WO1998050840A2 - System for the distribution of narcotics - Google Patents

Abstract

A drug distribution system (10) in which narcotics are tracked from the time they are delivered to the time they are administered to patients are provided in a health care facility. A locked vault (12) having multiple compartments (18) for accessing only through logging onto a computer (14) software system records drugs withdrawn and by whom. The system also provides an inventory and purchase order for restocking purposes.

Description

SYSTEM FOR THE DISTRIBUTION OF NARCOTICS

BACKGROUND AND SUMMARY OF THE INVENTION

The present invention relates generally to a system for the distribution of

narcotics by health care providers, and more particularly, is related to an electronic,

computerized drug information system that assists a health care provider in tracking

drug distribution at the health care provider facility.

Current trends in Controlled Substance Regulations were most influenced by the

creation of the Bureau of Narcotics and Dangerous Drugs (BNDD) and the adoption of

the Controlled Substance Act (CSA) of 1970. This Act established the rules and

regulations regarding handling, distribution and control of substances of abuse. The

BNDD was the governing body of the Federal government for the enforcement of these

rules and regulations. The CSA provided for the following:

a) The creation of the 5 Schedule model for the classification of controlled

substances with Class 1 (CI) having the highest potential for abuse, to Class 5 (CV)

having the lowest abuse or addictive potential. The classes are outlined below.

Class Schedule 1 (CI) meet this criteria:

Have no currently accepted medical use in the United States

Have the highest potential for abuse.

Have a lack of safety for use even under medical supervision.

Examples: Heroin, L.S.D.

Class Schedule 2 (CII) meet this criteria:

Have a currently accepted medical use in the United States. Have the highest potential for abuse.

Abuse of medication or substance may lead to severe psychological or

physical dependence.

Example: Cocaine, Morphine, Percocet

Class Schedule 3 (CIII) meet this criteria:

Have a currently accepted medical use in the United States.

Have a potential for abuse less than substances in CI or CII.

Abuse of the drug may lead to moderate or low physical dependence or

high psychological dependence.

Example: Tylenol with Codeine, Nicodin, Anabolic Steroids

Class Schedule 4 (CIV) meet the following criteria:

Have a currently accepted medical use in the United States

Have a low potential for abuse relative to substances controlled in CIII.

Abuse of the drug may lead to limited physical dependence or

psychological dependence, relative to substances controlled in CIII.

Example: Valium, Halcion

Class Schedule 5 (CV) meet the following criteria;

Have a currently accepted medical use in the United States.

Have a low potential for abuse relative to drugs controlled in CIV.

Abuse of the drug may lead to limited physical dependence or

psychological dependence, relative to substances in CIV.

Example Robitussin with Codeine Elixir b) Virtually every person who legitimately handled controlled substances

was subject to regulation by the BNDD. Entities subject to direct regulation through

licensing (registration) by the BNDD were hospitals, pharmacies, pharmacists,

researchers, drug manufacturers, drug distributors, physicians, nurses and many others.

In 1973, the BNDD was abolished. Its responsibilities were inherited by its

successor, the Drug Enforcement Agency (D.E.A.). The D.E.A. reports directly to the

FBI and has two missions. One is law enforcement, and the other is regulating the

handling of controlled substances. This was the first time that the FBI was given a

clearly defined role in federal drug law enforcement.

Controlled Substance Regulation Time-Line:

1968 BNDD formed by President Nixon

1970 Controlled Substance Act was signed

The Schedule model for controlled substance classification was established

1973 BNDD was abolished and D.E.A. was formed

FBI given a role in drug law enforcement

1978 Pyschotropic Substances Act was signed

1984 CSA was amended to allow expedited scheduling of substances posing public health hazard

1986 Controlled substance analogs to be placed in schedule CI

1988 D.E.A. now regulated precursor chemicals

1990 Anabolic Steroids added to D.E.A. control as CIII

Law enforcement handles the illicit aspects of the control of substances of

abuse. The regulatory responsibilities of the D.E.A. focus on the control of legitimate handlers of controlled substances, equipment and raw materials used to make them.

Prevention of such articles from being diverted into illicit channels is the primary goal

of this regulation. The D.E.A. shares its regulatory authority with the State Boards of

Pharmacy in each state. The D.E.A. 's power of enforcement is through the imposition

of fines or incarceration. The State Board of Pharmacy's power of enforcement is

through the ability to revoke privileges or licenses of individuals. The regulations

established by the D.E.A and State Boards of Pharmacy directly influences legitimate

controlled substance distribution.

The software of the present invention is named C Safe. This name comes from

the controlled substance classifications. Class CII has the highest abuse potential and is

recognized as a class which requires close monitoring. However, C Safe is equally

applicable to the other classifications. Another component of the present invention is a

narcotic vault. Hospital pharmacies have traditionally included a locked narcotics vault

with limited access to authorized personnel. The present invention is adapted to

electronically communicate with a latch on the door of a narcotics vault. The present

invention may also be adapted to electronically communicate with a free standing

commercially available multi-compartment narcotics vault. In one embodiment of the

present invention an eight door narcotics vault is electronically connected to the C^πSafe

computer which enables the C Safe computer to control the unlocking of individual

doors of the vault.

