Canadian Adverse Reaccion Newsletter

Pediatric Nursing (journal) (Photo credit: Wikipedia)

Esta en linea  el  Canadian Adverse Reaction Newsletter, Volume 22, No.
1* , correspondiente a enero 2012

Indice:

   * Second-generation antipsychotics and cardiometabolic adverse
     reactions in children and adolescents
   * Prescription drugs and pediatric patients
   * Canadian Paediatric Surveillance Program
   * Adverse reaction reporting in children: update
   * Adverse reaction reporting form
   * Did you know? The Drug Safety and Effectiveness Network (DSEN) and
     pediatric projects
   * Summary of advisories

Disponible* en:

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/bulletin/carn-bcei_v22n1-eng.pdf

Saludos,

Martín

Related articles

• Doctors Health Press Reports on Study: Researchers Working on Ways to Better Design Drugs to Prevent Serious, and Even Fatal, Adverse Reactions
• Medicine - the leading cause of death and injury in the US
• ER Visits Following Adverse Reaction to Zolpidem Rise by 220 Percent
• ER Visits Tied to Ambien on the Rise
• Abacavir Hypersensitivity
• Bad Drug Reactions can be Detected by Data Mining Electronic Medical Records
• ER Visits Tied to Ambien on the Rise
• Data Mining EMRs Can Detect Bad Drug Reactions
• Understanding adverse reactions from drugs
• Study: Ambien results in more trips to the emergency room

Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006–2012

Source: Pediatrics. Published online May 13, 2013

Full Text 

(doi: 10.1542/peds.2012-2554)       Pediatrics

1. Penina Haber, MPH^a,
2. Manish Patel, MD^b,
3. Yi Pan, PhD^a,
4. James Baggs, PhD^c,
5. Michael Haber, PhD^d,
6. Oidda Museru, MPH^a,
7. Xin Yue, MS^a,
8. Paige Lewis, MSPH^a,
9. Frank DeStefano, MD, MPH^a, and
10. Umesh D. Parashar, MBBS, MPH^b

+ Author Affiliations

1. ^aImmunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, Georgia;
2. ^bNational Center for Immunizations and Respiratory Diseases, Atlanta, Georgia;
3. ^cDivision of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and
4. ^dEmory University, Rollins School of Public Health, Biostatistics and Bioinformatics, Atlanta, Georgia

Abstract

BACKGROUND: In 2006 and 2008, 2 new rotavirus vaccines (RotaTeq [RV5] and Rotarix [RV1]) were introduced in the United States.

METHODS: We assessed intussusception events reported to the Vaccine Adverse Event Reporting System from February 2006 through April 2012 for RV5 and from April 2008 through April 2012 for RV1. For RV5, we conducted a self-controlled risk interval analysis using Poisson regression to estimate the daily reporting ratio (DRR) of intussusception comparing average daily reports 3 to 6 versus 0 to 2 days after vaccination. We calculated reporting rate differences based on DRRs and background rates of intussusception. Sensitivity analyses were conducted to assess effects of differential reporting completeness and inaccuracy of baseline rates. Few reports were submitted after RV1, allowing only a descriptive analysis.

RESULTS: The Vaccine Adverse Event Reporting System received 584 confirmed intussusception reports after RV5 and 52 after RV1, with clustering 3 to 6 days after both vaccines. The DRR comparing the 3- to 6-day and the 0- to 2-day periods after RV5 dose 1 was 3.75 (95% confidence interval = 1.90 to 7.39). There was no significant increase in reporting after dose 2 or dose 3. Over all 3 doses, the excess risk of intussusception was 0.79 events (95% confidence interval = –0.04 to 1.62) per 100 000 vaccinations. From the sensitivity analyses, we conclude that under a worst-case scenario, the DRR could be 5.00 and excess risk per 100 000 doses could be 1.36.

CONCLUSIONS: We observed a persistent clustering of reported intussusception events 3 to 6 days after the first dose of RV5 vaccination. This clustering could translate to a small increased risk of intussusception, which is outweighed by the benefits of rotavirus vaccination.

Related articles

• Rotavirus vaccine
• India develops new rotavirus vaccine
• Inventor of Rotavirus Vaccine Wants To End Parental Exemptions For School Vaccinations
• Rotavirus vaccine developed in India demonstrates strong efficacy
• National Vaccine Information Center Calls on FDA to Raise Vaccine Safety Testing & Labeling Standards
• Was Paul Offit MD "Reprimanded by Congress"?
• Adults' Prescription Drugs Implicated In Rise Of Child Poisonings.

