PHARMACY AUTOMATION GUIDANCE FOR THE CONTROLLED SUBSTANCE COORDINATOR Part 1: The Inspection Process The storage and administration of controlled substances have changed since the days when they were stored in a locked cabinet on the nursing unit and each dose administered was documented on a green sheet of paper, but the intent of the inspection process remains the same, to make sure that controlled substances are stored securely and that there is a chain of custody that can be traced from receipt into the pharmacy inventory to administration to the patient. During these presentations we will focus on that part of the inspection process that involves pharmacy automation that includes automation dispensing cabinets such as Pyxis and Omnicell and secure storage within the pharmacy in devices such as the Pyxis CII safe and the Omnicell Secure Vault to inspection of a narcotic vault that contains robotics such as a ScriptPro SP50. This presentation will be done in 2 parts. The first part will review the controlled substance inspection process and routine oversight. The second part which will be presented during next month’s call will cover discrepancy resolution and conducting an investigation into suspected diversion. We hope that you will find these sessions helpful. As we go through the presentation, you may type a question for the presenters which will be read and answered at the end of the presentation or you may ask your question verbally when the microphones are opened at the conclusion of the presentation. You may also download handouts pertaining to each of the machines by clicking on the notepad in the upper right hand corner of the screen.

OBJECTIVES Understand the VHA Handbook 1108.2 requirements that relate to automation Understand what reports should be requested from the pharmacy prior to performing a routine unit inspection Understand what reports should be reviewed as part of the overall inspection process. By the end of this presentation, we hope that you come away with an understanding of those parts of VA Handbook 1108.2 that pertain to the automation used to store, dispense and administer controlled substances within the facility. What reports should be requested by the inspectors prior to performing an audit of a nursing unit, the pharmacy or other areas that use controlled substances such as operating rooms and research areas and finally to gain an understanding of the reports that are used in the inspection of the machines that are used in the storage, dispensing and administration of controlled substances.

The Inspection Process Requirements from VHA Handbook 1108.2 Inspectors should have a password that permits access to the automated dispensing cabinets (ADC) only when accompanied by an authorized user Inspectors must verify source data including a spot check of ADC removals Report any unresolved discrepancies to the controlled substance coordinator for further investigation Review resolved discrepancies for trending purposes Review at least one day’s worth of ADC restocking So what are some of the requirements of VHA Handbook 1108.2, the handbook that outlines the requirements of a controlled substance program. Well for starters, controlled substance inspectors should have access to the ADC to perform the inspection, but should not have access prior to or at the conclusion of that inspection. The inspector should also ask for a report of one days worth of cabinet removals or maybe a week’s worth in an area that has infrequent use of controlled substance. He or she should use this report to verify that there is a valid order in CPRS for the item that was active at the time of the removal. If the inspector does find a discrepancy in the expected count during the inspection, he or she may attempt to resolve it with unit personnel, but the discrepancy should be reported to the CSC. Resolved discrepancies should be reviewed for trending purposes. This part of the inspection process verifies the integrity of the administration process. The inspector should also ask for one day’s worth of ADC restocking for the area(s) he/she is inspecting. The day should be random and of the inspector’s choosing. If there is no restocking activity on the chosen day, the inspector should chose another day. The inspector should verify that the amount of stock placed into the ADC is identical to the amount of stock removed from the pharmacy narcotic storage vault. This part of the inspection process verifies the integrity of the pharmacy dispensing process.

Inspecting an Automated Dispensing Cabinet Written instructions on accessing the automated dispensing cabinet in use in your facility to perform a narcotic inspection is a handbook requirement. Written instructions on accessing the automated dispensing cabinet in use in your facility to perform an inspection is a handbook requirement. The instructions should be developed by the Pharmacy Service which will base them on the type of automated dispensing cabinet that is in use, for example, Pyxis, Omnicell or MedSelect and the locally developed policies such as whether inspectors are issued temporary or permanent passwords. Ideally, a training session should be set up for new inspectors to allow the Controlled Substance Coordinator and/ or a member of the pharmacy service to go over the instructions to make sure the inspector is clear on how to successfully access the machine. If a training session is done, make sure to add it into LMS as a local orientation and initial certification training is also mandated in the handbook. All Controlled Substance Inspectors should do the training modules available in LMS as well.

Strategies for the Inspection Process Temporary Password Set Up When setting up passwords for the facility inspectors, they may be set up with a temporary password. The password can be set up to expire within a selected amount of time. There are a few ways to set up the inspectors’ passwords to allow them to document the inspection without having access to the machine’s inventory on an on-going basis. The first would be to assign a temporary password either for the day of the inspection or more ideally, the password may be set up at the machine at the beginning of the inspection and inactivated at the end of the inspection. The records will then contain the date and time of the inspection and the name of the individuals who performed it. The inspector should sign on as the witness when verifying the inventory in the machine.

