are readily retrievable and  problems with drawers identified via automatic notification on the cabinet., with error messages ont he main console.  There is little need for monthly review by the pharmacy staff.

I support the proposed regulation amendment for the following reaons:

1. Hospital pharmacies have quality control systems in place to look for many of the same items that are required by the Board in 18VAC 110-20-490.  However, it is rare that these quality control audits must be done monthly, since variance is unusual.  While I agree that these audits are important and necessary, requiring that the audits be performed monthly is time-consuming, and takes away time that could be used for other, more productive, activities.

2.  Specifically, 18VAC 110-20-490.5. requires monthly audits for 5 items that are actually reviewed by virtue of the very use of the machines.  Outdated drugs, location of drugs within the device, etc., are vital components of the drug delivery system, and must be part of the day-to-day operation of the department.  It would be more useful for the Board to know that the drug distribution system addresses these items on an ongoing basis than to see the results of monthly audits.

I hope the Board will consider revising these requirements.

I fully support the changes proposed for the regulation.  Automation offers mechanisms for expiration dates to be monitored, security to remain in tact, and ability to run audit reports as needed.

I fully support a change in 18VAC110-20-490 section 5.  The current process takes 40  to 60 man-hours each month to complete all audits required and does not identify possible diversion effectively.

Using a reconciliation software program similar to RxAuditor, Pandora or others - a 24-hour audit of all transactions for controlled substances becomes obsolete.  These programs show statistical analysis over a month.  Using the process set by the regulation, identifying possible diversion was hit or miss.  Using RxAuditor, we can identify specific employees to audit based on peer-to-peer comparisions of use for their unit. This is a more effective use of the auditors time and addresses the diversion concerns.

Combine this with a facility using their ADC on "profile" mode, where a pharmacist must enter the order into the hospital's Clinical System before the drug is available to the nurse (order verification).  The use of Controlled Substance perpetual inventory management systems (i.e. CII-Safe, NarcStation, etc) where issues remain open until appropriately stocked into the receiving ADC (narrowing the focus of audits for issue/restock).  Overrides and Open Discrepancies may be reviewed easily and in a more timely manner. 

Thank you for your consideration.

I fully support a change in 18VAC110-20-490 section 5.  The current process takes 40  to 60 man-hours each month to complete all audits required and does not identify possible diversion effectively.

Using a reconciliation software program similar to RxAuditor, Pandora or others - a 24-hour audit of all transactions for controlled substances becomes obsolete.  These programs show statistical analysis over a month.  Using the process set by the regulation, identifying possible diversion was hit or miss.  Using RxAuditor, we can identify specific employees to audit based on peer-to-peer comparisions of use for their unit. This is a more effective use of the auditors time and addresses the diversion concerns.

Combine this with a facility using their ADC on "profile" mode, where a pharmacist must enter the order into the hospital's Clinical System before the drug is available to the nurse (order verification).  The use of Controlled Substance perpetual inventory management systems (i.e. CII-Safe, NarcStation, etc) where issues remain open until appropriately stocked into the receiving ADC (narrowing the focus of audits for issue/restock).  Overrides and Open Discrepancies may be reviewed easily and in a more timely manner. 

Thank you for your consideration.

I fully support a change in 18VAC110-20-490 section 5.  My facility has 72 unique ADC locations and requires a full time pharmacy employee to perform the 24 hour audits. These audits are not an effective method of identifying potential diversion as the audit is a 24 hour snap shot within a months worth of activity.

I currently utilize a program that does statistical analysis on controlled substance activity over a 30 day period.  This statistical report identifies specific employees for each unique location and compares activity peer-to-peer.  This is an efficient and effective process and reviews a broader time frame to identify potential diversion.

In addition, orders are reviewed by a pharmacist and entered into the electronic MAR prior to the end user having access to the medication.  The use of a Controlled Substance perpetual inventory management system provides additional safe guards for potential diversion review.

I appreciate your consideration of this petition.

I am completely in support of changing 18VAC110-20-490 section 5. With increasing use of eMAR, CPOE, and other third party monitoring programs, users could effectively and efficiently be tracked and monitored. C2 Safe now allows perpetual inventory of controlled substances with easy electronic auditing.

The number of Pyxis machines being used in hospitals have increased significantly, requiring significant resources to keep up with the paper auditing.

I appreciate your consideration of this petition.

I am in full support to change 18VAC110-20-490 section 5.  The current process takes valuable pharmacist man-hours each month that could be used to promote patient care.

The manual audits required are not the most effective or efficient way to identify possible diversion. Using a reconciliation software program (i.e. RxAuditor, Pandora) quickly provides an audit of all transactions for controlled substances. These programs show statistical analysis for each user and medication. Using such a system, pharmacies can identify specific employees to audit based on peer-to-peer comparisons.

Thank you for your consideration.

I would like to add my voice to those who have already commented in favor of this change.  I feel that the process of performing these audits consumes valuable resources with very little to show for the effort in terms of uncovering diversion.  Systems such as Pandora or RxAuditor provide much more powerful and statistically relevant data for us. 

Thank you!

I would like to add my voice to those who have already commented in favor of this change.  I feel that the process of performing these audits consumes valuable resources with very little to show for the effort in terms of uncovering diversion.  Systems such as Pandora or RxAuditor provide much more powerful and statistically relevant data for us. 

Thank you!

As a longterm Pharmacist who has worked in a variety of settings I have had the opportunity to explore the potential requirements of the monthly audits as currently outlined.

In the face of diverse checks and balances in place  provided by automated dispensing cabinets daily as well as services such as RX Auditor, I find the additional auditing currently in the regs duplicative and labor-intense. In addition reports such as Compare within PYXIS  as well as daily all station reports for controlled substances, we have capability to already do this process on a prospective basis in our daily functions.