Newsletter: Pediatrics

Image via Wikipedia

Evidence-Based Medicine in the EMR Era

Jennifer Frankovich, M.D., Christopher A. Longhurst, M.D., and Scott M. Sutherland, M.D.

November 2, 2011 (10.1056/NEJMp1108726)

Many physicians take great pride in the practice of evidence-based medicine. Modern medical education emphasizes the value of the randomized, controlled trial, and we learn early on not to rely on anecdotal evidence. But the application of such superior evidence, however admirable the ambition, can be constrained by trials' strict inclusion and exclusion criteria — or the complete absence of a relevant trial. For those of us practicing pediatric medicine, this reality is all too familiar. In such situations, we are used to relying on evidence at Levels III through V — expert opinion — or resorting to anecdotal evidence. What should we do, though, when there aren't even meager data available and we don't have a single anecdote on which to draw?

We recently found ourselves in such a situation as we admitted to our service a 13-year-old girl with systemic lupus erythematosus (SLE). Our patient's presentation was complicated by nephrotic-range proteinuria, antiphospholipid antibodies, and pancreatitis. Although anticoagulation is not standard practice for children with SLE even when they're critically ill, these additional factors put our patient at potential risk for thrombosis, and we considered anticoagulation. However, we were unable to find studies pertaining to anticoagulation in our patient's situation and were therefore reluctant to pursue that course, given the risk of bleeding. A survey of our pediatric rheumatology colleagues — a review of our collective Level V evidence, so to speak — was equally fruitless and failed to produce a consensus.

Without clear evidence to guide us and needing to make a decision swiftly, we turned to a new approach, using the data captured in our institution's electronic medical record (EMR) and an innovative research data warehouse. The platform, called the Stanford Translational Research Integrated Database Environment (STRIDE), acquires and stores all patient data contained in the EMR at our hospital and provides immediate advanced text searching capability.1 Through STRIDE, we could rapidly review data on an SLE cohort that included pediatric patients with SLE cared for by clinicians in our division between October 2004 and July 2009. This “electronic cohort” was originally created for use in studying complications associated with pediatric SLE and exists under a protocol approved by our institutional review board.

Of the 98 patients in our pediatric lupus cohort, 10 patients developed thrombosis, documented in the EMR, while they were acutely ill. The prevalence was higher among patients who had persistent nephrotic-range proteinuria and pancreatitis (see tableResults of Electronic Search of Patient Medical Records (for a Cohort of 98 Pediatric Patients with Lupus) Focused on Risk Factors for Thrombosis Relevant to Our 13-Year-Old Patient with Systemic Lupus Erythematosus.). As compared with our patients with lupus who did not have these risk factors, the risk of thrombosis was 14.7 (95% confidence interval [CI], 3.3 to 96) among patients with persistent nephrosis and 11.8 (95% CI, 3.8 to 27) among those with pancreatitis. This automated cohort review was conducted in less than 4 hours by a single clinician. On the basis of this real-time, informatics-enabled data analysis, we made the decision to give our patient anticoagulants within 24 hours after admission.

Our case is but one example of a situation in which the existing literature is insufficient to guide the clinical care of a patient. But it illustrates a novel process that is likely to become much more standard with the widespread adoption of EMRs and more sophisticated informatics tools. Although many other groups have highlighted the secondary use of EMR data for clinical research,2,3 we have now seen how the same approach can be used to guide real-time clinical decisions. The rapid electronic chart review and analysis were not only feasible, but also more helpful and accurate than physician recollection and pooled colleague opinion. Such real-time availability of data to guide decision making has already transformed other industries,4 and the growing prevalence of EMRs along with the development of sophisticated tools for real-time analysis of deidentified data sets will no doubt advance the use of this data-driven approach to health care delivery. We look forward to a future in which health information systems help physicians learn from every patient at every visit and close the feedback loop for clinical decision making in real time.

Did we make the correct decision for our patient? Thrombosis did not develop, and the patient did not have any sequelae related to her anticoagulation; truthfully, though, we may never really know. We will, however, know that we made the decision on the basis of the best data available — acting, as the fictional detective Nero Wolfe would say, “in the light of experience as guided by intelligence.”5 In the practice of medicine, one can't do better than that.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMp1108726) was published on November 2, 2011, at NEJM.org.

