Category Archives: FDA

Cloud Based EMRs: Better Post-FDA-Approval Research

A recently closed longitudinal study of a medication to boost “good” HDL cholesterol concluded: “… that the HDL-boosting drug niacin failed to cut the risk for heart attacks and strokes.” The study was designed to track patients for 4 to 6 years but was terminated 18 months early based on the results to that point. The cost: $52.7 million or $15,500 per person for the 3,400 study participants. Fully networked, cloud based, electronic medical records (EMR) appear to offer a better solution.

The topic of this post is research about medications that have received FDA approval and are being prescribed for general use. The subject of a research study could be a new medication being tracked for purposes of risk management among patients who were not fully represented in the limited sample used to obtain FDA approval. It could also be an established medication where adverse events are suggesting that more needs to be learned or where there is reason to believe it is not significantly effective to justify continued sale. In this case, it was a matter of both effectiveness and risk.

The key to a better solution is the evolution of fully networked, cloud based EHRs that create a database that is large enough to provide meaningful statistics about specific occurrences. As an example, Practice Fusion now hosts electronic records created by 90,000 medical providers in a single database that has more than 12 million patient records and is growing. The data is being collected as part of physicians’ normal practice—the electronic version of historically hand written notes.

There are operational advantages:

• Data collection is conducted to serve the day-to-day needs of the physician and their staff so they have established procedures and a vested interest in quality.
• The use of the data is totally independent of its collection so there is no bias in the data collection process or the data; neither the doctor nor the patients are even aware of how the data may be used: a totally blind process.
• Separation of data collection and use remove any presumption of undue influence by the sponsor of the study.
• Data is uploaded by physicians daily so it can be made available in near real-time for use at checkpoints in the study.
• If an area of particular interest is discovered, e.g., women over 60 who are more than 20 pounds overweight, additional participants with those characteristics can be identified and added to provide a larger, more reliable sample of that group.
• The study can provide information about risks and effectiveness, increased levels of HDL, and continued use, i.e., prescription renewal.
• In many cases, patient history related to their disease including prior medications is available and information will be available about patients who stop taking the medication or change to a different medication.
• The same database can be used to create a control group of patients that are not taking the medication and have essentially the same medical conditions and demographics as those who are; if a member of the control group begins taking the medication they can be moved to the study group and replaced in the control group—there is no need to deny patients the opportunity to take the medication just to protect the integrity of the data.

The largest benefit is that there is no marginal cost for data collection. The data is already being collected. There are, of course, charges for extraction of the specific data required for the study, for HIPAA compliant de-identification of the data, and for the use of the data. The study costs cited in the introduction, $15,500 per participant, include costs in addition to data collection, but data collection is a major part of that cost and could be dramatically reduced through the use of fully networked, cloud based, electronic health records.

Better data for the reasons noted above at lower cost translate to better healthcare at lower cost.

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EMRs as Part of Larger Networks

Electronic medical records provide an alternative to paper based records. They are also a source of information that can be used as part of other processes to address a wide range of healthcare issues. Here’s one example:

Congress has passed a bill requiring food processors to implement systems to track cases of food that may be related to outbreaks of food-borne illness.

An estimated 76 million people contract food-borne illnesses in the U.S. each year, with 325,000 hospitalizations and 5,000 deaths, according to the Centers for Disease Control and Prevention in Atlanta. Those illnesses cost the U.S. economy $152 billion a year in health care and related expenses. Rapid identification of the source of these illnesses and their removal from the market is critical.

Under the required tracking system, farmers would scan individual cases of produce, keeping records of where they are shipped. If a recall is ordered by the FDA, the records would be quickly disseminated to trace the current location of the recalled produce.

Once specific cases have been identified as carrying a food-borne illness, the new system will allow those cases to be removed from the market; however this is only part of a complete system. How can the illness be linked to specific cases of food? Here’s where an EMR system can help.

Most EMR systems provide for reporting of food-borne illnesses. By adding a few additional elements of information, the search for the source can be narrowed very quickly. When a doctor enters a diagnosis of food-borne illness, the system can ask for the type of food that is suspect, i.e., eggs, fish, spinach, etc., and the name of the market where the suspected food was purchased. The EMR can track doctors’ reports and when a target number of similar reports is reached an analysis can be launched. A single answer will not be helpful, but if the answers from several cases list the same food and the same market or chain, that provides a place to start. Appropriate information can be forwarded to a public agency.

Samples can be acquired, tests run, and the investigation focused on just a few likely sources. Once a case of food carrying an illness is found, the food processors’ system can be used to find all of the cases from a specific producer and they can be remove from the market.

There is one other piece to the complete solution and that is rapid access to a large enough number of records to find what may be an isolated set of incidents. There are a number of organizations including the VA, Kaiser, and vendors of hospital systems that have large databases and could report to public health agencies or the FDA. There are also physician office systems like Practice Fusion that are database driven and can quickly draw information from more than five million patient records today.

The tracking process from identification of a problem to a solution would look like this:

A Food Illness Tracking Process

This provides an illustration of the way an EMR can also be linked to other tracking systems to identify and facilitate the search for health issues such as some common types of sports injuries or automobile accident injuries. EMRs are clearly more than just systems to replace doctors’ paper records.

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