Voluntary Reports Research Articles

Amended Final Report of the Safety Assessment of Drometrizole as used in Cosmetics1

Drometrizole is used in cosmetics as an ultraviolet (UV) light absorber and stabilizer. In an earlier safety assessment, the available data were found insufficient to support the safety of this ingredient, but new data have been provided and assessed. In voluntary industry reports to the Food and Drug Administration, this ingredient is reported to be used in noncoloring hair care products, and in an industry use concentration survey, uses in nail care products at 0.07% were reported. Drometrizole has absorbance maxima at 243, 298, and 340 nm. Drometrizole is used widely as a UV absorber and stabilizer in plastics, polyesters, celluloses, acrylates, dyes, rubber, synthetic and natural fibers, waxes, detergent solutions, and orthodontic adhesives. It is similarly used in agricultural products and insecticides. Drometrizole is approved as an indirect food additive for use as an antioxidant and/or stabilizer in polymers. Short-term studies using rats reported liver weight increases, increases in the activities of enzymes aminopyrine N-demethylase, and UDP glucuronosyl transferase, but no significant effects were noted in the activities of acid hydrolases or in hepatocyte organelles. Although Drometrizole is insoluble in water and soluble in a wide range of organic solvents, a distribution and elimination study using rats indicated that some Drometrizole was absorbed, then metabolized and excreted in the urine. Drometrizole and products containing Drometrizole were nontoxic in acute oral, inhalation, and dermal studies using animals. No increase in mortality or local and/or systemic toxicity were observed in a 13-week oral toxicity study using dogs; the no observed effect level (NOEL) was 31.75 mg/kg day(- 1) for males and 34.6 mg/kg day(-1) for females. In a 2-year feeding study using rats, a NOEL of 47 to 58 mg/kg day(- 1) was reported. Developmental studies of Drometrizole in rats and mice found no teratogenic effects and a NOEL of 1000 mg/kg day(- 1) was reported. Drometrizole was not genotoxic in Ames tests, a mouse bone marrow micronucleus test, or somatic mutation assays observing interphase nuclei and chromosomal aberrations using Chinese hamsters. There was no evidence of dominant lethal effects in studies using mice or rats. Drometrizole at a 1% concentration was minimally to moderately irritating to rabbit eyes, if followed by rinsing, but mildly to severely irritating in unrinsed eyes. A nail product containing 0.03% Drometrizole, however, was nonirritating to unrinsed rabbit eyes. A nail polish containing 1.0% Drometrizole was nonirritating to rabbit skin and Drometrizole was negative for sensitization in two Magnusson-Kligman maximization tests in guinea pigs. In clinical tests, Drometrizole at 1% was nonirritating in a single-insult patch test. No irritation or eczematous reactions were observed in 300 patients (with or without dermatosis) treated with daily applications of Drometrizole for 8 weeks. In a 3-year clinical therapeutic trial conducted to evaluate the effectiveness of two UV absorbing preparations containing up to 5% Drometrizole, two hypersensitivity reactions were observed during 445 applications. Although there are case reports in which Drometrizole was considered the sensitizing agent, clinical tests of cosmetic products containing 0.03% to 1.0% Drometrizole produced no irritation, sensitization, photosensitization, or phototoxicity in a total of 436 subjects. The Cosmetic Ingredient Review (CIR) Expert Panel assumes that Drometrizole is used in both noncoloring hair care and nail care products at low concentrations. The available safety test data do not suggest any adverse effects associated with exposure to Drometrizole. This toxicologic profile, coupled with the low concentration of use and the unlikely dermal penetration of a chemical that is insoluble in water, support the conclusion that Drometrizole can be safely used in cosmetics.

Participation Hospital’s Pharmacist in the Voluntary Reporting Adverse Drug Reactions and Costs Involved in their Management.

Participation Hospital’s Pharmacist in the Voluntary Reporting Adverse Drug Reactions and Costs Involved in their Management.

Rapid Identification of Hematology-Associated Serious Adverse Drug Reactions (sADRS) with Small Datasets: Findings from the Research on Adverse Drug Events and Reports (RADAR) Project.

