WO2001027841A1

WO2001027841A1 - Method, apparatus and system for providing a drug utilization review that integrates non-prescription items

Info

Publication number: WO2001027841A1
Application number: PCT/US2000/028153
Authority: WO
Inventors: Robert Judge
Original assignee: Wellpartner, Inc.
Priority date: 1999-10-12
Filing date: 2000-10-12
Publication date: 2001-04-19
Also published as: WO2001027842A1; AU8013300A; AU8013500A

Abstract

A method and apparatus for providing drug utilization review that integrates 'non-prescription' items over a global set of interconnected computer networks, i.e., the Internet or World Wide Web (110). The architecture illustrates a plurality of users (120), a health management and pharmacy service provider (130), and a plurality of health service or product providers (140-148), and an enormous amount of health service related information and resources (150) that are connected to the Internet.

Description

METHOD, APPARATUS AND SYSTEM FOR PROVIDING A DRUG UTILIZATION REVIEW THAT INTEGRATES NON-PRESCRIPTION

ITEMS

This application claims the benefit of U.S. Provisional Application No.

60/158, 788 filed on October 12, 1999 which is herein incorporated by reference.

The present invention relates to an apparatus, system and concomitant method for performing drug utilization review (DUR). More specifically, the present invention describes a novel approach for performing drug utilization review that integrates "non-prescription" items.

BACKGROUND OF THE DISCLOSURE The U.S. Drug Enforcement Agency (DEA) classifies drugs using a classification system of drug schedules. The DEA schedules range from Class I - V and define levels of management and control associated with drugs ranging from tightly controlled substances, such as opiates, to non- narcotic medications, such as drugs containing less than 100 mg of codeine. The distribution of these substances is managed through the U.S.

Food and Drug Administration (FDA). Management is maintained for "prescription" products (prescription drugs) and over the counter (OTC) drugs (non-prescription drugs) using National Drug Codes (NDC) numbers. The purpose of the NDC number is to establish the product manufacturer, the product content and its packaging size. NDC numbers are maintained for all prescription drugs, including those that have transitioned to OTC status. NDC numbers are not available for OTC products (that were not previously prescription drugs) or alternative medicines. In these instances Uniform Product Codes (UPC) may be used to identify products. When a patient purchases a prescription drug at a retail pharmacy, certain steps are taken to ensure there will be no adverse affects on the patient. These precautionary checks typically include one or more of the following reviews: 1. Drug to Drug Interactions

2. Duplication of Therapy

3. Drug/Age Contraindications

4. Drug/Gender Contraindications 5. Drug/disease state (known or inferred diseases)

6. Minimum dose

7. Maximum dose

8. Too Early Refill (TER)

Virtually all retail pharmacies today (community based independents as well as chain drugstores) have software on their computer system that performs one or more of these functions. For independents, this software checks activity in the patients "profile" at that store. For chain drugstores, these checks will often expand to include the patient's activity at any of the other chain's stores as well. Additionally, when a claim is submitted for insurance payment through a Pharmacy Benefits Manager (PBM), the PBM will likely perform these functions across the entire patient profile on file.

This process is sufficient for all active prescription drugs when profiled against a patient's active prescription medication profile. However, most pharmacies do not enter non-prescription items into the patient's pharmacy profile. Items such as over the counter medications, and herbals (e.g., the currently popular Chinese/eastern remedies) are not included in typical retail transaction processes, even though significant contraindications and patient risks may exist. Examples of this include the known issues of St. John's Wort with anti-depressants, use of Tagamet with certain prescription items such as propranolol, and etc. With more and more FDA approvals of prescription items to an OTC status (recent examples include Alleve, Tagamet, Zantac, Pepcid, Lamasil), and the popularity of herbals and alternative drugs, this represents a growing challenge in helping patients manage their drug related care. Non-prescription products such as these are usually considered "cash transactions" and are typically rung at the cash register. The drawback is that such purchases are not recorded and tracked by the pharmacy system, i.e., they are not captured in the patient profile. Retail pharmacy systems today maintain distinct and separate processes for completing transactions for prescription versus OTC/alternative medicines. At the time a transaction is processed for payment within a pharmacy for prescription drugs, the "pharmacy management system" may initiate an Online Transaction Processing

(OLTP) request that uses the drug's NDC number to execute a "concurrent" Drug Utilization Review (DUR).

