Patent Issued for Systems and Methods for Improving Patient Compliance with a Prescription Drug Regimen

By a News Reporter-Staff News Editor at Journal of Engineering -- A patent by the inventors Lara, Marcos (New York, NY); Lopez, Alberto (New York, NY); Lara, Miguel A (New York, NY); Rodriguez-Esteban, Ravl (New York, NY), filed on December 15, 2006, was published online on April 21, 2015, according to news reporting originating from Alexandria, Virginia, by VerticalNews correspondents.

Patent number 9015054 is assigned to ConnectUS LLC (New York, NY).

The following quote was obtained by the news editors from the background information supplied by the inventors: "Patient non-compliance, or the fact that patients do not take their medication as prescribed, is a major problem for the pharmaceutical industry and society as a whole. It is estimated that in the United States 125,000 people die each year due to problems associated with patient non-compliance, and the cost of non-compliance for the health care insurance industry is as high as $100 billion annually, including 10% of hospital admissions at a cost of $15.2 billion (2001) and 23% of nursing home admissions at a cost of $31.3 billion (2001). The United States economy is also impacted, as medication non-compliance leads to an estimated loss of 20 million work days annually (corresponding to $1.5 billion in lost revenue for employers).

"In the United States alone, the costs of non-compliance for pharmaceutical manufacturers exceed $30 billion in annual lost revenue. Improving patient compliance with prescription drug regimens would benefit all the parties in the health care sector, from the patients themselves to other major stakeholders: Medicare/Medicaid and other Health Management Organizations (HMOs) would benefit from the savings related to the reduction in hospital and nursing home admissions; drug manufacturers and pharmacies would benefit from the associated increase in drug sales; Pharmacy Benefit Management (PBM) organizations would benefit from increased bargaining power due to increased sales, improved revenues, and improved services to patients and other stakeholders; patients would experience better service, higher satisfaction, and increased safety by increasing medication compliance.

"Various systems have been devised in an attempt to overcome the causes of patient non-compliance, including simple forgetfulness of patients. These systems have included watches and other wearable devices, boxes of special design, and electronic medication dispensers. However, previous systems have proven to be workable only in controlled environments and they have failed to address a number of the causes of patient non-compliance. Prior art systems have failed to satisfy at least three requirements that must be met if a patient reminder system is to be workable in large commercial settings.

"First, a system must provide tangible benefits to the sponsors who pay for the system. Performance data collected by the system should demonstrate the financial benefits to potential sponsors and thus justify sponsor participation in the system. Under certain circumstances, funds from sponsors could be used to make the service free for the patients, which will in turn stimulate patient participation in the system.

"Second, the system must engage the patient. The advantage of using health-care providers to set up medications reminders has been noted in the prior art, for instance, research has demonstrated that 25-50% of patient non-compliance is derived from patient forgetfulness. However, prior art systems have lacked incentive systems to keep the patient engaged in the service over time. Additionally, many prior art systems, such as pager-based systems, have allowed limited or no patient participation.

"Third, the system must have a practical implementation. Most compliance solutions offer an abstract approach to the patient non-compliance problem. However, they do not address a critical question: how to reach a critical mass in the highly fragmented health care market. Critical mass is required to make the method profitable and ensure its survival in the long run. A system that does not tackle the issue of how to create a critical mass of pharmacies and patients adopting the system cannot be implemented, and is functionally useless.

"Prior art systems have failed to address the highly regulated nature of the health care industry, including regulation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Health care systems deal with sensitive patient information, and errors by these systems can lead to serious liability for service providers. For example, a service failure could cause a patient to improperly take or miss doses of medication. Hackers who compromise the system could obtain sensitive patient information. Any system that operates in the health care industry must be reliable and secure; otherwise, the risk of liability will prevent its adoption. Patient consent is a necessary part of such systems, and there is a need to define an effective security protocol to protect the system against external attack. Examples of security procedures that are required to allow the method to operate in a commercial setting are: authentication, encryption, firewalls, back-ups, and data protection mechanisms and procedures in case of catastrophic events.

"Prior art systems do not allow a reminder service to be transferred between pharmacy chains. Several pharmacy chains (e.g., Duane Reade) do not have terminals integrated to exchange patient data. This means that the service may not be transferable among pharmacy branches. As patients may change pharmacy chains, be restricted by health care network membership due to their insurance or for other reasons, or choose mail order pharmacies to fill certain prescriptions, it is important that a service be portable and transferable.