Strategies for the Inspection Process Permanent Password Set Up The facility controlled substance inspectors may be set up with a permanent password that only allows the user to act as a witness. This password will expire every 90 days similar to other passwords. Some facilities set up their controlled substance inspectors with a permanent password that only allows the user to perform the witness function. This may be attractive to those facilities that do not have a pharmacy technician accompany the inspectors during the inspection. The inspectors would go to the area to be inspected and announce the inspection. An area staff member, usually a nurse, would then have to sign onto the machine. The inspector would sign in as the witness and the inspection would be performed. Discrepancies, if any would be reported to the Controlled Substance Coordinator at the conclusion of the inspection. The password may be kept active for the entire three year term of the controlled substance inspector. If the site elects to go with this strategy, the written instructions for conducting an inspection of the automated dispensing cabinet must be very clear and detailed. As with other levels of access, the password must be renewed every 90 days.

Conducting the Inspection Area personnel should sign into the automated dispensing cabinet The controlled substance inspector should sign on as a witness Access the controlled substances stored in the cabinet. Count the items in each drawer or pocket Look for any discrepancy in count Conducting the inspection of an area that is using an automated dispensing cabinet would go as follows. The controlled substance inspector should go to the area to be inspected and announce the inspection. He or she should have area personnel sign into the unit to perform a cycle count or inventory option and the inspector should sign on as a witness. Choose the controlled substance selections and begin the inventory or count of each drawer or pocket. Look to see if there are any discrepancies between the inventory and the expected count. If there are any discrepancies in the inventory, this must be reported back to the Controlled Substance Coordinator even if the discrepancy is resolved.

Reports to Request for Inspection Inspectors must verify source data including a spot check of ADC removals The handbook requires that the inspectors verify provider orders in the inpatient or clinical setting Request one day of activity for busy areas or a week to a month of activity for areas that use few controlled substances The handbook requires that the inspectors verify provider orders in the inpatient or clinic setting. You may want to request a report of at least one day of activity for very busy areas such as ICU and a week or up to a month of activity in areas where the use on controlled substances is not as frequent. The inspector can randomly select a sample from the list and check to see that the item that was removed from the cabinet had a corresponding order in CPRS that was active at the time of the dispensing episode. BCMA or the administration history in CPRS may also be used to verify that the dose was actually administered to the patient.

Other Reports to Use in the Inspection of Specialty Areas Specialty areas such as Operating Rooms, Cardiac Cath Labs or Colonoscopy Suites may require other reports to verify documentation of administration OR Reports Case Reports Waste/Return Reports If the area being inspected is a specialty area such as an operating room, cardiac cath lab or colonoscopy suite, the inspector may be required to look at source data other than BCMA. A sample OR report or case report may be included as part of the initial training as well as how to locate the reports. If the reports are scanned into CPRS, the inspector will have to know how to access VistA Imaging to view the report. If the case report takes the form of a progress note, the inspector should know how to sort notes by title to access the correct note quickly. Also, these areas tend to use partial doses and the inspector should be familiar with the waste reports and how to account for the entire dose of medication removed from the cabinet. Finally, the inspector should be familiar with the facility’s policy for returning medication to the cabinet. Ideally unused medication should be returned to a return bin and the inspector should be familiar with how this return is recorded within your system. If you do allow the user to return the medication directly to the dispense area, there should be a policy to verify the count after the return.

Automation Specific Controlled Substance Activity Reports AcuDose Rx: Controlled Substance Dispense Report MedSelect: Controlled Substance Inventory Summary Omnicell: Transactions by Date or Specific Criteria Report Pandora: Med Usage Report/All Station Events Pyxis: All Station Events The following are reports that you should receive from the Pharmacy that detail controlled substance usage from the different types of dispensing equipment. Please make arrangements with the pharmacy to run these reports prior to the inspection.