DUR OLTP transactions are executed against an established rules databases (usually First Data Bank's MediSpan or NDDF) for prescription drugs. In this process, a check is submitted to the pharmacy's or PBM database where edit routines are returned to the pharmacist for issues that fall outside the established edit algorithms. The pharmacist can then consult with the patient's physician to alter the prescription or consult with the patient directly. Unfortunately, no such system exists for performing drug utilization review for non-prescription items. Such deficiency posts significant health risks to consumers who are consuming numerous OTC and herbal items without the benefit of a drug utilization review.

Thus, it would be very desirable to have a system and method that is designed to provide drug utilization review that integrates "non- prescription" items.

SUMMARY OF THE INVENTION In one embodiment of the present invention, a method and apparatus is disclosed that provides drug utilization review that integrates "non- prescription" items. Specifically, the invention provides a unique data structure that tracks the "source of prescription" information relating to non-prescription products. For example, the "source of prescription" information provides information as to whether a "non-prescription" item being purchased by a consumer is "physician directed" or "self directed". The purchased item and "source of prescription" information are stored in a medication profile.

In turn, rules from a standard DUR and the user's medication profile is then applied to the purchased "non-prescription" item. If an alert from the DUR is triggered, the "source of prescription" information will dictate how the alert will be handled. Specifically, if the "non-prescription" item is self-directed, the alert will be discussed with the user directly. Whereas, if the "non-prescription" item is physician-directed, the alert will be discussed with the prescribing physician and optionally with the user directly. The above process is also applied conversely. Namely, a newly prescribed prescription drug can be reviewed against a user's medication profile which may contain information about the user's current consumption of non-prescription products. Again, if the "non-prescription" item is self- directed, the alert will be discussed with the user directly. Whereas, if the "non-prescription" item is physician-directed, the alert will be discussed with the prescribing physician and optionally with the user directly.

BRIEF DESCRIPTION OF THE DRAWINGS The teachings of the present invention can be readily understood by considering the following detailed description in conjunction with the accompanying drawings, in which:

FIG. 1 depicts a block diagram of an overview of the architecture of the present invention for providing drug utilization review that integrates "non-prescription" items over a local network or a global set of interconnected computer networks, i.e., the Internet or world wide web; FIG. 2 depicts a block diagram of a data structure of a medication profile of the present invention; and

FIG. 3 depicts a block diagram of a flowchart of the method of the present invention for providing drug utilization review that integrates "non- prescription" items.

To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures.

DETAILED DESCRIPTION

The present invention is an apparatus, system and method that is designed to provide drug utilization review that integrates "non- prescription" items for consumers. In one illustrative embodiment, the present invention is implemented "online", i.e., over a local computer network and/or a global set of interconnected computer networks, i.e., the Internet or World Wide Web.

The Internet is a global set of interconnected computer networks communicating via a protocol known as the Transmission Control Protocol and Internet Protocol (TCP/IP). The World Wide Web (WWW) is a fully distributed system for sharing information that is based upon the Internet. Information shared via the WWW is typically in the form of HyperText Markup Language (HTML) or (XML) "pages" or documents. HTML pages, which are associated with particular WWW logical addresses, are communicated between WWW-compliant systems using the so-called HyperText Transport Protocol (HTTP). HTML pages may include information structures known as "hypertext" or "hypertext links." Hypertext, within the context of the WWW, is typically a graphic or textual portion of a page which includes an address parameter contextually related to another HTML page. By accessing a hypertext link, a user of the WWW retrieves the HTML page associated with that hypertext link.

FIG. 1 depicts a block diagram of an overview of the architecture 100 of the present invention for providing drug utilization review that integrates "non-prescription" items over a global set of interconnected computer networks, i.e., the Internet or World Wide Web. The architecture illustrates a plurality of users 120a-n, a health management and pharmacy service provider 130 of the present invention, a plurality of health service or health product providers 140-148, and an enormous amount of health related information and resources 150 that are all connected via the Internet. As discussed below, the present drug utilization review process can be implemented as a function that is operated within the health plan providers 140, within the pharmacies 142 and/or within the health management and pharmacy service provider 130.

