AU2003203618B2 - Dispensing pharmaceuticals - Google Patents

Description

P001 Section 29 Regulation 3.2(2)

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Application Number: Lodged: Invention Title: DISPENSING PHARMACEUTICALS The following statement is a full description of this invention, including the best method of performing it known to us: DISPENSING PHARMACEUTICALS Background The present invention relates to the supply of products which are subject to legislative restrictions on the manner in which they may be supplied to consumers. Although the invention is particularly useful in the case of the retail supply of prescription pharmaceuticals to patients, its use is not limited to that field. Accordingly, throughout this specification (including the claims) the term 'pharmaceutical' is used to include any product which is subject to legislative controls on the manner of its supply and/or dispensing.

Australian retail pharmacists in general sell two types of pharmaceuticals, in addition to a wide range of healthcare and personal care products. These are 'prescription only' products and 'pharmacy only' products. Prescription only products can be supplied only on the prescription of a physician, dentist or the like registered healthcare practitioner. Dispensing of 'prescription only' products may only physically be done by registered pharmacists. 'Pharmacy only' products can be retailed only under the supervision of a licensed pharmacist, but a prescription is not required for their purchase. Unlike the situation with the sale of some other types of substances (such as alcohol and tobacco) current Australian legislation does not require that purchasers of pharmaceutical products be of a minimum age. Supply of such products to 'under age' patients is at the discretion of the medical practitioner in the case of prescription only items, and at the discretion of the pharmacist in the case of pharmacy only products.

The sale of pharmaceuticals by pharmacists, whether the pharmaceuticals are 'prescription only' or 'pharmacy only', can be time consuming and demanding in terms of the resources required of the pharmacist. Particularly in the case of 'pharmacy only' products, when the pharmacist may need to inquire of the customer for symptoms or signs of a disorder and recommend an appropriate medication. In the case of 'self diagnosed' customers who order a specific medication, it is necessary for the pharmacist to warn the customer about sideeffects of medications. In some cases, it will be necessary for the pharmacist to refuse to sell medications to customers who are inebriated or otherwise suffering 2 from substance abuse. In the case of some specific pharmacy only medications such as pseudoephedrine a pharmacist is obliged to refuse to sell the product when there are grounds to suspect that it will be illicitly converted into a prohibited drug. (In the case of pseudoephedrine, converted into methylamphetamine.) There are thus circumstances in which the physical security of the pharmacist becomes an issue. These various requirements however contribute to increasing the expenses of operating a pharmacy.

The Australian Pharmaceutical Benefits Scheme (PBS) is a federal government financed scheme that addresses the costs of supply of pharmaceuticals to patients. The PBS commenced over 50 years ago. At that time, there was concern that many people could not afford expensive but valuable new drugs such as penicillin. A Pharmaceutical Benefits Advisory Committee (PBAC) was established. It recommended that a limited list of life saving or diseasepreventing drugs should be made available on prescription free of charge, the costs to be paid for by the Federal Government.

The PBS has evolved from a scheme that fully subsidised a small number of drugs to one that partially subsidises about 650 drugs. The cost of the PBS has escalated and patient co-payments, brand premiums and other strategies have been used to transfer some of the cost to consumers.

The PBS purchases about 90% of all prescription medicines in Australia. This near monopoly power has resulted in Australian drug prices being substantially lower than the OECD average while still retaining general access to a comprehensive range of medicines.

However the costs of the PBS have been continuously escalating. In 1948/1949 the PBS cost the Federal Government $298,074. It took 40 years for the costs to reach a billion dollars but more recently costs have been rising far more rapidly.

In 1999/2000 the PBS cost the government $3.45 billion, an increase of 16% on the previous year. The 2001 budget papers estimated PBS expenditure for 2000/01 to be $4.26 billion, a 22% increase on the previous year.

The Federal Government has attempted to introduce economies into the PBS by a number of mechanisms. On of these mechanisms is the encouragement of the use of generic or alternative pharmaceuticals. Products in the prescription pharmaceuticals market can generally be considered to be premium brands, alternatives, or generics. Premium brand pharmaceuticals generally first enter the market with patent protection and continue to have the major market share after the patent expires. 'Alternative' and 'generic' pharmaceuticals have the same pharmacologically active ingredients as do the corresponding premium brand, but sell at cheaper prices. The relevant laws were changed to allow a the dispensing pharmacist, with the consent of the patient, to dispense a cheaper generic or alternative when the physician has prescribed a premium brand.

Physicians are also being encouraged to prescribe alternatives or generics in the first instance, but this assumes that prescribing physicians are already aware of the names of alternative or generic pharmaceuticals. It also assumes that the physician is satisfied that the alternatives or generics are not inferior to the premium brand in quality or efficacy.

