Compliance with Recommendations for Prevention and Detection of Controlled-substance Diversion in Hospitals

Steven R. McClure; Brian C. O'Neal; Dennis Grauer; Rick J. Couldry; Allison R. King


Am J Health Syst Pharm. 2011;68(8):689-694. 

In This Article


The e-mail requesting participation in the survey was sent to 499 directors of pharmacy; 140 survey responses were received, an overall response rate of 28%. As 5 respondents did not provide information on the number of licensed beds, only 135 survey responses were included in the data analysis.

Selected characteristics of survey respondents' institutions are shown in Table 1. Of the respondents, 117 (87%) stated that their home institution was located in an urban area (population of >50,000); 95 (70%) reported private, not-for-profit ownership. Twenty-seven institutions (20%) were licensed for ≥700 beds, and 76 (56%) of the 135 institutions had at least 400 licensed beds. All survey respondents did not answer all survey questions; that is reflected in the data reporting (Table 2).

Ninety-seven percent of respondents (131 of 135) indicated that their institution was using decentralized ADMs, but almost 13% of institutions (17 of 134 respondents) reported the lack of an automated controlled-substance storage vault within the central pharmacy. Sixty-five percent of respondents (86 of 132) indicated the presence of cameras directed at controlled-substance storage areas in the pharmacy (only 36% of respondents [48 of 132] reported the use of cameras directed at storage locations for high-cost non-controlled medications). Only 31% of institutions (42 of 135) reported an existing policy banning all personal belongings (e.g., purses, backpacks) from drug storage areas. Four percent of respondents (6 of 135) indicated that they defaced boxes of high-cost medications (e.g., removed box top, discolored packaging with a marker) to inhibit their diversion and subsequent resale.

The most commonly reported method for purchasing controlled substances included having one person create and submit a controlled-substance purchase order and another person receive the purchase (109 of 135, or 81% of respondents). Approximately half of the respondents (71 of 133) reported that they allowed the purchaser to have access to controlled substances beyond what is necessary to create reports.

Twenty-nine respondents (22%) were using the DEA controlled- substance ordering system, which allows for electronic ordering of schedule II substances. Excluding these institutions, 85% of respondents (86 of 101) maintained a log of DEA 222 forms to ensure that all forms are accounted for.

Approximately 85% of respondents (114 of 134) reported performing an audit of controlled-substance purchases against inventory records at least quarterly. Seventy-four percent of respondents (97 of 131) reported auditing the use of and waste procedures for controlled-substance multidose vials to ensure accountability for all product; 70% (94 of 134) reported auditing person-to-person transactions (e.g., dispensing of a single fentanyl patch directly to a nurse) and other transfers to non-automated storage areas. Among institutions that employed an expired- returns company, reconciliation of records against returns to the company occurred in 88% of institutions. Only 34% (46 of 134) audit purchases of high-cost, noncontrolled medications against dispensation.

Operating Room Practices

Fifty-one percent of all respondents (69 of 135) reported use of a satellite pharmacy for dispensing to operating room (OR) suites. Of those, 12% (8 of 69) reported that the satellite pharmacy was staffed at all hours.

Fifty-five percent of respondents (74 of 135) reported that their facilities always reconciled medication quantities documented on the dispensing record against the quantities documented as administered or returned to the pharmacy as waste, while 36% (49 of 135) indicated such audits were performed sometimes. Twenty-four percent (32 of 135) of respondents reported that unused controlled substances were not returned from the OR to the pharmacy. Among respondents receiving returns of unused controlled substances, 46 said their institutions did not test to verify the drugs' identity.

Nursing Unit Practices

Ninety-five percent of respondents (125 of 131) reported that their facilities had a system capable of electronically identifying discrepancies between withdrawals from a controlled- substance vault in the central pharmacy and controlled substances received by an ADM on the nursing unit. For institutions using decentralized ADMs, 89% performed a "blind" count (the user was forced to enter the inventory count when accessing a controlled-substance pocket). Controlled-substance counts or inventories at an ADM were performed at each transaction by 30% of respondents (41 of 135), at each nursing shift change by 19% (26 of 135), daily by 9% (12 of 135), weekly by 33% (44 of 135), and at some other frequency by 9% (12 of 135). About 62% of respondents (84 of 135) reported use of biometric fingerprint-scanning technology for ADM access.

About 69% of respondents (93 of 135) reported that trends in controlled-substance audit discrepancies were monitored for investigation of users most frequently involved in discrepancy creation; flagged discrepancies often required the user to provide a reason at the point of resolution, and 92% of respondents (124 of 131) indicated that explanations were "always" or "sometimes" investigated for validity. About 59% of respondents (77 of 131) said ADM stock outages were investigated for potential diversion at least monthly.

Seventy-nine percent of respondents (106 of 134) reported use of diversion detection software capable of flagging users whose controlled- substance ADM withdrawals exceeded a defined threshold (e.g., 3 standard deviations above the mean number of controlled-substance transactions among peers). Software used by survey respondents is shown in Table 3.


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