Specifically, each user is an individual operating a general purpose computer or Personal digital assistant (PDA) or other Wireless Application Protocol controlled device 120 having a central processing unit (CPU) 122, a memory 124, and various Input/Output (I/O) devices 126. The input and output devices 126 may comprise a keyboard, a mouse, a modem, a camera, a camcorder, a video monitor, any number of imaging devices or storage devices, including but not limited to, a tape drive, a floppy drive, a hard disk drive or a compact disk drive. The general purpose computer allows the user to gain access to the services and information available on the Internet. Access to such services and products may include web sites operated by health plan providers (e.g., insurance companies) 140, pharmacies 142, drug companies 144, health care providers (e.g., hospitals, clinics, doctors, nurses, etc.) and any other 3^rd party health service provider 148. Finally, a wealth of health related information and resources are summarily represented by reference numeral 150 which may include medical journals, reports, studies, chat groups, seminars, support groups and the like. Unfortunately, although numerous healthcare products such as OTC drugs and herbal treatments are available to a consumer over the Internet, the consumer is often not aware of the effect of using such items in relation to other prescription drugs or other medical conditions of the consumer. The consumer may become complacent and presume incorrectly that such OTC drugs and herbal treatments are relatively safe. Thus, consumers often neglect to inform healthcare providers and pharmacists about their consumption of such OTC drugs and herbal treatments.

To address such deficiencies, the present invention provides a drug utilization review that integrates "non-prescription" items. Specifically, the present invention creates an online patient medication profile that includes both active prescription and non-prescription medicines. Under this approach, the present system will create an "active" patient medication profile that includes prescription and non-prescription drugs, including items that were previously identified as prescription, but are now OTC drugs.

In one embodiment, the present invention is deployed within a health management and pharmacy service provider 130. Effectively, the health management and pharmacy service provider serves as a healthcare portal that provides highly personalized health management resources and pharmacy services to consumers. As one of its many resources, the health management and pharmacy service provider may also implement the present invention to provide drug utilization review for its users.

The health management and pharmacy service provider 130 is also implemented using a general purpose computer having a central processing unit (CPU) 132, a memory 134, and various Input/Output (I/O) devices 136. The input and output devices 136 may comprise a keyboard, a mouse, a modem, a camera, a camcorder, a video monitor, any number of imaging devices or storage devices, including but not limited to, a tape drive, a floppy drive, a hard disk drive or a compact disk drive. In the preferred embodiment, various functions of the health management and pharmacy service provider 130 as discussed below are implemented (in part or in whole) by a software application that is loaded from a storage device and resides in the memory 134 of the computer. As such, the health management and pharmacy service provider 130 and associated methods and/or data structures of the present invention can be stored on a computer readable medium. For example, the present drug utilization review method that integrates "non-prescription" items can be stored on a computer readable medium.

Finally, it should be noted that the general purpose computer of the health management and pharmacy service provider 130 should be broadly interpreted to include one or more personal computers, servers, main frames and the like. Furthermore, the health management and pharmacy service provider 130 is disclosed in a copending US patent application entitled "Method, Apparatus And System For Providing Health Management Resources And Pharmacy Services To Consumers", with serial number _ x which is filed simultaneously with the present application and is herein incorporated in its entirety by reference.

Alternatively, the present invention can be implemented within one of the other service providers, e.g., the pharmacies 142 or the health plan providers 140. Namely, it is not necessary to implement the present invention within a health management and pharmacy service provider.

To illustrate, many pharmacies now have web sites that allow consumers to directly purchase prescription and non-prescription items. As such, as consumers purchase prescription and non-prescription items through the online pharmacy, the pharmacy may implement the present invention to perform a drug utilization review. Thus, the present invention will reside within a computer system of the online pharmacy having a CPU, a memory and 170 devices.

