Thursday, August 13, 2009

Most Critical Item Not Discussed in Health Care Debate

The raucous Health Care Reform debate has embroiled the country in a series of nasty town hall encounters around the nation that has been more in the tradition of a hooligan dominated international soccer football match than a community meeting for the exchange of ideas and viewpoints about healthcare. Despite all of the information and misinformation now flooding the media, supposedly based on thousands of pages of DRAFT legislation proposed by Congress to change the American healthcare system, not one word has been uttered about the MOST CRITICAL ITEM that is affecting the health of Americans. The missing words are DRUG INTERACTION.

Adverse drug reactions are the 4th leading cause of death in the United States and the leader for malpractice payouts. There are literally tens of thousands of prescription drugs available in the United States. Many years ago, the old standby reference generally found on most doctors’ desk, the Physician’s Desk Reference, provided an encyclopedic reference for all possible adverse interactions for all of the manufactured drugs known at the time. Needless to say in this day, when designer drugs are flooding the market, the Physician’s Desk Reference is no longer a serious reference for this type of critical information. A new pharmacological industry producing genetically engineered drugs is currently gearing up to launch an avalanche of new drugs into the healthcare marketplace. The design and engineering of these new drugs involves a radically new technology which bears very little similarity to the old traditional drug creation methodologies. For the reasons detailed above it is critical that management and control of DRUG INTERACTION be included in the new Health Care Reform legislation.

In addition to the physically disabling adverse drug reactions mentioned above is the horrific specter of an untold number of “accidents” that were caused by adverse drug interaction but were not reported as being caused by drug interactions. Obviously drug interaction problems account for many automobile accidents, but adverse interactions also may be the contributory source of many major house fires and the fatalities thereof. As outlined in the Health Care debate, patients are often referred to various specialists, who then independently prescribe medications for the patient’s complaint relative to the physician’s specialty. It is quite common for a patient to be seen by as many as three specialists over any one given period, with each physician prescribing a specific drug regimen over the course of the treatment period. Most physician offices have a new patient enrollment application which inquires as to all drugs that the new patient is currently taking. However, this is baseline information, and may not be available to all of the patient’s treating physicians. Also in many instances patients don’t have a clear understanding exactly how long they should continue taking certain medications. Further complicating the drug interaction problem is the physical condition of the patient along with the length of exposure to different drugs. Some patients have a higher tolerance of the effects of adverse drug reactions; conversely others have a low tolerance of the effects of adverse drug reactions.

The President has mentioned many times that digitized records must be included in the Health Reform bill, and I think that there is no opposition to this requirement. The President has also stated that digitized medical records will help prevent redundant medical testing and is therefore a cost cutting feature. However, digitized medical records will help but not prevent problems associated with adverse drug interactions, simply because the prescribing doctor may not know the extent of interaction between drugs that the patient is currently taking and the drug that he/she is about to prescribe.

I have compiled several statements that should form the basis for legislative language to be included in the Health Care Reform bill. These statements are captured in bold print below, but first an explanation of some of the terms appearing in each statement.

The term VAULT refers to a Government repository for each individual’s health records. Digitizing patient health records will be useless without a proper centralized repository where these records will be available for access by authorized medical personnel. A centralized repository also will offer the highest quality standardized security for protecting the privacy of patient records. Further, in concert with the latest revolutionary breakthrough in the world of internet digital access, namely CLOUD COMPUTING, a VAULT repository architecture available via the internet, would provide a seamless integration of this medical function into the 21st century world of computing.

The term FEDERAL REGISTRY defines another Government repository, but this online internet accessible facility will store all of the KNOWN DRUG INTERACTIONS for all of the prescription drugs available. Currently Drug manufacturers DO NOT have to supply any information concerning possible drug interactions of their new product when they file their New Drug Application (NDA) form. I propose that the NDA form be updated to provide the requirement that the drug manufacturer provide interaction information between this new drug and any other drugs currently available. Interaction possibilities of this new drug and other drugs already on the market must be included as part of the drug testing documentation. Approval of the FDA must be withheld until the manufacturer’s interactive data has been satisfactorily accepted and posted by the Federal Drug Interactive Registry. Whereas the Federal Drug Interaction Registry functions as a clearing house for this critical information, its facility must have the necessary computing power on site to not only constantly interface with drug manufacturers worldwide, but also upgrade its legacy information as new data flows into the facility. This form of cross checking guarantees that the drug interaction library will always be up-to-date and accurate for all accessing medical professionals. If a drug is superseded by a superior drug product and is retired from the registry, it must no longer be available for prescribing to the general public. The statements to be included in the Health Reform bill follow below.




"Digitize each individual's health records. Upload patient diagnosis and treatment records to the VAULT. Also write a copy of the patient’s records into a memory stick for each patient. The VAULT and memory stick records will be updated on subsequent Doctor/Hospital visits. Hospitals and Doctor’s offices need internet access to patient’s records in the VAULT via the internet."


"America needs a prescribed FEDERAL Drug Interaction REGISTRY! Registry must be digitally accessible to Doctors and Hospitals via the internet. Estimated time for residual effects of the drug to CLEAR the human body must also be included with the drug data! Verification that valid Drug Interactive data has been satisfactorily stored in the REGISTRY must be an integral part of the FDA approval process!"

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