To assess the use of acute pancreatitis (AP)-associated drugs in patients with AP, the relation between sales of these drugs and the incidence of AP, and the potential impact on AP severity and recurrence.
All patients with incident AP between 2003 and 2012, in a well-defined area, were retrospectively identified. Data regarding AP etiology, severity, and recurrence and use of AP-associated drugs were extracted from medical records. Drugs were classified according to an evidence-based classification system. Annual drug sales data were obtained from the Swedish drug administration service.
Overall, 1457 cases of incident AP were identified. Acute pancreatitis-associated drug users increased from 32% in 2003 to 51% in 2012, reflecting increasing user rates in the general population. The incidence of AP increased during the study period but was not related to AP-associated drug user rates (P > 0.05). Recurrent AP occurred in 23% but was unrelated to AP-associated drug use (P > 0.05). In logistic regression analysis, after adjustment for comorbidity, AP-associated drug use was not related to AP severity (P > 0.05).
Use of AP-associated drugs is increasingly frequent in patients with AP. However, it does not have any major impact on the observed epidemiological changes in occurrence, severity, or recurrence of AP.
Consumer reporting of adverse drug reactions (ADRs) has existed in several countries for decades, but throughout Europe the role of consumers as a source of information on ADRs has not been fully accepted until recently. In Europe, The Netherlands and Sweden were among the first countries to implement consumer reporting well before it was mandated by law throughout the EU. Consumer reporting is an integral part of the spontaneous reporting systems in both The Netherlands and Sweden, with yearly numbers of reports constantly increasing. Consumer reporting forms and handling procedures are essentially the same as for healthcare professional reporting; the message in the reports, not the type of messenger, is what is of importance. Studies have established the significant contribution of consumer reporting to ADR signal detection. Combining all reports regardless of reporter type is recommended since it yields the largest critical mass of reports for signal detection. Examples of signals where consumer reports have been of crucial importance for signal detection are electric shock-like sensations associated with the use of duloxetine, and persistent sexual dysfunction after discontinuation of selective serotonin reuptake inhibitors. An example of consumer reporting significantly strengthening a detected signal is Pandemrix(®) (influenza H1N1 vaccine)-induced narcolepsy. Raising public awareness of ADR reporting is important, but time- and resource-consuming. The minimum effort taken should be to passively inform consumers, e.g. via stakeholders' homepages and via drug product information leaflets. Another possibility of reaching out to this target group could be through co-operation with other (non-government) organizations. Information from consumer reports may give a new perspective on ADRs via the consumers' unfiltered experiences. Consumers' views may change the way the benefit-harm balance of drugs is perceived and assessed today, and, being the ultimate users of drugs, consumers could have a relevant influence in the regulatory decision-making processes for drugs. All stakeholders in pharmacovigilance should embrace this new valuable source of information.
The aim of this study was to examine epidemiologic characteristics of Adverse Drug Events (ADEs) among children and adolescents presenting to an Emergency Department (ED) in Newfoundland and Labrador (NL), Canada.
This study was conducted in three phases and included an ED chart review of visits to the Janeway Hospital in St. John's, NL, between 27th April 2006 and 26th April 2007. The first phase narrowed the sampling frame by excluding visits highly unlikely to be drug-related. In the second phase, a random sample of ED charts was selected for review by two research nurses using a Trigger Assessment Tool that classified ED visits according to their likelihood of being drug related ('high', 'moderate', 'low', 'very low', or 'no' probability). The third phase included a full chart review of all 'high', 'moderate', 'low', and 'very low' probability ADE charts, carried out independently by two ED pediatricians and two clinical pharmacists. Each ADE was also scored for severity and preventability, and consensus was reached among all four reviewers during meetings held at the end of this phase.