The PBS is just one of the schemes under which the Federal Government supplies subsidised or even free pharmaceuticals. These schemes include the 'gold cards' that are issued to war veterans and 'health care' cards that are issued on a 'means tested' basis.

Costs of supply of medicines apart, there are situations in which delay in the dispensing of prescriptions is unacceptable. As an example, the patient may have an immediate need, with urgent or emergency implications, to take a pharmaceutical such, for example, as an antibiotic drug prescribed by his or her physician to treat a bacterial infection.

There are also situations which contribute to the risk of errors in dispensing in a traditional pharmacy. The rate at which prescriptions are being written in Australia is consistently increasing by about 15% a year, while the supply of qualified pharmacists graduating is relatively static. These trends reinforce the trend towards larger pharmacies that arises from economies of scale. The result is that overall there tend to be fewer but larger pharmacies, each employing more pharmacists, with the result that the idle time of each pharmacist is decreasing.

However, the likelihood that a pharmacist will be interrupted in the course of dispensing a script is correspondingly increasing. This increased rate of interrupted tasks increases the risk of the pharmacist making an error in the course of dispensing.

Prior art United States patent 6,330,491 (Lion) partially addresses the problem of immediate supply of drugs. Lion provides a system whereby a prescription issued by a medical practitioner is supplied to a mail-order pharmacy or to a 'cyber' pharmacy. A 'cyber' pharmacy, in this context, means a pharmacy which is accessible by the patient via the Internet. Once the prescription has been processed by the pharmacy, that processing authorises the automatic release of the pharmaceutical from a dispensing machine when the patient enters a pharmacy-issued prescription identifier (RxID) into the dispensing machine. That is, the 'dispensing' of the pharmaceutical by the dispensing machine is automatic, conditional only on the entry of a valid RxlD into the machine. Lion thus suffers the disadvantage that the patient must go through a two-stage purchase process.

First, the patient must, using the Internet, have the prescription electronically 'filled' by a pharmacist. The patient must subsequently attend a dispensing machine for the actual physical supply of the pharmaceutical. Lion also suffers the disadvantage that physical step of actual supply of the pharmaceutical is not supervised by a pharmacist who can monitor the physical state of the patient who will be self-administering the pharmaceutical.

Summary of the invention The present invention accordingly provides system for dispensing a package of pharmaceuticals to a purchaser or the like on the production to the system of a prescription or the like, the system including: a remote dispensing machine adapted to dispense at least one of a plurality of drugs contained therein in accordance with a prescription or the like, the dispensing machine being in communication with an operator situated remote from the dispensing machine, the dispensing machine including: at least one video capture device adapted to capture an image of at least one of the purchaser, a prescription or the like for transmission to the operator and a label which has been attached to a package, audio communications means for establishing communications between the operator and the purchaser, and means operable by the operator to release a package of pharmaceuticals to the purchaser.

It is preferred that each prescription or the like that is presented includes a machine readable code which identifies at least one of the purchaser, the practitioner who issued the prescription, and the prescribed pharmaceutical.

It is preferred that the system further includes: a database which includes data on at least one of: persons who are entitled to discounts, benefits or the like on the purchase of pharmaceuticals; practitioners who are lawfully entitled to issue prescriptions; and the pharmacological properties of pharmaceuticals.

It is also preferred that each remote dispensing machine includes means adapted to electronically read a card or other token that is produced to the machine by a person who is entitled to discounts, benefits or the like on the purchase of pharmaceuticals.

It is also preferred that each remote dispensing machine includes means adapted to issue, consequent on the presentation of a prescription, a printed repeat authorisation which authorises the dispensing of at least one further supply of the pharmaceutical.

It is further preferred that each remote dispensing machine includes means for printing a label or the like and for fixing that label to the package of pharmaceuticals.

It is further preferred that each remote dispensing machine includes means which enables the operator to prevent the release of any package when the operator has identified a defect in the package.

It is further preferred that a dispensing machine includes an audio link which enables the purchaser and the operator to hold a conversation.

It is further preferred that a dispensing machine includes means operable by a user to attract the attention of a remote operator. It is especially preferred that the means for attracting the attention of the remote operator is operable to indicate that the user wishes to purchase a 'pharmacy only' item.

It will thus be seen that the present invention provides a system whereby a pharmacist can release a pharmaceutical product to the user almost contemporaneously with the user's presentation of a prescription. This contrasts with the operation of the Lion patent, which requires a two step process involving 'filling' of a prescription by a cyber pharmacy or the like, and subsequent automated release of product from a dispensing machine.

The present invention also provides a system whereby a centralised staff of pharmacists can efficiently supervise a distributed network of dispensing machines, which should in turn contribute to economics of operation, particularly to isolated locations and in 'late hours' locations.

The present invention also provides for the physical security of the pharmacists, who are located remote from the dispensing machines.

