News Scan for Jul 01, 2014

Childhood-vaccine safety
;
Rules for drug compounders
;
Two more MERS cases
;
Foodborne parasites
;
ACA and public health

Meta-analysis finds serious events rare with childhood vaccines

A 67-study meta-analysis found that vaccines recommended for US kids were safe and that serious side effects were rare, according to a Rand Corp. report today in Pediatrics.

Investigators searched 20,478 papers identified through PubMed, the Advisory Committee on Immunization Practices statements, package inserts, reviews, manufacturer information, and a 2011 Institute of Medicine (IOM) consensus report on vaccine safety. They augmented the IOM report with recent studies, included more vaccines, and included only studies that used active surveillance and had a control component.

From the 67 studies included in their review, the researchers determined that the strength of evidence was high for the measles, mumps, and rubella (MMR) vaccine to be associated with febrile seizures and the varicella (chicken pox) vaccine to be associated with anaphylaxis, a life-threatening allergic reaction. High strength of evidence also tied the varicella vaccine to other complications in immunodeficient children.

The team also found high strength of evidence that the MMR vaccine is not associated with autism, as has been determined in multiple studies. The group found moderate evidence that rotavirus vaccines are associated with intussusception—a telescoping of the intestines—and that flu vaccination is associated with febrile seizures and mild gastrointestinal symptoms.

For most vaccines, however, the group found little to no evidence of serious adverse events. A limitation of the review was that the severity of adverse events was inconsistently reported, the authors noted.

In an accompanying commentary, pediatrician Carrie L. Byington, MD, of the University of Utah wrote, "The adverse events identified by the authors in their evidence review were not unexpected. . . . If parents are not convinced by safety data, perhaps these data can be used to increase clinicians' confidence in the safety of the US vaccine schedule."
Jul 1 Pediatrics study
Jul 1 Pediatrics
commentary

 

FDA issues guidance for drug compounding agencies

As outlined under last year's Drug Quality and Security Act, the US Food and Drug Administration (FDA) today issued several guidance documents regarding compounded drugs: a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

The law originated from a multistate fungal disease outbreak of more than 700 cases in 2012 and 2013 linked to a contaminated injectable steroid from the New England Compounding Center in Framingham, Mass.

The draft interim guidance outlines the FDA's expectations regarding compliance with current good manufacturing practice requirements for compounding firms that register with the FDA.

The proposed rule revises the FDA's current list of drugs that may not be compounded because they've been removed from the market because they were unsafe or ineffective. The draft interim guidance and proposed rule are available for public comment for 60 days.

The final guidance describes the FDA's interim policies for compounding pharmacies and describes potential enforcement actions against violators.

In addition, the FDA posted two Federal Register notices on active pharmaceutical ingredients that may be used to compound drug products and opened the dockets to the public to nominate additional bulk drug substances.

"These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA's efforts to continue protecting patients," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in an FDA news release.
Jun 30 FDA news release

 

Two more MERS cases reported in Saudi Arabia

Saudi Arabia reported two more MERS-CoV (Middle East respiratory syndrome coronavirus) cases today, one of them in a healthcare worker.

The healthcare worker is a 53-year-old Saudi man who is hospitalized in Najran on the country's southern coast, the Ministry of Health (MOH) said. He has a preexisting disease.

The other case involves a 28-year-old Saudi woman in Riyadh who is hospitalized in an intensive care unit, the ministry said. It gave no information on how the patients were exposed to the virus, aside from the man's occupational status.

The two cases raised the MOH's MERS tally to 714 cases, with the death toll staying at 292.
Jul 1 MOH statement

 

FAO releases foodborne parasite top 10 list

The United Nations Food and Agriculture Organization (FAO) today unveiled a "top 10" list of foodborne parasites that have the biggest impact on human health and other factors, with pork tapeworms topping the list. The rankings are contained in a 324-page report about managing the risk.

After identifying gaps in knowledge about the source of the parasites and how they cause illness, the Codex Alimentarius Commission asked the FAO and the World Health Organization (WHO) to review the current knowledge on foodborne parasites, focusing on the public health and trade impacts.

The two groups put out a global call for information, and 21 nations and one regional health group responded. The data were analyzed by several experts on foodborne parasites.

The initial list contained 93 parasite offenders, which was whittled down to the 24 most damaging ones. The FAO said focusing on the top 10 is the first step in tackling the problem, and the Codex Committee on Food Hygiene is working on new guidelines for controlling the parasites.

Renate Clarke, the FAO's head of food safety and quality, said in the statement that the top 10 ranking doesn't reflect the problem at a national level, which would be more precise.

"But considering the problems they cause, these parasites do not get the attention they deserve. We hope that by releasing a top ten ranking we can increase awareness among policy makers, the media, and the general public about this major public health issue."
Jul 1 FAO press release
FAO and WHO report

 

Experts note possible public health benefits of ACA

The Affordable Care Act (ACA) of 2010 can advance public health by emphasizing disease prevention and cooperation between public health and healthcare services, according to a review today by federal experts in The Lancet.

Scientists from the US Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services wrote that the ACA will help move US healthcare from a "sick care" system, largely focused on treatment, to a system that integrates disease prevention, health promotion, early detection, and public health.

"The new law represents a historic opportunity for prevention and public health by establishing the first National Prevention Strategy, adding substantial new funding for prevention and public health programs, and promoting the use of proven clinical preventive services by removing barriers," said coauthor Andrew Rein, MS, formerly of the CDC, in a Lancet press release.

As an example of enhanced coordination of public health and healthcare afforded by the ACA, the authors note the development of novel healthcare delivery models, such as accountable care organizations (provider groups) and patient-centered medical homes, "which prompt health-care entities to broaden their focus from individual patients to their entire panels of patients or to the whole population," the authors wrote.

"Aligning, coordinating, and integrating the best of both systems has the potential to be a game-changer that improves the health of the US population," said Rein.
Jul 1 Lancet abstract
Jun 30 Lancet
press release

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