Delbert Siegmund, Pharm.D. Chief of Pharmacy Danville VAMC

Verifying Inpatient Orders in CPRS Verify five randomly selected patients to make sure that there is an administration to a patient recorded for the dose(s) removed. If your machine allows the addition of emergency or temporary cases, check to see that they are reconciled with the patient’s permanent records. The handbook requires the inspectors to randomly choose 5 patients in each area inspected and compare the records of removal from the machine with the records of administration in the medical record. This is done to prevent diversion resulting from creating fictitious patients and removing medication from the machine under the fictitious case. Most automated dispensing cabinets allow the user to remove medication to treat a patient emergently without entering a patient’s name into the machine. We do not recommend that this option be used for any controlled substance. However, an area may create a temporary case to allow for the treatment of a patient prior to formal admission to the system by HAS personnel. These cases should be matched to the permanent case as soon as possible to allow for a complete record as there may be other machine activity later after the patient is formally admitted and the machine receives the case information. Many machines are set up to allow medication to be pulled under a Floor Charge, Emergency or Generic Patient. If your facility has this option available, controlled substances should never be removed under this option. If the inspectors find an occurrence during their inspection, the area manager should be made aware as well as the Controlled Substance Coordinator.

Verifying Inpatient Orders in CPRS Access the patient and go to the “meds” or “orders” tab and find the order for the medication. Double click on the order and scroll to the bottom of the “inpatient medication details” box. Look for the date and time of the administration for the episode on your report There are a few places that an inspector can look to verify that the patient had an active order at the time the item was removed from the cabinet. You may verify that the medication dispensed from the automated dispensing cabinet had an active order at the time of the dispensing episode and that is was given within an hour of being issued by accessing CPRS and looking for the order on either the meds or the orders tab. Double click on the order and an “inpatient medication details” box will pop up. The medication administration history is at the bottom of this box by date and time. The inspector should look at the second column, labeled St for status and make sure that there is a “G” for given in that column. If the inspector sees “H” for held or “R” for refused, he or she should look for a corresponding return or waste of the dose on the automated dispensing report.

CPRS Screenshot of Meds Tab This is a screen shot of the CPRS Meds Order tab. Inpatient Medication is displayed at the top of the profile for inpatients, then non-VA supplied medication and outpatient orders are displayed at the bottom of the profile. If this were the profile of an outpatient, the order would be reversed. That is, the outpatient orders would display at the top, the non-VA supplied medication would be displayed in the middle and any inpatient orders at the bottom of the profile. Look through the profile and locate the order you want to look at it more detail.

CPRS Screenshot of Inpatient Medication Details Scroll Down Click on the order and the medication order details box opens up. The top of the screen displays information about the order itself such as when it was ordered, who ordered it, whether it is an active order or expired or discontinued and when it expired or was discontinued. This will allow you to make sure that the order was active when the medication was removed from the automated dispensing cabinet.

CPRS Screenshot of Inpatient Medication Details cont. Scrolling down to the bottom of the screen, you will be able to look at the medication administration history to see when a dose was recorded in BCMA as administered to the patient. The first column after the location displays the administration status. That is, G for given, H for Held, R for Refused. The fifth column displays the units given during the administration episode. If only one tablet or capsule was given, you will see a one, if two or more tablets or capsules were recorded as given, you will see that here as well.

CPRS Screenshot of Inpatient Medication Details (IV example) IV Medication order details display a little differently from the oral tablet and capsule order detail. The second column will still display the status of the dose, that is G for given, H for Held etc. , but the unit dispensed will be in the seventh column and will display the amount of the IV that was given.

BCMA Administration Reports Available in BCMA under “Med Administration History” Can also access “Med Administration Log” if the episode is recent Both reports are available in CPRS on the “Reports” tab The same information may also be found in BCMA using the “Med Administration History”

BCMA Medication Admin History Report This is a screen shot of the medication administration history tab as displayed in BCMA. This would display the orders on unit dose, IV/IVPB or IV tabs. If the button next to the tab name is green, there is data under that tab, if it is white, there is no data there. If you don’t see the order you want to check, look at the schedule type box in the upper right hand corner and make sure that the correct schedule type is checked. Only the schedule types that are checked will display. You can check all of them or only one type

BCMA Reports available in CPRS – Reports Tab You may also access the medication administration history from BCMA on the reports tab of CPRS. Click on the reports tab and look for it in the listings on the left hand side of the screen.

Verification of Orders in Outpatient Areas Outpatient Units Colonoscopy Suite Same Day Surgery Cardiac Catheterization Suite Work with HAS and Pharmacy to have clinic stop added to the unit Area personnel should not have to add patients on a routine basis. If your facility uses an automated dispensing cabinet in an outpatient setting such as a colonoscopy suite, same day surgery unit or cardiac catheterization lab. Some of the cabinets allow you to set up outpatient clinics to send ADT (that is, admission, discharge and transfer) information across the interface. If this is possible with your ADT, you should work with your Pharmacy and HAS service to have the clinic stop that is used by that clinic added to the unit so that the patient’s name is being pushed over from HAS as soon at the patient checks in. Clinic personnel should not be put into the position of having to do a work around and add all patients into the system as “emergent” cases. The addition of temporary or emergent cases as part of the clinic routine makes the facility vulnerable to diversion. The OIG recently arrested a nurse working in a VA Cardiac Catheterization Suite for diverting controlled substances by entering fictitious patients into the unit and withdrawing medication under the fictitious case.