Current FDA and pharmaceutical industry drug safety efforts rely on statistical review of large databases populated with voluntary reports of sADRs. These data are limited by low rates of complete reporting and high rates of underreporting. Improved post-marketing drug surveillance efforts are needed to improve patient safety. The RADAR project is an academic pharmacovigilance program that focuses on small numbers of thoroughly researched cases of sADRs. In the last decade, RADAR has utilized the resources of a comprehensive cancer center and a global network of collaborators to evaluate and disseminate information on sADRs, many of which are related to hematology. Between 1998 and 2007, RADAR investigated and reported 16 hematology-associated sADRs. RADAR disseminated information on over half of the sADRs within 2 years of FDA approval, compared to half of all new sADRs documented in the Physician's Desk Reference within 7 years of FDA approval. RADAR's novel pharmacovigilance methods identified previously undetected sADRs based on small numbers of completely described reports. The RADAR project's experience shows that private sector programs that utilize small yet comprehensive datasets can significantly contribute to pharmacovigilance networks in hematology. As the FDA develops public-private networks to evaluate safety concerns associated with new drugs, focused independent efforts can assume increasing importance to address unmet needs.Summary of 16 hematology-associated sADRs reported by RADAR since 1998.Drug (FDA approval)sADR (# of reports)Clinical Setting (yr)Data SourceTime to detection (yrs)FDA/Company alertPEG-rHuMGDF(unapproved)ITP (13)Healthy volunteers (2001)Phase I trialsPreclinical detectionNAPEG-rHuMGDF(unapproved)Lymphomas (3)Healthy volunteers (2003)Case reportsPreclinical detectionNATiclopidine (1991)TTP (13)CVA pts (1998)Case reports<1DHP letter; boxed warningGemtuzumab (2000)VOD (50)Leukemia or AML (2000)Phase II trials<1Boxed warningLenalidomide (2005)VTE (75)Multiple myeloma (2005)Phase III trial<1Boxed warningEnoxaparin (1993)Hemorrhage (5)PTCA (2003)Case reports1NAClopidogrel (1997)TTP (39)CAD pts (1998)Case reports1Company warningThalidomide (1998)VTE (91)Multiple myeloma (2002)Phase II trials1Black box warningNevirapine (1996)Stevens-Johnson syndrome (3)Healthcare workers (2002)Case series2Boxed warningNevirapine (1996)Hepatotoxicity (5)Healthcare workers (2002)Case series2Boxed warning; DHP letterEPO (1993)PRCA (9)ESRD (2000)Referral hematologist5Boxed warning; DHP letterEPO (1993)Loss of efficacy (2)Counterfeit drug (2000)Case reports7NAEPO(1993)/ Darb (2001)VTE (52)Cancer (2004)Phase III trial10(EPO)/3 (Darb)FDA alert; DHP letter; boxed warningEPO (1993)/ Darb(2001)Death (NA)Cancer (2006)Clinical trials10(EPO)/3 (Darb)FDA alert; DHP letter; boxed warningG-CSF (1991)AML/MDS (16)Breast Ca (2007)SEER-Medicare12NAPiperacillin (1981)Neutropenia (1)Infection (2006)Case reports25Precaution

Notificación de eventos adversos en un hospital nacional en Lima

Objective To establish a system for notifying adverse effects (AE) at the Dos de Mayo National Hospital. Method We performed an operative investigation of the implemen-tation of a confidential, voluntary reporting system with active surveillance from 1 October 2005 to 31 March 2006. A systems-based model was used for the management of AE. Results Among a total of 8,964 hospital admissions, 347 AE were reported. The rate of AE was 3.9% and there were 12 near misses (0.13%). The most frequent AE were nosocomial infections 241 (70%). The highest number of cases (47 [19.5%]) occurred in the neonatology department and the most frequent condition was neonatal sepsis (19 cases). The second most frequent AE were adverse drug reactions, amounting to 49 cases (14.2%). Of these, 39 (79.6%) were caused by antiretroviral therapy. Almost all notifications were obtained by active surveillance and there were only five voluntary reports. We found additional information in fragmented subsystems such as the nosocomial infections board, blood surveillance, pharmacology surveillance, the complaints system and audits. In addition, we searched for AE in non-elective surgical re-interventions. All AE were classified by frequency and impact. Conclusions The estimated overall rate of AE (3.9%) was lower than that in developed countries with better health conditions, suggesting a possible under-reporting bias. We infer that active surveillance of AE coupled with integration of subsystems is currently the most appropriate way to obtain information on AE.