The present invention works in communication with a computer console that

may be located in a hospital pharmacy, for example. The hospital pharmacy console processor may be arranged in a network configuration to communicate with one or

more automatic medicine dispenser units, sometimes referred to as medstations, which

are typically located at nursing stations on each floor of a hospital.

A further component may be needed for communication to be established

between the pharmacy console and the C Safe computer. This processor interface unit

has been referred to by the present inventors as Procar. Finally, Procar may be

electronically connected to a drug vendors computer system for sending and receiving

related messages.

The system components, including the locked vault, C^πSafe, Procar, the

pharmacy console, and the various medstations, all in electronic communication, is

believed to be unique.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a diagrammatical view of a preferred embodiment of the system of

the present invention;

Figure 2 is a flow chart of a preferred embodiment of the system of the present

invention;

Figure 3 is a diagrammatical view of a communications link between the C

Safe computer, the interface computer, and the pharmacy console computer of the

present invention;

Figure 4 shows an example of a Controlled Drug Administration Record;

Figure 5 shows an example of a 24 Hour Controlled Substance Record; Figure 6 shows an example of an Anesthesia Controlled Substance Sheet;

Figure 7A shows an example of an Expire Waste or Recall Transaction Record;

Figure 7B shows an example of the packaging is association with the record of

Figure 7A;

Figure 8A shows an example of barcode labels on various medications;

Figure 8B shows an example of a label for a particular medication; and

Figure 9 shows a diagrammatical representation showing audit, intervention and

reporting of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings, there is shown in Figure 1 a preferred

embodiment of the system of the present invention. The system 10, includes a

narcotics vault 12 in communication with a data processor 14 which is adapted to run

the C Safe program. A pharmacy console data processor 16 is in electronic

communication with one or more medstations 18 located at nursing stations 20 at

various wings of the hospital.

To facilitate communication between the C Safe data processor 14 and the

pharmacy console processor 16 an interface computer 22 is provided and is electronic

communication with both data processors 14, 16. A vendor 24 may have a computer in

communication with the interface computer 22. The vendor computer 24 may receive

electronic purchase orders from the interface computer 22 and respond with an

electronic acknowledgment of receipt of a purchase order. Upon confirming receipt of a drug purchase order, the vendor may ship the requested quantities of drugs to the

health care provider making the purchase order. The drugs are received by the health

care provider 26 and are later recorded and placed in the locked vault 12. The vault 12

may have multiple compartments 28 accessible through individual doors 30. The doors

30 may be equipped with electronic latches controlled by the C Safe computer 14. The

C Safe computer may be configured to prevent access by individuals who do not enter

an authorized personnel identification number. Once a health care provider has

successfully entered the C Safe software the computer 14 will prompt the user to enter

various information concerning the drug or drugs needed from the vault and the person

making the request to access the vault. If the transaction request is accepted, in a

preferred embodiment of the invention only the door or doors necessary to be opened to

access the particular requested drugs will open while the other doors to the narcotics

vault will remain locked. When a user has removed any drugs from the vault the user is

then prompted by the C Safe computer 14 to enter the type of drug removed from the

vault and the quantity removed. The user may be prompted to enter a count of the

drugs remaining in that compartment of the vault.

Once drugs are removed from the locked vault they are taken to the various

medstations 18 and loaded into preassigned compartments in the medstations. When a

nurse accesses a medstation and removes a drug to administer to a patient, the

medstation may refuse access to the nurse unless proper identification is entered into

the medstation 18. The medstation may prompt the user to enter the nursing station

location, patient identification, nurse identification, optional witness identification (who witnesses the nurse removing the drugs from the medstation), requested drug

identification, and actual drug count removed from the medstation. All of this

information may be electronically relayed to the pharmacy console 16 through the

interface computer 22 to the C Safe computer 14. This information may be used by

C Safe to determine when additional drugs need to be purchased to keep drug supplies

above a threshold value.

For example, if a predetermined threshold quantity of a particular drug supply is

set at 100 tablets for each medstation, C Safe will prompt the user if and when the

number of tablets at each medstation drops below 100. The system of the present

invention may be configured in a number of ways to automatically place purchase

orders with drug vendors when predetermined threshold quantity levels are

experienced. This aspect of the invention eliminates much of the conventional

handwritten purchase orders and handwritten inventory procedures that have been in

place at hospitals for many years. With each medstation reporting the quantity and

identification of drugs removed, to the pharmacy computer and the C^πSafe computer,

hospitals now have, with the present invention, the capability of just in time inventory

control of medicines in supply at the hospital.

When drugs are received by the hospital they may be bar coded upon receipt, or

they may be bar coded by the drug supplier prior to shipment. In either event, bar

coding of drug packaging may be useful to hospital technicians in entering drugs at the

vault. Instead of manually typing in each drug received at the pharmacy console or

C Safe computer, a commercially available bar code scanning device 23 may be used to gather the needed drug information (i.e., drug type, quantity, expiration date,

destination, etc.).

