News Column

Patent Application Titled "Sensitive Drug Distribution System and Method" Published Online

August 11, 2014

By a News Reporter-Staff News Editor at Pharma Business Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors Reardan, Dayton T. (Shorewood, MN); Engel, Patti A. (Eagan, MN); Gagne, Bob (St. Paul, MN), filed on March 19, 2014, was made available online on July 31, 2014 (see also Pharmaceutical Companies).

The assignee for this patent application is Jazz Pharmaceuticals, Inc.

Reporters obtained the following quote from the background information supplied by the inventors: "Sensitive drugs are controlled to minimize risk and ensure that they are not abused, or cause adverse reactions. Such sensitive drugs are approved for specific uses by the Food and Drug Administration, and must be prescribed by a licensed physician in order to be purchased by consumers. Some drugs, such as cocaine and other common street drugs are the object of abuse and illegal schemes to distribute for profit. Some schemes include Dr. shopping, diversion, and pharmacy thefts. A locked cabinet or safe is a requirement for distribution of some drugs.

"Certain agents, such as gamma hydroxy buterate (GHB) are also abused, yet also are effective for therapeutic purposes such as treatment of daytime cataplexy in patients with narcolepsy. Some patients however, will obtain prescriptions from multiple doctors, and have them filled at different pharmacies. Still further, an unscrupulous physician may actually write multiple prescriptions for a patient, or multiple patients, who use cash to pay for the drugs. These patients will then sell the drug to dealers or others for profit.

"There is a need for a distribution system and method that directly addresses these abuses. There is a further need for such a system and method that provides education and limits the potential for such abuse."

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors' summary information for this patent application: "A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in a central database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database for a valid DEA license, and optionally state medical boards to determine whether any corrective or approved disciplinary actions relating to controlled substances have been brought against the physician. Multiple controls beyond those for traditional drugs are imposed on the distribution depending on the sensitivity of the drug.

"Education is provided to both physician and patient. Prior to shipping the drug for the first time, the patient is contacted to ensure that product and abuse related educational materials have been received and/or read. The patient may provide the name of a designee to the central pharmacy who is authorized to accept shipment of the drug. Receipt of the initial drug shipment is confirmed by contacting the patient. Either a phone call or other communication to the patient within a set time after delivery may be made to ensure receipt. Further, a courier service's tracking system is used to confirm delivery in further embodiments. If a shipment is lost, an investigation is launched to find it.

"In one embodiment, the drug may be shipped by the central pharmacy to another pharmacy for patient pick-up. The second pharmacy's ability to protect against diversion before shipping the drug must be confirmed. This ability may be checked through NTIS and State Boards of Pharmacy.

"Prescription refills are permitted in the number specified in the original prescription. In addition, if a prescription refill is requested by the patient prior to the anticipated due date, such refills will be questioned. A lost, stolen, destroyed or spilled prescription/supply is documented and replaced to the extent necessary to honor the prescription, and will also cause a review or full investigation.

"The exclusive central database contains all relevant data related to distribution of the drug and process of distributing it, including patient, physician and prescription information. Several queries and reports are run against the database to provide information which might reveal potential abuse of the sensitive drug, such as early refills.


"FIG. 1 is a block diagram of a computer system for use in implementing the system and method of the present invention.

"FIGS. 2A, 2B and 2C are a flowchart describing a method for sensitive drug distribution at least partially utilizing a computer system such as that shown in FIG. 1.

"FIG. 3 is a flowchart of a physician success program at least partially implemented on a computer system such as that shown in FIG. 1.

"FIGS. 4A and 4B are a flowchart describing a method for handling refill requests at least partially utilizing a computer system such as that shown in FIG. 1.

"FIG. 5 is a flowchart of a process for requesting special reimbursement when a patient is uninsured or underinsured at least partially utilizing a computer system as that shown in FIG. 1.

"FIG. 6 is a flowchart of a process for inventory control at least partially utilizing a computer system such as that shown in FIG. 1.

"FIG. 7 is a block diagram of database fields.

"FIG. 8 is a block diagram showing a list of queries against the database fields.

"FIG. 9 is a copy of one example prescription and enrollment form.

"FIG. 10 is a copy of one example of a NORD application request form for patient financial assistance.

"FIG. 11 is a copy of one example voucher request for medication for use with the NORD application request form of FIG. 10.

"FIG. 12 is a copy of certificate of medical need.

"FIGS. 13A, 13B and 13C are descriptions of sample reports obtained by querying a central database having fields represented in FIG. 7."

For more information, see this patent application: Reardan, Dayton T.; Engel, Patti A.; Gagne, Bob. Sensitive Drug Distribution System and Method. Filed March 19, 2014 and posted July 31, 2014. Patent URL:

Keywords for this news article include: Jazz Pharmaceuticals Inc., Pharmaceutical Companies, Biotechnology Companies.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC

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Source: Pharma Business Week

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