Verification of Orders in Outpatient Areas Outpatient CPRS prescription (ex Methadone maintenance) OR Report (Same Day Surgery) Case Note (Cardiac Cath Lab, Colonoscopy Suite) Verification of 5 orders should still be done for the outpatient areas, but the documentation may not be in BCMA or the Inpatient Orders tab in CPRS. The order may be entered as an outpatient prescription or documented in an OR report or case note. If your facility does use an automated dispensing cabinet in an outpatient area, verify how the patient cases are entered into the cabinet’s data base, whether or not the cases are reconciled and what type of report is used to document administration. You may want to make up a table for your inspectors so they will know what type of report they should be asking for and, ideally, include examples so they will be comfortable with reading the documentation. Please be aware that recent progress notes may not be available to be viewed if they are not signed off. Your inspectors may want to pick cases that are a few days if they must view progress notes.

Jennifer Howard, Pharm.D. Director, Pharmacy Informatics San Diego VAMC

Methadone Maintenance Unit AMS Avatar System Verify opening amount, amount dispensed, quantity on hand. Verify 5 orders as previously outlined If your facility has a methadone maintenance unit, it may have a machine to aid the pharmacist in dispensing the daily dose. The two most popular systems in use in the VA are the AMS and the Avatar systems. Ask the area personnel to print the opening amount out of the machine and the amount dispensed. The difference should be the amount on hand. If the clinic is busy and uses several bottles of liquid methadone during the course of the day, you may find that you have more on hand than expected. This is a result of the overfill in each of the bottles of methadone. Many clinics add in the overfill into the amount on hand when the new bottle is added into the machine. Add this amount to the amount in the unopened bottles in storage.

Review Discrepancies Ideally, you should also look at both unresolved and resolved discrepancy reports Report any unresolved discrepancies to the controlled substance coordinator for further investigation Review resolved discrepancies for trending purposes A discrepancy should be considered just that, a difference between the count that is expected as a result of the machine’s records and what is actually found to be stored in the machine. There may be many reasons for a discrepancy. The previous user may have recorded the amount of medication removed incorrectly, or the amount of medication was counted after the doses that the user needed was removed, not prior to removal. Usually a review of the recent usage records can help to pinpoint the problem. Once it has been established that the discrepancy is the result of a documentation error, the discrepancy can be resolved. Ideally, you should also look at both unresolved and resolved discrepancy reports. The resolved discrepancies may be reviewed for trending purposes. If one type of discrepancy is seen more often, there may be a practice issue that could be resolved with training. If the inspector discovers a discrepancy during the course of the inspection and the unit is able to resolve it, it should still be reported to the controlled substance coordinator. You may wish to work with the pharmacy service equipment technician or other similar personnel to obtain this data.

Automation Specific Discrepancy Reports AcuDose Rx: Discrepancy by Station, Open Discrepancy By Station MedSelect: Top 25 discrepancies Omnicell: Pharmacy Discrepancy Report Pandora: Discrepancy Report Pyxis: All Discrepancies Discrepancy reports are listed by type of automated dispensing cabinet. You can ask the pharmacy to run the report for you. For a complete list of reports for the type of cabinet at your facility, click on the icon that looks like a notepad in the top right hand corner of the screen. Many stations use the Pandora software to monitor the machine’s activities as well. If your station uses the Pandora program, the reports that this software generates may display the data in a easier to read format. Check with your pharmacy service to see if your station uses this software. If a discrepancy cannot be resolved, refer it to the VA Police for further investigation. We will get into report oversight and discrepancy investigation in greater detail in the second part of this presentation.

Verification of Restock The handbook requires that the at least one days worth of restocking be verified as part of the inspection process. A report of restocks will need to be generated from the Pharmacy narcotic vault. This report may come from Vista, Pyxis CII Safe or Omnicell Secure Vault The handbook requires that the at least one days worth of restocking be verified as part of the inspection process. Prior to going to the area for inspection, you may want to have the pharmacy run a report of one day of the inspector’s choosing to check the restocking function. If the area to be inspected doesn’t have that much activity, the inspector may wish to have a week’s worth of activity included in the report, so that the inspector can be sure to have data to work with.