Use of a stand alone narcotics vault is preferred since it offers a greater degree

of control over drug withdrawals from the vault. One such stand alone vault is

commercially available from the Pyxis Corporation in San Diego, California, the

assignee of the present invention. The terminology "stand alone" is intended to mean

that the unit is not physically built into a hospital room as conventional vaults are

installed. The term "stand alone" is not intended to mean that it has no connections to

it; in fact it is important to the present invention that the vault be connected

electronically to an operating computer such as the C Safe computer. With a vault as

provided by Pyxis Corporation, different drugs may be housed in different

compartments of the vault with each compartment having its own access door which is

independently operable from all other doors in the vault. Thus, if a hospital employee

is only given authorization to access certain drugs in the vault, that employee's personal

identification number may be entered into the C Safe computer memory so that the

computer will only actuate those doors of the vault that offer access to the drugs that

employee is authorized to access. Other doors, protecting drugs not to be accessed by

that employee, will not open with that employee's personal identification number.

Furthermore, C Safe will provide a data trail tracking each person who accesses

the vault and recording what drugs each person removed. A user cannot physically

access the vault without first entering the user's personal identification code or PIN

number. While it is incumbent on the user to record what was removed by entering this data via the keyboard or keypad at the computer connected to the vault, the user may

also be required to enter a count of the quantity of drug still in that compartment of the

vault just accessed. In this manner it would be very difficult for any one individual to

take more drugs from the vault than that individual has recorded at the computer.

Drug tracking with the present invention occurs at each of the following steps:

1. incoming purchases from the drug wholesaler to the health care provider

pharmacy;

2. from pharmacy to nursing station;

3. from pharmacy to out-patient;

4. from pharmacy to IV Room to be compounded then back to pharmacy as new product;

5. from pharmacy to expired or waste status;

6. from pharmacy back to wholesaler or manufacturer as recalled product;

7. from pharmacy to secured inaccessible inventory;

8. from pharmacy to an outside pharmacy.

The system of the present invention operates in real time and stores data for an

extended number of years for quick reporting of drug distribution at the health care

facility for a given period of time. The system may also be used to flag drug

distribution counts that exceed a predetermined norm. For example, if a report

indicates that one particular employee is removing drugs in substantially greater

quantities than other employees similarly situated, the system reports will note this

abnormal behavior for further review by administrators. In effect, the system of the present invention closes the loop of drug distribution

at health care providers. The present invention enables users to track a drug from the

delivery truck into the pharmacy vault, to the nursing station medstations, and

ultimately to administration to each patient. Such a complete closed loop system has

heretofore not been available.

When a nurse removes a drug at a medstation, an electronic message of that

drug removal is sent to the C Safe computer and is used therein for many functions

including inventory tracking and reorders. If a nurse removes a drug from a

medstation and the patient refuses to accept the drug the nurse may return the drug to a

"return to bin" area within the medstation and the nurse records this information into

the medstation computer. At a future time, a technician will remove the drugs from the

"return to bin" area and return the drugs to the vault. At the vault, the technician must

enter the drug types and quantities of each that are being returned to the vault. If the

drug types and quantities entered at the vault C Safe computer by the technician do not

match the information previously received by the C^πSafe computer from the

medstations, a report printed by the C Safe computer will indicate this discrepancy for

an administrator to review.

Figure 2 shows a flow chart and Figure 3 shows a diagram of a communications

link between various components of this embodiment of the invention. It is to be

recognized that the Procar interface computer is a part of this embodiment in order to

IT * facilitate communications between C Safe and existing console software at the

pharmacy computer. It is to be recognized that other embodiments of the present invention may incorporate matching protocols at the console and C^πSafe to avoid use of

a proper interface.

Figure 4 shows an example of a printing of controlled drug administration

records (CDAR), another record form useful in the present invention. Laser printed

CDAR's are generated for non-MedStation areas. These unit-specific records can also

be utilized by ancillary areas that may only stock one or two controlled substances.

Each sheet is serialized and barcoded to prevent counterfeiting.

Figure 5 is another form of CDAR that C^π Safe is capable of printing. Be

aware that Control Drug Administration Records will be called many different names.

Some example names are: CDAR, CSAR, Day Sheet, 24 hour sheet, Single Sheet,

Shingle Sheet, Perpetual count sheet and Dispensation Record.

Figure 6 shows a form for controlled substances documentation for each kit for

an automated means for controlling the traditional OR/Anesthesiology Kit process.

This form allows for the creation of various types of kits and tracks their assigned

inventory. It prints a controlled substance documentation form for each kit. Kits can

be case or user specific.

Figure 7A may be used when a pharmacy encounters broken, outdated or

otherwise unusable controlled substances. These items remain part of the vault

inventory until destroyed, but destruction normally takes place with D.E.A.

authorization on 1-2 times per year. This often makes vault reconciliation more

confusing. C Safe allows assignment of medications to a "pending destruction" status to automatically keep track of these unusable items. Figure 7B shows an example of a

waste deposal packet for medications.

Figure 8 A shows an example of barcode labels on medication. Manufacturer's

barcodes can be scanned to identify medications in C^πSafe. C Safe can generate its

own barcode label if no manufacturers' barcode is available. In C Safe, barcodes are

especially effective in tracking the controlled substance transactions occurring outside

of the medstations. Figure 8B is an example of a label for a particular medication.

