Advanced Database Design Efforts in the Pharmaceutical Industry
The pharmaceutical industry is huge complex for various interests in developing, standardizing, and validating sensitive and specific new and novel tests using database components or batteries of tests with intelligent database query and reporting systems that will provide faster and less expensive alternatives to the use of standard laboratory animal tests,( i.e., assays for carcinogenicity, immunotoxicity, reproductive or developmental toxicity, dermal toxicity, and neuro or other organ system toxicity including acute local and systemic toxicity).
This is an excellent opportunity for database designers to step into the picture and help the total pharmaceutical industry cost picture improve by virtue of accurate and consolidated information readily available via the introduction of better and friendlier data query and accurate reporting interfaces.
This effort ultimately reaches into the health care system via reduced costs for new drug research and better database system management design that can dramatically improve the just-in-time drug manufacturing and delivery system to improve patient care in American and world wide hospital system.
This brief summary article is just a wake-up call to database designers who may avoid efforts in the pharmaceutical industry because of the vocabulary. Try some of these terms on internet search engines and you will discover many opportunities to design new database management systems.
The proposed tests cited here are only quick reference keyword suggestions that you can use for further research on the internet.
In addition to testing, the industry is interested in developing both high throughput screens that can be used to prioritize chemicals for definitive testing and in developing specific tests that meet regulatory requirements for toxicity tests. Again, new database designs become key ingredients in cost saving efficiencies.
The endpoints for these assays combined with new database designs should take advantage of the new technologies such as genomics, transcriptomics, proteomics, and bioinformatics and of novel endpoints (biomarkers) including those that are non-invasive.
Examples include but are not limited to:
A. Biokinetic models that include the integration of toxic dynamic and biokinetic modeling to predict systemic toxicity.
B. In vitro test methods (e.g., undifferentiated/ differentiated human/mammalian cell model systems, organotypic model systems) that can be used to predict acute and chronic toxicity by taking into account, for example, metabolism, the ability of chemicals to pass through barriers (i.e., blood brain, kidney, lung, gastrointestinal), and organ specific effects, or which allow the development of endpoints that can be extrapolated to in vivo biomarkers of toxicity.
C. Alternative assays to determine dermal irritation, dermal absorption, dermal hypersensitivity photo toxicity, and ocular toxicity are performed regularly.
D. Non-mammalian or invertebrate models for specific toxicities that utilize endpoint that are conserved across species so the results can be extrapolated to human risk.
There are plenty of opportunities to build professional system design teams around these topics.
The following may spur related thoughts:
(1) Glyco Nutrients & Stem Cell Production
(2) Surgical Biomaterials and Tissue Regeneration Technologies
Author: Tom Gruich
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can you help me? I have the answer to Obama’s needs for erecords and much more! This will be a billion dollar patent I have! Read below
PRESS CONFERENCE INTRODUCTION - Rep. Domino
For years Florida has been searching for the best solution to the growing problem of prescription drug abuse that now comprises 30% of our illegal drug use and claims the life of approximately 6 Floridians each day.
In the past, there was no ideal answer since systems were too expensive, took 35 days to provide information rather than immediately in
“real time“, and created privacy and theft identity issues.
We now have technology which will do what has been done for years with license testing and other situations requiring secure information….biometric ID for the purchase of Level II-V drugs.
HB 143 (Domino) and SB 614 (Aronberg) provide an economical system to pharmacies and dispensing doctors which simply does a biometric scan, gives the scan an ID number without disclosing the name, social security number, driver’s license number, or address of the patient to anyone other than the pharmacist who already has the information. That scan then allows the pharmacist to see immediately if there have been numerous other controlled drug prescriptions already dispensed. It can also assist pharmacists and dispensing doctors in identifying a medication prescribed which will not interact well with others the patient takes.
Florida has one of the bigger problems of prescription drug abuse in the nation. This legislation will allow us to take the lead with effective technology while providing Floridians both privacy and safety.
FACTS FOR POSTERS AT PRESS CONFERENCE
Bill numbers and sponsors - HB 143 (Rep. Domino) and SB 614 (Sen. Aronberg)
Prescription drug abuse accounts for 1/3 of the illegal drug abuse nationwide and is rapidly rising to the #1 drug problem.
In 2004 48% of the drug overdose deaths (6,035) involved prescription drugs and directly caused 2,181 - approximately 6 per day.
HB 145 and SB 614 FACT SHEET
THE PROBLEM
Prescription drug abuse accounts for 1/3 of the illegal drug abuse nationwide and is rapidly rising to the #1 drug problem.
In 2004 48% of the drug overdose deaths (6,035) involved prescription drugs and directly caused 2,181 - approximately 6 per day.
In 2004, Schedule IV drugs (such as Xanax and Valium) were found to be present in more overdose deaths than cocaine.
The number of Americans who abuse controlled drugs nearly doubled from 7.8 million to 15.1 million from 19992 to 2003 and more than tripled among teens in that time.