In yet another alternate embodiment, the present invention can be implemented within an isolated system. For example, for an independent pharmacy, a patient's profile is often stored locally since there are no other chain stores that the independent pharmacy can query to determine what other medications the patient has taken. In such situation, the "brick and mortar" pharmacy will perform a drug utilization review of the present invention locally. Thus, the present invention will reside within a computer system of the "brick and mortar" pharmacy having a CPU, a memory and I/O devices.

FIG. 2 depicts a block diagram of a data structure 200 of a medication profile of the present invention. Specifically, data structure 200 can be implemented as a computer-readable file that contains a database with records. Each record may correlate to one patient. Referring to FIG. 2, a record may contain several data elements, e.g., data fields. In one embodiment, the data elements may comprise a drug name field 210 (e.g., brand name or generic name of the drug), a drug code field 220 (e.g., the NDC number), a source of prescription field 230 (e.g., a value that may broadly include numbers, symbols and/or text), a dosage field 240 (e.g., the amount of dispensed medication and treatment duration), a medical condition field 250, a prescription date field 260 and other relevant fields. It should be noted that data fields can be added or deleted based upon the need of a particular implementation.

One unique aspect of the present invention is the new construct or field, known as the "source of prescription" 230. The source of prescription can be implemented with many sub-attributes, but the two predominant values (including symbols or text) being: "self-directed" and "physician directed" (or "doctor directed"). In fact, values such as "nurse directed", "therapist directed", "practitioner directed" and others may be used. Such additional values do not alter the present invention, but simply provide additional information for the drug utilization review process.

An important aspect of the present process is the tracking of the use of a product based upon the "source of prescription". That is to say, products taken by a patient may be self-directed or physician-directed.

The present system builds on existing processes for DUR by creating a process to integrate existing DUR for non-prescription products at the time the purchase is made. The handling of the DUR alerts by the dispensing pharmacist is based on the value of the source of prescription. In brief, if the source of prescription is "physician directed", then traditional DUR practices, interventions, and counseling are performed. However, if the "source of prescription" is "self-directed", then DUR interventions and counseling begin with the patient rather than the healthcare professional. FIG. 3 depicts a block diagram of a flowchart of the method 300 of the present invention for providing drug utilization review that integrates "non- prescription" items. Method 300 starts in step 305 and proceeds to step 310 where a user presents for purchase a non-prescription item. The purchase can occur online, e.g., via the Internet or can occur physically where the user is at a pharmacy.

In step 315, the source of prescription information associated with the non-prescription item is provided. The actual implementation of this step may vary depending on the application. For example, the user is queried as to who has "prescribed" this product. Choices will correspond to the values supplied to the "source of prescription field". Such choices can be presented as the following questions:

Did your DOCTOR prescribe this product?

Did a nurse or other healthcare professional prescribe this product? Have you SELF-DIRECTED this product (i.e., did you decide you need to take this product on your own, without the specific recommendation of a healthcare professional)?

Based upon the answers to the above questions, a "source of prescription code" is assigned to the item's purchase.

In step 320, method 300 applies the DUR database and the user's medication profile (if one exists) against the purchased product to determine potential health issues. The DUR database can be a standard DUR database or a custom database. The present invention is not limited to any particular DUR database.

In step 325, method 300 queries whether an alert is generated from applying the rules of the DUR database to the purchased item. If the query is negatively answered, then method 300 proceeds to step 330 where information pertaining to the purchased item is used to update the user's medication profile, e.g., the fields of data structure 200 are updated. If a user medication profile has not been previously created, a new user medication profile will be created. The method 300 then ends in step 360.

If the query is positively answered in step 325, then method 300 proceeds to step 340 where method 300 queries whether the purchased item is physician prescribed. If the query is negatively answered, then method 300 proceeds to step 345 where the user is directly notified as to the health concern that relates to the user's consumption of the purchased item. For example, the consumer will be contacted by the pharmacist either directly or via an alert (such as in the case of an "internet pharmacy" or mail service pharmacy) directing the patient to contact the pharmacist regarding the product in question.