Figure 9 represents a diagrammatical view of the forms used during the

controlled distribution process. In the hospital setting, the pharmacy is the cornerstone

of the controlled substance distribution process. Controlled substances remain under

pharmacy domain from the time a vendor shipment is received until the medications are

administered to the patient. This diagram outlines the controlled substance distribution

process. Effective audit trails are mandatory for each distribution area. Federal law

requires that records for controlled substances be accurate and readily retrievable for a

period of not less than two (2) years. Most State Boards of Pharmacy have chosen to

make this requirement more stringent and mandate that these records be readily

retrievable for five (5) years. The fine for inaccurate or incomplete record keeping is

$25,000 per line item. A line item is one medication, i.e., Morphine 15 mg tablet. If

the controlled substance records for a medication are inaccurate by one dose or one

thousand doses, the fine is still $25,000. With the average pharmacy stocking 100 to

250 different controlled substances (line items) in its inventory, the hospital is

potentially at risk for $2,500,000 to $6,000,000 if audited. The D.E.A. and State Boards of Pharmacy are continually monitoring the health

care continuum for possible diversion or misuse of controlled substances by performing

routine reviews. The routine audits do not usually result in the imposition of fines.

Fines and severe regulatory measures occur only if the D.E.A. or State Board uncover

gross negligence or have reason to believe that diversion is occurring in which case a

thorough audit ensues.

The D.E.A. performs many of its monitoring functions via various forms and

reports that every hospital is required to submit. These forms include D.E.A. Form

222, D.E.A. Form 41, D.E.A. Form 106 and the Biennial Inventory Report.

Several diagrams are included herewith to better explain the invention.

True just in time inventory

C^πSafe's suggested order function eliminates the need to "walk the shelves" by

listing medications which have fallen below the par days supply set by the user. This

report, listed below as Table 1, is based on the previous 90 days of utilization (more

heavily weighted towards the last 10 days to catch utilization spikes). The order report

will provide NDC numbers, vendor order numbers and suggested order quantities. This

report separates schedule II medications from other medications.

TABLE 1

SUGGESTED MEDICAL ORDER REPORT

C^πSAFE-NV

Prepared Date: 01-01-97 Time: 21:39:20

TRAN. CHECK : 770 C'Safe Software v4.0 DAYS CHECKED : 34

CUR WEEK(S) UTILIZATION TOT WKS SUG

DRUG ITEM PHY 1 2 3 4 USED SUP ORDER

ACETAMINOPHEN w/COD ELIX SML 17 96 132 264 395 527 640 1 92

N D C 00₃64760905 EACH S 045 AL S 41 40 ORDER NUMBER 857-645 PACKAGE SIZE PAR DAYS 10

ACETAMINOPHEN w/CODEINE 60 72 8 206 412 618 824 1001 0 286 MG

N D C 00364786501 EACH S 0 02 ALL S 5 43 ORDER NUMBER 540-091 PACKAGE SIZE PAR DAYS 10

DIAZEPAM 5 MG TAB 1 PACKET 92 15 105 210 315 420 510 0 135

N D C 54634187965 EACH S 0 02 ALL S 2 97 ORDER NUMBER 509-001 PACKAGE SIZE PAR DAYS 10

LORAZEPAM 0 5 MG TAB 97 22 24 49 73 97 118 1 13

N D C 00364615466 EACH S 0 02 ALL S 0 19 ORDER NUMBER 763-922 PACKAGE SIZE PAR DAYS 10

Value of This Order: $ 241.92 This report allows the user to predict drug utilization and increase inventory

turnover. N.D.C. and schedule II separation provides all information needed to

complete D.E.A. Form 222.

Streamline Pick and Delivery for MedStations

Table 2A represents data that can be generated for batch pick lists which

decreases the number of pharmacy transactions and streamlines the refill process.

Refill quantities are brought to the screen for the editing process and with one

keystroke, they are automatically deducted from the C^πSafe active inventory.

TABLE 2A

PHARMACY PREVIEW

C^πSAFE-NV Prepared Date: 04-21-1997 Time: 23:52:07

TABLE 2B

USE THE ARROW KEYS TO MOVE TO DRUG, THEN TYPE ANY CHANGE IN QUANTITY NEEDED

Reconciling Vault Issues/Returns for Medstations

Table 3 depicts a chart that will indicate transactions that must be manually

located. C Safe will automatically track medications that have been removed from

stock to be issued to a medstation and reconciles these issues with medstation

replenishment transactions. The same is true for unload transactions being returned to

the vault. C Safe reports notify the pharmacy of outstanding transactions in either

system.

TABLE 3

TRANSACTIONS THAT MUST BE MANUALLY LOCATED

C^USAFE-NV Prepared Date: 04-23-1997 Time: 16:14:20

TRANSACTIONS ENTERED IN THE MEDSTATION BUT NOT ENTERED IN C^πSAFE

EDI MORPHINE 10 MG TUBEX 20 01384 LOADED

SICU PCA-IV MORPHINE SULP (ADDVNT) 10 11151 LOADED

BICU NARCOTIC DRIP (FOR MEDSTATION) OT 10626 LOADED

EDI KETAMINE 100 MG/ML INJ SML VI 4 04711 LOADED

EDI MEPERIDINE HCL 50 MG INJ 1ML 10 01300 LOADED Single-Point Controlled Substance Reporting

Table 4 shows that C^πSafe tracks all areas of controlled substance migration

from the point of purchase to removal for patient administration. C Safe can provide

reports for any MedStation transaction, any controlled substance, or any user for any

time frame queried.