The present invention also provides for the supply of pharmaceutical products other than prescription only products.

Detailed description of preferred embodiments of the invention According to one embodiment the present invention provides system for dispensing a package of pharmaceuticals to a purchaser on the production to the system of a prescription which has been issued by a healthcare practitioner.

Following the issue of a prescription, the purchaser (who may be either the actual patient or the agent, parent or other custodian of the patient) presents the prescription to a dispensing machine which is part of the system. It is particularly preferred that dispensing machines be located in close proximity to, or actually within, the premises occupied by the healthcare practitioner.

The system includes a network of such dispensing machines, which are in data communications with a control centre that is staffed by qualified pharmacists.

Each dispensing machine contains a stock of various frequently prescribed pharmaceuticals and a stock of frequently used pharmacy only pharmaceuticals.

According to especially preferred embodiments of the invention, each package of pharmaceuticals is pre-printed or pre-labelled with a range of information. This information may include a barcode or other machine readable code that identifies the nature of the contents of the package, any special precautionary label that is required by the relevant law, and text label describing the nature of the contents of the package. According to preferred forms of the invention, the pre-printed or pre-labelled information includes a logo of the pharmacy or pharmacy franchise, the name, address and teldphone number of the prescribing pharmacy, and the name of the operating pharmacist.

Each dispensing machine also includes video cameras which are monitored by a pharmacist at the control centre and audio communications devices for establishing audio communications between the machine user and the pharmacist. The cameras have views of the user of the machine, of prescriptions presented to the machine, and of a package of pharmaceuticals before it is released from the machine. In alternative preferred embodiments of the invention, a single camera within the dispensing machine may perform two or more of these viewing functions. In yet further preferred embodiments, dispensing machines include apparatus for an audio link to a pharmacist at the remote control centre, so that users of the dispensing machine may have a conversation with a pharmacist at the remote control centre.

Each prescription includes bar coded data identifying the patient, the practitioner issuing the prescription, and the pharmaceutical to be dispensed. Each dispensing machine includes a bar code reader which is capable of capturing this data, and the data is transmitted to the remote control centre.

The system includes a database, located at the control centre or elsewhere, which includes data about generic substitutes for prescription pharmaceuticals.

When the system identifies the prescribed pharmaceutical as having an acceptable generic alternative, the pharmacist is prompted with this information so that the pharmacist can seek the purchaser's approval for the supply of the generic substitute.

In other preferred embodiments of this invention, prescribing physicians also have access to this database to enable them to make a decision whether or not to prescribe a generic or alternative rather than a premium brand pharmaceutical.

It is also preferred that the database includes records of the purchaser's or patients previous purchases of prescription pharmaceuticals, to identify when they qualify for any price discount that is related to previous purchase history.

The pharmacist at the control centre views the purchaser for physical characteristics such as sobriety. The pharmacist also views the prescription data, and any data on discount or benefits entitlements that the patient is entitled to.

According to some embodiments of the invention, the customer inserts into the remote machine a benefits card or like token that indicates that the customer is entitled to a discount or other benefit. Alternative especially preferred embodiments of the system include a database which includes data about persons who are entitled to discounts, benefits or the like on the purchase of pharmaceuticals.

On being satisfied that it is legal and ethical to dispense the pharmaceutical, and that the purchaser has tendered the correct payment through payment receiving means built into the machine, the pharmacist instructs apparatus within the dispensing machine to print an appropriate label and to affix the label to the package of pharmaceuticals. In an alternative preferred embodiment of the invention, information is printed direct onto the pharmaceutical package at this stage rather than onto a label which is then affixed to the package. In the embodiments where the package is pre-printed with basic information about the pharmaceutical before it is loaded into the machine, the printing at this stage can be limited to details such as the patient's name, any special instructions relating to administering the pharmaceutical, the number of authorised repeats of the pharmaceutical, and the script number. According to preferred forms of the invention, the information that is printed at this stage includes the product name, the patient name, instructions for use fo the pharmaceutical, the name of the issuing medical practitioner, the script number, the date of dispensing the pharmaceutical, and any repeat information. The product name will, in the case of a generic pharmaceutical, be the generic name of the product.

Once the label has been affixed to or printed on the package, the pharmacist inspects an image of the package to ensure that the details on it are correct and that any label has been correctly affixed to the package.

It is also especially preferred that each individual package of pharmaceuticals in the machine carries a machine readable code, such as a bar code, that has been printed on the package before it is placed into the machine. In such a case, a barcode reader in the machine also reads the package before it is released to a customer and description of the product corresponding to that bar code is communicated to the pharmacist. This procedure address the potential error at the time of stocking the machine of he wrong product being stacked into a dispensing stack within the machine.