Dramatic Jump Found in Medication-Related Deaths

Back to table of contents Previous article Next article Professional NewsFull AccessDramatic Jump Found in Medication-Related DeathsRich DalyRich DalySearch for more papers by this authorPublished Online:5 Oct 2007https://doi.org/10.1176/pn.42.19.0008Serious injuries, disabilities, and deaths related to the use of prescribed medications nearly tripled in recent years, according to research based on Food and Drug Administration (FDA) data.The total annual incidents of these events rose from 34,966 in 1998 to 89,842 in 2005, a 2.6-fold increase, according to a study in the September 10 Archives of Internal Medicine. A total of 467,809 such incidents were reported over that eight-year period to the FDA's Adverse Event Reporting System (AERS). The AERS is described as the world's largest database of voluntary spontaneous reports of adverse drug reactions and medication errors for prescription drugs, biological products (except vaccines), and over-the-counter drugs. The voluntary reports are submitted directly to the FDA by medical professionals and consumers through MedWatch or to drugmakers, which must forward them to the FDA.The researchers determined that the rise in injuries and deaths was attributed to “a minority of important drugs.” Drugs most associated with injuries and deaths were disproportionately painkillers and immune-system modifiers. Just 298 approved medications (20 percent) accounted for 87 percent, or 407,394, of the injuries and deaths reported.The adverse impact of medications was disproportionate among adults and children. A proportionately higher number of elderly patients were injured or died from medications, while proportionately fewer children were affected. Although researchers expected 13.8 percent of children under age 18 to have serious complications, based on the number of prescriptions written for this population group, only 7.4 percent of reports of serious adverse events involved children.People aged 65 and older accounted for 33.6 percent of the serious adverse events reported, although the number of prescriptions written for this age group led researchers to expect they would account for only 23.6 percent.The causes behind the increase were varied, according to the study authors. Twenty-five percent of the rise in adverse events, they estimated, was likely due to population growth and more intense use of medication therapy. Another 15 percent of the increase was attributed to 13 “biotechnological products,” including immuno-modulators created through genetic engineering, which were new to the market in the study period. The number of serious adverse events associated with 13 prominent biotechnology products grew nearly 16-fold, from 580 in 1998 to 9,181 in 2005.Contrary to the researchers' expectations, a modest and declining share of serious adverse events were linked to drugs that were the subject of safety withdrawals. Drugs linked to safety withdrawals accounted for less than 10 percent of serious adverse events reported and declined from 26.4 percent of health incidents in 1999 to less than 1 percent in 2005.Alfred Herzog, M.D., chair of APA's Committee on Patient Safety, said that the jump in reported adverse impacts of medication was probably at least partially linked to stepped-up reporting requirements that many states implemented in the early part of this decade. However, the ongoing shortage of nurses and hospital beds may have led to revisions of administrative medication guidelines that are more expedient but offer less protection to patients.Among psychiatric medications, the antipsychotic clozapine was the most frequent drug suspected in death and serious nonfatal outcomes, with 3,277 such cases reported over the eight years. The next highest ranked was the antipsychotic risperidone, which was the suspect drug in 1,093 deaths or serious injuries during the study period.The study excluded any adverse events reported as part of FDA drug trials.“ Health professionals” provided 70 percent of all adverse event reports, including 82 percent of all reported deaths.Future efforts to improve drug safety, wrote the study authors, will require “more accurate and capable systems to monitor postmarketing” injury and death. The growing toll shows that the existing system is inadequate to protect patients and underscores the need for legislative, institutional, and policy changes.The increase of adverse health events underscores the urgency for Congress to require electronic prescribing in Medicare, according to the Pharmaceutical Care Management Association (PCMA).“This study found that seniors are disproportionately affected by serious adverse drug events, which underscores why we need to require e-prescribing in Medicare immediately. Requiring e-prescribing in Medicare could prevent up to 1.9 million medication errors over the next decade,” said Mark Merritt, president and CEO of PCMA, in a statementE-prescribing technology aims to avoid adverse drug events by providing physicians with a comprehensive patient medication history and automatic electronic safety alerts before the prescription is sent to the pharmacy. A recent study by the Gorman Health Group also concluded that requiring e-prescribing in Medicare could prevent up to 1.9 million medication errors over the next decade.“Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005” is posted at<http://archinte.ama-assn.org/cgi/content/short/167/16/1752>.▪ ISSUES NewArchived

Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers. Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug Administration from 1998 through 2005. From 1998 through 2005, reported serious adverse drug events increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%). These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.