TABLE 4

C^πSAFE-NV

Total transactions: 4 Sum of all Trans: 258

Proactive Diversion Tracking Report

Table 5 shows a proactive diversion tracking report which allows comparison of

transactions per day by a given user listed by medication and by nursing station. All

usage falling above the norm by 2 standards of deviation (+2 std. deviations) or more

will be flagged. TABLE S

Med: Percocet Tab - 1 packet Interface #03706 STA: 4E Month:

NAME I.D. DOSES DAYS DOSES/DAY Santos, Gloria GASF 35 10 3.5

Devera, Ofelia OMD 34 7 4.857143

Generas, N. Teresa NTG 19 3 6.333333 Reed, Gwendolyn GBR 16 2 8 Padilla, Estrella EGP 42 6 7

Med: Percocet Tab - 1 packet Interface #03706 STA: 4E Month Total Transactions: Sum of Matching Transactions: Total User Days:

Sum of Accesses per Day:

Sum of the Squares of Accesses per Day:

Total Users:

Mean:

Standard Deviation:

All activity 2 standard deviations above the Mean

Transactions To/From Other Pharmacies

Table 6 shows that, in urgent situations, pharmacies may loan to or borrow

items from another local pharmacy. In some cases, such as for schedule II drugs, these

transactions may involve an actual sale or purchase of the item and exchange of a DEA-

222 form. Some states may not allow this, (i.e., California does not allow transfer of

C 's between pharmacies). C Safe records and tracks these transactions along with

DEA-222 information. C Safe will generate both a sender's copy, as shown below in

Table 6, and receiver's copy of the transaction. TABLE 6

MEDICATION SALE TO OUTSIDE PHARMACY

C^πSAFE-NV Prepared Date: 04-22-1997 Time: 23:57:15

OUR PHARMACY DEA NUMBER:

QTY # 25

DRUG: PERCOCET TAB 1 PACKET

REF. # S0471

PHARMACY SOLD TO: BAPTIST HOSPITAL

THEIR PHARMACY DEA NUMBER:

STREET ADDRESS:

CITY, STATE, ZIP:

SIG. OF RECEIVER:

DATE SOLD: 04-22- 1997

PHARMACIST: SAM DEA-222 ORDER NO.: 99999999

SENDER 'S COPY! SAVE AT SITE V/1616

Fill Prescription Function

Table 7 shows a Prescription Pick-Up Receipt in which C Safe generates labels

and keeps records for outpatient dispensing of controlled substances for take home

medications, pass medications, after hours emergency prescriptions and employee

prescriptions. Labels meet regulatory requirements, however, the user does have the

option to continue to utilize current system labels. Dispensed amounts are e automatically deducted from vault inventory. TABLE 7

PRESCRIPTION PICK-IJP RECEIPT

C^πSAFE-NV Prepared Date: 04-23-1997 Time: 12:19:31

QTY # 20

DRUG: ALPRAZOLAM 0.5 MG TAB 1 PACKET

REF. # 1091

PATIENT NAME: FEENEY, ROBERT

PHYSICIAN: LEE

DATED FILLED: 04-23-1997

PHARMACIST: SAM DATE PICKED UP:

SIG. OF DISPENSING R. Ph.

SIG. OF RECEIVER

Drug Stock Movement

Table 8 shows that C Safe will maintain transaction records for two stocks. An

area designated for storage of large volumes may be maintained separately from the

working stock. Medications may be easily transferred between stocks as a separate

transaction or during receiving shipments and dispensing medications to the nursing

stations. TABLE 8

DRUG STOCK MOVEMENT RECORD

C^πSAFE-NV Prepared Date: 04-21-1997 Time: 20:57:29

Total Medications to be Moved: 4

Compounding with Controlled Substances

As shown in Table 9, C Safe will also allow the pharmacy to define line items

which are compounded rather than purchased from suppliers. A ratio is established

between the manufactured product and the number of units of the compounded item

which can be prepared. When a manufactured drug is removed for compounding,

C Safe automatically transfers the controlled drug inventory from the original line item

to the compounded line item. Even a method for accounting for manufacturer overfill

is provided in tracking this inventory. TABLE 9

COMPOUNDING/ADD-MIXTURE RECORD

C^πSAFE-NV Prepared Date: 04-22-1997 Time: 13:31 :44

TRANSACTION NUMBER: 047008 DATE: 04-22-1997

DRUG USED: ACETAMINOPHEN W. COD ELIX BLK LINK : 196

MANUFACT:

VAULT BAL.: 480 QTY BEING USED: 480 LOT: EXP.

/ / CALCULATED AMOUNT OF WASTE:

VARIANCE DUE TO OVER or UNDER FILL: (Do not return variance to stock)

TOTAL AMOUNT WASTED:

DRUG BEING MADE: ACETAMINOPHEN W/COD ELLX 5ML LINK : 17

VAULT BAL.: 192 QTY BEING MADE: 96 EXP: / / (or) IN 12 MONTHS

SAMPLE LABEL

COMPOUND PERFORMED BY: (sig.)

INSPECTED AND VERIFIED BY: (sig)_

PAGE INTENTIONALLY LEFT BLANK

Reconcile Vault Inventory

Shown in Table 10 is a Controlled Substance Reconciliation Report for vault

inventory verification that breaks out accessible inventory from secured inventory.

