This is part two of a two-part series covering drug diversion In Iowa. Last week, we started with an overview of key questions and considerations when there is a drug diversion issue.
Stolen
What happens when drugs are stolen? When medication is stolen, you should perform an assessment of who needs to be aware of the missing medication. This includes but is not limited to:
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DEA - Under Title 21 part 1301 of the DEA regulations, the DEA registrant must report “significant loss or theft” of any controlled substance “within one business day of discovery of such loss or theft.” This reporting is required to be done to the field office in the area of the facility where the drugs were diverted or lost. The registrant must also complete a DEA form 106. While the DEA does not define what amount of drugs would constitute a “significant amount,” it does set out a six-point test requiring assessment of:
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The actual quality of controlled substances lost in relation to the type of business
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The specific controlled substances lost, whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances
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A pattern or losses over a specific time period, whether the losses appear to be random and the results of the efforts taken to resolve the losses
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If known, whether the specific controlled substances are likely candidates for diversion and local trends and other indicators of the diversion potential of the missing controlled substance.
Even if there is a determination that it is not necessary to report such loss to the DEA, those factors should be evaluated within the investigative report in order to later show how the decision to report or not report to the DEA was made.
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Boards of Licensure - If it has been determined that drugs were diverted or taken by a license holder, other license holders, including nurses, physicians, or pharmacists, have an ethical obligation to report that person to the appropriate Board. Typically, rather than have a series of physicians or nurses report a co-employee, the hospital or another facility will coordinate a single report. The facility will generally be asked for supporting documentation, investigative notes, personnel files and a wide array of other documentation as part of the investigative process. The licensure boards can all access such records as part of any report regarding a license holder.
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Payors - If the diverted medication is post-patient access, tampered with or otherwise paid for by a patient or a payor it may be necessary to report any diversion, misuse or tampering to the Center for Medicare/Medicaid services or any private insurance. If a patient did not get what his/her insurance paid for, that insurance company will need to know of the issue of drug diversion.
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HIPAA - In some instances of drug diversion, the entirety of a prescription bottle may be taken, prescription orders may have names only partially changed, there may be patient numbers or other potential access to patient-related information which would result in the requirement that the issue be reported to the Office of Civil Rights as a HIPAA violation.
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Tampering - If medication which would have been provided to a patient or was intended for patient use was tampered with, such as the withdrawal of medication from a bag, the scraping of a Fentanyl patch, or the replacement of a pill with an alternate substance, those actions form the basis of a tampering claim which may need to be reported to the Food and Drug Administration. The Food and Drug Administration has specific rules regarding the reporting of tampering which also need to be evaluated in any investigative report.
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Pharmacy Board - Pharmacy Board reporting for these issues is required pursuant to Iowa Law.
Adulterated Drugs Administered
If drug diversion occurs prior to patient access, the factors listed above are of primary consideration for the purposes of mandatory reporting. If a patient has received an adulterated drug, potentially been exposed to a pathogen or has been denied pain relief, additional requirements may apply. If the patient was a dependent adult, dependent adult abuse will need to be reported pursuant to the state statute. If a pediatric patient was involved and that child has been exposed to a pathogen or otherwise been denied critical care which would include the denial of pain relief, the facility is a mandatory reporter of child abuse under Iowa Code Chapter 232.
Long-Term Care
If the issues occur in a long-term care facility, skilled nursing or inpatient long-term care or hospice, the Elder Justice Act, part of the Affordable Care Act of 2010, requires immediate reporting to authorities. Diversion is considered to be exploitation of an elder as defined by the Act. Mandatory reporting under the Elder Justice Act includes reporting to the Department of Inspection and Appeals as well as local law enforcement. In instances of “extreme harm,” which could include unremitting pain, reports pursuant to the Elder Justice Act must be made within two hours, for less extreme cases reports must be made within 24 hours.
Bottom Line
It can be a complicated morass to determine who, what, when, access, and methodology for correcting a drug diversion problem. Working through the basics: a regular and consistent investigative process, creating and documenting an investigative report, and implementing a corrective action plan will help to manage any drug diversion issue.
