Helpful Ideas

Stepwise Approaches to CSA Compliance

Problem: It's been a long time since my pharmacy's last DEA review, and we want to do an internal review to make sure we're in full compliance, especially with Controlled Substances Act requirements. How should we go about this?

Solution: Establishing a system of continuous monitoring and internal compliance checks is an important part of maintaining violation-free CSA compliance.

Perhaps no area of pharmacy practice is more challenging-or more worrisome-than compliance with Drug Enforcement Administration regulations. Failure to comply can lead to a ruinous loss of DEA licensure, criminal charges, or stiff fines of up to $25,000 for each violation, even relatively minor record-keeping violations. A few years ago, one major long-term care pharmacy company was hit with a $750,000 fine for just these sorts of regulatory shortcomings.

For most pharmacists, particularly those just starting out in practice, DEA regulations are a source of considerable anxiety. One of the best ways to dispel potential confusion and boost pharmacy staff confidence levels is to institute a process of ongoing evaluation, training, and compliance checks. Regular internal reviews, or "self-audits," are an intregal part of this process.

Goals and Objectives

Continuous attention to, and checking of, any complex process invariably improves the results of that process and reduces disruptive variances.¹ The process of receiving, storing, and distributing large quantities of tightly regulated controlled substances is rife with opportunities for procedural breakdowns and record-keeping lapses, but one that lends itself well to internal monitoring through self-audit protocols.

The broad goal of an internal audit program is to ensure that all controlled substances are properly accounted for, and that records, inventories, and prescription documents contain the required information and are properly maintained.

Experts recommend that, at minimum, routine internal CSA compliance audits encompass the following areas: receipt of controlled substances; required records on bulk distribution; dispensing; accountability; disposal; access and storage (see box, this page); partial filling of Schedule II substances; returns to suppliers/manufacturers; accuracy of automated data processing systems for Schedules II-V drugs; tracking of and accountability for emergency kits; reporting and investigation of losses and thefts; and inventory accuracy.¹ Depending on the nature and complexity of the pharmacy's business, other internal audits may be in order.

Drug Storage Cabinet Checklist

• Is access limited to pharmacists and technicians accompanied by a pharmacist?
• Are the means of access (keys, cards, electronic code, lock combination) restricted to licensed pharmacists?
• For card systems, are the card number and date and time of each entry recorded and documented in a log book?
• For key lock systems, is an entry log maintained? Is access to keys controlled through sign in/sign out and shift transfer protocols? Are all keys kept in the pharmacy at all times?
• For electronic code systems, are the date and time of each entry recorded and documented in a log book?
• For combination lock systems, is knowledge of the combination limited to a minimum number of employees and changed upon termination of such employees?
• Does the registrant continuously monitor storage cabinet/enclosure and institute appropriate access controls?

An Added Measure of Confidence

All DEA-registered pharmacies are required by law to take an initial inventory upon commencing operations or a change in ownership, with subsequent inventories conducted every two years thereafter. To complement these mandatory biennial inventories, the pharmacy can undertake a perpetual inventory targeting the high-risk area of Schedule II controlled substances.

The Schedule II perpetual inventory provides a systematic approach to monitoring the receipt and dispensing or distribution of drugs and precisely accounting for the quantity of each drug on hand at any time (see box, next page).²

Perpetual Inventory Checklist

• If all pharmacists have access to the Schedule II log book, is one pharmacist responsible for maintaining the log book and ensuring its accuracy?
• Does the log book contain pages titled "Class II Drug Inventory Control Sheet"?
• Is one page in the log book assigned to each Schedule II drug on hand? Does each page include a beginning balance and space to indicate daily receipt and dispensing/distribution to allow monitoring of the current balance?
• Do log book entries for each drug/controlled substance contain the pharmacist's initials, the date, the prescription serial number, and the quantity received/dispensed/distributed?
• Each time inventory is added, does the receiving pharmacist enter an order form (DEA Form 222) number and the quantity added?
• Does the assigned pharmacist match all Schedule II prescriptions, or corresponding computer printouts, with entries in the Schedule II log book? Is a weekly inventory of all medications taken to verify the entry and accuracy of all prescriptions in the log book?
• Does the pharmacy manager verify the weekly inventory, investigate discrepancies, and reconcile any differences?

Any incidence of theft or significant loss of controlled substances detected during a self-audit must be immediately reported to a DEA field office using DEA Form 106.

Know Your Limits, Keep it Going, Keep it Positive

A few important notes: First, pharmacies with especially large, complex, or far-flung operations may want to consider retaining the services of an outside compliance consultant who can probe for problems in a wholly impartial manner and devote full attention to the job.

Second, remember that DEA compliance is an ongoing process. Since adherence to proper procedure tends to slip over time, it's a good idea to back up self-audits by periodically retraining staff and re-emphasizing previously identified problem areas. One or more persons designated to serve as the pharmacy's compliance "watchdogs" should be responsible for staying current on DEA regulations, training and retraining staff, and coordinating all self-audit activities.

Third, no matter what sort of internal audit is conducted, the process should focus on identifying problems, educating staff, and correcting deficiencies to prevent recurrences. If the process is perceived as primarily punitive, negative perceptions and anxiety will take hold, and staff will be less forthcoming in calling attention to problems-or worse yet, they may attempt to hide problems.

If properly targeted and done on an regular basis, self-audits not only reduce the chances of an unfavorable DEA audit outcome; they can yield a big pay-off in terms of operational streamlining, enhanced efficiency, and, ultimately, a better bottom line.

David K. Buerger
Associate Editor

Reference:

1 Buzzeo RW, Siecker BR, The consultant pharmacist's guide to the controlled substances act: regulatory guide and compliance manual, American Society of Consultant Pharmacists, 1996.

Editor's note: For more information about the regulatory guide referenced in this article, visit the "Products" area of ASCP's World Wide Web home page (www.ascp.com), or call ASCP Customer Service at 800-355-2727.

Share Your Great Ideas!

Have you developed a new patient care technique, documentation form, in-service strategy, or other innovative practice tool or program? If so, why not share it with your colleagues in Helpful Ideas? Send contributions to Associate Editor David Buerger, 1321 Duke Street, Alexandria, VA 22314; or call 703-739-1300, ext. 136, for more information.