TABLE 10

CONTROLLED SUBSTANCE RECONCILIATION REPORT

C^πSAFE-NV Prepared Date: 04-21-1997 Time: 21:00:26

Schedule II Auditor's

SIG:

ALFENTANIL 5ML AMP 4/21 REF: FORM: INJ PHYSICAL

COUNT:

LOCATION: ITEMS: 124 SCHEDULE II SECURED: 100 ACCESSIBLE: 41

AMOBARBITAL 500MG VIAL 07/29 REF: FORM: INJ PHYSICAL

COUNT:

LOCATION: ITEMS: 134 SCHEDULE II SECURED: 0 ACCESSIBLE: 4

BELLADONNA & OPIUM NO. 16A 6 08/09 REF: 00161 FORM: SUP PHYSICAL

COUNT:

LOCATION: ITEMS: 34 SCHEDULE II SECURED: 0 ACCESSIBLE: 53

C'SAFE v4.0

Page 1

Financial Reports

As represented by Table 11, C Safe can store cost information for each

medication. This allows for current inventory dollars values by medstation and the

value of all stock in the medstations throughout the hospital. This results in extensive

time savings during the annual pharmacy inventory. TABLE 11

Single Drug Hospital Wide

INVENTORY SUMMARY

PERCOCET TAB 1 PACKET D.E.A.

CLASS 2

WWP 15

SICU 21

MICU 25

IMU 38

EDI 11

BIMU 34

BICU 94

7W 113

7E 84

6W 16

6E 52

5IMU 23

4E 115

20B 25

11W 65

HE 92

10E 61

8W 50

CDA LOCKER 100

UCARE 15

PACU/SICU 25

SUB TOTAL OF UNITS: 1084 VALUE OF DRUG ON UNITS $ 1073.16 AMOUNT IN PHARMACY 7335 VALUE OF DRUG IN PHY. $ 7261.65 HOSPITAL WIDE TOTAL 8419 HOSPITAL WIDE VALUE $ 8334.81

Page 1 D.E.A. Form 222

Whenever a hospital needs to reorder C narcotics, the pharmacist in charge

must complete a D.E.A. Form 222 in triplicate. Fields to be completed on this form

include: the name and address of the vendor through which the medications will be

supplied, the name and National Drug Code (NDC) of each medication to be ordered,

the quantity requested, the hospital's name, address and D.E.A. registration number and

the signature of the pharmacy supervisor. Two copies of this form are mailed to the

vendor, one copy remains at the hospital. The vendor fills the order and sends one copy

of Form 222 to the D.E.A. The D.E.A. reviews these forms in order to detect excessive

amounts of controlled substances being ordered by pharmacists.

C^πSafe-NV, through its Suggested Order Report, will provide a separate list of

schedule C controlled substances that the hospital needs to order. This report

provides: medication name, NDC number, vendor's item number and the quantity of

medication the pharmacy should order based on utilization. By providing this

information, C^πSafe-NV eliminates the need for the pharmacist to look up the NDC

number in the order catalog, on microfiche or to walk to the shelf to check the numbers

on a medication label.

D.E.A. Form 41

Another form, D.E.A. Form 41, must be completed by a hospital to record the

destruction of outdated or unusable controlled substances. The pharmacy must submit

this form requesting authorization to destroy a controlled substance medication in the pharmacy. The D.E.A. reviews the Form 41 and sends notification of its approval to

dispose of these items on a specific day. The pharmacy must destroy the medications

and complete all appropriate documentation. In order to ensure that diversion does not

occur, the D.E.A. may appear, without notice, to witness the destruction. It is for this

reason that approval prior to destruction must be requested using Form 41.

C^πSafe-NN has an Expired Waste and Recall function in which all medications

"pending destruction" are recorded. C Safe-ΝV can print reports listing all

medications and quantities that need to be destroyed. This report makes the D.E.A.

Form 41 simple to complete.

D.E.A. Form 106

Form 106 must be submitted to the D.E.A. when a hospital experiences theft or

loss of any controlled substance. Missing controlled substances are most often

discovered during an inventory verification. Pharmacies usually perform a physical

count of all controlled substances every 14 to 30 days in order to reconcile their book

counts to the actual inventory. Nursing usually performs an equivalent process every 8

to 24 hours. When a variance is discovered, extreme measures are taken to locate and

resolve the discrepancy. In the event that the discrepancy remains unresolved, the

pharmacy is then required to submit a Form 106. Filing this form indicates point

toward diversion or inadequate record keeping procedures. It alerts the D.E.A. to the

unresolved discrepancy and may lead to an extensive audit. C^πSafe-NV was designed at a hospital which had experienced fines as a result

of incomplete record keeping. It is designed to put processes in place which will

eliminate lost doses from occurring. When used correctly, C Safe software combined

with Narc Vault hardware closes the loop for each dose of each controlled substance

which is received or dispensed by the pharmacy. By incorporating this form at the

nursing station level, each dose of each controlled substance can be tracked from the

time it is received from the wholesaler to the time it is removed to be administered to

the patient.

Biennial Inventory Report

While it is common to perform physical counts every 14 to 30 days, Federal

Regulations require a hospital wide inventory every two years (Biennial Inventory

Report). Submission of the biennial inventory report provides the D.E.A. with an

initial inventory level for auditing purposes and evidence of excessive supplies of

controlled substances.

