Override having built in audit trail for medication...

Data processing: generic control systems or specific application – Specific application – apparatus or process – Article handling

Reexamination Certificate

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C700S237000, C700S240000, C700S244000, C221S002000, C221S007000

Reexamination Certificate

active

06671579

ABSTRACT:

BACKGROUND OF THE INVENTION
A wide variety of apparatus are used in healthcare facilities for the dispensing and inventory of medications and medical supplies. For example, U.S. Pat. No. 5,520,450 discloses a supply station with an internal computer. The supply station is comprised of a cabinet having a plurality of lockable doors. Information is provided to a computer which unlocks the doors. The computer may be used to simultaneously and automatically update a patient's record, billing information and hospital inventory. The relevant data may be displayed on a display or printed on a sheet of paper by a printer connected to the computer. Other examples of computer controlled dispensing apparatus are found in U.S. Pat. No. 5,346,297, U.S. Pat. No. 5,905,653 and U.S. Pat. No. 5,745,366.
Such computer controlled dispensing apparatus have been developed in response to a number of problems existing in hospitals and other healthcare institutions. More particularly, computer controlled dispensing apparatus are operated according to programming that addresses problems such as the removal of medications by unauthorized personnel, dispensing the wrong medication for a patient, inaccurate record keeping, to name a few.
The AcuDose-Rx dispensing cabinet available from McKesson Automation Inc. of Pittsburgh, Pa. is an example of a computer controlled cabinet programmed to address the aforementioned problems. The user must first logon to the computer (thereby identifying who is removing medications). The user then identifies a patient and is presented with a list a medications that has been approved for administering to the identified patient (thereby addressing the problem of incorrect dispensing). Records are kept for each dispensing event thereby creating an audit trail.
To ensure the safe and accurate dispensing and administration of medications, a pharmacist reviews each prescription or medication order against that patient's medication profile and other relevant patient information to identify such items as therapeutic duplication in the patient's medication regimen; appropriateness of the drug, dose, frequency, and route of administration; medication allergies or sensitivities; potentially significant drug-drug, drug-food, drug-lab, and drug-disease interactions; contraindications to use; any organizational criteria for use; and other relevant medication-related issues or concerns. If a question or concern arises, the pharmacist contacts the person who prescribed the medication.
Many computer controlled dispensing apparatus have a “medication order profile interface” system that requires that all new medication orders for patients be entered into a pharmacy information system, where they are checked as discussed above. After the pharmacy information system completes the necessary clinical checks, data must be transmitted to the dispensing apparatus before the nurse is free to access the medication in the dispensing apparatus. That is done to ensure that medications are not dispensed and subsequently administered without a prior review by a pharmacist.
Problems can arise, however, when a pharmacist is not available to provide the necessary review. In many institutions, pharmacists are not available around the clock, although patients may be admitted at any time. Additionally, an emergency may arise or a doctor may write a STAT order. Under such circumstances, when a healthcare provider, typically a nurse, must retrieve medication from the dispensing apparatus, the patient may not be recognized by the dispensing apparatus, or the desired medication may not yet be approved for the patient. As a result, to enable a dispense to occur, the nurse must exit the normal dispensing routine by entering an override mode, emergency mode, or the like. Unfortunately, in such alternative modes, control is lost over why the dispensing operation is needed, for whom, and the like. That loss of control and information has been recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In its proposed medication use standards, JCAHO provides that when a pharmacist is not on the premises, nurses can administer any medication needed for the patient without a pharmacist's prior review if the healthcare institution has developed an alternative system for medication order review that minimizes the impact of skipping the pharmacist's review prior to administration. At a minimum, that must include the following: a retrospective review of the medication orders by the pharmacist as soon as a pharmacist is available; a review of the medication order by a qualified healthcare professional prior to administration of the medication for appropriateness against a database of information (e.g., drug interaction reference and drug profile); and an ongoing analysis and monitoring of the process for the incidence of medication errors as compared to the incidence of medication errors when the pharmacy is open. The need exists for a medication dispensing and administering apparatus that facilitates dispensing events in a controlled, traceable manner in situations where an event is requested for medication not approved for a patient.
SUMMARY OF THE INVENTION
The present invention is directed to a method of dispensing or administering medications which requires prompting the user for a reason if the user wants to dispense or intends to administer a medication that is not on the patient's medication profile. For example, a patient may be in severe discomfort, or some other condition exists, that requires dispensing and administration of a medication not approved by a pharmacist for the patient. The method prompts the user to supply a reason (exception) for the dispensing or administering that can be used to create an audit trail. The method may include identifying a patient, accessing a medication profile for the identified patient, selecting a medication for the identified patient, the selected medication not having been reviewed against the patient's medication profile, prompting the user to identify an exception, and reviewing the exception to determine its acceptability. If the exception is acceptable, access to a dispensing apparatus' storage compartment(s) for the purpose of dispensing the medication may be granted and a record of the dispensing event is created, or the healthcare giver may administer the medication and a record of the administration is created. If the exception is not acceptable, a record of the request to dispense or the request to administer is created. The method may further include transferring the override requests and override events to a database containing pharmacy orders. The requests, events, and orders may be sorted according to a predetermined criterion, and presented to a pharmacist for review.
The present invention prevents dispensing and warns against administering medications when the medication has not been approved for the patient and no acceptable reason exists for not waiting until a pharmacist can make the necessary review. If an acceptable reason exists for dispensing/administering before the necessary review by a pharmacist has taken place, the present invention provides documentation and an audit trail of the reasons for the event. With electronic collection and distribution of events or requests for events, efficiencies and cost savings are enabled. Further, that information can be sent to centralized 24/7 pharmacies that provide after-hours services to institutions that are not staffed in off hours, thereby insuring compliance even with reduced hours and staff. Those advantages and benefits, and others, will be apparent from the description below.


REFERENCES:
patent: 5314243 (1994-05-01), McDonald et al.
patent: 5346297 (1994-09-01), Colson, Jr. et al.
patent: 5520450 (1996-05-01), Colson, Jr. et al.
patent: 5597995 (1997-01-01), Williams et al.
patent: 5745366 (1998-04-01), Higham et al.
patent: 5805455 (1998-09-01), Lipps
patent: 5805456 (1998-09-01), Higham et al.
patent: 5905653 (1999-05-01), Higham et

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