Over the past few years, Florida has seen a high demand for prescription drugs on the street where the profit margin is high.
The majority of illegal prescription drug diversion begins with a stolen, forged, counterfeit, or altered prescription form. Patients may seek out multiple doctors to prescribe (doctor shopping), fill the same prescription at multiple pharmacies (pharmacy shopping), or present fraudulent prescriptions to pharmacies. There are also some unscrupulous physicians who simply sell prescriptions to patients (known as a drug mill).
HISTORY
In 2001 Florida passed a law making it a 3rd degree felony for doctors to write prescriptions for fictitious persons, write prescriptions solely to make money, or knowingly assist patients in fraudulently obtaining controlled substances. It also makes it a 3rd degree felony for a patient to withhold information regarding previous receipt of a prescription for a controlled substance (doctor shopping).
The National Schedules Prescription Electronic Reporting ((NASPER) Act in 2005 provided a framework and incentive for all states to establish an electronic database to monitor the prescription and use of Schedule II, III, IV and V drugs. However, lack of funding and HIPPA privacy issues have hindered the implementation.
To date roughly half the states have a monitoring program in place.
FLORIDA HAS NOT PASSED A PRESCRIPTION MONITORING BILL DUE TO COST, NO SYSTEM TO ADDRESS THE PROBLEM IN “REAL TIME” PROVIDING THE PHARMACIST/DISPENSING PHYSICIAN IMMEDIATE INFORMATION, AND PRIVACY CONCERNS. HB 145 AND SB ADDRESSES THOSE CONCERNS.
HB 143/145 AND SB 614/612
1. The War on Drugs has changed. It was focused on heroin, cocaine & marijuana in the 1980’s. Now 30% of the drug problem involves prescription drugs Prescription drug abuse is rapidly rising to #1.
2. In Florida, 8% of all prescriptions or 18 million scripts annually are written for medicines with high abuse potential.
3. In 2005, the National All Schedules Electronic Reporting (NASPER) Act was signed into law. The provisions were not funded, so only around half of states have a prescription monitoring program (PMP)
4. The current programs are little more than passive databases. Each
suspicious script must be individually queried to the database and does not interrupt drug diversion at its point of occurrence.
5. Past proposed database systems raised security & confidentiality concerns. They also did not operate in “real time” and required approximately 35 days to discover abuse.
Solution:
1. The system uses unalterable biometric data such as fingerprints which are already in frequent use for such events as license testing when privacy and security is needed and to prevent identity theft. The biometric is obtained at the time a controlled substance is dispensed, delivered or administrated to an outpatient.
2. Biometric data, prescription information & notes are sent anonymously using only an identifying ID for the print to a secure server. The patient’s privacy is completely secure.
3. The system analyzes all prescription information associated with each individual’s biometric data. An alert is generated to the pharmacist and the physician if there are changes to the script, there has been over prescribing, the patient is attempting to fill scripts from multiple providers, there are potentially adverse interactions between the various medications a single individual is taking.
4. Pilot programs are currently running successfully at 14 sites in South Florida on voluntary basis.
5. Doctor shoppers and organized prescription diversion are already being identified & prosecuted.
HB 145 and SB 614 PROVIDE THE LONG SOUGHT AFTER SOLUTION AND TECHNOLOGY FOR A SECURE AND SIMPLE SYSTEM. FLORIDA CAN NOW LEAD THE NATION IN THIS GROWING DRUG PROBLEM.
ADDITIONAL INFORMATION
COST: Approximately $300/system if implemented in volume and $150 or less per month to operate. Many financial incentives and saving to this cost are available also, such as continuing education credits. THERE IS NO REQUIRED COST TO THE STATE OF FLORIDA.
HOW WILL SURROGATES (OTHERS PICKING UP THE MEDICATION) BE HANDLED? All pharmacists currently have in place some system by which they determine to whom they will dispense. Working within that framework, the identifying code can be provided by the patient to the surrogate and then the surrogate can be given an ID. The system provides room for comments.
Consulting Team:
Louis Fischer- retired DEA pharmacist; was one of DEA’s top managers in drug diversion program; national speaker on drug abuse
Mike McManus- retired DEA investigator; was chief of DEA’s Central & South American operations; a well known speaker nationally on drug abuse
Marcella Gravalese- extensive experience in healthcare administration in Michigan & Florida; has managed programs at North Broward Hospital District and Nova SE School of Medicine
Steve Ballenger- practicing attorney experienced in health law; professor of health law at Nova SE law school
Moe Afaneh- practicing pharmacist; extensive experience in multiple types of pharmacies; owns & operates successful pharmacy in Ft. Lauderdale area
Larry Hooper, MD- medical physician; extensive & varied clinical background; current CEO of a medical device company in the R&D stage; previously chief flight surgeon for US Air Force’s B-2 Stealth Bomber