In this study, 69 patients presented to the ED either due to an ADE or a possible ADE (PADE). After a sample-weight adjustment, the prevalence of ADEs/PADEs was found to be 2.1%. The number of co-morbidities was inversely associated with medication-related visits. There was no significant difference found between patients with and without medication related visits with respect to mean age of the patient and the mean number of current medications being taken. Of the 69 confirmed ADE/PADEs, none were fatal, six (8.7%) were serious/life-threatening, and 63 (91.3%) were considered significant. Antimicrobial agents (45.0%) were the most common drug classes associated with ADEs/PADEs. Approximately 20% of the 69 ADEs/PADEs identified were considered preventable.
In St. John's NL, emergency department visits as a result of ADEs are common among the pediatric population and in many cases preventable. Age and number of current medications do not appear to be associated with ED visits related with ADE. Antimicrobial agents were found to be to the cause of most ADEs/PADEs.
Intensive care is advanced and highly technical, and it is essential that, despite this, patient care remains safe and of high quality. Adverse events (AEs) are supposed to be reported to internal quality control systems by health-care providers, but many are never reported. Patients on the intensive care unit (ICU) are at special risk for AEs. Our aim was to identify the incidence and characteristics of AEs in patients who died on the ICU during a 2-year period.
A structured record review according to the Global Trigger Tool (GTT) was used to review charts from patients cared for at the ICU of a middle-sized Swedish hospital during 2007 and 2008 and who died during or immediately after ICU care. All identified AEs were scored according to severity and preventability.
We reviewed 128 records, and 41 different AEs were identified in 25 patients (19.5%). Health care-associated infections, hypoglycaemia, pressure sores and procedural complications were the most common harmful events. Twenty two (54%) of the AEs were classified as being avoidable. Two of the 41 AEs were reported as complications according to the Swedish Intensive Care Registry, and one AE had been reported in the internal AE-reporting system.
Almost one fifth of the patients who died on the ICU were subjected to harmful events. GTT has the advantage of identifying more patient injuries caused by AEs than the traditional AE-reporting systems used on many ICUs.
The paper summarizes the results of a scoping review that focused on the occurrence of adverse events experienced by homecare patients.
The literature search covered published and grey literature between 1998 and 2007. Databases searched included: MEDLINE, EMBASE, CINAHL and EBM REVIEWS including the Cochrane Library, AGELINE, the National Patient Safety Foundation Bibliography, Agency for Healthcare Research and Quality and the Patient Safety Net bibliography.
Papers included research studies, review articles, policy papers, opinion articles and legal briefs. Inclusion criteria were: (i) homecare directed services provided in the home by healthcare professionals or caregivers; (ii) addressed a characteristic relevant to patient experienced adverse events (e.g. occurrences, rates, definitions, prevention or outcomes); and (iii) were in English. Data extraction A pool of 1007 articles was reduced to 168 after analysis. Data were charted according to six categories: definitions, rates, causes, consequences, interventions and policy.
Eight categories emerged: adverse drug events, line-related, technology-related, infections and urinary catheters, wounds, falls, studies reporting multiple rates and other. Reported overall rates of adverse events ranged from 3.5 to 15.1% with higher rates for specific types. Few intervention studies were found. Adverse events were commonly associated with communication problems. Policy suggestions included the need to improve assessments, monitoring, education, coordination and communication.
A standardized definition of adverse events in the homecare setting is needed. Prospective cohort studies are needed to improve estimates and intervention studies should be undertaken to reduce the risk that homecare patients will experience adverse events.
Comment In: Int J Qual Health Care. 2010 Apr;22(2):75-720144941
To determine factors affecting morbidity and mortality in a contemporary cohort of hospitalized SLE patients and estimate the rate of SLE hospitalization.
A retrospective chart review was done on all patients admitted to London Health Sciences Centre and St Joseph's Health Centre in London, Ontario, Canada, between January 2006 and June 2009.