Morbidity and mortality of pneumococcal meningitis and serotypes of causative strains prior to introduction of the 7-valent conjugant pneumococcal vaccine in England

To assess the incidence of pneumococcal meningitis, associated deaths and serotypes of causative pneumococci in England prior to the inclusion of the 7-valent conjugated pneumococcal vaccine in the routine childhood immunisation programme in 2006. Cases were identified using hospital episode statistics (HES) and voluntary reports or submission of isolates to the Health Protection Agency. Mortality data and population estimates were from the Office for National Statistics. Based on HES, the annual incidence of pneumococcal meningitis was about 1 case per 100,000 population between 1998 and 2005 (an average of approximately 480 cases per year) with case fatality rates increasing from 5% in <15 year olds to 30% in >64 year olds. Enhanced surveillance comprising a combination of voluntary reporting of cases and referral of isolates gave case ascertainment rates of 50-70% compared to those derived from HES, and similar case fatality rates. The age distribution of pneumococcal meningitis was similar with both datasets, infection being reported mostly commonly in children aged less than 5 years, with the highest incidence in children aged 2-11 months. Based on the serotype distribution of isolates obtained in 2005, the serotype coverage afforded by the 7-valent conjugate vaccine is 72% for patients aged less than 2 years. These data provide baseline information on the incidence of pneumococcal meningitis and associated mortality, together with the serotypes of infecting strains of pneumococci, which will be critical for evaluation of the public health impact of the 7-valent conjugated pneumococcal vaccine in England.

Physician Quality Reporting Initiative Begins

Physician Quality Reporting Initiative Begins

Medication safety in cancer clinical trials: An analysis of medication error reports at a comprehensive cancer center

6547 Background: Although medication errors comprise 10–25% of all medical errors, little is known concerning the occurrence or types of medication errors occurring while treating patients on a clinical trial. Therefore, we retrospectively reviewed the medication errors reported in patients enrolled on clinical trials at our center. Methods: As part of a multidisciplinary continuous quality improvement project, from January 2003 through December 2006, we collected voluntary reports of medication errors in adult and pediatric patients on clinical trials involving both oral and intravenous chemotherapy. All reports were classified prospectively regarding clinical trial involvement, severity category (A to I) per the National Coordination Council on Medical Error Reporting and Prevention, type, cause, and where in the medication use process the error occurred. Results: There were 163 reports involving patients treated on clinical trials. The most common errors were those corrected prior to reaching the patient in 68% of events (Category A&amp;B), while 31% reached the patient but did not result in harm (Category C&amp;D), with 1% resulting in temporary patient harm (Category E&amp;F). The most common type of errors were prescribing (66%), improper dose (42%), and omission errors (9%). Not following an institutional procedure or the protocol was the primary cause for these errors (39%), followed by the written order (30%), and poor communication involving both the healthcare team and the patient (26%). The processes where the errors initiated were in prescribing 47%, administration 10%, dispensing 6%, and monitoring 5%. Conclusion: Medication errors do occur in clinical trials, however the majority of these are corrected prior to reaching the patient or do not result in harm. Not following an institutional procedure or the protocol was the most common cause of error. This is most likely due to the protocol procedures differing from existing standards of care. Protocol-specific education through the Centralized Education and Training Service, a shared resource within our cancer center, addresses this issue enhancing the quality and safety of clinical trials through the education and training of healthcare professionals. No significant financial relationships to disclose.

Pay for Performance: Rationale and Potential Implications for Urology

Pay for performance represents a new paradigm for physician reimbursement based on the value based purchasing of health care services. Government and private payers have expressed an interest in moving toward this system with several pay for performance programs already in place. The rationale behind this initiative and what it means for the practicing urologist are discussed. MEDLINE and Internet based research focusing on the topics of health care quality, measures used to implement pay for performance, and private and public sector experience with pay for performance to date were reviewed. Health care quality can be assessed through 3 types of measures, including structure, process and outcome. Structure measures involve the environment where services are provided, whereas process measures capture how a particular provider delivers health care. Outcome assessment involves the results of the services provided. These measures are best used when they are used in coordination with each other, and when they are risk adjusted. Most pay for performance systems in use today are based on these measures. However, there are little data that show whether this reimbursement paradigm actually improves the quality of heath care provided. Many questions remain regarding the implementation of a pay for performance system in the field of urology. Government and private payers are motivated to implement pay for performance. However, specific evidence based metrics for urology that fairly and accurately define quality are currently lacking. Given that implementation of a nationwide pay for performance system appears to be inevitable, urology involvement in the development and implementation of these health care quality metrics is essential.

