Software Technology for Sensitive Drug Distribution System and Method

Invented by Dayton T. Reardan, Patti A. Engel, Bob Gagne, Jazz Pharmaceuticals Inc

The Jazz Pharmaceuticals Inc invention works as follows

Background for Sensitive Drug Distribution System and Method

Sensitive medications are monitored to reduce risk and ensure they are not abused or cause adverse effects. Food and Drug Administration has approved these sensitive drugs for specific uses. Consumers must have a prescription from a licensed doctor to purchase them. Cocaine and other street drugs are often the subject of illegal distribution schemes and abuse. Dr. shopping, pharmacy thefts, and diversion are some of the schemes. Some drugs require a locked cabinet or safe.

Certain agents such as Gamma Hydroxy Buterate (GHB), are abused as well, but are also effective in treating therapeutic purposes, such as the treatment of daytime catsaplexy among narcoleptic patients. Nevertheless, some patients will get prescriptions from several doctors and fill them at different pharmacies. A physician who is unscrupulous may write multiple prescriptions to a patient or patients that pay cash for their drugs. These patients then sell the drugs to dealers or other people for profit.

There is a requirement for a system and method of distribution that addresses directly these abuses. It is also necessary to have a distribution system and method which provides education, and reduces the possibility of such abuse.

A drug distribution method and system uses a central database and pharmacy to track all prescriptions of a sensitive drug. A central database is used to store information about all doctors who are allowed to prescribe a sensitive drug and all patients who receive it. Data in the database is monitored for patterns of prescriptions by physicians and prescriptions received by patients. The physician’s eligibility to prescribe controlled substances is further verified by checking a separate database to verify if the DEA license is valid. State medical boards can also be consulted to see if any disciplinary or corrective actions have been taken against the doctor. Distribution is subject to multiple controls, beyond the traditional ones for drugs.

Education will be provided both to the physician and patient. Before shipping the first drug, a patient is contacted in order to confirm that the product and abuse-related educational materials were received and/or viewed. The patient can provide the central pharmacy with the name of an authorized person to receive the shipment. Contacting the patient confirms receipt of the first drug shipment. To confirm receipt, a patient may be contacted by phone or through another communication within a predetermined time period after delivery. In other embodiments, the tracking system of a courier is used to confirm receipt. “If a shipment goes missing, an investigation will be launched to locate it.

In one embodiment, the central pharmacy may ship the drug to a second pharmacy for the patient’s pick-up. It is important to confirm that the second pharmacy can protect against diversion of drugs before shipping them. You can check this ability through NTIS or State Boards of Pharmacy.

Prescription refills may be made in the quantity specified on the original prescription. The refills of prescriptions requested by patients before the due date will also be scrutinized. The prescription/supply that is lost, stolen or destroyed will be documented and replaced as necessary. A full investigation or review may also occur.

The exclusive central database contains relevant information about the distribution and process of the drug, including data on patients, physicians and prescriptions. The database is queried and analyzed to find information that could reveal abuses of the drug.

In the following description it is made reference to the accompanying illustrations that are a part of this document, in which specific embodiments can be illustrated in which the invention could be used. The embodiments described herein are sufficiently detailed to allow those of skill in the art to implement the invention. It is understood that other embodiments can be used and that structural changes, logical changes, and electrical modifications may be made, without departing the scope and spirit of the present invention. The following description should not be interpreted in a narrow sense. Instead, the scope of this invention is determined by the claims that are attached.

In one embodiment, “the functions or algorithms described in this document are implemented by software or in a combination software and manually implemented procedures.” The software includes computer executable instructions that are stored on computer-readable media, such as memory devices or other types of storage devices. Computer readable media is also known as carrier waves. The term “carrier waves” is also used for the carrier waves that are transmitted with software. Modules can be software, hardware or firmware. The embodiments are examples, but multiple functions can be performed by one or more modules. The software is run on a digital sign processor, ASIC or microprocessor or another type of processor on a computer (such as a server, personal computer or other computer systems).

FIG. The simplified block diagram in Figure 1 shows a computer system, such as a PC, that can implement at least some of the described methods. The central processing unit 110 executes the computer programs that are stored in memory 120. In one embodiment, memory 120 contains one or more cache levels to accelerate the execution of programs and the access to the data that the programs use. In one embodiment, the CPU is directly connected to memory 120. CPU 110 and Memory 120 are both coupled to bus 130. The bus 130 is also connected to a storage 140, I/O150 and communications 160. Storage 140 can be a long-term storage device such as a DVD, CD, or tape drive. Storage 140 can be used in one embodiment to store a database that is compatible with the invention. I/O 150 includes keyboards, sound devices and displays, as well as other mechanisms that allow a user to interact with the computer 100. Communications 160 includes a phone connection, local network, wide network, or any other communication mechanism with external devices. These external devices include servers, peer computers and others. In one embodiment, the external device is a database that replaces the database stored on storage 140. You can also use other computer architectures that are capable of executing and interfacing with software, a database, and users. To ensure confidentiality, appropriate security measures are employed such as encryption. Data integrity and backup are also used to avoid data loss.

FIGS. The 2A, 2B, and 2C are the initial order entry processes for a sensitive medication, such as Xyrem. A medical doctor (MD), at 202, sends an Rx/enrollment via email, fax or any other method to 204. The specialist makes a copy stamped with ‘copy’. The original fax will be forwarded to the pharmacy team. The form includes information about the prescriber, prescriptions, and check boxes for the prescriber to indicate that they have read the materials, educated their patient, understood the use of treatment, and understood certain safety information. It also contains information about the patient.

The prescriber’s information includes standard contact information, as well as a license number, DEA code and physician specialization. The patient and prescription information contains name, social insurance number, date and gender of birth, contact information, identification of the drug, dosage of the patient, number of refills, as well as a space for the prescriber to sign. “Insurance information for the patient is also included.

If the information at 212 is complete, the MD will be contacted at 220 for verification of the Rx. This contact is entered in CHIPS. The specialist will then send a consent letter and form to the patient by calling 224. To verify benefits and coverage, the insurance provider is called at 226. In 228, coverage is determined for the drug. In the event that it is unavailable, it will be determined whether or not the patient has the ability and willingness to pay at 230. In this case, a procedure is followed to handle patients who are under- or uninsured. The process may be referred to in one embodiment as a NORD procedure.

If the patient has the ability and willingness to pay, at 230 the patient will be informed of the price of the product at 234 and given options for payment. Once payment has been received at 236, the intake reimbursement specialist will submit a coverage approval to the pharmacy as a notification for the prescription to be processed. If coverage was approved at 228 then the intake reimbursement specialist will also send the coverage approval form along with the enrollment form as notification to the pharmacy to process the prescription. The prescription processing is described in the following paragraphs.

If credentials haven’t been checked recently, the pharmacist checks credentials and enters findings into the database at 274.” If the credentials have been approved at 276, a physician’s screen is populated with information from the database and indicates that the physician has been approved. The prescription will be held until coverage approval is granted at 282.