This report is on record with the D.E.A. and subsequently it cannot be altered to

conceal diversion or inappropriate record keeping. The format and date of the biennial

inventory are specific. Counts include inventory in the pharmacy, on the nursing

stations and in any department that does not have its own D.E.A. registration number.

Biennial Schedule C medication inventories must be exact in count. Biennial

Schedule C through Schedule C medication inventories are visual estimates. Even

though the biennial Schedule C - C inventory is a visual estimate, records for all controlled substance transactions must be exact. The difference in the regulations

concerning biennial inventories and controlled substance transaction records leads to a

false perception that the record keeping for Schedule C^ιπ - C medications is less

stringent than that of Schedule C^π medications.

Adding to this perception is the regional differences in the policies used by the

D.E.A. to enforce and pursue compliance with the federal regulations. Many D.E.A.

inspectors do not enforce exact count record keeping on Schedule C^πι - C^v medications.

This does not prevent substantial fines from future audits. When diversion or loss is

reported, the D.E.A. often pursues compliance with regulations to the fullest extent. A

hospital that has not tracked Schedule C -C medications in the past, may find it

impossible to reconstruct transaction records, as required by law.

Performing a Biennial Inventory using manual methods can take several days.

If the hospital has C^πSafe in the pharmacy and medstations on the nursing stations, this

process is reduced to a matter of minutes.

Glossary of Terms

Accessible Stock Working inventory staff utilizes (may be entire inventory)

Allocation Dispense medication to a nursing unit

Acquisition Receive medications from the wholesaler

ADM Automated Dispensing Machine, (i.e. MedStations)

A.D.T. Admission, Discharge and Transfer information usually provided by the pharmacy information system. A chemistry term referring to a chemical or substance that is structurally similar to another chemical or substance.

Analog This similarity may also lead to a therapeutic similarity as well. Analogs can be modified chemically to produce the original chemical or substance.

Anesthesia Kit Group of medications used either by procedure or anesthesiologist. Usually in individual lockable cases.

Asynchronous Communication Type of communication used with interfaces. Transmission in which time intervals between transmitted characters may be of unequal length. Transmission is controlled by start and stop bits at the beginning and end of each character.

Audit Trail Complete accountability for all controlled substances from receiving through patient administration.

Automatic ADM Restock Function of C^πSafe-NV that suggests MedStation refill quantities to screen. User then edits and accepts.

Batched Signature Sheet Receipt listing all medications that were issued to an individual location. Used to show proof of receipt and or delivery Biennial Inventory Hospital wide inventory of all controlled substances completed every other year and filed with the DEA.

B.N.D.D. Bureau of Narcotics and Dangerous Drugs Precursor to the D.E.A.

C^πSafe-NV The ultimate controlled substance tracking system. Combination of C Safe software with the NarcVault hardware.

C.D.A.R. Controlled Drug Administration Record. A form used by non-automated nursing units for the purpose of recording patient administered doses of controlled substances. This form is either medication, unit or patient specific and may remain at the nursing unit until all doses dispensed with the form have been administered.

Closed Loop Complete accountability for all controlled substances from receiving through administering to the patient.

Compounding/ Add-Mixtures The process by which one medication is transformed into another. Based on the compounding ratio set for the medication being made, the inventory levels of all medications will be adjusted. Example: Cocaine powder is removed from inventory to create T.A.C. Solution (Topically Applied Cocaine). The T.A.C. solution inventory will be increased while the cocaine inventory is reduced. Preparation of drips, PCAs and epidurals maybe performed under this function. Prepacking also may utilize this function.

Compounding ratio The ratio set for compounding/add-mixtures function. Usually set to the smallest ratio available using whole numbers. Controlled Substance Medication in schedule C¹, C , C^m, C^IV or C^v. Any substance determined by the D.E.A. to have addictive or abuse potential. Substances in this category can cause severe to moderate psychological or physical dependence or are addictive in nature

C.S.A. Control Substance Act of 1970. Created for the purpose of providing clear guidelines for controlled substance regulation. The CSA governs the actions of wholesalers, distributors, researchers, manufacturers, physicians, pharmacists, pharmacies, nurses and others who legitimately handle controlled substances.

C.S.A.R. Controlled Substance Administration Record. See CDAR

Data Security interval Amount of time between data backups. Day Sheet A form used by non-automated nursing units for the purpose of recording patient administered doses of controlled substances. Usually preprinted, the form lists the controlled substances which may be used by the unit. This sheet is replaced daily, primarily for billing purposes.

Default Quantity Lowest quantity that a medication is dispensed in. usually the smallest package size.

D.E.A. Drug Enforcement Agency. Charged with the federal regulation of controlled substances.

D.E.A. Form 41 A mandatory form to be completed and filed with the D.E.A. listing all controlled substances which have expired or are otherwise unusuable. Permission to destroy is granted by the D.E.A. after receipt.

D.E.A. Form 106 A mandatory form to be completed and filed with the D.E.A. listing any missing doses of controlled substances. D.E.A. Form 222 A triplicate order form to be completed and filed with the wholesaler for replenishment of CII controlled substances. Wholesaler forwards third copy to D.E.A.