Medical errors after stroke

Like the aftershocks of an earthquake, harmful events that follow strokes can turn even mild strokes into full-blown disasters. Better surveillance and work on process can help us anticipate and avoid errors in patient care. In this issue of Neurology , Holloway et al.1 tackle the issue of errors and harmful events after hospital admissions for stroke. A focused and nonpunitive approach can guide efforts to improve neurology patient safety, just as the airlines used safety data (including reports of near misses) to prevent air disasters. By analyzing both voluntary and mandatory reports of adverse events in patients admitted with stroke over a 3-year epoch, Holloway et al. build on epidemiologic inferences of safety breaches from …

The effect of reporting frequency on the timeliness of earnings: The cases of voluntary and mandatory interim reports

We examine whether financial reporting frequency affects the speed with which accounting information is reflected in security prices. For a sample of 28,824 reporting-frequency observations from 1950 to 1973, we find little evidence of differences in timeliness between firms reporting quarterly and those reporting semiannually, even after controlling for self-selection. However, firms that voluntarily increased reporting frequency from semiannual to quarterly experienced increased timeliness, while firms whose increase was mandated by the SEC did not. We conclude that there is little evidence to support the claim that regulation forcing firms to report more frequently improves earnings timeliness.

Congressional Action Freezes Physician Payments

Congressional Action Freezes Physician Payments

Congress Rejects Big Cut In Medicare Payment

Back to table of contents Previous article Next article Government NewsFull AccessCongress Rejects Big Cut In Medicare PaymentMark MoranMark MoranSearch for more papers by this authorPublished Online:5 Jan 2007https://doi.org/10.1176/pn.42.1.0001An 11th-hour intervention by Congress averted a scheduled 5 percent across-the-board reduction in reimbursement for physicians and other health care professionals participating in the Medicare program in 2007. However, many physicians, including psychiatrists, will still see a decline in their 2007 reimbursement because of other government adjustments to the fee schedule.On the last day of the session before adjourning for the Christmas recess, Congress approved HR 6111, the Tax Relief and Health Care Act of 2006, which includes a provision eliminating the 5 percent overall payment reduction that was to take effect January 1 as part of an annual update issued by the federal Centers for Medicare and Medicaid (CMS). That update stemmed from a change to the “conversion factor” that is used in the formula to determine physician fees and is adjusted from year to year to maintain budget neutrality.The bill, which at press time was expected to be signed by President Bush, also includes a 1.5 percent “bonus payment” to physicians who voluntarily report certain quality data as part of a CMS pilot program. The 1.5 percent bonus is effective from July 1 to December 31, 2007.Left unaffected by the Congressional action is a separate adjustment to so-called work and practice expense relative value units (RVUs). That adjustment, the result of a recent five-year review of RVUs, is expected to decrease psychiatrists' payment under the Medicare program by 2 percent on average. On top of the 5 percent adjustment to the conversion factor, payment for psychiatrists had been expected to drop on average by 7 percent next year (Psychiatric News, December 15, 2006).Now, because of the Congressional action, payment for psychiatrists will drop on average by just 2 percent. Many other specialties will be experiencing greater cuts in payment even after the action by Congress.(The work and practice expense RVUs are components of the Resource-Based Relative Value Scale, the elaborate formula used to calculate physician payment under the Medicare program; another component is the malpractice insurance expense RVU. To derive a payment rate for each CPT code, the three components are added together and multiplied by the conversion factor.)HR 6111 states that the measures to be used for quality reporting are those formulated for the CMS Physician Voluntary Reporting Program. Among them are measures for reporting use of antidepressant medication for a new episode of major depression.APA and AMA welcomed the congressional action, while vowing to continue advocating for a reform of what AMA has persistently called a“ flawed” Medicare physician payment formula.Nicholas Meyers, director of APA's Department of Government Relations, said, “APA joins the AMA and all of medicine in thanking the members of the 109th Congress for their success in blocking a damaging Medicare cut,” he said. “The action amounts to a significant payment shift in favor of psychiatrists and other physicians.”Meyers added, however, that “this is not a permanent correction to the underlying flawed payment formula. We will continue our work with the AMA to fix the formula once and for all so our members don't have to worry about the payment fight every year.”In a statement released after passage of the bill, AMA Board Chair Cecil Wilson, M.D., said, “Congressional action to avert next year's 5 percent Medicare physician payment cut will help avert a potential sharp decline in access for America's seniors.”With respect to quality reporting, Wilson noted that the AMA Physician Consortium for Performance Improvement, which includes representation from APA, has already developed 151 quality measures.“We will work to ensure that consortium measures continue to form the foundation of a Medicare quality reporting program,” Wilson said.“ We will work closely with the incoming Congress to address concerns with the current reporting framework.”The text of the Tax Relief and Health Care Act of 2006 is posted at<http://thomas.loc.gov/home/c109query.html>.▪ ISSUES NewArchived