There were a total of 96 SLE patients meeting inclusion criteria hospitalized during this period resulting in 154 hospitalizations. Average age at diagnosis was 33.3 years (s.d. 13.7) and 46.5 years (s.d. 14.1) at hospitalization; 91.7% of hospitalized patients were female. The most common reasons for hospitalization included disease flare (17.5%), infection (mostly bacterial) (16.2%) and adverse drug reaction (8.1%). Acute coronary syndrome (2.6%) and venous thromboembolic events (1.9%) were less common causes of hospitalization. Mean hospitalization length was 8.5 (s.d. 11.2) days. Intensive care unit (ICU) admission occurred in 22 cases (13.8%) and mortality was significantly higher (27.3% of ICU patients died; P
As people get older, their sensitivity to drugs and adverse drug reactions can increase due to pharmacokinetic and pharmacodynamic changes. Older people with dementia are a particularly vulnerable group of people. They are at an increased risk of being prescribed potentially inappropriate medications, which may lead to harmful consequences. The aim of this study was to investigate the prevalence of potentially inappropriate medications among older patients with cognitive impairment.
Medical records for patients aged =65 years admitted to two hospitals in Northern Sweden were reviewed. Potentially inappropriate medications were identified using the EU(7)-PIM list as an identification tool.
Of 428 patients included in the study, 40.9% had one or more potentially inappropriate medication prescribed. The most commonly represented potentially inappropriate medication classes were hypnotics and sedatives, cardiovascular drugs and laxatives. The most commonly involved potentially inappropriate medications were zopiclone, digoxin and sodium picosulfate. There was an association seen between having a higher number of medications prescribed and having one or more potentially inappropriate medication.
Potentially inappropriate medications are prevalent among older people with cognitive impairment living in Northern Sweden. It is important to continuously evaluate the need for potentially inappropriate medications in this patient group, in order to prevent adverse drug reactions, especially among those who have a higher number of medications prescribed.
Department of Pediatrics, Dalhousie University and Canadian Center for Vaccinology, IWK Health Centre, 5850/5980 University Avenue, Halifax, NS, Canada B3K 6R8; Mailman School of Public Health, Columbia University Medical Center, 722 West 168th Street, New York, NY 10032, USA. Electronic address: email@example.com.
The Canadian Adverse Event Following Immunization Surveillance System (CAEFISS) receives reports via active syndromic surveillance for selected serious AEFI from the Canadian Immunization Monitoring Program Active (IMPACT) and via targeted passive surveillance from Federal/Provincial/Territorial health jurisdictions. Post-immunization seizure is a target of active and passive surveillance. Since 2009, the revised national AEFI reporting forms enable capture of terms specific to several Brighton Collaboration Case Definitions (BCCD) including generalized seizure and fever.
To evaluate feasibility of applying the BCCD for generalized seizure to adverse event following immunization (AEFI) reports collected by IMPACT and targeted passive surveillance (non-IMPACT).
Using a population-based self-controlled case series design, we examined data on children born between the years 2002 and 2009 in the province of Ontario, Canada. We specifically examined how socioeconomic status (SES) influences rates of adverse events following immunization (AEFI), defined as emergency room visits and / or hospital admissions. For vaccination at 2, 4 and 6 mo combined, the relative incidence of AEFI (95% CI) in the first 72 h after vaccination was 0.69 (0.67 to 0.71). For all three vaccinations combined, we observed no relationship between the relative incidence of an event and quintile of socioeconomic status (p = 0.1433). For the 12-mo vaccination alone, the relative incidence of events (95% CI) on days 4 to 12 following immunization was 1.35 (1.31 to 1.38). We observed a significant relationship between socioeconomic status and vaccination at 12 mo, with lower SES being associated with a higher relative incidence of events (p = 0.0075). When the lowest 2 quintiles of income combined were compared with the highest 3 quintiles, the relative incidence ratio (95% CI) was 0.94 (0.89 to 0.99, p = 0.02). These results translate to 150 additional adverse events in the lower SES quintiles as compared with the higher SES quintiles for every 100,000 children vaccinated, or 1 additional event for every 666 individuals vaccinated. Future studies should explore potential explanations for this observation.
Cites: Stat Med. 2006 May 30;25(10):1768-9716220518