"Patient reminder alerts are likely to be set up at a point in time different from the time the patient picks up the prescription. Thus, an activation mechanism must be in place to ensure that the alert system is activated at the right time, which would normally be defined by the prescription pick-up time. There is a need in the prior art to specify an activation mechanism that takes this delay into account.

"Any commercially viable reminder system must also be designed to allow high load of information input, storage and output. In order to provide high availability, servers must be mirrored and databases must be replicated."

In addition to the background information obtained for this patent, VerticalNews journalists also obtained the inventors' summary information for this patent: "The various embodiments disclosed herein are generally directed towards providing alerts to patients to improve compliance with a prescription drug regimen. The present invention subscribes patients to the reminder system, sets up patient alerts, and transmits alerts to patient communication devices. These alerts are dispatched to the patient to remind the patient to take prescriptions on schedule and refill prescriptions, or to perform any other task related to their health care treatment.

"The present invention includes a patient database for storing patient information and an alert database for storing prescription reminder alerts. A send program queries the alert database and sends the prescription reminder alerts to patients at a determinable time. According to some embodiments of the present invention, an incentives database may store incentives definitions which define events, the occurrence of which will trigger the rewarding of incentives to patients. An incentives program will receive notification of those events and send appropriate incentive verification messages. According to some embodiments of the present invention, a performance database will store information about alerts that have been sent and feedback messages that have been received along with other information usable to measure the performance of the prescription reminder system. A performance measurement program may query the performance database, perform analyses on the results of those queries, and generate reports based on those analyses.

"According to some embodiments of the present invention, an incentive system is available which refunds part of the savings to the patients as an incentive to participate in the system and comply with treatment regimens.

"According to some embodiments of the present invention, a performance subsystem is available allowing the measurement of the tangible benefits of the system to various parties, including increases in sales, savings in health care costs, and improved patient satisfaction. Quantifying the financial benefits of the system may provide data to raise funds from sponsors, thus increasing the chance that the system is adopted.

"According to some embodiments of the present invention the system may be interactive such that the patient can provide feedback, access his or her profile online, check for incentives, opt-out of the service, or receive additional health care information related to his or her disease.

"According to some embodiments of the present invention, the system detects when medications are going to be taken at the same time or close to one another. In such cases, it can provide the option of combining some or all of the messages associated with these prescriptions or, either locally or remotely, it can automatically merge all or part of the messages in order to reduce the number of messages that must be sent to the patient.

"According to some embodiments of the present invention, the system allows the point of service to quickly and efficiently set up known drug regimens. The system can include templates as a time-savings device during alert setup. The system may also be programmed to use e-Rx information or bar-code information to speed setup.

"According to some embodiments of the present invention, the system includes a computer-based security mechanism that will minimize liability risk for the service providers, notifying service providers of risk and not allowing alerts to be sent if unsafe conditions are detected.

"According to some embodiments of the present invention, the system allows service transferability from any dispensing point nationwide to another (e.g., from Walgreens to CVS, or to mail order pharmacy).

"Participants

"The patient is the individual who is subject to the drug regimen and who receives reminders from the system.

"The sponsor pays, in whole or in part, for the reminder service, maintenance, or incentives offered to a certain patient group. Numerous organizations may be sponsors, including pharmacies, drug companies, insurance companies, or pharmacy benefit managers. Any organization that stands to benefit financially from the reminder service may decide to become a sponsor.

"The point of service is where a patient interacts with the alert system, such as a pharmacy, a primary care physician, a cell phone, or a web site. Pharmacies are ideally situated as points of service, because they know when drugs have been picked up and can thus automatically activate the reminder system at that time. Physicians are another possible point of service, but because they do not know when prescriptions have been picked up, they may not be able to activate the service automatically.

"The service provider manages the operation of the alert system and provides the alert message to patients. Pharmacy Benefit Managers are in a unique position to operate as a service provider. Pharmacy Benefit Managers are ideal for offering the service to pharmacies, collecting patient information, measuring the performance of the system, and providing mail order services. Three Pharmacy Benefit Managers manage more than 50% of the prescriptions in the United States and the majority of mail order pharmacy prescriptions in the Unites States. With only one large Pharmacy Benefit Manager offering the service, the service will obtain the critical mass needed to be practical."

URL and more information on this patent, see: Lara, Marcos; Lopez, Alberto; Lara, Miguel A; Rodriguez-Esteban, Ravl. Systems and Methods for Improving Patient Compliance with a Prescription Drug Regimen. U.S. Patent Number 9015054, filed December 15, 2006, and published online on April 21, 2015. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9015054.PN.&OS=PN/9015054RS=PN/9015054

Keywords for this news article include: Hospital, Legal Issues, Investment and Finance.

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