Delivery Signature Sheet Receipt listing all medications that were issued to an individual location. Used to show proof of receipt and or delivery.

Deallocation Return of medication from the nursing unit. Diversion Drugs being routed through inappropriate channels, i.e., theft.

Drip Sheet A form used by nursing for the purpose of recording information regarding the administration of IV's.

Drug Class Ranking by D.E.A. based on addiction and abuse potential

GPO Group Purchasing Organization

Linkcode Secondary C Safe-NV drug identification number Lot Number Internal number which the manufacturer assigns to each "batch" of product produced. If a problem is identified with a batch of product, the lot number is used to identify all product manufactured at the same time.

Map Location Position in vault where medication is stored.

N.D.C. National Drug Code

Null Modem Cable Communication cable used for interface connection.

Par Days Number of days supply to carry as inventory. Based on average use.

Perpetual Inventory Running total of inventory. Pharmacy Review Report summarizing suggested medication refill quantities for ADMs. Allows user to verify quantities on hand prior to editing. Pick list Report summarizing medication refill quantities for ADMs. Used to pick medications from inventory by medication not transaction.

Precursor A chemistry term used to describe a chemical or substance from which the controlled substance originates. Example: Substance A + Substance B = Substance C. Substances A and B are precursors to Substance C.

Readily Retrievable Controlled substance records must be filed and stored on-site in such a manner as to be easily distinguishable from other non-controlled substance records. Many states mandate that CII records be filed separately from all other records. There must also be methods in place to accurately track each dose of each controlled substance during its life cycle in the hospital. Federal law mandates that controlled substance records be readily retrievable for a period of two (2) years. Most states have increased this requirement to 5 years.

RS232 Port A standard serial communications port found on most PC's.

Scheduled Medications Controlled substances. Secured Stock Excess inventory usually stored in secondary location.

Signature Sheet Receipt filed for proof of transaction (i.e., delivery, sale prescription)

Shingle Sheet A form used by non-automated nursing units for the purpose of recording patient administered doses of controlled substances. Easily recognizable by the multiple sub forms attached (shingles). This form is medication and/or patient specific and may remain at the nursing unit until all doses dispensed with the form have been administered. Shingles are used for billing purposes. Shingle-less Sheet Form generated by C^πSafe-NV resembling the layout of a shingle sheet. Used by non-automated nursing units for the purpose of recording patient administered doses of controlled substances.

Single Sheet Administration record with one medication.

Suggested Purchase Order Reorder function of C Safe-NV. Suggests quantities to reorder from wholesaler based on par day levels.

State Board of Pharmacy Each state has a Board of Pharmacy which governs the licensing of Pharmacists practicing in that state. The State Board can revoke a pharmacist's privileges to handle controlled substances or in situations where abuse of these privileges is proven, can revoke the pharmacist's license.

Wedge Decoder Device used between a laser scanner and the PC that converts scanned bar codes to key strokes.

The inventors herein have devised and reduced to practice a unique system for

the distribution of narcotics that overcome the shortcomings of the systems currently in

place at most medical institutions.

While the system and forms described herein constitutes a preferred

embodiment of the invention, it is to be understood that the invention is not limited

thereto, and that changes may be made therein without departing from the scope of the

invention which is defined in the appended claims.

Claims

What is claimed is:

1. A system for the distribution of narcotics at a health care facility, comprising:

a pharmacy computer adapted to record drug types and quantities administered

to patients;

a locked drug vault adapted to house a plurality of drugs; and

an inventory computer in electronic communication with said pharmacy

computer and said vault, such that said inventory computer receives information from

said pharmacy computer concerning drugs administered to patients and said inventory

computer controls access to said vault.

2. The system of claim 1, further comprising:

at least one automated medstation at a nursing station, said medstation adapted

to store drugs in electronically actuated compartments, said medstation electronically

connected to said pharmacy computer to send drug withdrawal information to said

pharmacy computer.

3. The system of claim 1, wherein said inventory computer is adapted to provide

real time inventory reports of drugs at said health care facility.

4. The system of claim 1, further comprising an automatic purchase order structure

in electronic communication with a drug supplier to order drugs from said supplier

when drug inventory levels reach predetermined threshold limits.

5. The system of claim 1, wherein drug types and quantities information are

contained in bar codes attached to drug packaging.

6. The system of claim 5, further comprising at least one bar code scanner in

electronic communication with said inventory computer.

7. A method of drug distribution, comprising the steps of:

providing a pharmacy computer adapted to record drug types and quantities;

providing a locked drug storage vault;

providing an inventory computer electronically connected to said pharmacy

computer and said vault;

accessing the contents of said vault by entering a personal code into said

inventory computer;

entering into said inventory computer the drug type and quantity withdrawn

from said vault;

entering into said pharmacy computer the drug type and quantity administered

to a patient;

reconciling the drug count withdrawn from said vault with the drug count

administered to a patient.

8. The method of claim 7, further comprising the step of providing an automated

medstation in communication with said pharmacy computer for storing drugs near

patient locations.

9. The system of claim 7, wherein said inventory computer is adapted to provide

printed reports of drug inventory and administration.

10. The system of claim 7, further comprising the step of automatically sending an

electronic purchase order to a drug supplier when predetermined drug inventory levels

are reached.