SOURCE INFORMATION

From the Division of Rheumatology (J.F.), the Division of Systems Medicine (C.A.L.), and the Division of Nephrology (S.M.S.), Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA.

REFERENCES

1. 1
   Lowe HJ, Ferris TA, Hernandez PM, Weber SC. STRIDE -- an integrated standards-based translational research informatics platform. AMIA Annu Symp Proc 2009;14:391-395
2. 2
   Prokosch HU, Ganslandt T. Perspectives for medical informatics: reusing the electronic medical record for clinical research. Methods Inf Med 2009;48:38-44
   Web of Science | Medline
3. 3
   Gunn PW, Hansen ML, Kaelber DC. Underdiagnosis of pediatric hypertension -- an example of a new era of clinical research enabled by electronic medical records. AMIA Annu Symp Proc 2007;11:966-966
4. 4
   Halevy A, Norvig P, Pereira F. The Unreasonable Effectiveness of Data. IEEE Intelligent Systems, March/April 2009:8-12.
5. 5
   Stout R. In the best families. New York: Viking Press, 1950:71.

Related articles

• Meaningful Use EMRs Gilbert and Sullivan Style..."I am the Model User of an EMR That's Meaningful..." (ducknetweb.blogspot.com)
• How Systemic Lupus Affects Children (everydayhealth.com)
• Why Many Clinicians Dislike Their EMRs (labsoftnews.typepad.com)
• The Electronic Medical Record (EMR) and what it accomplishes #cerner (greenbananablog.org)
• Dr. Heather J. Roberts Receives Meaningful Use Incentives Using NexTech EMR (prweb.com)
• Although Atorvastatin Fails To Slow Progression Of Atherosclerosis In Pediatric Lupus Patients, It Is Safe And May Help With More Severe Lupus (medicalnewstoday.com)
• Docs not tech savvy, or tech not doc savvy? (survivorpediatrics.wordpress.com)
• Penn Medicine to expand pilot using EMR app for clinical trial candidates (medcitynews.com)
• Bizmatics Announces Medical Billing Services to Complement PrognoCIS EMR and PM Solutions (prweb.com)
• SAP Entering the Mobile EMR Arena (medgadget.com)

Pediatric deaths due to varicella are becoming a thing of the past

                       Image via Wikipedia Source: MD Consult

ST LOUIS (MD Consult) - With implementation of the varicella vaccination program in the United States, deaths due to the disease among children and adolescents have virtually ceased, finds a study reported in the August 2011 issue of Pediatrics.

Using data from the Mortality Multiple Cause-of-Death records of the US National Center for Health Statistics, investigators analyzed temporal patterns of deaths among individuals of all ages for which varicella was listed as an underlying or contributing cause between 1990 and 2007. The vaccination program was introduced in 1995.

Over the first 12 years of the program, the annual average mortality rate for varicella listed as the underlying cause fell by 88%, from 0.41 per million population in 1990-1994 to 0.05 per million population in 2005-2007.

The same pattern was evident across all age-groups. The reduction was 97%, 90%, and 67% among children and adolescents younger than 20 years, among adults aged 20 to 49 years, and among adults aged 50 years or older, respectively.

In the last 6 years analyzed (2002-2007), there were 3 deaths each among children aged 1 to 4 years and aged 5 to 9 years; in sharp contrast, there were an average of 13 and 16 deaths annually, respectively, before the vaccine was introduced.

All of the deaths among children and adolescents younger than 20 years in 2002-2007 occurred in those who did not have high-risk conditions as strictly defined by the study, although 3 occurred in children or adolescents having conditions that could increase risk.

"The impressive decline in varicella deaths can be directly attributed to successful implementation of the 1-dose vaccination program," the investigators conclude. "With the current 2-dose program, there is potential that these most severe outcomes of a vaccine-preventable disease could be eliminated."

Pediatrics. 2011;128:214-220. 

 

• Did the varicella zoster vaccine prove to be effective long term?
• A prospective cohort study evaluated the long-term effectiveness of the vaccine, its impact on varicella and herpes zoster epidemiology, and the impact of a second dose of the vaccine.
• Long-term follow-up demonstrated that varicella vaccination was effective at preventing chicken pox and seemed to lower risk of herpes zoster over a 14-year period.

