7- DATA, DATA,& MORE DATA IN HEALTHCARE by PHARMAGEEK

The face of medical care is rapidly changing thanks to major advancements in the capture, proliferation, and analysis of medical data. Technologies like the electronic health records (EHRs) and personal health records (PHRs) are drastically improving the way data is aggregated and shared.

Now the hope is that big data analytics will help to make sense of seemingly endless streams of medical information.

As many doctors are painfully aware, outcome-oriented care is no longer a buzzword but a reality. The Center for Medicare and Medicaid Services has started to implement a program where payments are based on the ability of providers to meet key National Quality Strategy Domains (e.g. care criteria). Public payers are testing this new methodology, and private payers are expected to soon follow.

These big data analytics applications can also be relevant for the FDA, which may want to see how drugs perform in a non-test environment to ensure the appropriate patient populations are receiving the drug. I also expect pharmaceutical companies to actively scour this data to track drug efficacy post-release or identify markets that could “benefit” from increased penetration.

I am eager to see how the data evolution improves outcomes for doctors and patients.

more at http://venturebeat.com/2014/10/16/how-big-data-is-beginning-to-change-how-medicine-works/ ;

It's been tough to identify the problems that only turn up after medicines are on the market. An experimental project is now combing through data to get earlier, more accurate warnings.

No one likes it when a new drug in people's medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke.

To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there's a decent chance that it involves your medical records.

It's called Mini-Sentinel, and it's a $116 million government project to actively go out and look for adverse events linked to marketed drugs. This pilot program is able to mine huge databases of medical records for signs that drugs may be linked to problems.

The usual system for monitoring the safety of marketed drugs has real shortcomings. It largely relies on voluntary reports from doctors, pharmacists, and just plain folks who took a drug and got a bad outcome.

"We get about a million reports a year that way," says Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. "But those are random. They are whatever people choose to send us."

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.

Real-world data are increasingly viewed as a crucial factor in the eventual acceptance of biosimilar drugs, and indeed, current real-world evidence points to the safety and efficacy of these products in the marketplace.

In a recent paper, officials from the European Medicines Agency, the Organisation for Economic Cooperation, and other European government entities explained that such data can help make decisions about pharmaceuticals—from development to reimbursement—more efficient.

The authors called for international cooperation on a learning healthcare system that will better harness these data. 

The authors note that the expense of prospective data generation in a research setting is high, limiting the number of research questions that can be answered in a randomized controlled trial (RCT).

RCTs are rarely large enough to detect infrequent outcomes, nor are they long enough to determine long-term outcomes. 

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.

However, current inadequacies of EHRs present a “technical bottleneck” to the objective of gathering real-world data.  

The paper’s authors propose that governments establish and implement national health data governance frameworks to encourage the use of personal health data to serve the public interest.

The collection of data must translate into the production of useful evidence.

A coordinated and international effort will be key to speed the implementation of a true learning healthcare system for global benefit. 

read the news article at https://www.centerforbiosimilars.com/news/european-officials-promote-use-of-ehrs-to-gather-real-world-data-on-pharmaceuticals--

The face of medical care is rapidly changing thanks to major advancements in the capture, proliferation, and analysis of medical data. Technologies like the electronic health records (EHRs) and personal health records (PHRs) are drastically improving the way data is aggregated and shared.

Now the hope is that big data analytics will help to make sense of seemingly endless streams of medical information.

As many doctors are painfully aware, outcome-oriented care is no longer a buzzword but a reality. The Center for Medicare and Medicaid Services has started to implement a program where payments are based on the ability of providers to meet key National Quality Strategy Domains (e.g. care criteria). Public payers are testing this new methodology, and private payers are expected to soon follow.

These big data analytics applications can also be relevant for the FDA, which may want to see how drugs perform in a non-test environment to ensure the appropriate patient populations are receiving the drug. I also expect pharmaceutical companies to actively scour this data to track drug efficacy post-release or identify markets that could “benefit” from increased penetration.

I am eager to see how the data evolution improves outcomes for doctors and patients.

It's been tough to identify the problems that only turn up after medicines are on the market. An experimental project is now combing through data to get earlier, more accurate warnings.

No one likes it when a new drug in people's medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke.

To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there's a decent chance that it involves your medical records.

It's called Mini-Sentinel, and it's a $116 million government project to actively go out and look for adverse events linked to marketed drugs. This pilot program is able to mine huge databases of medical records for signs that drugs may be linked to problems.

The usual system for monitoring the safety of marketed drugs has real shortcomings. It largely relies on voluntary reports from doctors, pharmacists, and just plain folks who took a drug and got a bad outcome.

"We get about a million reports a year that way," says Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. "But those are random. They are whatever people choose to send us."

 more at http://www.npr.org/blogs/health/2014/07/21/332290342/big-data-peeps-at-your-medical-records-to-find-drug-problems?sc=tw