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

Disclosures

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

In This Article

Discussion

Preventing diversion of controlled substances is a challenging process for hospitals nationwide. The survey findings suggest varying levels of use of recommended diversion prevention practices at institutions represented in the survey. Currently, there are few reports or guidelines on the use of strategies to prevent diversion in the professional literature.

Although 94% of respondents reported use of ADMs, 16% did not use an automated controlled substance vault. This raises the question of how these institutions securely stored controlled substances in the pharmacy. Automated controlled substance vaults allow users to detect diversion through reporting software, maintain a perpetual inventory, and provide electronic documentation of all transactions. More than one third of institutions did not use cameras directed at controlled- substance storage areas. Cameras offer a relatively low cost:value ratio for detecting diversion, and even nonfunctioning cameras can offer some deterrent value.

The survey results suggest that the greatest opportunities for preventing diversion lie in the purchasing and storage of controlled substances. Most respondent institutions had one person purchase and another person receive controlled substances, which allows for tighter control of inventory through a system of checks and balances. About half of respondents did not allow the purchaser access to controlled substances beyond the access necessary to prepare reports for ordering purposes, but such restricted access is not always feasible. Smaller departments, for example, may have only one staff member to purchase and receive controlled substances and stock the drugs in ADMs on nursing units. Most institutions did not ban all personal belongings from drug storage areas, so there is a possibility that someone could place items in a purse or backpack to be taken out of the pharmacy at the end of a shift.

Auditing of controlled substance purchases helps ensure alignment of purchases with actual inventory. Most respondents reported maintaining a DEA form 222 log, but 12% of institutions did not conduct audits and thus might be at higher risk for diversion. Person-to-person transfers of controlled substances were audited by 69% of institutions, but such transfers can be difficult to monitor. One fourth of the respondents reported that they did not audit the use and waste of multidose vials of controlled substances; those institutions would be well advised to begin such auditing.

There is a high risk of controlled-substance diversion in the OR. We found that 51% of institutions had an OR pharmacy, and 55% of institutions reported always having a pharmacy staff member reconcile the medication dispensed against those documented as administered or returned to the pharmacy for wasting. About 9% of respondent institutions reported that pharmacy staff members were not involved in the reconciliation of OR controlled substances. Although there are barriers to this process (e.g., small pharmacy staff, small OR, budget constraints), pharmacy departments should strive to procure the necessary resources for this important function.

The pharmacy is accountable for all medications, whether stored in the pharmacy itself or in an ADM on a nursing unit. In 61% of respondent institutions, biometric fingerprint technology was used as the positive-identification system to control access to medications from an ADM. Biometric technology is the recommended identification system—nothing is more individualized than a person's fingerprint—and its use should be increased.

Not all of the institutions reporting use of ADMs also reported use of ADM software to identify controlled substance diversion. There may be inherent deficiencies in the software, but some investigation is better than none. Available software can identify users who are frequently involved in discrepancies involving controlled and non-controlled substances and can limit the quantity of controlled substances to which individual users are allowed access. Of the institutions that reported using basic software packages, 88% had purchased add-on software for more comprehensive diversion detection.

ADM pockets within the drawers can only hold a certain quantity of medications. A stock-out notification is typically sent to the pharmacy via the ADM when the quantity reaches a critical level, before the pocket is entirely depleted. The survey results indicated that stock-out notifications were immediately investigated by 42% of institutions for potential diversion, but 34% reported never conducting such investigations. Institutions should take an active role in investigating stock-outs as an important method for prevention or detection of diversion.

One major limitation to our study was a low response rate (28%). We suspect that many survey recipients ignored the e-mailed request to participate or forwarded it to another individual with more intimate knowledge of the questions asked. The survey's length (41 questions) and the limited response period (30 days) also might have contributed to the low response rate. Despite those limitations, we believe that the distribution of institution size suggests a good sample mix. While this study provides information on diversion prevention, the study was limited to hospitals that were members of UHC or had residency programs listed on the ASHP website.

More research needs to be conducted to better define current practices and develop national standards of practice for prevention of controlled-substance diversion.

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