If the query in step 340 is positively answered, then method 300 proceeds to step 355 where the prescribing physician is directly notified as to the health concern that relates to the user's consumption of the purchased item. Alternatively, the user can also be optionally notified in step 350. For example, the pharmacist will receive the alert and can decide to contact the patient's physician to alter the directed medication, advise the patient on health related issues or follow the pharmacy's procedures for handling DUR alerts. Method 300 then ends in step 360. Although the above description is provided with a scenario where a non-prescription is purchased and verified against the DUR database and the user's medication profile, it should be noted the same process is also applied to prescription items as well. Namely, the traditional process for evaluating prescription items is also amended to address the present criticality.

For example, if a DUR alert is generated for a new prescription drug, then the dispensing pharmacist will review the alert to determine whether a non-prescription item in the patient's medication profile is referenced. If the answer to the query is "negative", then normal DUR processing takes place. However, if the answer to the query is "positive" for physician directed non-prescription products, the pharmacist will receive the alert and can decide to contact the patient's physician to alter the directed medication, advise the patient on health related issues or follow that pharmacy's procedures for DUR alerts, according to the pharmacy's established protocol for handling severity levels on alerts. For self-directed products, the consumer will be contacted by the pharmacist either directly or via an alert (such as in the case of an 'internet pharmacy' or mail service pharmacy) directing the patient to contact the pharmacist regarding the non-prescription product in question. Several advantages can be realized with the implementation of the present concurrent drug utilization review method. First, the present invention capitalizes on the increasing trend of consumers to self-medicate themselves with non-prescription products that potentially have contraindications with their identified condition, gender or active medications. By providing a process to intercept these contraindications, this process provides improved consumer service, and potentially avoids adverse medical reactions.

Second, the present invention enables the FDA to continue to move prescription drugs to an OTC status, while preserving the advantages of the DUR processing. Additionally, as more drugs are moved to OTC status, consumers will be more understanding and more receptive to providing information to the pharmacist that will ultimately provide better health services to them.

Third, the present invention enables health plan providers, i.e., insurance companies, to cover selected OTC and other items (such as in step-care protocols) without giving up what they perceive as valuable functionality they receive via DUR processing. The consumers will benefit because of the additional coverage offered by the health plans.

Fourth, the present invention adds value to health plans and other payors of patient health costs by highlighting potential contraindications, thereby avoiding adverse medical reactions and/or drug induced hospital visits that add cost to the health plans.

Finally, for physicians and other healthcare providers, the present invention provides an added service by allowing these consumers to be alerted to non-prescription medicine issues against their patient's profiles by keeping all this information in a single electronic jacket for the patient.

Although various embodiments which incorporate the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise many other varied embodiments that still incorporate these teachings.

Claims

What is claimed is:

1. A method for providing a drug utilization review that evaluates a non-prescription item, said method comprising the steps of: a) identifying a non-prescription item; b) identifying a source of prescription for said non-prescription item, where said source of prescription is stored in a medication profile; and c) applying a drug utilization review against said non-prescription item using said medication profile.

2. The method of claim 1, further comprising the step of: d) updating said medication profile in accordance with said non- prescription item and said source of prescription.

3. The method of claim 2, wherein said non-prescription item is an over the counter (OTC) medication.

4. The method of claim 2, wherein said non-prescription item is a herbal product.

5. The method of claim 1, wherein said source of prescription comprises a value indicating whether said non-prescription item is self-directed or physician directed.

6. The method of claim 5, further comprising the step of: d) applying said source of prescription to determine the manner in which the result of said drug utilization review is to be handled.

7. The method of claim 1, wherein said applying step c) applies a drug utilization review on line.

8. A method for providing a drug utilization review that evaluates a prescription item, said method comprising the steps of: a) identifying a prescription item; b) identifying a medication profile having at least one non- prescription item that is identified with a source of prescription; and c) applying a drug utilization review against said prescription item using said medication profile.

9. The method of claim 8, further comprising the step of: d) updating said medication profile in accordance with said prescription item.