I am happy to expand upon this should additional information be required.

I therefore respectively request consideration to consider this audit requirement a limitation rather than enhancement of monitoring in the face of current automation as we know it in pharmacy practice

Thank you for your consideration.

Using a reconciliation software program similar to RxAuditor, Pandora or others - a 24-hour audit of all transactions for controlled substances becomes obsolete.  These programs show statistical analysis over a month.  Using the process set by the regulation, identifying possible diversion was hit or miss.  Using RxAuditor, we can identify specific employees to audit based on peer-to-peer comparisions of use for their unit. This is a more effective use of the auditors time and addresses the diversion concerns.

Combine this with a facility using their ADC on "profile" mode, where a pharmacist must enter the order into the hospital's Clinical System before the drug is available to the nurse (order verification).  The use of Controlled Substance perpetual inventory management systems (i.e. CII-Safe, NarcStation, etc) where issues remain open until appropriately stocked into the receiving ADC (narrowing the focus of audits for issue/restock).  Overrides and Open Discrepancies may be reviewed easily and in a more timely manner. 

Thank you for your consideration.

Makeityourring Diamond Engagement Rings

I am in support of modifications to 18 VAC 110-20.  The software upgrades that are available to monitor expiration dates as well as statistically analyze individual users if far superior to antiquated manual methods of audit and much more dependable in providing the evidence required to control narcotic misuse and diversion.  The shift in man-hours and staffing to more valuable clinical functions would further support the true role of pharmacist and pharmacy technicians in the healthcare environment.

Thank you for considering modifications to this regulation.

Please revise regulation to allow for some kind of automated program to be used (RX Auditor, etc) to be used as the first level of review to detect diversion.  Once we receive the Rx Auditor we would then follow up on the activity of employees found to be 3 or 4 or 5 standard deviations above the rest of smiliar employees.  We have been auditing acudoses for years and found little diversion in this fashion.  Once we started with RX Auditor we found and terminated 4 employees for diversion (and yes reported them to the Board!).  Auditing individual cabinets monthly is very labor intensive.  I feel we get more bang for the buck with Rx Auditor.

Thanks

 I am in full support to change 18VAC110-20-490 section 5.  The current process takes valuable pharmacist time each month that could be used to promote "Best Practice".

The manual audits required are not the most effective or efficient way to identify possible diversion. It has been reasearched and shown that using a reconciliation software program (i.e. RxAuditor, Pandora) quickly provides an audit of all transactions for controlled substances. These programs show statistical analysis for each user and medication. Using such a system, pharmacies can identify specific employees to audit based on peer-to-peer comparisons. This has moved diversion monitoring to a new level.

Thank you for your consideration.

Technology has and continues to change the pharmacy landscape that we work in, especially in the area of monitoring inventory and reconciliation of medication transactions. Currently available software programs give pharmacists the ability to assess and manage the entire drug supply chain from acquisition to administration to an individual patient. This includes the tracking and evaluation of controlled drug activity for an entire time period versus looking at a slice of activity and extrapolating the information obtained in that 24 hour period to an entire month. Hoping that diversion is not taking place on the dates not audited. In my experience an individual involved in diversion rationalizes and is willing to take a chance that they won't be caught on a routine audit. The methods and resources we had in the past for detecting diversion supported that rationalization.

There is the old adage that a system is only as good as the information it contains. Pharmacy resources would be better spent perfecting and tailoring the available software programs to meet the profile of our individual hospitals. Available programs give us the capability of looking at all transactions and then to use the power of statistics to identify where to concentrate our in-depth audits. I support this change in regulation.

I am in support of the modifications to 18 VAC 110-20.  There  is data available to monitor/audit these stations that is far less time intensive and labor intensive.  Removing this requirement will free up staff to provide more valuable clinical services. 

Thank you for considering modifications to this regulation.

I agree that automated dispensing cabinets and barcoded technology have allowed much of the experiation date information to be captured electronically.  As a clinical specialist that is expected to profile review 34 ICU patient beds, participate in interdisciplinary and bedside surgical rounding on patients daily, and focus on other medication safety issues / medication use evaluation development / and patient/staff education, having to spend time monthly for dispensing cabinet audits detracts from my ability to address critical issues in my sick patients.  If the technology has shown that it is effective in this aspect of pharmacy management, it would be much needed to free pharmacists up to focus on clinical services.

I fully support a change in 18VAC110-20-490 section 5. My facility has 43 unique ADC locations. The manual audits are not an effective method of identifying potential diversion as the audit is a 24 hour snap shot within a 30 day period of activity.

We current utilize a program that completes statistical analysis on controlled substance activity over a 30 day period. This statistical report identifies specific exmployees for each unique location and compares peer-to-peer activity. This is an efficient, effective and more thorough process and reviews a broader time frame to identify potential diversions.

Enhanced further is the use of an ADC in "profile" mode, where a pharmacist must enter the medication order into the hospital's clinical informatics system before the drug is available to the nurse in the ADC. The use of controlled substance perpetual inventory management systems such as CII Safe or NarcStation where issues remain open until appropriately stocked into the receivng ADC also support a more improved process over a manual review. Technology is available to meet the intent of the regulation.

I believe the combination of profile dispensing ADCs, automated controlled substance inventory systems and controlled substance statistical analysis software provide a much greater diversion tracking system than the current regulations of a manual review over a limited period of time.

Thank your for considering modifications to this regulation.

I support the proposed changes to 18VAC110-20-490 section 5. These changes will free valuable pharmacist man hours that can be dedicated to enhancing patient care without compromising the ability to detect diversion.