Automation Specific Restock Reports AcuDose Rx: Loading and Unloading Report MedSelect: Restock Summary Omnicell: Transactions by Date or End of Cycle Report (if site has Secure Vault) Pandora: Narc Vault Reconciliation Report Pyxis: Med Refill Activities These reports list all restocks completed by Pharmacy at the automated dispensing cabinet (ADC). The amounts removed from the vault should be double checked against the amount loaded into the automated dispensing cabinet. You can use it to review one day’s worth of restocking to make sure that the items were recorded correctly and that nursing personnel verified the count after the restock was completed.

End of Shift Count End of Shift Count or Weekly Count Not a handbook requirement May be required by local policy End of shift discrepancy report Best Practice While not specifically required in the handbook, a weekly inventory of the controlled substances and/or end of shift discrepancy report may be required by local policy. If your facility’s policy does require it, the inspectors should check that they were done in a timely manner and, in the case of an end of shift discrepancy report, that any discrepancy was resolved in a timely manner. If your facility does not currently require counts or discrepancy resolution, this may be an opportunity to align your facility with current best practice. As we go over conducting an investigation into an un unexplained loss, you will see that these counts will help you pinpoint the time that the inventory count was known to be correct and when the loss may have occurred. It also requires that area personnel count each drawer or pocket weekly, so a discrepancy in the count of an infrequently used drug will be discovered more quickly.

Inspecting the Pharmacy Narcotic Vault Automation that may be present in the vault Pyxis CII Safe or Omnicell Secure Vault Fast Fill Scriptpro SP50 Baker Cells There may be a number of machines in use within the pharmacy narcotic vault. In the inpatient areas, the pharmacy may have a storage unit such as a Pyxis CII safe or Omnicell Secure Vault. They can give you another level of security and we can discuss the kinds of report that can be used as oversight. In the outpatient areas, robotic fill devices such as a Fast Fill, a ScriptPro unit or Baker Cells may be used to aid the pharmacy in filling outpatient prescriptions. Regardless of the storage and dispensing device in use, all controlled substances including those stored in these devices must be inventoried every 72 hours and any inventory dispensed with the aid of these devices must also be removed from the controlled substance inventory in the VistA pharmacy system as the VistA inventory is the official inventory that may be audited by SOARS or OIG inspectors.

Inspecting the Pharmacy Narcotic Vault Pyxis CII Safe Omnicell Secure Vault These machine may be used to store narcotics within the pharmacy. It adds another level of security to the storage as they can documents who goes into the machine, what they removed and when they removed it. They can also allow the pharmacy to reconcile the amount of medication removed from the unit in the pharmacy and where it ended up. If the pharmacy technician removed 10 boxes of drug X, it is possible to trace all 10 boxes to their final destination though out the facility.

Inspecting the Narcotic Vault Pharmacy Dispense without (VA FORM 10-2638) LORAZEPAM 0.5MG TAB,UD Select NAOU: xx QUANTITY DISPENSED (TAB/25): 25// 25 JAN 01, 2001@08:21:51 DISP OMNICELL XX -25 If the machine used in the pharmacy does not have an interface that automatically deducts the amount of medication dispensed from the inventory, then it must be removed from the inventory by another means. The pharmacy VistA menu [PSD DISPENSE W/O GS] will allow the inventory to be removed without using the balance adjustment function. This has the advantage of recording the removal under the Narcotic Area of Use instead of having to enter the information into a comment. Inventory removed from the VistA inventory in this manner will display in the format seen in the third line. Please note that the VistA inventory is considered the official inventory and should accurately reflect the inventory.

Outpatient Robotic Prescription Fill Fast Fill Baker Cells ScriptPro The facility may also use robotic units to aid in filling controlled substance prescriptions. Some machines are more accurate that others. If you see that the pharmacy is making several small balance adjustments, that is less than 5 doses on a regular basis, you may want to meet with pharmacy personnel to make sure that the machine is working properly and that all policies for verification are being followed. You may also want to look at these balance adjustments for trending purposes. Is there a certain drug or certain location within the machine that is more vulnerable to inaccurate counts? A second verification count may be needed to make sure that the amount dispensed by the machine is accurate. Some machines such as the ScriptPro may be set up to require that verification count. This is a best practices and greatly increases the accuracy of the fill.

Questions??? Marian Daum - Coatesville VAMC Delbert Siegmund - Danville VAMC Jennifer Howard - San Diego VAMC Dionne Roney - Charleston VAMC Jolene Hallcroft - Sheridan VAMC We will now answer any questions received through live meeting then will open up the VANTS line for questions as well.