---

SUMMARY

Practice Update Editorial Team

Vaccination of children for varicella zoster virus (VZV) has substantially decreased incidence of disease. Before the vaccine was licensed and recommended in the United States, VZV infection was highly prevalent, with more than 90% of people experiencing an infection by the age of 20 years. The efficacy of one dose of this medication was shown to be high in clinical trials, with a recent implementation of a second dose showing increased effectiveness in multiple studies. The overall effect of this vaccination on herpes zoster (HZ) incidence is not well understood.
In this prospective cohort study, Baxter et al aimed to assess the long-term effectiveness of the vaccine, its impact on varicella and HZ epidemiology, and the impact of the second dose, which was introduced in 2006. The study was conducted at multiple Kaiser Permanente Northern California sites and included children 12 to 23 months of age who received varicella vaccination in 1995. Consenting parents were interviewed via telephone every 6 months for 14 years, until 2009. Outcomes included breakthrough cases of varicella, number of lesions, and rates of HZ. Person-time was calculated based on the interview cycle.
The analytic cohort included 7386 patients and a total of 103,098 person-years (PY) were collected. In the 14 years after varicella vaccination, there were 1505 cases of breakthrough varicella. All cases followed the first vaccine dose. No cases of breakthrough were reported after the second dose was received. The average incidence was 15.9 cases per 1000 PY (95% CI, 15.1–16.7). This finding represented a 9 to 10 times lower rate of incidence as compared with same-aged children in the era preceding vaccination. Effectiveness was 89% to 90%, depending on the reference study. Of the 113 reported cases of HZ, 46 cases were confirmed. This finding represented an incidence rate of 0.45 per 1000 PY (95% CI, 0.33–0.60). Compared to similar children who experienced naturally acquired varicella, this finding suggested a 40% decreased incidence in those who were vaccinated.
This prospective cohort study showed, over 14 years of follow-up, varicella vaccination was effective in preventing VZV, with no evidence of waning effectiveness. Further, findings suggested a decreased incidence rate of HZ among vaccinated children as compared with unvaccinated children of the same age.

 

Long-term Effectiveness of Varicella Vaccine: A 14-Year, Prospective Cohort Study

1. Roger Baxter, MD^a,
2. Paula Ray, MPH^a,
3. Trung N. Tran, MD, PhD^b,
4. Steve Black, MD^c,
5. Henry R. Shinefield, MD^d,
6. Paul M. Coplan, ScD, MBA^e,
7. Edwin Lewis, MPH^a,
8. Bruce Fireman, MA^a, and
9. Patricia Saddier, MD, PhD^b

+ Author Affiliations

1. ^aKaiser Permanente Vaccine Study Center, Oakland, California;
2. ^bEpidemiology Department, Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey;
3. ^cCenter for Global Health, Cincinnati Children’s Hospital, Cincinnati, Ohio;
4. ^dUniversity of California San Francisco Medical Center, University of California, San Francisco, San Francisco, California; and
5. ^ePurdue Pharma, Stamford, Connecticut

Abstract from Pediatrics

BACKGROUND: Varicella vaccine was licensed in the United States in 1995 for individuals ≥12 months of age. A second dose was recommended in the United States in June 2006. Varicella incidence and vaccine effectiveness were assessed in a 14-year prospective study conducted at Kaiser Permanente Northern California.

METHODS: A total of 7585 children vaccinated with varicella vaccine in their second year of life in 1995 were followed up prospectively for breakthrough varicella and herpes zoster (HZ) through 2009. A total of 2826 of these children received a second dose in 2006–2009. Incidences of varicella and HZ were estimated and compared with prevaccine era rates.

RESULTS: In this cohort of vaccinated children, the average incidence of varicella was 15.9 per 1000 person-years, nine- to tenfold lower than in the prevaccine era. Vaccine effectiveness at the end of the study period was 90%, with no indication of waning over time. Most cases of varicella were mild and occurred early after vaccination. No child developed varicella after a second dose. HZ cases were mild, and rates were lower in the cohort of vaccinated children than in unvaccinated children during the prevaccine era (relative risk: 0.61 [95% confidence interval: 0.43–0.89]).

CONCLUSIONS: This study confirmed that varicella vaccine is effective at preventing chicken pox, with no waning noted over a 14-year period. One dose provided excellent protection against moderate to severe disease, and most cases occurred shortly after the cohort was vaccinated. The study data also suggest that varicella vaccination may reduce the risks of HZ in vaccinated children.