If the pharmacist determines that the label details are not correct or if there has been a machine stocking error, then the pharmacist instructs the machine to retain the package within an area for rejected packages within the machine and not release the package.

Before releasing the pharmaceutical package from the dispensing machine, the pharmacist discusses the medication with the purchaser. At this stage, the pharmacist verbally gives the customer instructions and advice on the use of the pharmaceutical, and reinforces the warnings on any precautionary labels that are affixed to the package.

The pharmacist then operates the dispensing machine to release the package of pharmaceuticals to the purchaser.

Subsequent to, or contemporaneous with, the release of a package to a purchaser the machine also issues any necessary repeat authorisation to the purchaser.

According to other embodiments of the system of the present invention, the system further includes a facility for the dispensing of 'pharmacy only' items from the same machines that also supply 'prescription only' items. It is to be understood that these embodiments cater for the situation in which the purchaser requires 'pharmacy only' items but no 'prescription only' items, as well as for the situation in which the customer requires both 'pharmacy only' and 'prescription only' items.

In the situation in which the customer requires 'pharmacy only' items, the customer approaches a dispensing machine and presses an appropriately labelled button on the machine to obtain the attention of a pharmacist. If a pharmacist is not immediately available to attend to the customer, the request for attention is acknowledged by the playing of a recorded announcement, which is repeated at regular intervals under the control of the remote location until a pharmacist is available to attend to the customer.

When a pharmacist does become available to attend to the customer, the pharmacist has a conversation with the customer over the audio link that is incorporated into the dispensing machine, and the pharmacist diagnoses the customer's need for medication in the usual manner that would be followed in the course of a face-to-face conversation between a customer and a pharmacist. In especially preferred embodiments of the invention, the pharmacist also observes the demeanour of the customer over the video capture device that is incorporated into the dispensing machine. Once the pharmacist has diagnosed the needs of the customer, the pharmacist releases a package of the appropriate medication to the customer following payment.

Payments for the sale of products (be they prescription only or pharmacy only items) is handled in known manner by EFTPOS or credit card transaction or by the purchaser feeding cash into the dispensing machine and receiving appropriate change.

In the case of dispensing machines that are located in particularly remote locations, there is a facility for specifically authorised healthcare workers and emergency workers to obtain prescription pharmaceuticals from the machine without the prior issue of a prescription. The system includes data about such persons who can obtain prescription pharmaceuticals without a prior prescription.

In one preferred form, specific dispensing machines include means to dispense pharmaceuticals to a person who produces to the machine an electronically readable card or other token which identifies the person as being authorised ot obtain prescription pharmaceuticals without a prescription. In another preferred form, the operator situated remote from the vending machine releases a prescription pharmaceutical to a person who produces to the machine an electronically readable card or other token which identifies the peson as being authorised to obtain prescription pharmaceuticals without a prescription.

Claims (10)

1. A system for dispensing a package of pharmaceuticals to a purchaser on the production to the system of a prescription, the system S 5 including: a remote dispensing machine adapted to dispense at least one package of pharmaceuticals contained therein in accordance with said prescription, the dispensing machine being in communication with an operator situated remote 0 from the dispensing machine, the dispensing machine including: at least one video capture device adapted to capture an image of the prescription, a label which has been attached to the package, and an image of the purchaser for transmission to the operator; audio communication means for establishing communications between the operator and the purchaser; and means operable by the operator to release the package of pharmaceuticals to the purchaser.

2. A system as claimed in claim 1, in which each remote dispensing machine includes means adapted to electronically read a card or other token that is produced to the machine by a person who is entitled to discounts, benefits or the like on the purchase of pharmaceuticals.

3. A system as claimed in any preceding claim, further including means adapted to issue, consequent on the presentation of a prescription, a printed repeat authorisation which authorises the dispensing of at least one further supply of the pharmaceutical.

4. A system as claimed in any one of the preceding claims, in which each remote dispensing machine includes means for printing a label or the like and for fixing that label to the package of pharmaceuticals. O

5. A system as claimed in any one of the preceding claims, in which the C means operable by the operator to release a package of pharmaceuticals c to the purchaser is operable to prevent the release of any package when O the operator has identified a defect in the package.

6. A system as claimed in any one of the preceding claims, in which at least one dispensing machine includes means operable by a user to attract the attention of a remote operator.

7. A system as claimed in any one of the preceding claims, further including a database which contains pharmacological data about pharmaceuticals.

8. A system as claimed in claim 7, in which the pharmacological data identifies acceptable generics and alternatives to prescription pharmaceuticals.

9. A system as claimed in any one of the preceding claims, further including data about persons who are authorised to obtain prescription pharmaceuticals without the prior issue of a prescription and means to dispense to prescription pharmaceuticals to such a person on identification of that person as being so authorised.

10. A system as claimed in any one of the preceding claims, substantially as herein described.