medication errors, and allergic drug reactions were reported 61-99% of the time. Less than 1% of ADE reporters objectively assessed the probability of the ADE. All but one journal publishing the most ADE reports did not require such assessment. CONCLUSIONS: Professional journals might consider stricter requirements for publishing ADE reports. As a minimum, requirements should include an objective assessment of ADE causality, with explicit recognition in the published text and abstract of the report.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

Risk of myocardial infarction with combination antihypertensive regimens including a dihydropyridine calcium channel blocker in hypertensive diabetics.

OBJECTIVE: The primary objective of this study was to determine if there was an increased risk of myocardial infarction (MI) in a high-risk hypertensive diabetic managed care population receiving combination antihypertensive therapy including a dihydropyridine (DHP) calcium channel blocker (CCB). METHODS: A retrospective, population-based, case-control study design was used to determine the risk of MI versus the prescribed antihypertensive drug regimen. During 1997-1999, 6,096 diabetics with hypertension were identified. After exclusions, there were 131.high-risk. study patients who suffered an MI during the study period. These were compared to an equally matched sample. High-risk patients were defined as those with a medical history of previous MI, angina pectoris or ischemic heart disease, or those who had undergone a coronary artery bypass graft and/or angioplasty procedure. Patients were then assigned to Group I cases and controls (DHP use) and Group II cases and controls (no DHP use). Odds ratios (OR) and 95% confidence intervals (CI) were determined for the independent variables and antihypertensive drug regimens. Logistical regression analysis was used to model age, ethnicity, and potential risk factors to identify any differences among calcium channel blockers. RESULTS: After adjusting for age and gender, the OR for an MI in patients on a combination DHP regimen was 0.75 (95% CI, 0.44, 1.29). The OR for other regimens ranged from 0.52 to 1.16, with no significant difference between antihypertensive drug classes. In comparison to nondihydropyridines (NDHPs), the OR for DHPs was 1.38 (95% CI, 0.54, 3.54), but it was determined to not be statistically different ( P=0.5065). CONCLUSION: No increase in risk of MI could be determined with the use of a combination antihypertensive regimen including a DHP CCB when compared to other antihypertensive drugs in a matched high-risk population of patients with hypertension and diabetes. Choice of antihypertensive drug regimen may be less important than strategies that focus on achieving optimal disease outcomes to reduce the incidence of MI and hospitalization and lower health care costs in this high-risk population in managed care.

Antihypertensive Agents↗