CMS Ties 1.5% Bonus to Voluntary Reporting Program

CMS Ties 1.5% Bonus to Voluntary Reporting Program

Bonus Linked to Physician Voluntary Reporting

Bonus Linked to Physician Voluntary Reporting

Toward learning from patient safety reporting systems

Purpose To evaluate the frequency and type of factors involved in incidents reported to a patient safety reporting system and answer specific questions to enhance the value of PSRS data to improve patient safety. Materials and Methods Prospective cohort study of incidents reported from adult and pediatric intensive care units (ICUs) in the United States to the web-based, voluntary, and anonymous Intensive Care Unit Safety Reporting System. Results from July 1, 2002, to June 30, 2004. Main outcome variables were incidents that could or did lead to patient harm. Results Analysis includes 2075 incidents from 23 ICUs. Median number of reports/ICU/month was 3; 5 hospitals submitted 58% of reports. Harm was reported in 42% of incidents with 18 deaths. Common event types: medication/therapeutics (42%) and incorrect/incomplete care delivery (20%); 48% of line/tube/drain incidents led to physical harm. Deficiencies in training/education contributed to 49% of incidents and teamwork issues 32%; 42% of incidents had 2 or more contributing factors. As the number of contributing factors per incident increased, so did risk of harm. Conclusions The Intensive Care Unit Safety Reporting System provides a mechanism for multiple ICUs to identify hazards. Data trends show a correlation between multiple contributing factors and higher rates of harm. Further research is needed to help determine how to use PSRS data to improve patient safety.

CMS May Add Measures to Voluntary Reporting Program

CMS May Add Measures to Voluntary Reporting Program

Improving links between CAMHS and primary care

Only a small percentage of children and young people with mental health problems reach child and adolescent mental health services (CAMHS) (Young Minds 2003). Government policy, voluntary organisation reports and research all support the need for improved links and open communication between health services in order to address the mental health needs of children and young people.

Automated Surveillance for Adverse Drug Events at a Community Hospital and an Academic Medical Center

To compare the rates and nature of ADEs at an academic medical center and a community hospital using a single computerized ADE surveillance system. Prospective cohort study of patients admitted to two tertiary care hospitals. Outcome Measure Adverse drug events identified by automated surveillance and voluntary reporting. We implemented an automated surveillance system across an academic medical center and a community hospital. Potential events identified by the computer were reviewed in detail by medication safety pharmacists and scored for causality and severity. Findings were compared between the two hospitals, and with voluntary reports from nurses and pharmacists. Over the 8 month study period, 25,177 patients were admitted to the university hospital and 8,029 to the community hospital. There were 1,116 ADEs in 900 patients at the university hospital for an overall rate of 4.4 ADEs per 100 admissions. At the community hospital, 399 patients experienced 501 ADEs for a rate of 6.2 events per 100 admissions. Rates of antibiotic-associated colitis, drug-induced hypoglycemia, and anticoagulation-related ADEs were significantly higher at the community hospital compared with the university hospital. Computerized surveillance detected ADEs at a rate 3.6 times that of voluntary reporting at the university hospital and 12.3 times that at the community hospital. Operation of a common automated ADE surveillance system across hospitals permits meaningful comparison of ADE rates in different inpatient settings. Automated surveillance detects ADEs at rates far higher than voluntary reporting, and the difference may be greater in the community hospital setting. Community hospitals may experience higher rates of certain types of ADEs compared with academic medical centers.