10. The method of claim 9, wherein said non-prescription item is an over the counter (OTC) medication.

11. The method of claim 9, wherein said non-prescription item is a herbal product.

12. The method of claim 8, wherein said source of prescription comprises a value indicating whether said non-prescription item is self-directed or physician directed.

13. The method of claim 12, further comprising the step of: d) applying said source of prescription to determine the manner in which the result of said drug utilization review is to be handled.

14. The method of claim 8, wherein said applying step c) applies a drug utilization review on line.

15. A computer-readable medium (134, 136) having stored thereon a plurality of instructions, the plurality of instructions including instructions which, when executed by a processor, cause the processor to perform the steps comprising of: a) identifying a non-prescription item; b) identifying a source of prescription for said non-prescription item, where said source of prescription is stored in a medication profile; and c) applying a drug utilization review against said non-prescription item using said medication profile.

16. The computer-readable medium of claim 15, further comprising the step of: d) updating said medication profile in accordance with said non- prescription item and said source of prescription.

17. The computer-readable medium of claim 16, wherein said non- prescription item is an over the counter (OTC) medication.

18. The computer-readable medium of claim 16, wherein said non- prescription item is a herbal product.

19. The computer-readable medium of claim 15, wherein said source of prescription comprises a value indicating whether said non-prescription item is self-directed or physician directed.

20. The computer-readable medium of claim 19, further comprising the step of: d) applying said source of prescription to determine the manner in which the result of said drug utilization review is to be handled.

21. The computer-readable medium of claim 15, wherein said applying step c) applies a drug utilization review on line.

22. A computer-readable medium (134, 136) having stored thereon a plurality of instructions, the plurality of instructions including instructions which, when executed by a processor, cause the processor to perform the steps comprising of: a) identifying a prescription item; b) identifying a medication profile having at least one non- prescription item that is identified with a source of prescription; and c) applying a drug utilization review against said prescription item using said medication profile.

23. The computer-readable medium of claim 22, further comprising the step of: d) updating said medication profile in accordance with said prescription item.

24. The computer-readable medium of claim 23, wherein said non- prescription item is an over the counter (OTC) medication.

25. The computer-readable medium of claim 23, wherein said non- prescription item is a herbal product.

26. The computer-readable medium of claim 22, wherein said source of prescription comprises a value indicating whether said non-prescription item is self-directed or physician directed.

27. The computer-readable medium of claim 26, further comprising the step of: d) applying said source of prescription to determine the manner in which the result of said drug utilization review is to be handled.

28. The computer-readable medium of claim 22, wherein said applying step c) applies a drug utilization review on line.

29. An apparatus (130, 142, 140) for providing a drug utilization review that evaluates a non-prescription item, said apparatus comprising: first means (132) for identifying a non-prescription item; second means (132) for identifying a source of prescription for said non-prescription item, where said source of prescription is stored in a medication profile; and means (132) for applying a drug utilization review against said non- prescription item using said medication profile.

30. The apparatus of claim 29, further comprising: means (132) for updating said medication profile in accordance with said non-prescription item and said source of prescription.

31. The apparatus of claim 29, wherein said source of prescription comprises a value indicating whether said non-prescription item is self- directed or physician directed.

32. The apparatus of claim 29, wherein said applying means applies said drug utilization review on line.

33. An apparatus (130, 142, 140) for providing a drug utilization review that evaluates a prescription item, said apparatus comprising: a first means (132) for identifying a prescription item; a second means (132) for identifying a medication profile having at least one non-prescription item that is identified with a source of prescription; and means (132) for applying a drug utilization review against said prescription item using said medication profile.

34. The apparatus of claim 33, further comprising: means (132) for updating said medication profile in accordance with said prescription item.

35. The apparatus of claim 33, wherein said source of prescription comprises a value indicating whether said non-prescription item is self- directed or physician directed.

36. The apparatus of claim 33, wherein said applying means applies said drug utilization review on line.

37. A method for providing a drug utilization review that evaluates a non-prescription item, said method comprising the steps of: a) identifying a non-prescription item, where said identified non- prescription item is stored in a medication profile; and b) applying a drug utilization review online against said non- prescription item using said medication profile, where said online review is conducted via a global set of interconnected computer networks.